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Boxcar Scars Market |Exclusive Report on Latest Trends and Market Growth Opportunities – BioSpace

April 4th, 2021 6:48 am

Boxcar scars are a type of acne scars which look like round, oval depression. As the scars are of different types, for example, based on redness, depth or location, its treatment also varies. Microdermabrasion, Dermabrasion, Fillers, Chemical Peels, Laser Therapy, Microneedling, Punch Excision, and Subcision, are some of the treatments required for treating boxcar scars. As these scars cant go away of their own, People considering the treatment is growing.

Growing Preference for Micro needling and Ablative Lasers

The ablative lasers are considered as the gold standard for treating acne scars, patients have witnessed a 75% improvement in atrophic acne scars at 18 months after this high energy carbon dioxide laser treatment. The technique when used on dark skinned people showed good to excellent results in 74%, however hyper pigmentation was witnessed among 29% of patients. Due to its long time recovery process and various side effects, the ablative lasers have become less popular.

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Of late, microneedling is gaining momentum as they provide the best cosmetic outcomes. Due to its collagen inducing effect, the encouraging results prove that microneedling is an effective and inexpensive method for dealing with boxcar scars. It takes very less time for recovering, a study found that only after 3 treatments, patients can visibly see the positive effect in their scarring and is relatively risk free. Microneedling can be performed with a dermaroller or a microneedling pen. Microneedling involves puncturing the skin multiple times using needles, a tattoo gun or roller. When microneedling is combined with platelet rich plasma or glycolic acid peels, improvement in acne scar improved up to 62%.

Emerging Technologies Can Boost Adoption of Boxcar Scar Treatment

Researchers and scientists are always on the motion of developing and introducing new and more effective treatments for replacing the traditional therapies. For instance, a latest technology for the treatment of scarring is laser speckle contrast imaging (LSCI). LSCI helps in detecting the backscatter which eventually detects the blood flow by illuminating the tissue with its coherent laser light. The technique is relevant for scarring because the healing process of scarring requires adequate tissue perfusion. LSCI can also be used to treat patients with burn wounds as it detects the severity of partial thickness in wounds.

Complications in Laser Therapy

Side effects due to laser therapy such as burns, dyspigmentation and infection may happen after the laser treatment. Laser treatment has a risk of overheating the tissue through excessive heat generation or by a failure of the cooling techniques. The risk of burns is higher for lasers that use a continuous beam. Risk of dyspigmentation is higher in dark skinned or tan individuals. Due to such side effects, the treatment by laser may go back scale. However, latest innovations in the sector may help in mitigating the issue.

Competitive Landscape

The key players in the market include Merz, Inc., Cerave, Lumenis, Enaltus LLC, Scarsheal, Inc., CCA Industries, Proactiv Company, Cynosure, Inc., PCA Skin, Solta Medical, Smith and Nephew plc, Scarheal, Inc., NewMedical Technology, Inc., Bausch Health, Suneva Medical, Inc., Sonoma Pharmaceuticals, Inc., etc.

Latest development by doi.org shows 755nm picosecond Alexandrite laser has been effective in patients with acne scars. In the split face study, people were treated with laser in half of their face and that half showed effective improvement results in Post inflammatory erythema and acne scars. Patients stated that treatment was tolerable, with only mild erythema discovered as a side effect.

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A study reported in the Journal of cosmetic dermatology in February 2020 by Darrow Stem Cell Institute demonstrated that platelet rich plasma shows better response, fewer side effects, and shorter downtime as compared to combined subcision and PRP. The experiment was performed on 45 patients with atrophic acne scars by dividing the group into 3 and giving intradermal injection to first group, chemical reconstruction of skin scars was performed on second group and combined skin needling and PRP was performed on the third group. The third group witness significant improvement without any major side effect thus, reaching to the conclusion that PRP is beneficial for acne scars.

PICOCARE 450 is a US FDA approved machine developed by WonTech for laser skin care treatment. The innovative machine is responsible for treating all skin types, show faster visible results in less sitting. The technology targets only the pigment to be removed and is suitable for treating chickenpox scars, ice pink scars, boxcar scars, acne scars, etc.

Regional Outlook

According to WHO, scars affect almost 80-90% of teenagers in the western world. As per the study by National Library of Medicine, boxcar scars are prevalent and is almost in 54% population as post acne scar. Thus, rising incidences of burn cases and also increasing prevalence of boxcar scar cases is expected to drive the market during the forecast period. According to the survey by Harris Poll around 10 million patients who have had dermal filler have experienced filler treatment a good option, thus, its demand is also one of the factor for the boost of boxcar scar market.

Asia Pacific is also leading market for the boxcar scar treatment. Due to increased incidences of burns in India having a record of 70lakh burn injury cases every year, the adoption of treatment is also expected to surge. Rising awareness about the treatment of scars is yet another factor boosting the growth. Japan in Asian region is an ideal market due to availability of various treatment options owing to the increase in health care expenditure.

UK is a major contributor to the European market. According to British Association of Plastic, rising number of plastic surgery units in UK is fuelling the adoption of large number of incidences. Microneedling as a treatment is escalating in Europe owing to its benefits for skin tightening, better skin texture, scar reduction, improved skin tone, etc. Moreover, growing adoption of anti-ageing procedures, and awareness regarding the treatments is escalating the market further.

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Segmentation

By Treatment Type

By Laser Product

By End-user

By Region

Key Questions Answered

Carbon dioxide and Pulse dyed laser are some of the laser products used for boxcar scar treatment

Proactiv Company, Cynosure, Inc., PCA Skin, Solta Medical, Smith and Nephew plc, Scarheal, Inc., NewMedical Technology, Inc., Bausch Health, etc.

Latest innovations, growing awareness regarding the treatment, and comfortable treatment is giving people the confidence to treat.

US, UK, France, Germany and Italy are some of the largest markets for boxcar scars

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Boxcar Scars Market |Exclusive Report on Latest Trends and Market Growth Opportunities - BioSpace

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Merck Receives Positive EU CHMP Opinion for Updated Label of KEYTRUDA (pembrolizumab) To Include Results of Phase 3 KEYNOTE-361 Trial in Certain Adult…

April 4th, 2021 6:48 am

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that the European label for KEYTRUDA, Mercks anti-PD-1 therapy, be updated to include data from KEYNOTE-361, a Phase 3, open-label trial that evaluated KEYTRUDA as a monotherapy and in combination with chemotherapy for the first-line treatment of certain patients with advanced or metastatic urothelial carcinoma. In Europe, KEYTRUDA is approved for the treatment of adult patients with advanced or metastatic urothelial carcinoma (bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 with a Combined Positive Score (CPS) 10. This approval was based on a single-arm study, KEYNOTE-052; KEYNOTE-361 was conducted as part of a post-marketing commitment following the initial approval of KEYTRUDA for these patients.

As previously announced, KEYNOTE-361 did not meet its primary endpoints of progression-free survival (PFS) and overall survival (OS) for the combination of KEYTRUDA plus chemotherapy. However, the CHMP concluded that the benefit-risk profile remains positive and that including data from KEYNOTE-361 in the label allows physicians to evaluate the potential benefit-risk of KEYTRUDA on an individual basis.

KEYTRUDA has become an important treatment option for certain patients with locally advanced or metastatic bladder cancer in the European Union and other countries around the world, said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. We are pleased with todays positive opinion by the CHMP, which fulfills our post-marketing requirement for KEYTRUDA in these patients in the European Union and will enable continued access for patients in need of another treatment option.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,400 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications in the U.S.

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (CPS 10), as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Triple-Negative Breast Cancer

KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Selected Important Safety Information for KEYTRUDA

Severe and Fatal Immune-Mediated Adverse Reactions

KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.

Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of antiPD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.

Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% of these patients interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Systemic corticosteroids were required in 69% (33/48); additional immunosuppressant therapy was required in 4.2% of patients. Colitis led to permanent discontinuation of KEYTRUDA in 0.5% (15) and withholding in 0.5% (13) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Colitis resolved in 85% of the 48 patients.

Hepatotoxicity and Immune-Mediated Hepatitis

KEYTRUDA as a Single Agent

KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.4%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in 11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% (9) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Hepatitis resolved in 79% of the 19 patients.

KEYTRUDA with Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider monitoring more frequently as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen, which was at a higher frequency compared to KEYTRUDA alone. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. In patients with ALT 3 times upper limit of normal (ULN) (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT 3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. All patients with a recurrence of ALT 3 ULN subsequently recovered from the event.

Immune-Mediated Endocrinopathies

Adrenal Insufficiency

KEYTRUDA can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA depending on severity. Adrenal insufficiency occurred in 0.8% (22/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.3%) reactions. Systemic corticosteroids were required in 77% (17/22) of patients; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.3% (8) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Hypophysitis

KEYTRUDA can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Hypophysitis occurred in 0.6% (17/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.2%) reactions. Systemic corticosteroids were required in 94% (16/17) of patients; of these, the majority remained on systemic corticosteroids. Hypophysitis led to permanent discontinuation of KEYTRUDA in 0.1% (4) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Thyroid Disorders

KEYTRUDA can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Thyroiditis occurred in 0.6% (16/2799) of patients receiving KEYTRUDA, including Grade 2 (0.3%). None discontinued, but KEYTRUDA was withheld in <0.1% (1) of patients.

Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). It led to permanent discontinuation of KEYTRUDA in <0.1% (2) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Hypothyroidism occurred in 8% (237/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (6.2%). It led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.5% (14) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. The majority of patients with hypothyroidism required long-term thyroid hormone replacement. The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC, occurring in 16% of patients receiving KEYTRUDA as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. The incidence of new or worsening hypothyroidism was higher in 389 adult patients with cHL (17%) receiving KEYTRUDA as a single agent, including Grade 1 (6.2%) and Grade 2 (10.8%) hypothyroidism.

Type 1 Diabetes Mellitus (DM), Which Can Present With Diabetic Ketoacidosis

Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold KEYTRUDA depending on severity. Type 1 DM occurred in 0.2% (6/2799) of patients receiving KEYTRUDA. It led to permanent discontinuation in <0.1% (1) and withholding of KEYTRUDA in <0.1% (1). All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Immune-Mediated Nephritis With Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.1%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 89% (8/9) of patients. Nephritis led to permanent discontinuation of KEYTRUDA in 0.1% (3) and withholding in 0.1% (3) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Nephritis resolved in 56% of the 9 patients.

Immune-Mediated Dermatologic Adverse Reactions

KEYTRUDA can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, has occurred with antiPD-1/PD-L1 treatments. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes. Withhold or permanently discontinue KEYTRUDA depending on severity. Immune-mediated dermatologic adverse reactions occurred in 1.4% (38/2799) of patients receiving KEYTRUDA, including Grade 3 (1%) and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 40% (15/38) of patients. These reactions led to permanent discontinuation in 0.1% (2) and withholding of KEYTRUDA in 0.6% (16) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 6% had recurrence. The reactions resolved in 79% of the 38 patients.

Other Immune-Mediated Adverse Reactions

The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received KEYTRUDA or were reported with the use of other antiPD-1/PD-L1 treatments. Severe or fatal cases have been reported for some of these adverse reactions. Cardiac/Vascular: Myocarditis, pericarditis, vasculitis; Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barr syndrome, nerve paresis, autoimmune neuropathy; Ocular: Uveitis, iritis and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss; Gastrointestinal: Pancreatitis, to include increases in serum amylase and lipase levels, gastritis, duodenitis; Musculoskeletal and Connective Tissue: Myositis/polymyositis rhabdomyolysis (and associated sequelae, including renal failure), arthritis (1.5%), polymyalgia rheumatica; Endocrine: Hypoparathyroidism; Hematologic/Immune: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% of 2799 patients receiving KEYTRUDA. Monitor for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion for Grade 1 or Grade 2 reactions. For Grade 3 or Grade 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after antiPD-1/PD-L1 treatment. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute and chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between antiPD-1/PD-L1 treatment and allogeneic HSCT. Follow patients closely for evidence of these complications and intervene promptly. Consider the benefit vs risks of using antiPD-1/PD-L1 treatments prior to or after an allogeneic HSCT.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with an antiPD-1/PD-L1 treatment in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients with advanced NSCLC; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (20%) was fatigue (25%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (20%) were fatigue (33%), constipation (20%), and rash (20%).

In KEYNOTE-048, when KEYTRUDA was administered in combination with platinum (cisplatin or carboplatin) and FU chemotherapy, KEYTRUDA was discontinued due to adverse reactions in 16% of 276 patients with HNSCC. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). The most common adverse reactions (20%) were nausea (51%), fatigue (49%), constipation (37%), vomiting (32%), mucosal inflammation (31%), diarrhea (29%), decreased appetite (29%), stomatitis (26%), and cough (22%).

In KEYNOTE-012, KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. The most common adverse reactions (20%) were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of facial edema and new or worsening hypothyroidism.

Link:
Merck Receives Positive EU CHMP Opinion for Updated Label of KEYTRUDA (pembrolizumab) To Include Results of Phase 3 KEYNOTE-361 Trial in Certain Adult...

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BeyondSpring Announces Submission of New Drug Application to US FDA and China NMPA for Plinabulin and G-CSF Combination for the Prevention of…

April 4th, 2021 6:48 am

NEW YORK, March 31, 2021 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (the Company or BeyondSpring) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and the China National Medical Products Administration (NMPA) for use of plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia (CIN). Plinabulin in combination with a G-CSF therapy, which received breakthrough therapy designation from the U.S. FDA and the China NMPA for concurrent administration with myelosuppressive chemotherapeutic regimens in patients with non-myeloid malignancies for the prevention of CIN, has the potential to raise the standard of care in CIN for the first time in 30 years.

CIN remains a severely unmet medical need. Treatment or prevention of CIN with G-CSF has been the standard of care since Neupogen was approved in 1991. The main benefit of G-CSF treatment, however, is in Week 2 after chemotherapy. Week 1 after chemotherapy is considered the neutropenia vulnerability gap where over 75% of CIN-related clinical complications occur, including febrile neutropenia, infection, hospitalization and death. Plinabulin is the first agent seeking FDA approval that has the potential to fill this gap by working in Week 1 to prevent the onset and progression of CIN. Therefore, combining plinabulin and G-CSF may maximize the protection of patients for the full cycle of chemotherapy, as demonstrated in the PROTECTIVE-2 Phase 3 registration study.

CIN is a major concern for physicians and their patients undergoing cancer treatment. Plinabulin provides benefits above and beyond what is currently available on the market and has the potential to be a game-changer for patients undergoing chemotherapy treatment, said Dr. Douglas Blayney, Professor of Medicine at Stanford University Medical School and global PI for CIN studies. CIN, which can lead to life-threatening infections, is the number one reason for the 4Ds in chemotherapy (Decrease, Delay and Discontinue dose and Downgrade regimen). We hope plinabulin will allow patients to better tolerate chemotherapy, thus enabling patients to stick to their optimal treatment plan and avoid serious CIN complications.

The NDA submission is based on positive data from BeyondSprings PROTECTIVE-2 Phase 3 registration study which showed that plinabulin in combination with pegfilgrastim demonstrated superior CIN prevention benefit, compared to pegfilgrastim alone. The study met the primary endpoint, with a statistically significant improvement in the rate of prevention of grade 4 neutropenia (improved from 13.6% to 31.5%, p=0.0015) and met all key secondary endpoints, including duration of severe neutropenia (DSN) and absolute neutrophil count (ANC) nadir. In addition, the combination reduced clinical complications such as incidence and severity of febrile neutropenia (FN) and incidence and duration of hospitalization for FN patients. The combination is well tolerated, with an over 20% reduction of grade 4 Treatment-Emergent Adverse Events (TEAE) in the combination compared to that of pegfilgrastim alone. The NDA submissions will include five supportive trials that show consistent CIN prevention in various chemotherapy regimens and cancers in over 1,200 patients.

This NDA submission is the culmination of years of research to prove that plinabulin can improve the long-established standard of care and address an unmet medical need to further alleviate the risk burden of CIN for patients receiving chemotherapy, said Dr. Lan Huang, co-founder, CEO, and chairman of BeyondSpring. With CIN responsible for potentially delaying treatment and causing life-threatening infections, we hope that receiving the improved care represented by the plinabulin and G-CSF combination will allow patients to better tolerate chemotherapy and potentially see increased treatment success rates. We are grateful for the patients participation in plinabulins clinical trials and the participation and contributions of our investigators and our many other clinical partners.

Each year in the U.S., 110,000 patients receiving chemotherapy are hospitalized after developing CIN, a severe side effect that increases the risk of infection with fever (also called febrile neutropenia, or FN), which necessitates ER/hospital visits. Due to the COVID-19 pandemic, the updated National Comprehensive Cancer Network (NCCN) guidelines expanded the use of prophylactic G-CSFs, including pegfilgrastim, from high-risk patients only (chemo FN rate >20%), to include intermediate-risk patients (FN rate between 10-20%), to reduce the number of hospital/ER visits related to CIN. The revision of the NCCN guidelines effectively increases the addressable market of patients who may benefit from treatment with plinabulin, if approved, to approximately 440,000 cancer patients in the U.S. annually.

There is a large unmet medical need and a growing market for CIN prevention and treatment in China as well. According to Lancet Oncology, 60% of East Asia cancer patients are treated with chemotherapy1. In 2020, there were 4.6 million new cancer patients in China which could correspond to 2.8 million patients using chemotherapy and needing CIN prevention agents. According to IQVIA data, the G-CSF drug market (for CIN treatment) in China is growing at over 30% a year.

About PROTECTIVE-2 (Study 106) Phase 3 Registration Study The Phase 3 portion of PROTECTIVE-2 was a double-blind and active-controlled global registration study. It was designed as a superiority study to compare the safety and efficacy of plinabulin (40 mg, Day 1 dose) + pegfilgrastim (6 mg, Day 2 dose) versus a single dose of pegfilgrastim (6 mg, Day 2 dose) in patients with breast cancer, treated with docetaxel, doxorubicin and cyclophosphamide (TAC, Day 1 dose) in a 21-day cycle. TAC is an example of high FN risk chemotherapy and is the regimen used in all G-CSF biosimilar registration studies.

The primary endpoint was the rate of prevention of Grade 4 neutropenia and secondary endpoints included DSN and mean ANC nadir in Cycle 1. Literature shows that despite the use of pegfilgrastim, 83 to 93 percent of patients treated with TAC still suffer Grade 4 neutropenia (or rate of Grade 4 neutropenia prevention at 7-17%), which demonstrates the severe unmet medical need for improved treatment2,3.

The ANC data, which are used to calculate these endpoints, were obtained through central laboratory assessments by Covance Bioanalytical Methods using standardized and validated analytical tests. Covance was the clinical contract research organization (CRO) for patient recruitment and monitoring of global sites for this study.

About CINChemotherapy-induced neutropenia (CIN) is the primary dose-limiting toxicity in cancer patients who receive chemotherapy and is the primary cause for the 4Ds (Decrease, Delay, Discontinue dose and Downgrade regimen). The 4Ds lead to a decrease of the anti-cancer benefit of chemotherapy, e.g., >15% of dose reduction correlated to >50% survival reduction4. The National Comprehensive Cancer Network (NCCN) recently updated its treatment guidelines for CIN prophylaxis using G-CSFs to include both high- and intermediate-FN risk patients treated with chemotherapies, to preserve hospital and ER resources for COVID-19 patients, and to maximize protection from CIN. The NCCNs action effectively doubled the number of patients recommended to receive CIN prophylaxis.

About PlinabulinPlinabulin, BeyondSprings lead asset, is a selective immune-modulating microtubule-binding agent (SIMBA). A global Phase 3 clinical trial in CIN (PROTECTIVE-2) with plinabulin in combination with pegfilgrastim versus pegfilgrastim alone has been completed and is the basis for an NDA filing in the U.S. and China for the prevention of CIN. In this trial, plinabulin reduced the neutropenia vulnerability gap associated with G-CSF therapy alone. Additionally, a global Phase 3 study for the treatment of later-stage NSCLC in EGFR wild-type patients (DUBLIN-3) is now fully enrolled and will evaluate the combination of plinabulin and docetaxel versus docetaxel alone for overall survival in NSCLC patients. Plinabulin triggers the release of the immune defense protein, GEF-H1, which leads to two distinct effects: first is a durable anticancer benefit due to the maturation of dendritic cells resulting in the activation of tumor antigen-specific T-cells to target cancer cells5,6 and the second is early-onset action in CIN prevention after chemotherapy by boosting the number of hematopoietic stem/progenitor cells (HSPCs)7. Effects on HSPCs could explain the potential for plinabulin not only to prevent CIN but also to increase circulating CD34+ cells in patients. As a pipeline in a drug, plinabulin is being broadly studied in combination with various immuno-oncology agents that could boost the effects of the PD-1 / PD-L1 antibodies.

About BeyondSpringHeadquartered in New York City, BeyondSpring is a global biopharmaceutical company focused on developing innovative immuno-oncology cancer therapies to improve clinical outcomes for patients who have high unmet medical needs. BeyondSprings first-in-class lead asset plinabulin is a pipeline in a drug. It is filed for approval in the US and China for the prevention of chemotherapy-induced neutropenia (CIN) and has a fully enrolled pivotal study to test an anti-cancer benefit with an overall survival primary endpoint in non-small cell lung cancer (NSCLC). Additionally, it is being broadly studied in combination with various immuno-oncology agents that could boost the effects of PD-1 / PD-L1 antibodies. In addition to plinabulin, BeyondSprings extensive pipeline includes three pre-clinical immuno-oncology assets and a subsidiary, SEED Therapeutics, which is leveraging a proprietary targeted protein degradation drug discovery platform.

References:

Investor Contact:Ashley R. RobinsonLifeSci Advisors, LLC+1 617-430-7577arr@lifesciadvisors.com

Media Contact:Darren Opland, Ph.D.LifeSci Communications+1 646-627-8387darren@lifescicomms.com

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Oxford’s Genomics Pushing the Boundaries of Personalized Medicine – BioSpace

April 4th, 2021 6:47 am

Its something of the holy grailrun whole genome sequencing on a sample of a persons blood and identify their risk for disease, all quickly and affordably. Oxford, Englands Genomics, founded in 2014 out of Oxford University by Sir Peter Donnelly, may be getting close.

The company is launching a trial in a new NHS pilot project with 1,000 volunteers, focusing on heart disease. It also plans to begin a similar trial in Stanford Hospitals in California with about 5,000 patients between the ages of 40 and 60 starting this summer.

If effective, it would be able to help people in their 40s or 50s determine the likelihood of their developing heart disease. This would allow physicians to help patients make the appropriate lifestyle changes and begin taking necessary drugs, such as statins.

The volunteers in the studies will donate a blood sample and the Genomics technology platform leverages an algorithm to analyze their genetic patterns. Some of those patterns have been associated with an increased risk of heart attack later in life, even if they currently have no symptoms. They will then be given a personal polygenic risk score (PRS), which can be used alongside a clinical risk prediction tool that the NHS is already using, that takes into consideration things like BMI and cholesterol levels.

This is yet another example of the NHS leading the world with this trial, Donnelly told the Evening Standard. This is cutting edge [tech]. It is about getting it into healthcare now and increasing focus on prevention.

Although these studies are focusing on heart disease, the companys technology is also focused on a range of genetic patterns associated with other diseases, such as cancer and multiple sclerosis. Donnelly even thinks its possible that eventually it will be used to evaluate people in their 20s and 30s for diseases that are more commonly developed earlier, such as auto-immune diseases.

Of course, some people may not want to know.

I understand why someone would be a bit worried, Donnelly said. It is important to say that these are just risk factors. If you have a high PRS score for heart disease, you are around four to five times more likely to get it. Its not that genetics determine the outcome, it is a risk factor. In all cases, there are things you can do [to help prevent disease]. You can be more vigilant, you can have medical interventions. That is important to understand.

On March 1, Genomics completed a $30 million funding round, with investments from Foresite Capital and F-Prime Capital, joined by existing backers Oxford Sciences Innovation and Lansdowne Partners. The company plans to use the monies to expand its work building its health platform.

Jim Tananbaum, chief executive officer of Foresite Capital, stated, Genomics plc plays a key role in transforming how we understand and deliver precision medicine at scale. We are excited to support this talented management team as the company embarks on its next growth phase.

Stephen Knight, president and managing partner of F-Prime Capital, noted, The convergence of data sciences with life sciences is one of the most exciting areas in healthcare today and we see Genomics plc as a clear leader in that field. The companys proprietary research platform powered by a large dataset of genotypic and phenotypic information, combined with the leading statistical genomics team in the world, delivers unique insights in the discovery of new therapeutic targets as well as key advancements in preventative healthcare.

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Personalized medicine is the future of health care for troops, advocates say – Military Times

April 4th, 2021 6:47 am

Master Sgt. Geoff Dardia was nearly a decade into his Special Forces career when he says he hit a wall. He was struggling both mentally and physically to keep doing his job and couldnt explain why.

All of the sudden, I was just a shell of a person like everything you hear about feeling like youre dragging a dead body and losing your zest for life, Dardia said.

Plagued by severe migraines, fatigue and issues with his balance and vision, Dardia, now 44, sought help.

His superiors told him to visit a military behavioral health specialist and be treated for PTSD or depression, but Dardia was convinced his ailments were more than just psychological. So, he did what any good Green Beret would do and applied his training to research, analyze and attack the problem condition.

Following the steps of the military decision-making process, Dardia learned everything he could about his operational environment and the various ways it could affect him.

Traumatic brain injuries, toxic exposure to heavy metals and carcinogens, traumatic stress and sleep deprivation are unfortunately common occurrences for members of the special operations community.

After identifying the underlying causes for his symptoms, Dardia began planning a course of responsive action. The process was so simple, straightforward, and guided by existing military doctrine that it led him to question the Armys current approach to health care.

I was like, This is so easy. Why wouldnt we do this with health and wellness and medicine? Dardia said.

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At its core, thats what functional medicine is all about: finding and treating underlying causes of illness or pain. The Institute for Functional Medicine defines it as a systems biology-based approach that focuses on identifying and addressing the root cause of disease.

Also referred to as personalized, performance or lifestyle medicine, the approach is grounded in a philosophy of caring for a whole person made up of interconnected parts.

Its what Dardia and health care professionals spoke about on March 25 at the Warfighter Health Symposium in Tampa, Florida. Hosted by non-profits Task Force Dagger Special Operations Foundation and HunterSeven, the event served to informally educate active duty servicemembers, medical providers and veterans about the current issues and solutions in military health care. There were 50 people the maximum allowed under COVID-19 restrictions who attended.

After personally experiencing the difficulty of receiving holistic treatment, Dardia began making the changes he wanted to see. In 2012, when TFDSOF helped him through his personal health struggles, Dardia decided to give back by founding the organizations Health Initiative Program.

The program provides pathways and funding assistance for members of the military to seek treatment from outside health care providers and institutions in the field of personalized medicine.

Partnering with organizations like the Cleveland Clinic Center for Functional Medicine and becoming involved with active-duty health initiatives in the 3rd Special Forces Group, Dardia has been raising awareness of the power of preventative and holistic medicine for the better part of a decade now.

According to Dardia, the militarys current approach to health care is too reactive. Service members are treated for cancer or suicidal ideations or organ failures when such issues could have been prevented with proper countermeasures and education about their causes years earlier.

Just because you have mental health symptoms, doesnt mean mental illness is the cause, said Dr. Carrie Elk, founder of the Elk Institute for Psychological Health & Performance, a non-profit established to provide mental health education and treatment to servicemembers.

Elk has worked with SOCOM and the SOF community to treat operators for the underlying cause of post-traumatic stress disorder since 2010, when she first spoke at the Joint Special Operations Forces Senior Enlisted Academy on how PTSD works. Her practice now reaches both operators and members of the general military community.

They were applying the same stuff they used for mental illness to PTSD, but the problem is just the way the information is stored, said Elk. The audience was stunned by Elks presentation, and special operations personnel began filling the waiting room of her practice.

In just two hours of therapy, the doctor says, shes able to correct the storage of a traumatic memory.

In traumatic situations, according to Elk, memories are stored as sensory experiences. When servicemembers return home from traumatic environments, triggers like smells and sounds can bring them right back to places of anger, agitation, depression and anxiety.

Health care providers treating symptoms of depression and anxiety with prescription medications ignore the real problems at hand, according to Elk.

Were putting a Band-Aid on a bullet hole or at least trying to, said Elk. Youre not fixing the cause, youre just managing symptoms when you dont have to.

Functional approaches like Elks are growing in popularity. The Army adopted a section on holistic health in its updated physical fitness doctrine in September 2020 a combination of its previous initiatives like the Performance Triad and Army Wellness Centers.

The Holistic Health and Fitness program, or H2F, is the framework to encompass all aspects of human performance to include physical, sleep, nutritional, spiritual, and mental fitness, said Maj. Gen. Lonnie G. Hibbard, commander of the U.S. Army Center for Initial Military Training in a press release.

The Department of Veterans Affairs has introduced similar programming aimed at addressing the causes of illness rather than symptoms.

The biggest thing is awareness and education and advocacy, said Dardia. The earlier servicemembers can learn to prevent toxic exposure and recover from stress and sleep deprivation, the healthier theyll be in the long term.

Now the operations sergeant for 3SFGs Human Performance and Wellness program and the Medical Education Transition Advocacy and Assistance program, Dardia is focused on bringing personalized medicine programming to other Special Forces groups, veterans and units across the military.

At Thursdays symposium, Dardia spoke on functional, performance medicine alongside health care professionals from the HunterSeven Foundation.

Members of SOCOMs medical staff attended the three-hour conference in personal capacity, but SOCOM did not officially participate, according to a spokesperson.

Our main focus is research and education, given that we are medical experts with advanced clinical licenses and degrees, said Chelsea Poisson, an Army veteran, emergency nurse and clinical researcher with HunterSeven. The attendees were extremely receptive, I had many questions from members across all communities on resources and what to do next.

In addition to working with members of Congress to give suggestions and solutions to military health care legislature, HunterSeven provides TFDSOF with access to its extensive research on veterans health care issues.

HunterSeven is working on legislation and research to get laws passed that provide our people with better access to health care quicker, said Dardia. Theyre optimizing systems already in place, whether thats in the DoD or at the VA.

As functional, lifestyle-based medicine is adopted across the military, Dardia hopes to work himself out of a job. In years to come, the Green Beret hopes to begin correcting the problem of reactive health care in the civilian population, educating young people about disease prevention and holistic medicine.

We want to advocate this not just for military personnel and veterans; this applies to everybody, said Dardia. This isnt unique to the military. Cancer and suicide are rampant in the civilian population as well, and for the same reasons.

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Precigen CEO Envisions a Transformative 2021 with Precision Medicine Therapy – BioSpace

April 4th, 2021 6:47 am

Precigen Chief Executive Officer Helen Sabzevari pictured above.

The year 2020 and the COVID-19 pandemic created a number of challenges for individuals and companies. Despitethese hurdles, Maryland-based Precigen still managed to achieve its clinical milestones in oncology.

The company is advancing its UltraCAR-T cell therapy approach to treating cancer that Chief Executive Officer Helen Sabzevari believes will be transformative to the personalized cell therapy landscape for cancer patients.

This is what precision medicine in the twenty-first century should look like, Sabzevari told BioSpace in an interview.

Sabzevari joined Precigen in 2017after undergoing a rebranding effort that included a name change from Intrexon Corporation, as well as the divestiture of non-healthcare assets, such as AgBiotech and Intrexon Produce Holdings. The company now focuses on the development of next-generation gene and cell therapies that have potential to change the treatment paradigm in immuno-oncology, autoimmune disorders and infectious diseases.

While there are multiple companies pursuing programs of these types, Sabzevari said Precigen can differentiate itself through a unique precision medicine approach that could simultaneously impact different types of genetic expressions on cancer cells, both hematological and solid tumors. Additionally, Precigen believes its UltraCAR-T immunotherapies can be developed with fewer toxicity issues and manufactured at a lower cost than currently available CAR-T treatments.

She added the company has the most differentiated platform in cell and gene therapy compared to other companies in the space.

The company is developing two UltraCAR-T platforms. The first, PRGN-3005 UltraCAR-T, is a first-in-class investigational therapy currently being assessed in a Phase I/Ibclinical study for the treatment of advanced, recurrent platinum resistant ovarian, fallopian tube or primary peritoneal cancer.

In December, Precigen reported preliminary data from the study that showed a favorable safety profile with no dose-limiting toxicities (DLTs), neurotoxicity or cytokine release syndromes. What may be most important of all, Sabzevari said the study showed the UltraCAR-T treatment generated expansion and persistence after low dose IP infusion without lymphodepletion.

Precigen intends to begin a dose expansion of this study in the second half of the year. For the first time, Sabzevari said, they were able to show clinical efficacy in a solid tumor. Approximately 50% of patients showed a decrease in tumor lesions.

Precigen is also developing PRGN-3006 UltraCAR-T, a first-in-class investigational therapy currently under clinical evaluation in a Phase I/Ibstudyfor the treatment of patients with relapsed or refractory (r/r) acute myeloid leukemia (AML) or higher-risk myelodysplastic syndromes (MDS).

Preliminary Phase I data reported in December showed a favorable safety profile with no DLTs or neurotoxicity. Encouraging expansion and persistence of PRGN-3006 UltraCAR-T was observed in both lymphodepletion and non-lymphodepletion cohorts and across all dose levels. PRGN-3006 treatment indicated clinical activity as evidenced by reduction in AML tumor blast levels, the company said. Data from the PRGN-3006 study also revealed that UltraCAR-T cells persisted for more than seven months after a very low dose of 24 million total UltraCAR-T cells in a patient. Sabzevari said this highlights the difference between Precigens UltraCAR-Ts and other CAR-T programs, which introduce hundreds of millions of CARs in to patients during an infusion. Those CARs also have a shorter life than the Precigen assets, which means they can have a sustainable impact on cancer.

Following the revelation of the preliminary data, the U.S. Food and Drug Administration awarded PRGN-3006 with Orphan Drug Designation for AML.

While CAR-T therapies are not yet considered front-line defenses in cancer, Sabzevari predicted that cell and gene therapies will eventually move to first-line options.

Checkpoint inhibitors have become frontline therapies and thats the vision for CAR-T and cell therapies, she said.

Sabzevari likened the possibilities of Precigens UltraCAR-T therapies to antibiotics. If a doctor prescribes one and it does not produce the desired therapeutic effect, there will be another type available from the companys library that could treat the cancer.

If one target, for whatever reason isnt sufficient, you can switch overnight to change it with another. In our vision, a patient can come in and an oncologist could identify the indication of the cancer through screening, order a treatment from our UltraCar-T library and get it done, infuse the patient, Sabzevari said.

Because of the potential Precigens UltraCAR-T program has in oncology, Sabzevari believes the companys stock is significantly undervalued. In January, Precigenraised about $130 million. She believes the stock could go much higher and noted that Precigens market cap has tripled in the past year.

2021 promises to be another transformative year for our company with important data readouts and trial initiations anticipated for our key programs. We have a very good stretch of growth in front of us, Sabzevari said.

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Precigen CEO Envisions a Transformative 2021 with Precision Medicine Therapy - BioSpace

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What Are the Evolving Opportunities for the Players in the Precision Medicine Market? The Courier – The Courier

April 4th, 2021 6:47 am

According to P&S Intelligence, the precision medicine market generated $203.5 billion in 2019 and it is expected to reach $738.8 billion by 2030, progressing at a CAGR of 12.1% during the forecast period (20202030). This growth can be driven by the rising government support, escalating awareness regarding personalized treatments, rising number of approved personalized medications, increasing use of artificial intelligence (AI) in clinical trials related to precision medications, surging number of regulatory approvals, soaring cases of chronic and genetic diseases, and flourishing medical tourism industry.

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Governments across the globe are taking several initiatives to develop personalized treatment, thereby, playing a vital role in the precision medicine market growth. According to the World Economic Forum, Argentina introduced a Precision Medicine Initiative Grant, in 2017, to start the scientific procedures needed to introduce investigational precision medicine approaches into clinical practices. Similarly, the U.S. administration under its Personalized Medicine Coalition announced its plan, in July 2019, to bring down the costs of drugs in the country, to make them comparable with international rates.

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Globally, the North America held the largest share in 2019, and it is expected to continue its dominance during the forecast period. This is due to the rising incidence of lifestyle-associated and chronic diseases, like CVDs and diabetes, burgeoning healthcare spending, and increasing number of government initiatives in the form of awareness programs and funding for precision medicine. Whereas, the Asia-Pacific (APAC) market will register the highest growth in the forecast years, owing to the increasing healthcare expenditure, presence of players developing precision medicines, and growing awareness about these medicines.

Thus, the rising frequency of critical trials and the magnifying government support will propel the market growth in the coming years.

This study covers

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What Are the Evolving Opportunities for the Players in the Precision Medicine Market? The Courier - The Courier

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Global Nanomaterials in Personalized Medicine Market 2021 by Manufacturers, Regions, Type and Application, Forecast to 2026 The Bisouv Network – The…

April 4th, 2021 6:47 am

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Global Nanomaterials in Personalized Medicine Market 2021 by Manufacturers, Regions, Type and Application, Forecast to 2026 The Bisouv Network - The...

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How COVID-19 Will Help Denver Doctors Revolutionize Health Care – 5280 | The Denver Magazine

April 4th, 2021 6:47 am

The COVID-19 pandemic has spawned collaborations in the Denver medical community that could help usher in a new golden age of medicine.

As the medical director of the Medical Intensive Care Unit at Denver Health, Dr. Ivor Douglas knows better than most how devastating a toll COVID-19 has taken. Weve lost 400,000 people, which is as many Americans as were lost in the Second World War, he says. (The number topped 520,000 in early March.) And weve done it in a year.

At the same time, Douglas understands that the unwelcome arrival of the novel coronavirus presents an opportunity to advance health care at an unprecedented rate. Absolutely its going to have long-term effects on human health and scientific discovery, Douglas says. He believes such rapid progress will occur because, well, hes seen it happen.

For about 20 years, Denver Health has been treating acute respiratory distress syndrome (ARDS)when fluid builds up in the tiny air sacs in the lungs, limiting the air they can holdby rotating ventilated patients from lying on their backs to the prone position, on their stomachs, for prolonged periods of time. Although the practice seems counterintuitive (doesnt breathing on your stomach appear constrictive?), Denver Health and other hospitals believed the practice increased oxygen levels while decreasing ventilator-induced lung injuries. But because there hadnt been a consensus on the effectiveness of the procedure, and its cumbersome to move intubated patients from supine to prone (three to six people are required), few hospitals regularly performed the technique.

Then COVID-19 began causing ARDS in severe cases. A number of studies promptly affirmed that proning such patients was a potentially life-saving decision. Further, research co-authored by Douglas lent credence to the safety of prolonged proning, in which patients remain in the position for days at a timemore than 20 in some cases. Once the pandemic is over, doctors around the world will use that information to treat people suffering from ARDS caused by bacterial pneumonia or viral influenza.

Similar COVID-19-spawned symbioses are not rare in Colorado. Rival health systems have banded together; thousands of patients have donated their DNA to scientific research; and specialists have rebuilt relationships with community doctors. While the trauma of COVID-19 will endure for years, its lessons could inspire benefits that last for generations.

When confusion reigned, Colorados largest health care providers united to chart a course through the pandemic.

When COVID-19 first arrived in the United States, the Centers for Disease Control and Prevention advised that Americans who werent sick didnt need to wear masks. Back then, even experts didnt understand the best ways to combat the disease. No one knew what was going on, says Dr. JP Valin, chief clinical officer at SCL Health, and that includes the health care providers of Colorados seven largest hospital networks. So we just said, Lets work on this together, Valin says. Physician executives of SCL Health, UCHealth, HealthOne, Centura Health, Denver Health, Boulder Community Health, and Banner Health began meeting virtually every weekday (and some weekends) to share data, discuss best practices, and manage the local distribution of personal protective equipment. By the end of July, the networks had collaboratively cared for 98 percent of the COVID-19-related hospitalizations in Colorado, and according to a study about the partnership published in the New England Journal of Medicine Catalyst, they boasted lower mortality, lengths of stay, and mechanical ventilation rates than the national averages. The collaboration later became a model for other states. We cant lose this after the fact, Valin says. This is something special, and weve done some really cool things.

How the rival networks worked together to ensure Coloradans got the care they needed during COVID-19.Back to Top

Perspective: Before the state instituted a COVID-19 tracking system, the partnership recognized early outbreaks. In March and April 2020, Banner began seeing a spike in positive tests in Weld County. When UCHealths hospitals in Weld reported a similar flare-up, they traced the surge to patients employer: the JBS USA Greeley beef plant. The group notified the state and county, which closed the plant (although a Denver Post story questioned the speed with which Weld responded).

Patient advocacy: Many hospitals and clinics in rural areas are affiliated with a larger providerbut some are not, and more than 60 percent of U.S. rural hospitals dont have a single ICU bed. So the collaborative worked through the Colorado Hospital Association to set up partnerships between rural hospitals and larger ones. The relationships included dispensing advice and accepting patients if they required emergency care. In 48 hours, Valin says, we were able to quell a lot of unease in rural areas.

Partnership: When hospitals were allowed to perform elective surgeries again in late April, SCL Health developed an algorithm to assess the health of incoming patients, and it shared this with the other systems. So every patient in the state of Colorado who was getting an elective procedure followed that exact same protocol, Valin says, rather than patients and doctors being confused [about precautions], or one hospital being safer than another. We wanted there to be confidence in all of us.

Peer support: An unexpected benefit of the partnership was the partnership itself. Physician executives are often isolated from their peers (both from other doctors and other C-suite suits). Through working with execs at other systems, they enjoyed support, workforce development ideas, and, in late August, a happy hour. We went to the Lowry Beer Garden, where its all these picnic tables, Valin says. There was a lot of trust generated very quickly because we could say, Were doing the right thing.

Childrens Hospital Colorados virtual town halls became a must-listen for a pediatric community that needed healing.Back to Top

For most of Childrens Hospital Colorados 113 years, community doctors tended to the facilitys patients. But as the economics of medicine changed, fewer physicians could afford to leave their practices to spend time at the hospital. Specialists became primary caregivers for inpatients. As a result, says Dr. David Brumbaugh, chief medical officer of Childrens, the hospitals relationship with the local pediatric community grew distant. Then COVID-19 struck. To help terrified local doctors who needed concrete answers, Childrens began hosting virtual town halls. Eventually, about 500 providers began tuning in on Thursday nights to listen to Childrens docs review the latest science. The fringe benefit: The town halls began to rebuild the connection between the hospital and community providers. We spoke with some of Childrens most avid weekly audience members to hear how.

Dr. David Brooks | Valley View Hospital, Glenwood SpringsWe reached out to Dr. Sean OLeary [a pediatric infectious disease specialist at Childrens] and he presented a Zoom conference [on virtual learning] to about 200 people in the Roaring Fork Valley. After that, pediatricians here helped re-establish in-person learning. Im not sure we would have progressed to that point without the town halls.

Dr. Sharisse Arnold Rehring | Kaiser Permanente, DenverI think I personally received several face shields from Childrens in the mail because I didnt have any, and I wasnt sure we were going to get them at Kaiser Permanente. We did, but Childrens Hospital didnt ask any questions except, Whats your address?

Dr. Sharon Sagel | Southeast Denver PediatricsAt the beginning you felt like this very small fish in this really big pond. How do we practice? We felt like we were reinventing the wheel every day. And then all of a sudden youre connected to a whole community of pediatricians who are all in the same situation. I dont know what the future will look like, but I think there is this sense that were all better when we work together.

Dr. Matt Dorighi | Cherry Creek PediatricsThese town halls have certainly created the environment where you have that confidence to do new things, like telehealth. Its such a great format for getting information on new ideas. Itll be interesting to see what topics they shift to after the pandemic. But its been a really efficient way to affect change in the community.

Thanks to the telehealth boom, UCHealths Biobank connected with more patients than ever.Back to Top

Personalized medicinealso called precision or individualized medicinetailors treatment to the specific indicators locked away in our unique DNA (and other molecules). The discipline could help improve the outcomes of pharmacology and even predict future diseases, such as breast cancer, based on cellular variances. In order for personalized medicine to work, however, it needs data. Lots of data. The more DNA collected, the more connections that can be made. The University of Colorado Anschutz Medical Campus Colorado Center for Personalized Medicine launched its Biobank in 2016 to become the repository of such info for UCHealth. It has since signed up more than 173,000 patientsbut owes its biggest surge in outreach to COVID-19.

Biobank asks UCHealth patients to participate through the systems online patient portal, My Health Connection. Before the pandemic, though, fewer than half of the networks patients used the portal to, say, schedule appointments. When the pandemic forced UCHealth to switch primarily to telehealth visits, patients were suddenly required to use their portalsand, thus, interact with the Biobank consent form. Weve actually been able to reach out to more potential volunteers for the Biobank than we ever could have done before, says Kathleen Barnes, director of the center. Which means a global pandemic could play a part in helping make Coloradans healthier than theyve ever been before.

The pandemic has felt particularly isolating to new parents. Maybe thats not such a bad thing.Back to Top

In August 2020, three months before she was due, Aliesa Pope-Hodge gave birth to her second son, Reign, at the Medical Center of Aurora. Weighing one pound and eight ounces, Reign was immediately placed on a ventilation system that filled his underdeveloped lungs with about 360 breaths per minute. He looked like he was vibrating, Pope-Hodge says. She estimates she got to see Reign for 20 seconds before hospital staff ushered the baby into an ambulance for the 10-mile trip to Presbyterian/St. Lukes (PSL) Medical Centers newborn intensive care unit (NICU), a Denver facility qualified to serve the most acutely ill infants.

There, Pope-Hodge and her husband, Diamond Taylor, donned masks, scrubbed and washed their hands, and were screened for fevers every time they visited Reign. Neither family nor friends were allowed to join them. But the restrictions were nothing compared to Pope-Hodges own feelings of separation. While practicing skin-to-skin contact to encourage bonding between mother and child, Reign would often cry. His heart rate and oxygen levels would dropa common occurrence for preemies experiencing touch for the first timeand alarms would shriek. I felt scared to touch him, Pope-Hodge says. Like I was going to hurt him. Maybe I stress him out? I felt detached from Reign for a very long time.

Detachment might be the official emotion of the pandemicparticularly for new parents. Even though nascent research suggests COVID-19 is uncommon in newborns, even among those with COVID-19-positive mothers, most local hospitals and birthing centers have restricted access during birth to the parents (or mom and one support person, such as a doula). Once a baby heads home, many doctors recommend limiting visitation there as well.

While this has thwarted the ambitions of cheek-pinching grandparents, seclusion hasnt been all bad for parents. You arent trying to cater to extended family and keep them updated, says Dr. Anna Zimmermann, a neonatologist at PSLs Rocky Mountain Hospital for Children. It pares the experience down to the parents and allows them to just get to know their baby.

Research on the benefits of pandemic-induced alone time is minimal so far, but one study did test its impact on familial bonds. During April 2020, 70 pregnant women in Ireland participated in a survey that sought to quantify the emotional effects of social distancing. Of those whose relationships with their partners had not deteriorated (only three had), 34.3 percent said theyd grown closer, 28.4 percent said they talked more, and 20.9 reported exercising together.

Pope-Hodge and Taylor finally brought a five-pound Reign home from PSL in November and promptly barred visitorsa difficult decree considering they live with Taylors mother. She held him on Christmas, Pope-Hodge says. Other than that, she hasnt touched him, which is really hard for her. She feels stripped of the gift of being a grandmother.

The isolation, though, has allowed Pope-Hodge to form a connection with Reign that she never imagined possible at the NICU. [Our eldest son] King had his grandma and his aunties, and everyone else around him that gave him love, Pope-Hodge says. With Reign, I feel proud that I am, with Diamond, the ones who are taking care of him. Everything that he gets is from me. I feel really proud of that.

Confronting the connections between public health and health care in our local communities.Back to Top

More than any other disease, COVID-19 has drawn attention to the tether between social ills and physical illness. The pandemic has just brought it to the fore in ways that, frankly, diabetes didnt, kidney disease didnt, [and] high blood pressure didnt, says Dr. Jandel Allen-Davis, the president and CEO of Craig Hospital in Englewood. To illustrate the connection between COVID-19 and public health issues, Colorado Health Institute (CHI), a Denver-based public health advocacy group, created a Social Distancing Index (SDI). CHI gave each Colorado census tract a score from one to 10 based on its comparison to other tracts in the state in three areas: population density, overcrowded housing, and proportion of essential workers. The index is the average of a tracts three scores. The higher the score, the more vulnerable a tracts population is to the spread of COVID-19and, as noted below, a range of social inequities.

College ViewMore than 40 percent of children under 18 in College View live in poverty, compared to 18 percent countywide.

WestwoodThe four U.S. census tracts that make up the Westwood neighborhood are all at least 80 percent populated by people of color.

HilltopThe wealthiest tract in Denver County is in the Hilltop neighborhood (median household income: $209,000). It is 86.6 percent white.

MontbelloThis tract in the Montbello neighborhood is one of the 25 USDA-identified food deserts in Denver County, all but six of which have SDIs above the county median of 3.1.

East ColfaxAccording to the U.S. Department of Housing and Urban Development, the percentage of low- to moderate-income residents (those who earn less than 80 percent of the metro area median income) in this part of East Colfax ranges from 61.2 to 87.7 percent.

WindsorThe per capita income in this tract is $26,341, about three-fifths of Denver Countys per capita of $43,770.

Hampden SouthIn the tract with the lowest SDI, only 4.7 percent of residents live below the poverty line, compared to 12.9 percent across the county.

Bioethicist Matthew Wynia speaks out about the mortal dilemmas of the pandemicand how COVID-19 could forever guide our moral compass.Back to Top

Who gets a ventilator and who doesnt? Should everyone be forced to wear a mask? Which demographics deserve to receive the COVID-19 vaccine first? These are the questions the pandemic forced Dr. Matthew Wynia and other bioethicists to wrestle with as they attempted to guide the health care system through a stark market of supply and demand. Director of the University of Colorado Anschutz Medical Campus Center for Bioethics and Humanities, Wynia not only advised on state policy, but also helped oversee the UCHealth triage team as it made critical decisions. In the early stages of the vaccine rollout in Colorado, 5280 spoke with Wynia to better understand how local hospitals came to some very difficult decisions.

5280: Were the choices about, say, who would get ICU beds already determined before COVID-19 came along?Matthew Wynia: Not exactly. We had a framework because weve had prior pandemicsthe 2009 H1N1 influenza pandemic had generated a lot of interest in these issues. But it hadnt been adapted to COVID. So that was the initial work. Pull that off the shelf, open it up, and start making adjustments based on COVID. Very early on, we were already seeing that there might be a problem with blood clotting. Well, thats not a normal problem with influenza. How does that affect the clinical decision-making?

How does it?Those factors get put into your risk calculation for how likely a patient is to die if theyre really sick with COVID. Because if you think theyre going to die no matter what, youre better off not allocating them scarce resources. Also, if you think they might be able to pull through if they dont get the scarce resource, you similarly dont want to put them on the scarce resource.

So if a patient has a history of blood clots, no ICU?Well, Id be careful about that, because there are about 30 things in our calculation.

This is a question typically reserved for supervillains, but how did you sleep at night?I am famous in my family for being able to sleep anytime, anywhere. Thats my superpower. In March, for the first time in my life, I was tossing and turning, because we thought Colorado was going to get hit hard, and we were going to end up implementing our triage teams. The thing [we] do not want is the bedside doctor to be the one deciding who receives these resources and who doesnt. Number one, your bedside doctor should be your advocate. And number two, the bedside doctor does not have great situational awareness of what else is going on around the hospital or the region.

Yeah, but that means you have to make that decision.Yes, but based on better information than that individual doctor has.

Because of all the tough choices doctors had to make during the pandemic, do you think bioethics has evolved?If we make good decisions that clearly prioritize equity, we could come out of this with greater levels of trust in the health care system among racial and ethnic minority populations that havent always trusted the health care systembecause they didnt have a lot of good reasons to trust the health care system. Watching leaders in health care really struggle with how to do this right, so that we dont disadvantage this community, that can be a cohesion-building experience.

Spencer Campbell writes features and edits service packages.

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How COVID-19 Will Help Denver Doctors Revolutionize Health Care - 5280 | The Denver Magazine

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Perspectum: High Liver Fat (Hepatic Steatosis) Linked to Increased Risk of Hospitalization in COVID-19 Patients With Obesity – Business Wire

April 4th, 2021 6:47 am

OXFORD, England--(BUSINESS WIRE)--New research published this month in Frontiers in Medicine (Gastroenterology) reveals that individuals with both obesity and severe fatty liver are five times more likely to require hospitalization for the illness. The non-invasive liver imaging technology Perspectums LiverMultiScan was used to gather MRI scans for the study.

Obesity is often associated with fat accumulation in the liver, which can lead to liver disease, and emerging data suggests that patients with obesity are at an increased risk of becoming seriously ill with COVID-19. The World Obesity Federation summarizes recent reports suggesting in the US almost 50 percent of people hospitalized with COVID-19 were also affected by obesity. A new report from the CDC (Centers for Disease Control and Prevention, U.S.A.) indicates 78 percent of people who were hospitalized, placed on a ventilator or died from COVID-19 were overweight or obese.

The results of the imaging study, which explored whether having excess liver fat could influence severity of COVID-19 in obese individuals, showed that individuals with both obesity as well as fatty liver were five times more likely to require hospitalization for COVID-19. Notably, individuals with obesity and normal liver fat were not at increased risk of being hospitalized.

Some individuals with obesity have a normal level of liver fat and some non-obese individuals have high levels of liver fat. It is pertinent to establish whether pre-existing liver disease increases the risk of severe COVID-19 and how this relates to obesity, says Adriana Roca-Fernandez, first author and scientist at Perspectum, the company developing LiverMultiScan. Measurement of liver fat and detection of liver disease can be achieved using non-invasive imaging methods such as Perspectums well-validated, magnetic resonance imaging (MRI) technology to help identify patients with COVID-19 who are at increased risk of severe disease.

Understanding the contribution of liver fat to COVID-19 risk and outcomes is important for clinical understanding and management of COVID-19 and long COVID. The study, Hepatic Steatosis Rather Than Underlying Obesity Increases Risk of Infection and Hospitalization for COVID-19, Roca-Fernandez et al., 2021, also confirmed some previously reported risk factors for contracting COVID-19, such as being a male and having a lower socio-economic status. In addition, this study showed that the participants who had tested positive for COVID-19 were more likely to have higher liver fat. The MRI data were acquired before the COVID-19 pandemic by the UK Biobank, one of the largest biomedical databases in the world, and included 4,458 people who had later been tested for COVID-19.

According to Dr. Arun Sanyal, Virginia Commonwealth University, one of the authors of the study, The current study demonstrates pre-existing fatty liver disease is an independent risk factor for development of severe disease in those with COVID-19. This raises important questions about the role of hepatic steatosis and related liver injury as a disease modifying factor. These data highlight the public health relevance of NAFLD beyond cardiovascular, cancer and liver outcomes and provide a strong rationale for future studies to evaluate whether de-fatting the liver will reduce the likelihood of severe COVID-19 in affected individuals.

Determining all risk factors for increased severity of COVID-19 is crucial to help shape public policy measures to protect these high-risk individuals, such as social distancing, prioritization of people for vaccinations, and access to personalized medicine to guide clinical and lifestyle interventions, adds Roca- Fernandez.

Perspectum, a global medical technology company with offices in the U.K., the U.S. and Singapore, delivers leading digital technologies that help clinicians provide better care for patients with liver disease, diabetes and cancer. With a strong focus on precision medicine using advanced imaging and genetics, our vision is to empower patients and clinicians through quantitative assessments of health enabling early detection, diagnosis, and targeted treatment. With a diverse team of physicians, biomedical scientists, engineers and technologists, Perspectum offers a way to manage complex health problems at scale. For more information, visit perspectum.com.

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Perspectum: High Liver Fat (Hepatic Steatosis) Linked to Increased Risk of Hospitalization in COVID-19 Patients With Obesity - Business Wire

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Foundation Medicine Appoints Brian Alexander, M.D., M.P.H., as Chief Executive Officer – Business Wire

April 4th, 2021 6:47 am

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine, Inc. today announced the appointment of Brian Alexander, M.D., M.P.H., as chief executive officer, effective April 6, 2021. Dr. Alexander previously served as Foundation Medicines chief medical officer since 2019 and brings with him years of experience as a radiation oncologist at Dana-Farber/Brigham and Womens Cancer Center and an Associate Professor at Harvard Medical School. He succeeds Cindy Perettie, who has taken on a new role within Roche Diagnostics.

Brian has been instrumental in leading Foundation Medicine in its mission to rapidly advance personalized medicine for cancer patients on a global scale, said Severin Schwan, CEO, Roche Group. As an oncologist, he is uniquely positioned to help the company become an ever-more-essential partner for patients, physicians, and the researchers developing new cancer medicines by providing them with the insights they need to support critical decisions.

Dr. Alexander joined Foundation Medicine as senior vice president of clinical development in September 2018 and was promoted to Chief Medical Officer the following year. He has directed Foundation Medicines decision insights strategy to help more oncologists, both in community and academic settings, determine the right treatment, at the right time, for each unique patient. Under his leadership, Foundation Medicines medical team has expanded its molecular tumor board program to include over 90 leading oncology centers globally, launched a cross-functional genomics and health disparities effort, and has developed hundreds of studies and publications to advance the clinical utility of genomic profiling.

I am proud to be part of a team that has delivered groundbreaking innovations catalyzed by our unparalleled insights into cancer genomics, said Dr. Alexander. I am grateful to Cindy for her leadership and mentorship during such a transformative time for the company, and Im excited to lead the next chapter for this remarkable organization as we work to enable better therapeutic decision making and help our pharmaceutical and biotech partners advance the breakthrough therapies of tomorrow.

Dr. Alexander was the founding director of the Program in Regulatory Science at the Dana-Farber Cancer Institute and the Harvard/MIT Center for Regulatory Science. He also co-founded the Global Coalition for Adaptive Research, a non-profit organization focused on clinical trial innovations to accelerate the discovery and development of cures for patients with rare and deadly diseases and served as chair of the FDA/Project Datasphere task force on external control arms. He previously co-authored a book on the interpretation of diagnostic tests for medical decision making. Dr. Alexander is an is an affiliated researcher at the MIT Laboratory for Financial Engineering and affiliated faculty of the Harvard Kennedy School Healthcare Policy Program. He was named to Boston Magazines Top Doctors List in 2019, 2020, and 2021.

Previously, Dr. Alexander served as a White House fellow and Special Assistant to the Secretary of Veterans Affairs, where he helped prepare the VA for the transition of administrations, worked to develop a public reporting system for quality, and served as a health policy advisor to the Secretary. Dr. Alexander organized the standup of the VAs Coordinating Council on National Health Reform and directed the activities of its multi-team Health Reform Working Group. He was also a member of the Institute of Medicines Committee on the Governance and Financing of Graduate Medical Education.

Dr. Alexander received his B.A. from Kalamazoo College, M.D. from the University of Michigan Medical School, and M.P.H. from the Harvard School of Public Health. He completed his training in radiation oncology at the Harvard Radiation Oncology Program.

About Foundation Medicine

Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patients cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicines molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit http://www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).

Foundation Medicine is a registered trademark of Foundation Medicine, Inc.

Source: Foundation Medicine

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Foundation Medicine Appoints Brian Alexander, M.D., M.P.H., as Chief Executive Officer - Business Wire

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New Clinical Trial Studies Pancreatic Cancer Tumor Traits To Uncover Better Treatment Options – PRNewswire

April 4th, 2021 6:47 am

NEW YORK, March 30, 2021 /PRNewswire/ -- A new team of pioneering pancreatic cancer researchers has been formed to predict which treatments might work best for individual pancreatic cancer patients based on the molecular traits of tumors. The Pancreatic Cancer Convergence Dream Team is funded by the Pancreatic Cancer Collective, an initiative of the Lustgarten Foundation and Stand Up To Cancer (SU2C), SU2C Canada and Pancreatic Cancer Canada.

The team will be led by Jennifer Knox, MD, the Lewitt Chair in Pancreatic Cancer Research at the Princess Margaret Cancer Centre, part of University Health Network, and professor of medicine at the University of Toronto in Canada, and Elizabeth Jaffee, MD, a professor of oncology and deputy director of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore, Maryland.

"This team's cutting-edge work to better understand the makeup of pancreatic cancers will benefit tens of thousands of cancer patients in the United States and around the world," said Nobel Laureate Phillip A. Sharp, PhD, chair of the SU2C Scientific Advisory Committee, co-chair of the SU2C Canada Scientific Advisory Committee and Institute professor at the David H. Koch Institute for Integrative Cancer Research at Massachusetts Institute of Technology. "Pancreatic Cancer Collective-supported research has already contributed to a 2013 FDA approval of a combination therapy for advanced pancreatic cancer; the work of this Dream Team is an important next step in determining if that treatment, or another leading treatment, will work best for different pancreatic cancer subtypes."

Pancreatic cancer is the third leading cause of cancer-related death in both the United States and Canada and is exceptionally difficult to treat. The five-year survival rate for pancreatic cancer is around 10% in the United States and 8% in Canada. Additionally, Black people in the U.S. and Canada are more likely to develop pancreatic cancer than whites. In the U.S., the incidence of pancreatic cancer is 19% higher in Black men compared to white men, and 36% higher in Black women compared to white women. The Dream Team hopes to address this disparity by making recruitment of diverse patients a top priority in their research.

The Dream Team recently opened a phase II clinical trial entitled Pancreatic Adenocarcinoma Signature Stratification for Treatment (PASS-01) Trial looking more closely at the two leading treatments for advanced pancreatic cancer. One of those treatments is Modified FOLFIRINOX, which is a combination of four chemotherapy drugs. The other treatment is a combination of chemotherapy drugs gemcitabine and nab-paclitaxel. The U.S. Food and Drug Administration approved that treatment in 2013 based, in part, on the work of a previousSU2C Pancreatic Dream Team, which was a part of the Pancreatic Cancer Collective portfolio.

The two treatments are helpful for some pancreatic cancer patients but have little effect for other patients. The goal of the PASS-01 trial is to uncover more about how the two treatments work. Currently, precision medicine for pancreatic cancer patients includes a comprehensive evaluation of the tumor's genomic profile. But, doctors still don't know enough about the different types of pancreatic cancer to determine whether either treatment will help an individual patient, and if so, which treatment might work best. Building on the findings from a pancreatic cancer clinical trial conducted by the Ontario Institute for Cancer Researchwhich also is a collaborator on the PASS-01 trialpotential predictors of patient response to chemotherapy will be further tested by Knox and Jaffee and their Dream Team colleagues. They also hope the trial will help them learn more about biomarkers within patients' tumors. Their goal is to be able to identify specific biomarkers that indicate whether a pancreatic cancer will respond better to one treatment versus the other.

At the same time, the clinical trial will explore another promising method in fighting pancreatic cancer by uncovering the unique characteristics of individual patients' tumors. Collaborators at Cold Spring Harbor Laboratory in Cold Spring, New York, will create patient-derived organoids (PDOs) from biopsies of trial participants' tumors. The miniature 3-D structures are grown in lab dishes from tiny bits of tumors taken from patients. Scientists then see how the PDOs react to different types of cancer drugs. This work may lead to more effective individualized treatments for pancreatic cancer.

"We have brought together some of the finest pancreatic cancer researchers in North America; the time is right to dig in much deeper to help understand pancreatic cancer," Knox said. "We need to stop assuming one size fits all and instead advance the field by gaining a better understanding of every tumor. We believe our work can help doctors treat patients optimally today while providing a better understanding of this deadly disease into the near future."

"There is a critical need to identify ways that medicine can better treat pancreatic cancers," Jaffee said. "We believe by identifying and learning more about these biomarkers, we can help make that happen. We can give patients more hope that their cancers can be treated effectively."

"Personalized medicine has been a game changer in the treatment of many other cancers and this trial is a significant step toward offering this type of individualized care to metastatic pancreatic cancer patients," said David Tuveson, MD, PhD, chief scientist for the Lustgarten Foundation and director of the Lustgarten Foundation Pancreatic Cancer Research Lab at Cold Spring Harbor Laboratory where pancreatic cancer organoids were co-developed. "The international partnership between these organizations is a great example of collaboration between labs to help physicians make faster, better informed decisions in efforts to provide patients with better outcomes."

Knox and Jaffee have already begun enrolling clinical trial participants at Princess Margaret Cancer Centre and Johns Hopkins. The team hopes to enroll 150 patients in the trial, with four additional locations throughout the United States and Canada opening soon, including Memorial Sloan Kettering Cancer Center in New York City, Northwell Health in Long Island, Dana Farber Cancer Institute in Boston and BC Cancer in Vancouver, B.C.

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Media Contact:Mirabai Vogt-JamesStand Up To Cancer[emailprotected]

About Stand Up To CancerStand Up To Cancer (SU2C) raises funds to accelerate the pace of research to get new therapies to patients quickly and save lives now. SU2C, a division of the Entertainment Industry Foundation, a 501(c)(3) charitable organization, was established in 2008 by media and entertainment leaders who utilize these communities' resources to engage the public in supporting a new, collaborative model of cancer research, to increase awareness about cancer prevention, and to highlight progress being made in the fight against the disease. As of 2021, more than 1,950 scientists representing more than 210 institutions are involved in SU2C-funded research projects.

Under the direction of our Scientific Advisory Committee, led by Nobel laureate Phillip A. Sharp, Ph.D., SU2C operates rigorous competitive review processes to identify the best research proposals to recommend for funding, oversee grants administration, and ensure collaboration across research programs.

Current members of the SU2C Founders and Advisors Committee (FAC) include Katie Couric, Sherry Lansing, Kathleen Lobb, Lisa Paulsen, Rusty Robertson, Sue Schwartz, Pamela Oas Williams, and Ellen Ziffren. The late Laura Ziskin and the late Noreen Fraser are also co-founders. Sung Poblete, Ph.D., R.N., serves as SU2C's CEO. For more information, visitStandUpToCancer.org.

About the Pancreatic Cancer CollectiveThe Pancreatic Cancer Collective is an initiative of Lustgarten Foundation and Stand Up To Cancer to improve pancreatic cancer patient outcomes. Together, these leading cancer research organizations have funded 26 projects for a total of more than $108 million and are attracting new collaborators; employing big data to improve diagnosis of pancreatic cancer; finding new treatments for pancreatic cancer; and supporting the next generation of pancreatic cancer investigators. Engaging thought leaders, researchers, institutions, and companies, the Collective is innovating and accelerating research on the edge of science. For more information, visit PancreaticCancerCollective.org.

About the Lustgarten FoundationThe Lustgarten Foundation is the largest private funder of pancreatic cancer research in the world. Based in Woodbury, N.Y., the Foundation's mission is to cure pancreatic cancer by funding scientific and clinical research related to the diagnosis, treatment, and prevention of pancreatic cancer; providing research information and clinical support services to patients, caregivers and individuals at high risk; and increasing public awareness and hope for those dealing with this disease. Since its inception, the Lustgarten Foundation has directed more than $200 million to research and has assembled the best scientific minds with the hope that one day, a cure can be found. Thanks to separate funding to support administrative expenses, 100 percent of your donation funds pancreatic cancer research. For more information, visit Lustgarten.org.

About Stand Up To Cancer CanadaStand Up To Cancer Canada is a Canadian registered charity (Reg: # 80550 6730 RR0001), launched by the U.S.-based Entertainment Industry Foundation in 2014. Stand Up To Cancer Canada (SU2C Canada) raises funds to support collaborative cancer research teams, as well as education and awareness programs conducted in Canada.

Under the direction of our SU2C Canada Scientific Advisory Committee, co-led by Alan Bernstein, Ph.D., president of the Canadian Institute for Advanced Research (CIFAR) and Nobel laureate Phillip A. Sharp, Ph.D., SU2C Canada operates rigorous competitive review processes to identify the best research proposals to recommend for funding, oversee grants administration, and ensure collaboration across research programs. SU2C Canada currently supports three "signature" Dream Teams engaging dozens of the best and brightest researchers in different disciplines from 15 institutions across the country.

In addition to a board of leading Canadian broadcaster representation, SU2C Canada is guided by the SU2C Council of Founders and Advisors (CFA) including Katie Couric, Sherry Lansing, Kathleen Lobb, Lisa Paulsen, Rusty Robertson, Sue Schwartz, Pamela Oas Williams, and Ellen Ziffren. The late Laura Ziskin and the late Noreen Fraser were also co-founders. Sung Poblete, Ph.D., RN serves as SU2C CEO. The CFA includes entertainment industry leaders who utilize these communities' resources to engage the public in supporting this new, collaborative model of cancer research, to increase awareness about cancer prevention, and to highlight progress being made in the fight against the disease. For more information on Stand Up To Cancer Canada, visitStandUpToCancer.ca.

About Pancreatic Cancer CanadaPancreatic Cancer Canada is fighting to raise survival rates for the world's toughest cancer investing in targeted research, increased awareness and patient support, community activation and advocacy. We have taken on one of the world's deadliest cancers a disease with virtually no progress in survival in the past 40 years and a 92% mortality rate. We are aggressively fighting it with investments in research aimed at greater understanding of this cancer and better treatment options. At the same time, we are working to educate physicians about faster diagnosis and with patients/families to support them as they face the realities of this cancer in their lives. To learn more, please visitwww.pccf.ca.

SOURCE Stand Up To Cancer

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Natera and Tesis Labs Announce Strategic Collaboration on Prenatal Genetic Testing – PRNewswire

April 4th, 2021 6:47 am

AUSTIN, Texas, March 31, 2021 /PRNewswire/ --Natera, Inc.(NASDAQ: NTRA), a pioneer and global leader in non-invasive genetic testing and analysis of cfDNA, and Tesis Labs, a US multi-region lab services provider with labs in Colorado, Texas and Arizona, announced a strategic partnership in the field of prenatal genetic testing.

The collaboration will allow Tesis to broaden its portfolio of genetic testing offerings and participate in the fast growing screening market for over 4 million pregnancies in the United States. Tesis's state-of-the-art and highly scalable genetics laboratory in Lafayette, Colorado can serve many regions of the U.S. including Texas, Arizona and Colorado.

"Natera is pleased to partner with Tesis Labs to improve patient testing access and convenience in a number of critical regional markets for both Natera and Tesis," said Ramesh Hariharan, General Manager of Natera's Women's Health business.

"We are honored to partner with Natera," said Tesis Labs CEO Ron King. "Working together will offer new opportunities for early screening, allowing more informed treatment and care decisions for women and their families. Our combined expertise and technology will play a major role in helping patients."

About Tesis Labs

Tesis Labs' genetically integrated medical platform has revolutionized targeted genetic sequencing. Our mission is to change medicine by providing physicians, hospitals, and researchers with the tools to help patients treat and overcome major chronic conditions such as heart disease, lung disease, cancer, and diabetes through advanced genetic testing. Tesis offers healthcare providers, and physicians' access to our unique genetic testing and precision medicine, enabling them to create personalized care plans for treating chronic diseases individually and across generations. We also enable medical device companies and pharmaceuticals to bring new products to market and create a robust repository of genetic data and research. Visitwww.tesislabs.comto learn more.

Media Contact: Kim Warth, Amendola Communications303-918-9205[emailprotected]tingpr.com

About Natera

Naterais a pioneer and global leader in cell-free DNA testing from a simple blood draw. The mission of the company is to change the management of disease worldwide with a focus on women's health, oncology, and organ health. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. It offers proprietary genetic testing services to inform obstetricians, transplant physicians, oncologists, and cancer researchers, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit natera.com. Follow Natera on LinkedIn.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, whether the results of clinical or other studies will support the use of our product offerings, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera's recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at http://www.natera.com/investors and http://www.sec.gov.

Contacts

Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350

Media: Paul Greenland, VP of Corporate Marketing, Natera, Inc., [emailprotected]

SOURCE Natera, Inc.

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Outlook on the Biomarkers Global Market to 2025 – Rising Incidence of Diseases Presents Opportunities – GlobeNewswire

April 4th, 2021 6:47 am

Dublin, April 02, 2021 (GLOBE NEWSWIRE) -- The "Biomarkers: Technologies and Global Markets 2021" report has been added to ResearchAndMarkets.com's offering.

This new report, Biomarkers: Technologies and Global Markets, provides a comprehensive analysis of the biomarkers market in a global context, including market forecasts and sales through 2025. The report analyzes the market, segmenting it into various product offerings (i.e., instruments, consumables [reagents, kits and panels], services and software). Segmentation also provides analysis by popular technology type (genomics, proteomics and metabolomics, imaging and bioinformatics).

This study surveys the biomarker market by therapeutic area (cancer, cardiovascular and metabolic diseases, infectious diseases, neurodegenerative diseases, autoimmune diseases and others. End-users include academic institutes, pharma and biotechnology companies, clinical research organizations, hospitals and diagnostics. Geographic regions include North America, Europe and Emerging markets. Emerging markets include countries like India, China, Korea, Taiwan, Africa, Australia, New Zealand, Canada, Latin America, etc.

This report features new product developments and patents that are boosting global growth in this market.

This report provides comprehensive profiles of market players in the industry. The industry structure chapter focuses on changing market trends, market players and leading products. This chapter also covers mergers and acquisitions and other collaborations or partnerships that are expected to shape the industry.

Strengths, weaknesses, threats and opportunities are expected to play a role in the diagnostic biomarkers market. These are evaluated in detail.

The scope of the report excludes in vitro diagnostic products and regulatory aspects. Digital biomarkers are not covered in this report.

Report Includes:

Biomarkers, the biological indicators of health and disease, have come a long way, from being used as simple measurements of clinical diagnosis, to becoming essential tools in the clinical space and drug discovery and development. The utility of biomarkers has been expanding over the last couple of decades, due to the potential for predicting disease diagnosis and prognosis, treatment response, pharmacokinetics of drugs and monitoring therapy. During the COVID-19 pandemic, boosted R&D for novel diagnostics led to the approval of many biomarker-based diagnostic tests for early and rapid detection of the SARS-CoV-2 virus.

Pharmaceutical and biopharmaceutical drug developers struggle to overcome escalating cost barriers and high drug attrition rates in late-stage clinical trials. Biomarkers are promising tools to address drug development challenges. offering the prediction of drug toxicity and efficacy in early stages. The 21st Century Act allowed the Food and Drug Administration (FDA) to publish guidelines for Biomarker Qualification for use in drug development programs, paving the way for biomarker inclusion into drug development through either the drug approval process or the Biomarker Qualification Program.

Biomarkers are extremely useful in clinical trials, increasingly used to identify populations for a study, monitor therapeutic response and identify side effects. There is an emerging market of clinical research organizations (CROs) carrying out clinical trial recruitment and other services, while expanding technical expertise in bioanalytical and biomarker development. This enables pharmaceutical clients access to biomarker discovery and development.

The global biomarkers market is growing at a significant pace, driven by an explosion of publications and clinical trials. Enhanced analytical methods and the development of new, sophisticated and sensitive multiplex methods in gene expression analysis, proteomics, metabolomics and transcriptomics bring huge momentum to this market. The development of multi-biomarker assays, novel immunoassays and multi-modal imaging and mass spectrometry methods further drive market growth.

Collaborations and strategic partnerships, mergers and acquisitions and other deals between private and public players are on the rise. Companies are strengthening technical know-how and expanding product portfolios in order to offer enhanced services and new offerings to the biomarker research community. Precision medicine, particularly in the field of cancer, has contributed tremendously to an interest in biomarkers, with growing adoption of biomarkers in companion diagnostics and selecting targeted patient populations for high-value drugs. Other therapeutic areas, such as cardiovascular, neurodegenerative and autoimmune diseases are getting noticeable attention in biomarker research.

Challenges for this market, remain in the form of disparity in biomarker definitions at an international level and lack of any defined regulatory guidance for use in R&D. There is still a need to develop sensitive and robust methods of analysis for low concentration analytes via methods that can be validated. Lack of skilled manpower and the high cost of technology are other challenging factors.

Positive approaches in biomarker research, effective dialogue and collaborations between all stakeholders is expected to address challenges and take this market forward in coming years.

Key Topics Covered:

Chapter 1 Introduction

Chapter 2 Summary and Highlights

Chapter 3 Market and Technology Background

Chapter 4 Market Breakdown by Product Type

Chapter 5 Market Breakdown by Technology Type

Chapter 6 Market Breakdown by Therapeutic Area

Chapter 7 Market Breakdown by End User

Chapter 8 Industry Structure

Chapter 9 Clinical Trials

Chapter 10 Patent Analysis

Chapter 11 Analysis of Market Opportunities

Chapter 12 Company Profiles

Chapter 13 Appendix: Abbreviations/Acronyms

For more information about this report visit https://www.researchandmarkets.com/r/xjd6q0

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Cerba healthcare to welcome EQT as new shareholder to foster innovation and continue to meet the healthcare challenges – PRNewswire

April 4th, 2021 6:47 am

Cerba Healthcare, headquartered in France and firmly established in Europe and Africa through its historical routine and specialty biology expertise, also operates globally through its clinical trials business unit for the validation of new compounds and vaccines. It stands as a unique group in the diagnosis market, covering the needs for diagnostic tools and expertise for patients, physicians, hospitals and the pharmaceutical industry.

With this new partnership, Cerba HealthCare reinforces its capital structure with its existing shareholders -more than 400 long-time biologists and managers- and its long-term partner, PSP Investments, to sustain the Group's development strategy and current transformation.

Catherine Courboillet, CEO, Cerba HealthCare, states: "Over the past four years, Partners Group has shown a comprehensive understanding of our market and unwavering support in sustaining Cerba HealthCare's growth strategy. In order to continue to fulfill the Group's long-term development, we are excited to welcome a partner that shares the same vision and values, as well as a strong understanding of the importance of cutting-edge, personalized services. It is critical to keep on investing heavily in innovation, IT security and talents in order to drive further and faster our on-going transformationtowards better healthcare services for patients. With EQT, we have chosen an experienced partner that will strengthen our European positioning while helping us expand into new markets."

Nicolas Brugre, Partner, Investment Advisor at EQT Partners and Head of EQT France, comments:"EQT has followed Cerba HealthCare for a long time and we are deeply impressed with the company's unique platform for medical diagnoses and superior scientific expertise. Cerba HealthCare is a purpose-driven company with a culture that is well-aligned with EQT's values and we are happy to partner with its management team and with PSP Investments. EQT Private Equity is committed to invest in and future-proof Cerba HealthCare for the long-run to best serve patients and healthcare professionals."

Kim Nguyen, Partner, Private Equity Services, Partners Group, adds: "Cerba HealthCare operates in an important sector and we are proud to have successfully contributed to the sustainable growth strategy of the Company over the last four years. In line with Partners Group's focus on positive stakeholder impact and entrepreneurial governance, Cerba HealthCare has not wavered in its commitment to responding to the COVID-19 crisis. During our holding period, the Company has transformed into a market leader, penetrating new international markets, including in Africa and Italy, further consolidating its expertise in clinical trials and securing leadership in the veterinary biology sector. We are convinced Cerba HealthCare is poised for lasting success and that, after our strong and collaborative partnership, it is the right time and opportunity for all stakeholders that the Company move into its next phase of growth."

Simon Marc, Senior Managing Director and Global Head of Private Equity, PSP Investments, said: "Since our initial partnership with Cerba HealthCare in 2017, the company has gone from strength to strength, and we are excited to continue supporting Catherine and her talented management team as long term-partners. We look forward to welcoming EQT who has been one of PSP Investments core partners for many years, and who brings tremendous expertise in European healthcare. Together, we will provide the long-term strategic capital to support Cerba HealthCare in achieving its full potential through its next phase of development as a European leader in medical diagnostics."

Following the completion of the deal, which is subject to administrative notifications and regulatory approvals, EQT Private Equity and PSP Investments will work with Cerba HealthCare's management team, led by CEO Catherine Courboillet, to support the numerous growth opportunities of the business. These include the continuation of the Company's highly successful M&A strategy on a global scale, as well as the acceleration of organic growth and development in other segments.

About Cerba HealthCareCerba HealthCare, a leading player in medical diagnosis, aims to support the evolution of health systems towards more prevention. It draws on more than 50 years of expertise in clinical pathology to better assess the risk of diseases development, detect and diagnose diseases earlier, and optimize the effectiveness of personalized medicine.

Every day, on 5 continents, the Group's 8500 employees sustain the transformation of medicine, driven by one deep conviction: to advance diagnosis is to advance health.Cerba HealthCare, enlightening health.

About PSP InvestmentsPSP Investments is one of Canada's largest pension investment managers with approximately $169.8 billion of net assets as of March 31, 2020. It manages a diversified global portfolio of investments in public financial markets, private equity, real estate, infrastructure, natural resources and private debt. Established in 1999, PSP Investments manages net contributions to the pension funds of the federal Public Service, the Canadian Forces, the Royal Canadian Mounted Police and the Reserve Force. Headquartered in Ottawa, PSP Investments has its principal business office in Montreal and offices in New York, London and Hong Kong. For more information, visit investpsp.com or follow PSP Investments on Twitter and LinkedIn.

About Partners GroupPartners Group is a leading global private markets firm. Since 1996, the firm has invested over USD 145 billion in private equity, private real estate, private debt and private infrastructure on behalf of its clients globally. Partners Group is a committed, responsible investor and aims to create broad stakeholder impact through its active ownership and development of growing businesses, attractive real estate and essential infrastructure. With over USD 109 billion in assets under management as of 31 December 2020, Partners Group serves a broad range of institutional investors, sovereign wealth funds, family offices and private individuals globally. The firm employs more than 1,500 diverse professionals across 20 offices worldwide and has regional headquarters in Baar-Zug, Switzerland; Denver, USA; and Singapore. It has been listed on the SIX Swiss Exchange since 2006 (symbol: PGHN). For more information, please visit http://www.partnersgroup.comor follow us on LinkedInor Twitter.

About EQT EQT is a purpose-driven global investment organization with more than EUR 84 billion in raised capital and over EUR 52 billion in assets under management across 17 active funds. EQT funds have portfolio companies in Europe, Asia-Pacific and North America with total sales of more than EUR 27 billion and approximately 159,000 employees. EQT works with portfolio companies to achieve sustainable growth, operational excellence and market leadership.More info: http://www.eqtgroup.com Follow EQT on LinkedIn, Twitter, YouTube and Instagram

Press contacts: Cerba Healthcare, Emmanuelle Saby, +33 6 09 10 76, [emailprotected]; PSP Investments, Maria Constantinescu, 1 844 525 3795, [emailprotected]; EQT, Brunswick Paris: Benoit Grange, (+ 33 6 14 45 09 26); Hugues Boton, (+33 6 79 99 27 15), [emailprotected]; Press contact EQT: [emailprotected]- +46 8 506 55 334; Partners Group, Jenny Blinch, +44207575 2571, [emailprotected]

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SOURCE PSP Investments; Cerba Healthcare

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City of Hope Receives $50 Million Gift From Lennar Foundation to Build the Future of Cancer Care – BioSpace

April 4th, 2021 6:47 am

IRVINE, Calif.--(BUSINESS WIRE)-- World-renowned cancer research and treatment center City of Hope has received a $50 million gift from Lennar Foundation, the charitable arm of homebuilder Lennar Corporation. This transformational gift of hope is the largest single philanthropic contribution to City of Hope Orange County. It will expedite the health care organizations bold plans to invest $1 billion to develop and operate a comprehensive cancer campus in Irvine, California, and establish an Orange County network of advanced cancer care and research that will speed groundbreaking treatments directly to a community with growing needs.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210331005094/en/

Lennar Foundation Cancer Center, opening in 2022 (Photo: City of Hope)

The future 190,000-square-foot Lennar Foundation Cancer Center at City of Hope Orange County will be located on 11 acres at Five Points Great Park in the heart of Irvine. It will bring best-in-class cancer care, pioneering research and lifesaving treatments to the countys 3.2 million residents. Construction is already underway on the comprehensive cancer center, which will open in 2022. In addition, Orange Countys only hospital dedicated exclusively to treating and curing cancer will open at City of Hope Irvine in 2025.

City of Hopes presence in Orange County offers local access to City of Hopes National Cancer Institute-designated comprehensive cancer center with world-renowned cancer physicians and researchers who are singularly focused on finding better treatments and cures.

Lennar Foundation Cancer Center at City of Hope Orange County will bring to the region a host of distinguishing services, including:

As the country emerges from the COVID-19 pandemic, Lennar Foundations extraordinary contribution underscores the importance of investing in local health care resources and increasing access to leading-edge care. For Orange County, it is a reminder that cancer does not stop, and that City of Hopes mission is more important than ever.

Lennar has a long history in Orange County of developing thriving communities, including helping form the vision for a world-class recreation and lifestyle destination. This gift is an extension of this longstanding commitment to improving lives in the regions Lennar helps shape. A portion of the gift to City of Hope is designated to support clinical translational research between City of Hope and the Sylvester Comprehensive Cancer Center of the University of Miami, thus uniting two organizations supported by Lennars generosity who share similar goals in developing new treatments and cures for patients with cancer.

City of Hope and Sylvester Comprehensive Cancer Center serve two of the most diverse areas in the United States. Both organizations are committed to conducting high-impact research that addresses the cancer burden in their communities. This gift will enable collaborative, translational science that will drive innovation and catalyze timely and necessary progress towards health equity.

Lennar Foundations gift to City of Hope is a generous continuation of Lennars longstanding support of the comprehensive cancer center. Jon Jaffe, co-chief executive officer and co-president of Lennar Corporation, is a member of City of Hopes Construction Industries Alliance Leadership Advisory Council, which raises funds for cancer treatment and research. In recognition of his contributions, Jaffe was awarded City of Hopes highest honor The Spirit of Life Award in 2004.

City of Hope Newport Beach, the first phase of City of Hope Orange Countys expansion, opened in early 2020, providing Orange County residents first-time local access to world-renowned physicians backed by the powerful City of Hope network. City of Hope plans to open other clinical network locations across the region.

Supporting quotes

Robert Stone, president and CEO, City of HopeHelen and Morgan Chu Chief Executive Officer Distinguished Chair

This is the start and it is a monumental start to show the nation that our work in Orange County will catalyze incredible achievements in health care. Visionary donors and volunteers have been foundational to City of Hopes 108-year history, and we are deeply grateful to the Lennar Foundation for their extraordinary contributions and longstanding support. With this gift, we will achieve the nexus of unsurpassed medical expertise, future-focused communities, groundbreaking technology and innovation, all for the single purpose of saving lives. This partnership supports a system of care delivery that provides state-of-the-art treatments, the latest scientific and medical discoveries, and unprecedented access that will serve as a model across the country.

Stuart Miller, executive chairman, Lennar Corporation

At Lennar, we are committed to building communities, and we are pleased to support City of Hope to help build the future of cancer care. Together, we are building a state-of-the-art center for advanced cancer care and research that will make a difference in the lives of so many by turning science into practice and hope into reality.

Nicole Petersen Murr, grateful Orange County patient

City of Hope saved my life. My family and I will be forever grateful to my doctor and care team. Anyone who has heard the words You have cancer knows how those words change your life and affect every piece of it. I want everyone who hears those words to have the same compassionate care and access to the latest treatments that I had. Having City of Hope in Orange County changes everything for cancer patients present and future. Im so grateful to have this world-renowned care in my own community.

Annette M. Walker, president, City of Hope Orange County

This generous gift of hope is a historic moment for City of Hope. Thank you to Lennar Foundation, which is united in our vision and understands the urgency of our work, helping us ensure that our promise to Orange County will be fulfilled. We are building a place of hope and healing that will serve residents of Orange County and beyond for generations to come. Every one of us has been touched by cancer and we want all who are impacted by this disease to know we are here for you, your family, friends and neighbors.

Jon Jaffe, co-chief executive officer and co-president, Lennar Corporation

City of Hope is a leader in the treatment of and race to find a cure for cancer, and its gratifying to know that, with this gift, we will make a positive impact by expanding access to care and advancing the research that will treat, prevent and ultimately eliminate cancer we hope this contribution will encourage other philanthropic leaders to support City of Hope in the fight against cancer.

Kristin J. Bertell, chief philanthropy officer, City of Hope

This important contribution is a clear demonstration of the power of philanthropy to accelerate positive changes in health care delivery, spur advances in science, research and treatment, and give real hope to patients, families and communities. Lennar Foundations generosity continues a long philanthropic legacy that is the cornerstone of our history. There is no doubt that this gift will have a long-lasting impact, and we look forward to engaging the community to make the vision for Orange County and the future of cancer care a reality.

For more information on the progress of City of Hopes Orange County expansion and its first clinical network location in Newport Beach, please visit CityofHope.org/OC.

About City of Hope

City of Hope is an independent biomedical research and treatment center for cancer, diabetes and other life-threatening diseases. Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy. City of Hopes translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin, monoclonal antibodies, and numerous breakthrough cancer drugs are based on technology developed at the institution. Translational Genomics Research Institute (TGen) became a part of City of Hope in 2016. AccessHope, a wholly owned subsidiary, was launched in 2019, dedicated to serving employers and their health care partners by providing access to City of Hopes exceptional cancer expertise. A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope is ranked among the nations Best Hospitals in cancer by U.S. News & World Report. Its main campus is located near Los Angeles, with additional locations throughout Southern California and in Arizona. For more information about City of Hope, follow us on Facebook, Twitter, YouTube or Instagram.

About Lennar Corporation

Lennar Corporation, founded in 1954, is one of the nation's leading builders of quality homes for all generations. Lennar builds affordable, move-up and active adult homes primarily under the Lennar brand name. Lennar's Financial Services segment provides mortgage financing, title and closing services primarily for buyers of Lennar's homes and, through LMF Commercial, originates mortgage loans secured primarily by commercial real estate properties throughout the United States. Lennar's Multifamily segment is a nationwide developer of high-quality multifamily rental properties. LENX drives Lennar's technology, innovation and strategic investments. For more information about Lennar, please visit http://www.lennar.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210331005094/en/

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UM School of Medicine Dean Announces He Will Transition From The Deanship In 2022 After Completing 16-Year Tenure – PRNewswire

April 4th, 2021 6:47 am

BALTIMORE, March 31, 2021 /PRNewswire/ --University of Maryland School of Medicine (UMSOM) Dean E. Albert Reece, MD, PhD, MBA, a widely recognized visionary leader who elevated the UMSOM into a top-tier biomedical research and patient-focused academic center, announced that he will complete his 16-year tenure as Dean, at the end of the next academic year. He will return to the UMSOM faculty where he will lead a new Center, and continue research and teaching.

Dr. Reece, who is also Executive Vice President for UM Baltimore, and the John Z. and Akiko K. Bowers Distinguished Professor, was appointed as the UMSOM's 30th Dean in 2006. Over the course of his Deanship, he led the UMSOM through a period of unprecedented, record-breaking growth and achievements across all its areas of operation, enabling the UMSOM to reach major milestones in research, clinical care, reputation, and global impact. He is considered to be one of the most successful Deans in the U.S., as well as in our institution's rich 214-year history.

Under his leadership:

Dr Reece commented, "I deem it a distinct honor and privilege to have led the UMSOM over several years. Much of the accomplishments and successes in the UMSOM are due to the excellent team I have been blessed to work with, and the support of the UMB leadership over the years. The support from the UMSOM Board of Visitors, the alumni, Directors, Chairs, Dean's senior staff, and assistants have been truly invaluable." He continued, "I am most pleased to pass the baton to a new Dean who undoubtedly will take the UMSOM to new heights."

A leading physician-scientist, and member of the prestigious National Academy of Medicine (NAM), Dr. Reece has served on the NAM's Governing Council and the Executive Committee. He holds faculty appointments as Professor in the Departments of Obstetrics and Gynecology, Medicine, and Biochemistry & Molecular Biology. During his entire Deanship, Dr. Reece remained active in his NIH multi-million-dollar research laboratory group, studying the bio-molecular mechanisms of diabetes-induced birth defects. This laboratory was transitioned to become the Center for Birth Defects Research. Dr. Reece promoted his mentee and lab associate, Peixin Yang, PhD, Professor in the Department of Obstetrics, Gynecology, and Reproductive Sciences, to direct the Center with him. The Center is now supported by seven NIH RO1 grants. Notably, Dr. Reece and his colleagues have unraveled the molecular mechanism into the causation of diabetes-induced birth defects, and have identified and patented molecular targets to be used in preventive and therapeutic strategies.

At the national level, Dean Reece is well known among medical school deans for his mentoring of faculty across the U.S. who aspired to leadership positions. Through his active participation in the AAMC's Dean's Fellowship Program, many senior faculty members have "shadowed" Dean Reece during his tenure and received valuable mentoring from him.

Dean Reece has served on many medical, governmental and civic organization committees, including serving as Chair of the Council of Deans of the Association of American Medical Colleges (AAMC). He currently serves on the board of Research America, and has been recently named to the Board of the Lasker Foundation. During his career, he has served additional organizations, agencies, and cultural/educational institutions, including the Secretary of Health & Human Services Committee on Infant Mortality, The March of Dimes Birth Defects Foundation, the Harvard/ Massachusetts General Hospital Scientific Advisory Committee, and the Baltimore Symphony Orchestra.

Dr. Reece is a sought-after Visiting Professor and Lecturer at numerous institutions both nationally and internationally. He has published extensively in the scientific literature-12 books including revisions and more than 500 publications.

He has received from various universities and government organizations numerous special awards, citations, and honorary degrees in recognition of his distinguished leadership, lifetime achievement, and major contributions to science and medicine.

"I was heavily involved in the recruitment of Dean Reece when he came to UMSOM as Dean," said former University System of Maryland (USM) Chancellor "Brit" Kirwan, PhD. "I consider his appointment to be one of the most important efforts I was involved in as Chancellor of the University System of Maryland. Under Dr. Reece's leadership, our School of Medicine has soared to new heights of excellence as a powerhouse in medical research, a highly regarded institution for training the next generation of doctors, and a valued source of community engagement. His irrepressible commitment to excellence in all aspects of the School's mission has been transformative. He leaves a legacy of accomplishment that will endure for the benefit of generations to come," he said.

A Leader in Service

As Dean, Dr. Reece has also been a prominent leader in the local business and health care community as well. He has been a visible member of the local community and a familiar face to residents who attend the UMSOM's various community programs. Each year at Thanksgiving, Dean Reece has been a fixture at "Project Feast," where he serves dinner and engages with community residents. He is also well known by the hundreds of participants (both and adult and children) who are "students" in UMSOM's highly successful and longstanding "Mini-Med School" and "Mini-Med School for Kids" programs. At each Mini-Med School Graduation Ceremony, Dean Reece greets and delivers special completion certificates to each community participant.

With a new charter and new leadership, the UMSOM's Program in Health Equity and Population Health, Directed by Erin Hager, PhD, Associate Professor of Pediatrics, and Deputy Director Laundette Jones, PhD, MPH, Associate Professor of Epidemiology & Public Health, now combines research, education, and service to advance health equity by addressing the critical health issues often influenced by the social determinants of health. In recent years, the Program has generated 331 active grants with funding of $128 million.

Bruce E. Jarrell, MD, FACS, president of the University of Maryland, Baltimore, said,"I wish to thank Dean Reece for his outstanding leadership in creating an even stronger medical school and wish him all the best as he transitions out of the deanship. Dean Reece leaves the School of Medicine in an excellent position for a new leader to take the school into a post-COVID world."

Growth of the Academic Enterprise

During his Deanship at UMSOM, Dr. Reece presided over dramatic growth of an academic enterprise that now totals 45 academic units, including 25 departments and 20 research centers, institutes, and programs. He expanded the UMSOM's academic facilities to 17 buildings, covering more than 2.5 million square feet of research and academic space, and led the planning and construction of a 430,000 square foot, state-of-the-art advanced research facility. Subsequently, he launched a nationwide investigator recruitment effort, resulting in 30 teams of top NIH-funded scientists from leading institutions across the country, joining the UMSOM's faculty of more than 3,500 physicians and scientists. He also led the complete renovation of Leadership Hall into an elegantly designed 700-seat theatre-style structure that now hosts major conferences and special events.

Over the past five years, Dean Reece has successfully recruited a new generation of department chairs with the appointment of top physicians and scientists from both inside and outside the UMSOM.

From the beginning of his tenure as Dean, Dr. Reece was keenly focused on elevating the UMSOM's leadership position in biomedical research, building on the foundation laid by his predecessor, a visionary leader, Dean Emeritus Donald Wilson, MD.Dean Reece laid out a specific plan to focus on "Big Science Research," with the goal of fundamentally changing the health care landscape and making a lasting and direct impact on patients' health and well-being.

Soon after joining UMSOM as Dean, Dr. Reece and Dr. Bruce Jarrell ( who served as the UMSOM Executive Vice Dean), successfully recruited two well-known and highly accomplished scientists and their research teams to the UMSOM: Claire Fraser, PhD, who established a new Institute for Genome Sciences (IGS), and Robert Gallo, MD, who transitioned the Institute of Human Virology (IHV) to the UMSOM. In the ensuing years, Dean Reece launched additional centers, such as STAR (Shock Trauma, Anesthesiology Research Center), and the Center for Epigenetic Research in Child Health & Brain Development, the Center for Blood Oxygen Transport and Hemostasis, and others, now totaling 20. He also significantly expanded the Center for Vaccine Development & Global Health.

In 2013, in the midst of a challenging economy and a dearth of commercial construction, Dean Reece embarked on an ambitious plan to construct a new world-class research facility for UMSOM. Despite significant challenges, Dean Reece, along with then-University System of Maryland Chancellor, Brit Kirwan, PhD, and with former UMB Presidents, the late Dr. David Ramsay, and Jay Perman, MD (now USM Chancellor), relentlessly pursued, and successfully implemented, a multi-faceted plan to make the new facility a reality.

In December, 2017, the UMSOM opened its new 430,000 square-foot research building Health Sciences Research Facility III (HSRF III), becoming the largest building ever constructed in the University System of Maryland, and setting a new standard of excellence in biomedical research, innovation, and discovery. Working in HSRF III's state-of-the art laboratories with cutting edge genomic technology, faculty physicians and scientists are now working together on breakthrough treatments for cancer, diabetes, and heart disease.

In 2013, Dr. Reece launched Accelerating Innovation and Discovery in Medicine (ACCEL-Med), a major UMSOM initiative designed to increase the pace and scope of clinical and basic sciences research. The Accel-Med initiative was launched with the first UMSOM "Festival of Science," which has become an annual full-day symposium highlighting the breakthrough research being conducted by UMSOM faculty. A cornerstone of Accel-Med was the Dean's formation of the UMSOM's first "Scientific Advisory Council" (SAC) to review and evaluate the UMSOM's research efforts on an annual basis. The Council, which included preeminent scientists, Nobel laureates and National Academy members, continues today.

At the inaugural Festival of Science, Dean Reece announced the opening of new core biomedical research facilities with funding from National Institutes of Health (NIH), called the Center for Innovative Biomedical Resources (CIBR). It was the first time that the UMSOM had established a center of excellence for state-of-the-art technologies, high-tech instrumentation, and expertise to support biomedical research, clinical practice, and health care. Dean's Challenge Awards were also established to provide seed funding to UMSOM scientists and encourage collaborations across departments. In 2021, the UMSOM has climbed to the top tier of medical schools in federal research funding.

"Dean Reece's mark on the School of Medicine is unmistakable; he's been integral to its enormous success," said University System of Maryland Chancellor Jay A. Perman, MD. "It's fitting that Dean Reece leaves the deanship at a time when the school is enjoying such well-deserved acclaim, nationally and internationally. I wish him all the best as he transitions into a role that gives him the same personal and professional satisfaction as have his 15 years leading the UMSOM."

Major National Designation and Clinical Expansion

Dean Reece led significant growth of the UMSOM's clinical practices across the State of Maryland during his tenure as Dean:

Added Cynthia Egan, current Chair of the UMSOM Board of Visitors: "There are many grateful patients whose care and cures have come from the exemplary leadership of the School of Medicine under Dean Reece. His relentless focus for excellence in research, academics, and developing extraordinary faculty and practitioners have advanced UMSOM to be a powerful force in delivering the best of medicine. It has been and will continue to be a true privilege to work with Dean Reece."

Commitment to Diversity, Equity and Inclusion

Dean Reece is known by faculty, staff, and colleagues for his "relentless pursuit of excellence" mantra, and his sincere dedication to making an impact on people's lives every day. He has been recognized for initiating a long-term school-wide culture transformation in diversity, equity, and inclusion. Through his leadership and close collaboration with faculty, students, and staff, the Culture Transformation Initiative (CTI) has become a top priority for the institution, with new programs aimed at ensuring equity in opportunity, recruitment, promotion, and compensation.

Dr. Reece's commitment to increasing diversity across the UMSOM has ignited positive changes and has resulted in growing numbers of women (40-60 percent) and under-represented minorities among senior leadership, faculty, and students. Specifically, women now make up more than 40 percent of UMSOM's senior leadership; the percentage of women faculty has increased to 40 percent, with under-represented minorities making up 11 percent. In the UMSOM student body, 60 percent of students are now women, and 25 percent are under-represented minorities.

Shaping the Future of Medical Education

Dr. Reece, as a scholar and educator, shaped the future of medical education in significant ways. He launched the first program for MD students in the nation on the Foundations of Research and Critical Thinking (FRCT), ensuring that the new generation of physicians would be equipped with the problem-solving and decision-making skills required for the future. Dr. Reece himself has consistently taught in the course. To further provide MD students with experience in data analysis and personalized medicine, the UMSOM was also the first medical school to offer pharmaco-genetic testing to all of its MD students to determine individualized responses to medication.

In 2020, despite the challenges posed by the COVID-19 pandemic that restricted in-class instruction for MD students, Dr. Reece and his team in Academic Affairs successfully renewed and launched a new innovative MD program of medical study and training -- the Renaissance Curriculum. Developed over several years, this fully integrated curriculum takes a systems-based, holistic approach to learning, combining instruction in both the health and disease processes of the body related to major organ systems. Given its optimized format, the Renaissance Curriculum also allows students to enter the clinical portion of medical school earlier.

He has overseen the significant growth of UMSOM's Community Education Pipeline Program. The program, directed by two biomedical scientists, Greg Carey, PhD, Associate Professor Microbiology and Immunology and Director of Student Summer Research and Community Outreach in the Office of Student Research, and Bret Hassel, PhD, Professor of Microbiology and Immunology and Assistant Director for Training & Education. They have established education programs for undergraduate and high school students, as well as educational opportunities for STEM research and mentoring of students from a wide variety of backgrounds.

Michael Cryor, President of the Cryor Group, who served with Dean Reece for 10 years as Chair of the UMSOM's Board of Visitors, said, "As Chair Emeritus of the medical school's Board of Visitors, I have been witness to many facets of unparalleled growth at the medical school under Dean Reece's leadership-increased research funding, pivotal roles in vaccine development here and around the world and an increasing focus on student education. I was a member of the search committee to select the candidate who would follow the celebrated tenure of Dr. Donald Wilson. We were convinced Dean Reece was the right choice. His successful tenure is proof positive that we made the right selection," he said.

The Power of Partnership

Dean Reece's career at the University of Maryland has been marked by a collaborative approach to leadership and management at every level.

His close collaboration with the University of Maryland Medical System was highlighted as a national model in a 2012 article that he co-authored with former UMMS President & CEO Robert Chrencik, MBA, CPA, in the journal, Academic Medicine. The article, entitled, Fully Aligned Academic Health Centers: A Model for 21st-Century Job Creation and Sustainable Economic Growth, described the unique and highly effective alignment established between UMSOM and UMMS. Dr. Reece and Mr. Chrencik coined the phrase, "The Power of Partnership," noting that alignment of the clinical and research missions resulted in significant economic benefits for the State of Maryland.

The close partnership Dean Reece established between UMSOM and UMMS also resulted in expanded UMSOM faculty clinical practice locations in UMMS hospitals as well. New multi-specialty locations were established in Harford, Howard, and Prince George's County, with state-of-the-art facilities for urgent care, vascular surgery, trauma, orthopaedics, and other specialties.

Mohan Suntha, MD

"Throughout his tenure as Dean of the University of Maryland School of Medicine, Dr. Reece has been an unabashed champion of discovery-based medicine," said UMMS President and CEO Mohan Suntha, MD, MBA."His relentless focus has led to incredible advances and recognition for the university while simultaneously advancing our patient care mission. I have been truly blessed to call him a friend, mentor, and colleague throughout his 15 years at the helm of the School of Medicine."

Added Bert W. O'Malley, MD, President and CEO, University of Maryland Medical Center (UMMC). "From working with Dean Reece, and knowing of his many accomplishments, it is clear that he has a unique combination of visionary talent along with the ability to execute with surgical precision and exceed all expectations. I've greatly enjoyed our partnership in advancing the mission of academic medicine and look forward to continuing to work with him during his transition and in his new role."

Dean Reece also prioritized opportunities for UMSOM's collaboration with other universities in the USM, and with other schools at UMB. During his tenure, there was a significant increase in collaborative research efforts across the USM, with marked growth of interdisciplinary funding between UMSOM-both with the other schools at UMB, as well as with other USM campuses.

About the University of Maryland School of Medicine

Now in its third century, the University of Maryland School of Medicine was chartered in 1807 as the first public medical school in the United States. It continues today as one of the fastest growing, top-tier biomedical research enterprises in the world -- with 45 academic departments, centers, institutes, and programs; and a faculty of more than 3,000 physicians, scientists, and allied health professionals, including members of the National Academy of Medicine and the National Academy of Sciences, and a distinguished two-time winner of the Albert E. Lasker Award in Medical Research. With an operating budget of more than $1.2 billion, the School of Medicine works closely in partnership with the University of Maryland Medical Center and Medical System to provide research-intensive, academic and clinically based care for nearly 2 million patients each year. The School of Medicine has more than $563 million in extramural funding, with most of its academic departments highly ranked among all medical schools in the nation in research funding. As one of the seven professional schools that make up the University of Maryland, Baltimore campus, the School of Medicine has a total population of nearly 9,000 faculty and staff, including 2,500 student trainees, residents, and fellows. The combined School of Medicine and Medical System ("University of Maryland Medicine") has an annual budget of nearly $6 billion and an economic impact more than $15 billion on the state and local community. The School of Medicine, which ranks as the 8th highest among public medical schools in research productivity, is an innovator in translational medicine, with 600 active patents and 24 start-up companies. The School of Medicine works locally, nationally, and globally, with research and treatment facilities in 36 countries around the world. Visit http://www.medschool.umaryland.edu.

SOURCE University of Maryland School of Medicine

http://www.medschool.umaryland.edu

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UM School of Medicine Dean Announces He Will Transition From The Deanship In 2022 After Completing 16-Year Tenure - PRNewswire

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Health Logic Interactive Inc., Acquires Next-Generation Lab-On-Chip Medical Diagnostic Technology – PRNewswire

April 4th, 2021 6:47 am

TSX.V: CHIP.H

CALGARY, March 29, 2021 /PRNewswire/ -Health Logic Interactive Inc. ("Health Logic" or the "Company") (TSX.V: CHIP.H),is pleased to announce its wholly owned operating subsidiary, My Health Logic Inc. ("My Health Logic"), has entered into a license agreement (the "License Agreement")with an arm's length third party (the "Licensor") pursuant to which My Health Logic has a worldwide, exclusive license to the UAL-Chip, a patent pending lab-on-chip ("LOC") technology that has the potential to be used in a smartphone connected, hand-held device to provide rapid point-of-care ("POC") diagnosis of Chronic Kidney Disease ("CKD").

CKD is a life-changing chronic condition that is harmful for patients and extremely expensive to treat unless caught early. Over 850 million people globally and 37 million people in the United States have CKD, and total healthcare costs for treatment of CKD in the US exceed $120B per year. The key to preventing the major harms from CKD, such as kidney failure, kidney dialysis, and death, is early testing and treatment; however, approximately 90% of those afflicted by CKD do not realize they have it. We believe that providing patients and caregivers a low-cost, accessible tool for early diagnosis and treatment is an opportunity to help millions of at-risk patients and start to bend the cost curve for health systems worldwide.

UAL-Chip technology has the potential to drive a much-needed disruption of the legacy systems used for CKD testing and accelerate the trend towards automation, digitization and personalization in the healthcare industry. The UAL-Chip can utilizemicrofluidic technology to test for the albumin levels in urine and deliver rapid results to a users' smartphone and their healthcare practitioner. Currently, <50% of at-risk patients are tested; we expect that introducing digitally connected home testing solutions would increase this number by removing one of the current barriers to testing, being attendance at a central lab, and would also provide My Health Logic with the opportunity to develop a robust platform for continuous digital patient monitoring and care for CKD of all stages.

"CKD is common, costly and harmful for patients and communities. It is also under-recognized. Bringing the CKD diagnosis into the home is a disruptive approach that could bridge the screening gap for millions of patients, allowing early detection and treatment, preventing harms for millions, and reducing health costs by billions" Dr. Claudio Rigatto, Co-Inventor, Seven Oaks General Hospital

"Our lab-on-chip platform can give accurate results rivalling central laboratories in precision but in an accessible, low cost and rapid form usable in the home, fulfilling the dream of true point-of-care diagnosis and personalized medicine." Dr. Francis Lin, Lead Inventor

Highlights of the Market:

Highlights of the Technology:

The Technology was invented by the world-renowned team of nephrologists at Seven Oaks General Hospital including Dr. Navdeep Tangri, Dr. Paul Komenda, and Dr. Claudio Rigatto, and biomedical engineering LOC expert Dr. Francis Lin. The team of inventors are expected to play an active role in the ongoing development of the lab-on-chips, and MATLOC device as we pursue regulatory approvals with Health Canada and the US Food and Drug Administration ("FDA") via an accelerated 510K pathway. In addition to the ongoing guidance from the inventors, the Company plans to on board and engage strategic industry thought leaders and experts to best guide My Health Logic through the development process to successful commercialization, for which there is no guarantee.

My Health Logic's obligations under the License Agreement include: (a) developing, manufacturing and selling products that incorporate the licensed technology ("Licensed Products"); (b) marketing Licensed Products in the US and Canada within 6 months of receiving regulatory approval; (c) reasonably filling market demand for Licensed Products following marketing; (d) obtaining all necessary governmental approvals for the activities in (a); and (e) spending at least $650,000 on the development of Licensed Products during the first four years of the License Agreement. As consideration for the license and other rights under the License Agreement, My Health Logic will pay Licensor annual royalties on net sales of Licensed Products, cover past patent costs, pay annual license maintenance fees and make certain payments upon the occurrence of milestone events in the regulatory approval process with respect to Licensed Products.

The Company is also pleased to announce that it plans to conduct a non-brokered private placement for gross proceeds of up to $1.4M, subject to approval of the TSX Venture Exchange.

About the Company

Health Logic Interactive, through its wholly owned operating subsidiary My Health Logic, is developing and commercializing consumer focused handheld point-of-care diagnostic devices that connect to patient's smartphones and digital continued care platforms. The Company plans to use their patent pending lab-on-chip technology to provide rapid results and facilitate the transfer of that data from the diagnostic device to the patient's smartphone. The Company expects this data collection will allow it to better assess patient risk profiles and provide better patient outcomes. Our mission is to empower people with the ability to get early detection anytime, anywhere with actionable digital management for chronic kidney disease. For more information visit us at:www.healthlogicinteractive.com

Neither the TSX Venture Exchange nor its regulation services provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward Looking Statements

Cautionary Note Regarding Forward-Looking Statements: This release includes certain statements and information that may constitute forward-looking information within the meaning of applicable Canadian securities laws. Forward-looking statements relate to future events or future performance and reflect the expectations or beliefs of management of the Company regarding future events. Generally, forward-looking statements and information can be identified by the use of forward-looking terminology such as "intends" or "anticipates", or variations of such words and phrases or statements that certain actions, events or results "may", "could", "should", "would" or "occur". This information and these statements, referred to herein as "forwardlooking statements", are not historical facts, are made as of the date of this news release and include without limitation, statements regarding discussions of future plans, estimates and forecasts and statements as to management's expectations and intentions with respect to, among other things: development, manufacture and sale of Licensed Products; performance of obligations under the License Agreement; plans to engage the inventors and other experts to assist with regulatory approval and commercialization of Licensed Products; plans for and expected benefits of the licensed technology; and the Offering.

These forwardlooking statements involve numerous risks and uncertainties and actual results might differ materially from results suggested in any forward-looking statements. These risks and uncertainties include, among other things: My Health Logic's ability to develop, manufacture and sell the Licensed Products, perform its obligations under the License Agreement and otherwise implement its business strategies; My Health Logic's ability to obtain regulatory approval of Licensed Products; and the Company's ability to obtain regulatory approval of the Offering and complete the Offering on the proposed terms.

In making the forward looking statements in this news release, the Company has applied several material assumptions, including without limitation, that: My Health Logic will be able to develop, manufacture and sell the Licensed Products, perform its obligations under the License Agreement and otherwise implement its business strategies; My Health Logic will be able to obtain all necessary regulatory approvals with respect to Licensed Products; and the Company will be able to obtain all necessary regulatory approvals with respect to the Offering, and the Company will be able to complete the Offering on the proposed terms.

Although management of the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements or forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. Readers are cautioned that reliance on such information may not be appropriate for other purposes. The Company does not undertake to update any forward-looking statement, forward-looking information or financial out-look that are incorporated by reference herein, except in accordance with applicable securities laws. We seek safe harbor.

SOURCE Health Logic Interactive Inc.

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Health Logic Interactive Inc., Acquires Next-Generation Lab-On-Chip Medical Diagnostic Technology - PRNewswire

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Seventure Partners: New Report Reveals Links Between Covid-19 and the Microbiome – Business Wire

April 4th, 2021 6:47 am

PARIS--(BUSINESS WIRE)--Seventure Partners, one of Europes leaders in financing innovation and a world leader in life science microbiome investment, has published an analysis highlighting the close links between Covid-19 and the individuals microbiome.

The report titled Understanding the potential to monitor and modulate the COVIBIOME to improve patient resilience and outcome analyses a number of features of Covid-19 that are believed to have links to the microbiome, including:

In recent years, we have seen an increasing amount of data that indicate that the microbiome is likely to have strong links with our immune system and our immune health. As our understanding steadily grows on how Covid-19 affects our body, it also gives us an opportunity to understand how our microbiome is affected and how we can use this knowledge to improve treatments or enhance protection. Our report reveals a series of scientific findings on the connection between the virus and our microbiome, said Isabelle de Cremoux, CEO and Managing Partner, Seventure Partners, who led Health for Life Capital fund raising and microbiome strategy and author of the report.

To request a copy of the report, please email contact@seventure.fr

-ENDS-

Notes to Editors

About Seventure Partners

With 850m net commitments under management as of the end of 2020, Seventure Partners is a leading venture capital firm in Europe. Since 1997, Seventure Partners has been investing in innovative businesses with high growth potential in two fields: Life sciences across Europe, Israel, Asia and North America, and Digital technologies in France and Northern Europe.

In life sciences, the main areas of focus include classic approaches such as biotechnology and pharmaceuticals, diagnostic and medtech, industrial biotechnology, as well as beyond the pill approaches such as MICROBIOME-linked innovations, nutrition, foodtech, digital/connected health, wellbeing and personalized medicine & personalized nutrition.

About Health for Life Capital

Seventure Partners launched Health for Life Capital, the first venture capital fund focused mainly on investments beyond the pill in the microbiome and nutrition space. Europe is the primary focus of the fund, but it also invests in North America, Asia and Israel.

The 160m first fund launched in 2014 has invested in 20 companies at the forefront of their fields, such as Enterome, Vedanta Biosciences, MaaT Pharma, Eligo Bioscience, Ysopia Bioscience, TargEDys, A-Mansia Biotech, BiomX, Microbiotica, LiMM Therapeutics, Siolta Therapeutics, DayTwo, Zipongo (renamed Foodsmart), Cambrooke, Mdoloris Medical Systems, MycoTechnology, etc.

In 2019 it launched second fund Health for Life Capital II with a target fund size of over 200m which invested in Axial Therapeutics, BCD, Citryll, Dermala, Ervaccine, Federation Bio, Galecto, etc.

Both first fund and second fund attracted strategic investments from prestigious organizations including Danone, Novartis, US based global food ingredient providers (to be disclosed), Lesaffre, Tornier, Tereos, Unigrains and Bel, as well as financial institutions, family offices and entrepreneurs.

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Seventure Partners: New Report Reveals Links Between Covid-19 and the Microbiome - Business Wire

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Cell and Gene Therapy Drug Delivery Devices Market, 2030 – Market Opportunities in the Strong Pipeline of Cell and Gene Therapies – PRNewswire

April 4th, 2021 6:46 am

DUBLIN, March 30, 2021 /PRNewswire/ -- The "Global Cell and Gene Therapy Drug Delivery Devices Market: Focus on Product Type, Commercialized Drug Delivery Devices, Country Data (16 Countries), and Competitive Landscape - Analysis and Forecast, 2020-2030" report has been added to ResearchAndMarkets.com's offering.

The global cell and gene therapy drug delivery devices market was valued at $55.75 thousand in 2019, and is expected to reach $375.13 thousand by 2030, registering a CAGR of 16.61% during the forecast.

Cell and gene therapy drug delivery industry is a transformative industry whose full potential is only just beginning to emerge. Cell and gene therapy involves the extraction of cells, protein, or genetic material (DNA) from the donor, and altering them to provide highly personalized therapy. Cell and gene therapies may offer longer-lasting effects than traditional medicines.

One of the significant drugs of the cell and gene therapy industry is CAR-T cell-based medicines, which include both cell therapy and gene therapy. Various market players are actively investing in the research and development of the cell and gene therapy industry. The players are offering improved and new products, which meet the critical needs of patients.

The growth is attributed to major drivers in this market such as the increasing prevalence of cancer and chronic diseases, increased funding in the cell and gene therapy market, rising need to develop novel treatment options for rare diseases, and rising biopharmaceutical R&D expenditure, and rising number of the FDA approvals of cell and gene therapies & clinical trials. The market is expected to grow at a significant growth rate due to various potential opportunities of growth that lie within its domain, which include drug approvals and strong pipeline of cell and gene therapies.

Various new cell and gene-based therapy approaches use biological engineering to improve the immune system's capacity to fight disease while sparing healthy tissues in the body. For instance, there are antibody-based therapies that can make T-cells more effective by increasing their interactions with cancer cells. Other modifications, such as adding complexity to the CAR-T and cancer cell interaction, which can further sharpen T-cells' cancer-targeting ability by reducing damage to normal cells.

The increase in the geriatric population and an increasing number of cancer cases, and genetic disorders across the globe are expected to translate into significantly higher demand for cell and gene therapy drug delivery devices market.

Furthermore, the companies are investing huge amount in research and development of cell and gene therapies and associated drug delivery devices products. The clinical trial landscape of various genetic and chronic diseases has been on the rise in the recent years, this will fuel the cell and gene therapy drug delivery devices market in future.

Within the research report, the market is segmented based on product type, commercialized drugs, and region. Each of these segments covers the snapshot of the market over the projected years, the inclination of the market revenue, underlying patterns, and trends by using analytics on the primary and secondary data obtained.

Competitive Landscape

The exponential rise in the application of precision medicine on a global level has created a buzz among companies to invest in the development of novel cell and gene therapy drug delivery devices.

Due to the diverse product portfolio and intense market penetration, Novartis AG, Kite Pharma Inc., and Dendreon Pharmaceuticals LLC. have been the pioneers in this field and been the major competitors in this market.

The other major contributors of the market include companies such as Vericel Corporation, Amgen Inc., Bausch & Lomb Incorporated, Spark Therapeutics, Inc., and Becton, Dickinson and Company.

Based on region, North America holds the largest share of cell and gene therapy drug delivery devices market due to substantial investments made by biotechnology and pharmaceutical companies, improved healthcare infrastructure, rise in per capita income, early availability of approved therapies, and availability of state-of-the-art research laboratories and institutions in the region. Apart from this, Asia-Pacific region is anticipated to grow at the fastest CAGR during the forecast period.

Key Topics Covered:

1 Technology Definition

2 Research Scope

3 Key Questions Answered in the Report

4 Research Methodology

5 Market Overview5.1 Introduction5.2 Cell and Gene Therapies and Drug Delivery Devices Industry5.3 Cell and Gene Therapy Drugs and Their Clinical Importance5.4 Cell and Gene Therapy Drug Delivery Devices Market: Current Scenario5.5 Cell and Gene Therapy Drug Delivery Devices Market: Future Perspective

6 Global Cell and Gene Therapy Drug Delivery Devices Market and Growth Potential, 2020-20306.1 Overview6.2 Pipeline Analysis6.2.1 Drug Delivery Systems in Development: Current Scenario6.2.1.1 Ongoing Clinical Trials of Drug Delivery Systems6.2.1.2 Limitations of Cell and Gene Therapy Drug Delivery Devices6.2.1.3 Recent Advancements in Gene Therapy Drug Delivery6.3 Cell and Gene Therapy Drug Delivery Devices Market and Growth Potential6.4 Cell and Gene Therapy Drug Development and Commercialization Landscape6.5 Impact of COVID-19 on Cell and Gene Therapy Drug Delivery Devices Market6.5.1 Impact of COVID-19 on Global Cell and Gene Therapy Drug Delivery Devices Market Growth Rate6.5.2 Impact of COVID-19 on Supply Chain of Cell and Gene Therapy Drug Delivery Devices Market6.5.3 Clinical Trial Disruptions and Resumptions

7 Emerging Technology Landscape7.1 Potential Technologies in Cell and Gene Therapy Drug Delivery Devices Market7.2 Microchip Technology7.3 Nanotechnology-Based Drug Delivery Devices7.4 Lipid Nanoparticles in Gene Therapy

8 Market Dynamics8.1 Impact Analysis8.2 Market Drivers8.2.1 Increasing Prevalence of Cancer and Chronic Diseases8.2.2 Increased Funding of Cell and Gene Therapies8.2.3 Rising Number of FDA Approvals of Cell and Gene Therapies, and Clinical Trials8.3 Market Restraints8.3.1 Stringent Legal Requirements and Regulations8.3.2 Injuries and Infections Caused by Needles8.4 Market Opportunities8.4.1 Strong Pipeline of Cell and Gene Therapies

9 Industry Insights9.1 Regulatory Scenario of Cell and Gene Therapy Drug Delivery Devices Market9.1.1 Overview9.1.2 Risk Assessment of Medical Devices9.1.3 Regulation of Medical Devices in the U.S.9.1.4 Regulation of Medical Devices in Europe9.1.5 Regulation of Medical Devices in Asia-Pacific9.2 Pricing and Reimbursement of Cell and Gene Therapy Drug Delivery Devices

10 Patent Landscape

11 Global Cell and Gene Therapy Drug Delivery Devices Market (by Product Type)11.1 Overview11.2 Subretinal Injection Cannula11.3 Extension Tube11.4 Intravenous Catheter11.5 Sterile Insulin Syringe11.5.1 Sterile Insulin Syringe (Size 1.0 ML, 31-Gauge Needle)11.5.2 Sterile Insulin Syringe (Size 0.5 ML, 22 Gauge Needle)11.6 Pre-Filled Syringe11.6.1 Pre-Filled Syringe (Size 1.0 ML, 22-26 Gauge Needle)11.6.2 Pre-Filled Syringe (Size 4.0 ML, 22-26 Gauge Needle)11.7 Infusion Bags11.7.1 Infusion Bags (Size 10 ML to 50 ML)11.7.2 Infusion Bags (Size 68 ML)11.7.3 Infusion Bags (Size 60 ML)11.7.4 Infusion Bags (Size Up to 65 ML)

12 Global Cell and Gene Therapy Drug Delivery Devices Market (by Commercialized Drugs)12.1 Commercialized Drugs12.1.1 Luxturna12.1.2 Kymriah12.1.3 Provenge12.1.4 Zolgensma12.1.5 Yescarta12.1.6 Strimvelis

13 Global Cell and Gene Therapy Drug Delivery Devices Market (by Region)13.1 Overview

14 Competitive Landscape14.1 Key Developments and Strategies14.1.1 Overview14.1.2 Regulatory and Legal Developments14.1.3 Synergistic Activities14.1.4 M&A Activities14.1.5 Funding Activities14.2 Market Share Analysis

15 Company Profiles

For more information about this report visit https://www.researchandmarkets.com/r/2mcxqt

Media Contact:

Research and Markets Laura Wood, Senior Manager [emailprotected]

For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716

SOURCE Research and Markets

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Excerpt from:
Cell and Gene Therapy Drug Delivery Devices Market, 2030 - Market Opportunities in the Strong Pipeline of Cell and Gene Therapies - PRNewswire

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