StemCell Therapy

Dr Jane Cooke Wright whether youve heard of her or not, her research changed the path of oncology, paving the way for cancer treatment as we know it.In a time when medicine and research were predominantly white and male, Jane and her family had challenged the preconceptions of what a scientist should be. Jane and her sister, Barbara, represented the third generation of Wright family medics; the tradition began with their grandfather, who, after being born into slavery, later graduated from Meharry Medical College as valedictorian of his class. Their father, Dr. Louis Tompkins Wright, was one of the first African-American graduates of Harvard Medical School and founded the Harlem Hospital Cancer Research Foundation (HHCRF).

After briefly considering the idea of pursuing an art degree, Wright graduated with honors from New York Medical College and in 1949 began working with her father at the HHCRF.

Chemotherapy wasnt always one of the go-to approaches for cancer treatment. In the early to mid-20th century, using drugs to treat cancer was considered somewhat experimental, only to be used if other treatment avenues had been exhausted. Despite the hesitant attitudes towards chemotherapeutic agents, Wright and her colleagues made many strides towards establishing chemotherapy as a viable treatment for cancer.

One of the most significant came in 1951; Wright led a seminal piece of research that laid the foundations for treating solid tumors chemotherapeutically.1 The study primarily established the efficacy of methotrexate, a folic acid antagonist, in treating breast cancer, which was a major result in itself. However, it also demonstrated the long-term efficacy of combination therapy and adjustment of treatment regimens according to the individual patients symptoms of toxicity. Methotrexate continues to be used to this day, alone or in combination, to treat a range of cancers from head and neck to non-Hodgkins lymphoma.

Adjusting treatment according the individual was an idea forming the basis of much of Wrights research, representing some of the early steps towards personalized medicine. Whilst previous researchers had used mice tumors as a model for predicting response to different chemotherapeutics, Wright and her colleagues cultured tumor tissue taken from patients. Once grown, the primary cultures were treated with a variety of chemotherapeutic agents and their response was assessed. In doing so, Wright helped to develop a method for testing and selecting the most effective course of chemotherapy for a particular tumor in an individual patient.2

The solution came in 1964, in the form of the American Society of Clinical Oncology (ASCO), of which Wright was a founding member and notably, the only woman of the founding group. In a 2010 interview, Wright explained why the society was created:

Our goals were to bring about a set of standards for a clinical oncology specialty, to enlarge the area of knowledge in the field and to ensure that vital information was readily available and disseminated.3Wright set out to achieve these goals during her tenure as associate dean and professor of surgery at her alma mater, New York Medical College, developing cancer treatment guidelines and a program teaching doctors how to use chemotherapy. Her appointment to the position was also a significant social feat at the time; upon taking office in 1967, Wright became the highest ranked African American woman at a nationally recognized medical institution. This was only one of a number of high-ranking positions held by Wright over the next 20 years.

In a 2011 interview, Wrights daughter, Alison W. Jones, PhD, gave an insight into how her mother achieved so much in a time and society which often had preconceptions of what a womans life should be. She never looked at things as obstacles, Jones explained. She looked at them as challenges and I think that she was a very ambitious person and I think that she never let anything stand in the way of her doing what she wanted to do.

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Jane C. Wright: The Woman Who Changed the Landscape of Oncology - Technology Networks

Drug testing and screening for cancer drug discovery can take years and the 2D cell cultures and animal models used to estimate their efficacy before reaching human trials are often not representative of the human body, which is why researchers are turning to bioprinting technologies to increase the success rate during human trials by providing human-specific preclinical data. In 2018 there were 17 million new cases of cancer worldwide, and the disease is expected to affect 27.5 million people each year by 2040, this high incidence level makes tackling the disease enough of a reason for researchers to consider new technologies that could accelerate drug discoveries and screenings. Although still in its lab phase, a new development that uses immersion bioprinting of human organoids could change 3D drug screening.

Researchers from Cornell University, Wake Forest School of Medicine, Virginia Polytechnic Institute and State University and The Ohio State University have published an article in Micromachines, demonstrating an immersion printing technique to bioprint tissue organoids in 96-well plates to increase the throughput of 3D drug screening. Using a hydrogel bioink comprised of hyaluronic acid (HA) and collagen they were able to bioprint it into a viscous gelatin bath, which blocks the bioink from interacting with the well walls and provides support to maintain a spherical form.

According to the article, the use of bioengineered human cell-based organoids may not only increase the probability of success during human trials, but they could also be deployed for personalized medicine diagnostics to optimize therapies in diseases such as cancer. However, they suggest that one limitation in employing organoids in drug screening has been the difficulty in creating large numbers of homogeneous organoids in form factors compatible with high throughput screening, so bioprinting can be used to scale up the deposition of such organoids and tissue constructs.

The team of scientists employed two commercially available bioprinters to evaluate the compatibility of the collagen-HA hydrogel and the HyStem-HP hydrogel: Cellinks INKREDIBLE bioprinter and Allevis Allevi2 bioprinter. This method was validated using several cancerous cell lines and then applied to patient-derived glioblastoma (GBM) a fast-growing brain tumor and sarcoma (or malignant tumor) biospecimens for drug screening.

For the initial analysis of hydrogel biocompatibility, researchers used two common cell lines: human liver cancer and human colorectal cancer.

While carrying out patient-derived tumor biospecimen processing, they obtained two glioblastomas and one sarcoma biospecimen from three surgically treated patients in adherence to the guidelines of the Wake Forest Baptist Medical Center IRB protocols. These biospecimens were processed into cell suspensions, successfully yielding millions of viable cells from each sample. The cells were then combined with the collagenHA bioink for deployment in immersion bioprinting. After bioprinting, the GBM and sarcoma patient-derived tumor organoids (PTOs) were maintained for seven days in the incubator, after which a chemotherapy screening study was initiated.

Schematic of the printing process using 2 bioinks in two commercially available bioprinters: Cellink Inkredible and Allevi 2 (Image: Cornell University/Wake Forest)

The researchers claim that while their PTOs have been useful for disease modeling, mechanistic study, and drug development, they have also used these models in a diagnostic sense to influence therapy, which might just be the ultimate goal of their work.

This 3D bioprinting approach called immersion bioprinting is an efficient way to surpass the limitations that have plagued tumor organoid systems. The experts, in this case, suggest that there have been few advances in regard to approaches to the printing process itself, or generation of novel, more user-friendly bioinks. Indicating that unfortunately, many bioprinting studies are somewhat repetitive, falling back on traditional biomaterials and their crosslinking approaches, which were never developed to be bioprinted or to accurately represent the complexities of the native ECM (extracellular matrix).

Results of the published study suggests that the realization of this technology that can fabricate PTOs in a consistent and high-throughput fashion will provide a valuable ex vivo/ in vitro tool that can be deployed for many subsequent studies, including target discovery, mechanistic investigation of tumor biology, drug development, and personalized drug screens to aid in treatment selection in the clinic.

Clinical oncology is faced with some critical challenges during this decade, from inefficient trial design to integrating new technologies in diagnostics and drug trails. However, advances in new methodologies, from hardware design to improved bioinks developed specifically for bioprinting, are opening up new opportunities for bioprinting-based applications. This new study, in particular, suggests that with advances in bioprinting hardware, software, functional ECM-derived bioinks, and modifications to printing protocols, bioprinting can be harnessed not only to print larger tissue constructs, but also large numbers of micro-scaled tissue and tumor models for applications such as drug development, diagnostics, and personalized medicine.

Employing bioprinted patient-derived tumor organoids in a clinical precision medicine setting (Image: Cornell University/Wake Forest)

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New Method: Immersion Bioprinting of Tumor Organoids Will Increase the Throughput of 3D Drug Screening - 3DPrint.com

Lee Carmen, Associate VP for Information Systems and CIO, University of Iowa Health Care

Lee Carmen, Associate VP for Information Systems and CIO, University of Iowa Health Care

Lee Carmen was appointed associate vice president for information systems in July 2007. Carmen oversees information technology services, including technical support, applications development, and clinical applications across the University of Iowa Health Care enterprise

As a CIO, what are some of the recent trends that you see in the healthcare space?

As the CIO of a large Midwestern quaternary care medical center, I have expertise in varied domains from electronic medical records (EMRs) and clinical systems to security, networking, data management, and analytics. As far as the recent trends are concerned, with the advent of technologies like artificial intelligence, healthcare organizations are highly interested in partnering with companies that have experience in managing and analyzing large data sets.

How do you keep abreast of the innovative technologies entering the healthcare space?

Fortunately, the information architecture at Iowa is quite similar to the architectures at peer institutions. They not only have the same EMR solution but also analytics tools, nurse call systems, clinical monitoring systems, allowing us to collaborate, inform and advise each other on new technology advances and implementations. To leverage more from this professional networking, we interface with our key vendor partners for EMRs,or clinical equipment and our ERP partners. We engage the early adopters of emerging technologies to reap the benefits of the services today as well as in the future. Being an academic medical center, we have many nationally recognized researchers, who share new technologies of interest or value with us. To gain more insight into the ever-evolving technology landscape, we keep an eye on the new patents being released, the venture capitalists funding, and the IPOs from a business angle.

What is your checklist for choosing technology vendors?

Many IT companies today have limited experience in healthcare operations, so one of the first things we check is the vendors experience in the space based on the customers they are currently working with. Since we operate with 850 beds, generating yearly revenue of $2.5 billion, a vendor for a 100-bed community hospital might not be a match. However, we further look at their viability, operational tenure, and funding model. Our team of security, data architecture, data networking, and user design experts works closely with the vendor, to ensure they both are on the same page of design, scalability, and architecture.

As we expand our technology footprint in a healthcare setting, we also need to train our workforce for implementing and supporting the technicalities

Elaborate on some of the current projects that you are currently overseeing, and what impacts do you hope to get out of them?

With provider productivity, efficiency, and burnout being the hot issues today, the introduction of additional technology into clinical settings can often have a negative effect on the healthcare providers. To ensure that the technology we bring in is a net benefit instead of a net detriment to the providers, we focus on designing, configuring, and implementing systems in a way that supports their everyday workflows.

While many new players are making their way into the healthcare communication space, there are established vendors refreshing their product lines on-the-move. Looking at the communication between clinicians and patients during treatment, we evaluate whether the tools in place are adequate to meet the care delivery needs, or do they need modernization. We provide patients with self-service tools, enabling them to schedule appointments and ask questions of their providers. We are configuring our existing enterprise systems to allow them to take inpatient data from network-enabled devices such as Apple watches or glucose monitors. Further, the next step is to augment this collected data in a safe, scalable, secure way that is relatively easy for our patient population to access.

Do you have any additional highlights on the challenges persistent in the healthcare arena?

There is a never-ending challenge to recruit talented technology professionals in the healthcare space. As we expand our technology footprint in a healthcare setting, we also need to train our workforce for implementing and supporting the Technology.

What are some of the leadership principles that you abide by to influence your peers and subordinates?

I believe I am here to work for my staff, rather than having them work for me. My role is to communicate between other leaders in the organization and my team about the strategic direction and operational needs of the company and accentuate areas of focus. Understanding my teams requirements in terms of direction and resources to further meet the organizational needs, I act as a buffer between these two parties. I also attempt to remove the barriers for my technology teams, allowing them to bring out the best of their abilities and get solutions into production, as timely as possible. In addition, my responsibilities include working with and advising our executive leadership team on what we could develop or implement to support the growth of the organization.

How do you think the future of healthcare would turn out to be?

With healthcare in rural settings being a big issue for us, projecting forward, the focus will be on the telemedicine space and on the ability to deliver and receive care from providers at any geographic location convenient for the patient. Besides the advances in automation, we will be witnessing the rise of technology-enhanced alternate care delivery models, which will be different from visiting a physical clinic or an emergency room. At our organization, one of our physician-researchers has developed the first FDA approved AI device that screens patients for diabetic retinopathy by taking images of their eye and running it through an AI engine for a clinical interpretation. This device cuts down the physician's need to diagnose, freeing up their time to focus on more complex areas. Besides the development of tools like EMRs to accept different types of data inputs, advancements are occurring in the personalized medicine space and the ability to find diagnosis and treatment strategies for patients based on their unique requirements, all driven by data.

What is your advice to an aspiring CIO of a healthcare establishment?

Healthcare organizations are unique places to work in as you are surrounded by some of the smartest, most dedicated, and hard-working members of our society, such as doctors, nurses, pharmacists, and others. My advice to the junior staff is to take advantage of the environment they are working in, and understand how every different person and team interacts with a patient. Be it an outpatient world, an inpatient one, an emergency room, an intensive care unit, or an operating roomall come with different requirements; you need to be exposed to different health care delivery areas to understand its nuances. Aspiring healthcare IT professionals need to listen and absorb everything from the various clinical settings as it will have a significant impact on the services that they can ultimately deliver back to the organization.

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Keeping Up with the Change in Healthcare - CIOReview

Most development-stage biopharmaceutical companies pin their hopes on a single clinical hypothesis evaluated with a handful of drug candidates at best. Fate Therapeutics(NASDAQ:FATE) is not most early stage companies.

The cellular therapy pioneer is developing 13 unique pipeline programs. That may give the impression that Fate Therapeutics is throwing everything at the wall and seeing what sticks, but a closer look shows there's been a rational build-out of the pipeline. That doesn't necessarily mean all of the hypotheses will work -- development-stage biopharmas are inherently risky investments -- but if the lead clinical programs report promising data in 2020 from the next wave of major trials, investors might begin to see the value of the company's vision.

Here's why this pharma stock is my top buy in March.

Image source: Getty Images.

Fate Therapeutics has staked its future on the general idea that first-generation immunotherapies leave much room for improvement. It's not wrong. The successful development of chimeric antigen receptor (CAR) T cells put cellular therapy on the map a few years ago, but there are inherent limitations to their production and use.

Take Yescarta as an example. In the second half of 2017, it became the second CAR-T drug to earn approval from the U.S. Food and Drug Administration (FDA). It's a personalized medicine used to treat certain cancers of white blood cells. To make a dose, immune cells are harvested from a patient, isolated, genetically engineered to attack the patient's cancer, multiplied in the lab, and then administered back into the patient.

The immunotherapy is highly effective. In a large post-approval study involving 533 individuals, Yescarta achieved an overall response rate of 84% and a complete response rate of 66%. That means 84% of individuals responded to treatment and 66% of individuals had no evidence of disease after six months. The study proved why Gilead Sciences was wise to acquire Kite Pharma, which developed Yescarta and pioneered CAR-T therapies.

But first-generation immunotherapies such as Yescarta have limitations. Using donor- or patient-derived cells increases the complexity of treatment, which increases costs and the potential for errors. Manufacturing a dose of a patient-derived CAR-T therapy can take two to three weeks and cost $425,000. Hospitals administering CAR-T therapies can charge as much as $1.5 million to ensure they aren't losing money while adhering to stringent protocols.

CAR-T therapies can also cause severe side effects including cytokine release syndrome (CRS) and neurotoxicities (Yescarta comes with a boxed warning for these side effects). They can only be dosed once. And engineering them with first-generation gene editing tools such as CRISPR/Cas9 has been found to be error-prone. Fate Therapeutics thinks there's a better way.

Image source: Getty Images.

Fate Therapeutics is developing cellular therapies that address most of the concerns of first-generation CAR-T therapies.

Rather than rely on cells derived from each individual patient, the company engineers cells from a master clonal cell line. That allows for an off-the-shelf drug product that can be easily reproduced, confidently characterized for quality control, and efficiently manufactured in batches. The company estimates its manufacturing cost is less than $2,500 per dose. Individuals can also receive treatment in an outpatient setting and avoid racking up massive hospital bills.

The development-stage biopharma is also relying mostly on natural killer (NK) cells, which have several advantages compared to CAR-T cells.NK cells shouldn't be accompanied by severe side effects such as CRS or neurotoxicities, can rally the rest of an individual's immune system to attack tumors, and can be dosed multiple times to extend the duration of response. It's also possible to combine NK cells with other drugs, especially monoclonal antibodies, which could provide unique synergies to improve patient outcomes.

Fate Therapeutics has also tapped Inscripta's novel CRISPR gene-editing tool, which uses a novel cutting enzyme that has been shown to be more efficient than Cas9. That's important for ensuring all cells used for a drug product are homogeneous, rather than a distribution of cells with varying genetic profiles and levels of activity.

On paper, the company's approach stacks up favorably against a general first-generation cellular therapy.

Metric

First-Generation Cellular Therapy

Fate Therapeutics

Starting material

Cells derived from patient

Cells derived from master clonal cell line (nine of 13 clinical programs)

Manufacturing process

Complex process required to make a single dose

Manufactured in batches (many doses from one production run)

Manufacturing time and cost

2-3 weeks and $450,000

Available off the shelf and less than $2,500

Engineering tools

Error-prone first-generation CRISPR/Cas9 tools

Next-generation CRISPR tool using MAD7 enzyme is more efficient than Cas9 (first drug candidate could begin trials in 2020)

Cell type and dosing

CAR-T cells that can be dosed only once

Mostly NK cells that can be dosed multiple times (eight of 13 clinical programs)

Side effects

CRS and neurotoxicities

No cases of CRS reported in early studies of NK cells

Data source: Fate Therapeutics.

The benefits on paper are nice, but investors will be more concerned with how the approach stacks up in the real world -- and 2020 might be the year they get an answer.

Fate Therapeutics is developing cellular therapies against a range of solid tumor cancers and blood cancers. The company made six presentations at the American Society of Hematology (ASH) annual meeting in December, which provided investors with the first real glimpse of the pipeline's potential.

The takeaways were mostly positive and certainly raised the level of intrigue on Wall Street, as evidenced by a rising stock price. Fate Therapeutics notched several industry firsts (such as with FT500, which became the first off-the-shelf derived NK cell therapy to begin a clinical trial) while setting the stage for more important data readouts in 2020.

Drug Candidate, Cell Type

Indication

Last Update

FT516 (monotherapy), NK cell

Acute myeloid leukemia (AML)

First patient received one cycle of three once-weekly doses, had no evidence of disease in bone marrow at Day 42.

FT516 (combination therapy), NK cell + monoclonal antibody

B-cell lymphoma

First patient received one cycle of three once-weekly doses, no data reported.

FT500 (monotherapy or combination), NK cell or NK cell + checkpoint inhibitor

Advanced solid tumors in individuals who failed prior checkpoint inhibitor therapy

12 patients total, six of 11 evaluable patients achieved stable disease after first cycle, no cases of CRS or neurotoxicity in 62 total doses.

Data source: Fate Therapeutics Press releases.

Fate Therapeutics also plans to initiate new studies in 2020. A combination therapy comprising a FT596 (an NK cell drug candidate) and rituximab (a monoclonal antibody) is expected to begin a phase 1 study in lymphoma in early 2020. Meanwhile, the company expects to submit investigational new drug (IND) applications for its first off-the-shelf CAR-T cell product, FT819, and first CRISPR-edited product, FT538, in the second quarter of this year.

Fate Therapeutics began the year with $261 million in cash, which means investors and Wall Street analysts will be solely focused on clinical results and the continued buildout of the pipeline in 2020.

While all development-stage biopharma stocks are inherently risky, the number of shots on goal insulates investors from a single failure. In fact, each drug candidate is genetically engineered against unique molecular targets, or used in specific combinations, which means any single clinical failure can't be extrapolated across the entire pipeline.

Fate Therapeutics still needs to generate clinical results demonstrating its next-generation approach to cellular therapy can lead to robust clinical benefits for patients, but Wall Street and deep-pocketed industry leaders might coalesce around the development-stage company if early and mid-stage studies continue to impress. That could make its current $2.3 billion market valuation a bargain for investors with a long-term mindset -- and with an appetite for above-average risk.

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Here's My Top Stock to Buy in March - Motley Fool

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Global Personalized Medicine Market 2020 Industry Analysis, Trends, Size, Growth, Share, Strategies And Forecast To 2025 - NJ MMA News

NoCamels Hezekiah Bird, Shuli Finley, Katie Hemmons, and Shana Jacobson contributed to this report.

Women make up 60-70 percent of roles in the biotechnology sector in Israel, a number that has not changed in almost a decade, according to the Nisha group, an Israeli recruitment and placement firm that specializes in biotech, biomed, fintech, and cleantech. But while women are ahead in the field, leading research teams and heading clinical trials, men still dominate upper management and executive roles, Nisha noted in a comprehensive report focused on women in biotech that was first published in 2012.

On Sunday International Womens Day 2020 Lizi Shoov London, Nishas partner and managing director of the companys Biotech division, confirmed to NoCamels that the numbers have not changed.

SEE ALSO: Whats The Best Advice You Got? 5 Questions With 10 Israeli Women Innovators.

Professor Rivka Carmi, former president of the Ben-Gurion University of the Negev the first and only woman to hold this position at a university says that despite the expectations that the field would mature and more women would take on executive roles, this hasnt been the case yet.

There are a lot of female researchers involved in biotech companies, she tells NoCamels, but there are not enough women in leadership roles or who have their own startups. In a time where high-tech and biotech go hand in hand, Carmi says, women only make up a third of the pie, not 50/50. The latest High-Tech Human Capital Report 2019 published by Start-Up Nation Central and the Israel Innovation Authority last month showed that the rate of women employed in the sector is at a standstill at about 30 percent, with just 22 percent for technology positions and 18 percent for tech management roles.

Carmi, who made it her mission during her 12 years as BGU president to increase cooperation between academia and industry she called it applied research set out to work with government authorities to push major biotech initiatives that would potentially make the future of women as biotech leaders a reality. These initiatives included the National Institute For Biotechnology In The Negev (NIBN), established as a company in November 2009 through a trilateral agreement between the Israeli government, founder Dr. Edgar de Picciotto, and Ben-Gurion University of the Negev, to become the first independent research entity established under the auspices of a university in Israel.

While she didnt specifically do so to put women in executive biotech positions, this was very unusual at the time, she says of NIBNs mission to bridge the gap between basic and applied research, while figuring out how to go about commercializing novel ideas and technologies developed by NIBN researchers.

I see how difficult it is for women to get leadership roles, so I am very vocal about it, she says. Women are in the minority in terms of having their own biotech startups. Many of them have to balance career and family. Not many of them want to make that concession. Its a lot of work building a startup and attracting investors.

Every woman will tell you that she encounters obstacles, Professor Carmi tells NoCamels.

Israels biotechnology and life sciences industry is a fast-growing sector, with at least 1,600 companies, including nearly 1,400 companies that were established since 2009 (thats 139 companies every year), according to the 2019 Israeli Life Sciences Report from the Israel Advanced Technology Industries (IATI.) The sector, which employs 83,000 people across the country, according to the report, has seen upwards of $1.5 billion from investors.

Even so, Dr. Irit Yaniv says that the Israeli biotech sector is enriched with but not yet dominated by women.

Dr. Yaniv is a less typical example, as she calls herself. The accomplished medtech and biopharma executive is a co-founder and investor now serving as a managing partner for health care venture capital fund Accelmed Ventures II. Dr. Yaniv has held top-level positions as CEO of heart medical device firm Impulse Dynamics and Type 2 diabetes treatment firm Metacure and a number of chairperson and board member positions at various medtech, biotech, and life science companies. She also co-founded Type 2 diabetes firm Digma Medical and obesity treatment firm NitiNotes Surgical.

But she also knows firsthand the obstacles women run into in the biotech industry. We do see many women holding mid-level positions, however when it comes to C-level (specifically, CEOs and chairperson positions), the picture is not much different from other sectors, she says.

And there is so much room for improvement. Women are still lacking the extensive networking ties and some assistance from our peers, she tells NoCamels. Women, especially younger women, are keen for proper mentoring to assist them to grow and stay at the top. I believe developing the right networks as well as other soft skills, will make a difference in the long run.

Realizing the need for mentorship and a support network for both newbies and veterans in the industry, Dr. Yaniv co-established a forum called Life Science Women. The open forum, which got too big for WhatsApp and is now on Telegram and LinkedIn, aims to establish a womens network for professional topics in the life sciences space, including HR, content, questions, lectures, and education.

The forum currently includes 300 women who use it on a daily basis, Dr. Yaniv says, with questions such as Who is willing to give a presentation at a conference? or Who knows a great service provider for regulatory matters?

Dr. Yaniv also believes another gap that prevents women from reaching high-level positions is the dissonance between how women perceive themselves and their real competencies and capabilities. For that reason, Dr. Yaniv, together with Ronit Harpaz, co-founder and CEO of medical device company Endoron Medical, and the support of the 8400 The Health Network, with a mission to advance the healthcare and life science industry in Israel, will be establishing an academic organization for junior women who have been recognized as having the potential to reach key managerial positions in their organizations. The academy will focus on teaching soft skills, networking, and specific theoretical content. It will also feature inspirational talks from prominent role models and theory segments from professional speakers.

Working together with the talented women that made it to the top, I believe we can make the change and, in the future, see more women in C-positions, including directors, she says. My wish is that there will be no need for specific women guidelines for places like board of directors, as there will be enough women holding senior positions everywhere.

SEE ALSO: Annual Biotech Confab Highlights Role of Advanced Tech Rehabilitation

Professor Carmi and Dr. Yaniv are just a few of the Israeli women who have made great strides for women in biotechnology. As the world marked International Womens Day 2020 on Sunday, NoCamels wanted to highlight the women who are making an impact in the field.

Professor Shulamit Levenberg, dean of the Faculty of Biomedical Engineering at the Technion Israel Institute of Technology, is one of the worlds leading scientists in the field of tissue engineering. As the head of the 3D Bio-Printing Center for Cell and Biomaterials Printing, launched last year, Levenberg is poised to lead the Technions tissue engineering into new territory. Professor Levenbergs stem cell and tissue engineering research has shown that it is possible to generate tissues and blood vessels in a lab that can in the future be implanted and integrated into human hosts.

Professor Levenberg is also the co-founder and Chief Scientific Officer of Aleph Farms, a clean meat Israeli company that unveiled the worlds first lab-grown steak prototype grown from animal cells in Dec 2018. Founded in 2017, Aleph Farms has raised more than $14 million and is working to transform its prototype into a commercial product.

Professor Levenberg has co-authored more than 100 publications, including six in 2019. In 2007, she appeared on Scientific Americans list of 50 leading scientists, Last year, she was named one of 50 influential women in 2019 by Israeli magazine Lady Globes.

Dr. Ora Dar has almost three decades of science, tech, and management experience, including 13 years as the head of the life sciences sector at the Israel Innovation Authority (then the Office of the Chief Scientist.) She also spent 16 years on academic research and has been a venture capital consultant for over two decades.

Today, Dr. Dar leads the National Infrastructure Forum for Research and Development (Telem) at the Israel Innovation Authority. She is also among the leaders of the Israeli National Genomic and Personalized Medicine Initiative, which includes a research-oriented genomic-clinical database of 100K volunteers.

Dr. Dar co-chairs the annual MIXiii-BIOMED Conference and Exhibition, a leading biotechnology and healthcare conference for both Israeli and international professionals.

Dr. Nuha Higazi, a neurology doctor, is the CTO and co-founder of PamBio, a biotechnology company developing drug therapy for hemorrhagic stroke (intracranial bleeding and ICH) and other acute bleeding conditions.

The company, co-founded with her husband Professor Abd Higazi with the support of Hadassah Medical Centers technology transfer company Hadasit, was conceived as part of the Nazareth-based incubator (NGT)3 and has received $7 million in a Series A round and $3 million from both (NGT)3 and the Israel Innovation Authority since it was founded in 2014.

Dr. Higazi is also the CTO and co-founder of medical device company Plas-free, which has developed ClearPlasma, a medical device that helps coagulation and complex treatments for massive bleeding. The company was founded in 2017.

Professor Mouna Maroun researches PTSD on animal models while focusing on developmental differences at the Univerity of Haifas Sagol Department of Neurobiology. She heads the Universitys Laboratory for Neurobiology of Emotions.

In 2018, Professor Maroun was named by the business publication TheMarker as one of the top 20 women changing the face of the Israeli medical scene today.

As an Arab woman, my belief is that the revolution towards gender and ethnic equality starts top-down at academic institutions, she told the University of Haifa magazine in 2018. Recruiting outstanding women as faculty members Jewish, Arab, Ethiopian and Haredi especially in sciences and STEM [Science, Technology, Engineering and Mathematics] subjects is one of the first steps to ensure the representation of women in higher education and to convey a clear message to the younger generation that there is no glass ceiling for girls.

Since joining genomics-based cancer immunotherapy and diagnostic discovery company Compugen in 2002, Dr. Anat Cohen-Dayag has held numerous positions including vice president of R&D as she climbed up the ladder. In 2010, Dr. Cohen-Dayag was named Compugens president and CEO and has been on the companys board of directors since 2014.

Last month, Compugen announced the expansion of its cooperation agreement with international firm Bristol-Myers Squibb to conduct cancer treatment trials. This week, the company reported promising data from on ongoing Phase 1 trial of its lead product candidate, COM701, a first-in-class anti-PVRIG antibody, for the treatment of solid tumors.

Dr. Cohen-Dayag is also the director of the Israel Advanced Technology Industry (IATI), Israels umbrella organization of high-tech and life science industries, heading up more than 700 members from every level and aspect of the ecosystem including venture capital funds, R&D centers, and startup incubators.

Another biotech force is Dr. Kinneret Livnat-Savitzky, the CEO of Israeli biotechnology accelerator FutuRx Ltd established in 2014. She joined Compugens board of directors in 2018.

She previously completed a seven-year stint as CEO of clinical-stage, publicly-traded biopharma company BioLineRX, which focuses on oncology, as well as seven years as VP of biology at Compugen.

Professor Ester Segal is currently leading a research group focusing on the broad interface between materials science and biotechnology in the Faculty of Biotechnology and Food Engineering at the Technion Israel Institute of Technology. She is also head of the Esther Segal lab at the Technion, which implements a multidisciplinary approach that couples materials science with engineering, and chemistry with biotechnology to address problems in biotechnology, food engineering, and medicine.

Professor Segal is a recipient of the 2019 Advances in Measurement Science Lectureship Award for her work on photonic crystal sensing.

Last year, she was named among the top 50 most influential women in Israel in 2019 by Lady Globes magazine.

Nora Nseir is the co-founder and CTO of Nurami Medical, a medical device company with a breakthrough nanofiber and sealant technology for the soft tissue repair market. Nseir, a biomedical engineer co-founded the startup in 2014 with Dr. Amir Bahar, a multidisciplinary entrepreneur and neuroscientist. Nseir previously held R&D positions in the medical devices industry focusing on the development of bone grafts and hemostatic devices.

In 2015, she co-founded the Arab Women in Science forum, which encourages Arab women and girls in sciences and entrepreneurship.

In 2017 and 2018, Nseir was also included in the Lady Globes Women of Influence list.

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Israeli Women Are Ahead In Biotech, But Don't Have The Leadership Roles Just Yet | Health News - NoCamels - Israeli Innovation News

Study by UC San Diego Health Sciences finds difference in breast milk concentrations impacts growth up to age 5

San Diego Community News Group

Breastfeeding affects infant growth and, researchers have found, helps prevent obesity, both in childhood and later in life. However, the components of breast milk responsible for these beneficial effects remain mostly a mystery.

Human milk is an elaborate blend of proteins, fats, minerals, and vitamins, plus complex sugar molecules called human milk oligosaccharides or HMOs. There are approximately 150 types of HMOs. Like thumb and tongue prints, the combination and concentration of HMOs is unique to each nursing mother.

In a new study, published in the Feb. 18, 2020, online issue of "The American Journal of Clinical Nutrition," researchers at University of California San Diego School of Medicine confirmed the findings of previous pilot studies that found an association between HMO concentrations and infant weight and body composition.

The earlier pilot studies looked at a smaller, combined cohort of approximately 30 infants who were exclusively breastfed and who displayed excessive weight gain over a period of six months. The UC San Diego study examined a much larger cohort of 802 mothers and their children, part of the longitudinal Steps to Healthy Development of Children (STEPS) study, led by researchers at the University of Turku in Finland. The children were examined from birth to age 5.

The researchers found that high concentrations of one HMO called 2-Fucosyllactose (2FL) and low concentrations of another HMO known as Lacto-N-neotetraose (LNnT) were associated with growth in infancy and early childhood. Depending upon concentrations of HMOs in mothers milk, but independent of the mothers pre-pregnancy body mass index or duration of breastfeeding, infant height and weight can vary by half a standard deviation. Standard deviation is a measure of how spread out numbers are.

We were surprised by the magnitude of the association, said senior author Lars Bode, Ph.D., professor of pediatrics at UC San Diego School of Medicine and director of the Larsson-Rosenquist Foundation Mother-Milk-Infant Center of Research Excellence. The impact persisted long after actual exposure to HMOs during breastfeeding. Our analytical platform allows us to measure and associate individual HMOs with specific health and development outcomes.

HMOs are natural prebiotics that contribute to the shaping of the infant gut microbiome, which may affect health and disease risk. But they also act independently of the microbiome, protecting the infant from diseases, such as infectious diarrhea or necrotizing enterocolitis, a serious condition that impacts the intestine of premature infants. HMOs potentially also reduce the risk for non-communicable diseases, such as asthma, allergies, and obesity later in life.

Our goal is to generate a deep mechanistic understanding of how HMOs in a moms milk can contribute to infant health and development. Although we are only at the very beginning, the generated knowledge provides fascinating new opportunities, said Bode. Some HMOs could help infants who are behind the growth curve; other HMOs could do the opposite and help lower the risk of childhood obesity. We could even imagine applying HMOs as novel therapeutics for adults who either need to gain weight or suffer from overweight and obesity.

Bode said the study is also an example of how data can help guide the development of HMO blends for different products promoting health. We could tailor HMO composition in products based on actual scientific evidence and desired outcomes. Much like personalized medicine.

The association results from cohort studies are an impactful way to generate new hypotheses, said the researchers, especially if several different cohorts show very similar associations. However, association studies do not prove causality. Bode said his teams next steps include bringing the data back to the lab to test whether or not HMOs, either alone or in combination, affect growth and to pinpoint the underlying mechanisms.

Co-authors include: Chloe Yonemitsu and Julia Gupta, UC San Diego; Hanna Lagstrm, Samuli Rautava, Helena Ollila, Anne Kaljonen and Olli Turta, University of Turku; and Johanna Mkel, Tampere University Hospital.

Full study:https://doi.org/10.1093/ajcn/nqaa010

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Study by UC San Diego Health Sciences finds difference in breast milk concentrations impacts growth up to age 5 - Breastfeeding affects infant growth...

Prime Healthcare utilizes the latest in diagnostic testing, state-of-the-art surgical and non-surgical treatments, the most advanced technology, research, residency programs and a compassionate staff to create five award-winning hospitals that provide comprehensive care for residents of Essex, Morris, Passaic, Sussex and Warren counties.

Prime Healthcare hospitals include:

Services available at all Prime Healthcare campuses include but are not limited to:

Saint Clares Health

Their multidisciplinary team of physicians, staff and volunteers at Saint Clares Denville Hospital, Saint Clares Dover Hospital and Saint Clares Behavioral Health are committed to providing the most advanced treatments and technology in a patient-centered environment. Saint Clares Health has been recognized for its award-winning care, receiving Pathway to Excellence designation, achieving Five Star Rating one of only two hospitals in New Jersey from the Centers for Medicare and Medicaid, achieving Leapfrog A Rating for patient safety, and being accredited as a Comprehensive Center by the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program. Saint Clares Behavioral Health provides a comprehensive range of emergency services, inpatient and outpatient programs, a substance abuse walk-in program, and one of the areas only psychiatric medical care units located at Saint Clares Dover Hospital. The psychiatric medical care unit allows patients to stay in one unit to receive their psychiatric and medical care. Saint Clares Center for Cancer Care offers the latest in radiation treatment close to home. TrueBeam Radiotherapy System gives patients treatment that is powerful and precise, minimizing damage to surrounding tissue and in some cases, less than five visits. Emergency services are available at two convenient locations Denville and Dover and have the shortest wait times in the area. Outpatient services include rehabilitation services, cardiac rehabilitation, breast services, laboratory, and radiology. For more information about Saint Clares services, visit saintclares.com.

Saint Marys General Hospital

St. Marys General Hospital is a community-based tertiary medical center that emphasizes quality, compassionate care. Fully accredited by The Joint Commission, St. Marys General is an award winning acute care hospital offering a broad range of cardiovascular services as well as a comprehensive program for cancer care. St. Marys General also is a center of excellence for maternal-child health and outpatient behavioral health services. It is the recipient of various Healthgrades awards, including the Excellence Award for Gynecologic Surgery. St. Marys General is a State Designated Heart Center, Certified Stroke Center and is The Joint Commission Top Performer on Key Quality Measures for three consecutive years. It is the only hospital in Passaic County with over 550 physicians and 1,200 employees one of the largest employers in the county. Every member of the St. Marys General team is committed to providing respectful, personalized, high-quality care. The hospitals goal is to satisfy patients needs and exceed their expectations. St. Marys General Hospital is a member of the Prime Healthcare System family, which has been lauded as a Top 15 Healthcare System by Truven Health Analytics. To learn more about St. Marys General Hospital, visit http://www.smh-nj.com.

Saint Michaels Medical Center

Saint Michaels Medical Center is a 358-bed regional tertiary-care, teaching and research hospital located in the heart of Newarks thriving business and university community. For more than 150 years, the hospital has served the health care needs of Newark residents as well as the surrounding community. Saint Michaels is a major teaching hospital affiliated with New York Medical College, offering an internal medicine residency as well as fellowships in cardiology, interventional cardiology, gastroenterology, oncology, infectious disease, pulmonary and critical care. The hospital has recently invested millions of dollars in new telemetry equipment throughout the hospital, a top-of-the-line Varian TrueBeam Radiotherapy System in its Cancer Center, and two advanced, state-of-the-art catheterization laboratories that allow the hospital to offer Transcatheter Aortic Valve Replacement (TAVR), a minimally invasive cardiac procedure for patients suffering from a faulty heart valve condition known as cardiac stenosis. Saint Michaels is one of Americas 100 Best Hospitals for Cardiac Care for two consecutive years (2018 and 2019). The hospital is ranked among the top 10% in the nation for cardiac surgery by Healthgrades and is a recipient of Healthgrades 2019 Cardiac Surgery Excellence Award and Cardiac Care Excellence Award. Healthgrades also named Saint Michaels a Five Star Recipient for coronary bypass surgery, treatment of heart attack, treatment of heart failure and for pacemaker procedures. Saint Michaels is a leader in the treatment of womens health issues. The hospitals highly skilled team of obstetrician/gynecologists and primary care physicians provide patient-focused, compassionate quality care using state-of-the-art technology in line with Saint Michaels mission to heal with dignity and respect. Saint Michaels Emergency Department has among the shortest wait times in the Greater Newark area and provides a FastTrack option for patients with less serious ailments. Saint Michaels has received a grade of A for patient safety for the last three periods from Leapfrog as well as the Patient Safety Excellence Award from Healthgrades.

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Award-winning Prime Healthcare provides exceptional, personalized care for patients - Jersey's Best

The world is surrounded by technology technology that makes our jobs easy, the technology that makes our commute easy, the technology that makes out communication easy and so on. Hence, such advancements have turned into a boon to our lives while easing out numerous works that would conventionally take a long time to complete. Now that we look back we see so many new technologies have taken over the world that its nearly impossible to enlist them at once. And how further advancements will impact our lives in new ways we cannot even imagine.

MIT has drafted a list of top 10 strategic technology breakthroughs that will revolutionize our lives in the coming years.

An internet based on quantum physics will soon enable inherently secure communication. A team led by Stephanie Wehner, at Delft University of Technology, is building a network connecting four cities in the Netherlands entirely by means of quantum technology. Messages sent over this network will be unhackable.

The Delft network will be the first to transmit information between cities using quantum techniques from end to end.The technology relies on a quantum behavior of atomic particles called entanglement. Entangled photons cant be covertly read without disrupting their content.

Heres a definition of a hopeless case: a child with a fatal disease so exceedingly rare that not only is there no treatment, theres not even anyone in a lab coat studying it. Too rare to care, goes the saying.

Thats about to change, thanks to new classes of drugs that can be tailored to a persons genes. If an extremely rare disease is caused by a specific DNA mistakeas several thousand aretheres now at least a fighting chance for a genetic fix through hyper-personalized medicine. One such case is that of Mila Makovec, a little girl suffering from a devastating illness caused by a unique genetic mutation, who got a drug manufactured just for her. Her case made the New England Journal of Medicine in October after doctors moved from a readout of her genetic error to treatment in just a year. They called the drug milasen, after her. The treatment hasnt cured Mila. But it seems to have stabilized her condition: it has reduced her seizures, and she has begun to stand and walk with assistance.

Milas treatment was possible because creating a gene medicine has never been faster or had a better chance of working. The new medicines might take the form of gene replacement, gene editing, or antisense (the type Mila received), a sort of molecular eraser, which erases or fixes erroneous genetic messages. What the treatments have in common is that they can be programmed, in digital fashion and with digital speed, to correct or compensate for inherited diseases, letter for DNA letter.

Last June Facebook unveiled a global digital currency called Libra. The idea triggered a backlash and Libra may never launch, at least not in the way it was originally envisioned. But its still made a difference: just days after Facebooks announcement, an official from the Peoples Bank of China implied that it would speed the development of its own digital currency in response. Now China is poised to become the first major economy to issue a digital version of its money, which it intends as a replacement for physical cash.

The first wave of a new class of anti-aging drugs has begun human testing. These drugs wont let you live longer (yet) but aim to treat specific ailments by slowing or reversing a fundamental process of aging.

The drugs are called senolyticsthey work by removing certain cells that accumulate as we age. Known as senescent cells, they can create low-level inflammation that suppresses normal mechanisms of cellular repair and creates a toxic environment for neighboring cells.

The universe of molecules that could be turned into potentially life-saving drugs is mind-boggling in size: researchers estimate the number at around 1060. Thats more than all the atoms in the solar system, offering virtually unlimited chemical possibilitiesif only chemists could find the worthwhile ones.

Now machine-learning tools can explore large databases of existing molecules and their properties, using the information to generate new possibilities. This AI enabled technology could make it faster and cheaper to discover new drug candidates.

Satellites that can beam a broadband connection to internet terminals. As long as these terminals have a clear view of the sky, they can deliver the internet to any nearby devices. SpaceX alone wants to send more than 4.5 times more satellites into orbit this decade than humans have ever launched since Sputnik.

These mega-constellations are feasible because we have learned how to build smaller satellites and launch them more cheaply. During the space shuttle era, launching a satellite into space cost roughly US$24,800 per pound. A small communications satellite that weighed four tons cost nearly $200 million to fly up.

Quantum computers store and process data in a way completely different from the ones were all used to. In theory, they could tackle certain classes of problems that even the most powerful classical supercomputer imaginable would take millennia to solve, like breaking todays cryptographic codes or simulating the precise behavior of molecules to help discover new drugs and materials.

There have been working quantum computers for several years, but its only under certain conditions that they outperform classical ones, and in October Google claimed the first such demonstration of quantum supremacy. A computer with 53 qubitsthe basic unit of quantum computationdid a calculation in a little over three minutes that, by Googles reckoning, would have taken the worlds biggest supercomputer 10,000 years, or 1.5 billion times as long. IBM challenged Googles claim, saying the speedup would be a thousandfold at best; even so, it was a milestone, and each additional qubit will make the computer twice as fast.

AI has a problem: in the quest to build more powerful algorithms, researchers are using ever greater amounts of data and computing power and relying on centralized cloud services. This not only generates alarming amounts of carbon emissions but also limits the speed and privacy of AI applications.

But a countertrend of tiny AI is changing that. Tech giants and academic researchers are working on new algorithms to shrink existing deep-learning models without losing their capabilities. Meanwhile, an emerging generation of specialized AI chips promises to pack more computational power into tighter physical spaces, and train and run AI on far less energy.

In 2020, the US government has a big task: collect data on the countrys 330 million residents while keeping their identities private. The data is released in statistical tables that policymakers and academics analyze when writing legislation or conducting research. By law, the Census Bureau must make sure that it cant lead back to any individuals.

But there are tricks to de-anonymize individuals, especially if the census data is combined with other public statistics.

So the Census Bureau injects inaccuracies, or noise, into the data. It might make some people younger and others older, or label some white people as black and vice versa while keeping the totals of each age or ethnic group the same. The more noise you inject, the harder the de-anonymization becomes.

Differential privacy is a mathematical technique that makes this process rigorous by measuring how much privacy increases when noise is added. The method is already used by Apple and Facebook to collect aggregate data without identifying particular users.

Ten days after Tropical Storm Imelda began flooding neighborhoods across the Houston area last September, a rapid-response research team announced that climate change almost certainly played a role.

The group, World Weather Attribution, had compared high-resolution computer simulations of worlds where climate change did and didnt occur. In the former, the world we live in, the severe storm was as much as 2.6 times more likelyand up to 28% more intense.

Earlier this decade, scientists were reluctant to link any specific event to climate change. But many more extreme-weather attribution studies have been done in the last few years, and rapidly improving tools and techniques have made them more reliable and convincing.

This has been made possible by a combination of advances. For one, the lengthening record of detailed satellite data is helping us understand natural systems. Also, increased computing power means scientists can create higher-resolution simulations and conduct many more virtual experiments.

These and other improvements have allowed scientists to state with increasing statistical certainty that yes, global warming is often fueling more dangerous weather events.

By disentangling the role of climate change from other factors, the studies are telling us what kinds of risks we need to prepare for, including how much flooding to expect and how severe heatwaves will get as global warming becomes worse. If we choose to listen, they can help us understand how to rebuild our cities and infrastructure for a climate-changed world.

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Top 10 Strategic Technology Breakthroughs That Will Transform Our Lives - Analytics Insight

When you first meet her, you wont be able to tell that Ipek Kuzu suffers from a rare genetic disease. The three-year-old plays happily on her own for hours, driving her toy cars and cooking in her pretend kitchen. But shes not well. Shes a little wobbly on her feet and doesnt say much, and if nothing is done, she may die by her mid-20s. Ipek has ataxia-telangiectasia, or A-T, a disease caused by an error in her DNA. It causes the loss of brain cells, along with a high risk of infection and cancer.

Its the sort of problem that makes doctors shake their heads. But Ipeks father, Mehmet, and mother, Tugba, hope shell escape that fate. Thanks in part to the persistence of Mehmet, a programmer at Google, in January she became one of the first handful of US patients to receive a hyper-personalized gene medicine, tailored to treat a unique mutation. The one-person drug, designed for her by a Boston doctor, Timothy Yu, is being called atipeksen, for A-T and Ipek.

To create atipeksen, Yu borrowed from recent biotech successes like gene therapy. Some new drugs, including cancer therapies, treat disease by directly manipulating genetic information inside a patients cells. Now doctors like Yu find they can alter those treatments as if they were digital programs. Change the code, reprogram the drug, and theres a chance of treating many genetic diseases, even those as unusual as Ipeks.

The new strategy could in theory help millions of people living with rare diseases, the vast majority of which are caused by genetic typos and have no treatment. US regulators say last year they fielded more than 80 requests to allow genetic treatments for individuals or very small groups, and that they may take steps to make tailor-made medicines easier to try. New technologies, including custom gene-editing treatments using CRISPR, are coming next.

Where it had taken decades for Ionis to perfect its drug, Yu now set a record: it took only eight months for Yu to make milasen, try it on animals, and convince the US Food and Drug Administration to let him inject it into Milas spine.

I never thought we would be in a position to even contemplate trying to help these patients, says Stanley Crooke, a biotechnology entrepreneur and founder of Ionis Pharmaceuticals, based in Carlsbad, California. Its an astonishing moment.

Antisense drug

Right now, though, insurance companies wont pay for individualized gene drugs, and no company is making them (though some plan to). Only a few patients have ever gotten them, usually after heroic feats of arm-twisting and fundraising. And its no mistake that programmers like Mehmet Kuzu, who works on data privacy, are among the first to pursue individualized drugs. As computer scientists, they get it. This is all code, says Ethan Perlstein, chief scientific officer at the Christopher and Dana Reeve Foundation.

A nonprofit, the A-T Childrens Project, funded most of the cost of designing and making Ipeks drug. For Brad Margus, who created the foundation in 1993 after his two sons were diagnosed with A-T, the change between then and now couldnt be more dramatic. Weve raised so much money, weve funded so much research, but its so frustrating that the biology just kept getting more and more complex, he says. Now, were suddenly presented with this opportunity to just fix the problem at its source.

Ipek was only a few months old when her father began looking for a cure. A geneticist friend sent him a paper describing a possible treatment for her exact form of A-T, and Kuzu flew from Sunnyvale, California, to Los Angeles to meet the scientists behind the research. But they said no one had tried the drug in people: We need many more years to make this happen, they told him.

Courtesy Photo (Yu)

Kuzu didnt have years. After he returned from Los Angeles, Margus handed him a thumb drive with a video of a talk by Yu, a doctor at Boston Childrens Hospital, who described how he planned to treat a young girl with Batten disease (a different neurodegenerative condition) in what press reports would later dub a stunning illustration of personalized genomic medicine. Kuzu realized Yu was using the very same gene technology the Los Angeles scientists had dismissed as a pipe dream.

That technology is called antisense. Inside a cell, DNA encodes information to make proteins. Between the DNA and the protein, though, come messenger molecules called RNA that ferry the gene information out of the nucleus. Think of antisense as mirror-image molecules that stick to specific RNA messages, letter for letter, blocking them from being made into proteins. Its possible to silence a gene this way, and sometimes to overcome errors, too.

Though the first antisense drugs appeared 20 years ago, the concept achieved its first blockbuster success only in 2016. Thats when a drug called nusinersen, made by Ionis, was approved to treat children with spinal muscular atrophy, a genetic disease that would otherwise kill them by their second birthday.

Yu, a specialist in gene sequencing, had not worked with antisense before, but once hed identified the genetic error causing Batten disease in his young patient, Mila Makovec, it became apparent to him he didnt have to stop there. If he knew the gene error, why not create a gene drug? All of a sudden a lightbulb went off, Yu says. Couldnt one try to reverse this? It was such an appealing idea, and such a simple idea, that we basically just found ourselves unable to let that go.

Yu admits it was bold to suggest his idea to Milas mother, Julia Vitarello. But he was not starting from scratch. In a demonstration of how modular biotech drugs may become, he based milasen on the same chemistry backbone as the Ionis drug, except he made Milas particular mutation the genetic target. Where it had taken decades for Ionis to perfect a drug, Yu now set a record: it took only eight months for him to make milasen, try it on animals, and convince the US Food and Drug Administration to let him inject it into Milas spine.

Whats different now is that someone like Tim Yu can develop a drug with no prior familiarity with this technology, says Art Krieg, chief scientific officer at Checkmate Pharmaceuticals, based in Cambridge, Massachusetts.

Source code

As word got out about milasen, Yu heard from more than a hundred families asking for his help. Thats put the Boston doctor in a tough position. Yu has plans to try antisense to treat a dozen kids with different diseases, but he knows its not the right approach for everyone, and hes still learning which diseases might be most amenable. And nothing is ever simpleor cheap. Each new version of a drug can behave differently and requires costly safety tests in animals.

Kuzu had the advantage that the Los Angeles researchers had already shown antisense might work. Whats more, Margus agreed that the A-T Childrens Project would help fund the research. But it wouldnt be fair to make the treatment just for Ipek if the foundation was paying for it. So Margus and Yu decided to test antisense drugs in the cells of three young A-T patients, including Ipek. Whichever kids cells responded best would get picked.

Matthew Monteith

While he waited for the test results, Kuzu raised about $200,000 from friends and coworkers at Google. One day, an email landed in his in-box from another Google employee who was fundraising to help a sick child. As he read it, Kuzu felt a jolt of recognition: his coworker, Jennifer Seth, was also working with Yu.

Seths daughter Lydia was born in December 2018. The baby, with beautiful chubby cheeks, carries a mutation that causes seizures and may lead to severe disabilities. Seths husband Rohan, a well-connected Silicon Valley entrepreneur, refers to the problem as a tiny random mutation in her source code. The Seths have raised more than $2 million, much of it from co-workers.

Custom drug

By then, Yu was ready to give Kuzu the good news: Ipeks cells had responded the best. So last September the family packed up and moved from California to Cambridge, Massachusetts, so Ipek could start getting atipeksen. The toddler got her first dose this January, under general anesthesia, through a lumbar puncture into her spine.

After a year, the Kuzus hope to learn whether or not the drug is helping. Doctors will track her brain volume and measure biomarkers in Ipeks cerebrospinal fluid as a readout of how her disease is progressing. And a team at Johns Hopkins will help compare her movements with those of other kids, both with and without A-T, to observe whether the expected disease symptoms are delayed.

One serious challenge facing gene drugs for individuals is that short of a healing miracle, it may ultimately be impossible to be sure they really work. Thats because the speed with which diseases like A-T progress can vary widely from person to person. Proving a drug is effective, or revealing that its a dud, almost always requires collecting data from many patients, not just one. Its important for parents who are ready to pay anything, try anything, to appreciate that experimental treatments often dont work, says Holly Fernandez Lynch, a lawyer and ethicist at the University of Pennsylvania. There are risks. Trying one could foreclose other options and even hasten death.

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Kuzu says his family weighed the risks and benefits. Since this is the first time for this kind of drug, we were a little scared, he says. But, he concluded, theres nothing else to do. This is the only thing that might give hope to us and the other families.

Another obstacle to ultra-personal drugs is that insurance wont pay for them. And so far, pharmaceutical companies arent interested either. They prioritize drugs that can be sold thousands of times, but as far as anyone knows, Ipek is the only person alive with her exact mutation. That leaves families facing extraordinary financial demands that only the wealthy, lucky, or well connected can meet. Developing Ipeks treatment has already cost $1.9 million, Margus estimates.

Some scientists think agencies such as the US National Institutes of Health should help fund the research, and will press their case at a meeting in Bethesda, Maryland, in April. Help could also come from the Food and Drug Administration, which is developing guidelines that may speed the work of doctors like Yu. The agency will receive updates on Mila and other patients if any of them experience severe side effects.

The FDA is also considering giving doctors more leeway to modify genetic drugs to try in new patients without securing new permissions each time. Peter Marks, director of the FDAs Center for Biologics Evaluation and Research, likens traditional drug manufacturing to factories that mass-produce identical T-shirts. But, he points out, its now possible to order an individual basic T-shirt embroidered with a company logo. So drug manufacturing could become more customized too, Marks believes.

Custom drugs carrying exactly the message a sick kids body needs? If we get there, credit will go to companies like Ionis that developed the new types of gene medicine. But it should also go to the Kuzusand to Brad Margus, Rohan Seth, Julia Vitarello, and all the other parents who are trying save their kids. In doing so, they are turning hyper-personalized medicine into reality.

Erika Check Hayden is director of the science communication program at the University of California, Santa Cruz.

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If DNA is like software, can we just fix the code? - MIT Technology Review

To characterize different patterns of variability of three repeated within-visit blood pressure (BP) readings and to determine the prevalence of specific variation trends in systolic (SBP), diastolic (DBP) blood pressure and pulse pressure (PP).Data from 53737 subjects from the National Health and Nutrition Examination Survey were analyzed. In each subject, three consecutive BP measurements were performed with a minimum time-interval of at least 30s. We propose three patterns of within-visit BP variability (separately for SBP, DBP and PP): (1) increasing trend (BP3>BP2>BP1); (2) decreasing trend (BP1>BP2>BP3) and (3) no trend (BP3BP2BP1). A threshold of minimum change (P>3mmHg) between BP1-BP2 and BP2-BP3 was also applied as a prerequisite for the definition of these trends.An increasing trend was observed among three consecutive measurements of SBP, DBP and PP in 7.4, 10.4 and 10.2%, respectively. When a minimum threshold of 3mmHg was set the respective increasing trends were observed in 1.8, 2.9 and 4.4%, respectively. There was a higher prevalence of decreasing trend within three consecutive SBP, DBP and PP readings: 17, 13.1 and 16.2%, respectively, whereas using a threshold of P >3mmHg the respective prevalence was 6.3, 4.1 and 7.7%. A maximum absolute difference >10mmHg within triplicate of SBP/DBP/PP readings was observed in 12.9, 13 and 29.4%, respectively. In the era of personalized medicine, these patterns are well worth further investigation concerning their pathophysiologic and clinical relevance.

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A cohort-based comprehensive characterization of different patterns of very short-term, within-visit, blood pressure variability. - Physician's Weekly

during the forecast period. The growth in this market is attributed to technological advancements in single-cell analysis products, increasing government funding for cell-based research, growing biotechnology and biopharmaceutical industries, wide applications of single-cell analysis in cancer research, growing focus on personalized medicine, and the increasing incidence and prevalence of chronic and infectious diseases.

New York, Feb. 28, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Single-cell Analysis Market by Cell Type, Product, Technique, Application, End User - Global Forecasts to 2025" - https://www.reportlinker.com/p04579530/?utm_source=GNW However, the high cost of single-cell analysis products is expected to restrain the growth of this market to a certain extent during the forecast period.

The academic & research laboratories segment accounted for the largest market share in 2018On the basis of end user, the single-cell analysis market is segmented into academic and research laboratories, biotechnology and pharmaceutical companies, hospitals and diagnostic laboratories, and cell banks and IVF centers.The academic and research laboratories segment accounted for the largest market share in 2018.

Factors such as growth in funding for life science research and the increasing number of medical colleges and universities are driving the growth of this end-user segment.

Flow cytometry is the largest technique segment of the single-cell analysis marketBased on technique, the single-cell analysis market is segmented into flow cytometry, NGS, PCR, microscopy, mass spectrometry, and other techniques.The flow cytometry segment accounted for the largest market share in 2018.

The large share of this segment is attributed to the wide usage of flow cytometry in detecting and measuring the physical and chemical characteristics of a population of cells or particles.

North America will continue to dominate the single-cell analysis market in 2025The single-cell analysis market, by region, is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.In 2018, North America accounted for the largest share of the single-cell analysis market.

The large share of North America can be attributed to the increasing drug development activities in the pharmaceutical and biotechnology industries, rising prevalence of chronic and infectious diseases, and an increase in stem cell research activities.

The breakup of primary participants is as mentioned below: By Company Type - Tier 1: 45%, Tier 2: 30%, and Tier 3: 25% By Designation - C-level: 35%, Director-level: 25%, and Others: 40% By Region - North America: 40%, Europe: 20%, Asia Pacific: 25%, Latin America: 10%, and the Middle East & Africa: 5%

Prominent players in the single-cell analysis market include Becton, Dickinson and Company (US), Danaher Corporation (US), Merck Millipore (US), QIAGEN (Netherlands), Thermo Fisher Scientific (US), General Electric Company (US), 10x Genomics (US), Promega Corporation (US), Illumina (US), Bio-Rad Laboratories (US), Fluidigm Corporation (US), Agilent Technologies (US), NanoString Technologies (US), Tecan Group (Switzerland), Sartorius AG (Germany), Luminex Corporation (US), Takara Bio (Japan), Fluxion Biosciences (US), Menarini Silicon Biosystems (Italy), and LumaCyte (US).

Research Coverage:The report analyzes the single-cell analysis market and aims at estimating the market size and future growth potential of this market based on various segments such as product, cell type, technique, application, end user, and region. The report also provides a competitive analysis of the key players in this market, along with their company profiles, product offerings, recent developments, and key market strategies.

Reasons to Buy the ReportThe report will enrich established firms as well as new entrants/smaller firms to gauge the pulse of the market, which, in turn, would help them garner a greater share of the market. Firms purchasing the report could use one or a combination of the below-mentioned strategies to strengthen their positions in the market.

This report provides insights into: Market Penetration: Comprehensive information on the product portfolios of the top players in the single-cell analysis market. The report analyzes this market by product, application, cell type, technique, end user, and region Market Development: Comprehensive information on the lucrative emerging markets by product, application, cell type, technique, end user, and region Market Diversification: Exhaustive information about products, growing geographies, recent developments, and investments in the single-cell analysis market Competitive Assessment: In-depth assessment of market shares, growth strategies, product offerings, and capabilities of leading players in the single-cell analysis marketRead the full report: https://www.reportlinker.com/p04579530/?utm_source=GNW

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

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The global single-cell analysis market is projected to reach USD 5.6 billion by 2025 from USD 2.1 billion in 2019, at a CAGR of 17.8% - Yahoo Finance

Machine learning is helping Penn Medicine researchers identify the size and shape of brain networks in individual children, which may be useful for understanding psychiatric disorders. In a new study publishedin the journalNeuron,a multidisciplinary team showed how brain networks unique to each child can predict cognition. The study, which used machine learning techniques to analyze the functional magnetic resonance imaging (fMRI) scans of nearly 700 children, adolescents, and young adults, is the first to show that functional neuroanatomy can vary greatly among kids, and is refined during development.

The human brain has a pattern of folds and ridges on its surface that provide physical landmarks for finding brain areas. The functional networks that govern cognition have long been studied in humans by liningup activation patternsthe software of the brainto the hardware of these physical landmarks. However, this process assumes that the functions of the brain are located on the same landmarks in each person. This works well for many simple brain systems. However, multiple recent studies in adults have shown this is not the case for more complex brain systems responsible for executive functiona set of mental processes which includes self-control and attention. In these systems, the functional networks do not always line up with the brains physical landmarks of folds and ridges. Instead, each adult has their own specific layout. Until now, it was unknown how such person-specific networks might change as kids grow up, or relate to executive function.

The exciting part of this work is that we are now able to identify the spatial layout of these functional networks in individual kids, rather than looking at everyone using the same one size fits all approach, says senior authorTheodore D. Satterthwaite, an assistant professor of psychiatry in the Perelman School of Medicine. Like adults, we found that functional neuroanatomy varies quite a lot among different kidseach child has a unique pattern. Also like adults, the networks that vary the most between kids are the same executive networks responsible for regulating the sorts of behaviors that can often land adolescents in hot water, like risk taking and impulsivity.

Read more at Penn Medicine News.

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Machine learning identifies personalized brain networks in children - Penn: Office of University Communications

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Shares of Iovance Biotherapeutics shot up Tuesday on rumors the company could be up for sale. The news comes a day after the company said it intends to speak with regulatory agencies later this year about its programs in melanoma and cervical cancer.

First reported by Bloomberg, Iovance is reportedly working with a financial adviser about a potential sale following conversations about a potential takeover from a larger company. The information was provided by unidentified sources who are familiar with the matter, Bloomberg said. The news sent shares of Iovance up more than 30% in Tuesdays trading. Part of that boost was due to the companys fourth-quarter progress in its clinical pipeline. In anticipation of potential approval and commercialization of its lead candidates, Iovance said it was building its internal manufacturing capability, as well as expanding its commercial team and infrastructure.

While nothing has been formally stated, Benjamin Burnett, an analyst with Stifel Financial Inc. said in a note that acquiring Iovance would make sense for some companies, including Takeda Pharmaceutical and Gilead Sciences, Bloomberg reported. This morning, Takeda announced its intention to acquire celiac disease-focused PvP Biologics for $330 million to complement its gastrointestinal pipeline. Burnett said Iovance is one of the few cell therapy companies in the coverage of Stifel Financial that has been de-risked to a large degree by a proof-of-concept study. Because of that, Burnett said they can see how this might be one of the more interesting cell therapy take-out candidates.

Despite the potential for an acquisition, Iovance could opt to remain independent, the unidentified sources told Bloomberg. A representative for Iovance declined to comment, Bloomberg added.

San Carlos, Calif.-based Iovance specializes in cell therapy focused on treating solid tumors with tumor infiltrating lymphocyte (TIL) therapies. In a previous interview with BioSpace, Iovance Chief Executive Officer Maria Fardis explained that TIL technology is a boosting of the bodys natural immunity. The TIL is removed from a cancerous tumor, amplified in number through cell culture to attack the disease, then are reinserted into the tumor to do the work. Because the amplified TILs can attack the whole tumor, including any potential mutations, Fardis described it as the most exquisite kind of personalized medicine for a patient.

Iovances investigational candidates include lifileucel, which is being investigated as a potential treatment for melanoma and LN-145, a potential treatment for patients with recurrent, metastatic or persistent cervical carcinoma. Lifileucel has received both fast-track and regenerative medicine advanced therapy from the U.S. Food and Drug Administration in melanoma, a common type of skin cancer, accounting for approximately 96,000 patients diagnosed annually and 7,200 deaths each year in the United States, Fardis said in a call with analysts Tuesday, according to transcripts.

In its most recent announcement regarding lifileucel in melanoma, the company reported an overall response rate (ORR) of 36.4% in 66 patients who were heavily pretreated.

The company is enrolling patients in a second pivotal study of LN-145 in patients with metastatic cervical cancer. During 2019, LN-145 received breakthrough therapy designation or BTD, as well as fast-track designation from the FDA. These designations were supported by compelling data demonstrating a 44% ORR from 27 patients in the ongoing study, Fardis said.

Read more:
Report: Iovance Exploring Potential Sale of the Company - BioSpace

The various technologies that make up IT infrastructure are the foundation for all the other forms of health IT that make hospitals and health systems operate effectively. As such, infrastructure technologies are among the most important in the healthcare information technology arena, and they must be operating optimally.

Here, three infrastructure technology experts from Cisco Systems, Dell Technologies and VMware offer best practices for optimizing infrastructure so that it is working best for individual healthcare provider organizations. They target their advice at healthcare CIOs and other health IT leaders who are looking to make sure their infrastructure is rock solid and humming along smoothly.

To fully optimize infrastructure, IT needs to plan for the entire business transformation journey to include reimagining their apps for the patient/clinician experience and then build the infrastructure for those experiences, said Kathryn Howe, Cisco healthcare director, Americas industry digital transformation.

Patients today need humanized experiences from healthcare providers, personalized interactions, easy access to information, and on-demand responses from clinicians, she explained. To keep up with the ever-changing patient needs, healthcare organizations are becoming more digitized, offering new apps and more. Adopting new technologies can create as many challenges as advantages if organizations focus only on optimizing IT infrastructure. IT needs a digital transformation framework to succeed.

Kathryn Howe, Cisco Systems

Integrating, securing and optimizing the IT infrastructure is the first step in the digital transformation framework, she said.

Its the enablement stage where healthcare providers optimize their IT infrastructures to digitize existing services, she noted. This step will streamline and enhance employee and customer experiences through primary offerings such as home care services, mobile engagement and location-based analytics. With the infrastructure in place, CIOs get to optimize their resources to deliver more value, such as implementing personalized engagement strategies, offering online support groups and virtual services.

The IT infrastructure is fully optimized when it is being used to power the organizations most sophisticated endeavors, she added, from new business models to disruptive digital experiences like AI-driven patient scheduling and predictive analytics.

On another front, typically, when a healthcare provider organization is looking to invest in an IT optimization project, it first considers its internal resources, specifically budget and the potential for staff disruption, said David Dimond, healthcare and life sciences chief innovation officer at Dell Technologies.

We can learn from some of the recent rocky implementations of electronic health records in which budgets exceeded expectations and significant delays were experienced in implementation and integration, he stated. According to one survey, 56% of respondentsdidnt believe that the challenges of adopting a new EHR system were equal to, or outweighed, the benefits of integration.

David Dimond, Dell Technologies

Examples like these have made healthcare organization boards circumspect in investing in digital health projects, Dimond contended.

This thinking is unfortunate, as some infrastructure optimizations can free up resources to invest in innovation, as is the case with multi-cloud deployment, he explained. Adopting, or optimizing, a multi-cloud infrastructure allows healthcare organizations to capture, process and access data significantly faster wherever it resides improving everything from patient care delivery to billing.

Just as every healthcare provider organization must have its own specific business model, each companys cloud strategy must match its specific clinical and business workload needs, he asserted.

Cloud strategies are ever-evolving, not simple one-off solutions, he said. Multi-cloud solutions have come a long way you adopt a hybrid cloud environment with an integrated cloud infrastructure compute, storage, networking and security that runs on premises and in public clouds. Organizations should expect consistent operations with infrastructure across private and public cloud, and the edge for a true hybrid cloud experience that is seamless to its end users.

For example, on-premises solutions may be optimal for certain workloads and ideal in terms of risk reduction and monitoring, while off-premises solutions offer better manageability, ease of procurement and cost, he said.

For this reason, every healthcare provider must decide their own workload priorities and optimize their cloud strategy to match the best location for data and applications, he said. A multi-cloud infrastructure provides a single pane of glass to identify and monitor the data across the healthcare ecosystem, simplifying intelligence at the point of care and collaboration among clinicians.

Christopher Logan, director of healthcare industry strategy at VMware, offers another best practice when optimizing infrastructure technology: operational automation.

Automation in healthcare, when coupled with emerging technologies like AI, does not get its fair amount of press or headlines, he said. When applying automation across/within the infrastructure, basic operational tasks and administration can result in a number of efficiencies like better patient experience, greater employee satisfaction, increased quality of services, improved project delivery and a significant reduction in cost.

Christopher Logan, VMware

Another best practice, he said, is workforce transformation.The workforce is constantly evolving, due to factors such as technological advancements and the demand for new skill sets.

Coupled with the fact that employees today have high expectations for their digital experiences, workforce transformation is critical in achieving broader digital transformation, he explained. It is imperative that all healthcare organizations find the right tools and technologies that provide employees with flexibility and secure access to ease IT management burdens and improve productivity.

This does not stop there, as providing a consistent user experience has the capability to transform both the patient and employee experience, which is critical for engagement and retention, he added.

When it comes to optimizing infrastructure, cybersecurity strategies need to permeate infrastructure as well as all levels of a healthcare provider organization, said Howe of Cisco.

Todays CIOs face more than the risk of costly data breaches, she said. Failing to meet standards like HIPAA can result in fines for up to $1.5 million per year. In order to protect patient data and meet compliance standards, CIOs need to enforce a strategy that permeates all layers of the organization, from technologies to the people.

At the network level, a fully integrated secure IT infrastructure will be key to enabling IT teams to maintain a pulse on all activities in real time and address potential risks before they occur, she advised.

An effective tactic is using micro-segmentation to limit the spread of attacks between devices and across the network by creating profiles, policies and permissions that are specific to those devices, reducing unauthorized access for all users, she said.

At the user level, it is vital to empower and train teams to keep data secure.

Implementing two-factor authentication platforms for patients, healthcare staff and third-party vendors should be a non-negotiable, and can help organizations stay compliant and safe by ensuring that only trusted users and devices can access certain sensitive applications or data, she cautioned. This is especially important as more healthcare organizations adopt remote access technologies and devices to deliver seamless connected experiences to patients and streamline workflows for clinicians.

Logan of VMware agrees with Howe that cybersecurity must be a big part of infrastructure optimization.

Sophistication and frequency of cyberattacks are increasingly placing a strain across all sectors, especially in healthcare, he noted. In order to navigate these complex and dynamic environments, healthcare organizations and their leaders must have a strong investment in digital technologies, and an even larger investment on cybersecurity strategies.

A proactive cybersecurity strategy and shift needs to continue happening across healthcare to protect patient data from security threats, ensuring the availability and integrity of critical healthcare workloads, he added.

Elsewhere, he said that hybrid and public cloud migration is an important part of infrastructure optimizxation.

Organizations across all industries are increasingly adopting hybrid and public cloud models, due to its offerings of scalability, agility and speed to market, he said. By making use of cloud solutions whether from Google, Amazon, Microsoft or another provider healthcare providers can simply scale the technical resources needed to run critical applications and drive cost savings.

At the same time, this is preparing those providers to adopt IT modernization to deliver dynamic on-demand services to meet the needs of their workforce and patients, he added.

The Internet of Things is a big part of healthcare IT infrastructure. An emerging focus for healthcare organizations is building out their IoT strategy.

IoT and edge solutions have been adopted by consumers, most notably, fitness trackers and smartwatches, said Dimond of Dell Technologies. A study by Statistafound that more than 56.7 million people wore wearables like smartwatches and Fitbits in 2019. This market will continue to grow and analysts predict the number of users will increase to 67 million people in 2022.

In an acute care setting, there are 10-15 connected devices for every U.S. hospital bed, which creates a significant amount of data, he noted. Overall, healthcare data grew 878%from 2016 to 2018, with much of it coming from sensors, wearables and mobile apps for preventative care and chronic disease management.

However, it is one thing to generate all this data, and quite another challenge to digest it all and generate patient insights. Healthcare providers are investing in distributed analytics to improve patient safety and monitor recovery, expand chronic disease management, enhance precision medicine through research, and manage pharmaceutical supply safety just to name a few applications, Dimond said.

Real-time analytics at the edge creates an opportunity to identify, refine and understand the data where it originates, for the fastest possible insights and action, he said. To support the distributed network of data-driven devices, healthcare organizations require a multi-faceted approach.

As healthcare provider organizations build their edge and IoT strategy, they need to evaluate their unique multi-cloud approach in parallel with specific application workloads, he advised.

Depending on classification, some data such as EHRs, laboratory information systems and clinical decision application data may be stored on-premises, he concluded. Other data may be stored in the cloud whether private, public or hybrid. It is important to consider how data can flow securely and efficiently from the edge to the data center and to multiple clouds.

Twitter:@SiwickiHealthITEmail the writer:bill.siwicki@himssmedia.comHealthcare IT News is a HIMSS Media publication.

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Tech optimization: Keeping infrastructure tech rock solid - Healthcare IT News

ST. PETERSBURG, Fla.--(BUSINESS WIRE)--InformedDNA, the nations largest independent provider of genetics services, today announced the addition of healthcare industry veterans to its executive leadership team and its board of directors. Paul Danao has joined the company as chief growth officer, responsible for driving revenue growth and retention through sales, marketing and client management. Dr. Jacqueline Kosecoff, a renowned healthcare industry expert, has joined InformedDNAs board as an independent director.

Founded in 2007, InformedDNA was the first company in the U.S. to use telephonic services to connect genetic counselors to patients. Since then, it has expanded to provide technology-led services to patients, healthcare providers, health systems, health plans, and life science organizations.

While the healthcare industry is in the infancy of a genomics revolution, its crucial for health systems, payers and providers to determine now how to infuse the rapid pace of discoveries into the healthcare ecosystem, said David Nixon, chief executive officer at InformedDNA. Jacqueline and Paul both have extensive executive leadership experience at major health plans and health systems. Each will no doubt make substantial contributions to InformedDNA, in their respective roles, as we help bring about a future in which genomics expertise will inform most healthcare decision-making, enabling true precision medicine to become a ubiquitous reality.

Dr. Kosecoff works in private equity to identify, select, mentor and manage health services and IT companies. She is managing partner at Moriah Partners, LLC, and senior advisor at Warburg Pincus. Previously, she served as a senior executive with UnitedHealth Group-PacifiCare where she was chief executive officer of OptumRx. Dr. Kosecoff was founder, president and chief operating officer of Protocare, and earlier, served as professor of Medicine and Public Health at the University of California, Los Angeles. She holds a B.A. from the University of California, Los Angeles, an M.S. in Applied Mathematics from Brown University, and a doctorate from the University of California, Los Angeles.

Said Dr. Kosecoff, Having been involved with InformedDNA as an advisor for the last year, Ive seen first-hand how the company brings a rare depth of genomics expertise to the healthcare industry, leading it to experience more than 50 percent annual growth in each of the last two years. I look forward to my new director role and increased interaction with the companys leaders as we enable additional healthcare companies to better understand the genomics space. This will facilitate better genetics-related decisions that result in more personalized care, improved outcomes, and lower costs.

Danao will focus on aligning sales, marketing and client management activities to deliver consistent and high-value contact to accelerate customer acquisition and retention. Prior to joining InformedDNA, he held senior leadership roles at several healthcare technology and service companies, including BlueCross BlueShield Association, AIM Specialty Health, and Healthcare Payment Specialists. Danao holds a B.B.A. from the University of Michigan and a Master of Health Services Administration from the University of Michigan School of Public Health.

This is a transformational time in the era of genetics-based medical care. InformedDNAs continued commitment to maintaining the highest level of genetics expertise and service excellence has already helped many leading U.S. healthcare organizations to decode the business of genetics, said Paul Danao, InformedDNAs new chief growth officer. Its with much enthusiasm that I join such a talented team of professionals to lead the companys sales and marketing initiatives for services that guide healthcare providers clinical decisions, help shape clinical trial processes, and enable insurers to craft evidence-based coverage policies for genetic tests.

About InformedDNA

InformedDNA is the authority on the appropriate use of genetic testing. It leverages the expertise of the largest, full-time staff of independent, board-certified genetics specialists in the U.S. to help ensure that health plans, hospitals, employers, clinicians and patients all have access to the highest quality genetic services. Key offerings include clinical genetic counseling, genetic testing utilization management, genetic testing payment integrity, and expert genetics clinical trial support. For more information: http://www.InformedDNA.com

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InformedDNA Recruits New Chief Growth Officer, Welcomes Industry Veteran to Board of Directors - Business Wire

WASHINGTON, Feb. 21, 2020 /PRNewswire/ --In a report released this morning, the Personalized Medicine Coalition (PMC) explains how 12 personalized treatments and seven diagnostics the U.S. Food and Drug Administration (FDA) approved or cleared in 2019 will improve patient care and make the health system more efficient by addressing root causes of rare diseases, expanding treatment options for cancer patients, and targeting therapies to responder populations. The approvals and clearance decisions expand the frontiers of the rapidly evolving field of personalized medicine for the benefit of patients and health systems.

Personalized Medicine at FDA: The Scope & Significance of Progress in 2019defines personalized medicine as a field "in which physicians use diagnostic tests to determine which medical treatments will work best for each patient or use medical interventions to alter molecular mechanisms, often genetic, that cause disease or influence a patient's response to certain treatments." The report classifies 11 new therapeutic molecular entities and one gene therapy as personalized treatments. Five of those treatments are the first to address root causes of devastating rare diseases. Four others provide new options for cancer patients, and two include FDA labeling that will help patients avoid debilitating and costly adverse side effects. The report also explains how seven newly cleared or approved diagnostics will help make the health care system more efficient by targeting treatments to only those patients who will benefit from them, sparing expenses and side effects for those who will not.

"Personalized Medicine at FDA: The Scope & Significance of Progress in 2019 reminds us that personalized medicine offers new hope to patients with devastating diseases as well as opportunities to avoid prescribing therapies that will be unsafe or ineffective for certain populations of patients," said Edward Abrahams, President, PMC.

In classifying 11 of the 44 (25 percent) new therapeutic molecular entities FDA approved last year as personalized medicines, this year's report marks the sixth straight year that personalized medicines have accounted for more than 20 percent of the agency's new drug approvals. These approvals have increased sharply since 2005, when personalized medicines accounted for just 5 percent of newly approved therapies.

About the Personalized Medicine Coalition:The Personalized Medicine Coalition (PMC), representing innovators, scientists, patients, providers and payers, promotes the understanding and adoption of personalized medicine concepts, services and products to benefit patients and the health system. For more information about PMC, visit http://www.personalizedmedicinecoalition.org.

PRESS CONTACT

Christopher J. WellsVice President, Public AffairsPersonalized Medicine Coalitioncwells@personalizedmedicinecoalition.org (202) 589-1755

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US researchers continue ongoing research into 3D printed pharmaceuticals, presenting their unique findings in Polymers for Extrusion-Based 3D Printing of Pharmaceuticals: A Holistic Materials-Process Perspective.

While many have predicted that the pharmaceutical industry was perched on the edge of a massive transformation due to the advantages offered by 3D printing, there are still many ongoing studies regarding suitable printers, materials, and critical issues such as the impacts of DIY drugs and more formalized manufacturing. In this study, the researchers examine both extrusion-based FDM 3D printing and pressure-assisted micro-syringe 3D printing as they compare them to more traditional processes, along with techniques, challenges, and consider the general direction of the industry overall.

Within the pharmaceutical industry today, 3D printing has made impacts in digital fabrication of drugs, implants, drug delivery systems, and more; however, the researchers point out the importance of such processes especially in creating personalized medications. Citing the success, and FDA approval, of epilepsy drug SPRITAM, the authors stress advantages in the trend toward patient-specific treatmentand specifically, medicine.

Current pharmaceutical manufacturing practices are not costeffective for personalized medicine, state the researchers. 3D printing pharmaceuticals are more suitable than current manufacturing practices for tailored solid dosages.

Although the first waves of pharmaceutical 3D printing began with inkjet printing, strides since then have been not only impressive, but fascinating to much of the public, including:

FDM and PAM printing processes have been most attractive to users due to accessibility and affordability, the potential for fabricating and tuning complex geometries, and more.

(a) The proportion of research articles published on different types of 3D printing processes in the last five years (20152019, total 202 articles); (b) The number of published scientific articles (research and review) in the period from 2015 to 2019 which reported the use of extrusionbased (fused deposition modeling (FDM) or pressureassisted microsyringe (PAM)) 3D printing (source: Scopus database and PubMed).

Choosing the right materials is critical to the success of 3D printing medications also, along with the capability for attaining FDA approval. As a highly suitable material, polymers may be used to print the following in relation to tablets and caplets:

Polymers multifaceted utilization in solid dosage drug delivery systems solidifies its importance in pharmaceutical 3D printing applications, state the researchers.

2dimensional (2D) schematic of the extrusionbased 3D printing process: (a) fuseddeposition modeling (FDM), (b) pressureassisted microsyringe (PAM).

And while they have reviewed studies from multiple other scientists, the authors here point out that while such guides are needed, no detailed discussion on how polymers should be selectedalong with other detailsexists.

Comparison of FDM and PAM 3D printing technologies

Processing is very similar via FDM or PAM, with the extra benefit of being more environmentally friendly, offering the ability for remote control of printing, and small batch, on-demand printing.

Comparison of different processing steps required for traditional direct compression (DC) tablet manufacturing vs. advanced manufacturing, 3D printing (FDM or PAM).

Typical polymers that can be used for 3D printing in pharmaceuticals include:

Summary of polymers based on (a) water solubility and drug release type, (b) their selection for either FDM or PAM 3D printing method.

Obviously, the pharmaceutical industry is highly regulated, with good reason, and the production of medications can be complex due to stringent requirements in production for the safety of the patient. In terms of 3D printing, however, a list of challenges still present themselves such as lack of predictability and consistency in quality of product due to issues like shrinkage or warping, problems with mechanical stability and other properties, and more.

Though a large-scale production of pharmaceuticals using 3D printing might be a long way from now, personalized medicine is possible inhouse for immediate use, conclude the researchers. Future work to enable drug product manufacture using FDM and PAM 3D printing technologies should include the suitability and characterization of polymers and other excipients amenable to processing.

Polymer materials and their properties, specifically their rheology should be investigated to allow a wider formulation and 3D printing design space. A better understanding of the rheological properties of APIpolymer mixtures and their measurement is necessary for the successful 3D printing of pharmaceuticals.

What do you think of this news? Let us know your thoughts! Join the discussion of this and other 3D printing topics at 3DPrintBoard.com.

Characterizations required for 3D printed structure, drug, and polymer (or other functional excipients, if necessary).

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US Researchers Provide Holistic Perspective on Extrusion-Based 3D Printing of Personalized Medicine - 3DPrint.com

DUBLIN, Feb. 20, 2020 /PRNewswire/ -- The "Global Personalized Medicine Market Analysis 2019" report has been added to ResearchAndMarkets.com's offering.

The Global Personalized Medicine market is expected to reach $3.92 trillion by 2026, growing at a CAGR of 12.1% during the forecast period.

The efficient and advanced technology and higher prevalence of disease are driving the market growth. However, the higher cost of research and developments is hampering the market.

Based on the End-user, the hospital's segment is estimated to have a lucrative growth due to the lower cost personalized medicines availability in the hospitals. As the practice of personalized medicine becomes more widespread, hospitals will also experience the need to adapt. That does not mean every hospital and medical centre should try and drive the science, but they should be open to collaborations to facilitate such work.

The key vendors mentioned are Abbott Laboratories, Affymetrix Incorporated, Agendia N.V, Agilent Technologies, Inc, Amgen, Inc, Asuragen Incorporated, Bayer Healthcare Pharmaceuticals, Llc, Celera Diagnostics LLC, Celgene Corporation, Roche Diagnostics Corporation, Precision Biologics Incorporated, Siemens Healthcare Diagnostics, Inc, Sigma-Aldrich Corporation, Johnson & Johnson, Novartis AG, Decode Genetics Inc., Exact Science Corporation, Exagen Diagnostics Inc., GE Healthcare, and Genelex Corporation.

Key Questions Answered in the Report

Key Topics Covered

1 Market Synopsis

2 Research Outline

3 Market Dynamics3.1 Drivers3.2 Restraints

4 Market Environment

5 Global Personalized Medicine Market, By Product5.1 Introduction5.2 Diagnostics5.3 Personalized Medical Care5.4 Personalized Nutrition & Wellness5.5 Therapeutics

6 Global Personalized Medicine Market, By Technology6.1 Introduction6.2 Metabolomics6.3 Pharmacodynamics6.4 Pharmacogenetics6.5 Pharmacogenomics6.6 Pharmacokinetics6.7 Pharmacoproteomics6.8 Point-of-Care Testing6.9 Stem Cell Therapy

7 Global Personalized Medicine Market, By Therapeutic Area7.1 Introduction7.2 Autoimmune Diseases7.3 Blood Transfusion Safety7.4 Cancer Management7.5 Cardiovascular Diseases (CVD)7.6 Central Nervous System (CNS) Disorders7.7 Coagulation Therapy7.8 Diabetes7.9 Infectious Diseases7.10 Antiviral7.11 Neurology7.12 Psychiatry7.13 Oncology7.14 Immunology7.15 Respiratory

8 Global Personalized Medicine Market, By Distribution Channel8.1 Introduction8.2 Dietary Care Centers8.3 Hospital's Pharmacies8.4 Retail Pharmacies8.5 Other Distribution Channels

9 Global Personalized Medicine Market, By Application9.1 Introduction9.2 Biomarker Identification9.3 Clinical Research Applications9.4 Companion Diagnostics9.5 Health Informatics

10 Global Personalized Medicine Market, By End-user10.1 Introduction10.2 Academic Institutes10.3 Bio and Health Informatics Companies10.4 Clinical Care and Research Laboratories10.5 Contract Research Organizations10.6 Hospitals10.7 Molecular Diagnostic Laboratories and Testing Facilities10.8 Research Laboratories10.9 Service Providers10.10 Partner10.11 Venture Capitalists10.12 Other End-users

11 Global Personalized Medicine Market, By Geography11.1 North America11.2 Europe11.3 Asia-Pacific11.4 South America11.5 Middle East & Africa

12 Strategic Benchmarking

13 Vendors Landscape13.1 Abbott Laboratories13.2 Affymetrix Incorporated13.3 Agendia N.V13.4 Agilent Technologies Inc.13.5 Amgen Inc.13.6 Asuragen Incorporated13.7 Bayer Healthcare Pharmaceuticals, LLC13.8 Celera Diagnostics LLC13.9 Celgene Corporation13.10 Roche Diagnostics Corporation13.11 Precision Biologics Incorporated13.12 Siemens Healthcare Diagnostics Inc.13.13 Sigma-Aldrich Corporation13.14 Johnson & Johnson13.15 Novartis AG13.16 Decode Genetics Inc.13.17 Exact Science Corporation13.18 Exagen Diagnostics Inc.13.19 GE Healthcare13.20 Genelex Corporation

For more information about this report visit https://www.researchandmarkets.com/r/37rw80

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

Media Contact:

Research and Markets Laura Wood, Senior Manager press@researchandmarkets.com

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JUPITER, Fla., Feb. 20, 2020 /PRNewswire/ -- Jupiter Medical Center is pleased to announce an affiliation with Sylvester Comprehensive Cancer Center at the University of Miami Leonard M. Miller School of Medicine, providing access to groundbreaking cancer treatments to residents in Palm Beach County and the Treasure Coast. Part of the University of Miami Health System, Sylvester is South Florida's only National Cancer Institute (NCI)-designated cancer center.

The affiliation between Sylvester Comprehensive Cancer Center and Jupiter Medical Center will enable Jupiter cancer patients to have seamless access to Sylvester's highly specialized treatments, innovative therapies, world-renowned experts and clinical trials.

Patients with highly complex or rare cancers will benefit from the specialized expertise, leading-edge technology and clinical research available at NCI-designated cancer centers, such as Sylvester. Those treatments include bone marrow transplants, CAR T-cell immunotherapy, precision medicine approaches, cancer prevention, proton therapy coming later this year, and other new methods to preventing and treating cancer.

"Our affiliation allows patients to continue to receive world-class, personalized and comprehensive cancer care at Jupiter Medical Center, while making it easier for our patients to access the experts, specialized technology and scientific breakthroughs being made at Sylvester," said Dr. Amit Rastogi, president and chief executive officer of Jupiter Medical Center. "The relative proximity of Jupiter Medical Center and Sylvester will help support collaboration and cooperation between the medical teams at both institutions."

"We have a highly-qualified team of more than 300 cancer-focused physicians and researchers working together to deliver world class expertise in cancer prevention, innovative treatments and survivorship to patients," said Dr. Stephen D. Nimer, director of the Sylvester Comprehensive Cancer Center. "This affiliation allows Sylvester to work with a hospital that shares our mission to make advanced cancer care available to a broader community. We are very happy to have an opportunity to work with Jupiter Medical Center to provide pioneering treatments to more patients from Palm Beach County and the Treasure Coast."

Dedicated nurse navigators will facilitate communication and coordination of care between the medical teams at Sylvester Comprehensive Cancer Center and Jupiter Medical Center. The agreement also provides opportunities for cancer experts from both medical centers to collaborate on patient evaluation, diagnosis, and treatment, sharing best practices to determine the best treatment plans for all types of cancer.

Jupiter Medical Center is home to the new Anderson Family Cancer Institute, a 55,000-square-foot, state-of-the-art cancer center opening in March 2020. Accredited by the American College of Radiology, the Commission on Cancer and the National Accreditation Program for Breast Centers, Jupiter Medical Center offers full spectrum of cancer care, including advanced diagnostics, personalized treatments provided by a multidisciplinary team of clinicians, support services for family and caregivers and survivorship programs.

Sylvester Comprehensive Cancer Center is one of only 71 NCI-designed centers nationwide. This designation recognizes cancer centers that meet rigorous standards for multi-disciplinary care and state-of-the-art research focused on developing new approaches to treating and curing cancer.

About Sylvester Comprehensive Cancer Center

Sylvester Comprehensive Cancer Center, part of UHealth - University of Miami Health System and the University of Miami Miller School of Medicine, is the only cancer center in South Florida designated by the National Cancer Institute. NCI designation recognizes that Sylvester has met the most rigorous standards for cancer research, beginning in our laboratories, extending to patient care, and meeting specific needs in our community. Sylvester is known as South Florida's leader in patient-focused cancer research and care, offering the only Phase 1 Clinical Trials program the first step in evaluating how patients respond to the latest investigational treatments. NCI designation further expands Sylvester's ability to provide access to novel therapies through more clinical trials and collaboration with other designated centers. Equipped with a highly qualified team of more than 300 cancer-focused physicians and researchers working together, Sylvester discovers, develops, and delivers more precision cancer care. To serve current and future patients, Sylvester has a network of conveniently located outpatient treatment facilities throughout South Florida.

About Jupiter Medical Center

Ranked #1 for quality, patient safety and patient satisfaction, Jupiter Medical Center is the leading destination for world-class health care in Palm Beach County and the greater Treasure Coast. In 2019, the Leapfrog Group named Jupiter Medical Center a "Top Hospital," a distinction earned by only 6 percent of hospitals nationwide. Jupiter Medical Center is also the only hospital in Palm Beach, Martin, St. Lucie and Indian River counties to receive a 4-star quality and safety rating from the Centers for Medicare & Medicaid Services (CMS). Outstanding physicians, state-of-the-art facilities, innovative techniques and a commitment to serving the community enable Jupiter Medical Center to meet a broad range of patient needs. The region's only independent, not-for-profit hospital, Jupiter Medical Center offers specialty concentrations in orthopedics and spine care; cancer care and oncology; cardiac and vascular care; neuroscience and stroke care; women's and children's services; urgent care; and other key areas. For more information on Jupiter Medical Center, please call (561) 263-2200 or visit jupitermed.com.

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SOURCE Jupiter Medical Center

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Jupiter Medical Center and Sylvester Comprehensive Cancer Center, part of the University of Miami Health System, Enter Affiliation to Advance Cancer...