StemCell Therapy

THEO Campbell has had a furious row with fellow Love Islander Idris Virgo who claimed he is FAKING his blindness in one eye.

The pair clashed online as their private conversations were leaked to fans.

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Theo shared a snap of Idris telling fans: "Think it's fake tbh" after being told about Theo's "lost vision".

Alongside the image, he tweeted: "You missed out the part where youre telling youre little people Im lying about my eye.. only a idiot like yourself would lie about such a thing.

"And that fact youre putting our convo on Twitter just proves once again what a BEG you are. BEG BEG BEG such a loser."

Theo added: "Youre boring. You didnt get an invite to the reunion because you had 0 personality on the show.

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"Everyone else should, only you shouldnt.

"And because your a puppet thats why you wont get casted again. I duno why you try so hard online to make noise. But carry on its laughable."

Refusing to back down, Idris replied: "Who are you again? People only know who you are because of your girlfriend other than that youre irrelevant. Man had to shoot him self with a cork to get clout."

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Theo went blind in his right eye after being hit by a champagne cork in a freak accident in August.

The 28-year-old was forced to undergo two rounds of surgery after his eye "split in half".

He's been supported by his Love Island girlfriend Kaz Crossley who slammed trolls who had accused Theo of making it up.

After someone spotted Theo had worn his eyepatch on both eyes, Kaz barked: "I dunno it must of mirrored on the front camera u lot saying this have way too much time. Haters will say it's fake[sic]."

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For now, Theo has lost his visionbut he is remaining positive that one day he will regain it.

He said recently: "I always preach about being patient and having hope.

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"I think the body, especially my body can heal from anything so I am going to get some vitamins and a lot of darkness."

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Theo Campbell has furious row with Love Island co-star Idris Virgo after he claims Theo is FAKING his - The Sun

HTC filed a motion to dismiss Motivas claim for willful infringement. HTC asserted that Motiva has failed to adequately allege that HTC had knowledge of the patents-in-suit. HTC also argued that Motivas factual allegations of willful blindness are insufficiently specific and otherwise unsupported as an evidentiary matter to state a claim for willful infringement.

In analyzing the motion to dismiss, the district court noted that Motiva did not allege actual knowledge for the pre-suit period, but also explained that Motiva was not required to do so as willful blindness could supply the requisite knowledge. Warsaw Orthopedic, Inc. v. NuVasive, Inc., 824 F.3d 1344, 1347 (Fed. Cir. 2016) (recognizing that the Supreme Court has repeatedly held that willful blindness can supply the requisite knowledge for indirect infringement) (citing Commil USA, LLC v. Cisco Sys., Inc., 135 S. Ct. 1920, 1926 (2015); see also Global-Tech Appliances, Inc. v. SEB S.A., 563 U.S. 754, 766 (2011).

Accordingly, the district court looked at whether the allegations of willful blindness were pleaded sufficiently. The district court examined two of the factual allegations pleaded by Motiva and found that either were sufficient to satisfy the plausibility standard under the Supreme Courts decision in Twombly. Bell Atl. Corp. v. Twombly, 550 U.S. 544, 556 (2007).

Motiva first alleged that HTC has a policy or practice of not reviewing the patents of others. The district court noted that creating a policy prohibiting review of patents is a specific kind of deliberate action[] to avoid learning of potential infringement. See Global-Tech, 563 U.S. at 768. This allegation, which the district court had to accept as true at this stage of litigation, raised a reasonable expectation that discovery will reveal evidence of the nature, scope, and wording of that policy, in support of Motivas claims of willful blindness. The district court concluded that [s]ince Motiva has alleged that HTC has such a specific policya policy prohibiting review of patentsMotiva has plausibly alleged that HTC was willfully blind.

Second, Motiva alleged that HTC performed specific acts to implement and enforce this policy. The district court explained that Motiva specifically alleges that HTC executed its policy prohibiting review of patents by instructing its employees to not review the patents of others. Again, the district court found that [s]imilar to the allegations related to the existence of HTCs policy, these allegations plausibly suggest that additional discovery will reveal evidence in support of Motivas claim. Twombly, 550 U.S. at 556. Motivas allegations plausibly suggest that discovery will reveal what instructions were given by HTC, to whom they were given, and whether HTCs employees complied. Id. at 556. Accordingly, Motiva has adequately alleged willful blindness on this factual basis as well.

As a result, the district court denied the motion to dismiss and concluded that the requirements of Twombly are met when a plaintiff identifies the existence of a specific policy of willful blindness or specific acts of willfully blind conduct. Either factual allegationthe existence of the policy or its implementation in the form of specific acts of willfully blind conductis sufficient to state a claim at the pleading stage.

Motiva Patents, LLC v. HTC Corp., Case No. 9-18-CV-00180-JRG-KFG (E.D. Tex. Sept. 27, 2019)

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Motiva v. HTC: Allegations of Willful Blindness Sufficient to Defeat Motion to Dismiss a Claim for Willful Infringement - Lexology

SAN CARLOS, Calif., Oct. 9, 2019 /PRNewswire/ --Apexigen, Inc. announced today that Herb C. Cross has joined its Board of Directors as an independent director. Mr. Cross joins Apexigen's Board of Directors with over 20 years of experience in executive leadership roles at both public and privately held biotechnology companies and will serve as Chair of the Board's Audit Committee.

"We are excited to welcome Herb to Apexigen's Board of Directors, which is further strengthened by his impressive list of accomplishments in finance, operations and business development," said Kenneth Fong, Ph.D., Chair of Apexigen's Board of Directors. "We look forward to benefiting from Herb's guidance and leadership."

Mr. Cross is currently Chief Financial Officer of Atreca, a biotechnology company that completed its initial public offering in June of this year, and which is focused on developing novel therapeutics based on a deep understanding of the human immune response. Prior to joining Atreca, Mr. Cross served as CFO of ARMO Biosciences. While at ARMO Biosciences, Mr. Cross led all administrative functions and corporate development while driving their successful initial public offering in 2018 followed by the sale of the company to Eli Lilly & Co. for $1.6 billion later that year. In recent years, Mr. Cross served as CFO of Balance Therapeutics, KaloBios Pharmaceuticals, and Affymax. Prior to joining Affymax, he was Vice President of Finance and served in other key roles at Neoforma, PDL BioPharma and Facet Biotech. Mr. Cross began his career at Arthur Andersen LLP.

"This is an exciting time for Apexigen with its broad clinical development program for APX005M, the company's lead product candidate, and its pipeline of licensed and proprietary programs. I look forward to working closely with Apexigen's management team as they continue the evolution of the company," said Mr. Cross.

In addition to Mr. Cross, Apexigen's Board of Directors includes Xiaodong Yang (CEO), Kenneth Fong, William Rutter, George Lee, Daniel Zabrowski, Karen Liu and Scott Smith

About ApexigenApexigen is a clinical-stage biopharmaceutical company discovering and developing a new generation of antibody therapeutics for oncology, with an emphasis on new immuno-oncology agents that could harness the patient's immune system to combat and eradicate cancer. APX005M, a CD40 agonistic antibody, and Apexigen's additional preclinical programs were discovered using APXiMAB, Apexigen's proprietary product discovery platform. Apexigen and its various licensees are using this platform to seek to discover and develop high-quality therapeutic antibodies against a variety of molecular targets, including targets that are difficult to drug with conventional antibody technologies. Six product candidates discovered using APXiMAB are currently in clinical development, either internally by Apexigen or by its licensees. For more information, please visit http://www.apexigen.com.

Investor Contact:Jennifer PorcelliSenior Vice PresidentSolebury Trout646-378-2962Investors@apexigen.com

Apexigen Contact:Mark NevinsVice President, Business DevelopmentApexigen650-931-6236mnevins@apexigen.com

SOURCE Apexigen, Inc.

http://www.apexigen.com

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Apexigen Appoints Biotechnology Financial Executive Herb Cross to Board of Directors - PRNewswire

What happened

Shares of Puma Biotechnology (NASDAQ:PBYI) fell as much as 20.2% after the company disclosed through a filing with the Securities and Exchange Commission that Chief Commercial Officer Steven Lo will resign on Oct. 18 to become the CEO of an emerging pharmaceutical company. However, a departing executive isn't the real reason shares are tumbling.

In an unrelated move, Goldman Sachs analyst Paul Choi downgraded Puma Biotechnology stock from neutral to sell, changed the price target from $24 to $8 per share, cut his 2025 sales estimate by 25%, and reminded investors thatSeattle Genetics (NASDAQ:SGEN) has a drug candidate that might compete well against Puma's Nerlynx, according to StreetInsider.com.

As of 11:08 a.m. EDT, Puma Biotechnology stock had settled to a 17.4% loss.

Image source: Getty Images.

Puma Biotechnology hasn't been able to convince investors or Wall Street that Nerlynx can live up to its blockbuster potential. The drug product, prescribed for one year to individuals that have completed treatment for breast cancer, has faltered recently. A significant number of individuals have to discontinue treatment due to severe side effects, although that decision is a lot easier for doctors to make considering the drug's questionable value and high cost.

While Nerlynx has gradually earned supplemental approvals from regulators to expand its use, revenue growth has slowed significantly due to patient churn. Sales in the second quarter of 2019 grew only 6% from the year-ago period. Licensing revenue from international sales should begin to trickle in soon, and operating losses are beginning to shrink, but investors are concerned with the drug's future. Nerlynx is the only drug product or drug candidate owned by Puma Biotechnology.

Nerlynx has struggled to overcome its own inherent problems relating to tolerability, which Choi thinks could be further exposed by a drug candidate from Seattle Genetics. Tucatinib is being evaluated in the same settings as Nerlynx, has proven to have fewer side effects, and is expected to have new data from an important clinical trial before the end of 2019. Choi thinks better tolerability could allow tucatinib to grab more market share than Nerlynx even if it proves less effective, but the drug candidate has to earn marketing approval first.

It may be tempting to label Puma Biotechnology as a value stock, especially considering that the company's market cap now sits at just $325 million. On the one hand, the business could achieve sustainable operations with just a little more growth from Nerlynx. Choi's optimism for tucatinib from Seattle Genetics may be a bit premature and overblown. After all, many have questioned the value of Nerlynx based on its high cost and slight improvement to overall survival, so could a less effective drug really make a splash even if it has fewer side effects?

On the other hand, Nerlynx is clearly not living up to expectations. It should receive a boost from recent supplemental approvals and international expansion, but investors might be better off waiting to see another quarter or two of operating results before getting too carried away.

Originally posted here:
Here's Why Puma Biotechnology Tumbled Today - The Motley Fool

Doesnt matter if you want to invest into these US based biotechnology companies or want to work for them. If your query has anything to do with the best biotechnology companies in the US region, then believe it or not, you are at the right place! In this article, Ive not only listed the 10 best companies, but Ive also listed other interesting details such as projects theyve worked on, upcoming projects and other details which can help you learn more about them!

It is said by stock market experts that the Biotechnology field is one of the safest. But I think that they are not just safe, but they also have huge potential. Imagine, the company working on a formula which could solve a serious disease such as cancer? Well, not only will it save lives, but people would spend huge on such medicines and that could be a boom time for the people who hold stocks of such companies or work there.

Do you acknowledge the potential of Biotechnology? It has opened up the gateways to extreme possibilities. The ideas that were only a small fragmentation of our minds are possible to manifest due to the advancements in Biotechnology.

Over time, with technology, many diseases evolved, which challenge the existence of our kind. The spectrum is highly untapped. However, some bio-pharmaceutical companies were diligent in entering the world of the unknown.

Since then, these companies have come a long way and evolved to be one of the well-established organizations around the globe. Their bold actions and willingness to explore and discover the treatment for some of the grotesque conditions, have led them to become the top 10 companies leading biotech.

Gilead Sciences exists since 1987 in the heart of Foster City as one of the prominent Biotechnology companies. It specializes inantiviral drugsconcerning life-threatening diseases like Hepatitis B and C, HIV AIDS, and Influenza. The company is also a member of the S&P 500 and theNASDAQ Biotechnology Index. Both are related to the security-related stock index for Pharmaceuticals or Biotechnological companies.

The two flagship products of the company are Sovaldi and Harvoni. These two were engineered to fight against the hepatitis C viruses successfully. The popularity of the drugs led the company to gain 4th rank in Forbes rank for exceptional growth in market capitalization. It has merged with some of the most potential companies over the years.

However, There have been controversies regarding the pricing of the drugs of the company. Although the cases did not bear any result, the company significantly dropped the rate of their drugs.

In countries like India, licensed companies of Gilead Sciences provided the drug in the range of USD 4. The company holds the strength of over 10,000 employees spread worldwide. While the company attained total equity of around 21 billion, it has a revenue going into losses of equal value.

There are changes in the revoking patent and contracts if there is a lack of substantial discovery in the upcoming years. It also faces several backlashes from the criticism. However, the company stands strong and plans on making groundbreaking discoveries in the field of HIV. If the research bears fruits, the company may manage to survive in the US, as its branching units are doing fine with decent capital income.

Recent Official News articles About Gilead:

Amgen is a biopharmaceutical company that has flourished since its foundation in 1980 by George B. Rathmann. The company specializes in Molecular Biology and Biochemistry, which led to the discovery of several useful products over the years. Its products are used to prevent infection and other unwanted abnormalities during the treatment of severe conditions like cancers. The discovery of Epogen drug has brought the company into the competition amongst the giants of the industry.

Epogen was primarily discovered for the treatment of Anemia for critical kidney failure. However, its potential led it to receive approval for curing anemia in the candidates who undergo chemotherapies, or HIV aids treatment. Their Neupogen became the second prominent product which helped in preventing infections in the patients with the weakened immune system after treatment. Thus, Neulasta, a better and improved immunostimulator, came in the light.

Much like other big names on the list, the company also got under the fire of controversies. There have been whistleblower cases to which Amgen pled guilty. It delivered compensation. However, there havent been many solid cases or controversies regarding the company. Its news and information usually revolve around the discovery of some new form of treatment or drug.

It showcases the impeccable excellence of over 21,000 employees of Amgen. There have been successive series of products from the company and featured in several popular magazines like Fortune 500. From arthritis to tumors, the company deliberately laid its foundation for the integration of various drugs. The company has a remarkable revenue of around 24 billion, with equities reaching about $30 billion. Much like other companies on the list, it has undergone some significant mergers.

Latest News About Amgen:

Celgene started in 1986 by the founder Sol J. Barer with specialization regarding Cancer treatment and other inflammatory diseases. However, the company consistently works on improving human lifestyles by presenting innovative treatments to fight diseases. It grew popular due to the out of the box thinking capabilities. The community or organizational standards do not restrict the personnel of Celgene.

One such example is incorporating thalidomide in the treatment for cancer patients, which flourished. Hence, it shows their fearless approach and the stop at no cost mindset. Several social figures have also passed commendable remarks regarding the endeavors of the company. The company has received several awards and commendations for exceptional services over the years.

It does not hesitate to help those in need, not words, but the actions are evident. One of the feats includes continuous services to the patients and families on the east coast after Hurricane Sandy. The employees of the company worked to make sure nobody was left unchecked. Revlimid is the flagship product of the company. It is a treatment available for multiple myeloma, a rare blood cancer disease.

There are several other products available in the market. Showcasing human well-being over anything else, the company has also developed medication for ADHD in children. Furthermore, treatment for conditions like Leukemia was also made available. Despite its contributions, the company fell prey to allegations and claims over the years. It is very normal for such gigantic companies.

Emerging victorious, the company has a revenue of 13.5 billion, with a workforce of over 7,500 employees backing its trustworthy and reliable foundation. Currently, its headquarters is located at Summit, New Jersey, in the United States of America.

The company is primarily known for its specialty regarding neurodegenerative diseases. But it has expanded its horizons to other aspects like hematologic and autoimmune diseases. It is a multinational company, prospering since 1978 with headquarters in Cambridge, Massachusetts, U.S. With several major mergers with companies, it is one of the larget companies. It is successfully enlisted in many stock index groups over the years.

Biogen has rolled out several products over the years. Hemophilia A and B, sclerosis, psoriasis, and leukemia are some of the known conditions the products work on. From relapsing to the prevention of bleeding, these drugs have made the lives easier for people. The company is also consistently partnering with other companies on vital projects.

It partnered with Samsung for Samsung Bioepis. The project accumulates the resources and specialization of the two companies in their respective fields to enter the field of biosimilars. There are other ventures with companies like Eisai Inc. regarding the treatment of Alzheimers. There have been some successful reports which may potentially reduce the speed of the disease.

There has been a separate spin-off of the company completely focused on Hemophilia in May 2016. The company is proudly known as Bioverativ. Its overall growth and profit have also assured the name of the Fortune 500 companies. Thus, it reflects the exceptional proficiency of the professionals the company is working with.

The founding party is full of brilliant scientists and experts in their field who won awards for their contributions. Their impact reflects on the integrity and stature of the company. It encompasses the potential of around 7,500 employees and revenue closing 13 billion.

Latest news:

Leonard Schleifer and George Yacopoulos founded Regeneron with the intention of studies of neurotrophic factors and their regenerative capabilities. Since its establishment in 1988, the company has developed several drugs and treatments with the help of its excellence in the regenerative field, hence the name of the company Regeneron. The company has branched out to dig into the other spectrum of the aspects like cytokine and tyrosine kinase receptors.

Aflibercept was the first drug that came in the light. It was primarily used to cure wet macular degeneration. It was a VEGF inhibitor that is a protein-related to the growth and development of blood vessels. In 2012, there was news of the development of a drug that would reduce the cholesterol levels in a person by up to 72%. Other successful products include Eylea, which is to cure blindness due to aging. Dupixient for atopic dermatitis is also a popular product of the company.

Compared to other humongous companies on the list, it has a revenue of 5.8 billion but an employee strength of over 6,200. It is successfully on the list due to a lack of controversies and lawsuits against the company. Furthermore, the company has done a remarkable job in the discovery of various drugs for the treatment of rare diseases. Their technology and two different methods also make them unique and stand them out from their competitors.

The company has also shown a drastic increase in growth during recent years, since 2012. Hence, its potential finalizes its name among the list of the top biopharmaceutical companies. Currently, the headquarters of the company is situated in Eastview, New York, the heart of the USA.

Alexion was established in 1992 as an American pharmaceutical company. It specializes in research regarding the immune system and autoimmune diseases. Their development of specialty drugs has put them apart from the competition. It is now a global biopharmaceutical company with its branches all around the world.

The company is primarily known for the development of Soliris drug. It is a worldwide approved drug around several nations used for treating atypical hemolytic uremic syndrome and paroxysmal nocturnal hemoglobinuria. Strensiq was the second production targeting a metabolic disorder, hypophosphatasia. Kanuma was the third drug that fights lysosomal acid lipase deficiency, a disease that builds fatty acids in the bloodstream, veins, and organs.

These contributions to the development of drugs for rare diseases have put the company into a prestigious position. Apart from the above three, there are six other projects under research and development. The studies and research are regarding several rare diseases or disorders like molybdenum cofactor deficiency Type A in newborns. The company continuously strives to discover innovative medical therapies for patients all around the world.

The company has been a target for many other competitors. It also retains grounds for several controversies regarding the Soliris drug. Although the company is striving to achieve treatment options for other untouched diseases, it would still require to maintain profits to be in the business. Thus, the allegations and controversies were proven to be false.

Alexion houses over 2,500 employees worldwide. There are several other facilities under the company, like manufacturing units in Smithfield and translational medicinal facilities in Cambridge. It shows their deliberate expansion to conveniently reach patients all around the globe. With a revenue of over 3.5 billion, the company stands strong with a new headquarters in Boston, Massachusetts.

Vertex was founded by Joshua Boger and Kevin J. Kinsella in 1989. The company primarily focused on viral infections, autoimmune diseases, and cancer treatment. Later, it expends to genetical conditions and other spectra of the bioengineering fields. The company is awarded several times for its contributions to the medical field.

There have been countless product developments from the company. The oral treatment for hepatitis C, telaprevir, is a popular product. However, Ivacaftor became the flagship product of the company. It was developed to treat the underlying causes of cystic fibrosis.

The company invested in exploring the potential of the drug and made other variations of the drugs available. Lumacaftor and Tezacraftor were the results. These drugs broke the age-restriction of the original medicine, to be available for the masses above the age of 12. For a while, the company provided the drug for free.

The triple combination treatment also came under the light. It was a new CFTR in combination with the two flagship medicines. The results were successful, with benefits to 90% of Cystic fibrosis patients. It opened a doorway for them to treat mutations.

Due to their success in the genetic branch of the individuals, the company started to focus on exploring more possibilities. They established research and development teams working on modifying genetics intending to provide treatments for several genetic diseases and disorders.

Vertex Pharmaceutical owns three research facilities in San Diego, California, and Milton Park, Oxford, England. It has a revenue of $3 billion, with over 2,000 employees worldwide. The company has featured among the top 15 best-performing companies on Standard and Poos 500. Its use of rational drug design also makes it stand out from its competitor companies.

With headquarters in San Diego, California, the American company started in April 1998 as a developer and manufacturer of analytical machinery for Genetics and biological aspects. One of the most remarkable feats Illumina achieved was reducing the cost of sequencing the human genome from 1 million to 1,000 USD. The company consistently works in researching various fields like reproduction, agriculture, science, and the flagship research of genomes.

The company strongly believes in the potential of genetic engineering. By tapping into the genomes, they can potentially increase the chances to cure several underlying diseases. Uncurable conditions like Cancer and others should be in the grasp of humanity. The company is known for introducing DNA Sequencing into the industry.

Their machinery is state of the art with clients all around the globe. Several genetic research centers, academics, and pharmaceutical companies integrate Illuminas innovation in their facilities. Their contributions include the expansion of analysis of genomic sequences, which provides for protein analysis, gene expression, and SNP genotyping. The company has established a branch named Grail.

Grail focuses on blood tests for cancer tumors. It has grand investors like Bill Gates and Jeff Bezos in their projects. Thus, ensuring the authenticity of the company and sending a powerful message to the world. The company completely utilize each product of Illumina for their testing and analysis and plan to discover exceptional breakthrough.

The company has a revenue of 3.33 billion, with operating income touching the $1 billion milestone in upcoming years. It employs a qualitative workforce of over 7,500 employees worldwide. The company is prominent in the field of genome-sequencing, with over 70% of dominance in machinery used by the research facilities.

BioMarin Pharmaceutical Inc. is an American company with dominion spread across the world in the regions of the United States, South America, Asia, and Europe. It is prominently known for the specialization in the Enzymes Replacement Therapies. A procedure used to replace a deficient enzyme in the patients body. Christopher Starr and Grant W. Denison Junior were the founding members of the BioMarin.

The company has six orphan drugs in the market: Kuvan, Naglazyme, Firdapse, Vimizim, and Brinuera. The various drugs target some of the rare forms of diseases and conditions like phenylketonuria, mucopolysaccharidosis type VI, and Batten Disease, and so on. There are several other projects under development and awaiting approval. One such product is Valoctocogene Roxaparvove for the treatment of Haemophilia A by replacing the factor VIIIs function in the system of the human body.

Their successive research bore fruits in the form of the first therapeutics for phenylketonuria, also known as PKU. They have also developed the primary treatment for mucopolysaccharidosis type 1, popularly known as Aludrazyme. Thus, with succession, the company seeks to discover new methodologies and research for several other medications. They have made commendable contributions to the diabetic society, as well.

BioMarin has consistently expanded its horizons to several fields for contributions. It acquired several research facilities and companies over the years. They focused on areas for the treatment of glycan metabolism, neurological disorders, and genetically defined cancers. There have been several controversies surrounding the company with credible lawsuits.

However, the company emerged victoriously and still thrives. These suits and controversies further reinforced the image of the company. With a little blowback, the company has a revenue of over 1.3 billion, with around 2,600 employees. It is growing exponentially, with total equity falling approximately 3 billion.

Agilent is popularly known as a spin-off or the child company of HP (Hewlett Packard) founded in 1999. At the time, the company grew in popularity due to its record in the Public Investment in the year 2000 with the worth of over $2 billion. It was established with the sheer intention of contributions in medical research and developments. The company has managed to retain its image as a provider of equipment about research and analysis.

Agilent managed to branch out to other aspects like food, environment, chemicals, and energy production. The company concerns itself with the machine and equipment department compared to others on the list. It covers every possible aspect of the scientific, medical, and research developments. Most of the products focus on providing precise analysis of the subjects and accurate readings.

Agilent provides Automation, FISH probes, and other essential components to significant manufacturing companies around the globe. It dominates the innovative approach and scientific brilliance for the production of state of the art facilities. Not only focusing on the performance but also the economic value, it has grown remarkably over the years. The company has the following divisions: CrossLab Group, Diagnostic and Genomic Group, Life Science, and Applied Markets Group.

It has also stepped into the world of electronics for testing and measurement. Agilent has acquired an incredible workforce of over 13,500 by the year 2019 and revenue touching $3 billion. The total equity of the company has surpassed the $5 billion standards. There are countless buildings with four in San Fransisco Bay and seven in China. It has also stepped into European territories like Germany, UK, and Denmark.

Backed up by decades of research, these companies have stepped into the world of rare diseases and conditions. Each one awarded significantly for their contributions in the field of biotech and medical science. Their bold moves have resulted in the provision of treatment of several unknown and underlying diseases.

Despite the controversies surrounding them, they have acquired a prosperous stage. With the objective of human well-being for the longevity of life, they diligently work to deliver the best results to the public. Due to the consistent progress of these companies, we may discover a cure to conditions like cancer and other unknown and fatal problem.

Read more here:
10 Biotechnology Companies That Rule in the United States - TeckFlock

In the past few years, six decades after Francis Crick and James Watson discovered the chemical structure of DNA, scientists have developed CRISPR technologies that prevent disease by pinpointing unhealthy genetic sequences and replacing them with healthy ones. These technologies locate and repair errant mutations to the lengthy, repeating patterns of genetic code that form DNAs double helix. In so doing, they cure disease. In addition, CRISPR can create optimal outcomes such as increased resistance to illness and other desired physical and mental attributes that make the technology exciting but also slightly scary.

In business as in biotechnology, progress requires identifying vulnerabilities and addressing them before they can cause damage. In less controversial ways, businesses need to be able to detect and modify parts of their supply chains to harness the flexibility and capabilities necessary to manage their spend and drive optimal outcomes. For example, when businesses join digital networks, they gain visibility into the interconnected operations of trading partners. This transparency places into sharp focus any underperforming suppliers, as well as alternative providers that may be better suited to create value and extend competitive advantage.

Business and biotechnology also have in common the importance of continual innovation, which often arises from the detection of previously unseen patterns. What could businesses discover about themselves, their trading partners, their customers if they, not unlike CRISPR, probed the vast repositories of information available to them for patterns, anomalies and meaning?

Every day throughout the regular course of operations, businesses accumulate massive amounts of data chronicling transactions, internal processes and marketing activities. Yet only a fraction of that volume is ever analysed. What efficiencies go unrealised? What insights remain out of reach? What value lies hidden away amid the endless zeros and ones and the myriad suppliers involved in their digital supply chain? Seeking clarity, business leaders are turning to digital networks and emerging technologies like artificial intelligence. By linking together millions of buyers and suppliers, these cloud-based networks offer newfound insights into previously uncorrelated data, fuelling the rise of intelligent enterprises.

This digital transformation, aided by cognitive technologies, arrives at just the right moment for business. Faced with ongoing turbulence in the financial markets and trade tensions roiling nearly every industry, senior executives need to stay ahead of the only constant they can count on: the relentlessness of change itself. Enterprises that embrace digital technologies and predictive analytics bolster their ability to manage operational (and other types of) risk. They can anticipate bottlenecks, stockouts or other challenges and rectify them before they dent a balance sheet. Visibility across supply chains can equip businesses with alternative sources and shipping routes, thus diminishing the potential for disruption caused by tariffs, direct material shortages, labor strife or weather disasters. A nimble value chain must remain flexible enough to cut out and replace suppliers as needed, yet supple enough to reward those proven capable of meeting requirements despite unexpected logistical challenges.

As businesses embrace digital networks, they also realise opportunities for collaboration with their trading partners. Working together in real-time, buyers and suppliers can spur innovation, optimise operational costs, and procure with purpose. Connecting legacy systems to the cloud is like flipping on a light switch, illuminating the supply chain in all directions. Meanwhile, the advent of cognitive technologies lends cloud-based networks greater insight than ever. Applying machine learning and other forms of artificial intelligence, a digital network can augment an organisations strategic planning with sophisticated predictive analytics to avoid bottlenecks, shortfalls and other operational disruptions.

Yet for all their transformative effects on the supply chain, digital networks most sweeping benefit may accrue to procurement professionals themselves by taking on many of the tactical, paper-based tasks traditionally associated with sourcing, contracting, purchasing and payments. Relieved of these activities, procurement professionals can refocus their talents on more strategic activities such as shoring up the supply chain, and collaborating to create mutual value, and fostering an ecosystem where innovation thrives.

The transparency made possible by digital networks reveals much more than systemic threats to a business operations. It sheds light on crucial quality issues as well. How do a companys stakeholders suppliers, customers, employees interact with its e-commerce platforms? Are these systems intuitive to navigate? Do they learn from past use to improve subsequent activity? Do they integrate data from related systems into a unified interface? What do users cite as their pain points? Or does the company even ask?

One cannot fix what one fails to measure. Thats why intelligent enterprises increasingly take the pulse of their stakeholders via sophisticated experience management capabilities, which capture and analyse their feedback so that business leaders may promptly act on it. Here, too, CRISPR technologies provide an instructive parallel. These advanced medicines hold out the promise of a substantially improved quality of life for untold numbers of people worldwide. By literally rewriting the faulty patterns within DNA that cause disease, CRISPR stands poised in years ahead to alleviate suffering and reshape the human experience for the infinitely better.

Meanwhile, the world of business takes inspiration from that of biotechnology, by upgrading supply chains with new patterns and insights and by infusing new skills and capabilities into its very DNA.

Patrick McCarthty, senior vice president and general manager, SAP Ariba

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Patterns of innovation in business and biotechnology - ITProPortal

Global Biotechnology Algae Cultivation Process (Micro Algae) Market 2019-2025 : Covering both the industrial and the commercial aspects of the Global Biotechnology Algae Cultivation Process (Micro Algae) Market, the report encircles several crucial chapters that give the report an extra edge. The Global Biotechnology Algae Cultivation Process (Micro Algae) Market report deep dives into the several parts of the report that plays a crucial role in getting the holistic view of the report. The list of such crucial aspects of the report includes company profile, industry analysis, competitive dashboard, comparative analysis of the key players, regional analysis with further analysis country wise. Moreover, one of the uniqueness in the report is that it also covers the country-level analysis of the regulatory scenario, technology penetration, predictive trends, and prescriptive trends. This not only gives the readers of the report the actual real-time insights but also gives country-wise analysis, that plays a vital role in decision making. The inclusion of the report is not limited to the above mention key pointers. The report also emphasizes on the market opportunities, porters five forces, and analysis of the different types of products and application of the Global Biotechnology Algae Cultivation Process (Micro Algae) Market.

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The Leading Market Players Covered in this Report are : Cellana, Ecoduna, Algenol Biofuels, Solix Biofuels, Sapphire Energy, Solazyme, Seambiotic, LGem, Cyanotech, DENSO, Mialgae, Neoalgae,

The top manufacturers/competitors are thoroughly analyzed in terms of the production capacity, total annual revenue generated by each company, asset market value, market share, are systematically covered in the research report. The Global Biotechnology Algae Cultivation Process (Micro Algae) Market report also encompasses a thorough financial analysis that covers several key Financials ratios and figures like operating income, operating margins (%), EBITDA, Other operating expenses, business segment revenue split, market share by business segments, etc.

Decision Market Reports provide the most recent and well-organized Market report. Our reports provide crucial insights to the readers that help to gain a deeper understanding of an industry. This helps them in taking some crucial decision-making steps for expansion, investment, and market analysis. Global Biotechnology Algae Cultivation Process (Micro Algae) Market report delivers comprehensive analysis and viable analysis by region including crucial information that includes process of manufacturing, equipment suppliers and raw material, various cost associated with manufacturing, revenue, futuristic cost and historical cost, and data for demand-supply.

Global Biotechnology Algae Cultivation Process (Micro Algae) Market Splits/Segmentation by Product Type:

Euglenophyta (Euglenoids) Chrysophyta (Golden-Brown Algae and Diatoms) Pyrrophyta (Fire Algae) Chlorophyta (Green Algae) Rhodophyta (Red Algae) Paeophyta (Brown Algae) Xanthophyta (Yellow-Green Algae) Others

Global Biotechnology Algae Cultivation Process (Micro Algae) Market Splits/Segmentation by Application:

Food Fertilizer and Agar Pollution Control Energy Production

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The Report Scope: This report thoroughly examines the current status and outlook of the key market players on the global level and regional level that are associated with Global Biotechnology Algae Cultivation Process (Micro Algae) Market. The report also covers the top key manufacturers across the globe and appropriately splits the Global Biotechnology Algae Cultivation Process (Micro Algae) Market by segments like type and applications/end users. The Global economic slowdown in 2016 has adversely impacted the growth of both emerging markets and developed markets. While both interest rates and equity markets advanced favourably moving towards the end of 2017. Global Biotechnology Algae Cultivation Process (Micro Algae) Market is a highly concentrated market. The top 10 Market players account for about 90% of the total market share in 2017. The Global Biotechnology Algae Cultivation Process (Micro Algae) Market has been regionally segmented into Europe, Asia, North America, Latin America, and Middle East and Africa. North America held the largest share in the global market with shares exceeds XX% in 2018. Europe also holds an important role in Global Biotechnology Algae Cultivation Process (Micro Algae) Market. European Market is valued at xx million US$ in 2017 and is estimated to reach xx million US$ in 2024, growing with a CAGR of XX. The Global Biotechnology Algae Cultivation Process (Micro Algae) Market is valued at XX million US$ in 2017 and is expected to reach XX million US$ by the end of 2024. Growing at a higher CAGR of XX% between 2019 and 2024, the Global Biotechnology Algae Cultivation Process (Micro Algae) Market is likely to experience huge growth in the revenue until the end of 2024. Asia-Pacific being the most advancing region is likely to occupy a higher market share by the end of 2024. The United States is one and the major revenue contributing countries will always have a special role in the global market. Even the slightest change from North America can affect the ongoing trend of Global Biotechnology Algae Cultivation Process (Micro Algae) Market.

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Market Overview Of Biotechnology Algae Cultivation Process (Micro Algae) Market In Global Industry 2019-2025 - Space Market Research

The leading research firm Zion Market Research published a research report containing 110+ pages on Biotechnology Reagents Market by Technology (Chromatography, Electrophoresis, PCR, Mass Spectrometry, Flow Cytometry, Expression & Transfection) for DNA & RNA Analysis, Protein Purification, Drug Testing, Gene Expression and by End user: Global Industry Perspective, Comprehensive Analysis, Size, Share, Growth, Segment, Trends and Forecast, 2015 2021, which serves with all-inclusive, highly-effective, and thoroughly analyzed information in a well-organized manner, based on actual facts, about the Biotechnology Reagents Market. The whole information from scratch to the financial and management level of the established industries associated with the Biotechnology Reagents Market at the global level is initially acquired by the dedicated team. The gathered data involves the information about the industrys establishment, type and the form of products it manufactures, annual sales and revenue generation, the demand of the manufactured product in the market, marketing trends followed by the industry, and a lot more important information.

The industry analysts begin their task by compiling this huge pile of information, graphically expressing, anticipating the future market growth, offering the ways to improve the business, and many other important viewpoints explained by them in the Global Biotechnology Reagents Market report.

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The Global Biotechnology Reagents Market report elucidates the comprehensive analysis of the market-derived on the basis of regional division:

The report comprises precise analytical information related to market forecasts for several upcoming years. The report also includes the particulars about the valuation of macro and microelements significant for the growth of already established Biotechnology Reagents Market contenders and emerging new companies.

The industries majorly comprise the global leading industries:

Abbott, Beckman Coulter, Agilent Technologies Inc., Water Corporation, Bio-Rad, Roche, Sigma-Aldrich, Life Technologies, Betcon Dickinson and Thermo Fisher Scientific among others

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The report covers forecast and analysis for the Global Biotechnology Reagents Market on a global and regional level.

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Detailed information about market opportunities are discussed.

The key target audience for the market has been determined in the report.

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The market numbers have been calculated using top-down and bottom-up approaches.

The Global Biotechnology Reagents Market has been analyzed using Porters Five Forces Analysis.

The market is segmented on the basis of Component, applications, connectivity, and end-user, which in turn bifurcated on the regional level as well.

All the segments have been evaluated based on present and future trends.

The report deals with the in-depth quantitative and qualitative analyses of the Biotechnology Reagents Market.

The report includes detailed company profiles of the prominent market players.

The Global Biotechnology Reagents Market report also delivers the accurately estimated pattern of CAGR to be followed by the market in the future. The numerous highlighted features and enactment of the Biotechnology Reagents Market are examined based on the qualitative and quantitative technique to deliver the whole scenario of the current and future evaluation in a more effective and better understandable way.

The report covers a forecast and an analysis of the Biotechnology Reagents Market on a global and regional level. The study provides historical data from 2015 to 2018 along with a forecast from 2019 to 2027 based on revenue (USD Billion). The study includes the drivers and restraints of the Biotechnology Reagents Market along with their impact on the demand over the forecast period. Additionally, the report includes the study of opportunities available in the Biotechnology Reagents Market on a global level.

In order to give the users a comprehensive view of the Biotechnology Reagents Market, we have included a competitive landscape and an analysis of Porters Five Forces model for the market. The study encompasses a market attractiveness analysis, wherein all the segments are benchmarked based on their market size, growth rate, and general attractiveness.

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Biotechnology Reagents Market Size & Share Revenue To Surge To USD 94.6 Billion in 2021 , Globally - Market News Network

It's almost time for the American Academy of Opthalmology's (AAO) annual meeting again, and this year's event will contain some high-stakes presentations. This year, all three of these biopharmaceutical companies will present clinical trial results that could send their stock prices soaring -- or tumbling.

Data source: Company Filings, Yahoo! Finance.

Which stocks have the best chance to climb this week? Here's what to look out for when investigators from each company present their results at AAO.

Image source: Getty Images.

Ophthalmologists have been treating age-related macular degeneration (AMD) and similar causes of blindness with vascular endothelial growth factor (VEGF) inhibitors like Eylea fromRegeneronfor a long time. Sadly, many patients continue losing their sight despite VEGF treatment and Kodiak has an elegant solution to the problem.

Ophthalmologists would like to apply a VEGF treatment to the retina every few days but nobody wants to visit the doctor to get a needle in the eye more often than necessary. Four- and eight-week intervals are the norm and toward the end of each interval, there are days where treatments have already been depleted. That allows new blood vessels to begin invading the retina until the next generation.

On Friday, Oct. 11, 2019, Kodiak will present durability data from an ongoing study with patients that are losing their vision to AMD or a related disorder. The company's lead candidate, KSI-301 is a VEGF antibody with long, heavy hair extensions calledphosphorylcholine. That's the same biopolymer used in drug-eluting stents.

Kodiak's KSI-301 appeared to work well after at a 12-week checkup, but that's not very long. If durability data presented on Friday continues to impress, this stock's terrific run-up in 2019 could go much further.

Image source: Getty Images.

In September, Adverum Biotechnologies stock sank after the company reported 24-week data for the first six patients treated with a single injection of ADVM-022, its experimental gene therapy for many of the same AMD patients that Kodiak's aiming at. A one-time treatment that keeps invading blood vessels at bay for the rest of a patient's life would be a welcome improvement, but patients experienced an average loss of two letters when their best-corrected visual acuity (BCVA) scores were assessed.

While Adverum hailed the results as a success because none of the patients received rescue injections with a regular VEGF treatment, some observers wondered why rescue injections weren't provided. According to Adverum, AMD wasn't responsible for the observed vision losses, and the gene therapy actually worked as expected.

On Friday, Oct. 11, Adverum will present more details from the disappointing 24-week data that hammered the stock a month earlier. If the company can convince investors that the results they saw earlier contained strong signs of encouragement, the stock could regain some of last month's losses.

Unfortunately, ADVM-022 doesn't appear to work any better than AVA-101, another experimental gene therapy that Adverum quit developing years ago when the company was still named Avalanche Biotechnologies. Investors should know that the company ended up settling a class action lawsuit for $13 million rather than try to defend itself against allegations of false statements and omissions of important information that would have sent investors running for the hills much earlier than they did in 2015.

Image source: Getty Images.

At last year's AAO conference, Regenexbio stock soared after the company presented early clinical trial results for RGX-314, an experimental gene therapy for AMD patients. In May, the company completed dosing all 42 patients in the trial with five escalating dosages of RGX-314. On Friday, Oct. 11, Regenexbio will present 18-month data for cohort three and interim data from cohorts four and five.

Only three out of six patients in group three were still VEGF injection-free 18 months after a single dose of RX-314, so success with a larger dosage is a must for this program.If interim data from cohorts four and five lead to a stronger response that keeps invasive blood vessel formation from robbing patients of their vision.

So far, we've seen dosage-dependent responses in cohorts one through three, and a continuation of this trend in cohorts four and five could send this biotech stock through the roof.

Image source: Getty Images.

While Adverum's gene therapy seems headed for further trouble, Regenexbio's gene therapy has a pretty good shot at impressing investors later this week. Further down the line, however, Kodiak Sciences probably has the best chance to successfully launch a new drug for the treatment of AMD and related causes of blindness.

There's a lot to like about single-shot solutions from Adverum and Regenexbio, but they could end up solving a problem that isn't really a big problem anymore. That's because Kodiak's candidate might be able to outperform standard care with just a couple of injections per year instead of every four to 12 weeks as is the norm today.

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3 Blindness-Fighting Biotech Stocks That Could Surge This Week - The Motley Fool

The Ambulatory Healthcare IT Market report has been crafted carefully to provide the latest insights into the significant aspects of the Market. This Ambulatory Healthcare IT Market research report is the exhaustive analysis of the market across the world. It offers an overview of the market including its definition, key drivers, key market players and key segments. In addition, the study presents statistical data on the status of the market and hence is a valuable source of guidance for companies and individuals interested in the Industry. Market segmentations break down the key sub sectors which make up the market.

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Ambulatory care is also referred as outpatient care. It is a medical care given on outpatient criteria such as consultation, rehabilitation, observation, intervention, diagnosis, and treatment services. Ambulatory care involves emergency care, primary care, ambulatory services, and others. In this intervention and surgery, overnight hospital stay is not required.

The report highly involves chapter wise explanation for every aspect of the market wherein the drivers, trends, opportunities, leading and trending segments are discussed in detail with specific examples. Profiles of leading players are also discussed along with their business expansion strategies.

Few of the major market competitors currently working in the global ambulatory healthcare IT market are AmSurg Corp, Surgical Care Affiliates, Surgery Partners, Healthway Medical Group, SurgCenter, Trillium Health Partners, Medical Facilities Corporation, Nueterra Capital, Aspen Healthcare, Suomen Terveystalo Oy, IntegraMed America, Inc., SHERIDAN HEALTHCARE, NueHealth, Athenahealth, GENERAL ELECTRIC, Optum, Inc., Apria Healthcare Group, Inc., DaVita Inc., LVL Medical, Fresenius Kabi AG, Sonic Healthcare among others.

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Global Ambulatory Healthcare IT Market By Type (Ambulatory Services, Primary Care Offices, Outpatient Departments, Emergency Departments, Surgical Specialty, Medical Specialty, Others), Modality (Hospital-affiliated, Freestanding), Surgery Type (Opthalmology, Orthopedics, Gastroenterology, Pain Management, Others), Application (Laceration Treatment, Bone Fracture Treatment, Emergency Care Service, Trauma Treatment)

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Ambulatory Healthcare IT Market Insights, Online Research With AmSurg Corp, Surgical Care Affiliates, Surgery Partners, Healthway Medical, SurgCenter,...

Kathi C. Huddleston PhD, RN, CNS, CCRC

Citation: Huddleston, K., (December 23, 2013) "Ethics: The Challenge of Ethical, Legal, and Social Implications (ELSI) in Genomic Nursing" OJIN: The Online Journal of Issues in Nursing Vol. 19 No. 1.

DOI: 10.3912/OJIN.Vol19No01EthCol01

Nurses have always been a cornerstone of healthcare literacy and education. It is essential that, in the complex and quickly changing world of genetics and genomics, they maintain this position. Genetics is the study of the function of a single gene; whereas genomics widens the view to include all genes, and their expression and effects on cell growth, utilizing DNA and bioinformatics (which is the use of biological knowledge to organize and analyze large amounts of data). Genomics includes the emerging fields of omics,such as proteomics (study of protein structures), metabolomics (study of chemical cellular metabolites), and transcriptomics (the study of RNA molecules).

Nurses will soon become as familiar with the omics as they are with vital signs. They will blend this new knowledge into their patient care, while continuing to address, with patients and community members, the ethical, legal, and social implications (ELSIs) of future health interventions. These ELSI implications will require basic genetic and genomic health literacy and an understanding of the expectations of the public. The need for the nurse to have baseline competencies in these areas has been well established (American Nurses Association, 2006; Calzone et al., 2012; Gelling, 2013). The multiple findings from studies that have explored health behaviors and attitudes towards genetic testing suggest that people want to know their genetic sequencing results, so as to better understand their personal health profiles (Haga et al., 2013; Hodgson & Gaff, 2013). The ever-expanding discoveries in genomics challenge the nurse to be competent in genomic medicine and knowledgeable in associated, and often difficult, ethical situations (Milton, 2012).

The genomic revolution began with the completion of the sequencing of the human genome in 2003. In the past 10 years, we have seen almost daily releases of studies and reports linking specific changes in genomes with diseases. New genomic discoveries are visible in every arena. Over the past two decades, there has been a growing realization of the complexity of disease and the pathogenesis of both acute and chronic illness (Hamilton, 2009; Lea, 2008). We now know that cancer is not one disease; rather it occurs in different forms with each form being a different disease. Our understanding of several common medical disorders now demonstrates that these disorders are anything but common; they differ in their predisposition, initiation, and path of progression. Something as prevalent as hypertension has proven to be a complex and confusing disorder with numerous etiologies and multiple triggers.

Currently, whole genome sequencing (WGS) serves primarily as a research tool, but that is rapidly changing. We are now seeing the use of WGS in the clinical diagnosis and treatment of complex illnesses (Tabor, Berkman, Hull, & Bamshad, 2011). The impact of genomics research on healthcare and society depends on our ability to deal with the complexity of the genomic revolution and the integration of knowledge to inform our ethical, legal, and social issues (Milton, 2013).

The concepts of autonomy, respect, beneficence, nonmalificence, and justice provide ethicists with a common language and a set of beginning assumptions upon which they can discuss the dilemmas presented to them. Although these concepts can frame the discussion, they are limited in providing answers to the new and complex questions raised by genomics. For example, the concept of autonomy would support the right of persons to obtain their genomic information, but it could also be used to defend their right to refuse such information. Consider a woman who had been found to have a BRCA1 (breast cancer susceptibility gene) variant during genetic testing for a different disorder, in light of the concept of autonomy. She may choose not to learn the results of this incidental finding that she had not consented to. She has the right to refuse that discovery information from her healthcare provider. If she does elect to learn her BRCA1 status, the question arises as to whether she has any obligation to share that information with her sisters or her mother who may have a 1:2 chance of also carrying the disease-causing gene. Does she have the right to test her child? Should the childs right to autonomy reign so that she delays involving her child until the child comes of age and consents to genetic testing? Every ethical question can be discussed and framed to defend or to counter any assumed correct decision.

Today, professional organizations are actively providing guidance and recommendations regarding these questions. The American Nurses Association (2006) has gathered important information about ethical challenges confronted by people receiving genetic- and genomic-based healthcare. Professional codes of ethics, including that of the American Nurses Association and those of professional organizations in other countries, such as Canada and the United Kingdom, provide guidance. These codes provide a framework for nurses who respond to the expansion of the science of genomics in fields such as genetics and genomics. Additionally, the American College of Medical Genetics and Genomics has recently posted a controversial recommendation for the reporting of incidental findings (Green et al., 2013). As the science advances, specialty organizations will also provide recommendations and guidance. To do this effectively, a basic framework is needed to understand the reason and the rationale for specific decisions so as to provide a consensus of leadership (Evans & Rothschild, 2012; Levenson, 2012).

As knowledge of genomics increasingly influences clinical care, the ethical, legal, and social implications of care decisions demand further inquiry and discussion within hospitals, medical practices, and communities. In my role as Director of Clinical Research at the Inova Translational Medicine Unit, I work with over 1500 families who have enrolled with their newborns to participate as a family in whole genome sequencing research. These families are participating in the exploration of molecular causes of prematurity and the longitudinal study of genomic correlations to childhood health outcomes. We are searching for genomic correlations as to causes of premature birth; but in the course of that research we may incidentally find a baby with a BRCA1 variant. This genetic variant is solely related to the adult onset of breast cancer. Should that result be reported to the mother and father? Would they make choices based on that knowledge that may affect the child? Should the child have the right to choose whether or not she wants to know this finding? What about other children? The question remains as to whether a mother should be told about that genetic susceptibility as it may relate to her reproductive health?

The ethical challenges in our genetic and genomic era regarding questions like these are intertwined with legal and social issues that lead to different interpretations of data privacy. The healthcare world has numerous privacy regulations. However, genomics is different because, although the genomic information belongs to an individual, it is relevant to the family. The patients parents, siblings, and children share roughly 50% of that genomic background, which is central their identity. Patients genetic information can change their perspective of who they are, who their parents are, their place in the world, and their time in the world.

All healthcare professionals must honor the principles of privacy and confidentiality. The technical challenges of coding protected health information through unique, unrelated, numbering systems that are read by computers, as well as the challenges of storing such grand-scale data on secure systems, are creating new markets and new requirements to support confidentiality, patient privacy, and choice. The risks to confidentiality related to genomic information have profound regulatory and insurance implications.

Ethical issues in informed consent have gained greater urgency because of the rapid advances in genomics. Genetic-informed consent is more than a signed document and more than a permission to perform genetic testing. It involves an interaction between the healthcare provider/research team member and the patient/participant. It requires listening and reviewing participants specific needs to ascertain their understanding. Some have even argued that it is not possible to provide informed consent for genetic research because knowledge is advancing so rapidly that we do not know what tests will be possible or what variants may be identified next week.

The increasing utilization of genomics in research and clinical care requires the development of a bioethical framework that considers the ethical, legal, and social implications necessary to advance healthcare and incorporate genomic information into health-related practices. With scientific breakthroughs emerging daily, for example the discovery of bacterial genomes and their interactions with human genomes as they affect health and disease, nurses are faced with more questions than answers. The translation of new knowledge and discoveries requires the integration of science into practice. There are no easy answers to these difficult ethical challenges. Science will continue to push our practice out in front of our comfort zone. Nurses need to develop guiding resources and recommendations, and establish educational competencies, to provide for the challenges of ethical, legal, and social implications in genomic nursing.

Kathi C. Huddleston PhD, RN, CNS, CCRCEmail: kathi.huddleston@inova.org

Dr. Huddleston currently serves as the Director for Clinical Research Projects at the Inova Translational Medicine Institute, Inova Fairfax Medical Campus, Falls Church, VA. She has over 30 years of nursing experience, working in pediatrics, critical care, surgery, and cardiac care. She has worked in childrens hospitals and has practiced in a variety of geographical areas, including Washington DC, Denver (CO), Fresno (CA), and Norfolk (VA). She has now returned turned home to the Washington DC area. Dr. Huddleston has always been interested in clinical outcomes research; and genomic research is a natural progression for her. She notes that one can argue whether genomics is the driver or the passenger in our advancing technologies, but there is no doubt that the genomics vehicle is in the race to the finish! She earned her PhD from George Mason University in Fairfax, VA, her MSN from the California State University in Fresno, and her BSN form the University of Maryland (Baltimore).

American Nurses Association. (2006). Essential genetic and genomic competencies. http://www.nursingworld.org/MainMenuCategories/EthicsStandards/Genetics-1/Essential-Genetic-and-Genomic-Competencies-for-Nurses-With-Graduate-Degrees.pdf

Calzone, K.A., Jenkins, J., Yates, J., Cusack, G., Wallen, G., Liewehr, D.J., McBride, C. (2012). Survey of nursing integration of genomics into nursing practice. Image: The Journal of Nursing Scholarship, 28(2), 101-106.

Evans, J.P., & Rothschild, B.B. (2012). Return of result: Not that complicated? Genetics in Medicine, 14 (4), 358-60. doi: 10.1038/gim.2012.8

Gelling, L. (2013) Let's tap the patient potential. Nurse Researcher, 20(3), 3.

Green, R. C., Berg, J. S., Grody , W.W., Kalia, S.S., Korf, B. R., Martin, C. L., Biesecker, L.G. (2013). ACMG recommendations for reporting of incidental findings in clinical exome and genome sequencing. Genetic Medicine, 15(7), 565-574. Doi: 10.10.38/gim.2013.73

Hamilton, R. (2009). Nursing advocacy in a postgenomic age. Nursing Clinics of North America, 44(4), 435-446.

Hodgson, J., & Gaff, C. (2013). Enhancing family communication about genetics: Ethical and professional dilemmas. Journal of Genetic Counseling, 22(1), 16-21.

Lea, D. (2008). Genetic and genomic healthcare: Ethical issues of importance to nurses. OJIN: The Online Journal of Issues in Nursing, 13(1). doi: 10.3912/OJIN.Vol13No01Man04

Levenson, D. (2012). The tricky matter of secondary genomic findings: ACMG plans to issue recommendations. American Journal of Medical Genetics. Part A, 158(7), ix-x. doi: 10.1002/ajmg.a.35521

Milton, C.L. (2012). Ethical implications and interprofessional education. Nursing Science Quarterly, 25(4), 313-5. doi: 10.1177/0894318412457066

Milton, C.L. (2013) The ethics of research. Nursing Science Quarterly. 26(1), 20-23. doi: 10.1177/0894318412466740

Tabor, H.K., Berkman, B.E., Hull, S.C., & Bamshad, M.J. (2011). Genomics really gets personal: How exome and whole genome sequencing challenge the ethical framework of human genetics research. American Journal of Medical Genetics Part A. 155(12), 29162924. doi:10.1002/ajmg.a.34357

2013 OJIN: The Online Journal of Issues in Nursing Article published December 23, 2013

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Ethics: The Challenge of Ethical, Legal, and Social ...

A leading medical ethicist lists his top 5 ethical issues in medicine today and in the near future.

No one knows exactly how many people are killed each year by medical errors, but it is in the hundreds of thousands in the United States and tens of thousands in the United Kingdom. Along with heart disease and cancer, it is a leading cause of death. Many more people are injured non-fatally by errors and the cost of payouts for clinical negligence claims in England in 2017/2018 was 2.23 billion.

Reducing the human and financial cost of medical errors is an ethical priority. The recent Bawa-Garba case, in which a junior doctor contributed to the death by sepsis of a 6-year-old-boy, highlighted the need to address both individual and systemic issues to reduce errors.

Reducing the human and financial cost of medical errors is an ethical priority. The recent Bawa-Garba case, in which a junior doctor contributed to the death by sepsis of a 6-year-old-boy, highlighted the need to address both individual and systemic issues to reduce errors.

Clinicians have an ethical obligation to be open about their medical errors but how do we encourage them to do so when the personal and professional consequences of honesty can be devastating? The reality is that some medical errors are never disclosed to patients, who are then deprived of compensation, and little is learnt from the mistakes.

The population is ageing and our ability to keep desperately sick people alive is ever-increasing. Should we help people who want to end their lives? If so, should it only be terminally ill patients or should it include those suffering from psychiatric disease, like Aurelia Brouwers, the 29-year-old Dutch woman who was so unhappy that she described her mental suffering as unbearable? She lawfully drank lethal poison in the Netherlands in January 2018. Parliament must urgently consider whether to create a law allowing clinicians to help patients die in certain circumstances.

Doctors have an obligation to keep their patients secrets but when can this be breached? If a person tells their GP that they have been a victim of domestic abuse but refuses to tell the police, should the doctor do so? What about the bus driver with epilepsy who continues to drive but withholds the diagnosis from the Driver and Vehicle Licensing Agency (DVLA)? If a patient has a serious genetic disease which a relative may also have, such as Huntingdons disease (a fatal, incurable condition which is passed on to children 50% of the time), should doctors tell the relative even if the patient refuses permission? Confidentiality is one of the most common issues raised by doctors when they contact the British Medical Associations Ethics Department.

How much money should the NHS receive from the government? Dr Richard Smith, a former editor of the British Medical Journal, recently argued that the NHS should not receive any more funds because 90% of health results from environment, genes and lifestyle and healthcare rapaciously swallows up funds that would do much for health if invested in education, housing, poverty reduction, the environment, community development.

Within the healthcare budget, how much should be given to each condition? Should acute conditions, such as brain haemorrhages, get more investment than long-term ones, such as diabetes?

Artificial Intelligence is infiltrating the field of medicine, with AI software already interpreting the scans of radiologists, making treatment plans, and assisting surgeons in the operating theatre. Over the next few years, the role of AI will continue to grow but ethical and legal issues are yet to be addressed. Who will be to blame, if anyone, if the AI proves malfunctions?

Over the next few years, the role of AI will continue to grow but ethical and legal issues are yet to be addressed. Who will be to blame, if anyone, if the AI proves malfunctions?

The developer, the manufacturer, the maintenance people, the hospital, the clinician? How can doctors obtain informed consent from patients if no one quite understands how the AIs self-learning algorithm works because it is too complicated, or when the error rate is unknown? And what if the algorithm contains or develops biases, discriminating against certain types of patients: the young, the old, the rich, the poor, men or women?

Several of these ethical issues are likely to be relevant to us at some point in our lives, whichever side of the stethoscope we stand. It is in our collective interest, therefore, to reflect on them and find practical solutions.

Daniel Sokol, PhD, is a medical ethicist and barrister at 12 Kings Bench Walk. His book Tough Choices: Stories from the Front Line of Medical Ethics is published in October 2018 and is available for pre-order.

Dr Daniel Sokol is a medical ethicist and clinical negligence barrister at 12 Kings Bench Walk, London.He has taught medical ethics and law at Keele, St Georges and Imperial College London, and sat on committees for the Ministry of Defence and the Ministry of Justice.He is the author of 3 books and over 250 articles on medical ethics and law.www.medicalethicist.net

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Top 5 ethical issues in medicine - The Hippocratic Post

The Science of Precision Medicine

GenomicInsightis our latest precision-based medicine test, and is a clinical DNA test that analyzes single-nucleotide polymorphisms (SNPs).

While all humans share a similar genome, individual differences occur from human to human. GenomicInsightidentifies the SNPs that represent these differences. Opus23 Explorer is an AI-powered informatics platform that allows practitioners to view over 5,000 SNPS that impact over a dozen areas of patient health using one comprehensive data file.

GenomicInsightallows practitioners to take personalized medicine and precision medicine to the next level. Curated reports identify what disease risks a patient may have, what nutraceutical or pharmacological drugs their genome will best react to, and what lifestyle factors can help prevent a harmful gene from expressing itself.

In the field of DNA testing and precision medicine, GenomicInsightis the most dynamic and comprehensive test available. Practitioners can now use the genome, unique to each patient, to influence critical areas of patient health, including methylation, hormone metabolism, aging, detoxification, HPA-Axis, and more.

Precision medicine practitioners are embracing the field of nutrigenomics. Nutrigenomics uses nutrition to influence a patients unique genome to treat or prevent disease. DNA testing and clinical understanding of the human genome is the epitome of personalized medicine.

Learn More About GenomicInsight

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Personalized Medicine | Diagnostic Solutions Laboratory

There is still some confusion surrounding the difference between precision medicine and personalized medicine. Some argue for a strict distinction between the two. For them, using the term precision medicine instead of personalized medicine offers a more accurate representation of practices involving the customisation of healthcare services.

Others have used the two interchangeably however. The public and mainstream media, as well as industry practitioners and non-profit healthcare and scientific organizations have used a degree of freedom in switching between the two terms.

A 2011 report prepared by a committee of the U.S. National Research Council suggested the use of the term precision medicine instead of personalized medicine. Note that NRC is the working arm of the United States National Academies responsible for shaping policies and advancing the pursuit of science, medicine, and engineering.

The report defines precision medicine as the tailoring of medical treatment to the individual characteristics of each patient. The report added, It does not literally mean the creation of drugs or medical devices that are unique to a patient, but rather the ability to classify individuals into subpopulations that differ in their susceptibility to a particular disease, in the biology and/or prognosis of those diseases they may develop, or in their response to a specific treatment.

In explaining the difference between precision medicine and personalized medicine, the report said the latter is susceptible to misinterpretation. Some might regard personalized medicine as a concept that implies the design of unique treatments for each individual. This is not the actual case in practice as iterated in the definition of precision medicine.

An executive at Merck Research Laboratories and geneticist also explained the distinction between the two. In his blog article, Robert M. Plenge, MD, PhD, considered the term personalized medicine as synonymous with practices involving basic patient care. According to him, physicians generally make decisions about the best course of treatment based on patient preferences. This should be the actual and most basic definition of personalized medicine.

Plenge also said that there are some burdens associated with personalized medicine. When the Human Genome Project was nearing it completion in 2000, people hoped that the identification of genetic markers would clearly differentiate patients between responders and non-responders. Personalized medicine was a buzzword around this time. This did not happen due to the polygenicity of complex traits.

Gary An, MD, and Yoram Vodovotz, MD, also trace the popularity of the term personalized medicine from the assumptions associated with the Human Genome Project. These assumptions revolved around using sequence data and information such as demography, medical histories, and responsiveness to medications to determine therapies that would work best for an individual patient. The assumptions never materialised however. An and Vodovotz said that precision medicine has become a more appropriate terminology to describe a healthcare approach involving the analysis of precisely defined subgroups of patients using genomic sequence data and metadata from existing therapies.

Others have used the terms precision medicine and personalized medicine despite some strict calls to use the former. This is evident in casual and formal discourse, as well as in scientific and non-scientific literatures.

During his 2015 State of the Union Address, President Obama announced an initiative centred on promoting precision medicine. His speech interestingly highlighted how some people use the term personalized medicine.

Publications from non-profit organisations have also switched the two terms with a high degree of liberty. For example, an article published online by the American Cancer Society featured personalized medicine in its headline. Author Elizabeth Mendes also mentioned that the definitions of precision medicine and personalized medicine seem to be merging.

The patient information website of the American Society of Clinical Oncologists has also used the terms interchangeably throughout its contents. In a specific info page about cancer treatment options, ASCO included personalized medicine in the list. However, some of its blog articles featured precision medicine in their headlines.

Note that personalized medicine seems an obsolete term based on the arguments by NRC and other physicians. However, organizations such as pharmaceutical companies and scientific communities are still using it in their publication. Companies such as Bayer and Pfizer, for instance, have made information webpages about personalized medicine. Pfizer describes the term as an approach involving the tailoring of drugs to match the genetic variability of diseases.

The Jackson Laboratory, a non-profit biomedical research institution, also uses personalized medicine as a term to describe tailoring of healthcare services based on genomics. Other organisations use precision medicine such as the National Health Institute and U.S. Food and Drug Administration.

Journals under the Nature Publishing Group and Public Library of Science have also featured articles using either the terms precision medicine or personalized medicine. There are even journals that are carrying the either of the two. Examples of these are the The Journal of Personalized Medicine of Molecular Diversity Preservation International, Personalized Medicine by Future Medicine, and the Personalized Medicine Universe by the Society of Personalized Medicine; as well as The Journal of Precision Medicine and Advances in Precision Medicine, among others.

However, PHG Foundation has concluded that the two terms have specific meanings. In their position paper, the UK-based health policy think thank suggested that personalized medicine is a more general or broader concept. Under this broad concept are specific concepts such as precision medicine, stratified medicine, and P4 medicine. PHG Foundation is still on the process of reviewing and analysing relevant literatures to come up with a more concrete suggestion as regards the use of these terminologies.

The concepts behind precision medicine and personalized medicine are hardly new. But there is a discord among stakeholders regarding their exact definitions and differentiations. One of the probable reasons behind this discord is that the actual application of each concept is relatively new. Another reason is that the overlaps between precision medicine and personalized medicine are very evident that their differences become negligible. Then there are those who consider the debate as nothing but a case of preferential difference.

Further readings: (1)An, Gary and Vodovotz, Yoram. 9 March 2015. What Is Precision Medicine And Can It Work? Elsevier Connect;(2)Mendez, Elizabeth. 3 April 2015. Personalized Medicine: Redefining Cancers And Its Treatment. ACS Research Updates. American Cancer Society;(3)National Research Council. 2011. Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease. ISBN: 978-0-309-22222-8;(4)PHG Foundation. n.d. Many Names For One Concept Or Many Concepts In One Name? PHG Foundation;(5)Plenge, Robert M. 16 March 2013. Personalized Medicine vs. Precision Medicine. Plenge Gen Blog

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Precision medicine vs. personalized medicine | Version Daily

Personalised medicine is a move away from a one size fits all approach to the treatment and care of patients with a particular condition, to one which uses new approaches to better manage patients health and targets therapies to achieve the best outcomes in the management of a patients disease or predisposition to disease.

We are all unique. Our health is determined by our inherent differences combined with our lifestyles and environment. By combining and analysing information about our genome, with other clinical and diagnostic information, patterns can be identified that can help to determine our individual risk of developing disease; detect illness earlier; and, determine the most effective interventions to help improve our health, be they medicines, lifestyle choices, or even simple changes in diet.

The concept of personalised medicine is not new. Clinicians have been working to personalise care, tailored to peoples individual health needs, throughout the history of medicine, but never before has it been possible to predict how each of our bodies will respond to specific interventions, or identify which of us is at risk of developing an illness. New possibilities are now emerging as we bring together novel approaches, such as whole genome sequencing, data and informatics, and wearable technology. It is the interconnections between these innovations that makes it possible to move to an era of truly personalised care.

Technological and scientific advances are already here and will continue to develop and improve medical practice; change is inevitable. For the NHS, we must consider not whether we should go down this path of personalised medicine, but instead how we can best respond and adapt, to ensure everyone benefits regardless of where people live, the illnesses they have, or where their care is provided.

We are on a journey towards embedding a personalised medicine approach into mainstream healthcare. NHS England is beginning a discussion about what we mean by personalised medicine, now and in the future, and the approach we will take, working with our partners, so that we can embrace new approaches, while ensuring that ethical, equality and economic implications are fully understood and addressed.

Through the 100,000 Genomes Project, a ground breaking and world leading initiative, the NHS is building partnerships with academia and industry to decode the human genome, in people with rare diseases and cancer. This will help to predict the future development of disease, to make a diagnosis where one has not existed previously and to identify treatments where possible. Please see the genomics page for further information.

Improving Outcomes through Personalised Medicine

If you have any queries regarding any aspect of personalised medicine please contact the Genomics Team at NHS England via:england.genomics@nhs.net

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NHS England Personalised medicine

Industry Insights

The global personalized medicine (PM) market size was estimated at USD 1.57 trillion in 2018 and is anticipated to expand at a CAGR of 10.6% during the forecast period. Personalized medicine promises a paradigm shift in diagnosis and care delivery as the treatment is based on data leveraged from a holistic view of an individual patient. Proliferation of sequencing methodologies, especially Next Generation Sequencing (NGS), due to rising cost of sequencing and development of Human Genome Project in genomics field is expected to drive the market.

NGS technology delivers the data related to the genetic makeup of the patient and response of drugs on patient, thereby fostering the development of precision medicineto treat diseases. Moreover, NGS combined with Companion Diagnostics (CDx) is expected to play a major role for advancement of personalized diagnostics and therapeutics over the forthcoming years. Advent of novel CDx and biomarkers for non-oncology therapeutic applications have forced companies to improve their precision medicine portfolio; focusing oninfectious diseases and Cardiovascular Diseases (CVDs).

This generates a strong impetus for scaling up the CDx tests to form PM for non-oncology cases. Increasing prevalence of cancer, which boosts demand for personalized cancer diagnostics and therapeutics, is also one of the key factors responsible for the growth of the market. As per data GLOBOCAN 2018, the global burden of cancer has increased to 18.1 million new cases in 2018. Growing cancer-related spending is also amongst the drivers for growth.

Key companies in the personalized medicine market are involved in several investment programs pertaining to the precision medicine. This has resulted in an increased commitment of leading pharma competitors toward this sector. Furthermore, companies providing molecular decision support system are combining genomic data with clinical data to minimize the gaps in precision medicine practice.

Personalized nutrition & wellness was the largest product segment in 2018. Availability of a wide range of nutrition & wellness products and increased Over The Counter (OTC) sale of these productsplay a significant role in boosting the segment growth. Companies are undertaking several initiatives for sustaining market competition. For instance, in March 2018, DSM partnered with Mixfit to provide personalized nutrition solutions by combining Artificial Intelligence (AI) technology.

This strategic partnership was targeted towards offering consumers a personalized approach regarding nutrition. PM therapeutics includes pharmaceuticals, genomic medicine, and medical devices for personalized therapies and it is anticipated to witness the highest CAGR during the forecast period. Advent of high-capacity rapid sequencing platforms and reducing cost of sequencing whole human genome plays a major role in the segment development.

Genomic medicine has emerged as a significant segment in PM therapeutics. Availability of large databases of genomic data enables researchers to develop accurate and effective therapeutic products for several medical conditions. Consequently, this results in high utilization of human genome sequencing techniques for genomic medicine.

Led by U.S., North America was the dominant regional personalized medicine market in 2018. Increasing adoption of NGS methods and healthcare IT systems in clinical workflow along with supportive government policies and funding drives the regional market.

For instance, in September 2018, the All of Us Research Program initiated by the National Institutes of Health (NIH) awarded funds of USD 28.6 million to three genome centers of the U.S. This funding supported the generation of genomic data from biosamples by these centers, which is a critical component of precision medicine discoveries.

However, Asia Pacific is projected to witness the highest CAGR over the forecast period owing to low cost of clinical trialsof newly developed precision medicines and diagnostic products. Moreover, rising disposable income levels and growing economy of emerging countries will boost the market further.

Some key companies in this market include GE Healthcare; Illumina, Inc.; Asuragen, Inc.; Abbott Laboratories; Dako A/S; Exact Science Corporation; Danaher Corporation (Cepheid, Inc.);Decode Genetics, Inc.;Genelex Corporation; Exagen Diagnostics, Inc.; Precision Biologics, Inc.; QIAGEN; Celera Diagnostics LLC; and Biogen, Inc.

These companies invest in personalized products-focused innovations and developments for business expansion. For instance, in April 2018, Ilumina helped various startup companies by offering them financial support. One of such startups, TruGenomix Health, Inc. focused on individualized treatment options, thereby advancing personalized therapies.

Attribute

Details

Base year for estimation

2018

Actual estimates/Historical data

2014 - 2017

Forecast period

2019 - 2025

Market representation

Revenue in USD Million and CAGR from 2019 to 2025

Regional scope

North America, Europe, Asia Pacific, Latin America, and MEA

Country scope

U.S., Canada, Germany, U.K., Japan, China, Brazil, and South Africa

Report coverage

Revenue forecast, company share, competitive landscape, growth factors and trends

15% free customization scope (equivalent to 5 analyst working days)

If you are looking for specific information, which is not currently within the scope of the report, we will provide it to you as a part of customization

This report forecasts revenue and volume growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research has segmented the global personalized medicine (PM) market report on the basis of product and region:

Product Outlook (Revenue, USD Million, 2014 - 2025)

Regional Outlook (Revenue, USD Million, 2014 - 2025)

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Personalized Medicine Market Size & Forecast | Industry ...

In the United States, despite high hopes, our health-care system still generally operates as a one-size-fits-all model. Some refer to this as a population model. This paradigm suggests that in the majority of people, an ailmentbe it a common cold or cancerhas a common predicted trajectory, and most people will benefit from a homogeneous course of treatment. If a particular treatment does not work, then the second-most likely successful treatment plan is prescribed.

This continues until the ailment is relieved. Treatments are set based on available population statistics, and trial and error is used until the patient is well. In this model of medicine, personal characteristics, risk factors, lifestyle choices and genetics are rarely considered. Therefore, the treatment approach will not be ideal in all cases, failing those who do not fit with average parameters.

Personalized medicine, on the other hand, advocates the customization of health care. It aims to prevent diseases, as well as tailor treatments to an individual so a disease or illness can be targeted in a way that promises the highest chance of success based on the attributes of the individual. An underlying assumption of this approach is personalized medicine (PM) takes into account that drugs and interventions will have varying efficacy based on the person being treated.

Now that science possesses a complete map of all the genes in the body, personalized medicine is manifesting as a reality.

Angelina Jolies public disclosure about carrying a BRCA1 gene mutation, which puts her at high risk of breast cancer and ovarian cancer, brought some of these concepts to the publics attention. Making choices based on gene type might not yet be the norm in everyday health-care practice, but it is becoming more prevalent.

Oncology is an area of medicine where DNA sequencing technology has a lot of potential. For example, for lung cancer, there are many personalized treatment options now available based on different lung cancer biomarkers. If there is a medical indication, genetic tests can often be covered by insurance, especially if there is an FDA-approved drug or treatment that is tied to a genetic mutation.

Recently, researchers have also used DNA sequencing to establish the connection between bovine leukemia virus (BLV) and breast cancer. It was previously believed that this cattle virus cannot infect humans. However, a study conducted by the University of California, Berkeley, and the University of New South Wales, Sydney, showed that BLV can be present in human tissue three to 10 years before cancer gets diagnosed, indicating a strong correlation.

Genome-driven medical care is becoming increasingly utilized due to the development of next-generation sequencing (NGS) technologies.

According to The National Human Genome Research Institute, whole genome sequencing can now be performed in less than 24 hours for under $1,000. The genetic services have become more accurate and affordable and are now used in both public and private institutions. However, numerous challenges still need to be tackled. For instance, many doctors may lack training opportunities and are unfamiliar with the emerging technologies. Some experts also warn that there needs to be a balance between hope and hype and that ethical issues should be strictly monitored.

Perhaps one of the most sensational innovations in the area of personalized medicine is printing 3-D organs from ones own cells. It is predicted that in about 10 to 15 years, organs will routinely be produced from cells harvested from patients themselves using 3-D bioprinting technology. In the future, organ transplantations might eventually be replaced by customized organ-growing.

Anthony Atala, M.D., the Director of the Wake Forest Institute for Regenerative Medicine (WFIRM), has already demonstrated that transplantable kidneys can be produced using such a technique, helping to curb a crisis resulting from organ shortage. Currently, scientists at WFIRM are engineering over 30 different tissues and organs that could be used as replacement organs. Organovo, a company working on personalized bioprinted human tissue, has so far produced 3-D liver models that stay functional and stable for up to 60 days, which is an improvement from the previously established functionality of 28 days. The printed liver tissue can be used for drug testing, offering an alternative to animal and in vitro experiments. It also offers new hope to people with various genetic conditions who could benefit from a transplant. In 2016, Chinese scientists successfully printed a part of the hearts left atrium (left atrial appendage). Occlusion of this part can play a role in preventing stroke in patients with atrial fibrillation. It appears that 3-D technology can offer an improved presentation of an individuals left atrial appendage compared to conventional imaging methods. This is essential for surgeons as they need an accurate preoperative reference before they start with the occlusion procedure.

Eric Topol, the Director and Professor of Genomics at Scripps Translational Science Institute, describes the now-ubiquitous smartphones as the hub of future medicine. Mobile phones and mobile peripherals can be used as biosensorsmeasuring blood pressure, heart rhythm, blood sugar levels and even brain wavesas well as functioning as a personal scanner such as an otoscope or ultrasound. People can now perform many measurements by themselves, when they want and where it is most convenient for them. They can view and interpret their data without having to visit the doctor, making health care increasingly more personal and individual-based.

Since the dawn of personalized medicine, several limitations of this approach have been discussed. Some experts argue that it carries a risk of reducing medicine to molecular profiling. A properly executed traditional medicine practice should already include a degree of personalization by looking at your unique characteristics, medical history and social circumstances. Many social scientists and bioethicists believe that the label personalized medicine could involve a radical shift of responsibility toward the individual, potentially dismissing other socioeconomic factors that are important to examine as well. The approach might in some cases contribute to the culture of blaming the victim, creating stigmatization of certain groups of people and taking the public health resources away from initiatives that try to address the social disparities and inequity that also affect health.

An article published by the Hastings Centera research institute that addresses ethical and social issues in health care, science, and technologyhighlighted that there might be some erroneous expectations surrounding personalized medicine. It is very unlikely that in the future, you will be able to receive a unique prescription or a treatment specific to you alone. Personalized medicine is more about classifying people into groups based on genomic information and looking at your health risks and treatment responses in the context of that genetic group.

Many people are concerned that being classified as a member of a certain subgroup could, for example, increase your insurance rates or make you a less desirable job candidate. These considerations are not unfounded. Personalized medicine goes hand in hand with increased data accumulation, and data security remains a challenge. Moreover, being in a certain subgroup might oblige you to participate in screening programs as a matter of social responsibility somewhat reducing the freedom of personal choice.

There are also potential ethical implications for doctors handling genomic information. For instance, doctors might need to contemplate withdrawing some pieces of information that have no medical utility. The disclosure process would require some careful editing to prevent confusing or scaring the patient further. However, this could signal the return to paternalistic medicine where the doctor decides what is best for you and what you should be told. There is clearly a need for a solid ethical framework in this field, as well as a need for careful monitoring to ensure concerns are balanced with benefits.

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Moving from Population Medicine to Personalized Medicine

Molecular profiling has emerged to play a pivotal role in personalized medicine, classifying tumors based on genetic profiles for the purposes of cancer diagnosis or treatment,or predicting response to therapy. Innovative technologies, including next generation sequencing (NGS), can now clinically identify an extensive panel of actionable and exploratory genetic alterations.

In the US, Sarah Cannon physicians identify and order the most appropriate molecular test(s) from a number of best in class commercial laboratory service providers, such as Foundation Medicine,PathGroup, or Caris Life Sciencesaccredited from the Commission on Laboratory Accreditation of the College of American Pathologists (CAP). The NGS panels that are ordered target 35 to over 400 genes that are currently known to be altered in solid tumors or blood cancers. The appropriate molecular test and/or NGS panel is chosen based on tumor characteristics.

In the UK, Sarah Cannon is working withUniversity College London - Advanced Diagnostics (UCL-AD), a CPA-accreditedmolecular profiling laboratory, to develop novel technologies and assay menus and provide a clinical service to the private sector and the NHS, as well as a comprehensive research platform to the pharmaceutical industry.

With access to thousands of patients with different tumor types and access to the latest technologies used for molecular profiling, we are able to rapidly identify eligible patients for early and late-phase clinical trials and explore novel biomarkers that predict response to specific treatments.

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Personalized Medicine | Sarah Cannon

Fact Sheets about Genomics | NHGRI Skip to main content

The National Human Genome Research Institute (NHGRI) has produced this series of fact sheets to explain complex concepts in genomics research to a non-scientific audience. Teachers, students and the general public alike will find the materials clearly written and easy to understand.

A biological pathway is a series of actions among molecules in a cell that leads to a certain product or a change in the cell.

Genomics is the study of all of a person's genes (the genome), including interactions of those genes with each other and with the person's environment.

Chromosomes are thread-like structures located inside the nucleus of animal and plant cells.

Cloning describes a number of different processes that can be used to produce genetically identical copies of a biological entity.

Comparative genomics is a field of biological research in which researchers compare the complete genome sequences of different species.

DNA sequencing determines the order of the four chemical building blocks - called "bases" - that make up the DNA molecule.

Epigenomics is a field in which researchers chart the locations and understand the functions of all the chemical tags that mark the genome.

Genetic mapping offers evidence that a disease transmitted from parent to child is linked to one or more genes and clues about where a gene lies on a chromosome.

A knockout mouse is a laboratory mouse in which researchers have inactivated an existing gene by replacing it or disrupting it with an artificial piece of DNA.

Newborn screening tests use a dried blood sample collected during the first week after birth to measure the presence of disease biomarkers.

Data used to estimate the cost of sequencing the human genome over time since the Human Genome Project.

The X chromosome determines your sex, gives some females super color vision and lends its magic to a certain breed of cat.

The Y chromosome of all living men is related through a single male ancestor who lived over 100,000 years ago.

Genetics refers to the study of genes and their roles in inheritance. Genomics refers to the study of all of a person's genes (the genome).

Last updated: November 9, 2015

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Fact Sheets about Genomics | NHGRI - genome.gov

For the most comprehensive take on all of David Sinclairs recommendations and the best ideas on optimizing healthspan, check out The Table of Longevity | The 5 Pillars to Optimize for Increasing Healthspan and Living Your Best LifeKey Takeaways

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David Sinclair, Ph.D. - The Joe Rogan Experience #1349 ...