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Archive for the ‘Investment in Technological Breakthrough’ Category


Supreme Court declining to hear an appeal from Sequenom, that markets a Prenatal Test based on Screening Fetal DNA – A Natural Biological Process

Reporter: Aviva Lev-Ari, PhD, RN

Supreme Court on Monday left a whole lot of biotech entrepreneurs fearful that their inventions may not be worth all that much after all.

The justices spooked the industry by declining to hear an appeal from Sequenom, a California company that markets a prenatal test based on screening fetal DNA. A lower court had ruled that Sequenom couldn’t patent the test because it was based on a natural biological process.

“This is a huge ruling,” said David O. Taylor, an assistant professor at Southern Methodist University’s Dedman School of Law.

Justices in lower courts were effectively pleading for the Supreme Court to provide some guidance on the issue of patent eligibility in biotech, Taylor said. The top court’s silence leaves an entire industry guessing.

Taylor predicted that companies and investors will be less likely to fund expensive research for fear of having patents invalidated by the courts. Sequenom CEO Dirk van den Boom made a similar argument.

“Their refusal to clarify this area of the law would seem to point in the direction of reduced investment in diagnostic invention, and that is obviously problematic from a public health concern,” Taylor said.

Sequenom’s opponent in the legal case, Ariosa Diagnostics, said the fetal test was not novel enough to deserve a patent. Asking the justices to intervene “is inviting the court to revisit and rewrite decades of jurisprudence covering patent-eligible subject matter,” the company wrote in a brief. “In the future, there may be a case that tests the boundaries” of what’s appropriate to patent, Ariosa wrote, “but this is not that case.”

The tell-tale DNA

Sequenom’s story begins in 1996, when a pair of doctors noted that there were trace amounts of tell-tale fetal DNA in the plasma of expectant mothers. So they created a test that could extract that DNA and determine a baby’s sex and risk of genetic disorders like Down syndrome, without the need for the invasive procedures that were then the norm. They patented the idea the following year, and their test is now sold by Sequenom as MaterniT21. But a lower court invalidated that patent in 2013.

He and others fear that the Supreme Court’s ruling in Mayo was so broad that judges will be able to invalidate a slew of life science patents by picking apart the components of an invention to find the naturally occurring biological process that inspired it.

Even Noonan, however, said courts were unlikely to invalidate patents based on truly novel discoveries, such as CRISPR-Cas9 gene editing, which is about to be tested in humans.

The CRISPR technology harnesses a naturally occurring process, but it’s “so revolutionary,” Noonan said, “that even the Supreme Court wouldn’t overrule it.”

 

Damian Garde can be reached at damian.garde@statnews.com
Follow Damian on Twitter @damiangarde

 

BIOTECH CRISPR DIAGNOSTICS – See LINKS at

The Supreme Court decision that’s shaking up biotech

Read more from STAT & other publishers

Drug industry overstates impact of patent reviews on innovation
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Supreme Court’s ruling in patent case a blow to drug industry
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Supreme Court skeptical in case backed by drug makers
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Clash of scientific titans: CRISPR hits the courts, with money and prestige at stake
STAT
Pharmalot, Pharmalittle: AstraZeneca takes $80 million hit on ‘ineffective’ flu vaccine
STAT
Sequenom Patent Invalidation May Enable Other NIPT Firms to ‘Innovate’ if Ruling is Upheld
GenomeWeb, 2013
USPTO Grants Ariosa Request to Review Key Sequenom Patent
GenomeWeb, 2013
Ariosa Files Petition with USPTO to Re-Examine Sequenoms 540 Patent
GenomeWeb, 2012
Federal Court Invalidates Patent Underlying Sequenoms MaterniT21 Plus
GenomeWeb, 2013
Sequenom Patent Invalidation May Have Ramifications for NIPT Field, Entire MDx Industry
GenomeWeb, 2015

 

SOURCE

https://www.statnews.com/2016/06/27/supreme-court-biotech-patents/?s_campaign=tw&utm_content=buffer5a219&utm_medium=social&utm_source=twitter.com&utm_campaign=buffer

 

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A New Standard in Health Care – Farrer Park Hospital, Singapore’s First Fully Integrated Healthcare/Hospitality Complex

Author: Gail S. Thornton, M.A.

Co-Editor: The VOICES of Patients, HealthCare Providers, Caregivers and Families: Personal Experience with Critical Care and Invasive Medical Procedures

Farrer Park Hospital, Singapore’s newest private healthcare service provider, headed by newly appointed Chief Executive Officer Timothy Low, M.D., is a private, acute tertiary institution that represents an innovation in hospital administration, incorporating the latest technology to support better decision making for better patient outcomes and shorter hospital stays along with the beauty of nature and art to enhance the patient experience. The hospital, opened in March 2016, is sited within Singapore’s first, fully integrated healthcare and hospitality complex, called Connexion, which is Asia’s first, integrated lifestyle hub for healthcare and wellness. Connexion houses the 220-bed Farrer Park Hospital with its more than 300-accredited specialists and 18 operating rooms, a 10-floor specialist Medical Center, along with a five-star hotel and spa. In 2016, Farrer Park Hospital was awarded best new hospital of the year in Asia Pacific by Global Health and Travel Awards.

Farrer Park Hospital at Connexion at night

Image SOURCE: Photograph courtesy of Farrer Park Hospital, Singapore. An integrated healthcare and hospitality complex, called Connexion, Asia’s first, integrated lifestyle hub for healthcare and wellness, which includes Farrer Park Hospital.  

The hospital is also a teaching site for undergraduate medical training, providing enhanced medical care, service quality and professional integrity and value. Supported by approximately 600 hospital staff, specialists at Farrer Park Hospital provide a range of services, such as cardiology, oncology, orthopedic surgery, gastroenterology and ophthalmology. A 24-hour emergency department provides attention for acute illnesses and the hospital has the most modern facilities for diagnostic imaging, nuclear medicine, radiotherapy and clinical laboratories.

Image SOURCE: Photographs courtesy of Farrer Park Hospital, Singapore. Left is a deluxe suite, top right is Farrer Park Hospital lobby, bottom right is Farrer Park Hospital building.

 

Medical tourism — the process of traveling outside your country of residence to receive medical care — represents a worldwide, multi-billion-dollar business that is expected to grow considerably in the next decade. Interestingly, Singapore’s medical tourism market is projected to grow by 8.3 percent annually and reach revenue of USD $1.36 billion a year by 2018.

My first question is: Why has Singapore emerged in the past few years as an international healthcare and research hub?

Dr. Low:  With Singapore’s excellent patient services and its dedication to research and wellness, the country continues to remain as the top destination for those seeking medical care. By providing convenience and trust in our medical sector, there is no doubt that it will continue to expand and grow. Our dedication is towards the patient, cutting-edge technology and personalized care. This makes Singapore a multi-faceted medical hub and a center of excellence. Patient can receive excellent standard of medical treatment, comparable to the Europe and the USA.

Currently, we are attracting foreign patients who expect five- or six-star hotel service, because we’re a private hospital. That’s why I’m strict about appearances. We have to look as groomed, and we need to be as personable, as those in hospitality and the airlines.

Please describe the concept behind Farrer Park Hospital as Singapore’s first, fully integrated healthcare and hospitality complex.

Dr. Low: The Farrer Park Hospital was designed and built to be a hospital of the future, combining innovation in medical care and medical education. The hospital was initially created by medical specialists to respond to the growing challenges of healthcare in Singapore and, more broadly, throughout the Asia Pacific region. We have ‘reimagined’ private healthcare in order to enhance medical care, service quality, professional integrity and value.

We are leading the way in healthcare innovation as we are a premier institution for medical care and education that is based upon three important tenets for the patient — comfort, fairness and value. In fact, our top accredited medical staff, along with state-of-the-art equipment and technology, contributes to increased efficiency, reduced cost, and most, importantly improved patient outcomes.

As an innovation in hospital administration, Farrer Park Hospital embraces technology and improves medical care through its state-of-the-art equipment that facilities telemedicine consulting services across the world. To create a conducive environment for medical professionals, the hospital’s 18 operating rooms are linked via fiber-optic connections to various locations through the Connexion complex, including the hospitals’ education center and lecture hall, teaching clinics and tutorial rooms as well as the hotel’s function rooms. In addition to being equipped with the latest in useful medical technology, the hospital has state-of-the-art information technology which enables seamless and rapid flow of information between the admission services, inpatient areas, operating theaters, diagnostic and therapeutic centers, clinical laboratories and medical clinics. We also are the country’s first private hospital to become a teaching site, with the medical students from Lee Kong Chian School of Medicine at Nanyang Technological University.

What is the type of environment you are creating at Farrer Park Hospital?

Dr. Low: Our care philosophy extends beyond healing and the management of disease to engaging with our patients as partners in pursuit of good health and providing an oasis for healing and relaxation. Throughout our facility, patients will find that attention has been given to every aspect and detail of our facility – from the comfort of our patients, to its impact on the environment, to the speed and ease of obtaining medical attention and to the maintenance of hygiene.

As healthcare players go, we are small and that has made us very aware of our challenges. As such, we have encouraged a culture of innovation, to grasp opportunities quickly. Healthcare is a very traditional industry, resistant to change and thus tend to be laggards in technology. Farrer Park Hospital, however, embraces technology. The seamlessness of information flow was the focus at the onset of the project. This hospital was planned technologically to be relevant for the next 20 years.

Being an institution built by healthcare practitioners has its advantages. We achieve painstaking perfection in our attention to detail. The hospital has many practical features that serve the needs of practitioners and patients while the hoteliers add details for comfort, luxury and aesthetics.

Our hospital is also supported by a hospital staff, who provide a range of specialty services, such as cardiology, oncology, orthopedic surgery, gastroenterology and ophthalmology, along with a 24-hour emergency clinic, which provides immediate care for acute illnesses. The hospital also has the most modern facilities for diagnostic imaging, nuclear medicine, radiotherapy and clinical laboratories. There is even a holistic service which focuses on screening, preventive medicine and lifestyle enhancement.

What is your perspective of engaging with patients?  

Dr. Low: The hospital’s care philosophy extends beyond healing and the management of disease to engaging patients in pursuit of good health. Healing does not end after a successful operation. It is not just about coming to the hospital for a procedure and then recuperating at home. It is about having the best and most comfortable services to get the patient on their feet. And having a family support structure close by, where relatives can stay close to the hospital, is essential in the rehabilitation process. That is why, as part of Connexion, the hospital is Asia’s first, integrated lifestyle hub for healthcare and wellness that is linked to a five-star hotel and spa.

Patients are treated by an experienced team of medical and health specialists in an environment meticulously designed to maximize comfort and efficiency while promoting well-being, rest and recovery.

How are you positioned technologically to be a leader in developing first-rate patient care? 

Dr. Low: We have taken the lead in many areas. Our facility is wired completely, any tests and treatments is automated whenever possible and the information is sent in real time to all stakeholders who require it. Our doctors can access this technology and make decisions as if they are in the hospital anywhere in the world.

What type of physician are you attempting to attract?

Dr. Low: The environment at Farrer Park Hospital is about clinical and service excellence, supported by physical and technological constructs that facilitates both these endeavors. We are building a culture of fairness and promoting decision making that is free from self-interest and toward better patient outcome. The doctors who join us must be aware that we take our code of comfort, fairness and value seriously.

What is the thinking behind the philosophy of incorporating nature and art into healthcare in Farrer Park Hospital?

Dr. Low: The architecture of Farrer Park Hospital and Connexion reflects the deep commitment to creating a true learning environment. Synergies between our hospital along with a closely linked hotel stimulate many innovations for improving the healthcare experience. The concept of a hospital near a hotel is not new, however, to integrate it to the level that we have is something novel. We followed a biophilic architecture approach throughout the facility, incorporating nature and art to enhance healing. Hospitals are traditionally not the best place for recuperation. We strive to have the restful ambiance of a hotel, in addition to proximity of doctors and family under the same roof, as well as using technology to enable seamless and speedy decision making; all this in support of better patient outcome and shorter stays.

You could say we are different in how we view private healthcare. A traditional hospital would not carve out 15 gardens at multiple levels throughout the facility so that patients and families can have places to feel the warmth of the sun and breathe fresh air whenever they like. The facility also hosts a private collection of over 700 commissioned Asian paintings meant to enhance the healing environment.

In land-scarce Singapore, a typical businessperson would not have fewer paid parking lots, making them one and a half times the size of a standard lot to allow a patient on crutches to comfortably extend the car door fully to disembark. A standard project manager would not insist that contractors construct a curved sink so that surgeons will not have water dripping down his elbows after scrubbing his or her hands, or a bath bench with a cut out that allows patients to sit while washing themselves. This may seem unnecessary but these innovative approaches translate to actual benefits to people who ‘value’ them.

Everyone has the same end goal, a good experience and better patient outcome. Our strategy is simple. We take our responsibilities to patients, their families and the clinicians seriously. Attend to their needs, anticipate their wants, and find the best way to address these concerns through innovation and technology. This ultimately brings value to patients.

How does nature and art come together at Farrer Park Hospital?

Dr. Low: The hospital, hotel and specialist center share and enjoy 15 gardens created at multiple levels in the building. One of the gardens, The Farm @ Farrer, grows fruits, vegetables and herbs for the hotel kitchens, and at the same time, is a large outdoor green space for recovering patients to stroll and sun. Uniquely, Farrer Park Hospital patients enjoy meals prepared by chefs in the hotel’s kitchens and confectionery.

Our inpatient food service, for example, is also automated, so whatever appears on the electronic screen on a patient’s personal tablet matches their dietary restrictions. The menu is a matrix of over 200 items customized by hotel chefs and our hospital nutritionist. Food that is fresh, delicious and safe for patient consumption is our primary focus.

Not only do we benchmark ourselves with hospitals, but also we take our inspiration from other industries. We believe to be at the top, you need to look beyond, break through and recreate process models and apply them for use in healthcare.

 

Dr. Timothy Low Photo

Image SOURCE: Photograph of Chief Executive Officer Timothy Low, M.D., courtesy of Farrer Park Hospital, Singapore.

Chief Executive Officer of Farrer Park Hospital, Timothy Low, M.D., brings a strong leadership background in managing award-winning hospitals. Prior to his current role, Dr. Low served as CEO of Gleneagles Hospital in Singapore. Through his leadership, the hospital established itself as a six-star private healthcare provider, clinching 14 local and regional awards including the prestigious Asian Hospital Management Award as well as the the ‘National Work Redesign Model Company’ by Spring Singapore, a governing agency for innovation in Singapore. Under his leadership, revenues exceed 42 percent to over USD $100 million.

Having also served in senior management positions for pharmaceutical and medical device industries in the Asia Pacific region, Dr. Low’s breath of exposure allowed him to pioneer the establishment of a global contract research organization, validating Singapore as its regional headquarters.

With more than 28 years of experience in the health care industry with such leading companies as Covidien, Covance and Schering-Plough, Dr. Low brings with him a strong background of leadership within the business and medical community. With his vast experience and contributions to the industry, Dr. Low is listed in the ranks of Stanford Who’s Who.

Dr. Low received his Bachelor of Medicine and Bachelor of Surgery from the National University of Singapore (NUS) and is also a graduate of the NUS Graduate School of Business, Stanford University Executive Program and the Singapore Management University Asia Pacific Hospital Management Program.

 

REFERENCE/SOURCE

Tan, W. (2016). Farrer Park Hospital patients can recuperate at adjoining hotel to ease ward crunch. The Straits Times. Retrieved from  http://www.straitstimes.com/singapore/health/farrer-park-hospital-patients-can-recuperate-at-adjoining-hotel-to-ease-ward-crunch

Tan, W. (2016). New Farrer Park Hospital aims to offer ‘affordable’ private care. The Straits Times. Retrieved from http://www.straitstimes.com/singapore/health/new-farrer-park-hospital-aims-to-offer-affordable-private-care

Anonymous (2012). Singapore Medical Tourism: Farrer Park Healthcare and Hospitality Complex Will Open in 2013. International Medical Travel Journal. Retrieved from http://www.imtj.com/news/singapore-medical-tourism-farrer-park-healthcare-and-hospitality-complex-will-open-2013/

Retrieved from http://news.asiaone.com/news/yourhealth/farrer-park-hospital-appoints-new-ceo

Retrieved from http://today.mims.com/topic/farrer-park-hospital-opened-with-a-call-for-healthcare-changes-to-adapt-for-an-ageing-population-

Retrieved from http://www.farrerpark.com/hospital/Pages/Home.aspx

Retrieved from http://www.straitstimes.com/singapore/health/new-farrer-park-hospital-aims-to-offer-affordable-private-care

Retrieved from http://www.bca.gov.sg/friendlybuilding/FindBuilding/Building.aspx?id=4534

Retrieved from http://www.ttgasia.com/article.php?article_id=23292

 

Other related articles were published in this Open Access Online Scientific Journal include the following: 

2016

Third Annual BioPrinting and 3D Printing in the Life Sciences, 21-22 July 2016 at Academia, Singapore General Hospital Campus

https://pharmaceuticalintelligence.com/2016/01/18/third-annual-bioprinting-and-3d-printing-in-the-life-sciences-21-22-july-2016-at-academia-singapore-general-hospital-campus/

2015

Patient Satisfaction with Hospital Experience

https://pharmaceuticalintelligence.com/2015/11/15/patient-satisfaction-with-hospital-experience/

2013

Cardiac Surgery Theatre in China vs. in the US: Cardiac Repair Procedures, Medical Devices in Use, Technology in Hospitals, Surgeons’ Training and Cardiac Disease Severity 

https://pharmaceuticalintelligence.com/2013/01/08/cardiac-surgery-theatre-in-china-vs-in-the-us-cardiac-repair-procedures-medical-devices-in-use-technology-in-hospitals-surgeons-training-and-cardiac-disease-severity/

Risk Factor for Health Systems: High Turnover of Hospital CEOs and Visionary’s Role of Hospitals In 10 Years

https://pharmaceuticalintelligence.com/2013/08/08/risk-factor-for-health-systems-high-turnover-of-hospital-ceos-and-visionarys-role-of-hospitals-in-10-years/

Hospitals in China

https://pharmaceuticalintelligence.com/options/scientific-delegation/shanghai-may-2013/hospitals-in-china/

 

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The Role of Big Data in Medicine

Author: Gail S. Thornton, M.A.

In order to meet the increasing demands placed on the health care system due to increases in longevity and chronic disease awareness levels, delivery systems for health care are changing rapidly and a large portion of the decisions behind these changes are driven by data (Marr, 2015). Practitioners are now attempting to understand as much as possible about patients as early as possible in their lives, so that they can pick up on the warning signs of serious illness at an early stage and thereby possibly prevent or lessen the severity of illness as its onset.

Big-Data_Shutterstock_image_132470879

Image SOURCE: Big-Data_Shutterstock_image_132470879

Over the course of the past several decades, rapid advancements have been made in an evolving field, called Big Data, which takes extremely large volumes of data that are analyzed to reveal patterns, trends and associations as well as comprehend their meaning and significance. Big Data also enables business throughout every industry to achieve increases in both efficiency and production (Marr, 2015). The data which are analyzed can originate from business transactions, both financial and nonfinancial (Perry, 2016). This is, particularly true in health care, where Big Data is making great inroads to predict epidemics, help researchers  find cures for disease, improve quality of life and decrease the number of preventable deaths (Marr, 2015).

Mobile Technology Is Rapidly Growing

Millions of people throughout the world now use mobile technology to develop and live a healthier lifestyle. Mobile technology, such as smartphones and tablets, enables individuals to undertake self-care measures to help achieve and preserve health. For example, there are applications that measures the distance individuals walk each day, as well as provides calorie counters to plan their diet. Current examples of wearable devices that are specifically designed to achieve this purpose, include Fitbit, Jawbone and Samsung Gear Fit (Marr, 2015). Using this technology, users have the ability to track their progress and upload their data (Marr, 2015). Soon, it will also be possible for users to share their data with their doctors, which allows primary care providers to consider this information when addressing their patients’ care. This technology gives the public access to large, rapidly growing data bases of information, all which leads to achieving and maintaining optimum health.

In the near future, an individual’s data won’t be treated in isolation. It will be compared and analyzed alongside thousands of others, highlighting specific threats and issues through patterns that emerge during the comparison. This enables sophisticated predictive modeling to take place – a doctor will be able to assess the likely result of whichever treatment he or she is considering prescribing, backed up by the data from other patients with the same condition, genetic factors and lifestyle. Programs such as this are the industry’s attempt to tackle one of the biggest hurdles in the quest for data-driven healthcare: The medical industry collects a huge amount of data but it is stored in archives controlled by different doctors’ surgeries, hospitals, clinics and administrative departments (Marr, 2015).

Barriers of Technical Expertise and Integrated Security

The majority of health systems continue to handle their analytics and reporting needs without using Big Data (Adamson, 2016). Yet, at present, the majority of healthcare institutions are overwhelmed with the ordinary problems of regulatory reporting and difficulties with operational dashboards. Two of the primary barriers that impede healthcare facilities from addressing these problems using Big Data are lack of technical expertise and sufficient integrated security (Adamson, 2016). These deficiencies limit the use of Big Data and confine it, for the most part, to research applications because it requires a highly specialized skill set.

Within healthcare settings, HIPAA compliance is an absolute, non-negotiable necessity. No other considerations are understood to take precedence over ensuring the primacy and security of patient data. This is also a problem for Big Data, as experts indicate that there are not many good, integrated methods for managing security (Adamson, 2016). It is recommended that healthcare organizations purchase well-supported, commercial security distribution systems (Adamson, 2016).

Evidence-Based Medicine (EBM) As Gold Standard

Over the course of the past several decades, Evidence-Based Medicine (EBM) has become the gold standard for evaluating the efficacy of new methods and technology (Sim, 2016). EBM and Big Data can be understood as two distinctly different ways for addressing the information produced by empirical research.

The EBM approach is to pose a hypothesis, collect data by implementing a research study, and then analyze findings using biostatistics, which determines whether or not findings support the hypothesis (Sim, 2016). In contrast to this paradigm, the thinking of data science practitioners is derived from a computational tradition that is driven by data, rather than from hypothesis testing (Sim, 2016). Their deductions are based on raw observation and do not encompass context knowledge into consideration of evident production (Sim, 2016). Consequently, use of an algorithm has the potential to detect patterns in the database, without recognizing whether these patterns are “true, spurious or affected by bias” (Sim, 2016).

EBM prioritizes having explicit control of bias, while Big Data approaches seldom incorporate protocol-directed data collection, but rather focus on maximizing precision and external validity through use of the dictum “more data are better than better data” (Sim, 2016).

Both of these methods for understanding knowledge offer advantages and, therefore, experts consider these two methods to be complementary. The advantages of EBM are well-known and Big Data methods offer the potential inherent in expanded research power, particularly, in analytics studies that focus on “classification, prediction, modeling, and simulation” objectives (Sim, 2016).

REFERENCE/SOURCE

Adamson, D. (2016). Big data in healthcare made simple: Where it stands today and where it’s going. Health Catalyst. Retrieved from https://www.healthcatalyst.com/big-data-in-healthcare-made-simple

Marr, B. (2015). How big data is changing healthcare. Forbes Magazine. Retrieved from http://www.forbes.com/sites/bernardmarr/2015/04/21/how-big-data-is-changing-healthcare/#5b3a37a32d91

Perry, P. M. (2016). Harnessing the power of big data and data analysis to improve healthcare entities. Hfm (Healthcare Financial Management), 70(1), 74. http://search.ebscohost.com/

Sim, I. (2016). Two Ways of Knowing: Big Data and Evidence-Based Medicine. Annals Of Internal Medicine, 164(8), 562-563. doi:10.7326/M15-2970

Other related articles:

http://www.mckinsey.com/industries/healthcare-systems-and-services/our-insights/the-big-data-revolution-in-us-health-care

http://www.realworldhealthcare.org/category/big-data/

http://content.healthaffairs.org/content/33/7/1123.abstract

https://hbr.org/2014/12/why-health-care-may-finally-be-ready-for-big-data

Other related articles published in this Open Access Online Scientific Journal include the following:

2016

10 Most Successful Big Data Technologies

https://pharmaceuticalintelligence.com/2016/04/25/10-most-successful-big-data-technologies/

Big Data Self-Delusion

https://pharmaceuticalintelligence.com/2016/04/02/big-data-self-delusion/

Top 100 Big Data Experts to Follow

https://pharmaceuticalintelligence.com/2016/01/20/top-100-big-data-experts-to-follow/

Healthcare conglomeration to access Big Data and lower costs

https://pharmaceuticalintelligence.com/2016/01/13/healthcare-conglomeration-to-access-big-data-and-lower-costs/

2015

Future of Big Data for Societal Transformation

https://pharmaceuticalintelligence.com/2015/12/14/future-of-big-data-for-societal-transformation/

 

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Invivoscribe, Thermo Fisher Ink Cancer Dx Development Deal

Reporter: Stephen J. Williams, PhD

 

NEW YORK (GenomeWeb) – Invivoscribe Technologies announced today that it has formed a strategic partnership with Thermo Fisher Scientific to develop multiple next-generation sequencing-based in vitro cancer diagnostics.

Under the deal, Invivoscribe will develop and commercialize immune-oncology molecular diagnostics that run on Thermo’s Ion PGM Dx system, as well as associated bioinformatics software for applications in liquid biopsies. The tests will be specifically designed for both the diagnosis and minimal residual disease (MRD) monitoring of various hematologic cancers.

Additional terms of the arrangement were not disclosed.

“We are … very excited to provide our optimized NGS tests with comprehensive bioinformatics software so our customers can perform the entire testing and reporting process, including MRD testing, within their laboratories,” Invivoscribe CEO Jeffrey Miller said in a statement.

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Problem of Science Doctorate Programs

Larry H. Bernstein, MD, FCAP, Curator

LPBI

 

 

The Problem in Biomedical Education

Henry Bourne (UCSF)

Dr. Henry Bourne has trained graduate students and postdocs at UCSF for over 40 years. In his iBiology talk, he discusses the imminent need for change in graduate education. With time to degrees getting longer, the biomedical community needs to create experimental graduate programs to find more effective and low cost ways to train future scientists and run successful laboratories. If we don’t start looking for solutions, the future of the biomedical enterprise will grow increasingly unstable.

Watch Henry Bourne’s iBioMagazine: The Problem in Biomedical Education

https://youtu.be/V9peRqNr-L0

Henry Bourne is Professor Emeritus and former chair of the Department of Pharmacology at the University of California – San Francisco. His research focused on trimeric G-proteins, G-protein coupled receptors, and the cellular signals responsible for polarity and direction-finding of human leukocytes. He is the author of several books including a memoir, Ambition and Delight, and has written extensively about graduate training and biomedical workforce issues. Now Dr. Bourne’s research focuses on the organization and founding of US biomedical research in the early 20th century.

Related Talks

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GSK Partners With SG3 Ventures to Add $100 Million to the Pittsburgh Biotech Scene

From Biospace News: Backed by GlaxoSmithKline (GSK), New VC Firm SG3 Ventures Has $100 Million to Bet on Pittsburg Startups

Reporter: Stephen J. Williams, Ph.D.

Source: http://www.biospace.com/News/backed-by-glaxosmithkline-new-vc-firm-sg3-ventures/412039/source=TopBreaking?intcid=homepage-seekernewssection-tabtopbreakingnews

 

Pittsburgh-area entrepreneurs will soon have another funding option for growing early phase startup companies.

Pharmaceutical giant GlaxoSmithKline has thrown its support behind the creation of a $100 million venture capital fund, which will help meet a need for early stage business startup capital in the Pittsburgh area. Philadelphia-based SG3 Ventures anticipates awarding its first round of funding in about a year, according to Brian McVeigh, vice president of worldwide business development transactions and investment management at GSK.

From Pittsburgh Post Gazette: http://www.post-gazette.com/business/healthcare-business/2016/03/11/New-early-stage-venture-fund-forming-with-eye-on-Pittsburgh-startups/stories/201603090016

New early-stage venture fund forming with eye on Pittsburgh startups

Pittsburgh-area entrepreneurs will soon have another funding option for growing early phase startup companies.

Pharmaceutical giant GlaxoSmithKline has thrown its support behind the creation of a $100 million venture capital fund, which will help meet a need for early stage business startup capital in the Pittsburgh area. Philadelphia-based SG3 Ventures anticipates awarding its first round of funding in about a year, according to Brian McVeigh, vice president of worldwide business development transactions and investment management at GSK.

“There is a huge untapped opportunity,” Mr. McVeigh said. “Let’s bring the money here.”

New prescription drug treatments will be a priority for fund investments, but a balanced portfolio including life science technologies is planned.

In the venture ecosystem, insurers, pension funds and other institutions use such funds to invest in promising startup companies — both to balance their portfolios and to get a shot at investment returns that would not otherwise be possible. The venture funds oversee allotting capital to a portfolio of startup companies.

The investment money enables startups to mature and eventually bring in other investors through a public offering or acquisition by a larger company, generating money to repay the initial investors.

GSK and other big pharmaceutical companies are making similar investments to maximize returns and keep their product pipelines full, but GSK has been focusing on earlier stage companies, shifting its focus to pre-clinical technologies about five years ago, Mr. McVeigh said.

In addition, Big Pharma is increasingly relying on outsourced research and development operations, often in collaboration with universities, to fill industry product pipelines. GSK has funded a number of these initiatives, including a cancer collaboration with the University of California, San Diego School of Medicine and Moores Cancer Center.

SG3 Managing Director Keith Marmer said the new venture fund will be committed to technologies developed outside the better known tech hubs of Silicon Valley and Boston-Cambridge.

“We’re here, we’re from here, and we want to be here,” he told a group of entrepreneurs at a recent breakfast meeting in Oakland. “Sustaining technology through research funding isn’t happening anywhere.”

Parsippany N.J.-based GSK closed its consumer health care operations in Moon in 2015, eliminating 274 jobs a year after the company’s merger with Swiss vaccine maker Novartis. Mr. McVeigh works at the company’s offices in King of Prussia, Pa.

With federal research dollars flat in recent years, universities nationwide have been turning to commercialization of intellectual property as a new source of revenue.

At the same time, Pittsburgh’s startup community is showing signs of new life.

Among the signs: Patrick Gallagher’s commitment to the commercialization of faculty research since becoming University of Pittsburgh chancellor 18 months ago, awakening a sleeping giant of economic development and innovation and hospital system UPMC’s creation of a commercial enterprises arm to fund promising technologies.

The timing couldn’t be better for venture capital funds like SG3.

Nationwide, early stage funding has been chasing fewer deals, according to a report by Money Tree, which was compiled by PricewaterhouseCoopers and the National Venture Capital Association based on data provided by Thomson Reuters.

Early stage investments nationally last year totaled $19.8 billion, a 23 percent increase from $16.1 billion in 2014. But the number of deals were essentially flat from the previous year, suggesting that some companies were left out in the cold.

What’s more, the amount of money available to Pittsburgh-area entrepreneurs after the earliest rounds of investment isn’t keeping pace with the innovations coming out of the city’s universities, said Dietrich Stephan, a serial entrepreneur who also chairs the human genetics department at Pitt.

“There’s real substance here,” he said. “Without money, we can’t build.”

Seed investment funding — the earliest level of funding — is not a problem in Pittsburgh, said Buchanan Ingersoll Rooney PC lawyer Jeremy Garvey, who also chairs the Bridgeville-based Pittsburgh Venture Capital Association.

“The predominance of funding in this market comes in the earliest stages,” he said. “Institutional funding is much harder to get in this market.”

Early stage venture funding began drying up with the stock market crash of 2008, which also chilled the financial markets for initial public offerings for biotech companies, Mr. McVeigh said. Eventually, conditions thawed for IPOs, but the lower valuations for new companies than before 2008 made that less attractive than before.

“We’re really energized by the energy there” in Pittsburgh, Mr. McVeigh said. “We’re looking to bring venture capital to the region.”

Kris B. Mamula: kmamula@post-gazette.com

About SG3 Ventures

SG3 Ventures is an early stage life science venture capital firm. Our primary focus in on therapeutics and digital health; however, we will invest opportunistically when presented with a potential vehicle to drive superior returns for our limited partners. We are active in company formation, deploying financial and human resources to help deliver value. In addition, we access deep industry networks to ensure a path to market with strong commercial partnerships built into our companies from the beginning. SG3 prefers to invest in the greater Philadelphia Region (Princeton to the north, Baltimore to the south and Pittsburgh to the west). We prefer to make initial investments at the formation or seed stage with a focus on providing financing through mature rounds of investment.

  • Website

    http://sg3ventures.com

  • Industry

    Financial Services

  • Type

    Partnership

  • Headquarters

    3711 Market Street Suite 800Philadelphia, PA 19104 United States

  • Company Size

    1-10 employees

More articles on the Open Access Journal on Biotech Investing Include

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Bristol-Myers Squibb: A global BioPharma leader – Tracing the innovative biotech core of $3.7 billion R&D Investment and $16.4 billion in Net Sales

 

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Starting a Biotech the European Way

Author:  Stephen J. Williams, Ph.D.

A wonderful post by Tony Marcel in Nature Biotechnology highlights some of the structural differences in the way biotech startups are formed in Europe contrasted with bio-entrepreneurship as conducted in the United States.  Tony Marcel is currently the CEO of FGene S.A. and gives a personal experience  of the European biotech startup scene and highlights the differences, as he sees it, in the unique business development models occurring in Europe versus the US.  This post will highlight features from the article.

  • US model of biotech is not easily transferable to how Europe does business
  • US model involves developing a specific technology platform then selling that tool, service or platform to pharma for R&D $ and royalties
  • European perspective is to build networks instead of platforms which can deliver capabilities or one product to pharma
  • The article discusses three weaknesses identified in the biotech world with respect to Europe and the US

Three ” weaknesses” identified which may affect decision to start a biotech in Europe include:

  1. European academic scientists have trepidation making deals with big pharma
  2. European scientists are not as eager as US counterparts to start a biotech
  3. biotechs still are not as good as pharma in drug development so even their pipeline of “hits” are failing in clinical trials

The article aims to use these weaknesses to define a European way involving

  • defining management players and market niche early on
  • reducing the barriers to entry (i.e. legal)
  • establishing the relationships to increase viability

 

The full article can be found at the following link:

http://www.nature.com/bioent/2003/030101/full/nbt0299supp_9.html

 

An emerging European model for bioentrepreneurship

Tony Marcel

Tony Marcel is CEO of FGene S.A., 91, Avenue Kléber, 75116 Paris, France

e-mail:  tonymftmcgene@compuserve.com.

The US model for biotechnology is not easily exportable to Europe, but an alternative European business model may be adaptable everywhere.

There is a widespread opinion that biotechnology companies worldwide need to follow business models initiated in the US. These models, generally speaking, are based on development of a specific technology platform. The prevailing wisdom suggests this technology can be sold as a tool or service to pharmaceutical companies or can be used to develop a lead compound that can then be sold to big pharma for R&D dollars and single-digit downstream royalties.

But my experience as a former academic medical researcher who has helped discover, develop, and market drugs for Hoechst, Laboratoires Roussel, Roussel-Uclaf, Rhône-Poulenc Sante, and Amgen has taught me that there is an appealing alternative to this model that may be more practical from the European perspective. Rather than building technologies, one can build networks that have the capability of delivering to big pharma the one product they cannot refuse: validated lead compounds for unmet medical needs.

Identifying a market niche

My background has taught me that an effective way to find solutions is to look at weaknesses perceived by the status quo, and then to develop a strategy to turn them into strengths. Biotechnology’s biggest weakness was its lack of products, in traditional pharmaceutical terms. Relatively few lead compounds have made their way through clinical trials and onto the market. So to separate your company from the crowd, my first conclusion is that it needs to be product-based. It should develop lead compounds that can be sold to big pharma, or take those compounds through clinical trials and to the market.

How do you accomplish this in Europe? I identified three weaknesses from a traditional biotechnology or pharmaceutical perspective that I felt could be developed into strengths. The first was that European scientists are much more risk averse than their American counterparts when it comes to setting up their own business. The legal, financial, and cultural infrastructure to take such a step is far more developed in the US than elsewhere.

The second was that European academic scientists tended to be mistrustful of big pharma’s intentions in licensing discussions. Taking the fruits of their research and developing it into a business is an uncharted area for most, and their unfamiliarity with this process made them cautious.

Finally, biotechnology startups everywhere, not just in Europe, are usually not very efficient in conducting pharmaceutical development. In general, they are discovery-focused companies that lack both the expertise and the contacts in these areas to efficiently manage this process.

These three weaknesses provide the basis for my product-based business plan. The fact that European scientists are not as ready to start companies as in the US makes Europe a source of world-class research not already tied up commercially. In addition, my experience in the pharmaceutical world has demonstrated that a commitment to building a relationship based on trust with scientists and their university licensing departments tremendously enhances the quality of these exchanges and, over time, provides remarkable access to a pipeline of innovative lead compounds.

Finally, the pharmaceutical industry’s move to outsource much of the development and clinical trials process has created a remarkable infrastructure for moving lead compounds through development. One only needed to know when this was appropriate and to have the money to commit to that project to realize a major portion of the development process.

The business model that results from uniting these strengths is a company dedicated not to a specific technology platform, but rather to the development of innovative compounds discovered and patented by academia. The company’s niche is to license in molecules at an early stage and demonstrate proof of principle, and take them through regulatory preclinicals, as well as phase I/II clinicals. At that point, the company licenses its products to big pharma. Profit is generated by the substantial risk-to-reward ratio between the cost of licensing in molecules and the outlicensing price to big pharma.

Management

Contrary to the way many US biotechnology companies are run, the management structure of such a company is not a one-person show. This strategy relies heavily on a supervisory board made up of representatives from European ministries and major European banks. It is also dependent on a scientific advisory board (SAB) with members from key European states. Unlike the boards of some biotechnology companies, the individuals selected are not merely figureheads. They must be committed to an operational role in which they are regularly consulted about the company’s plans.

The key to making this work is to maintain permanent links with academia, the source of new molecules, through publications, meetings, and also through SAB members. One also needs to develop comparable relationships in the pharmaceutical industry in order to keep abreast of licensing-in needs. Using this dual approach, a company will be able to identify discoveries relevant to a major pharmaceutical market before they are published. The company can then select candidates for licensing based on demonstrations of their potentially useful activity, the proof of pilot synthesis and purification capability, and sufficient intellectual property protection.

Given the academic scientist’s aversion to starting a business, where will this network of managers come from? In Europe, the merger and acquisition fever that has hit both the pharmaceutical and banking industries has created a large pool of experienced professionals, acquainted with science, marketing, and business. Some of these individuals will be at a point in their lives where setting up companies is an exciting alternative career.

The challenge for this new generation of European bioentrepreneurs will be to develop their ability to create a new level of cross-talk between inventors and developers. Their core responsibility will be much in keeping with their training: Build and nurture a portfolio of molecules at various stages of development.

Barriers to entry

If this model is so straightforward, why do pharmaceutical companies not eliminate the biotechnology middleman and reap the rewards directly? One of the three premises of this model is that a small biotech company is more able to concentrate on an academic alliance than a large pharmaceutical company. Biotechnology’s close identification with academia through the training of both its management and staff gives it a cultural advantage in assuming this role.

Historically, the model in which big pharma establishes a direct relationship with academia has never proven successful. For example, SmithKline and French invested much of its Tagamet earnings into developing academic alliances to fill its pipelines. Nonetheless, investing a substantial amount of money in these relationships over a significant period of time did not prevent this group from having to merge with Beecham. Nearly every working pharmaceutical executive today has a similar war story.

The reason it has failed for the past 20 years, and is likely to continue to fail for the next 20, is that it concentrates efforts in the hands of the most powerful pharmaceutical companies and key research institutions. The resulting bureaucracy is so overwhelming it not only alienates the scientific innovators, but creates a stifling atmosphere in which decisions simply cannot be made.

But old habits die hard, and this model has long been a tradition in Europe—particularly in France. Therefore, it is likely, if for no other reason than to reap the potential financial returns of such a model, that pharmaceutical companies will continue to make this model work.

However, the important role that biotechnology can play in this process is being recognized by some individuals now in positions of responsibility in pharmaceutical companies, academic institutions, and government offices. These individuals are doing their best to support biotechnology’s role in the development of innovative new medicines.

Viability

If you have read this far, you are probably persuaded by the arguments, but may wonder, “If it is such a great business model, why hasn’t anyone done it before?” Well, they have. In 1995, FGene was founded in France as a company devoted to the development of biopharmaceutical products. The company was initiated by the willingness of the Paris-based Institut Pasteur, a major European academic institution, to license molecules to it. This relationship allowed the beginning of the process I have just described.

The resolve of the French government, key players in academia, the investment community, and the pharmaceutical industry to enhance the growth of biotechnology in France is an opportunity we have seized. We have tried to duplicate in Europe the remarkable links developed between biotechnology startups and academia in the US, and hope to create a viable business serving the needs of the world’s largest pharmaceutical companies that are literally in our backyard.

In three years of existence, FGene already boasts five products in its active development portfolio: a recombinant protein for the treatment of traumatic spinal section; a peptide for the prevention and therapy of cardiovascular and cerebrovascular ischemia, such as coronary diseases; a selective IL2 receptor agonist for the treatment of cancer; a peptide active on kidney and bone for the treatment of bone and mineral balance disorders, such as osteoporosis; and a peptide for improving male pattern sexual arousal.

We are encouraged that we have made this much progress in such a short time. While this model is still not proven in terms of financial success, it provides a much stronger foundation for growing a biotechnology company than most biotechnology business plans currently in use because costs are directly related to the development of marketable products.

Conclusions

For budding European bioentrepreneurs, this model recommends itself for three reasons: First, it uses unexploited resources that are difficult to access through traditional biotechnology or pharmaceutical models. Second, it is based on pharmaceutical customers’ high-priority needs. And third, it provides a company with a burn rate that is in direct proportion to the realization of a marketable product.

This model has first taken hold in France because of a unique set of circumstances, but its applicability seems uthe commitment of a network of individuals to build a new kind of biotechnology company.

My vision is that companies formed will reinvigorate the European pharmaceutical industry. In the end, everyone wins. Academic science has a new route to receive fair payment for their innovations, biotechnology companies show a rapid timeline to profitability, making investors happy, and pharmaceutical companies fill their pipelines with truly innovative medicines. But the real winner in the end will be the consumer—the rapid translation of genomic products will lead to medicines that improve healthcare at an affordable price, in a much shorter time frame than previously possible.

 

source: http://www.nature.com/bioent/2003/030101/full/nbt0299supp_9.html

More articles on BioEntrepreneurship in this Online Open Access Journal Include:

11:00AM – 10/1/2014: Scientific Collaborations @14th Global Partnering & Biotech Investment, Congress Center Basel – SACHS Associates, London

9:00AM 10/1/2014: Partnering I @14th Global Partnering & Biotech Investment, Congress Center Basel – SACHS Associates, London

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Next-generation Universal Cell Immunotherapy startup Adicet Bio, Menlo Park, CA is launched with $51M Funding by OrbiMed

Recent Breakthroughs in Cancer Research at the Technion-Israel Institute of Technology- 2015

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