Life-Science Panorama

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February 17th, 2011

FDA Initiative Encourages Innovation and Streamlines Regulatory Evaluation

By Staff

On February 8, the FDA announced the launch of its new Medical Device Innovation Initiative. “This initiative has broad implications for how the FDA does business, and how we support and will continue to support important opportunities for innovation,” commented Dr. Margaret Hamburg, FDA Commissioner. “The pace of biomedical discovery continues to accelerate and the stakes have never been higher. By the end of the decade, a combination of trends, including international competition, will test America’s role as the Global leader in medical product innovation. And as a nation, we have important choices to make about how we move forward. As we do, the FDA is eager and prepared to help lead the way.” Hamburg added. 

As part of this Medical Device Innovation Initiative, CDRH is considering a series of actions aimed at encouraging innovation, streamlining regulatory and scientific device evaluation, and expediting the delivery of innovative medical devices.

“Each year, millions of American patients benefit from innovative medical devices that reduce suffering and treat previously untreatable conditions,” said CDRH Director Jeffrey Shuren, M.D., J.D. “CDRH’s Innovation Initiative will help accelerate the development of and patient access to innovative medical devices, which often fulfill unmet public health needs,” Shuren added.

To support this initiative, FDA plans to take action that will:

  • Facilitate the development and regulatory evaluation of innovative medical devices by:
    • Establishing the Innovation Pathway - a priority review program for pioneering medical devices; and
    • Streamlining the de novo pathway.
  • Strengthen the U.S. research infrastructure and promote high-quality regulatory science by:
    • Establishing a voluntary third-party certification program for U.S. medical device test centers;
    • Creating a publicly-available core curriculum for medical device development and assessment;
    • Leveraging device experience and data collected outside the United States; and
    • Advancing regulatory science for medical devices through prioritizing scientific research, establishing public-private partnerships, collaborating with other government agencies, and holding public workshops.
  • Prepare for and respond to transformative innovative technologies and scientific breakthroughs by:
    • Enhancing CDRH’s current horizon scanning process by adopting emerging horizon scanning methods, seeking public input to identify important and innovative medical device technologies as they arise, and periodically reporting its horizon scanning findings to the public; and
    • Developing a Network (or Networks) of Experts to serve as a resource to assist in addressing scientific questions about emerging technologies with which our reviewers might not be immediately familiar.

Through the implementation of the Innovative Pathway premarket review process, FDA expects to conduct premarket reviews within 150 days, nearly half the time it currently takes the agency to review most premarket approval applications.

The FDA is soliciting public comment on the Innovation Initiative and will host a public meeting on the topic on March 15, 2011 at the Center’s White Oak campus. 

Additional details on FDA’s Medical Device Innovation Initiative are available through the following resources:

Medical Device Innovation Initiative White Paper:
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHInnovation/ucm242067.htm

FDA’s Medical Device Innovation Initiative Press Briefing:
http://www.youtube.com/watch?v=bN36QVZhMv0

CDRH Medical Device Innovation Initiative Home:
http://www.fda.gov/deviceinnovation

February 10th, 2011

IBM’s Watson Supercomputer Could Help Doctors Improve Healthcare

By Daniel R. Matlis

In the TV series Star Trek: Voyager, the ship’s Doctor was a computer program called the Emergency Medical Hologram (EMH).  The EMH program was built into the starship’s sickbays as a stop-gap measure for use if the ship’s doctor should be temporarily unable to perform his duties. But in the first episode, Voyager’s medical personnel are killed, and the EMH is called into action as Chief Medical Officer for the duration of the series.

Whenever someone walked into sickbay, the program was engaged and The Doctor would greet the patient with the phrase: “Please state the nature of the medical emergency.”

That’s all Science Fiction….it will never happen you say?

Enter IBM Watson. Named after IBM founder Thomas J. Watson, IBM Watson is a breakthrough in the field of open-domain Question Answering (QA).

The QA technology that underlies Watson is called DeepQA, and was developed by IBM Research in collaboration with leading universities. DeepQA represents a quantum leap in Web search technology.

Watson goes well beyond simply answering questions. It actually learns by being exposed to large data repositories, much like people have to think through our learning and experiences to answer questions. To do this, Watson parses through unstructured content, such as natural language text, speech, images, and video to analyze vast amounts of content.

The complex algorithms for the analytics engine behind Watson are tuned specifically for open-domain QA. These algorithms help Watson handle the broad range of information that language can express and evaluate the evidence it collects to produce its confidence level to answer the question at hand.

IBM will showcase Watson’s capabilities in the TV quiz show Jeopardy!.  Billed as “The First-Ever Man Vs. Machine Jeopardy! Competition,” Watson will compete against two of the most well-known and successful Jeopardy! champions - Ken Jennings and Brad Rutter.

The Watson episodes are scheduled to air over three consecutive days, February 14 -16, 2011.

How Can Watson Help Doctors?

“In ‘Jeopardy’, built into the game is this notion confidence; that it’s not worth answering unless you’re sure. And in the real world, there are lots of problems like that. You don’t want your doctor to guess. You want him to have confidence in his answer before he decides to give you a treatment,” commented Dr. Katharine Frase, VP, Industry Solutions and Emerging Business at IBM Research. 

Healthcare delivery has become increasingly reliant on a sophisticated mix of medical devices, diagnostic and therapeutic equipment, and the multimodal data they provide. The delivery of high quality healthcare is dependent on a wide variety of diagnostic, surgical, therapeutic systems, the environment of care, as well as supporting IT infrastructures. This abundance of data has created challenges for healthcare providers.

“For at least thirty years, it’s been humanly impossible for a physician to master all the material they need to practice at the highest level,” said Dr. Herbert Chase, Professor of Clinical Medicine at Columbia University. “Medical literature has doubled in size every seven years” he added.

“You are never going to replace a trained doctor or nurse,” said Dr. Joseph Jasinski, Healthcare and Life Sciences at IBM Research. “But certainly a system like Watson could be a Physician’s Assistant. Suppose you are a clinician, a doctor, a nurse trying to diagnose a very complex case. You have some ideas, but in order to confirm your hypothesis, confirm what you think is wrong; you need a lot of information.” he added

In addition to assisting with Medical diagnosis, Watson could help lower the occurrence of Medical errors and Hospital acquired infections, a key issue facing the healthcare system. “Twenty percent of medical errors are diagnostic errors. And it’s not that they’ve missed diagnoses, often that they are delayed.” said Dr. Chase. “Watson has the capacity to get the diagnoses up there sooner”

A system like Watson could be tied into a hospital’s facilities and biomedical systems and Healthcare management infrastructure to ensure that assets were cleaned, sanitized or sterilized before they are available for use with a new patient. It could also ensure that clinical equipment which has been recalled or is under a service alert, is removed from service before it is used on a patient. These scenarios would help to proactively reduce the opportunity for medical errors and preventable infections acquired in Hospital.

“It is the effective and efficient storage, retrieval, analyses, and use of biomedical information to improve health. At the end of the day, the goal is to improve health,” said Dr. Chase.

In the not too distant future, when you visit a healthcare provider, don’t be surprised if you are faced with an avatar like Watson’s in a white coat asking you “Please state the nature of the medical emergency.”

February 1st, 2011

Life Sciences Summit 2011 Brings Thought-Leaders Together in NYC

By Daniel R. Matlis

The challenges and opportunities facing Life Science and Healthcare organizations today must be addressed through the collaboration of all constituents in this complex ecosystem.

The Life Sciences Summit 2011 provides a unique opportunity to hear from thought-leaders in the Medical Technology, Pharmaceutical, Healthcare and Venture Capital/Private Equity field. The event is sponsored by Landmark Ventures.

Scheduled to present at the Life Sciences Summit 2011 are:

  • Paul Teitelbaum, Managing Director & Head of Life Sciences - Landmark Ventures
  • Dr. Kenneth Stein, Senior Vice President & Chief Medical Officer, CRM - Boston Scientific 
  • Dr. Ross Segan, Chief Medical Officer, International - Covidien
  • Dave Hickey, EVP Strategy & Business Development - Siemens Healthcare 
  • Dr. Greg Wiederrecht, Vice President & Head, External Scientific Affairs, Worldwide Licensing - Merck & Co 
  • Dr. Tillman Gerngross, CEO - Adimab 
  • Dr. Gualberto Ruano, CEO - Genomas
  • Dr. Andrew Jay, Managing Partner, Healthcare - Siemens Venture Capital 
  • Terry McGuire, Co-Founder and General Partner - Polaris Venture Partners 
  • Dr. Steve Gullans, Managing Director - Excel Venture Management 
  • Dr. Jon Edelson, Venture Partner - Ascent Biomedical Ventures 
  • Dr. Neil Kurtz, CEO - Golden Living
  • Dr. Martin Arron, Vice President, Ambulatory Operations at Beth Israel Medical Center - Continuum Health Partners
  • Dr. Peter Elkin, Professor of Medicine, Vice-Chairman, Department of Internal Medicine, Director, Center for Biomedical Informatics - Mount Sinai School of Medicine

According to Eric Sugar, General Partner at Landmark Ventures, this year’s summit is expected to bring together over 200 professionals representing leading organizations including Abbott Labs, Amgen, AstraZeneca, B. Braun Medical, Bain Capital, Bayer, BD Ventures, Boston Scientific, Canaan Partners, Consonance Capital, C.R. Bard, Edison Venture Fund, Forest Laboratories, Galen Partners, GE Healthcare, Genzyme, GlaxoSmithKline, HCA, Henry Schein, Integra Life Sciences, Johnson & Johnson, Kaiser Permanente, Medtronic, Merck, NEA, Novartis Ventures, Pfizer, Philips, Roche, Siemens, Third Rock Ventures, TM Partners and Venrock.

I will have the privilege of covering the Life Sciences Summit 2011, scheduled for Wednesday, February 9th at the New York Academy of Sciences in New York City

Stay tuned for highlights from the Life Sciences Summit 2011 in Life Science Panorama.

For additional information about this invitation-only event, please contact Sara Hames, Director of Strategic Projects - Landmark Ventures at sara.hames@landmarkventures.com

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