FasterCures: Clinical Trials Recruitment and Retention

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Six years ago I attended a biotech conference in San Francisco. One of the panels that intrigued me most was entitled, "Personalized Medicine: to Market in Five Years." Certainly, everyone was talking about the New Era of Personalized Medicine and I attended to listen to as many different perspectives on emerging industry trends as possible. The panel was exciting, the potential for individualized medicine was here today and all we needed to do was interpret the genetic data we were generating by the bucket load and bring new products to market!

Let's do it!

So how many clinical development people were there? None. How many commercial development or marketing people were there? One, just me. So how on earth were all these R&D and genomics folks going to get to market? I asked - there was a pregnant pause...

Okay, so now it's 2006. Last week I attended the Second Annual Burrill & Co., Personalized Medicine Conference at Mission Bay in San Francisco. Six years ago the Mission Bay conference center had not yet broken ground. Today it stands as a tribute to a new era of biotechnology in San Francisco. But our new era of personalized medicine is still very much under construction. At the start of the year Steve Burrill predicted that, "The trend towards personalized medicine will accelerate. The pressure from payers will result in more product bundling, more personalized medicine, less "blockbusterology" (fewer "one size fits all" drugs). The FDA's Critical Path Initiative will drive progress in personalized medicine/theranostics. In 2006, the big stories at FDA will continue to center on the need to make reforms that strengthen drug safety while goosing innovation-goals agency officials insist are complementary."

In 2006 the big story at the FDA, leaving aside the Crawford departure or the elevation of politics over good science, was funding. In 1988, the FDA's budget was 97% of the Centers for Disease Control and Prevention (CDC) and 8% of the National Institutes of Health (NIH). In 2006, while the FDA's budget grew, it was only 28% of the CDC's budget and 5% of the NIH's. Going backwards is a strange way to accelerate!

So how can we accelerate genetically informed approaches to promote the faster development of safer and more effective drugs, to implement new genetic tests to determine which drugs work best for people, and to provide better information on the relative risks and benefits of medicines?

Make like dolphins!

Let's go back into the conference room. Who was there this week? There was very little representation from payers, even though everyone agreed they are a critical player in new medicine. There were very few technologists - even though everyone agrees that mass information sharing and communication is critical to better decision-making. How do we get everyone involved?

The problem is that few companies or government agencies are integrating web technologies effectively. Those who are - Revolution Health, Patients Like Me, are learning from the social networking leaders - Myspace, Second Life, YouTube, Google. Like dolphins they are using the web to gather, share and act on a constant flow of complex information to improve outcomes and further progress.

The decisions we make today about the future of medicine affect our fitness as a species. We have the technology, the innovation, and the money - we just have to make the right choices. It is only advantageous to follow the choice of a few individuals if they have more information regarding the entire situation and can communicate it effectively. Like dolphins, we need to use social networking technologies to accelerate the healthcare decision-making process. We are all in one big room on the Internet - patients, payers, regulators, scientists, leaders, followers, connectors, thinkers... Let's broaden the discussion, drive a consensus, and truly accelerate the new era of personalized medicine.

Through our Personalized Medicine news channel we will continue to comment on and distribute information for fellow dolphins out there - here's this weeks PM Alert:

Personalized Medicine Roadblock Alert! The federally sponsored Healthcare Information Technology Standards Panel delivered its first set of harmonized health IT standards last month. The panel was asked to select standards for automating three common health-related activities:

  • Patient registration and medication history - the kind of information patients typically provide by filling out a paper form.
  • Rapid transmission of data from doctors and emergency rooms to support biosurveillance and help alert officials to disease outbreaks.
  • Electronic delivery of lab test results to doctors. But given changes in the house and senate and the Bush administrations ongoing unwillingness to support major federal funding for health IT federal agencies said they weren't ready to put the standards into practice.

Bring in the dolphins!

This week's events

7th Annual Somatic Cell Therapy Symposium

Dates: September 26, 2007 - March 28, 2007

Presented by International Society for Cellular Therapy
Venue: Hyatt Regency Bethesda Hotel

36th Annual Meeting ISEH Society for Hematology & Stem Cells

Dates: September 28, 2007 - September 30, 2007

Presented by the International Society for Experimental Hematology
Venue: Congress Center Hamburg


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Stem Cells Events
Personalized Medicine Events