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Trilogy Tidings
August 2011
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in this issue
A Radical Proposal for Drug Approvals
Assessing Commercial Opportunities for New Products
Breaking News on FDA's 510(k) Program
Resources from our Archives
What does Trilogy do?

     Our heat wave persists, my workload threatens, a vacation intrudes (not really a problem), so time is short for writing this monthly brief. But I soldier on.

 

     Two items -- one new, one old. Both rather interesting and potentially important. Read on.

 

Regards,
Joe

   Change Ahead

 

A Radical Proposal for Drug Approvals
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Drug ApprovalsSeveral months ago I made an offhand suggestion in this communiqu� that medical device regulatory approvals could be greatly eased without compromising patient safety simply by having FDA require proof of safety but allowing clinicians to establish product efficacy over time. This would be a combined regulatory and market-based approach. I think the scheme could actually be made to work, but the howls of many patient advocates would be deafening indeed.

 

     Now, I dare not claim that they appropriated my idea -- after all, ideas are everywhere and untrackable -- but Michele Boldrin and S. Joshua Swamidass of Washington University published an opinion piece in the Wall Street Journal on July 25 touting a rather similar notion. I've quoted the essence of their idea from the article:

"We can reduce the cost of the drug companies' bet by returning the FDA to its earlier mission of ensuring safety and leaving proof of efficacy for post-approval studies and surveillance. It is ensuring the efficacy -- not the safety -- of drugs that is the most expensive, time-consuming and difficult. All the usual mechanisms of ensuring the safety of drugs would remain firmly in place. In exchange for this simplification, companies would sell medications at a regulated price equal to total economic cost until proven effective, after which the FDA would allow the medications to be sold at market prices. In this way, companies would face strong incentives to conduct or fund appropriate efficacy studies."

     I recommend the article to your attention. Its title is "A New Bargain for Drug Approvals". You can read it online with a WSJ online subscription.

     Interesting idea? You bet. Could it work? Just like mine, I think so. Does it have any chance of adoption? Unlikely, but you decide!

 

Assessing Commercial Opportunities for New Products 
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New ProductsI do opportunity assessments for medical product suppliers, among other things. (The other things include negotiating with my wife and adult children, negotiating with business associates, tolerating the talking heads and our ship of fools in Washington, and serving as an overworked secretary in my office.)

 

     So, given my time crunch this month, I decided to recycle a piece I wrote a decade ago about how to properly conduct opportunity assessments for greatest benefit. I then started work on updating the article. Lo and behold, I found it nearly perfect as is! Aside from being a bit dated on the subject of U.S. healthcare, this stimulating piece fits as well today as it did in 2001. Great literature prevails! Check it out here.
Breaking News on FDA's 510(k) Program 
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MassDeviceThe Institute of Medicine (IOM) has finally issued its report on the 510(k) program for medical device clearances.  It recommends scrapping the program and starting over!  The IOM took 22 months to reach its conclusions, yet provided very few specifics to guide future FDA action.  Read a news item here.

     Just what patients, suppliers, clinicians, and regulators need right now: More uncertainty! 
Resources from our Archives 
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     Check out our Reading Room to view my published articles, presentations and white papers on a variety of topics.

 

     And, you can examine an archive of my prior newsletters (since February 2007).

 

What does Trilogy do? 
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     Trilogy Associates facilitates business growth and renewal through commercialization of new products, providing the following services:
  • Opportunity assessment
  • Business planning and enterprise growth strategies
  • New-product conceptualization, commercialization and marketing
  • Market research and competitive assessment
  • Business development and partnering
  • Market and technological due diligence
  • Assessment of the therapeutic and diagnostic potential of novel technologies
  • Design of efficient and effective development strategies for early-stage biomedical products
  • Business and technical writing/publishing

     Inquiries to establish whether and how we might support your business initiatives are always welcome.  Contact us.  And check out our partner, Innovalyst, A Catalyst for Innovation.

Contact Information
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ContactInfoJoseph J. Kalinowski, Principal
919.533.6285
LinkedIn Profile: www.linkedin.com/in/trilogy
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