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Trilogy Tidings
July 2009
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in this issue
Understand the Economics of Your Clinical Method
CER Priorities from the Institute of Medicine
Combination Products
Do Medical Devices and Diagnostics Rule?
Resources from our Archives
What does Trilogy do?
     Potpourri this month: A sampling of some recent work and published items that are worthy of your attention.

     To my American clients, colleagues and friends: Happy Independence Day!

     Carry on, and remember: Refuse to participate in the recession!

Regards,
Joe

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Understand the Economics of Your Clinical Method 
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     Following my warnings last month about the lurking impacts of Comparative Effectiveness Research (CER) and its inevitable linkage to cost effectiveness, I developed a generic outline of a process for comparing clinical methods on an economic scale.  You might find this outline useful as a roadmap in understanding and communicating your product's economic value to a target audience (practitioner, institution, payer or society) as a complement to its clinical value.
 
     There are certainly many ways to think about this issue; I'd be pleased to hear yours.
CER Priorities from the Institute of Medicine
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     And, on the subject of CER, the American Recovery and Reinvestment Act of 2009 called on the Institute of Medicine to recommend a list of priority topics to be the initial focus of a new national investment in comparative effectiveness research.  The IOM came up with a list of 100 topics, grouped by priority into four sets of 25.  I think we can be confident that many, if not all, of the top 25 topics will be funded and addressed.
 
     I took special note of the following highest-priority items that could influence your strategies and future success:
  • Treatment strategies for atrial fibrillation (surgery, catheter ablation and drugs) 
  • Upper endoscopy for gastroesophageal reflex disease (GERD)
  • Screening, prevention and treatment of MRSA
  • Reduction of healthcare associated infections (HAIs), especially those related to central lines
  • Management strategies for localized prostate cancer
  • Imaging technologies applied to diagnosing, staging and monitoring patients with cancer
  • Genetic and biomarker testing applied to the prevention and treatment of cancer 

Thoughts to share?

 
Combination Products
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     I've been interested in the future of combination products - the most common example being the drug-eluting stent - for some time.  There are a great many possibilities, some real and some ethereal.  A recent article in MD&DI does a nice job of summarizing the categories of such products and raising some not-so-obvious impacts on partnering relationships and clinical trials.  I'm especially intrigued by three kinds of combinations:
 
  • Polymers impregnated with drugs or biologics
  • Localized drug delivery
  • Ingestible electronics for medication tracking and physiological monitoring

     That last one is a little "out there", but you never know!

 
Do Medical Devices and Diagnostics Rule?
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     Steven Burrill, the life science investor and analyst, is always an interesting read.  His interview, recently published in Life Science Leader, a new trade magazine, includes the following remarkable exchange:
 
Interviewer
: "You run a venture firm that invests almost exclusively in life science companies.  What existing or emerging technologies would you recommend for investment?"
 
Burrill
: "Historically, the life sciences industry has relied on revenue from high-value-high-margin therapeutics (Rx) and lower-value-lower-margin medical devices and diagnostics (Dx).  However, with healthcare reform going forward and the changes in science that allow us to move closer to a personalized, predictive, and preventative medicine world, there is going to be a reversal in the Rx/Dx value proposition - that is, I believe Dx rather than Rx will drive future profitability in the life sciences sector.   In the future, the Rx business will be transformed from a high-value-high-margin into a high-volume-low-margin proposition, whereas the Dx side of the business will change from a high-volume-low-margin to a high-value-high-margin opportunity."
 
     We report, you decide. 

Thoughts to share?

 
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.

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