Companion Diagnostics in Personalized Medicine – Keys to Reliability and Success



January 20, 2011
11:30 a.m. to 1:30 pm EST


Course Description:
The desire for a more precise, personalized approach to patient care decisions is heard from pharmaceutical companies with new products and from regulators, both wishing for safer and more effective products. Payers look to cost effective and clinically effective treatments that reduce needless spending, and patients simply want to get better. In many cases, diagnostic company innovation holds the key to many of these wishes. This symposium will discuss evolution of the companion diagnostic environment, with a particular eye on issues affecting what seems to be an intuitively obvious win-win for everyone.

Learning Objectives:

  • Provide a fundamental review of need and issues of Rx-Dx collaborations
  • Offer examples of current experience with tests in “broad use”
  • Provide perspectives from both sides, including potential collaboration models
  • Discuss market development and pre-launch strategic challenges


Who Should Attend:

  • Manager- Director level pharma staff interested in basic primer on companion diagnostics and how it can affect their commercial responsibilities
  • Manager-Director level diagnostic company  staff looking to better understand how connections to the pharma industry will impact new diagnostic products


Instructor Biography:
Charlie Raffin, Partner, CJR Advisors, L.L.C., a consultancy specializing in commercial strategies associated with the promise of Personalized Medicine

Charlie Raffin provides a deep array of business acumen. His background includes 15 years in biopharmaceuticals and nearly 20 years in clinical diagnostics. After starting out as a Hematology and Blood Bank Supervisor, he transitioned to industry 30 years ago, producing award winning performances in Sales, Marketing and Business Development at numerous levels in both drug and diagnostic product groups in the Johnson & Johnson Family of Companies.  He has held a wide variety of Manager, Director and Vice President positions in 5 different operating units of J&J.

Charlie's experiences have created strategic commercial expertise in oncology, hematology, anemia management, capital equipment for labs, blood typing and transfusion safety, point of care devices, molecular diagnostics, organ transplantation, OB-GYN, HIV, and cardio-metabolic disease diagnostics.  He has covered several diagnostic product areas, as well as provided significant leadership work in worldwide biopharmaceutical sales & marketing for Erythropoiesis Stimulating Agents (EPO), organ transplant rejection and Rh Immune Globulin.  Included has been involvement with products at every stage of lifecycle, including earliest product concept assessments, line extension strategies, and several product launches (and recalls) in both domestic and international environments.

Charlie has been an invited advisory board member and speaker at several industry events.  He has conducted multiple market research initiatives and Payer Advisory Boards, presenting and moderating Opinion Leader debate.  Of recent, he is utilizing his unique combination of backgrounds to help understand the promise of personalized medicine - where companion diagnostics enable more effective drug selection decisions.
Charlie holds a Bachelor of Science Degree in Medical Technology from Wayne State University and an MBA from The University of Michigan.  He retired from Johnson & Johnson in 2010 as Vice President, Commercial Assessment, Worldwide Franchise Development. 

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