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Partnerships in Personalized Medicine Conference

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Recognizing the Opportunity in Personalized Medicine Through Partnerships in the Development and Commercialization of Companion Diagnostics

 

April 12-13, 2010
San Mateo, California

 

This conference program will provide a platform for both diagnostic and therapeutic companies to come together to discuss the challenges and inherent opportunities that exist in partnerships established to enhance personalized medicine and companion diagnostics. Through case studies that highlight the successes in development, regulatory hurdles and commercialization of these companion tests, to round-table discussions that delve into specific therapeutic areas such as cancer, heart disease and diabetes.

 

Distinguished Presenters to Include

 

Chris Meda, BSc
CEO
Arcxis Biotechnologies

 

Jason Coloma
Head of Strategic Planning & Partnering
Roche

 

Andrea Lauber, PhD
Head, Technology Transactions for Clinical Biomarkers and Pharmacodiagnostics (STG)
Bristol-Myers Squibb

 

Bill Pignato
Global Head Regulatory Affairs
Novartis

 

 

Topics to Include

  • First steps in attracting pharmaceutical companies and engaging the in partnership activity
  • Co-development opportunities for companion diagnostics: Clinical, Regulatory & Reimbursement challenges
  • Bridging the gap between pharmaceutical and diagnostic perspectives on personalized medicine
  • Case studies highlighting strong relationships between Rx and Dx
  • Recognizing differences in pharmaceutical and diagnostic business models and their impact on partnering
  • Understanding what each type of organization can bring to a partnership
  • Regulations impacting genetic testing and the fall-out on personalized medicine
  • Pricing and reimbursement considerations for companion diagnostic tests
  • Reimbursement pathways for diagnostic tests being sold and marketed with therapeutics
  • Regulatory guidance impacting new molecular diagnostic testing
  • Contracting and IP protection, making the most of internal assets
  • Clarification on CLIA waivers and MIA; pathways impacting diagnostics
  • Utilization of companion diagnostics in the clinical setting
  • Global regulatory and commercialization considerations
  • Best practices in establishing strong partnerships with pharmaceutical companies
  • Working with universities to further R&D efforts and technology transfer considerations
  • Establishing a high level of clinical utility for new and existing products

 

For more information please contact:
Paul Hernandez, Marketing Manager
phernandez@Q1productions.com
312-602-9684