December 10 @3:30-5:00pm

Panel III - Drug-Diagnostic Co-Development and Partnerships in Personalized Medicine

• From the Dx company perspective:
  • when should the Dx company become involved in the pharma project? Why then and not later? What does the Dx company bring to the pharma company at each stage of development? What does it need from the pharma company to be an effective partner?
• From the pharma company perspective:
  • when should the Dx company become involved in the project? Why then and not sooner? What does the pharmaco need from the Dx company?
• What is the latest stage of Rx development that the Dx company can begin test development without delaying the NDA filing? Is this compatible with development of non-oncology drugs? How can the co-development timelines for e.g. neuro drugs be accelerated?
• Will co-development require additional clinical trials? Larger clinical trials? How can these be planned?
• What is the appropriate role of the Dx partner in the drug phase III pivotal trials? What Dx assay can be used? Can data be bridged between a non-regulated test and an RUO/IUO to IVD approval? Is data specific to the device regulatory submission (i.e. data that wouldn't ordinalrily be generate for the drug NDA) necessary from the pivotal clinical trial?
• How should the co-develoment partners approach the FDA? EC?
• In business deals:
  • How can Dx handle the risk of failure of the co-developed drug? How can this be factored into a Dx-pharma deal?
  • Should a deal be exclusive? What are the pros and cons for Dx? for pharma?
  • How is test distribution and marketing controlled? Whose hands are on the steering wheel?
• How does the emphasis on PMA approval for Companion Diagnostics affect the competitive landscape?
  • What are the risks/benefits to pharma?
  • Risks/benefits to the diagnostic industry?
  • Risk/benefits to the laboratory industry?

Moderator:
Brian Spear, Ph.D., Director of Pharmacogenomics, Abbott Laboratories

Panel Participants:
Glenn Miller, Ph.D., VP and General Manager, Genzyme Analytical Services
Andrea Lauber, Ph.D., Head, Tech Transactions for Clinical Biomarkers & Pharmacogenomics, Strategic Transactions Group, Bristol-Myers Squibb
Cecilia Schott, PharmD., MBA, Business Development Director, Personalized Healthcare, Strategic Planning & Business Development, AstraZeneca
Carol Berry, MBA, Vice President / General Manager, Pharmacogenomic Services, Asuragen Inc.
Prof. Hartmut Juhl, Ph.D., Chief Executive Officer, Indivumed GmbH and Inostics GmbH, Germany