Wednesday, September 19
7:30-9:00 am Registration for Pre-Conference Workshop
9:00-9:15 Chairperson’s Opening Remarks
9:15-9:40 Lessons Learned in the Development of Companion Diagnostics
Theo McCormick, Director, RxDx Services, Management Science Associates, Inc.
Navigating the scientific, medical, regulatory, contractual and political interactions and dynamics between health care professionals, the clinical laboratory, drug manufacturers, IVD diagnostic kit manufacturers and health plans are essential for optimal uptake of drug-diagnostic companion products. Those early decisions in the development cycle have complex downstream impact. This session will map out the trouble spots and potential effects of those decisions.
9:40-10:05 Strategies for Companion Diagnostic Development and Commercialization: Perspectives from a Global IVD Leader
John F. Beeler, Ph.D., Director, Theranostics and Business Development, bioMerieux
The drug development process is witnessing a paradigm shift in which new therapies need to be tailored to well defined patient sub-groups via a companion diagnostic assay. With several theranostics partnerships in place at bioMerieux, the speaker will address the challenges of co-development programs and discuss strategies to achieve successful commercialization of these IVD products.
10:05-10:30 The Business of Successful Companion Diagnostic Partnerships
Kathryn B. Becker, Ph.D., Director, Companion Diagnostics and Global Marketing, Abbott Molecular
The business aspects of creating a successful companion product will be discussed. Pharma and IVD manufacturers have the need to engage in efficient partnerships in order to drive specific but flexible and timely health care solutions. Until recently, the "opportunistic" partnering model has prevailed, but will this give way to alternatives as the CDx market continues to grow exponentially? This talk will focus on collaborative partnerships that drive results and models for successful development and market acceptance.
10:30-11:00 Coffee Break
11:00-11:25 Adding a New Indication to an Approved Companion Diagnostic: How Hard Can It Be?
Hans Christian Pedersen, M.Sc., Department Manager, Research & Development, IHC pharmDx, Dako Denmark
HercepTest was originally developed and FDA approved as a pharmacodiagnostic test to determine breast cancer patients’ HER2 status in order to assess eligibility for Herceptin (trastuzumab). An sPMA was approved by the FDA in 2010 extending intended use for HercepTest to include gastric cancer and GE junction cancer. This talk will go over the development, approval and launch of HercepTest for gastric cancer.
11:25-11:50 Design of Drug Clinical Trials Incorporating a Companion Diagnostic
Sabah Malek, Senior Regulatory Scientist, IVD/Medical Devices, Voisin Consulting Life Sciences
Designing clinical trials, undoubtedly a key part of drug development, is challenging enough, which makes the addition of companion diagnostics an obstacle that some drug developers hesitate to face as they do not know how to proceed. The FDA has provided guidance on the optimal way to coordinate and design a clinical trial of a targeted therapeutic with a companion diagnostic; however, this is often not easily feasible in practice. This presentation will describe when and how a companion diagnostic should be included in drug trials. It will also cover meeting coordination with agencies and description of case studies.
12:00-1:00 pm Luncheon Technology Showcase (Sponsorship Opportunities Available)
Contact Ilana Quigley at email@example.com or 781-972-5457
Partnering Strategies in Drug-Diagnostic Co-Development
1:00-1:25 Personalized Healthcare: Innovation Partnering for the Future
Cecilia Schott, Pharm.D., M.B.A., Executive Business Development Director, Personalized Healthcare, AstraZeneca
The pharmaceutical industry is increasingly investing in personalized healthcare (PHC), and has projected that drug treatments developed with a PHC strategy will comprise greater that 50% of their pipelines. The influence of new stakeholders, demands from regulators, payers, advocacy groups to mention just a few, add to the complexity to global medical practice. PHC deals cover a wide range of collaborations from biomarker discovery and test assay development through the commercialization of companion diagnostics. Collaborations between pharma and diagnostic companies are becoming increasingly more complex. Flexible negotiations will result in deals that are structured to be mutually beneficial, creating incremental value through customized approaches to achieve common goals.
1:25-2:30 Panel Discussion
Moderator: Cecilia Schott, Pharm.D., M.B.A., Executive Business Development Director, Personalized Healthcare, AstraZeneca
- John F. Beeler, Ph.D., Director, Theranostics and Business Development, bioMerieux
- Kathryn B. Becker, Ph.D., Director, Companion Diagnostics and Global Marketing, Abbott Molecular
- Hans Christian Pedersen, M.Sc., Department Manager, Research and Development, IHC pharmDx, Dako Denmark
- Finley Austin, Ph.D., Personalized Healthcare and Biomarker Strategy Director, AstraZeneca
- Anjan Thakurta, Ph.D., Senior Director, Translational Development Integration, Celgene
- Christine Gathers, M.S., RAC, Senior Director, Global Regulatory Affairs, Diagnostics, Eli Lilly and Company
- Sushma Selvarajan, Ph.D., Head, Business Development and Strategy, Roche Molecular Systems
Discussion topics include:
- What factors influence the pharma’s choice of diagnostic partner (including IP considerations, diagnostics platform requirements, commercialization capabilities, etc.)?
- What are the advantages for pharma to develop in-house diagnostics vs. partnering with Dx companies?
- How to navigate the regulatory landscape for Rx-Dx co-development? What strategies can expedite approval of Rx-Dx product? What additional regulatory guidance is needed?
- What are the strategies to develop biomarker clinical development programs that lead to companion diagnostics? How to get both partners involved at early stages of drug development?
- What makes a diagnostics company an attractive partner for co-development partnership? What are the benefits of IVD manufacturing capabilities and CLIA laboratory infrastructure in potential Dx partners?
- What are the different collaboration models in Rx-Dx co-development and what are the strategies in negotiating a successful collaboration agreement?
- What are the risks and benefits to both partners in the Rx-Dx co-development partnership? What strategies can minimize the risk for the Rx-Dx product development?
- What are the requirements from the diagnostics partner in assay development and validation?
- What are the strategies to get buy-in from payers, physicians and patients?
*Separate Registration Required