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WEDNESDAY, SEPTEMBER 15
7:00 am Registration Open
8:00-8:30 Morning Coffee
8:25-8:30 Chairperson’s Opening Remarks
8:30-9:00 FDA Points to Consider When Planning Your Companion Diagnostic Devices
Donna Roscoe, Ph.D., Scientific Reviewer, DIHD/OIVD/CDRH, U.S. Food and Drug Administration
There are many important considerations and time-sensitive components to the regulatory process for co-development of drugs and devices. This talk is intended to provide the current perspective of the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) in the FDA’s Center for Devices and Radiological Health (CDRH) on the regulatory process for companion in vitro diagnostics, describe the types of information that companies should be prepared to provide before using the test in a Phase III trial, and insight into issues related to companion diagnostics.
9:00-9:30 Aligning Drug and Diagnostic Development Processes for a Sound Companion Diagnostic Strategy with Oncology Drugs
Miro Venturi, Ph.D., Senior Biomarker & Experimental Medicine Leader – Oncology, Pharma Research & Early Development, Roche Diagnostics GmbH
This presentation will discuss the need to generate early biomarker hypotheses and testing in EIH trials, as well as the development of appropriate tools and technologies that are amenable to quickly
transition to CoDx platforms. Considerations of timelines, pitfalls and opportunities for an early companion diagnostic strategy in oncology will also be addressed. We will also outline some case studies to illustrate the points of discussion.
9:30-10:00 Successful Partnering Strategies: Learnings from a Leading Global IVD Company
Iain D. Miller, Ph.D., Executive Director, Theranostics Strategy and Business Development, bioMerieux
The speaker will discuss bioMerieux’s strategy for successful companion diagnostic test development. The talk will discuss recent market developments and the evolving commercial landscape. Partnering and alliance management strategies will be reviewed, with reference to bioMerieux’s co-development alliances with pharmaceutical partners.
10:00-10:30 Emerging Best Practices in Developing Companion Diagnostic Tests for Clinical Trials and Commercial Launch
Brian Buxton, M.B.A., Principal, Easton Associates, LLC
Distillation of the emerging best practices from pharmaceutical and biopharmaceutical companies that have mastered the challenges of starting early enough, evaluating enough biomarkers, selecting the right partners, and including the right features in the companion diagnostic test to ensure the a high level of commercial adoption, so that the drug in a drug-test combination reaches its peak sales.
10:30-11:30 Networking Coffee Break with Poster and Exhibit Viewing
11:30-12:30 pm Drug-Diagnostic Co-Development
Moderator: Brian T. Edmonds, Ph.D., Research Advisor, Global External Research & Development, Lilly Corporate Center
12:30-2:00 Lunch on Your Own
2:00-2:30 Fulfilling the Promise of a Sequenced Human Genome
Eric D. Green, M.D., Ph.D., Director, National Human Genome Research Institute, National Institutes of Health
The Human Genome Project’s completion of the human genome sequence in 2003 was a scientific achievement of historic proportions. It also signified a critical transition, as this new foundation of genetic information started to be used in powerful ways by researchers and clinicians to tackle increasingly complex problems in biomedicine. Current efforts in genomics research are focused on using genomic data and technologies to acquire a deeper understanding of biology and to uncover the genetic basis of human disease. Together, these pursuits are moving us down an exciting path towards genomic medicine and fulfilling the promise of a sequenced human genome.
2:30-3:00 Personalized Medicine, Companion Diagnostics and Regulatory Considerations
Živana Težak, Ph.D., Associate Director for Science and Technology, Personalized Medicine/OIVD/CDRH, U.S. Food and Drug Administration
The U.S. FDA evaluates many of the products that will ultimately allow personalized medicine to be successfully implemented. This talk will focus on regulatory and scientific issues in personalized medicine, in particular on the diagnostic part, including companion and novel diagnostic devices. There are a number of approaches for clinical study designs used to evaluate companion diagnostic assays that may include specific diagnostic and therapeutic considerations. FDA faces evolving regulatory challenges for in vitro diagnostic assays, including further development of the regulatory structure for companion diagnostics and clarity on co-development issues. The talk will describe some of FDA efforts to integrate the various medical product regulatory authorities in order to improve clarity and efficiency in regulating personalized medicine products.
3:00-4:00 Networking Refreshment Break with Poster and Exhibit Viewing
4:00-4:30 Understanding the Partnering Divide: Where Rx and Dx Diverge
Mollie Roth, J.D., Corporate Counsel, Vice President, Business Development, Diaceutics; Visiting Faculty Fellow, Center for Law, Science and Innovation, The Sandra Day O’Connor College of Law, Arizona State University
A personalized or targeted therapy is not the same as a one-size-fits-all therapy, often requiring different drivers and financial metrics to ensure successful launch and adoption. Furthermore, fully integrated coordination between the two primary stakeholders involved in development of such therapies is imperative to effectively achieve these goals. This presentation will address the drivers necessary to ensure the successful launch of a personalized or targeted therapy, how to optimize resources behind those drivers and how to ensure that the optimal partnership model is put into place between the pharmaceutical and diagnostic partner to meet those goals. We will look at a suggested model of drivers necessary to ensure optimal net present value of a personalized medicine is achieved. This discussion will lay the foundation for consideration of resource requirements necessary to power those drivers to guarantee achievement of the targeted therapies goals for return on investment without loss of resource. We will then consider how these goals are best effectuated and allocated within the Rx/Dx partnership and means to provide incentives to ensure therapy targets are met.
4:30-5:30 Panel Discussion: Strategies for Drug-Diagnostic Co-Development
Brian T. Edmonds, Ph.D., Research Advisor, Global External Research & Development, Lilly Corporate Center
Miro Venturi, Ph.D., Senior Biomarker & Experimental Medicine Leader - Oncology, Pharma Research & Early Development, Roche Diagnostics GmbH
Andrea H. Lauber, Ph.D., Head, Transactions for Clinical Biomarkers and Pharmacodiagnostics, Strategic Transactions Group, Bristol-Myers Squibb Co.
Mollie Roth, J.D., Corporate Counsel, Vice President, Business Development, Diaceutics
5:30 Close of Day