BayBio Lunch & Learn: Strategic Considerations for Companion Diagnostics
One of the hottest areas for drug development is companion diagnostics, or personalized medicine more generally. Both device and diagnostic companies are increasingly leveraging molecular and genomic diagnostics to design products that offer the most benefit and least side effects for patients. But developing and commercializing a diagnostic assay, or a corresponding therapeutic, requires an in-depth understanding of numerous legal and strategic issues.
This session will provide attendees with strategic insights on key issues for companion diagnostics. The program will provide a cross-disciplinary approach, addressing FDA regulatory policy, intellectual property considerations, and strategic issues for collaboration transactions involving the development and commercialization of companion diagnostics.
This program will address the following key issues for companion diagnostics:
- FDA Regulatory Considerations: It is critical to understand how FDA regulates companion diagnostics, in order to develop a coherent regulatory strategy. While historically FDA regulated companion diagnostics on a case-by-case basis, in recent years the agency’s policies have become more rigid and formalized. The presenters will discuss key challenges in pursuing a parallel drug/diagnostic development strategy, using real world examples and scenarios based on experience advising both diagnostic and pharmaceutical companies.
- Recent IP developments: Ensuring robust patent protection is critical to any development strategy. However, as a result of several recent court decisions, securing patent protection for diagnostic assays and corresponding therapeutic products has become complex. Moreover, the IP landscape could shift again in the future. For example, the Supreme Court is expected to address the patentability of human DNA sequences in the pending Association for Molecular Pathology v. Myriad Genetics case. The presenters will provide an overview of the key issues for patenting diagnostic or therapeutic products, and insights on the potential impact of future legal changes.
- Strategic Issues for Companion Diagnostic Collaboration Transactions: Collaboration transactions between drug and device companies arise in a range of contexts and raise a host of important issues for consideration. The presenters will provide highlights with respect to recent deal activity in this space and overview key transactional considerations, including timing considerations, compensation arrangements, expected exclusivity commitments, and the implementation of terms to ensure coordinated supply and commercialization activities to support the combination use of the companion diagnostic and therapeutic products in relevant markets.
- Kurt Calia, Partner, Covington & Burling LLP
- Scott D. Danzis, Partner, Covington & Burling LLP
- Emily Leonard, Partner, Covington & Burling LLP
BayBio Lunch & Learn:
June 6, 2013
HCP/BayBio Event Center
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