Precision Medicine: Developing Companion and Complementary Diagnostics in an Evolving Regulatory Environment
Menlo Park, CA
Hogan Lovells Office, 4085 Campbell Ave. #100, Menlo Park, CA
Precision Medicine: Development Companion & Complementary Diagnostics in an Evolving Regulatory Environment
As the U.S. healthcare system seeks to improve outcomes, while simultaneously decreasing cost, the ability to precisely target therapeutic approaches becomes increasingly important. Whether by leveraging the expanding knowledge of genomics and proteomics, or through development of novel biomarkers that predict response to therapeutic tools, precision medicine holds the keys to unlocking these target goals.
On April 27, members of our FDA and Health regulatory teams will lead a discussion on several of the key legal and regulatory considerations that commonly arise in relation to development of “personalized” or “precision” medicine tools.
During the program, our team will cover:
- FDA regulatory considerations when co-developing companion and complementary diagnostics with therapeutic products, including a discussion of recent guidance documents on this topic.
- The impact of companion and complementary tests on the development of novel advanced therapy, stem cell, and regenerative medicine products.
- Regulation of labs conducting companion/complementary diagnostic assays.
- Coverage and reimbursement considerations when developing companion/complementary diagnostics, and developing the type of data that payers are looking for in making coverage determinations.
Following the program, you will have the opportunity to network with other companies in this space over cocktails and hors d’oeuvres in our courtyard.
- Robert F. Church, Partner, Los Angeles
- Yarmela Pavlovic, Partner, San Francisco
- Michael N. Druckman, Partner, Washington, D.C.
- Randy J. Prebula, Partner, Washington D.C.
- Brooke Bumpers, Counsel, Washington D.C.
- Jon Layman, Partner, San Francisco, Silicon Valley