Personalized medicine has been viewed as the future of medicine in the pharmaceutical world since the development of advanced diagnostic tests that rely on information from the completion of the Human Genome project in 2003 and is expected to increasingly impact drug development and delivery. Yet, much of the pharmaceutical industry is slowly breaking into the market. Early personalized medicine initiatives by pharmaceutical companies have included partnering with diagnostic companies to develop in vitro companion diagnostic devices for their drug products as well as initiatives to develop companion diagnostics in-house. Many of the companies that have pursued such endeavors have done so somewhat cautiously, while others are watching from the sidelines.
Amid calls for greater clarity on the regulatory challenges related to companion and co-developed diagnostics, the FDA has begun to focus on this dimension of personalized medicine. In July 2011, it published the first of several planned guidance documents on “high-risk” companion diagnostics intended to direct the use of novel therapeutics. While this guidance promises to provide a roadmap for review, approval and labeling of companion and co-developed diagnostics, the space is still developing and much uncertainty remains regarding other key dimensions of the FDA’s overall regulatory approach to personalized medicine.
At the same time, meaningful changes affecting personalized medicine in other applicable legal and regulatory realms -- Medicare reimbursement policy, intellectual property, and federal and state privacy and security – are evolving, introducing development and implementation planning challenges..
How can companies make sense of this dynamic environment?
Join us for this interactive 90-minute webinar to discuss the current landscape and future of personalized medicine and companion diagnostics with Bernadette M. Broccolo, a partner in the Health and Life Sciences Industry Advisory Practice of McDermott Will & Emery LLP, who specializes in the legal and regulatory dimensions of leading-edge personalized medicine initiatives.
Learning Points:
- Overview of the field of personalized medicine and current in vitro companion diagnostic device development regulatory challenges and opportunities
- Discover who is doing what, why and how, and what business models are emerging from the initiatives of pharmaceutical and diagnostic companies
- Understand key legal and regulatory compliance considerations that will affect the strategic and financial planning for personalized medicine initiatives
- Learn about evolving and anticipated changes on Capitol Hill
Who Should Attend:
- General/corporate counsel
- Compliance officers
- Regulatory/legislative affairs professionals
- Risk-management specialists
- Executive management
- Sales/marketing personnel and management
- Medical science liaisons
- Strategic planning and business development staff
Speaker's Biography:
Bernadette M. Broccolo is a partner in the Health Law Department of McDermott Will & Emery LLP. She has been counseling health industry organizations for 32 years. She also currently serves as chair of the Life Sciences Division of the firm’s Health Law Department and as co-chair of the Personalized Medicine Team. Bernadette advises clients on leading-edge health industry relationship formation and realignments, health information technology acquisitions, and electronic data warehouses and tissue repositories to support translational research and personalized medicine. Bernadette has been named as a Fellow of the American Health Lawyers Association. For more than 20 years, she has been included in The Best Lawyers in America for her expertise in health care law and was named Chicago Health Lawyer of the Year by The Best Lawyers for 2010. She has also been named for several years as an Illinois Super Lawyer to the Leading Lawyers Network. Bernadette earned her J.D. from the University of Notre Dame Law School and her undergraduate degree from Boston College.
