Business Roundtable
A Primer on Post Approval Regulatory and Reimbursement Issues
Wednesday, February 13, 2008
9:30 AM
Duke of Windsor
The goal posts are moving with new requirements for post-marketing studies under REMS (Risk Evaluation and Mitigation Strategy) and it seems like the reimbursement landscape is changing on a daily basis. When does an emerging biotechnology company dial these issues into their strategy? How will they affect timing, uptake and profitability of a new drug launch?
Moderators
- David Blazczak; Sr Vice President, Policy Research, Stanford Group Company
Panelists
- Jayson Slotnik, Hogan & Hartson LLP
- Sandra Dennis; Biotechnology Industry Organization (BIO), Deputy General Counsel, Healthcare Regulatory Affairs (BIO)
- Mike McCaughan; Senior Editor, RPM Report
Who's Who
Mr. Blaszczak specializes in the area of medical technology policy issues for Stanford Group Company's Policy Research, which provides political, economic and industry research for institutional and corporate investors. Prior to joining Stanford Policy Research, Mr. Blaszczak worked in the Office of the Administrator at the Centers for Medicare and Medicaid Services. He worked on the implementation of the Medicare Modernization Act working with key Administration officials. In addition, Mr. Blaszczak has prior experience with State government and the health insurance industry. He has earned a bachelor?s degree in Health Administration and a master?s degree in Public Policy from the University of Maryland, Baltimore.
Jayson Slotnik?s practice focuses on health care regulatory issues, with an emphasis on coverage, coding and reimbursement for devices, diagnostic tests, drugs, and biologicals under all parts of Medicare. Prior to joining Hogan & Hartson, Jayson was Director of Medicare Reimbursement and Economic Policy at the Biotechnology Industry Organization in Washington, D.C. where he represented the industry in front of the Centers for Medicare and Medicaid Services, U.S. Congress, and other regulatory agencies. Jayson counseled companies of all sizes on an appropriate reimbursement strategy. Before that, he spent several years as a health care regulatory associate where he focused on legal, regulatory, and federal legislative issues arising under Medicare, Medicaid, and the Federal Food, Drug and Cosmetic Act, and functioned as regulatory counsel to managed care organization operating in nine states. While attending law school, Jayson served as a judicial clerk for the Honorable Charles Day on the U.S. District Court for the District of Maryland. He also interned at the National Cancer Institute, National Institutes of Health where he drafted memoranda and reviewed licensing agreements on behalf of branch scientists.
Sandi Dennis is the Deputy General Counsel for Health Care Regulatory Affairs at BIO. She joined BIO in January in January 2007, having been a partner in the FDA/Healthcare practice of Morgan Lewis & Bockius, LLP since 1998, and a partner at Fox, Bennett & Turner previously. Ms. Dennis has a long history of counseling corporate and nonprofit entities on regulatory and compliance matters, and has worked extensively on FDA and healthcare policy and legislative matters affecting the research, development and marketing of drugs, biologics, foods and medical devices. At BIO, she provides legal counsel on a broad range of FDA and CMS regulatory matters, as well as legislative issues including drug safety and follow-on biologics. Ms. Dennis received her B.A. in journalism from the Pennsylvania State University in 1978 and her J.D. from the University of South Carolina in 1984, following a brief career as a television news reporter in Columbia, South Carolina.
Michael McCaughan, senior editor of The RPM Report, is the former Editor-In-Chief of "The Pink Sheet," the leading news publication for the pharmaceutical industry. He frequently speaks at prominent health care conferences on FDA and CMS policies and how they impact the pharmaceutical industry.