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