INDIANAPOLIS, IN--(Marketwired - May 7, 2015) - Pharmaceutical regulatory policy experts will discuss how to prepare for and implement game-changing Food and Drug Administration (FDA) policy initiatives at a conference May 20, 2015, from 8:30 am - 10:30 am EDT, at the Mandarin Oriental Boston. The conference is organized by YourEncore (www.yourencore.com), a company that helps firms in the life sciences, consumer productsand food sciences industries solve complex innovation, compliance and productivity challenges. Click to Tweet.
Regulatory R.A.N.T: Relevant Assessments, New Trends will feature a panel of policy insiders and key influencers, including former FDA and pharmaceutical executives:
- Tim Franson, M.D., chief medical officer for YourEncore, board member for the Critical Path Institute, and president of the USP Convention. Dr. Franson co-authored the first patient advocacy-initiated guidance for a rare disease, which was submitted to the FDA in 2014.
- Joe Lamendola, Ph.D., the former vice president of regulatory sciences for Bristol-Myers Squibb, who is responsible for more than 16 global approvals across 10+ therapeutic areas.
- Peter Pitts, the former Associate Commissioner at the FDA, president of the Center for Medicine in the Public Interest, and the founder of drugwonks.com.
Members of this panel helped shape PDUFA II, III, IV and V, and briefed Capitol Hill staff on various provisions of the act. These experts will share their best thinking on what is coming and how both large and small pharma companies can prepare. Topics will include both the strategic and operational implications of:
- PDUFA VI: Renewal, Revival or Retreat?
- 21st Century Cures
- Biosimilars, Bioidenticals or Biobetters?
- FDA Commissioner Leadership Transition: Who and When?
- New Pathways
The conference is free and targeted to pharmaceutical executives and regulatory/policy leaders in both large and small pharma companies. For more information and to register go to http://yourencoreevents.com.
Indianapolis-based YourEncore, an Inc. 5000 company, helps companies in the life sciences,consumer products and food industries solve complex innovation, compliance and productivity challenges by deploying highly-experienced and immediately effective experts.YourEncore experts, which include MDs, PhDs, executives and practitioners, have on average 25 years of experience and are behind many of the most successful products on the market. In addition to advisory services, the company also offers the resources to act on its recommendations. Founded in 2003, YourEncore today works with 12 of the 15 leading global pharmaceutical companies and four of the six top consumer care companies. For more information, visit www.yourencore.com and follow us on Facebook and LinkedIn.