Webcast
FDA Drug Approval and U.S. Market Access Trends: A 2011 Assessment
Tuesday, October 11, 2011 at 10:00 a.m. EST
Thursday, October 13, 2011 at 2:00 p.m. EST
Please join PAREXEL Consulting for a complimentary one-hour webinar on the detailed findings from our proprietary analysis of new drug review outcomes and trends within the FDA's Center for Drug Evaluation. By combining brand new data that we have obtained from the FDA and our own tracking analysis, we can provide you with unique information in a way that is simply otherwise unavailable. We will also provide an update on the Reimbursement & Market Access landscape and discuss how to align your commercialization efforts with your development strategy.
Speakers:
Mark P. Mathieu
Director of Strategic Research
PAREXEL Consulting
Charles A. (Chuck) Stevens, JD, MBA
Vice President & General Manager, Commercialization Strategy
PAREXEL Consulting
Our webinar will focus on:
CDER-level trend data (through April 1, 2011):
- 1st cycle review outcomes for NMEs and NDAs
- 1st cycle review outcomes for new drugs by priority/standard designation
- Shifting trends in the granting of priority review designations
- Pending NDA workloads at CDER and divisional levels (NDA submission trends by CDER and division level)
Commercialization:
- Engaging regulators and payers to create an enhanced clinical development strategy
- Review of patient access hurdles
- Developing economic modeling - pricing, contracts, cost effectiveness / utility
- Understanding the importance and value of the AMCP/Global dossier
Having performed Executive Briefings on these trends at a number of leading companies, the PAREXEL Consulting team is confident that its data will provide new insights into the state of the FDA new drug review and approval process as well as help you benchmark your own regulatory efforts against the rest of industry both at a center-wide and, more importantly, on a divisional-level basis.
This event is free of charge for members of the biopharmaceutical industry.