SOURCE: INC Research

INC Research

June 27, 2011 15:58 ET

INC Research Sponsors FierceBiotech Clinical Insights Executive Breakfast on Crafting a Regulatory Strategy for Biotech

Regulatory Veterans Participate in Roundtable Discussion on the Latest Issues Facing Drug Developers in Obtaining FDA Approval

WASHINGTON, DC--(Marketwire - Jun 27, 2011) - INC Research, LLC, a therapeutically focused contract research organization (CRO) with a trusted process for delivering reliable results, is the lead sponsor of FierceBiotech's Fierce Clinical Insights Executive Breakfast: Best App in Town: Crafting a Regulatory Strategy for Biotech on Wed., June 29, from 7:00 a.m. - 8:30 a.m., held at the Grand Hyatt in Washington, DC.

This event will provide valuable insight for biotechs looking for guidance in obtaining FDA approval. FierceBiotech Editor-in-Chief John Carroll will moderate the roundtable discussion featuring regulatory veterans from AstraZeneca, Sanofi-Aventis, Human Genome Sciences, Biogen Idec, and Acorda.

Executives will discuss how drug developers can craft the best new drug applications for the FDA and provide key strategies like priority review, fast track status and Special Protocol Assessments to help improve development efficiencies and increase the odds of a successful regulatory review at the end of the process. They will also offer their guidance on how developers can tap officials at the FDA for more insight into the kinds of data that are likely to satisfy staffers as well as the critical advisory committees that can dictate the success or failure of a drug development program.

The unique format of the event provides attendees with an opportunity to exchange their ideas with experienced regulatory executives about the latest issues facing today's drug developers as they navigate the challenges involved in obtaining FDA approval.

To register for FierceBiotech's Fierce Clinical Insights Executive Breakfast, click here.

For more information on INC Research's strategic and regulatory consulting services, click here.

About INC Research, LLC.
INC Research is a therapeutically focused contract research organization with a high performance reputation for conducting global clinical development programs of the highest integrity. Pharmaceutical and biotechnology companies look to INC Research for a complete range of customized Phase I through Phase IV programs in therapeutic areas of specialty, and in innovative pediatric and women's health trials. The company's Trusted Process® methodology and therapeutic foresight lead customers to more confident, better-informed drug and device development decisions. INC Research is headquartered in Raleigh, NC. For more information please visit or follow us at @inc_research.

Contact Information