Tuesday, August 24, 2010

Drug Development Strategies: Planning a Successful Clinical Development Program

"It is inappropriate to modify prespecified endpoints after results of the studies are known.”
--FDA Reproductive Health Drugs Advisory Committee, June 18, 2010.

After 15 years of research, a high-profile compound was recently rejected by an FDA Advisory Committee. It did make clinically and statistically significant improvement of one important endpoint--just not the one FDA requires.

But it doesn’t have to be this way.  While there is no drug R&D crystal ball, the right development strategy will help you successfully navigate the approval process, and take your drug on the shortest route to your customers. 

In this 90 minute webinar, William Sietsema, Ph.D. will show how to reverse engineer your drug development process, providing the steps proven to minimize approval risks, and prevent delays to market.  

After this program, you will know:

• The 13 components of clinical development plans—what is essential, and where most organizations err in the process
• How to reverse engineer a clinical development program, beginning with label claims and working backwards to study designs
• Insight to be gleaned from research guidance documents and prior development programs
• How to project overall clinical program timing and costs

William will also answer your team's questions in the Q&A session.

Who should attend...

• Pharma and biotech executives
• Clinical trial and outcomes research developers
• Research and development professionals
• Corporate strategists and decision-makers
• Business development
• Approvals and submissions staff

For one low price, you and your entire team from one location can take part in this fast-paced, insightful webinar. Best of all, you'll be able to connect personally with our panelists when we open up the phone lines for live Q & A.

SPEAKER

Webinar Details

DATE: Tuesday, August 24, 2010
TIME: 1:00 PM ET • 11:00 AM MT • 10:00 AM PT
DURATION: 90 Minutes

Benefits

What does registration get me?

• One (1) phone line, for you alone, or around which to gather your team(s). Toll-free in the U.S. only.
• One (1) password to a website on which you'll be taken through the presenters' slides as they speak to them.
• An interactive Q&A round with speakers by phone and electronic submission.
• The insight you've come to expect and respect from Elsevier Business Intelligence and our guest speakers.

• Convenience—and lower cost. Your entire team can listen in one room. No travel required!
• A team approach. You've often wanted to have everyone on your team getting the same knowledge and insight you derive from physical conferences. Now you can.
• Interactivity. You're remote, but not removed. Our webinars let you ask the important, burning, controversial questions of our speakers that you'd be able to pose at a physical conference.
• Flexibility. Want to be able to review what you learn? No problem ... just register for the live webinar PLUS a digital copy of the entire event to listen to at your convenience. Interested in the topic but have a scheduling conflict? Don't worry — the recording is available for purchase at any time

SUPPORTING PUBLICATIONS

REGISTRATION

• Buy the recording/transcript: Click here for just the recorded webinar with the complete transcript, $349
• Register by email: custcare@elsevier.com
• Register by phone: +1 (800) 332-2181 (U.S.) / +1 (908) 547-2159 (non- U.S.)

Webinar Cancellation Policy: No refunds or credits will be given one week prior to the scheduled webinar, or after the webinar presentation materials and access instructions have been sent to participants. In lieu of cancellation, you may substitute another delegate from your company as a replacement.