Thursday, July 8, 2010

Approval Strategies: Leveraging the Unapproved Drug Initiative

Opportunities to fill your drug pipeline are still out there; one may even lie in the next warning letter.

On March 30, 2009, the FDA sent warning letters to seven manufacturers of morphine sulfate (oral solution, 20 mg/ml), and gave them six months to stop shipping the drug. But one of those companies—Roxane Laboratories—didn’t just shut down production and destroy all their stock.

They submitted a 505(b)(2) application, and on January 25, 2010 received FDA approval. Now they have marketing exclusivity, while their competitors are subject to seizure and injunction if they ship another drop.

Since those March 2009 warning letters, the FDA has issued 30 more under the Unapproved Drug Initiative—and with as many as 3,000 drugs currently on the market without approval, there is no reason to think the FDA’s efforts will slow down.

In this 90 minute webinar, drug development expert Ken Phelps will examine how the Unapproved Drug Initiative has impacted the competitive landscape. He will also show you, through case studies, how to obtain approval for these “new” drugs, thereby ensuring compliance, and gaining the upper hand over your competition.

After this program, you will know:

What the next target of the Unapproved Drug Initiative likely looks like
If DESI or grandfathered “designation” is a defense against FDA enforcement efforts
The pathways for gaining approval of a drug flagged by the Unapproved Drug Initiative
The documents, data, and processes the FDA will need for approving an unapproved drug via a 505(b)(2) application
Go or no-go: 5 red flags that indicate it won’t be worth the effort or cost of getting approval

Ken will also answer your team’s questions in the Q&A session.

Who should attend...

CEOs and executives
Submissions professionals
Corporate strategists and pricing decision-makers
Regulatory affairs and compliance staff
Business development and M&A experts
Risk management specialists
Clinical trial developers

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.

SPEAKERS

Ken Phelps
Camargo Pharmaceutical Services

Ken Phelps, President and CEO of Camargo Pharmaceutical Services, has more than three decades of experience in the health science and services industry. As an expert in drug development, specifically the 505(b)(2) regulatory approval pathway, he has aided in the successful FDA approval of numerous compounds. He also draws on his company’s expertise to assist in 505(b)(1) projects as well as ANDA’s that have difficult bioequivalence problems, such as clinical endpoints needed for topical drug products.

Prior to founding Camargo, Ken held positions at Duramed Pharmaceuticals, as well as Marion Merrell Dow and its predecessor companies. Among his diverse experience is a 3-year assignment in Italy, where he had responsibility for quality and process technology at 29 facilities world-wide. He began his career synthesizing, characterizing and performing drug metabolism studies of potential carcinogens with the Eppley Center for Research in Cancer.

Webinar Details

DATE: Thursday, July 8, 2010
TIME: 10:00 AM PT • 11:00 AM MT • 1:00 PM ET
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.

What are the unique benefits of a webinar?

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
Resgister by email: custcare@elsevier.com
Resgister 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.