Wednesday, January 20, 2010

Upcoming Webinar: The Road to FDA Approval: Advisory Committee Survival Strategies

Getting a drug or medical device to market has never been more expensive, time-consuming, or difficult. New legislation increases the likelihood that your product will wind up in front of an FDA advisory committee. With the road to approval becoming even tougher, just having solid data to support your product may not be enough.

Knowing how to avoid common pitfalls, effectively present your story to an increasingly skeptical audience, and manage Q&A can make or break your new drug or device application.

Experts agree that the advisory panel process itself has changed. Because of tighter conflict-of-interest rules, panelists tend to be less well-informed about your product and indication, and more concerned than ever about product safety. The combination makes for a particularly challenging meeting. But there are strategies and processes that can help you prepare your team, better explain the issues, and increase your chances for product approval.

We bring you seasoned veterans who have successfully steered Rx drugs and first-in-class switches through the approval process. Presenters include regulatory executives from pharmaceutical companies and communications and risk management experts.

In this webinar, these experts will take you through a strategic approach to preparing for an advisory committee that maximizes your chance of success, no matter your level of experience in this challenging process.

So join us, in the convenience of your own office, for a thought-provoking analysis of the issues central to your company's success. Gather your team (or several teams), a conference room at your office, a phone, and if possible, a computer with web access. No travel required!

You’ll learn how to ...

• Adopt the critical strategies for success
• Avoid the common mistakes companies make
• Communicate most effectively with the FDA
• Build your presentation team
• Identify and prepare for critical issues early in the process
• Determine and write your product’s story
• Stay on message – while remaining flexible
  

SPEAKERS

	Deborah J. Henderson, R.N., M.S.N. Director, Officer of Executive Programs, Center for Drug Evaluation and Research, Food and Drug Administration Since 1992, Ms. Henderson has served as the Director for the Office of Executive Programs in the Center for Drug Evaluation and Research (CDER) at FDA.  This office oversees a variety of Center-wide programs, housing an executive project management staff, the Center’s executive secretariat function, the scientific advisory committee staff, the Division of Training & Development, the office of the CDER ombudsman, CDER’s international program, and a program/administrative management staff.  In addition to supervising these staff offices, Ms. Henderson serves as a senior advisor to the Center Director, assuming additional responsibility for a wide range of regulatory and public health projects.  She served as the FDA chair of the post-market safety working group as part of the recently negotiated commitments under the Prescription Drug User Fee Act (PDUFA IV) and currently is leading CDER’s “Safety First” initiative.  Ms. Henderson joined the FDA 1988 as Special Assistant to the Director of the Center for Biologics, where she also served as the Associate Director for Regulatory Policy in the Office of Therapeutics Research and Review.  Prior to joining FDA, Ms. Henderson worked at the National Institutes of Health in the Clinical Center as an intensive care nurse and hospital epidemiologist and later as Special Assistant to the Director of the National Institute of Allergy and Infectious Diseases.  She earned Bachelor’s and Master’s degrees in nursing from the Catholic University of America.
	Dr. D. Bruce Burlington Infectious Disease Internist and Independent Consultant on pharmaceutical product development and regulatory affairs He has special interests in helping companies plan development of their drugs based on FDA and European Union requirements; prepare for meetings with FDA or its advisory committees; develop risk management plans; conduct product due diligence evaluations; and set up process, organizations, and staffing plans to achieve their regulatory obligations. His experience includes senior positions at both the FDA and in the pharmaceutical industry. He blends long experience in development strategy with insightful analysis of the underlying medical problems, patient needs, how the results will be viewed by the FDA and EMEA, and what outcomes will result in commercial success. Dr. Burlington was Executive Vice President and worldwide head of Regulatory Affairs, Human Safety, and Quality at Wyeth. He led the company in the development and U.S. and global registration of many products as well as improving Wyeth’s compliance posture. He also successfully navigated the company through an FDA consent degree. During these eight years, as a member of many Wyeth governance councils and committees, including the executive licensing, capitol expenditure, and commercial councils, he participated broadly and in depth analyzing the interaction between regulatory standards and the complex business forces driving the pharmaceutical industry. Before joining Wyeth, Dr. Burlington served at the FDA for 17 years.  He was the first physician named as director at of the Center for Devices and Radiological Health (CDRH), where he led major changes, increased the rigor of clinical investigation for medical devices, and championed innovations in how the Center could work more productively with industry. Before that he was a research immunologist and then a manager in both the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). In these centers he had responsibility for viral vaccines, investigational biologics, BLA review, NDA approvals, and generic drugs. As Deputy Director of CDER for Medical Affairs, he also oversaw policy and compliance decisions for pharmaceuticals.  Dr. Burlington is a frequently public speaker on drug development, risk management, and how to work successfully with regulators. He has helped organize and chaired numerous symposia and courses in the field including the American Course in Drug Development and Regulatory Science, and has been a member of several trade association and public committees as well as three Boards of Directors and four Scientific Advisory Boards.
	William E. Pullman, BMedSc, MB, BS, Ph.D., FRACP Former Executive Vice President and Chief Development Officer, Dyax He has served as Executive Vice President and Chief Development Officer since joining Dyax in October 2007. In this position, Dr. Pullman is responsible for overseeing the clinical, regulatory and program management departments. Prior to working with Dyax, Dr. Pullman served as Senior Vice President and Chief Medical Officer at Cubist Pharmaceuticals. Previously, he served as Senior Vice President, Exploratory Development at Transform Pharmaceuticals. From 2001 to 2005, he filled various senior management positions at Sanofi-Aventis and from 1995 to 2001 held multiple director level positions of increasing responsibility at Eli Lilly and Company. He began his pharmaceutical industry career at Pfizer as a clinical pharmacologist. Prior to that he was a practicing gastroenterologist. Dr. Pullman received his medical degree (MB, BS) from the University of Western Australia, his Ph.D. from the Australian National University and is a Fellow of the Royal Australasian College of Physicians (FRACP).

REGISTRATION

• Register online: Click here for the live webinar
• Register online: Click here for the live webinar PLUS recording
• Buy the recording: Click here for just the recorded webinar
• 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.

WEBINAR DETAILS

DATE: Wednesday, January 20,2010
TIME: 2 PM EST
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
• Online access to the audio and slides of the entire event if you can't attend the webinar live, and still want to hear the content.
• The insight you've come to expect and respect from Windhover Webinars 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!
  

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