Part II:
Product Development Strategies for Follow-on Biologics

In part two of How to Compete in the Brave New World of Follow-on Biologics, we'll continue the conversation with product development strategies for FOBs. Whether you've developed the science yourself or acquired it, to succeed in your development efforts you'll need a skillful and informed approach to formulate the best path to approval. We'll cover key aspects of FOB development considerations and how these differ from the development of new biological entities. This is a must event for anyone in this product space.

Here’s a sample of what you’ll learn during the 90-minute Part II of this audio conference:

• The global challenges in selecting and sourcing the reference product
• Developing a state-of-the-art physico-chemical and biological comparability program
• The importance of bioassays and availability of bio/surrogate markers  
• The value of nonclinical testing
• Designing and optimising equivalence trials
• How much clinical safety data will be required
• Extrapolating to other indications, dosage regimens and patient populations
• Immunogenicity testing
• Where to perform clinical trials
• Developing FOBs with ROI and profitability in mind

The discussion will be delivered in a convenient audio conference format, and capped off with an interactive Q&A round.

So join us, in the convenience of your own office, for a thought-provoking analysis. Grab your team (or several teams), a conference room at your office, a phone and a computer with Web access (that last one's optional). No travel required.

	Dr. BRUCE BABBITT is a Principal Consultant at PAREXEL Consulting, where he draws on 20 years of R&D, drug development and regulatory affairs expertise to assist biotechnology companies in formulating strategies to quickly move into the clinic with investigational drugs. Dr. Babbitt has expertise in development across a broad range of biologics including recombinant proteins, blood products, vaccines, and cellular therapies targeting indications such as oncology, infectious diseases, and autoimmune diseases. Prior to joining PAREXEL, Dr. Babbitt was a consultant with Elgix. He has held positions in industry as Vice President of R&D and Quality Assurance/Control at Cellcor, and as Group Director of R&D at Lipogen. He holds a PhD in biochemistry from the University of Tennessee and a BS degree from Worcester Polytechnic Institute, and has completed postdoctoral studies in cellular immunology at Harvard Medical School and Washington University Medical School.
	CECIL NICK is Vice President, Biotechnology at PAREXEL Consulting. Mr. Nick provides expert consulting services to clients particularly on the clinical and regulatory development of biotech and biological products. He has been involved in the development and regulatory approval of a number of innovative and biosimilar medicinal products in Europe. Mr. Nick has extensive experience in the development and EU registration of biotechnology and blood products, devices, new chemical entities, CMC, orphan drugs, health economics, and scientific advice. He also has extensive therapeutic area experience including: diabetes, hematology, oncology, lupus, epilepsy, growth, wound healing, gynecology, HIV, anti-inflammatory agents, and vaccines.
	SAUARBH AGGARWAL, PhD is a Senior Consultant in Reimbursement and Market Access (RMA) at PAREXEL Consulting. Saurabh’s expertise areas include investment strategy in biologics, pricing strategy, market access and value proposition of novel drugs. Previously, he led the healthcare strategy and policy initiative at Alliance Bernstein. Before Bernstein, Dr. Aggarwal was a Senior Consultant in Pricing and Reimbursement practice of IMS Health, where he led international and US based projects on oncology, diabetes, infectious diseases, arthritis and cardiovascular drug candidates. Dr. Aggarwal has published articles on the biologics market including ‘What’s fueling the biotech engine’ in Nature Biotech. Saurabh holds a PhD in Biomolecular Engineering from The Johns Hopkins University, and MS/BS in Biotech from IIT Delhi.
	M. NIELSEN HOBBS is the Editor of “The Pink Sheet” and “The Pink Sheet” DAILY. He covered the prescription drug industry for 12 years, and his particular areas of focus include Capitol Hill, advertising  and drug safety.

  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!

__________________________________________________________

Get the complete picture!

Purchase the audio recording of
Part I: Preparing for the Changing Regulatory Landscape of Follow-on Biologics
90 minutes • WMV file + slides • $399

As the U.S. Congress works on an approval pathway for follow-on biologics (FOBs) and, with some sort of legislative movement expected in 2009-10, more and more companies are gearing up to compete in this product space. However, given the increased complexity and associated costs of developing and commercializing FOBs as compared to classic generics drugs (typically low molecular weight, synthetic compounds), companies must develop sound strategies and partnerships in order to rapidly and successfully bring FOBs to the market.

In part one of this two-part series, we provided the background you need on FOBs, including where they fall in the biologics product develoment continuum and what special considerations they'll require. You'll also hear from two companies focused in this space and learn about its overall development and marketing strategy.

Here’s a sample of what you’ll learn during this comprehensive 90-minute audio conference:

• Defining the world of follow-on biologics
• What is the spectrum of complexity related to current FOB regulations?
• Update on the current and likely future legislative and regulatory actions expected for this product group
• Can all biologicals be effectively reverse engineered?
• Demonstration of comparability; How similar is "similar?"
• Biosuperiors (second generation biologics) versus biosimilars
• Interchangeability and substitutability, and what this means for your company
• How one U.S. company is currently approaching this market

Webinars presented by

For more information on FDC-Windhover Webinars, visit us at www.windhover.com or www.fdcreports.com, or send an email to fdcwindhover.custcare@elsevier.com.

Windhover Webinars
Elsevier Business Intelligence
P.O. Box 7247
Philadelphia, PA 19101-9257
* Tel: +1 (800) 332-2181 (U.S.)
or +1 (908) 547-2159 (non-U.S.)
* Fax: +1 (908) 547-2165