SubscribeIndustry innovators are set to share their knowledge and vision of the combination products industry as speakers at PharmaMedDevice™, the world’s first extensive forum for the converging medical device, pharmaceutical, and biologic industries.
The event premieres April 24-26, 2007 in New York City and will feature speakers from regulatory, business and academia to provide a balanced perspective and comprehensive coverage on the trends, technologies and regulations driving the combination products market.
More than 70 speakers from the FDA, industry consulting firms, university research centers, combination product manufacturers and non-profit industry associations will provide PharmaMedDevice conference attendees with a well-rounded education on the converging industry's most pertinent issues as recommended by a stellar Advisory Board, the editors of FDC Reports' The Gray Sheet, The Silver Sheet and The Pink Sheet and BEACON, the Biomedical Engineering Alliance and Consortium.
Bill Cook, Chair and CEO of the Cook Group, Inc.
The PharmaMedDevice conference program will include two visionary keynotes. Bill Cook, Chair and CEO of the Cook Group, Inc. will give a presentation entitled "What's Next: Where Devices and Medicine Go from Here...," and G. Steven Burrill, CEO of Burrill and Company, will explore the future of the biotech Industry.
G. Steven Burrill, CEO of Burrill and Company
A workshop on the FDA pre-market review process for combination products, featuring experts from the FDA, industry and the legal profession, is an example of the kind of real-world insight attendees will gain at PharmaMedDevice. In the workshop, Mark Citron from BioMimetic Therapeutics, Inc. will describe the path to approval for GEM 21S® Growth-factor Enhanced Matrix, while the attorney who handled the approval process, David Fox of Hogan and Hartson, will provide his legal perspective.
Mark Kramer, Director of the Office of Combination Products, will also be joining the workshop to provide regulatory insight and will also be giving a separate presentation on inter-center consultations and collaborations. Mr. Kramer was recently quoted as saying, "combination products have the regulatory flexibility to apply the most appropriate regulation to a combination product by tailoring the approach to taking pieces of drug regulation, pieces of device regulation, or biologics, as appropriate." He will elaborate more at PharmaMedDevice 2007.
The PharmaMedDevice conference program promises to be as interesting as it is educational with presentations on exciting topics like the development of the industry's pioneering combination product -- the drug eluting stent, the future of device biologics, implantable delivery devices and transdermal drug delivery.
About the Conference Program Tracks
To address the multi-dimensional aspects of combination product development and the needs of the unique audience that PharmaMedDevice will attract, the conference program is organized into two tracks. The Bioengineering Track, co-produced by BEACON (Biomedical Engineering Alliance and Consortium), will present the new technologies and topics that are revolutionizing the biomedical engineering industry. Conference sessions include such cutting-edge topics as bionanotechnology, molecular and infrared imaging, personalized medicine, virtual instrumentation, and vascular tissue engineering.
The Converging Technologies Track, co-produced by the editors of FDC Reports' The Gray Sheet, The Silver Sheet and The Pink Sheet, will provide needed clarity, practical advice and in-depth coverage on how to handle issues critical to bringing new combination products and advanced drug delivery technologies to market. In addition to both pre-market and post-market regulatory sessions, the program will include a focus on research and development as well as partnerships and collaborations. Leading innovators in the combination products industry will present a showcase of their technologies and share their experiences in this fast growing market.
"PharmaMedDevice's conference programs enable medical device, biotech and drug companies to uncover collaborative opportunities for all three industries, while learning from the combination product industry's leading experts," says Christine Ford, Event Director of PharmaMedDevice. "For most companies, bringing a successful combination product to market requires the right partner, technology and strategy for commercialization through a certain synergy that can be found at PharmaMedDevice."
Norwalk, CT (Dec. 11, 2006)
About Reed Exhibitions
Reed Life Sciences - a division of Reed Exhibitions, which manages more than 420 trade shows annually worldwide, is a member of the Reed Elsevier Group plc, a world-leading provider of information-driven services and solutions. Reed Exhibitions offers integrated market access programs covering exhibitions, trade publications, direct marketing and the Internet to a database of 3.5 million in North America. Reed has North American offices in Norwalk, CT, Newton, MA, Palm Beach, FL, Las Vegas, NM and Toronto, Canada. Reed also has sales operations offices worldwide. Reed Elsevier Group is a publicly-traded company (NYSE:RUK/ENL).