Conference program to provide comprehensive education and market intelligence on combination productsThe producers of the PharmaMedDevice Conference and Exhibition recently announced the event’s 2008 conference program. Following on the success of its inaugural event, the PharmaMedDevice conference program will feature visionary presentations from today’s leaders in the combination product market, such as Deloitte and Touche, Johnson and Johnson, AdvaMed, Tyrx Pharma, Vyteris, the FDA, and many more.
PharmaMedDevice’s move from New York City to Philadelphia, a major life sciences hub, is poised to draw even greater numbers of the global medical device companies, pharmaceutical firms, and research institutions throughout New Jersey, Pennsylvania, and Delaware. The new location also allows PharmaMedDevice to remain within proximity of the show’s strong New York and Northeast participant base.
As the first event to address the converging medical device, pharmaceutical and biologic industries, the PharmaMedDevice conference program will provide insightful education on a wide spectrum of topics, ranging from regulatory issues and investment trends to nanobiotechnology and regenerative medicine. The event caters to the needs of scientists, executives from R&D and business development, product managers, manufacturing engineers, QA/QC personnel, and regulatory specialists interested in exchanging information, ideas and opinions about the dynamic combination products market.
The fact that every multi-billion dollar pharmaceutical and medical device company has combination product development plans in their future underscores the need for comprehensive education on this critical topic. There are several factors fueling the combination product movement, including:* The need to combine approved drugs with a biologic and/or device to extend the life of pharmaceuticals, many of which are set to go off patent by 2010.* An aging population’s desire for superior or novel products.* The ability of combination products to breathe new life into failed pharmaceutical products that exhibited systemic toxicity as a pharmaceutical drug, but demonstrate good efficacy when delivered locally through a combination product.* The growth and stability of the medical device market.Developed in conjunction with the editors of FDC Reports’ The Gray Sheet and The Pink Sheet, the 2008 PharmaMedDevice Conference Program will offer four tracks that address the multi-dimensional nature of the combination product market, including: Regulatory Issues, Manufacturing Challenges, Innovative Technologies and Research & Development.
Regulatory IssuesAs the number and diversity of combination products in development grows, there is a need for greater understanding of the regulatory approval and reimbursement processes. The path to global commercialization is further complicated by a lack of defined regulations in Europe and Asia. The PharmaMedDevice conference program aims to simplify these challenges with several insightful presentations on regulatory issues. Among the important topics that will be addressed in this track will be AdvaMed’s presentation on preparing for and managing FDA inspections.
Manufacturing ChallengesIn response to high attendee interest level, PharmaMedDevice has expanded the Manufacturing Challenges track to include additional topics such as materials & coatings, packaging & sterilization, and product testing and outsourcing. These presentations also address practical manufacturing considerations to help turn combination product concepts into commercial innovations such as customized packaging, partnering and licensing strategies, and design for manufacturability.
Innovative TechnologiesNew combination products are providing effective treatment options where traditional pharmaceuticals have previously failed. With a growing pipeline of novel combination products in the areas of nanobiotechnology, regenerative medicine and orthopedics, the Innovative Technologies track will educate attendees on the key trends and opportunities in these market segments.
Research & DevelopmentGiven the complexity of combination product development and regulatory approval, it is critical that considerations such as those related to partnering, clinical trials and scale-up be made early on. PharmaMedDevice’s Research & Development track provides a platform for sharing insight on the topics that are critical to providing a framework for successful combination product development.
“As a presenter at the 2007 inaugural event, I was truly impressed with the quality and diversity of the conference program and the event as a whole,” said Raj Bawa, Ph.D., President at Bawa Biotechnology Consulting and Adjunct Associate Professor at Rensselaer Polytechnic Institute. “No other event addresses scientific, regulatory and business aspects of combination products in the way that PharmaMedDevice does. Fellow speakers were top-notch, and I am pleased to be presenting again at the 2008 event.”
Co-located with INTERPHEX2008, PharmaMedDevice attendees have access to INTERPHEX’s value-added conference program, including its ground-breaking keynote presentations. Of particular interest to combination product developers will be the March 27th keynote, entitled “Innovation to Commercialization: Executive Life Science Panel Discussion.” Featuring CEOs from the medical device, pharmaceutical and biotechnology industries, this high level panel discussion will address current trends in innovation, global market challenges and collaborations across these converging markets.
In addition, INTERPHEX and PharmaMedDevice will be featuring a keynote by G. Steven Burrill entitled, “Biotech 2008: A 20/20 Vision of 2020” on March 26th, and a panel discussion keynote entitled, “From Pandemics to Bioterrorism: The Role of Bio Manufacturing in Global Healthcare” featuring a lineup of industry leaders on March 28th.
PharmaMedDevice also leverages INTERPHEX’s more than 18,000 attendees and exhibitors to provide cross-industry networking opportunities for PharmaMedDevice participants.
“PharmaMedDevice is the only event that truly addresses the comprehensive needs of the burgeoning combination products market,” says Christina Lorelli, Conference Manager, PharmaMedDevice. “In drawing a cross-section of industry leaders from business, academia, and the FDA, PharmaMedDevice provides a balanced perspective on the vast universe of issues facing combination product developers.”