The producers of the PharmaMedDevice conference and exhibition announce the event's 2007 conference programme, to provide clarity and in-depth coverage for bringing new combination products to market
PharmaMedDevice 2007 is said to be the first event of its kind to address the needs of the emerging combination products market and the exciting innovations taking place in drug delivery technology and healthcare.
The programme will provide life science companies with a roadmap for speeding new combination products - drugs, medical devices, and/or biologics, combined through physical or chemical means - to market and extending product lifecycles.
In addition, the conference will address the exciting new technologies and topics that are revolutionizing the healthcare industry - including personalized medicine, bionanotechnology, artificial organs and other novel treatment options.
Designed to address the entire universe of issues facing life science companies involved in or considering similar product development, conference tracks will focus on: FDA regulatory issues, partnerships and collaboration, manufacturing and commercialization, innovative technologies, and research and development.
To provide insight on the constantly evolving regulations and changing technology of this market, PharmaMedDevice has partnered with FDC Reports.
The sessions developed by the editors of FDC Reports' The Gray Sheet, The Pink Sheet, and The Silver Sheet, will provide needed clarity, practical advice and in-depth coverage on how to handle issues critical to bringing new combination products to market.
Conference attendees will learn how to navigate the FDA's application process, address international regulatory issues, successfully develop contracts or licensing agreements with partners, understand appropriate manufacturing processes, and more.
A careful selection process will ensure that only the most qualified speakers and pertinent topics are included in the conference program.
PharmaMedDevice will draw speakers from the FDA, companies that have achieved approval for combination products, and industry leaders specializing in the medical device, pharmaceutical, diagnostics and biologics industries to provide a balanced perspective.
The event will attract a broad range of professionals interested in combining technologies for novel product applications.
It will provide scientists, executives from RandD and business development, product managers, manufacturing engineers, QA/QC personnel, and regulatory specialists with opportunities to meet, network, and address the challenges of developing and bringing combination products to market.
"Our conference program will bring together some of the nation's best talent from government, business, academic, and laboratory settings to facilitate the collective sharing of information and industry knowledge," says Christine Ford, event director.
"We plan to establish a dynamic platform to encourage cross-collaboration and networking across the life science industries and allow attendees to gain a broad perspective and new insights for accelerating product innovation." New conference manager.
To oversee conference development, PharmaMedDevice also announces the appointment of Christina Giuliano as conference manager.
Giuliano is tasked with planning and steering the conference program, including developing the agenda, finalizing conference tracks and selecting both keynote and general conference-session speakers.
Having worked as a research scientist with a consulting firm in the DC metro area, Giuliano will utilize her life science know-how to realize a conference programme that addresses the unique challenges facing combination product manufacturers.
Giuliano received her bachelor of science degree in biology at Boston University, and then went on to obtain her master of science degree, also in biology, at Northeastern University.
"We are delighted to have Giuliano on our team," Ford adds.
"PharmaMedDevice takes three of the world's most dynamic disciplines and brings them together".
"We selected Giuliano for her ability to take this concept, understand the potential it promises for the life science industry and turn it into a cohesive, enlightening conference programme." The proposed FDA regulatory track will provide attendees with perspective on determining primary mode of action (PMOA) and handling coordination between the Office of Combination Products (OCP) and the different regulatory centers, including the Center for Devices and Radiologicial Health (CDRH), the Center for Drug Evaluation and Research (CDER), and the Center for Biologics Evaluation and Research (CBER).
Partnership and collaboration sessions will uncover challenges and solutions for resolving conflicts, addressing regulatory issues on an international level, protecting intellectual property, extending product lifecycles, and developing contracts with partners.
The proposed manufacturing track will address a broad range of crucial topics, such as equipment and facility needs, current Good Manufacturing Practices (cGMP), collaboration across product development teams, and post-market reporting requirements.
To provide a window into new and emerging combination products, innovative technology sessions will highlight novel drug delivery systems, as well as new applications for personalized medicine, biomarkers and other high-growth life science areas.
The proposed research and development track will focus on the impact of changing regulations on the speed and cost of development.
It will also explore academia's role in technology transfer, and the differences in drug/biologic components versus medical device components in terms of stability, contamination, handling and expiration dates.
An online call for papers submission form is also available.
PharmaMedDevice is described as the only comprehensive forum that fully illuminates the convergence of the medical device, pharmaceutical, and biologic industries.
The first annual PharmaMedDevice will be co-located with Interphex at the Jacob Javits Convention Center in New York April 24-26, 2007.
Pharmaceutical and medical manufacturers will converge at these two events to find answers to their regulatory challenges, create new partners, and source solutions for new product development.
