Combination products and convergence: an overview of clinical benefits, regulatory issues and manufacturing challenges - part 1

Despite the controversy, the best known example of a combination product is the drug-eluting stent. However, the drug-eluting stent is also an extremely primitive example of a combination product. The quintessential example of a combination product is tissue engineering. Why? Because we have cells (biologics) producing proteins (biotech drugs) growing on polymer substrates (medical devices).

It’s hard to imagine more of a combination product than that – or can we? During this two-part interactive workshop, participants will be exposed to examples of combination products on the market, under development and on the drawing board.

• What is a combination product? How are they regulated now and what will likely change in the future?
• How do the cultural and philosophical differences between CDER, CBER and CDRH impact the FDA approval process?
• What value does the FDA Office of Combination Products (OCP) really provide? What does the OCP do that’s not on their web page?
• How can we use the request for designation (RFD) and primary mode of action (PMOA) concepts to our advantage in bringing products to market more efficiently?
• What are the challenges of convergence? How can drug, biotech and medical device companies communicate when they don’t speak the same language?

• Research & Development
• Manufacturing Profesional
• Regulatory Professional
• QA managers and personnel
• Legal
• Marketing

Instructor Profile:
Michael Drues, Ph.D., is President of Vascular Sciences (www.vascularsci.com) in Grafton, Massachusetts. Vascular Sciences offers a full range of consulting services to medical device, pharmaceutical and biotechnology companies including: prototype design, product development, testing and evaluation, animal and clinical trials, business development, strategic planning, technology assessment and regulatory affairs. Dr.Drues received his B.S., M.S., and Ph.D. degrees in Biomedical Engineering from Iowa State University in Ames, Iowa. He has worked for and consulted with leading medical device, pharmaceutical and biotechnology companies ranging in size from start-ups to Fortune 100 companies. He also works on a regular basis for the U.S. Food and Drug Administration (FDA).

Dr. Drues is an Adjunct Professor of Medicine & Biotechnology at Northeastern University (Boston), Steven’s Institute of Technology (Hoboken), Boston College (Boston), University of Wisconsin (Madison), Drexel Medical School (Philadelphia) and University of California (Irvine). He regularly teaches both undergraduate and graduate courses in pathophysiology, biotechnology, regulatory affairs and clinical trials. Dr. Drues conducts seminars and short courses for medical device, pharmaceutical and biotechnology companies, the European Patent Office and the FDA. Current offerings include: Designing Cardiovascular, Peripheral and Neurovascular Devices Designing Gastrointestinal and Urinary Devices Minimally Invasive Technologies Combination Products: Medical Devices Meet Drugs, Biologics & Beyond™ Overview of Biotechnology Emerging Trends in the Medical Device Industry™ Big Picture Issues in Clinical Trials™ Regulatory Affairs for Non-Regulatory Professionals.

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