Combination products and convergence: an overview of clinical benefits, regulatory issues and manufacturing challenges - part 2
Instructor:
Michael Drues
Product ID: 701160
- Duration: 90 Min
Medical products, no matter how well designed, can only do so much to address many of the clinical problems today. In order to tackle the clinical problems of the future, medical devices will be used in combination with drugs and biologics (called combination products) to treat a wide range of diseases from heart attack and stroke to Alzheimer’s and diabetes and beyond!
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 Attendees will Learn- What precedent exists for combination products, i.e., drug-device, biologic-device, drug biologic and device-drug-biologic product examples?
- Must combination products involve only drugs, biologics and medical devices? What about pharmaceutical-nutraceutical and medical device-nutraceutical combinations?
- What are the manufacturing challenges of combination products, i.e., sterility, shelf-life, packaging, etc.?
- What can we learn from drug-eluting stents?
- How does the future of combination products look? i.e., case studies in nanotechnology, tissue engineering and beyond!
This webinar will provide valuable assistance to all regulated companies, including companies in the Medical Device, Biotech, Pharmaceutical, and BioPharma. The employees who will benefit include:
- 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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