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Pioneering New Frontiers: Advanced Drug Delivery Technologies and Cell/Gene Therapies in Combination Products
Session Chair(s)
James Wabby, MHS
Global Head, Regulatory Affairs, Emerging Technologies and Combination Products
AbbVie, United States
Advanced Therapies and combined advanced therapies emerging as innovative medical products due to their contribution to advancing medical care and are thus expected to have major impact in the coming years. Future technologies are most appealing to patients with ongoing medical conditions that require consistent treatment with daily injections or weekly procedures and unmet medical needs. Overall, the successful development of combination products will require great collaboration within the industry to overcome regulatory, clinical, and technical challenges. When developing an advanced therapy product, there are many things to be considered – relationships between tissue, biologic, and device development as well as early establishment of regulatory and clinical strategies, understanding user needs, determining product requirements, as well as device manufacturing variation. With the dawn of a new millennium and the rapidly aging baby-boomer population, the pressure for companies to create safer and more effective treatments is growing. Advanced therapies are one of the solutions that have emerged to meet the more rigorous demands of patients. Drug-enhanced devices, including drug eluting stents and antimicrobial-coated catheters, have already proven themselves on the market. Pre-filled syringes and transdermal patches, which are novel drug delivery systems, have also been widely used treatments. However, advanced therapies and combined advanced therapies are innovative products and could provide solutions as well as cures for previously untreatable conditions, which can truly change the face of the industry. Speakers will be FDA and industry leaders and FDA illustrating hot topics and example case studies in a panel discussion for us to navigate the future regulatory framework for unmet medical needs and next generation of medical products.
Learning Objective : Analyze latest regulatory expectations and challenges; Identify potential future innovation platforms; Acknowledge potential and future global convergence/harmonization initiatives for combination products; Describe the regulatory challenges and opportunities ahead.
Speaker(s)
FDA Update
Andrea Gray, PhD
FDA , United States
Biomedical Engineer Advisor, CBER
Panelist
Rob Schulz
Suttons Creek, Inc., United States
President and COO
Panelist
William Daunch, PhD
Focal Medical, Inc., United States
Chief Technology Officer
Panelist
Michael Lehmicke, MSc
Alliance for Regenerative Medicine, United States
Senior Vice President, Science and Industry Affairs
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