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PDUFA, MDUFA and 21st Century Cures all address the issues companies are facing or will face in bringing combination products to market.  It is fair to say that changes of this magnitude have not been seen since 2002, when the Office of Combination Products was established.  Given the criticality of combination products to the innovation pipeline for  many pharm and medical devices companies, it is imperative that companies understand the shifting landscape.  This webinar will examine the Regulatory, Clinical, Supply Chain and other relevant issues that many stakeholders are facing and the anticipated changes resulting from User Fee negotiations and 21st Century Cures implementation. Join us as we discuss: 

  • Relevant portions of the PDUFA, MDUFA and 21st Century Cures related to combination products
  • Strategic considerations for commercial leaders, when planning the timelines and budget for bringing combinations products to market
  • Global insights regarding the alignment between countries and a predictable pathway for combination product registration
  • Lessons learned from past combination product development efforts, clinical evidence strategies, and registrations

About the Speakers:

Janet Vargo, Ph.D.:  Dr. Vargo is a Strategic Advisor to YourEncore and a member of the Medical Devices and Diagnostics Practice.  Prior to joining YourEncore, Dr. Vargo served as Board Member and Head of Clinical and Regulatory Affairs for Mentor, LLC, a Johnson & Johnson Company, and she advised on clinical trial design, device and biologics safety analyses, due diligence efforts, and regulatory strategy for new-to-the-world products for the entire Johnson & Johnson Medical Device and Diagnostic sector. 

Minnie Baylor-Henry, J.D.: Minnie Baylor-Henry, J.D. is a Strategic Advisor to YourEncore and the Medical Devices and Diagnostics Practice Lead.  Prior to assuming her current role in 2015, she was the Worldwide Vice-President for Regulatory Affairs for Johnson & Johnson’s (J&J) Medical Devices & Diagnostics business.

Tim Franson, M.D.: Dr. Franson is the Chief Medical Officer for YourEncore and industry expert in regulatory affairs and drug development policy.  Dr. Franson is the Chairman of the Board for the Critical Path Institute, the Immediate Past President of the USP, and former VP of Global Regulatory Affairs and Patient Safety for Eli Lilly & Company.  

Joseph Lamendola, Ph.D.: Dr. Lamendola is the SVP of YourEncore's biopharma practice and the former US VP of Regulatory Sciences for Bristol-Myers Squibb.  Over a 25 year regulatory career, Dr. Lamendola is responsible for 20+ approvals across 10+ therapeutic areas.  With hundreds of agency interactions under his belt, Joe provides clients with the insights, relationships, and credibility needed to bring drugs to patients quicker.