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Session 5: Innovator's Perspective
Session Chair(s)
Bill Zeruld
Business Development - Digital Strategy, Otsuka America Pharmaceuticals, Inc., United States
There is tremendous buzz around novel combination product solutions leveraging digital technologies and other approaches. This session will spotlight the opportunities and challenges for such innovative solution providers in navigating the regulatory pathway. Hear from industry pioneers in a panel discussion that will highlight how their efforts in collaboration with the Agency are helping identify new approaches that will ultimately support and encourage ongoing innovation.
Learning Objective : At the conclusion of this session, participants should be able to:- Describe challenges and opportunities for innovators bringing novel solutions through the regulatory pathway
- Identify how the Agency is collaborating with industry to encourage innovation
- Outline models/approaches pursued by early innovators to bring their solutions to market
Speaker(s)
Innovator's Perspective
Yuri Maricich, MD, MBA
Chief Medical Officer and Head of Development, Pear Therapeutics, United States
Innovator's Perspective
Darin Seth Oppenheimer, DRSc
Executive Director, Device & Digital Health Solutions, Merck & Co., Inc., United States
Innovator's Perspective
Kevin Wurch
Director, Program Management, Otsuka America Pharmaceuticals, Inc., United States
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