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Sheraton Silver Spring

2018 年 10 月 11 日 7:30 上午 - 2018 年 10 月 12 日 4:45 下午

8777 Georgia Ave, Silver Spring, MD 20910

Combination Products Conference

Session 5: Innovator's Perspective

Session Chair(s)

Bill  Zeruld

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)

Yuri  Maricich, MD, MBA

Innovator's Perspective

Yuri Maricich, MD, MBA

Pear Therapeutics, United States

Chief Medical Officer and Head of Development

Darin Seth Oppenheimer, DrSc

Innovator's Perspective

Darin Seth Oppenheimer, DrSc

Merck & Co., Inc., United States

Executive Director, Device & Digital Health Solutions

Kevin  Wurch

Innovator's Perspective

Kevin Wurch

Otsuka America Pharmaceuticals, Inc., United States

Director, Program Management

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