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Innovation Gridlock: When Misaligned Policies Threaten Progress for Patients
Session Chair(s)
Alexis Reisin Miller, JD
Head, Global Regulatory Policy
MSD, United States
Examines how fragmented policies, trade barriers, pricing pressures, and other restrictions create innovation gridlock—blocking or stalling R&D, delaying clinical trials, disrupting supply, and threatening patient access to critical therapies.
Learning Objective : Identify key policy and regulatory misalignments contributing to innovation gridlock in biopharma; Assess the global impact of these barriers on patient access to transformative therapies. and prioritize action based on criticality; Examine opportunities and actionable policy levers to realign systems and accelerate innovation for patients.
Speaker(s)
PMDA perspective
Representative Invited
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
FDA perspective
Representative Invited
FDA, United States
Panelist
Representative Invited
National Medical Products Administration (NMPA), China
EMA perspective
Representative Invited
European Medicines Agency, Netherlands
Industry perspective
Michelle Rohrer, PHD
Genentech, A Member of the Roche Group, United States
Senior Vice President, Global Head of Product Development Regulatory and Policy
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