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Breaking Boundaries: Overcoming Policy Crosstalk and Globalization Barriers to Foster Innovation
Session Chair(s)
Virginia Acha, PhD, MSc
AVP, Global Regulatory Policy
Merck Sharpe & Dohme LLC , United States
We all want to see innovation in treatments and prevention that meets the many unmet needs of patients globally. And yet, despite this compelling goal, the complexity and uncertainty involved in delivering innovation has baffled policy makers, regulators, healthcare systems and companies at every step of the process. The response has been to establish policies and requirements to “direct” innovation to best effect. The result has been a confused environment where crosstalk of policy measures and requirements collectively and often constrain, rather than enable, innovation.
In this forum, we are going to aim to take a more holistic framing of the drive for innovation and explore three recent cases where policy crosstalk risks frustrating innovation.
Learning Objective : Explore how various legislative and other policy-related initiatives, including some not directly targeting the industry, are threatening the climate for development of innovative products.
Speaker(s)
Policy Cross-Talk Case Study: Clinical Research
Karen A Noonan, MA
Association of Clinical Research Organizations (ACRO), United States
Senior Vice President, Global Regulatory Policy
Policy Cross-Talk Case Study: Supply Chains and Resilience
Christopher Colwell, MPA
US Pharmacopeia, United States
Vice President, International Government and Regulatory Affairs
Policy Cross-Talk Case Study: Pricing and Access Policies
Duane Schulthess, MBA
Vital Transformation LLC, United States
Chief Executive Officer
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