Amy Replogle, MS

“My years in industry taught me to anticipate the issues that matter and connect the evidence to a clear scientific story. I bring that experience to helping clients prepare for critical regulatory conversations and communicate with confidence.”

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Amy brings more than 25 years of experience in pharmaceutical and consumer health to 3D. Her background spans clinical research, scientific strategy, real-world evidence, and benefit-risk assessments. Having contributed to regulatory submissions and FDA Advisory Committee meetings, including as a primary scientific presenter, she understands firsthand the need to develop and deliver a clear, credible scientific story—and the work required to prepare teams for critical regulatory interactions.

Approach

Amy approaches scientific communications with the regulatory decision in mind. She works with teams to identify strengths and gaps in their evidence, anticipate questions, and develop a narrative that clearly explains the findings and their implications. Her experience designing studies, interpreting data, and developing regulatory materials helps her connect the scientific details to the broader benefit-risk discussion. She also brings a practical understanding of how patient behavior and appropriate use influence outcomes beyond approval and how evidence can support better decisions across regulators, healthcare professionals, patients, and other stakeholders. Her public health perspective adds a broader lens on how scientific and regulatory decisions ultimately influence access to care and health outcomes.

Background

Amy held scientific strategy leadership roles at Bayer and Merck, following earlier roles in clinical research and data management at Merck and the Merck/Johnson & Johnson joint venture. At Bayer, she led developmental programs  across multiple therapeutic areas and was selected as a Bayer Science Fellow. At Merck, she led the development program for Oxytrol for Women through NDA submission, FDA Advisory Committee review, and approval.

Her experience includes authoring benefit-risk assessments, integrated summaries, clinical study reports, and FDA meeting materials, as well as leading clinical, behavioral, and epidemiological research. She holds an MS in environmental biology from the University of Pennsylvania and a BS in education from Indiana University of Pennsylvania. She is pursuing a PhD in public health with a focus on epidemiology.

Special Interests

Outside of work, Amy values spending time with family and friends and enjoys gardening, traveling, reading, and being outdoors. Her interests include yoga, hiking, and exploring new approaches to health and wellness. She also serves as Member Engagement Co-Chair of ISPOR’s Global Access to Medical Innovation Special Interest Group, reflecting her longstanding interest in public health and expanding access to healthcare.