AMY R. REPLOGLE
Schwenksville,PA
Summary
I’m a science-driven leader dedicated to transforming how evidence translates into access and outcomes that improve global public health.
With deep experience in scientific strategy and public-health innovation, I bridge data, policy, and payer perspectives to deliver real-world evidence that advances sustainable healthcare access.
My career centers on creating pathways that connect evidence generation, value communication, and health equity. I’ve led cross-functional teams spanning medical, regulatory, commercial, and advocacy functions—aligning diverse stakeholders around a shared purpose: bringing trusted, evidence-based innovations to the people who need them most.
Now completing my PhD in Public Health and Epidemiology, I’m expanding my leadership into HEOR, RWE, and integrated evidence strategy—where rigorous science meets practical decision-making to shape coverage, influence policy, and elevate population health outcomes.
I thrive where data becomes insight, insight becomes strategy, and strategy becomes impact.
Overview
27
27
years of professional experience
5
5
years of post-secondary education
Work History
Science Strategy Leader
Bayer Consumer Health
Whippany, NJ
01.2014 - Current
- Directed Rx-to-OTC programs, integrating regulatory, medical, and consumer insights to expand patient self-care access, unlocking over $100 million in growth opportunities.
- Shaped regulatory and evidence strategies for women’s health, cardiovascular, gastrointestinal, and allergy, establishing foundations for policy and payer alignment.
- Led cross-functional preparation and external engagement for FDA Advisory Committees (AdComs), achieving favorable decisions that set industry precedents.
- Partnered with Medical Affairs, Commercial, and Clinical teams to enhance long-term access and public health value through lifecycle strategies.
- Championed an organizational model to reduce hierarchy and accelerate delivery, enhancing team ownership and decision-making speed.
- Developed advocacy strategies, including KOL boards and stakeholder engagement, to strengthen alignment with access goals.
- Recognized as a Science Fellow at Bayer Consumer Health for pioneering Rx-to-OTC switch science and regulatory innovation, I advanced external standards through publications and panels.
- Evaluated current processes to develop improvement plans.
Director & Switch Program Leader
Merck
West Point, PA
01.2009 - 09.2014
- Led the Rx-to-OTC switch of Oxytrol through NDA submission and FDA Advisory Committee approval, creating a new access pathway for women with overactive bladder (OAB).
- Initiated and managed multiple early-phase switch programs, aligning regulatory, clinical, and commercial strategies.
- Drove cross-functional collaboration with marketing, medical, and regulatory teams to position new categories for sustainable access and growth.
- Leveraged professional networks and industry knowledge to strengthen stakeholder engagement.
- Spearheaded innovative approaches to resource allocation and strategic planning.
- Recruited, hired, and trained initial personnel, working to establish key internal functions and outline scope of positions for new organization.
Clinical Research Lead
Merck
West Point, PA
01.2002 - 01.2009
- Directed clinical programs for safety, efficacy, pharmacokinetics, pharmacodynamics, and bioequivalence, enhancing self-care practices.
- Designed consumer behavior programs focusing on self-selection, label comprehension, and actual use to promote safe usage.
- Supported multiple NDA and AdCom milestones by integrating evidence to highlight public health benefits.
- Emphasized value of access in clinical program development to improve overall healthcare outcomes.
Project Lead, Data Management
Merck
West Point, PA
08.1998 - 01.2002
- Directed Pepcid clinical data strategy, focusing on design, collection, and standards.
- Implemented CDISC to ensure submission-ready, high-integrity datasets.
- Managed 10 data managers across pharmaceutical and consumer portfolios to drive project success.
- Presented findings at investigator meetings to share insights and foster collaboration.
Education
PhD - Public Health/Epidemiology
Walden University
Minneapolis, MN 08.2023 - Current
M.S. - Environmental Biology
University of Pennsylvania
Philadelphia 09.2000 - 05.2003
B.S. - Science Education (Psychology minor)
Indiana University of Pennsylvania
Indiana05-1991
Skills
- Scientific and regulatory strategy
- Rx-to-OTC switch innovation
- Evidence generation and value communication
- FDA advisory committees
- IND/NDA and labeling strategy
- Consumer behavior studies
- PK/PD/BE study design
- Cross-functional leadership
- Public health and health equity
- Policy and stakeholder engagement
- CDISC and data integrity
- Publications and external representation
Selected Publications
- Lanza F, Replogle A, Stauffer L, Furtek C, Levine JG, Comparison of the onset of the acid-reducing effect of famotidine/antacid combination tablets, omeprazole 20 mg and placebo on gastric pH profiles in healthy volunteers, Am J Gastroenterol, 2003, 98, 9, S51–S52
- Korn SH, Villani M, Tipping RW, Replogle AR, Levine JG, Famotidine 20 mg is superior to Famotidine 10 mg in preventing heartburn symptoms when administered prior to a provocative meal, Gastroenterol, 2004, 126, 4, A-340
- Avins AL, Manos MM, Levin TR, Ackerson LM, Zhao WK, Murphy RC, Watson DJ, Hwang PMT, Replogle AR, Levine JG, Lovastatin is not hepatotoxic to patients with pre-existing liver disease, Gastroenterol, 2006, 130, 4, T-2021
- Replogle A, Midgette P, Levy S, Levine J, Hemwall E, SELECT: A Case Study in Innovative Consumer Behavior Study Strategies, Self Care, 2010, 1, 4, 124–135
- Brass EP, Vassil T, Replogle A, Hwang P, Rusche S, Shiffman S, Levine JG, Can consumers self-select for appropriate use of an over-the-counter statin? The Self Evaluation of Lovastatin to Enhance Cholesterol Treatment (SELECT) Study, Am J Cardiol, 2008, 101, 10, 1448–55
- Hemwall E, Replogle A, Neumann S, Licata K, Vassil V, Nonprescription oxybutynin transdermal patch: Improving self-care options for overactive bladder in women, Self Care, 2013, 4, 3, 66–74
Timeline
PhD - Public Health/Epidemiology
Walden University
08.2023 - Current
Science Strategy Leader
Bayer Consumer Health
01.2014 - Current
Director & Switch Program Leader
Merck
01.2009 - 09.2014
Clinical Research Lead
Merck
01.2002 - 01.2009
M.S. - Environmental Biology
University of Pennsylvania
09.2000 - 05.2003
Project Lead, Data Management
Merck
08.1998 - 01.2002
B.S. - Science Education (Psychology minor)
Indiana University of Pennsylvania