Andrea Meyers
Amgen
Ridgefield,CT
21
years of professional experience
Experienced epidemiologist and observational study researcher driving impactful and innovative real-world evidence strategy. Thoughtful colleague with a proven history of leading high-performing teams and executing strategic initiatives that drive team development and professional growth. Demonstrated leadership and communication skills that fostered stakeholder confidence, collaborative and respectful culture and execution and successful delivery of high value and impactful results.
Work History
Director, Center for Observational Research
2 Years 10 Months- Global Product Lead (GPL) for priority, rare disease biologic, for the management of 3 newly approved neuromuscular and inflammatory indications (i.e., IgG4-RD, NMOSD and gMG) and 3 pipeline indications (i.e., PMN, rAIH, and CIPD).
- Spearheaded real-world evidence initiatives for inebilizumab-cdon (Uplizna®) portfolio - approved and pipeline indications.
- Offered strategic and scientific direction to team members, shaping recommendations and executing scientifically sound, value-focused real-world evidence solutions for cross-functional stakeholders.
- Facilitated navigating stakeholder engagements, research priorities and timelines, protocol and SAP development and approval, socialization of study concepts to achieve stakeholder alignment and funding commitments.
- Oversaw multi-year contracts with vendors and academic partners with an approximate total value of $10M.
- Supported all regulatory submissions involving PASS and PMR protocols and study reports, FDA and EMA information requests, ODD applications, FDA briefing documents, and PIPs. Provided all epidemiological work for successful securing an ODD for IgG4-RD.
- Developed, validated and applied algorithms for identifying patients with IgG4-RD earlier in the disease process. Goal to diagnose patients earlier and reduce misdiagnosis and improve clinical management by treating earlier and more effectively.
- Implemented innovative data methodologies such as AI-driven platforms and analytics in developing product registries, developing predictive models for early patient identification, risk factors for disease progression and treatment switching and burden.
- Directed Amgen's natural history study of IgG4-RD in the US and UK. Developed and presented comprehensive study proposals, securing endorsement from cross-functional teams and senior leadership.
Articulated the significant value of these initiatives for enhancing healthcare professional understanding of the disease. - Developed research posters for annual Congresses, such as AAN, AANEM, ACR, APA, ECTRIMS, EULAR, UEGW in 2025 and 2026.
- Directed a team of 5, composed of epidemiologists, health economist, safety scientist and pharmacists.
- Thoughtful people leader passionate about the development, growth, interests and success of team members.
- Member of several CfOR decision-making bodies, such as its Extended Leadership Team, Talent and Culture Team, Hiring Team, Program Review Team and the Observational Research Review Group (ORRG) which reviewed the scientific and strategic qualities of protocols.
Director, Epidemiology and Real-World Evidence
5 Months- Led development and implementation of real-world evidence generation activities to enhance Horizon's rare disease pipeline (e.g., IgG4-RD, gMG, NMOSD, Sjögren's Disease, CIDP, and SLE).
- Collaborated with epidemiology, medical affairs and clinical development colleagues on defining the target patient populations with Sjögren's for the Phase 3 clinical trials for dazodalibep.
- Led cross-functional teams to drive strategic initiatives and enhance organizational performance.
- Engaged cross-functional teams, including clinical development, regulatory, medical affairs, commercial, and safety, to identify evidence gaps and implement effective solutions.
- Delivered insights from observational studies in collaboration with epidemiology colleagues, enhancing understanding of patient characteristics and treatment patterns across multiple rare diseases. Produced comprehensive estimates of incidence and prevalence for conditions like systemic lupus erythematosus, lupus nephritis, generalized myasthenia gravis, thyroid eye disease, uncontrolled gout, and IgG4-related disease. Identified critical unmet needs and assessed clinical impacts within diverse patient populations suffering from numerous rare diseases.
- Oversaw development and submission of J-NDA and ODD applications, enabling successful Tepezza market entry in Japan.
- Collaborated with leadership teams to drive initiatives in safety, clinical development, evidence generation, and global brand planning.
- Collaborated with safety and regulatory professionals to evaluate risks and formulate effective mitigation strategies for long-term safety studies.
- Facilitated growth and visibility of epidemiologists and analysts through customized development plans and leadership opportunities.
- Oversaw the refinement and modernization of standard operating procedures to improve the efficiency of observational studies using both primary and secondary data.
Director, Medical and Payer Evidence
1 Year 1 Month- Collaborated with cross-functional teams on innovative, evidence-driven and impactful real-world evidence strategy for respiratory and immunology therapeutic area, and conducted non-interventional research to support approved strategy.
- Served as Medical Evidence Lead for novel biologic pipeline asset for chronic obstructive pulmonary disease and acute respiratory failure.
- Synthesized priority evidence gaps identified by clinical development colleagues as well as key opinion leaders, and developed integrated and phased strategies, to enhance enrollment, design of several clinical trials and strengthen regulatory submissions.
- Spearheaded evidence workshops for cross-functional teams with the aim of communicating the value of real-world data and evidence and brainstorming leveraging real-world data assets.
Div Principal, Epidemiology & Data Analytics
5 Months- Divisional Principal leading a team of 30 epidemiologists, health economists, biostatisticians, data scientists and programmers.
- Oversaw the delivery of a broad range of high-quality real-world evidence solutions by team members per expectations of pharma clients.
- Accountable for the implementation of three Centers of Excellence (COE) within the Health Economics, Epidemiology and Data Analytics organization. These COEs included: Chart Review Studies and Survey Design; Database Studies.
- Accountable for meeting multi-million dollar sales targets, and leading capability presentations to potential clients.
Sr. Principal, Epidemiology & Data Analytics
1 Year 5 Months- Coordinated comprehensive portfolio of epidemiological research and data analysis efforts, ensuring adherence to research standards and methodologies.
- Enhanced real-world evidence solutions and business offerings resulting in improved team effectiveness. Implemented a strategic team structure that maximized members' expertise and experience. Fostered leadership development opportunities for team members, leading to greater project impact.
- Directed team efforts to meet and exceed established business and sales objectives.
- Directed efforts to modernize resource management and update procedures in alignment with compliance requirements.
- Directed efforts in establishing and operationalizing center of excellence teams focused on advancing skills in systematic literature reviews, conducting observational studies, and developing qualitative surveys.
- Led team efforts on successful bid defenses and capabilities meetings.
- Crafted research proposals to address RFPs, supporting evidence generation and data source evaluation across diverse therapeutic areas.
- Delivered strategic and scientific insights for projects, driving successful outcomes. Managed relationships with key clients on research projects, facilitating regulatory submissions and ensuring alignment with industry standards.
Consultant, Real World Evidence Solutions
3 Months- Engaged with clients to assess strategic requirements and formulate bespoke real-world evidence strategies.
- Designed and implemented data-driven real-world evidence generation plans in partnership with clients, ensuring alignment with key priorities and deadlines.
- Performed in-depth evaluations of database capabilities to ensure alignment with requirements for natural history research.
- Delivered comprehensive study protocols that enhanced understanding of clinical burden and unmet needs. Facilitated in-depth analysis of natural history and treatment patterns, contributing to improved healthcare strategies. Achieved clarity in burden of disease assessments through structured research methodologies.
- Crafted and delivered impactful presentations to clients, aimed at communicating project outcomes and actionable insights.
- Developed targeted educational content focusing on real-world evidence and disease state knowledge to empower field medical staff in their roles.
Director, Epidemiology and Real World Evidence
2 Years 9 Months- Supported US and Global Product Teams on pipeline and approved indications in cardiovascular, renal and metabolic therapeutic areas.
- Spearheaded real-world evidence generation activities to support expanded indications.
- Collaborated with cross-functional teams on feasibility and strategic value of proposed RWE plan and tactics.
- Presented integrated evidence plans and comparative effectiveness studies to governance teams and senior management for endorsement.
- Collaborated with key clinical and methodological experts on developing and validating claims-based algorithms for clinical outcomes for use in safety and effectiveness studies.
- Developed observational study protocols and SAPs, executed studies, disseminated results and provided data driven insights and recommendations.
- Global Process Owner (GPO) for simplification and implementation of new SOPs on conducting observational studies based on primary and secondary data collection.
- Contributed to writing and submitting regulatory submissions (e.g., PASS, PMRs, ODDs, RMPs, PIPs)
- Author on published manuscripts and congress posters.
- Collaborated with Medical Affairs teams on developing and facilitating advisory board activities.
- Co-led and facilitated two annual real-world evidence workshops.
Director, Real World Evidence, Value and Access
1 Year 4 Months- Senior epidemiologist on observational studies, spanning a breadth of therapeutic areas (e.g., rare disease, metabolic, cardiovascular, ophthalmology, oncology, and respiratory) study designs and research objectives, and leveraging various data sources (e.g., claims, EHR, patient reported outcomes, and surveys).
- Developed high-performing team by providing mentoring, scientific guidance and opportunities for professional growth.
- Lead epidemiologist on RWE activities in support of client regulatory submissions, including post-market Aggregate & Periodic Reports, RMPs and REMS, and PASS/PMR safety studies.
- Developed study protocols, SAPS, physician surveys, data abstraction instruments for observational studies.
- Developed medical communications material for marketed products.
Senior Research Associate
1 Year- Conducted real-world evidence research and analytics, spanning safety and effectiveness, treatment patterns, clinical and economic burden of disease, natural history of disease and targeted and systematic literature reviews.
- Ensured quality of research deliverables, managed timelines, budget and scope of work.
- Prepared research protocols and associated SAPs, evaluation of data sources for conducting observational studies based on secondary data.
- Prepared study reports, interpreted and communicated study results and recommendations to clients.
- Supported initiative to develop guidance documentation and knowledge materials for developing SAPs, study protocols and key data elements for study conduct.
- Co-developed the inaugural Observational Protocol Review Committee (OPRC).
- Co-lead on internal knowledge sessions on epidemiologic study designs, methodologies and statistical analysis.
- Presented research proposals to potential clients and external partners.
Director and Ophthalmology TA Lead
2 Years 1 Month- Lead epidemiologist and outcome researcher for ophthalmologic therapeutic area.
- Developed and executed upon real-world strategy supporting life-cycle management (Phase 1 through Phase 4) for back-of-eye products.
- Collaborated on observational research projects with HEOR colleagues to describe clinical and economic burden of ocular disorders (e.g., glaucoma/refractory glaucoma, retinal vein occlusion, diabetic macular edema, posterior segment uveitis).
- Developed KAB (Knowledge, Attitudes, Behavior) Survey for physician comprehension and attitudes towards medical communication materials.
- Provided epidemiological insights to support global development, product value substantiation, commercialization and regulatory submissions.
- Updated SOPs and work instructions for conducting observational studies and RMPs that were implemented across various real-world evidence generation teams.
- Prepared epidemiology responses to FDA and EMA information requests and attended discussions with FDA as subject matter expert.
- Provided scientific and development guidance to more junior epidemiologists and safety scientists.
Senior Epidemiologist
1 Year- Principal epidemiologist supporting development of Oracle analytic tools for, safety signal detection and evaluation, incidence/prevalence estimation, outcomes research, and treatment patterns, leveraging large claims data sources.
- Provided insights, guidance and translation of fundamental study design, methodologies and statistical tests to application developers and programmers to build capabilities into Oracle software.
- Contributed to defining requirements and testing approaches for Oracle health analytics platforms. Developed use case scenarios with statisticians to evaluate performance of software.
- Collaborated with colleagues on enhancing data mining, analytics and visualization products.
Associate Director, Global Epidemiology
5 Years 11 Months- Lead epidemiologist on pre- and post- marketing BMS drugs within the cardiovascular and oncology therapeutic areas.
- Provided real-world evidence consultation (with focus on epidemiology and outcomes research) to cross-functional stakeholders, including clinical development, pharmacovigilance, medical affairs and regulatory.
- Designed and conducted epidemiological activities to evaluate potential safety signals observed in clinical trials.
- Member of alliance team supporting joint AstraZeneca and BMS clinical trials.
- Member of protocol review committee for epidemiology and health economics studies.
- Worked closely with HEOR counterparts on comprehensive and integrated real-world evidence plans.
- Worked with fit-for-purpose population-based data sources to conduct observational research.
- Developed RFPs for outsourced real-world evidence projects and assessed vendor proposals.
- Supported all regulatory documents and submissions on assigned products. Developed FDA Risk Evaluation and Mitigation Strategies for key BMS products.
Education
Doctor of Public Health - Epidemiology
Master of Public Health - Environmental Health
Skills
Planning and execution of real-world evidence initiatives
Conducting Data Feasibility Assessments
Conducting Natural History Studies
Product and Disease Registry Development
Comparative Effectiveness Study Design and Causal Inference
Protocol and SAP Development
Stakeholder Relationship Building and Management
Clear Communication of Observational Research and Results Interpretation
Empathetic leadership
Conducting PASS/PMR studies
Regulatory Documents and Submission Experience
Disease State Expertise Across Multiple Therapeutic Areas
Publications
Need to put together list of publications and posters.
Timeline
Director, Center for Observational Research
Amgen
10.2023 - 08.2026Read More
Director, Epidemiology and Real-World Evidence
Legacy Horizon Therapeutics
05.2023 - 10.2023Read More
Director, Medical and Payer Evidence
AstraZeneca Pharmaceuticals
02.2022 - 03.2023Read More
Div Principal, Epidemiology & Data Analytics
ICON, Plc
09.2021 - 02.2022Read More
Sr. Principal, Epidemiology & Data Analytics
ICON, Plc
04.2020 - 09.2021Read More
Consultant, Real World Evidence Solutions
Freelance
01.2020 - 04.2020Read More
Director, Epidemiology and Real World Evidence
Boehringer Ingelheim Pharmaceuticals
02.2017 - 11.2019Read More
Director, Real World Evidence, Value and Access
Ipsos Healthcare
10.2015 - 02.2017Read More
Senior Research Associate
PPD Evidera Solutions
10.2014 - 10.2015Read More
Director and Ophthalmology TA Lead
Allergan Pharmaceuticals
04.2012 - 05.2014Read More
Senior Epidemiologist
Oracle Health Sciences
04.2011 - 04.2012Read More
Associate Director, Global Epidemiology
Bristol Myers Squibb
04.2005 - 03.2011Read More
Columbia University, Mailman School of Public Health
Doctor of Public Health from Epidemiology
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Columbia University, Mailman School of Public Health
Master of Public Health from Environmental Health
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