COA Annual Meeting Resources

2026 COA Annual Meeting

C-Path’s Clinical Outcome Assessment (COA) Program recently held its Annual Meeting in Rockville, MD. Roughly 300 attendees gathered for two days of sessions and discussions on the methodologies and strategies that will advance drug development and regulatory approaches in COAs across a wide range of therapeutic areas.

This year’s meeting brought together leaders from across industry, regulatory agencies, academia, patient organizations, and technology and allied service partners to advance the science and application of COAs in medical product development. Building on the strong engagement and momentum from last year, the 2026 program featured deep-dive sessions, case studies, and multi-stakeholder discussions on pressing issues in the field, including:

Using patient experience data to inform value assessment for access decision making
Pulling back the curtain: Multi-stakeholder insights on electronic clinical outcome assessment implementation
Incorporating the patient voice into clinical trial design: More than just checking the box
From meaningful aspect of health to metric to endpoint: How multidisciplinary teams form a comprehensive approach to digitally-derived endpoints
Revisiting meaningful change: Current thinking on establishing and applying benchmark
Addressing challenges in rare disease clinical trials: Methodological case studies

Please see the detailed recap, complete with session recordings and presentations below:

2026 Clinical Outcome Assessment Program Annual Meeting

Agenda – Day 1


8:00 – 9:00 a.m.	Registration and Breakfast – Veranda (Outside Salon E-H)
9:00-9:15 a.m.	Welcome Cheryl D. Coon, PhD – Vice President, Clinical Outcome Assessment Program, Critical Path Institute Klaus Romero, MD – Chief Executive Officer and Chief Science Officer, Critical Path Institute
9:15-10:15 a.m.	Update on FDA’s COA Qualification Program, ISTAND Program, and Patient-Focused Drug Development Initiatives Presenters: Robyn Bent, RN, MS – Director, Patient-Focused Drug Development Program, Center for Drug Evaluation and Research, U.S. Food and Drug AdministrationMichelle Campbell, PhD – Associate Director for Stakeholder Engagement and Clinical Outcomes, Office of Neuroscience, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug AdministrationSelena Daniels, PharmD, PhD – Deputy Division Director, Division of Clinical Outcome Assessment, Office of Drug Evaluation Sciences, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration David S. Reasner, PhD – Division Director, Division of Clinical Outcome Assessment, Office of Drug Evaluation Sciences, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration Vanitha Sekar, MS, PhD – Division Director, Division of Biomedical Informatics, Research, and Biomarker Development, Office of Drug Evaluation Sciences, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
10:15-10:30 a.m.	Spotlight: Best practice recommendations and considerations for designing and electronically implementing event-driven diaries in clinical trials Presenter: Florence Mowlem, PhD – Chief Scientific Officer, uMotif Q & A
11:00 a.m.–12:15 p.m.	Incorporating the Patient Voice into Clinical Trial Design: More Than Just Checking the Box Moderator: Nicki Bush, MHS – Global Head, Endpoint Strategy and COA Measurement, Patient-Centered Outcomes, OPEN HealthPresenters: Pujita Vaidya, MPH – Director, Regulatory Science and Policy, North America, SanofiAmanda Decoker, MA – Sr. Director, Head of Patient Engagement, Experience and Recruitment, TakedaPanelists: Cynthia Grossman, PhD – Division Director, Division of Patient-Centered Development, Center for Devices and Radiological Health, US Food and Drug AdministrationSamantha Parker, MBA – Patient Engagement Lead, Italfarmaco & Vice-Chair International Rare Disease Research ConsortiumDominique Pichard, MD, MS – Chief Science Officer, International Rett Syndrome FoundationQ & A
1:30–1:45 pm	Patient-Centered Evidence Consortium Update Sonya Eremenco, MA – Executive Director, Patient-Reported Outcome Consortium, Critical Path Institute
1:45–3:00 p.m.	Pulling Back the Curtain: Multi-stakeholder Insights on Electronic Clinical Outcome Assessment Implementation Moderator: Scottie Kern – Executive Director, Electronic Clinical Outcome Assessment Consortium, Critical Path Institute Panelists: Caroline Anfray – Principal, Head of COA Author Collaborations and Licensing Services, IQVIA Jennifer Cook – Senior Project Manager, Accellacare Site Network Lynn Germscheid – Associate Director, eCOA Management GDM, Bristol Myers Squibb Paul O’Donohoe – Senior Director, eCOA Product and Science, Medidata Solutions Alexandros Rokotas – Expert eCOA Project Manager, Bayer Q & A
3:30–3:45 p.m.	Rare Disease Clinical Outcome Assessment Consortium Update Lindsey Murray, PhD, MPH – Executive Director, Rare Disease Clinical Outcome Assessment Consortium, Critical Path Institute
3:00–4:30 pm	Expanding the Toolbox to Interpret the Meaningfulness of Treatment Effects Moderator: Fraser Bocell, MEd, PhD – Senior Clinical Outcome Assessment Scientist, Clinical Outcome Assessment Program, Critical Path Institute Panelists: Kim Cocks, PhD – Senior Director, Patient-Centered Outcomes, Adelphi Values Andrew Trigg, MSc – Statistical Innovation Lead, Bayer Kevin P. Weinfurt, PhD – James B. Duke Distinguished Professor of Population Health Sciences, Duke University School of Medicine Q & A

Agenda – Day 2


7:30–8:30 am	Registration and Breakfast – Veranda (Outside Salon E-H)
8:30–8:45 am	Welcome and Electronic Clinical Outcome Assessment Consortium Update Scottie Kern – Executive Director, Electronic Clinical Outcome Assessment Consortium, Critical Path Institute
8:50–10:00 a.m.	Using Patient Experience Data to Inform Value Assessment for Access Decision Making Moderator: Ebony Dasheill-Aje – Executive Director & Head, Patient Centered Outcomes Science (PCOS), BioMarin Presenters: Jessica Abel, MPH – Director, Patient Experience Data Policy and Best Practices, AbbVie Iyar Mazar, PhD – Director of Patient-Centered Outcomes Assessment, Pfizer Leah Howard, JD – Chief Executive Officer, National Psoriasis Foundation Panelists: Dana McCormick – Senior Director, Practice Strategy & Innovation, AMCP Q & A
10:30–11:30 a.m.	Navigating Methodological Challenges in Rare Disease Clinical Trials: Lessons from Real-World Case Studies Moderator: Lindsey Murray, PhD, MPH – Executive Director, Rare Disease Clinical Outcome Assessment Consortium, Critical Path InstitutePresenters: Nicola Williamson, MSc –Patient Centered Outcomes Research Lead, UCBBryce Reeve, PhD – Professor, Population Health Science and Pediatrics, Duke University School of MedicinePanelists: Michelle Campbell, PhD – Associate Director for Stakeholder Engagement and Clinical Outcomes, Office of Neuroscience, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug AdministrationSue Vallow, MBD, MA – Senior Director Patient Centered Evidence, AgiosTerry Jo Bichell, PhD – Chief Executive Officer, COMBINEDBrain
11:30 a.m.-12:30 p.m .	How Multidisciplinary Teams Form a Comprehensive Approach to Digitally-derived Endpoints Moderator : Cheryl D. Coon, PhD – Vice President, Clinical Outcome Assessment Program, Critical Path Institute Presenters: Tom Willgoss, PhD – Immunology Lead, Roch Products, Ltd Marie McCarthy – Digital Endpoint Lead Director, Novartis Panelists: Andrew Potter, PhD – Associate Director, Biostatistics, BMS Abigail Newell, PhD – Senior Director, Research, Cancer Support Community Liam Kaufman, MS – Executive VP, Partnerships and Strategic Projects, Cambridge Cognition Q & A

2025 COA Annual Meeting

2025 Clinical Outcome Assessment Program Annual Meeting

April 9-10, 2025

Bethesda North Marriott Hotel & Conference Center
5701 Marinelli Rd
Rockville, MD 20852

Agenda – Day 1


7:30–8:30 am	Registration and Breakfast – Veranda (Outside Salon E-H)
8:30–8:40 am	Welcome Cheryl D. Coon, PhD – Vice President, Clinical Outcome Assessment Program, Critical Path Institute
8:40–9:00 am	FDA Update Presenters: Robyn Bent, RN, MS – Director, Patient-Focused Drug Development Program, Center for Drug Evaluation and Research, U.S. Food and Drug Administration David S. Reasner, PhD – Division Director, Division of Clinical Outcome Assessment, Office of Drug Evaluation Sciences, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
9:00–10:15 am	Session 1: Current thinking on the accessibility and burden of eCOA & DHT system use Moderator: Scottie Kern – Executive Director, Electronic Clinical Outcome Assessment Consortium, Critical Path Institute Presenters: Lee Aiyegubsu, MBChB, PhD – Associate Professor and Deputy Director, Centre for Patient-Reported Outcomes Research (CPROR), University of Birmingham, UK Alisa Heinzman, MFA – Senior Project Manager, Electronic Clinical Outcome Assessment Consortium, Critical Path Institute Panelists: Katy Benjamin, SM, PhD – Senior Principal Scientist, Patient Centered Endpoints and Strategies (PaCES), Merck & Co., Inc. Ian Pallett, BSc, HNC – Sensor Solutions Director, Parexel Q & A
10:15–10:45 am	Break
10:45–12:15 pm	Session 2: The potential of AI for COA development and deployment in clinical trials Moderator: Fraser Bocell, MEd, PhD – Senior Clinical Outcome Assessment Scientist, Clinical Outcome Assessment Program, Critical Path Institute Presenter: Cole Ayasse, PhD – Clinical Outcome Assessment Scientist, Clinical Outcome Assessment Program, Critical Path Institute Panelists: Lynn Brielmaier, BSEET – Person living with amyotrophic lateral sclerosis (PLWALS) Jarjieh Fang, MPH – Senior Manager, Senior Manager, Patient-Centered Outcomes Assessment (PCOA), Pfizer, Inc. Kelly McCarrier, PhD, MPH – Senior Director and Global Lead – Qualitative Research, OPEN Health Group Jonathan Norman, PGDip – Director, Localization Services, YPrime Q & A
12:15–1:30 pm	Lunch – Veranda (Outside Salon E-H)
1:30–2:10 pm	Patient-Focused Drug Development at the Center of C-Path’s Solutions Cheryl D. Coon, PhD – Vice President, Clinical Outcome Assessment Program, Critical Path Institute Klaus Romero, MD – CEO, Critical Path Institute Diane Stephenson, PhD – Vice President, Neurology, Executive Director, Critical Path for Parkinson’s, Critical Path Institute Collin Hovinga, PharmD, MS, FCCP – Vice President, Rare and Orphan Disease Programs, Critical Path Institute
2:10–2:30 pm	Patient-Reported Outcome Consortium Update Sonya Eremenco, MA – Executive Director, Patient-Reported Outcome Consortium, Critical Path Institute
2:30–3:00 pm	Break
3:00–4:30 pm	Session 3: Regulatory pathways for using patient experience data: Navigating benefit risk assessment pre-approval and communications consistent with labeling post approval Moderator: Robyn Carson, MPH – Vice President & Head, Patient-Centered Outcomes Research and HEOR-Strategy Aesthetics, AbbVie Presenters: Niklas Karlsson, PhD – Senior Director, Patient Centered Science Respiratory & Immunology, AstraZeneca Denise Sánchez Palomo, JD, MS, MA – Principal Consultant, Opus Regulatory Jonathan Stokes, MBA – Senior Director, Patient-Centered Outcomes Research, AbbVie Panelists: Charu Gandotra, MD, MS, FACC, FASE – Acting Associate Director for Therapeutic Review, Division of Cardiology and Nephrology, Office of Cardiology, Hematology, Endocrinology and Nephrology, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration David S. Reasner, PhD – Division Director, Division of Clinical Outcome Assessment, Office of Drug Evaluation Sciences, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration Tricha Shivas, MBe – Chief of Staff and Strategy, Foundation for Sarcoidosis Research Q & A
4:30–4:35 pm	Day 1 Closing Remarks Cheryl D. Coon, PhD – Vice President, Clinical Outcome Assessment Program, Critical Path Institute
4:35–5:00 pm	Open
5:00–6:30 pm	20th Anniversary Celebration/Reception – Foyer E-H and Veranda

Agenda – Day 2


7:30–8:30 am	Registration and Breakfast – Veranda (Outside Salon E-H)
8:30–8:50 am	Welcome and Electronic Clinical Outcome Assessment Consortium Update Scottie Kern – Executive Director, Electronic Clinical Outcome Assessment Consortium, Critical Path Institute
8:50–10:00 am	Session 4: Implementation insights in rare disease clinical outcome assessment Moderator: Lindsey Murray, PhD, MPH – Executive Director, Rare Disease Clinical Outcome Assessment Consortium, Critical Path Institute Panelists: Kayci Capps, MEd – Dravet Patient Advocate, Dravet Syndrome Foundation Lisa Dilworth, BS, MAS – Vice President, Disease Monitoring Program Strategy and Management, Ultragenyx Diana Rofail, PhD, CPsychol, MBA – Global Head of Patient-Centered Outcomes Research & Digital Health (PCOR-DH), Regeneron R.J. Wirth, PhD – CEO & Managing Partner, Vector Psychometric Group, LLC Q & A
10:00–10:30 am	Break
10:30–10:45 am	Rare Disease Clinical Outcome Assessment Consortium Update Lindsey Murray, PhD, MPH – Executive Director, Rare Disease Clinical Outcome Assessment Consortium, Critical Path Institute
10:45–12:15 pm	Session 5: Using patient-centered evidence to inform decision making across the drug development lifecycle: navigating a varied landscapeModerator: Sonya Eremenco, MA – Executive Director, Patient-Reported Outcome Consortium, Critical Path Institute Presenters: Chantal Quinten, PhD – Senior Expert in Health Analytics, European Medical Agency Benoit Arnould, PhD – Head, Clinical Outcomes Assessments, Sanofi Lynda Doward, MRes – Vice President & European Head Patient-Centered Outcomes Assessment, RTI Health Solutions Panelists: Cherié Butts, PhD – Senior Medical Director, Biogen Michelle Campbell, PhD – Associate Director, Stakeholder Engagement and Clinical Outcomes, Office of Neuroscience, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration Jen Horonjeff, PhD – Founder and CEO, Savvy Cooperative Dan O’Connor, PhD – Director Regulatory and Early Access Policy, Association of the British Pharmaceutical Industry (ABPI) Matt Reaney, PhD, CPsychol, CSci – Head of Science and Analytics, Patient Centered Solutions (PCS); and Head of PCS Institute, IQVIAQ & A
12:15–12:20 pm	Annual Meeting Wrap Up Cheryl D. Coon, PhD – Vice President, Clinical Outcome Assessment Program, Critical Path Institute
12:20–1:30 pm	Lunch – Veranda (Outside Salon E-H)

Posters summarizing the status of the PRO Consortium’s working groups, the Rare Disease Subcommittee activities, and the ePRO Consortium are available below:

Chronic Heart Failure Working Group

Cognition Working Group

Depression Working Group 2.0

Irritable Bowel Syndrome Working Group

Multiple Sclerosis Working Group

Pediatric Asthma Working Group

Rheumatoid Arthritis Working Group

Small Cell Lung Cancer Working Group

Rare Disease COA Consortium

eCOA Consortium

2024 COA Annual Meeting

2024 Clinical Outcome Assessment Program Annual Meeting

April 17-18, 2024

Bethesda North Marriott Hotel & Conference Center
5701 Marinelli Rd
Rockville, MD 20852

On April 17-18, 2024 the Clinical Outcome Assessment Program Annual Meeting was held in Rockville, MD.

The following agenda provides an overview of the day-and-a-half-long meeting as well as links to the session recordings, slide decks, and posters.

Agenda – Day 1


7:30–8:30 am	Registration and Breakfast – Veranda (Outside Salon E-H)
8:30–8:45 am	Welcome Cheryl D. Coon, PhD – Vice President, Clinical Outcome Assessment Program, Critical Path Institute
8:45–9:15 am	Rare Disease Clinical Outcome Assessment Consortium Update Lindsey Murray, PhD, MPH – Executive Director, Rare Disease Clinical Outcome Assessment Consortium, Critical Path Institute
9:15–10:30 am	FDA Update Moderator: Michelle Campbell, PhD –Associate Director, Stakeholder Engagement and Clinical Outcomes, Office of Neuroscience, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration Presenters: Robyn Bent, RN, MS – Director, Patient-Focused Drug Development Program, Center for Drug Evaluation and Research, U.S. Food and Drug Administration Selena Daniels, PharmD, PhD – Deputy Division Director, Division of Clinical Outcome Assessment, Office of Drug Evaluation Sciences, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration Lili Garrad, PhD – Master Scientist, Patient-Focused Statistical Scientists (PFSS), Division of Biometrics III, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration Jessica Mavadia-Shukla, PhD – Director, Medical Device Development Tools Program, Center for Devices and Radiological Health, U.S. Food and Drug Administration David S. Reasner, PhD – Division Director, Division of Clinical Outcome Assessment, Office of Drug Evaluation Sciences, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
10:30–11:00 am	Break
11:00–12:15 pm	Session 1: Leveraging Digital Health Technology and Partnership Opportunities to Measure Clinical Outcomes That Matter Moderator: Maria Mattera, MPH – Scientific Director, Patient-Reported Outcome Consortium, Critical Path Institute Presenters: Katelyn Keyloun, PharmD, MS – Director, R&D Digital and Data Strategy, AbbVie Chad Gwaltney, PhD – President, Gwaltney Consulting Christine Guo, PhD – Chief Scientific Officer, ActiGraph Panelists: Jen Horonjeff, PhD – Founder and CEO, Savvy Cooperative Dilorom (Delia) Sass, PhD, RN, AGPCNP-BC – Clinical Analyst, Division of Clinical Outcome Assessment, Office of Drug Evaluation Sciences, Office of New Drugs, Center for Drug Evaluation Research, U.S. Food and Drug Administration Michelle Campbell, PhD – Associate Director of Stakeholder Engagement and Clinical Outcomes, Division of Clinical Outcome Assessment, Office of Neuroscience, Office of New Drugs, Center for Drug Evaluation Research, U.S. Food and Drug Administration
12:15–1:30 pm	Lunch – Veranda (Outside Salon E-H)
1:30–2:00 pm	Patient-Reported Outcome Consortium Update Sonya Eremenco, MA – Executive Director, Patient-Reported Outcome Consortium, Critical Path Institute
2:00–3:15 pm	Session 2: eCOA and DHTs in Oncology: Realizing the Digital Dividend Moderator: Scottie Kern – Executive Director, Electronic Clinical Outcome Assessment Consortium, Critical Path Institute Presenters: Ari Gnanasakthy, MBA, MSc – Principal Scientist, RTI Health Solutions Jennifer Lord-Bessen, PhD – Senior Director, Global HEOR Advanced Scientific Capabilities, Patient-Reported Outcomes Assessment (PROA), Hematology-Oncology, Bristol Myers Squibb Florence Mowlem, PhD – Vice President of Science, ObvioHealth; 2024 eCOA Consortium Industry Co-Director Elena Izmailova, PhD – Chief Scientific Officer, Koneksa Health T. J. Sharpe – Patient Engagement Program Manager, Medidata Solutions Panelist: Vishal Bhatnagar, MD – Associate Director for Patient Outcomes, Oncology Center of Excellence, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
3:15–3:45 pm	Break
3:45-5:00 pm	Session 3: Clinical Outcome Assessments Used in Trial Entry, Stratification, and Endpoints: Evidence and Implications to Ensure They’re Fit For Their Purpose Moderator: Cheryl D. Coon, PhD – Vice President, Clinical Outcome Assessment Program, Critical Path Institute Presenters: Cole Ayasse, PhD – Clinical Outcome Assessment Scientist, Critical Path Institute Panelists: Katherine Bevans, PhD – Director, Patient Reported Outcomes, Johnson & Johnson Innovative Medicine Onyeka Illoh, OD, MPH – Team Leader, Division of Clinical Outcome Assessment, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration Gahan Pandina, PhD – Senior Director, Compound Development Team Leader, Johnson & Johnson Innovative Medicine Mitchell Psotka, MD, PhD – Medical Officer, Division of Cardiology and Nephrology, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration RJ Wirth, PhD – CEO & Managing Partner, Vector Psychometric Group, LLC
5:00–5:10 pm	Day 1 Closing Remarks Cheryl D. Coon, PhD – Vice President, Clinical Outcome Assessment Program, Critical Path Institute Adjourn
5:10–5:30 pm	Open
5:30–7:00 pm	Reception – Foyer E-H and Veranda

Agenda – Day 2


7:30–8:30 am	Registration and Breakfast – Veranda (Outside Salon E-H)
8:30-9:00 am	Welcome and Electronic Clinical Outcome Assessment Consortium Update Scottie Kern – Executive Director, Electronic Clinical Outcome Assessment Consortium, Critical Path Institute
9:00–10:15 am	Session 4: Mitigating Challenges in Clinical Outcome Assessments With Multiple Respondents: Sharing Lessons Learned From Across the Clinical Outcome Assessment Program Moderator: Lindsey Murray, PhD, MPH – Executive Director, Rare Disease Clinical Outcome Assessment Consortium, Critical Path Institute Presenters: Lindsey Murray, PhD, MPH – Executive Director, Rare Disease Clinical Outcome Assessment Consortium, Critical Path Institute Adam Scheller, PhD – Senior Scientist, Clinical Outcomes, Denali Therapeutics Claire Trennery, MSc – Associate Director, Patient-Centered Outcomes, Adelphi Values Jill V. Platko, PhD –Vice President, Scientific Services, Suvoda Panelists: Sarita Edwards, MHA – CEO & President, The E.WE Foundation Marian M. Strazzeri, MS – Mathematical Statistician, Patient-Focused Statistical Scientists, Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration Nicole Lyn, MPH – Global Health Economics and Value Assessment Business Partner, Sanofi
10:15–10:45 am	Break
10:45–12:00 pm	Session 5: Patient-Reported Outcome Measurement Now and Into the Future: Multi-Stakeholder Perspectives Regarding the Optimization of Patient-Reported Outcome Data in the Decision-Making Process Across the Healthcare Continuum Moderator: Adam Gater, MSc – Senior Director, Adelphi Values Presenters: Sharan Randhawa, MSc – Senior Research Manager, Adelphi Values Loriana Hernández-Aldama, BA – 2x Survivor, Patient Advocate, ArmorUp for Life John Powers, III, MD – Professor of Clinical Medicine, George Washington University School of Medicine Bellinda King-Kallimanis, PhD – Senior Director of Patient-Focused Research, LUNGevity Foundation Gary Rice, RPh, MS – Senior Advisor of Specialty & Clinical Strategy, MedImpact Healthcare Systems, Inc. Eleanor Perfetto, PhD – Professor, University of Maryland Claire Snyder, PhD – Professor of Medicine, Oncology, and Health Policy & Management, Johns Hopkins University, PROTEUS Consortium (participating as a private consultant) Panelist: Selena Daniels, PharmD, PhD – Deputy Division Director, Division of Clinical Outcome Assessment, Office of Drug Evaluation Sciences, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
12:00–12:15 pm	Annual Meeting Wrap Up Cheryl D. Coon, PhD – Vice President, Clinical Outcome Assessment Program, Critical Path Institute
12:15–1:30 pm	Lunch – Veranda (Outside Salon E-H)