Advancing the Science of Study Endpoints
- Head, Patient Reported Outcomes
- RTI Health Solutions, United States
Alan Shields, PhD
- Vice President Patient Centered Outcomes
- Adelphi Values, United States
Alan is Vice-president at Adelphi Values, a global health outcomes consultancy, and is trained as a clinical psychologist with emphasis in research methods, instrument development, and psychometrics. He has 20 years of experience in clinical research focusing on PRO questionnaire development, implementation, and evaluation. As an industry consultant, Alan works cross-functionally with sponsors to implement PRO and other COA instruments for use in regulated trials to support labeling, achieve product differentiation, and inform patient, physician, and payer decisions. Alan received his PhD from the University of Montana and completed his clinical training at McLean Hospital in the Harvard Medical School.
Diane M Turner-Bowker, PhD
- Engagement Leader
- Quintiles, United States
Chad Gwaltney, PhD
- Gwaltney Consulting, United States
Chad Gwaltney, Ph.D. is President and Principal Consultant at Gwaltney Consulting. Dr. Gwaltney develops innovative methods to measure patient-centered outcomes in clinical trials. His academic and industry research include the design of electronic platforms for the collection of information in real-time in the patient’s natural environment. He has published numerous articles and book chapters addressing how the patient’s perspective can be examined to better understand medical product efficacy and safety. He has served on US NIH review committees and has co-authored ISPOR best practice guidelines on the development and use of patient-reported outcomes.
David Cella, PhD
- Professor, Department of Medical Social Sciences
- Northwestern University, United States
Daniel Eek, PhD
- Patient Reported Outcomes Director
- AstraZeneca, Sweden
Harris Kaplan, MBA
- Managing Partner
- Red Team Associates, Div of Healogix, United States
Elektra Johanna Papadopoulos, MD, MPH
- Division of Clinical Outcome Assessment, OND, CDER
- FDA, United States
Dr. Papadopoulos serves as the Associate Director of the Clinical Outcome Assessments Staff in the Office of New Drugs in the Center for Drug Evaluation and Research (CDER). The staff provides consultation to CDER’s Review Divisions as well as other FDA Centers on clinical outcome assessments (COAs) regarding their development, validation, interpretation and overall suitability to support labeling claims and also manages the COA drug development qualification program.
John H. Powers, MD, FACP
- Professor of Clinical Medicine
- George Washington University School of Medicine, United States
Dr. Powers is a physician/investigator and an internist and specialist in infectious diseases. Dr Powers has particular expertise in the design, conduct and analysis of clinical trials and has published numerous articles and book chapters in this area.
- Global Head of Patient-Centered Outcomes Research for Oncology Prod. Dev.
- Genentech, A Member of the Roche Group, United States
Elizabeth Lauren Lindner
- Clinical Trial Manager, II
- Sucampo Pharma Americas, United States
- Cancer Patient Advocate
- Cancer Information and Support Network, United States
Paul Kluetz, MD
- Deputy Director of the Oncology Center of Excellence, CDER
- FDA, United States
Paul Kluetz is a medical oncologist and the Associate Director of Patient Outcomes in the Oncology Center of Excellence at the U.S. FDA. His interests include defining clinical benefit in oncology trials, the use of expedited programs such as accelerated approval, and opportunities and challenges associated with patient reported outcomes (PRO) data, wearable technologies, and other methods to obtain data on the patient experience both in the clinical trial and “real-world” settings. He is currently leading a team to develop regulatory science and policy initiatives to advance patient-focused drug development in cancer trials.
Ashley F. Slagle, PhD, MS
- Principal, Scientific and Regulatory Consulting
- Aspen Consulting, LLC, United States
Ashley Slagle, Principal of Aspen Consulting, LLC, provides strategic regulatory and scientific advice to drug product developers on matters related to patient-focused drug development, with a particular focus on patient-relevant endpoints and Clinical Outcome Assessments (COAs). Previously, she served as Scientific Coordinator for the FDA/CDER Drug Development Tool COA qualification program. She also provided recommendations on COAs submitted to FDA/CDER through the IND/NDA/BLA pathways across all therapeutic review divisions, and participated in FDA policy and guidance development. Dr. Slagle received her PhD in Pharmaceutical Health Services Research from the University of Maryland, Baltimore.
Gina Calarco, BSN, MPH
- Director of Pediatric Strategy and Planning
- Covance, United States
Gina Calarco is Director of Operational Strategy and Planning for the Rare Disease and Pediatric Team at Covance. She is a nurse and received her MPH from the University of Kansas. She is an affiliate member of the American Academy of Pediatrics Section on Advances in Therapeutics and Technology and holds a coordinator certification through ACRP. Her main area of focus and interest throughout her career has been pediatric clinical research. In addition, Gina is an experienced and certified yoga and meditation instructor and brings that knowledge and skill set to her work in clinical research.
Linda S. Deal, MS
- Head of Patient-Centered Outcomes Measurement
- Pfizer Inc., United States
Linda currently serves as PCOA Lead working across Pfizer’s therapeutic categories addressing efforts to develop, validate and use COAs as endpoints for providing evidence of medical treatment benefit differentiation, labeling and value. Linda has served patients and the pharmaceutical industry for the past 20 years in similar roles at Wyeth, Janssen, Shire and Pfizer. Linda has developed and/or validated COAs across multiple therapeutic categories. Linda is trained as a statistician.
Marianne Clancy, MPA
- Executive Director
- Cure HHT, United States
Lori McLeod, PhD
- Head, Psychometrics
- RTI Health Solutions, United States