Pat Furlong is the Founding President and CEO of Parent Project Muscular Dystrophy (PPMD), the largest nonprofit organization in the United States solely focused on Duchenne muscular dystrophy (Duchenne). Their mission is to end Duchenne. They accelerate research, raise their voices in Washington, demand optimal care for all young men, and educate the global community.

Bennett Levitan, MD-PhD is Executive Director, Global R&D Epidemiology at J&J. He introduced state of the art patient-focused benefit-risk (B-R) assessment to Janssen and his team has led numerous clinical teams in B-R assessments and patient preference studies. He co-led development of the PhRMA BRAT Framework, the MDIC Patient-Centered B-R Framework, the IMI PREFER public-private partnership and ISPOR's Quantitative B-R Task Force. He serves on committees that inform policy including the ICH Working Group on Patient Preference Studies, MDIC's Science of Patient Input Project and PhRMA's Patient-Focused Drug Development Work Group. He received a B.Sc. (Elec Eng) from Columbia Univ and an M.D.-Ph.D. (Bioengineering) from the Univ of PA.

Elaine H. Morrato, DrPH MPH is a public health expert with a diverse background in industry, academia, and service with the FDA. She is founding dean of the Parkinson School of Health Sciences and Public Health at Loyola University Chicago. She directs the NIH-funded Institute for Translational Medicine at Loyola in collaboration with the University of Chicago and Rush University. Trained in epidemiology and board-certified in public health, Dr. Morrato’s research focuses on accelerating the translation of medical innovation and drug warnings into clinical practice. She chairs the Benefit-Risk Assessment, Communication and Evaluation Special Interest Group for the International Society of Pharmacoepidemiology.

Rebecca (Becky) Noel is currently the Global Leader for Benefit-Risk Assessment at Eli Lilly. Since joining Lilly, Becky has been extensively involved in leading the development of systematic approaches to benefit-risk assessment, both internally at Lilly and externally via the PhRMA Benefit-Risk Action Team (BRAT), the Innovative Medicines Initiative PROTECT project, the International Conference on Harmonization, and via multiple other forums.

Kim McCleary has been at the forefront of patient engagement for more than 30 years. She is a nationally regarded subject matter expert on patient-focused medical product development, patient-centered benefit-risk assessment, and organizational change. Kim has authored scores of publications, served on dozens of steering committees and advisory boards, is a sought-after speaker, and has an extensive network of leadership contacts. Her passion for this work is rooted in personal experience, lived and as a family caregiver. To speed adoption of patient-centricity by life science companies, not-for-profit organizations, and academic research teams, in early 2018 Kim established a professional services firm, The Kith Collective, LLC.

Dr. Metcalf leads GSK’s Centre of Innovation to enhance pharmacovigilance, benefit-risk evaluation, and collaboration with patients. The Centre strives to advance insight, communication, and work practices by engaging with partners inside and outside the company. Dr. Metcalf is a member of GSK’s Global Safety Board and Central Safety Department Leadership Team. She participates in patient/industry/academic alliances including Patients as Partners, DIA Patient Engagement, and TransCelerate.

Meredith is a health services and implementation science researcher with + 20 yrs of experience in the pharmaceutical industry where she has held senior positions in drug safety, health economics and regulatory affairs. Currently, she is a Fellow of the Int. Society for Pharmacoepidemiology, and a faculty member at the Alfred E. Mann School of Pharmacy & Pharmaceutical Sciences at the University of Southern California. Meredith has been an invited participant in numerous risk management workshops and panels sponsored by the US FDA, and has served as a member of CIOMS IX Practical Approaches to Risk Minimisation for Medicinal Products, CIOMS XI Patient Involvement in the Development and Safe Use of Medicines and IMI-PREFER.

Marc Boutin is the Global Head of Patient Engagement at Novartis where he leads a global team implementing an enterprise-wide patient engagement strategy. Before joining Novartis, he was the CEO of the National Health Council where he was deeply involved in health advocacy, policy, and legislation. He has designed and directed numerous advocacy strategies for issues ranging from access to health care to cancer prevention.

Dr. Robert Califf is an Adjunct Professor of Medicine at Duke University and a practicing cardiologist. He served as FDA Commissioner (2016–2017) and Deputy Commissioner for Medical Products and Tobacco. At Duke, he was Vice Chancellor for Clinical and Translational Research and founding director of the Duke Clinical Research Institute. A globally recognized expert in cardiovascular medicine and clinical research, he has over 1,200 peer-reviewed publications. Dr. Califf is a member of the National Academy of Medicine and has served on numerous FDA and NIH advisory boards. He co-founded the Clinical Trials Transformation Initiative and led several national research infrastructure programs.

Bray was the Director of Strategic Partnerships at Evidation Health. She develops collaborations to support the design and implementation of participant-centered studies and measures, and serves on the All of Us National Advisory Panel and the Digital Medicine Society Scientific Leadership Board. Previously, Bray served on the National Academies of Sciences, Engineering, and Medicine (NASEM) Health Science Policy Board, led engagement for the Duke Clinical Research Institute Project Baseline Study Coordinating Center, and served as co-chair on the Advisory Committee to the NIH Director that authored the Precision Medicine Initiative's Cohort Program. Bray holds a BS degree from the University of Georgia and MFS from National University.

Andrea is the President and Chairman of LUNGevity Foundation, the nation's leading lung cancer non-profit. Andrea's strong business background combined with her connections to the worlds of research and advocacy have enabled her to build the preeminent patient advocacy organization in the lung cancer space. LUNGevity funds translational research into both early detection and more effective treatments of lung cancer. LUNGevity also conducts research on patient needs through Patient FoRCE, LUNGevity's patient focused research center. LUNGevity empowers patients and their families by providing education, support and survivorship programs and the largest grassroots events network in the country.

Ari Gnanasakthy, MBA, MSc, is Head of Patient-Reported Outcomes at RTI HS. He has 30+years of experience in the pharmaceutical industry. After receiving his bachelor's degree in mathematics, statistics, and computing, Mr. Gnanasakthy joined Rothamsted Experimental Station (UK), where he was responsible for the statistical analysis of survey data of agricultural soil in England and Wales. Mr. Gnanasakthy's extensive experience in the field of statistics and outcome research has resulted in numerous abstracts and almost 40 publications. Mr. Gnanasakthy has developed and validated over a dozen patient-reported outcomes instruments and currently serves in the editorial board of Cancer Clinical Trials.

Juhaeri Juhaeri, Ph.D., is Vice President and Global Head of Epidemiology and Benefit-Risk at Sanofi. An epidemiologist and statistician, he has held global leadership roles in Medical and Pharmacovigilance functions for more than two decades in the pharmaceutical industry. A passionate leader, he has built and developed different new teams at Sanofi and led successful programs leading to products’ approval and maintenance. He has led different working groups in various public-private partnerships in benefit-risk evaluation, pharmacovigilance, real-world evidence, and patient preference. He holds adjunct faculty positions at the School of Public Health, University of North Carolina Chapel-Hill.

Richard Klein is the director of the FDA’s Patient Liaison Program in the Office of Health and Constituent Affairs, the primary interface between the agency and patient and patient advocate communities. The program interacts with outside communities and within the agency’s scientific & policy offices to facilitate patient engagement, and to address issues and concerns of patients. The program ensures that patient communities are represented in approval and policy decisions at FDA.

Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads various efforts including Patient-Focused Drug Development and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee. She led FDA negotiations for 2017 reauthorization of the Prescription Drug User Fee Act and also led the 2002, 2007 and 2012 PDUFA reauthorization cycles providing $1B in annual funding.  She received the 2019 Reagan-Udall Foundation Leadership Award for Innovations in Regulatory Science, US Food and Drug Law Institute 2017 Distinguished Service and Leadership Award, 2011 Presidential Rank Award for Distinguished Service, for Meritorious Service in 2006. 

Dr. Tarek Hammad, VP & Head of Medical Safety for Marketed Products at Takeda Pharmaceuticals, is a renowned expert in drug safety, benefit-risk assessment, and pharmacoepidemiology. With extensive experience at major pharmaceutical companies like Sanofi and Merck, as well as a distinguished 13-year career at the US FDA, he has received numerous awards for his contributions. Dr. Hammad is a sought-after speaker, actively involved in industry initiatives and has held several academic appointments. He has authored over 80 peer-reviewed articles, book chapters, and letters to the editor, offering valuable insights in the field. Learn more at www.DrTarekHammad.com.

As COO of Accelerated Cure Project, Sara Loud ensures delivery of research resources to scientists studying multiple sclerosis. Passionate about the integration of people into “people-powered” research, Sara combines a love of technology, business expertise, and social enterprise into her work, most recently focusing on the development of iConquerMS, a people-powered research network. Sara holds a BS/MS in electrical engineering from Northeastern University and a MBA from Babson College.

Kathryn (Katie) O'Callaghan is dedicated to building productive partnerships and promoting use of actionable information to reduce health disparities and to drive more patient-centric medical product innovation, evaluation, access, and care. Katie oversees a broad and diverse program portfolio at CDRH and her focus is on directing the Center’s 2016-2017 Strategic Priority of Partnering with Patients. Execution impacts more than 1700 employees and dozens of programs and processes across eight organizational departments, and strengthens CDRH’s ability to meet its mission to protect and promote public health. Katie is a biomedical engineer by training and worked in academic research and MedTech industry prior to her 12+ years at FDA.

Richard Forshee is the Associate Director for Benefit-Risk Assessment in the FDA Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology. His portfolio includes benefit-risk assessment, real world evidence, pharmacoepidemiology, and artificial intelligence for regulatory science. He has won several awards including the FDA Award of Merit. Before joining the FDA, he was the Director of the Center for Food, Nutrition, and Agriculture Policy at the University of Maryland, College Park.

Lisa LaVange, PhD, is Professor and Chair of the Department of Biostatistics in the Gillings School of Global Public Health at the University of North Carolina at Chapel Hill and former director of the department’s Collaborative Studies Coordinating Center (CSCC). From 2011 to 2017, Dr. LaVange was director of the Office of Biostatistics in the United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). Prior to her government and academic experience, she spent 16 years in non-profit research and 10 years in the pharmaceutical industry. Dr. LaVange is an elected fellow of the American Statistical Association (ASA) and was the 2018 ASA President.

Telba is Senior Scientific Director in Quantitative Sciences at Janssen R&D. She comes from FDA where she pioneered the use of Bayesian statistics and wrote several guidance documents. She received the FDA Excellence in Analytical Science Achievement Award for spearheading innovative regulatory science studies culminating in the release of novel guidance documents, supporting complex policy decision making and changing the submission review paradigm. Recently at the Center for Biologics, her portfolio expanded to include the Science of Patient Input, Complex Innovative Designs, and trials for rare diseases. She received a PhD from Berkeley, is fellow of the American Statistical Association and member of International Statistical Institute.