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.

As Commissioner, Dr. Califf oversees the full breadth of the FDA portfolio and execution of the Federal Food, Drug, and Cosmetic Act and other applicable laws. This includes assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices; the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation; and the regulation of tobacco products. Dr. Califf has had a long and distinguished career as a physician, researcher, and leader in the fields of science and medicine.

As president and CEO, Ellen Coleman leads VOZ Advisors and is responsible for all aspects of the overall firm path and direction. Ellen brings considerable experience in working with patients with life-threatening and chronic illnesses giving her a view of the entire patient experience. Prior to joining VOZ, she was executive vice president of EmergingMed, spent 11 years as associate executive director for CancerCare, and worked at Johnson & Johnson. She served for 10 years as a medical social worker caring for people with HIV at the Cleveland Clinic Foundation and assisting neurosurgery patients at Westchester County Medical Center. She has an MPH from Columbia's Mailman School of Public Health and an MSSA from Case Western Reserve.

Ken Getz is the Executive Director and a Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical research enterprise. A well-known speaker at conferences, symposia, universities, investor meetings and corporations, Ken also holds a number of board appointments in the private and public sectors. He received an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor’s degree, Phi Beta Kappa, from Brandeis University.

As Global Director of Engagement for DIA, Ms. Lincoln heads up DIA’s patient initiatives to build long-term engagement with and contribution from patient advocates and leads a human resource (HR) function internally. Her background demonstrates her versatility and wide range of experience in human capital development. Prior to joining DIA, she provided HR consulting services to clients of the Delaware Valley area’s largest privately-held career consultancy and human performance firm. Previous to that, Ms. Lincoln worked for a global management consulting company providing Fortune 500 clients with change management consulting services.

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. Roz Schneider is a catalyst toward patient-centered healthcare and research, transforming healthcare quality and efficiency by partnering with patients. She applies human-centered design toward better health outcomes, and to create and communicate with stakeholder communities. Patient centeredness has been a common thread through Roz's clinical practice and her academic and industry career, including a global role she created in Pfizer's Chief Medical Office; as an independent consultant to companies, educational, and non-profit initiatives; and now as VP, Scientific, Medical, and Patient Affairs at Theravance Biopharma.

Suz Schrandt, JD, is Patient Engagement Director at the Arthritis Foundation. She was previously Deputy Director, Patient Engagement for PCORI, where she helped to launch key efforts including the Engagement Rubric. Schrandt's patient engagement focus stems from her own rheumatological diagnosis at age 14. Prior posts include roles in health and disability law and policy, genetics, and public health. Schrandt is chair of the ISPOR Patient Roundtable and a member of the FDA’s PEAC.

Sudip S. Parikh, PhD, serves as Senior Vice President and Managing Director for DIA Americas. He previously served as Vice President and General Manager of Health & Consumer Solutions at Battelle, leading its Healthcare Improvement, Public Health Research, and Consumer, Industrial, and Medical Technology Development teams in R&D supported by government and commercial clients. Dr. Parikh is a board member of Research America, the Friends of Cancer Research, and the Food Innovation Center. He was a Presidential Management Fellow at the National Institutes of Health, and was awarded a National Science Foundation Graduate Research Fellowship while earning his PhD in Macromolecular Structure and Chemistry from The Scripps Research Institute

Stella is an Associate Director, Health Outcomes and Payer Policy on the Payer Relations and Reimbursement Team at Foundation Medicine. She leads analysis of real-world biomedical data with a focus on clinical use cases, including clinically-relevant genomic signatures, clinical utility of next-generation sequencing, and the impact of diagnostics on patient health and care. Professionally she is interested in driving Foundation Medicine’s clinical publication roadmap in partnership with medical affairs, clinical development, and data strategy teams. Prior to her role at Foundation Medicine, Stella was the Assistant Director of Statistics and Analytics at the Tufts Center for the Study of Drug Development.

Joanne Buzaglo, PhD is SVP of Research & Training at the Cancer Support Community’s (CSC) Research and Training Institute. She is a health researcher and clinical psychologist. Her focus is on translating research into community-based practice with an emphasis on psychosocial screening and decision support. She leads the Cancer Experience Registry, an online research initiative tracking patient-reported outcomes to garner patient insights, and inform and develop innovative programmatic, educational and policy initiatives. Prior to joining CSC, she was the Deputy Director of Fox Chase Cancer Center’s Behavioral Research Core Facility.

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. 

Mary Stober Murray is a leading voice and collaboration-builder for health equity and patient engagement in pharmaceutical development operations. In her role at National Minority Quality Forum, Mary leads multi-stakeholder collaborative networks to improve lives in high-risk communities using actionable research, data science, education and advocacy. In previous roles, Mary brought internal and external stakeholders together to strive for better patient experience outcomes and diverse representation through creative patient engagement, health literacy and best-practice frameworks. Mary chairs DIA’s Patient Engagement Community and received DIA’s regional Inspire award in 2017. Mary has an MBA and a Masters in Population Health.

Alan Rosenberg is currently President of alanbrosenberg healthcare consulting, Inc. and recently retired as Vice President of Medical and Clinical Pharmacy Policy for Anthem, Inc. and President of its subsidiary Anthem UM Services, Inc. Dr. Rosenberg led Anthem’s processes for evaluating and determining its medical and pharmacy policies for over seventeen years. He currently serves as Chairman of the URAC Board. He has also served on PCORI’s Advisory Panel on Prevention Diagnosis and Treatment, the Agency for Health Research and Quality's Effective Health Care Program Stakeholder Group and the Institute for Clinical and Economic Review's (ICER) Advisory Board.

Mary Short is a Research Advisor for Pediatric Capabilities and co-chair of the Pediatric Steering Committee at Eli Lilly and Company. Mary supported multiple clinical trials including pediatric sepsis and pulmonary hypertension. She is a RN, a Perinatal Clinical Nurse Specialist, and has a Master of Science in Nursing from Indiana University. Mary has publications on research in neonatal neuromuscular development, neonatal sepsis, pediatric informed consent, and medication errors in children.

Dr. Rebecca Ashkenazy is the US Men’s and Women’s Health Medical Affairs Lead within Pfizer Essential Health, leading medical strategy engagement, lifecycle and innovation platforms. She is a leader with broad experience from R&D through commercialization. Dr. Ashkenazy joined Pfizer R&D in 2007, serving in Strategy and Business Operations. She held key roles in the Pfizer-Wyeth integration and lead clinical operations, sourcing and organization transformation efforts. Prior to Pfizer, Dr. Ashkenazy served as a healthcare consultant and biotechnology analyst. She received her MD from Johns Hopkins, completed residency at Beth Israel Deaconess and holds Finance and Neurobiology BS undergraduate degrees.

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.

Karlin Schroeder, M.A., is the Associate Vice President of Community Engagement at the Parkinson’s Foundation, where she leads the Research Advocacy program. Through this program, Karlin creates and directs projects to incorporate patient expertise into research design and implementation with industry, academic centers and government. Her special interests include metrics and improving diversity in patient engagement in research. She is a steering committee member with the Clinical Trials Transformation Initiative, working on the Quality by Design initiative. She is also a member of Patient Focused Medicines Development. Karlin has a B.S. in psychobiology and psychology and an M.A in health advocacy.

Elizabeth Turcotte is a design thinker and marketer with sixteen years of experience in the pharmaceutical industry. In her current role as the Director of the Patient Hub at Bristol-Myers Squibb, Elizabeth is responsible for patient experience across the enterprise. She has developed design-based organizational capabilities that allow the company to innovate its patient offerings with a human-centered lens. Her team’s flagship capability is the Universal Patient Language (UPL) — a set of resources that support communicating complex topics to patients. The UPL is derived from hundreds of hours co-creating and prototyping with patients, and has been made available as an open-source capability on UPL.org.

Dr. David Weinstock is an Associate Professor at Harvard Medical School and Dana-Farber Cancer Institute, where he leads a translational and basic research program focused on the targeting of lymphomas and leukemias. With Professor Andrew Lo at MIT Sloan School of Business, he proposed a financing strategy that would expand access to expensive and short-course therapeutics.

Lode Dewulf, MD, serves as Chief Patient Officer for Servier, reporting to the CEO on Servier’s Patient IN strategy, a core company pillar. A physician with 30 years of global industry experience, Dr. Dewulf is an internationally known and trusted leader and reference for developing and implementing patient engagement practices, driving culture change within and between organizations to deliver better health solutions. Dr. Dewulf is Co-Founder and Director of Corvalus and a Board Member of the Open Medicine Institute; he also serves as Deputy Editor for Therapeutic Innovation & Regulatory Science and as Patient Engagement Co-Editor for the DIA Global Forum. He earned his Medical Degree from the University of Leuven (Belgium).

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.

Mary Jo Lamberti is on the faculty at Tufts University and is Director of Sponsored Research at Tufts Center for the Study of Drug Development (CSDD). She is a global expert on benchmarking drug development operating practices. Her research focuses on a variety of areas including outsourcing and partnerships, clinical supplies, investigative site initiation and management, patient recruitment and retention, and the use of technologies and digital solutions in clinical trials. She has published extensively and is a frequent speaker at global conferences. Dr. Lamberti holds a BA from Wellesley College and a PhD in psychology from Boston University.

As Head of Translational Medicine Enabling Solutions, she leads an organization that drives the development and execution of translational and clinical sampling strategies and program plans from Discovery through Life Cycle management. She is responsible for evolving the capability of the BMS biorepository, redesigning informed consent processes and tools, and ensuring robust operational interfaces with specialty labs, academic labs and key opinion leaders for Clinical Biomarkers and Imaging modalities. Deb is also a core member of TransCelerate’s eConsent initiative to create an industry aligned position on consent processes and technologies.

Ms Sullivan is a Senior Fellow at the Tufts Center for the Study of Drug Development. She has more than 30 years of experience working in the Healthcare and Clinical Research industries helping organizations optimize processes to improve financial and quality outcomes. She founded and served as Executive Director of the Metrics Champion Consortium, an industry consortium created to bring clinical research stakeholders together to collaboratively develop standardized performance metrics that help organizations manage studies, identify areas in need of improvement and assess process improvement activities. She has been a featured speaker at industry meetings, hosted podcasts and published articles in leading journals.

Anjali Trasy leverages patient insights and deep understanding of patient needs to support Sanofi products and services in delivering superior patient outcomes and experiences. Anjali utilizes her expertise in creative design, crowdsourcing, and use of digital channels to engage with patients as a critical business differentiator that enhances all of Sanofi’s business franchises. Anjali was previously Consumer Marketing Director in the US where she spearheaded the development and implementation of Sanofi’s industry-leading COACH programs. Since joining Sanofi in 2004, she has served in various US and Global marketing and staff positions. Anjali graduated from Johns Hopkins University and has an MBA from NYU.

Stephen Yates a Clin Prog Dir and Head, Pt Engagement Strategy with UCB Biosciences, Inc. He provides strategy for Ph2 through 4 clinical studies focused in neurology and metabolic disease. Stephen also provides oversight of UCB’s strategy for patient engagement throughout the development continuum and is leading a team at UCB to establish a strategy for consistent patient partnering. Stephen holds a BS in biol and biochem from the University of Tampa and a PhD in neuropharmacol from UCONN.

Ronald Bartek, MS, serves as President of the Friedreich’s Ataxia Research Alliance, on the Board of Directors for the National Organization for Rare Disorders, and as a Board Director for the Alliance for a Stronger FDA. Ron previously served for twenty years in the federal government executive and legislative branches, including in the Policy Staff of the House Armed Services Committee and the US State Department, in defense, foreign policy, and intelligence. He is also a member of the US National Institutes of Health (NIH) NCATS Advisory Council/Cures Acceleration Network Review Board, and of the NIH/NINDS National Advisory Council. Ron earned his Master’s Degree in Russian Area Studies from Georgetown University.

Carrie is a pharmacist with clinical and pharmaceutical industry experience. Currently she supports the Janssen global commercial organization including capturing performance metrics in patient engagement and establishing a framework for complying with company policies and global requirements while encouraging engagement with patients.

Michael Goettler has a broad and international background in general management, sales, marketing, business development, new product planning and eBusiness. His professional experience includes being Regional President for Asia Pacific, Regional President for Europe, and Global Commercial Officer for Pfizer’s Global Innovative Pharma Business. He is also a member of the board of directors of PSI (Population Services International), a global health organization dedicated to improving the health of people in the developing world. A native German, he studied in Germany, France and the US. He holds an MBA from the University of Texas at Austin and graduated from the Koblenz School of Corporate Management in Germany.

Since April 2015, Nikki has been the VP of Patient Engagement at Alkermes plc, managing a variety of partnerships to incorporate the patient perspective into the company's programs in an effort to improve the health and lives of people affected by serious central nervous system (CNS) diseases. She oversees the company's philanthropic efforts to support patients and their families and manages relationships with advocacy organizations, non-profit groups and others to ensure the company's efforts are patient-centric.

Christine is the President of the Society for Clinical Research Sites, a global trade organization representing over 9,000 sites in 47 countries committed to providing sites a community and voice for site sustainability. Christine is an internationally recognized expert on the global investigative site landscape and operational management change to facilitate collaboration between industry and sites.

Ron Wincek is CEO of a technology-based training company with an Education Specialist degree in Psychometry. His first clinical trial experience was a year-long Phase 2 study for newly diagnosed, non-PD medicated individuals. Becoming interested in supporting research initiatives he joined the Parkinson’s Foundation’s PAIR program. Ron presents “Getting Involved in Research” to local PD support groups and on topics like a “Patient’s User Experience in Clinical Trials” at investigator meetings. As a patient stakeholder advisor, he has participated in patient centricity and other working groups, reviewed study protocols and grant proposals, and assisted with a PCORI-funded research program.