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Measuring Impact in Patient-Centered Drug Development Conference


Speakers

  • Cynthia  Grossman, PhD

    Cynthia Grossman, PhD

    • Director, Science of Patient Input
    • FasterCures, A Center of the Milken Institute, United States

    Dr. Cynthia (Cyndi) Grossman is director, Science of Patient Input at FasterCures, a center of the Milken Institute, leading efforts to improve health by expanding opportunities for patients’ perspectives to shape the processes by which new therapies are discovered, developed and delivered. Dr. Grossman earned her PhD in clinical psychology from the University of Vermont, completed a Postdoctoral Fellowship at Brown University, and has been the recipient of awards from NSF and NIH.

  • Patricia L. Jones, DrPH, MPH

    Patricia L. Jones, DrPH, MPH

    • Lead, Common Metrics Initiative, Program Director
    • National Institutes of Health (NIH), United States

    Dr. Patricia Jones joined NCATS as a Program Director in April 2016. She began her federal career with the Centers for Disease Control and Prevention in 2004 and has been with NIH since 2012. Dr. Jones has experience managing and evaluating prevention science programs, implementation science, and international and domestic clinical trials sites. She was Adjunct Faculty in Translational Health Sciences, Psychology, and Research Methods at various institutions. Currently she leads the Common Metrics Initiative at NCATS. Dr. Jones is a Behavioral Scientist and holds a doctorate in Public Health in Health Promotion and Health Education from Loma Linda University.

  • Roslyn  Schneider, MD, FACP

    Roslyn Schneider, MD, FACP

    • Principal
    • Rozmd Patient Affairs Consulting LLC, United States

    Roz Schneider is the Global Patient Affairs Lead at Pfizer driving more systematic, end to end patient centricity at Pfizer. She has held roles in Medical Affairs, Development and Strategy at Pfizer since 2006. She received her BS from the Sophie Davis School of Biomedical Education of the City College of New York, her MD from Mount Sinai School of Medicine, and MSc in Pharmaceutical Medicine from Hibernia College. She is a retired Clinical Professor of Medicine of Albert Einstein College of Medicine, Internist, Pulmonologist, Intensivist and was in clinical practice and academia for twenty years before joining Pfizer.

  • Linda B. Sullivan, MBA

    Linda B. Sullivan, MBA

    • Executive Director
    • Metrics Champion Consortium, United States

    Ms. Sullivan is the Co-Founder & Executive Director of the Metrics Champion Consortium (MCC), an industry association dedicated to leading the drug-development enterprise in the adoption and utilization of standardized metrics and benchmarks to drive performance improvement. She has more than 30 years of experience working in the Healthcare and Clinical Research industries helping organizations improve processes to improve financial and quality outcomes. Ms. Sullivan received a B.S. in Biology from Trinity College and a M.B.A. from Dartmouth College where she was named a Tuck Scholar.

  • Lee  Thompson, MS

    Lee Thompson, MS

    • Senior Researcher
    • American Institutes for Research, United States

    Lee B. Thompson, MS is a senior researcher at AIR. She provides leadership for research and technical assistance projects, develops research designs and audience-focused project plans and addresses individual and group technical assistance and stakeholder needs. Since 2010, she has led a number of projects and tasks to increase stakeholder engagement and disseminate best-practices from a variety of health and health care initiatives. Currently, she is the Project Director for the PFE Contractor for Partnership for Patients. She is also providing outreach and dissemination support to promote adoption of the AHRQ Quality Indicators. Ms. Thompson received a MS in Community Development and Applied Economics from the University of Vermont.

  • Suzanne  Schrandt, JD

    Suzanne Schrandt, JD

    • Director, Patient Engagement
    • Arthritis Foundation, United States

    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.

  • Stella  Stergiopoulos

    Stella Stergiopoulos

    • Research Fellow
    • Tufts Center for the Study of Drug Development, United States

    Ms. Stella Stergiopoulos manages multi-sponsored and grant funded research projects at Tufts CSDD. She has experience conducting research on pharmaceutical industry practices and trends affecting pharmacovigilance, non-clinical drug development, pharmaceutical outsourcing practices, cycle time metrics, resource management, and protocol design. She has also been a speaker at conferences and has published articles in peer-reviewed and trade journals. Prior to joining Tufts CSDD, Ms. Stergiopoulos was a research associate at The Brattle Group and a researcher at Massachusetts General Hospital. She holds a BA from Brandeis University, and an MS and MPH from Tufts University.

  • Mathieu  Boudes, PhD

    Mathieu Boudes, PhD

    • PARADIGM Coordinator
    • European Patients' Forum, France

    Mathieu Boudes, PhD, joined the European Patients’ Forum (EPF) in 2018 as coordinator of the PARADIGM project, a public-private partnership financed by the Innovative Medicines Initiative and co-led by EPF and EFPIA (European Federation of Pharmaceutical Industries and Associations). Strong of 34 partners (patient organisations, pharmaceutical / biotech companies, regulators, HTA bodies and academic teams), PARADIGM (for Patients Active in Research and Dialogues for an Improved Generation of Medicines) will strengthen the understanding of stakeholders’ needs, the systems-readiness, ensure maximum synergies with other initiatives and develop an inventive and workable sustainability roadmap.

  • Ellen  Coleman, MPH, MS

    Ellen Coleman, MPH, MS

    • President & CEO
    • MK&A, United States

    As president and CEO, Ellen Coleman leads MK&A 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 MK&A, 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.

  • Carrie  Corboy, PharmD, RPh

    Carrie Corboy, PharmD, RPh

    • Senior Director, Standards & Execution Excellence
    • Janssen Global Services, United States

    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.

  • Jennifer  Miller, PhD

    Jennifer Miller, PhD

    • Assistant Professor
    • Yale School of Medicine, United States

    Jennifer E. Miller, PhD, is an Assistant Professor in NYU School of Medicine and President of Bioethics International. She is also the Creator of the Good Pharma Scorecard, an index that ranks new drugs and pharmaceutical companies on their ethics and public health performance to help recognize good practices in companies, improve trustworthiness, and incentivize change where needed. Prior to joining NYU, Dr. Miller was based at Duke University and Harvard University. Dr. Miller serves on NYU’s Pharmacy and Therapeutics Committee, Stem Cell Research Oversight board, and J&J-NYU Compassionate-Use Advisory Committee (monitor).

  • Nancy  Mulligan

    Nancy Mulligan

    • Executive Director, Patient & Physician Services
    • United BioSource Corporation (UBC), United States

    Ms. Mulligan has more than 20 years of experience in medical and pharmaceutical communications. In her current position, Ms. Mulligan designs and executes aggressive, multi-media initiatives and site-based programs for various stakeholders. Ms. Mulligan is responsible for program operations of all PPS strategies. Prior to joining UBC, Ms. Mulligan was a consultant with Booz Allen Hamilton. Ms. Mulligan holds a B.S., in Communications from The University of Massachusetts.

  • Theresa  Mullin, PhD

    Theresa Mullin, PhD

    • Associate Director for Strategic Initiatives, OCD, CDER
    • FDA, United States

    Theresa Mullin, Ph.D., serves as CDER’s Associate Director for Strategic Initiatives. She leads the Patient-Focused Drug Development initiative, which includes work related to the FDA Reauthorization Act and implementation of the 21st Century Cures Act. Leads FDA Patient Focused Drug Development and heads the FDA delegation to ICH. She previously served as director of CDER’s Office of Strategic Program (OSP) for almost a decade. Under her leadership, the office became a critical part of CDER’s sustained effort to modernize drug regulatory operations. Dr. Mullin received her bachelor’s degree in economics from Boston College and a Ph.D. in public policy analysis from Carnegie-Mellon University.

  • Bray  Patrick-Lake, MS

    Bray Patrick-Lake, MS

    • Director, Strategic Partnerships
    • Evidation Health, Inc., United States

    Bray Patrick-Lake supports efforts to actively engage patients, health advocacy organizations, and other stakeholders in Duke Clinical Research Institute’s local and national research programs. She has led extensive efforts through the CTTI to incorporate patient voice into clinical trial design, conduct, oversight, and regulatory frameworks, as well as improvement of the clinical trial enterprise. She currently serves as the DCRI Coordinating Center’s engagement lead for the Project Baseline study and NIH’s ECHO program. She serves on the NASEM Board on Health Sciences Policy, the All of Us National Advisory Panel, and the NASEM Committee on the Return of Individual Research Results.

  • Karlin  Schroeder, MD, MA

    Karlin Schroeder, MD, MA

    • Senior Director, Community Engagement
    • Parkinson's Foundation, United States

    Karlin Schroeder, M.A. is the Director of Community Engagement at the Parkinson's Foundation leading the Parkinson's Advocates in Research (PAIR) program. She has twenty years experience as a health educator and community organizer in New York City with expertise in facilitating interchanges between medical professionals and patients to improve health outcomes. Through PAIR, Karlin creates partnerships between people with Parkinson's disease, care partners and research teams in industry, academia and government who collaborate to move research forward more efficiently and effectively by incorporating patient expertise into the research process. She received her M.A. in Health Advocacy from Sarah Lawrence College.

  • James E. Valentine, JD, MHS

    James E. Valentine, JD, MHS

    • Attorney
    • Hyman, Phelps & McNamara, PC, United States

    James Valentine, JD, MHS is an attorney at Hyman, Phelps & McNamara where he assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Mr. Valentine has been central to the transition of the FDA Patient-Focused Drug Development (PFDD) program to externally-led meetings, having helped plan and moderated the majority of those, and is also working on novel methodologies for capturing patient experience data. Mr Valentine has also authored an anlaysis cataloguing FDA's flexibility in assessing efficacy in the approval of drugs for rare, or orphan, conditions.

  • Nicholas  Brooke, MBA

    Nicholas Brooke, MBA

    • Executive Director, Patient Focused Medicines Development (PFMD)
    • The Synergist.org, Belgium

    Nicholas Brooke is Founder of The Synergist, a collaboration platform incubator that brings key players together with the express aim of solving significant societal problems through collective action. Under Nicholas’ leadership, The Synergist acts as a backbone, providing vision, strategy, stakeholder alignment and execution on multiple international, multi-stakeholder programmes. He is the Executive Director of Patient Focused Medicines Development, a global collaborative platform dedicated to stimulating innovation in medicine development through systematic engagement with patients.

  • Dawn P. Richards, PhD

    Dawn P. Richards, PhD

    • Vice President
    • Canadian Arthritis Patient Alliance, Canada

    Dawn Richards, PhD, lives with rheumatoid arthritis and is a volunteer Vice President of the Canadian Arthritis Patient Alliance. She advocates for arthritis awareness, access to treatments, patient participation in decision-making and as research collaborators, and the importance of research. Professionally, her firm, Five02 Labs Inc., intertwines her formal training as an analytical chemist with her passion for the patient perspective to inform research and healthcare. Clients include the Network of Networks, Clinical Trials Ontario (where she is the Director of Patient and Public Engagement), the SPOR Chronic Pain Network, and the CIHR Institute of Musculoskeletal Health and Arthritis.

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