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Bethesda North Marriott Hotel and Conference Center

2018年10月02日 (火) 午前 7:00 - 2018年10月03日 (水) 午後 3:00

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Measuring Impact in Patient-Centered Drug Development Conference

スピーカー

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  Jones, DrPH, MPH

Patricia 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

Vice President, Head of Global Patient Affairs, Rozmd Patient Affairs Consulting LLC, United States

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.

Linda B Sullivan, MBA

Linda B Sullivan, MBA

Senior Fellow, Tufts Center For the Study of Drug Development, United States

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.

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

Founder, Chief Executive Office and Chief Patient Advocate, ExPPect, 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, MPH, MS

Stella Stergiopoulos, MPH, MS

Director, Health Economic and Outcomes Research, EQRx, United States

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.

Mathieu  Boudes, PhD

Mathieu Boudes, PhD

Patient Engagement Director, Montsouris Consilium, 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 and Chief Executive Officer, VOZ Advisors, United States

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.

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

Associate Professor of Medicine; Co-Director, Program for Biomedical Ethics, 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, 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 Center Director - Strategic Initiatives, CDER, FDA, United States

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. 

Bray  Patrick-Lake, MS

Bray Patrick-Lake, MS

Senior Digital Health Specialist, DDH, CDRH, FDA, United States

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.

Karlin  Schroeder, MA

Karlin Schroeder, MA

Associate Vice President, Community Engagement, Parkinson's Foundation, United States

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.

James  Valentine, JD, MHS

James Valentine, JD, MHS

Director, 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 analysis 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), PFMD, Belgium

Nicholas Brooke is the Founder and Executive Director of The Synergist, an incubator and managing organization to multi-stakeholder platforms that brings key players together with the express aim of solving significant societal problems through collective actions. The Synergist also helps individual organizations to build the capacity and capability to better engage with key stakeholders in partnerships to solve societal issues. Bringing his Synergist and caregiver hats together, he is the Executive Director of PFMD.org, a pre-competitive multi-stakeholder global collaborative platform dedicated to stimulating innovation in medicine and device lifecycles, digital health, and health system through systematic patient engagement, WITH patients

Dawn P. Richards, PhD

Dawn P. Richards, PhD

Director, Patient and Public Engagement, Clinical Trials Ontario, Canada

Dawn Richards, PhD, is the founder of Five02 Labs Inc., and Director of Patient and Public Engagement at Clinical Trials Ontario. With a PhD (Analytical Chemistry) from the University of Alberta and experience in different roles over 25 years, it is her diagnosis with rheumatoid arthritis in 2006 that led her to combine her passion for science with making the most of her diagnosis. In her role at CTO, Dawn is charged with executing on CTO’s strategic pillar of patient and public engagement.

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