Virtual Program

Nancy S. Berg is chief executive officer (CEO) and executive director of ISPOR—The Professional Society for Health Economics and Outcomes Research, the leading global scientific and educational organization for health economics and outcomes research. Ms. Berg has over 30 years of experience in health care and scientific/technical association leadership, and has been an entrepreneur and business consultant to both commercial and nonprofit organizations. At ISPOR, Ms. Berg is responsible for the Society’s global strategic direction and leadership of the association. She has led the organization, in concert with the Board of Directors, to design and implement a new strategic plan, mission, and vision to guide the Society into the future.

Previously, Ms. Berg led the International Society for Pharmaceutical Engineering (ISPE) as president and CEO. ISPE is the world's largest professional society fostering dialogue and education on technical, scientific, and regulatory best practices in the pharmaceutical and biotech industries. During her tenure with ISPE, Ms. Berg was the architect of the Society's Strategic Plan, focusing ISPE's energies and expertise on high-value initiatives related to drug shortages, quality metrics, global manufacturing quality, facility and supply chain issues, and patient experiences in clinical trials. Prior to her role at ISPE, Ms. Berg served as executive director and CEO of the Society of Manufacturing Engineers (SME). She also previously founded a strategic and business development consultancy company.

Ms. Berg has been engaged in education and business issues at national and international levels. She has served on many government initiatives involving business, community, development, growth, revitalization, and labor issues. She is a supporter of the Leukemia and Lymphoma Society’s Team in Training Program cycling events and a patron of many other charities. Ms. Berg is a graduate of the University of Michigan-Flint and is married to Timothy Jackson.

Suz Schrandt is a patient and patient engagement engineer with a health and disability law and policy background.  She is the Founder and CEO of ExPPect, a patient engagement initiative focused on improving healthcare and research through the expertise and partnership of skilled patient partners.  Schrandt previously served as the Director of Patient Engagement at the Arthritis Foundation and as the Deputy Director of Patient Engagement for the Patient-Centered Outcomes Research Institute (PCORI); in both capacities she led the development and execution of patient engagement strategies to support research, medical product development, care delivery, and other innovation.

Before joining PCORI, Schrandt served as the Health Reform Team Leader for the Kansas Health Institute and she has held roles in bioethics, the study of genetic discrimination, and chronic disease self-management, as well as patient-led clinical training aimed at increasing early diagnosis and appropriate, patient-centered management of chronic disease. Schrandt’s passion for patient engagement began in large part from her own experience, having been diagnosed with polyarticular juvenile idiopathic arthritis as a teenager, several years before the first biologics were available.  She has undergone multiple joint replacement and other orthopedic surgeries and has logged nearly thirty years of first-hand experience with the healthcare system. 

Schrandt is one of nine voting members on the FDA’s inaugural Patient Engagement Advisory Committee.  She has been the Chairperson for the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) North American Patient Representative Roundtable since 2016, co-chaired the Patients as Partners conference from 2016 to 2018, and has been an invited speaker at numerous national and international conferences.  Schrandt received her law degree from the University of Kansas School of Law and has co-authored multiple peer-reviewed articles on the value and importance of patient engagement. 

 

Brett Hauber, PhD, is a Senior Economist and the Vice President of Health Preference Assessment at RTI-HS and an Affiliate Associate Professor in the School of Pharmacy at the University of Washington. He has more than 20 years of academic, research, and government experience in health and environmental economics. He was the principal investigator for developing the Catalog of Methods for Assessing Patient Preferences for Benefits and Harms of Medical Technologies for the Medical Device Innovation Consortium (MDIC). He is currently Co-Chair for Benefit-Risk Assessment in the Benefit-Risk Assessment, Communication, and Evaluation (BRACE) Special Interest Group (SIG) of the International Society for Pharmacoepidemiology (ISPE). He previously served as chair of the Conjoint Analysis Good Research Practices Task Force of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) that developed the report on Good Research Practices in Statistical Methods for the Analysis of Discrete-Choice Experiments and was a member of the ISPOR task force that developed the ISPOR Checklist for Good Research Practices in Conjoint Analysis. Dr. Hauber is currently the Principal Investigator for the What Matters Most Study sponsored by AD PACE, a patient- and caregiver-led collaboration of industry, academics, and government agencies. He was recently the lead investigator an MDIC-sponsored study to elicit patient preferences for benefits and risks of medical devices to treatment Parkinson’s disease. The Parkinson’s preference study was the result of a collaborative effort by MDIC, the Center for Devices and Radiological Health of the Food and Drug Administration (FDA), The Michael J Fox Foundation for Parkinson’s Research, and the Massachusetts Institute of Technology to develop a patient-centered design for clinical trials of devices to treat Parkinson’s disease. Dr. Hauber is currently a member of the Scientific Advisory Board for IMI-PREFER. His research has been published in numerous health outcomes and medical journals.

Anindita (Annie) Saha is the Director of Partnerships to Advance Innovation and Regulatory Science (PAIRS) in the FDA’s Center for Devices and Radiological Health (CDRH), Office of Strategic Partnerships and Technology Innovation (OST). PAIRS develops and manages CDRH’s external collaborations and public-private partnerships including the Medical Device Innovation Consortium (MDIC) and the Network of Experts program, fellowship programs including the Medical Device Fellowship and AIMBE Scholars programs, and technology transfer and collaboration efforts for the Center. PAIRS directs and coordinates CDRH’s Regulatory Science and Critical Path programs to facilitate research to promote the development and assessment of high quality, safe, and effective medical devices. Ms. Saha and PAIRS work closely with the Patient Science and Engagement team at CDRH on patient preference information and patient-reported outcomes to foster incorporation of the patient perspective in our decision making.  Ms. Saha began her FDA career as a researcher in the CDRH’s Office of Science and Engineering Laboratories in the Division of Imaging and Applied Mathematics in the area of imaging display technologies before moving to PAIRS to coordinate Critical Path and Regulatory Science activities for the Center. Ms. Saha has a Bachelor of Science in Bioengineering and Minor in History from the University of Pittsburgh. She was a student researcher at the McGowan Institute for Regenerative Medicine working in tissue engineering and wound healing.

 

Dr. Christina Webber is a Staff Fellow on the Partnerships to Advance Innovation and Regulatory Science (PAIRS) team in the Center for Devices and Radiological Health at the U.S. Food and Drug Administration. She is currently working on efforts to promote inclusion of the patient voice in clinical investigations, especially those used in regulatory submissions, using patient-reported outcomes (PROs), patient-generated health data (PGD), and patient preference information (PPI). Dr. Webber has also initiated a project highlighting advances in regulatory science as a result of FDA’s Public Private Partnership with the Medical Device Innovation Consortium (MDIC). She began her time at the FDA as an AIMBE Scholar. Prior to joining the FDA, she completed her Ph.D. in Biomedical Engineering and Physiology at the Mayo Clinic Graduate School of Biomedical Sciences. Her doctoral research focused on upper extremity biomechanics, characterizing the independent function in adults with traumatic brachial plexus injuries. Dr. Webber also holds an M.S. degree in Biomedical Engineering, specializing in biomechanics, from the University of Akron where she conducted lower extremity prosthetics research. She earned her B.S. in Bioengineering at the Pennsylvania State University.

Dan has operational expertise in a broad array of medical device functions, currently as Vice President of Regulatory, Quality and Strategy at Tusker Medical (now part of Smith+Nephew).  Tusker Medical has developed a device/drug combination product that enables the placement of tympanostomy tubes using local anesthesia in an Ear, Nose and Throat office setting.  Tympanostomy procedures are very common in young pediatric patients, and have traditionally been performed using general anesthesia in an operating room setting.  The Tusker technology includes the otic local anesthetic TYMBION®, an Iontophoresis System to deliver TYMBION to the tympanic membrane, and a Tube Delivery System to facilitate rapid tympanostomy delivery.

Prior to Tusker Medical, Dan was Sr. Director of Clinical and Regulatory for Acclarent, a developer of innovative Ear, Nose, and Throat technology.  Previously, Dan held management positions in marketing and business development at Guidant, and as an engineering manager at Lockheed Martin Space Operations.  

Dan received a BSE in Biomedical Engineering from Duke University, an MSE in Biomedical Engineering from Tulane University, and an MBA from Stanford University.

Barry Liden is Vice President of Patient Engagement for Edwards Lifesciences (NYSE:EW), the global leader in patient-focused innovations for structural heart, as well as critical care and surgical monitoring.  He is responsible for helping the Irvine, California-based company engage with, learn from and empower patients and their families to improve the healthcare experience.  Liden joined Edwards in 2002 as Director of Global Communications, and has served in a number of public affairs positions, most recently as Vice President of Government Affairs.

Before joining Edwards, Liden served for seven years in leadership positions at public relations and integrated marketing consulting firms.   He began his public affairs career in 1990 as the Director of Government Relations for the Los Angeles Area Chamber of Commerce, responsible for policy development and advocacy for the greater L.A. business community. 

For almost three decades, Liden has integrated public policy, government relations, public relations and crisis management practices to provide strategic solutions to unique challenges.  He enjoys sharing this experience, having taught seven years at the University of Southern California as an adjunct faculty member in the Annenberg School for Communications and is currently an adjunct faculty assistant professor at Georgetown University’s School of Nursing and Health Studies.  He also serves as a Board Member of the Alliance for Aging Research in Washington, DC.

Liden has a bachelor of science in public administration from the University of Southern California, and a juris doctor from Loyola Law School of Los Angeles.  He lives in Garrett Park, Maryland.

Christine Poulos, PhD is Senior Economist and Global Head of Health Preference Assessment at RTI Health Solutions, Research Triangle Park, NC, USA. She has more than 20 years of academic, research, and government experience in health and environmental economics. She is an expert in the design of stated preference surveys and she has extensive experience in applying stated preference methods to measuring the benefit-risk preferences of patients and other health care decision makers. Her most recent work has applied these studies to support decision making throughout the clinical product development cycle for treatments for conditions including severe emphysema, Alzheimers’ disease, multiple sclerosis, endometriosis, type 2 diabetes, and infectious diseases. She is currently Co-Chair for the Health Preference Research Special Interest Group of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Her research has been published in numerous health outcomes and medical journals.

Todd is the Senior Vice President of Quality Assurance, Regulatory and Clinical Affairs for NxStage Medical of Fresenius Medical Care North America.  He has more than 20 years of quality, regulatory, and operational leadership experience in the healthcare industry overseeing quality assurance, regulatory affairs and compliance for renal disease systems, parenteral fluids, vascular care products, rare disease treatments, genetic testing, and other therapeutic areas.

Todd is currently responsible for Quality Assurance, Regulatory, and Technical Communications at Fresenius Medical Care focusing on the NxStage Medical product families.  Previously he led Quality Assurance, Regulatory and Clinical Affairs for NxStage Medical, Inc., a public company focused on the treatment of renal disease.  Prior to joining NxStage in 2012, he served as the Vice President of Quality Assurance, Regulatory Affairs for Vascular Therapies at Covidien supporting the growth and integration of a new Vascular Therapies business. Todd held various Quality and Regulatory Compliance leadership roles at the Genzyme Corporation including the Vice President of Quality and Regulatory Compliance at Genzyme Genetics and Directory of Corporate Quality Systems. Todd began his career in Quality and Operations at the General Electric Company where he held multiple quality and operational leadership roles. Prior to his work in healthcare, Todd served as a Captain in the United States Army.  Todd received his BS in Systems Engineering from the United States Military Academy (West Point, NY) and his MBA in Operations Management from University of Colorado (Colorado Springs).

Kimberly Brown Smith, M.D., Ph.D., is an ophthalmologist, glaucoma expert, and biomedical engineer. Currently, she is on the Clinical and Scientific Policy Staff in the Office of Product Evaluation and Quality in FDA’s Center for Devices and Radiological Health. In addition, for over ten years she has cared for patients at the Walter Reed National Military Medical Center Ophthalmology Clinic. Previously, she was on faculty at the University of Maryland, College Park in the Biological Resources Engineering Department. She started her career as a Corporate Research Fellow with AT&T Bell Laboratories.

Michelle Tarver is the Director of the Patient Science and Engagement Program at the Center for Devices and Radiological Health (CDRH).  The Patient Science and Engagement Program fosters innovative approaches to collecting, analyzing and integrating the patient perspective in the development, evaluation and surveillance of medical devices, including digital health technologies.  Under her leadership, CDRH is making the integration of the patients’ perspectives throughout the total product lifecycle of medical devices part of its daily business.  She also leads the CDRH Patient Engagement Advisory Committee efforts, an advisory panel comprised entirely of patients and caregivers providing their perspectives on general issues related to the regulation of medical devices.  In addition to her experience in patient-focused efforts, Dr. Tarver has extensive experience in premarket and postmarket review of various medical devices, developing guidance documents and standards, and fostering external collaborations.  

Dr. Tarver attended Spelman College in Atlanta, GA where she received a B.S. in Biochemistry.  She completed the M.D./Ph.D. program at The Johns Hopkins University Bloomberg School of Public Health (Ph.D. in clinical epidemiology) and The Johns Hopkins University School of Medicine.  Following her internal medicine internship, she completed a residency in ophthalmology with fellowship training in ocular inflammation (uveitis) both at the Wilmer Eye Institute (Johns Hopkins). As an epidemiologist and board-certified ophthalmologist, she has worked on longitudinal epidemiological studies, clinical trials, registries, developing patient-reported outcome measures as well as surveys to capture patient preferences with medical devices.  Her research has resulted in numerous peer-reviewed publications and published book chapters.  As a dedicated clinician, she continues to evaluate and treat ophthalmology patients at Solomon Eye Associates in Bowie, MD.  

Ryan Fischer serves as the Sr. Vice President of Community Engagement for Parent Project Muscular Dystrophy (PPMD) and has been with the organization for 16 years. PPMD is the leading organization in the fight to end Duchenne Muscular Dystrophy. Within PPMD, Ryan oversees patient advocacy, patient-focused drug development initiatives including patient-preference research, and the strategic development of the largest patient reported registry in Duchenne developed by PPMD, The Duchenne Registry. Since joining PPMD, Ryan has led legislative efforts toward passage of the MD-CARE Act Reauthorization of 2008, the MD-CARE Act Amendments of 2014, and the Patient Focused Impact Assessment Act (PFIA, 2015).  

PPMD was one of the early pioneers of investing in patient preference research for rare disorders, and advocating for advancing the science of patient input. In 2012, Ryan was a member of the core team led by Dr. John Bridges (JHSPH) who developed and produced the first-ever patient preference study on caregiver benefit-risk preferences and priorities for emerging treatments in Duchenne. Since then, Ryan has led the development of 5 additional studies collaborating with Dr. Bridges as well as Dr. Holly Peay (RTI International).

In 2014, Ryan led the Community Advisory Board charged with guiding the development of the first-of-its-kind patient initiated Draft Guidance on Duchenne Muscular Dystrophy submitted to the FDA. This landmark document informed the development of the FDA’s guidance on Duchenne Muscular Dystrophy, finalized in 2016.

Ryan believes the patient voice is the most powerful tool in the rare disease arsenal and advocates for patient and caregiver engagement within all aspects of drug development as part of PPMD’s mission.

David Gebben, PhD is a research economist focusing on stated preference methods applied within a health care context. Specifically, how stated preference methods can advance regulatory science to inform benefit risk evaluations, clinical trial endpoints, and inform ordering of patient priorities. Currently David works at Calvin University, and previously he has worked at the FDA, and prior to joining the Federal government he worked at RTI Health Solutions assisting and helping oversee studies sponsored by industry. Prior to working in a health context, David completed a post-doctorate at Queen’s University Belfast studying preferences for invasive plant species management. David completed his PhD at Colorado State University with Dr. John Loomis and completed his MS and Michigan State University with Dr. Frank Lupi. Prior to graduate school David worked in international development, completing a 2.5-year internship in Haiti.

Dr. Gonzalez is an Assistant Professor in the Department of Population Health Sciences at the Duke University School of Medicine. He is an expert in the design of stated-preference survey instruments and the use of advanced statistical tools to analyze stated-preference data. His research has focused on two main areas: 1) transparency in benefit-risk evaluations of medical interventions, and 2) elicitation of health preferences from multiple stakeholders to support shared decision making.

Dr. Gonzalez Co-led the first FDA-sponsored preference study. The study was highlighted in FDA’s recent precedent-setting guidance for submitting patient-preference evidence to inform regulatory benefit-risk evaluations of new medical devices. More recently, Dr. Gonzalez collaborated with the Medical Devices Innovation Consortium (MDIC) to prepare the first catalog of preference-elicitation methods suitable for benefit-risk assessments of medical devices. The catalog was part of the Patient-Centered Benefit-Risk Assessment Framework developed by MDIC. As a core group member of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Conjoint Analysis Task Force, Dr. Gonzalez helped draft good-practice recommendations for statistical analysis, interpretation, and reporting of health preference data. Dr. Gonzalez is the current Chair of the ISPOR special interest group on stated-preference research.

Bennett Levitan, MD, PhD is Senior Director, Benefit-risk Assessment, Department of Epidemiology at Janssen R&D, Pharmaceutical Companies of Johnson & Johnson. He introduced state of the art patient-focused benefit-risk assessment to Johnson & Johnson and his group has led numerous clinical teams in preparation of benefit-risk assessments and patient preference studies for regulatory submissions and health authority advisory meetings. He has co-led cross-disciplinary teams to implement processes to support growing regulatory requirements for patient-focused benefit-risk assessment both during development and post-approval. Bennett has published widely on both theoretical and pragmatic aspects in benefit-risk and patient preference studies and is a frequent speaker on these topics in national and international conferences.  He co-led development of the PhRMA Benefit Risk Action Team (BRAT) Framework for drug benefit-risk assessment and the Medical Device Innovation Consortium (MDIC) Patient Centered Benefit-Risk Framework. Bennett serves on several committees that inform policy on benefit-risk methods including the IMI PREFER project on patient preference studies, the ISPE Benefit-Risk Assessment, Communication and Evaluation (BRACE) team, the CTTI Patient Groups & Clinical Trials work stream, the PCORI Advisory Panel on Patient Engagement and the PhRMA Patient-Focused Drug Development Work Group.  Bennett received his BSc (Electrical Engineering) from Columbia University in New York and his MD-PhD. (Bioengineering) from the University of Pennsylvania and was a postdoctoral fellow at the Santa Fe Institute. 

Michelle Tarver is the Director of the Patient Science and Engagement Program at the Center for Devices and Radiological Health (CDRH).  The Patient Science and Engagement Program fosters innovative approaches to collecting, analyzing and integrating the patient perspective in the development, evaluation and surveillance of medical devices, including digital health technologies.  Under her leadership, CDRH is making the integration of the patients’ perspectives throughout the total product lifecycle of medical devices part of its daily business.  She also leads the CDRH Patient Engagement Advisory Committee efforts, an advisory panel comprised entirely of patients and caregivers providing their perspectives on general issues related to the regulation of medical devices.  In addition to her experience in patient-focused efforts, Dr. Tarver has extensive experience in premarket and postmarket review of various medical devices, developing guidance documents and standards, and fostering external collaborations.  

Dr. Tarver attended Spelman College in Atlanta, GA where she received a B.S. in Biochemistry.  She completed the M.D./Ph.D. program at The Johns Hopkins University Bloomberg School of Public Health (Ph.D. in clinical epidemiology) and The Johns Hopkins University School of Medicine.  Following her internal medicine internship, she completed a residency in ophthalmology with fellowship training in ocular inflammation (uveitis) both at the Wilmer Eye Institute (Johns Hopkins). As an epidemiologist and board-certified ophthalmologist, she has worked on longitudinal epidemiological studies, clinical trials, registries, developing patient-reported outcome measures as well as surveys to capture patient preferences with medical devices.  Her research has resulted in numerous peer-reviewed publications and published book chapters.  As a dedicated clinician, she continues to evaluate and treat ophthalmology patients at Solomon Eye Associates in Bowie, MD.  

Shelby Reed, PhD, RPh is Professor in Population Health Sciences and Medicine at Duke University, Faculty Leader of the Center for Informing Health Decisions, and Director of the Preference Evaluation Research (PrefER) Group at the Duke Clinical Research Institute.  She also is core faculty and serves on the executive committee at the Duke-Margolis Center for Health Policy. Dr. Reed has over 20 years of experience leading multidisciplinary health outcomes research studies. Dr. Reed has extensive expertise in designing and conducting trial-based and model-based cost-effectiveness analyses of diagnostics, drugs and patient-centered interventions. In evaluating health policy issues, she has developed computer models to evaluate the economic impact of trends in clinical trial design, changes in reimbursement policies, a new financing scheme to spur drug development for ultra-rare conditions, and the societal value of alternative approaches to identifying drug safety problems. Over the last several years, her research has increasingly focused on stated-preference studies to evaluate benefit-risk tradeoffs, patient-centered value, and their application in comparative effectiveness research and clinical decision making.  Dr. Reed earned pharmacy and doctoral degrees from the University of Maryland and completed a post-doctoral fellowship at the University of Washington. She serves on editorial advisory boards for Value in Health and Health Services Research.  She served as President of ISPOR in 2017-2018.

Mr. Bruhn-Ding has over 35 years of experience in the medical device industry.  He has held various positions at St. Jude Medical, CPI/Guidant and Angeion in research, product development, regulatory affairs, quality assurance, and clinical affairs.   Most recently prior to CVRx®, Dean was the Vice President of Regulatory Affairs for St. Jude Medical (SJM), Cardiology Division and held other Vice President and Director positions at the SJM Daig Division in Regulatory Affairs, Clinical Affairs, and Quality Assurance.  He is actively engaged with AdvaMed as a T&R and clinical working group member, along with Co-Chair of the PMA working group.  He is also participating in MDIC projects and is currently working group chair for the heart failure medical device patient preference study.

Louis Jacques, MD is Chief Clinical Officer and a Senior Vice President at ADVI, a health care advisory services firm, where he is also a partner.  He also serves on several institutional boards and advisory panels.  Before joining ADVI in 2014, Dr. Jacques was the Director of the Coverage and Analysis Group (CAG) in the Centers for Medicare & Medicaid Services (CMS) from 2009 - 2014, where he managed Medicare fee for service coverage policy development on technologies as diverse as molecular diagnostic testing, implanted cardiac devices, advanced imaging, chemotherapeutics, wound care, and screening and preventive services. From 2004 – 2009 he was a division director within CAG, focusing on Part B drugs and diagnostic tests.

Before joining CMS in 2003, he served as the Associate Dean for Curriculum at Georgetown University School of Medicine; where he also saw patients at the Lombardi Cancer Center in his practice of hospice and palliative medicine.  

Ravishankar Jayadevappa, Ph.D. is a Research Associate Professor at the Perelman School of Medicine, University of Pennsylvania as well as a member of the Abramson Cancer center, Senior Fellow at the Leonard Davis Institute of Health Economics, Fellow at the Institute of Aging, University of Pennsylvania, and Core Investigator at the Center for Health Equity Research and Promotion (CHERP), Corporal Michael J. Crescenz VA Medical Center, Philadelphia. Primary areas of research interests are: patient-centered care, patient reported outcomes, preference assessment, shared decision-making, health care disparity, healthcare systems, health economics, regulatory economics, and comparative effectiveness. With several ongoing projects are directly related to health services research, especially research related to chronic diseases such as prostate cancer, bladder cancer, lung cancer, breast cancer and Alzheimer’s. Jayadevappa is also the principal and collaborative investigator on several federal and non-federal funded grants, and have published over 60 peer reviewed papers.

 

 

Melissa West is the Acting Vice President for Research, Discovery and Innovation at the ASN Alliance for Kidney Health (ASN). Within ASN’s portfolio for Research, Discover and Innovation are KidneyX, a public-private partnership with the Department of Health and Human Service (HHS) to accelerate innovation in the prevention, diagnosis, and treatment of kidney diseases and Kidney Health Initiative (KHI), a public-private partnership between the American Society of Nephrology, U.S. Food and Drug Administration and over 100 member companies and organizations focused on fostering innovation and enhancing patient safety in kidney disease.   Prior to joining ASN in 2012, Ms. West served as a consultant for the pharmaceutical industry coordinating their activities at scientific conferences.  She was employed with Abbott Laboratories during their launch of Zemplar Capsules in 2004-2006.  Her career started in the not-for-profit industry with Smith, Bucklin and Associates, including management positions with the American Society of Psychiatric Nurses, International Society of Clinical Densitometry and ending with ASN.  She joined ASN as a full time employee in 2000 as Director of Programs with Kidney Week and assisting with corporate development.  With her 20-year career in nephrology, Ms. West is please to lead ASN’s initiatives to drive innovation and help facilitate the passage of drugs, device and biologics for kidney disease patients.

Lucinda Orsini is currently Associate Chief Science Officer at ISPOR, the leading society for health economics and outcome research. The science office at ISPOR develops, leads, and supports strategic initiatives related to research, scientific, and content priorities. While Lucinda holds a professional medical degree, she has spent most of her ~20-year career in health economics and outcomes research. Starting at The Medstat Group (Truven Health Analytics) Lucinda managed projects using health care claims data for external clients. She has worked in the pharmaceutical industry at Bristol-Myers Squibb and subsidiaries in Global HEOR focused on oncology and immunotherapy leading and publishing on patient reported outcomes, health economic modeling and real-world evidence studies – both prospective and retrospective in many different tumor types. Lucinda has recently led HEOR efforts at PAREXEL a full-service contract research group prior to coming to ISPOR.

Michelle Tarver is the Director of the Patient Science and Engagement Program at the Center for Devices and Radiological Health (CDRH).  The Patient Science and Engagement Program fosters innovative approaches to collecting, analyzing and integrating the patient perspective in the development, evaluation and surveillance of medical devices, including digital health technologies.  Under her leadership, CDRH is making the integration of the patients’ perspectives throughout the total product lifecycle of medical devices part of its daily business.  She also leads the CDRH Patient Engagement Advisory Committee efforts, an advisory panel comprised entirely of patients and caregivers providing their perspectives on general issues related to the regulation of medical devices.  In addition to her experience in patient-focused efforts, Dr. Tarver has extensive experience in premarket and postmarket review of various medical devices, developing guidance documents and standards, and fostering external collaborations.  

Dr. Tarver attended Spelman College in Atlanta, GA where she received a B.S. in Biochemistry.  She completed the M.D./Ph.D. program at The Johns Hopkins University Bloomberg School of Public Health (Ph.D. in clinical epidemiology) and The Johns Hopkins University School of Medicine.  Following her internal medicine internship, she completed a residency in ophthalmology with fellowship training in ocular inflammation (uveitis) both at the Wilmer Eye Institute (Johns Hopkins). As an epidemiologist and board-certified ophthalmologist, she has worked on longitudinal epidemiological studies, clinical trials, registries, developing patient-reported outcome measures as well as surveys to capture patient preferences with medical devices.  Her research has resulted in numerous peer-reviewed publications and published book chapters.  As a dedicated clinician, she continues to evaluate and treat ophthalmology patients at Solomon Eye Associates in Bowie, MD.