2014 Annual Meeting

Gathering industry, government, and nonprofit partners to advance the regulatory science of medical devices.

Wednesday, June 25, 2014 | 10 a.m. to 4 p.m. EST
The Pew Charitable Trusts | 901 E Street NW | Washington, D.C.

The annual meeting is an opportunity for members of MDIC and the broader medical device community to network, learn what MDIC and our partners have accomplished in our first full year, and find out what’s ahead. The meeting agenda will feature an overview of MDIC, our vision and strategy, and a progress report on our key projects.

 

FDA Keynote: Jeff Shuren, MD, JD | Director, CDRH, US FDA

MDIC Overview: Bill Murray | CEO, MDIC


Project Updates

Clinical Trials Innovation & Reform (CTIR) Project update

Stephanie Christopher | Program Manager, MDIC
Susan Alpert, PhD, MD | Principal, SFA Consulting
Karim Benali, MD, MS | Chief Medical Officer, Abiomed

CTIR Q&A Panel:   Susan Alpert, Karim Benali, Stephanie Christopher, Kathryn O’Callaghan

Computer Modeling & Simulation (CM&S) Project update

Dawn Bardot, PhD | Sr Program Manager, MDIC
Randy Schiestl | VP, Global Technology, Boston Scientific

CM&S Q&A Panel:  Dawn Bardot, Kyle Myers, Randy Schiestl

Patient Centered Benefit-Risk Assessment (PCBR) Project update

Stephanie Christopher | Program Manager, MDIC
Brett Hauber, PhD | Sr Economist, VP, Health Preference Assessment, RTI-HS
Bennett Levitan, MD, PhD | Director, Quantitative Safety Research, Department of Epidemiology, Janssen R&D of Johnson & Johnson
Diana Salditt, FRAPS | Distinguished Regulatory Affairs Advisor, Medtronic

PCBR Q&A Panel:  Stephanie Christopher, Brett Hauber, Bennett Levitan, Diana Salditt, Telba Irony

Role of Regulatory Science-MDIC in Molecular Diagnostics: A CMS Perspective

Tamara Syrek Jensen, JD | Acting Director, Coverage and Analysis Group, CMS

MDIC First-Year Perspective:

Michelle McMurry-Heath, MD, PhD | Associate Director for Science, CDRH, US FDA
Bill Murray | President & CEO, MDIC

Speaker Biographies

Susan_AlpertSusan Alpert, PhD, MD | SFA Consulting, LLC

Dr. Alpert is Principal of SFA Consulting. She was most recently the Senior Vice President, Chief Regulatory Officer of Medtronic and was responsible for all Medtronic global regulatory efforts. Prior to joining Medtronic, Dr. Alpert served as Vice President of Regulatory Sciences for C.R. Bard, Inc. She also previously worked at FDA, where she held a variety of positions in the Centers dealing with drugs, devices and radiological health, and foods, including six years as the Director of the Office of Device Evaluation. Dr. Alpert is a microbiologist and a pediatrician with a specialty in infectious diseases and has practical experience in laboratory research and clinical trials. Dr. Alpert completed her undergraduate degree at Barnard College, Columbia University and holds a Master’s degree and Ph.D. in Biomedical Sciences from New York University. She received her Medical Degree from the University of Miami (Florida) and completed her clinical training at Montefiore Medical Center in the Bronx, New York and at Children’s National Medical Center in Washington, D.C.

 

benaliKarim Benali, MD, MS | Abiomed

Dr. Benali joined Abiomed in 2004 as Vice President of Product Development responsible for planning and directing the full range of Abiomed’s product development policies, objectives, and initiatives. In 2006, Dr. Benali was appointed Abiomed’s Chief Medical Officer. Dr. Benali is responsible for leading the clinical strategy and initiatives to advance the field of acute heart failure for patients that are supported with Abiomed’s products through evidence-based medicine and the design and execution of large and complex trials and registries. Dr. Benali came to Abiomed with twelve years of international experience in medicine, clinical research, bioengineering, and biostatistics, with a strong focus on cardiology. Prior to Abiomed, Dr. Benali worked for GE HealthCare, where he led the introduction of two of the company’s top products in cardiology. As the Global Clinical Research Leader for the GE cardiovascular business, he led the clinical introduction of the world’s first digital flat panel imaging system, which has become a standard in the CathLab. After that, as Global Manager, he pioneered the first cardiac procedures on the newly introduced hybrid imaging platform and positioned GE as market leader in Cardiac PET/CT. Prior to GE, Dr. Benali worked in the academic field at several renowned European medical and research institutions, including the Assistance Publique – Hopitaux de Paris, the Cyceron research center, and the Inserm Institute. He was part of the French multidisciplinary team that contributed actively to the bourgeoning field of the human brain mapping project, using multimodality imaging techniques. In the 1990s, he was a key member of the small team that pioneered one of the first real-time neuronavigation procedures in brain surgery using real-time, quantitative spatial fusion of 3D MR/CT/PET images with the patient’s brain. In parallel, Dr. Benali directed the clinical research program at the High Institute of Technology and Management in Paris, France, where he taught biostatistics and Six Sigma methodology. Dr. Benali earned an MD degree from the Institut National de l’Enseignement Superieur des Sciences Medicales in Algiers, an MS in Bio-imaging and Bio-engineering from the University of Val de Marne — Paris XII, and a Pierre & Marie-Curie University Diploma in Biostatistics and Clinical Research from University Paris VI.

 

Hauber_A_B_1874-600Brett Hauber, PhD | RTI International

Dr. Hauber is a Senior Economist and Vice President of Health Preference Assessment at RTI-HS. He has more than 15 years of academic, research, and government experience in health and environmental economics. His primary area of specialization is in conducting conjoint analysis and discrete-choice experiments to quantify preferences for medical interventions and health outcomes. He also has extensive experience in conducting benefit-risk analysis of patients and other health care decision makers, estimating willingness to pay and examining the relationship between patient preferences and adherence. He has studied the theoretical and empirical relationships among various health utility measures. His most recent applied work has included discrete-choice experiments of patient and physician benefit-risk preferences for treatments for conditions in numerous therapeutic areas, including neurology, infectious diseases, women’s health, gastrointestinal diseases, diabetes, and oncology. He has also studied the theoretical and empirical relationships among various health utility measures. Dr. Hauber regularly teaches courses on conjoint analysis. He currently is the chair of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Conjoint Analysis–Statistical Analysis, Reporting, and Conclusions (CA-SARC) task force and was previously a member of the ISPOR task force that developed the ISPOR Checklist for Good Research Practices in Conjoint Analysis. Dr. Hauber’s research has been published in numerous health outcomes and medical journals.

Dr. Hauber has a PhD, Economics and MA, Economics from University of Delaware, Newark, DE and Bachelor of Business Administration (summa cum laude) from Temple University, Philadelphia, PA.

 

Bennett_LevitanBennett Levitan, MD, PhD | Janssen R&D, Johnson & Johnson

Dr. Levitan is Director, Quantitative Safety Research, Department of Epidemiology at Janssen Research and Development LLC, Pharmaceutical Companies of Johnson & Johnson.  He is also an adjunct professor at the Center for Bioinformatics & Computational Biology at the University of Delaware.  Dr. Levitan has over 20 years’ experience in decision analysis, modeling and simulation in both consulting and pharmaceuticals. He specializes in pharmaceutical benefit-risk assessment and is a frequent speaker at meetings on the topic. He designs and oversees the development of benefit-risk analyses for use in advisory committee and health authority submissions worldwide for compounds both in development and post-approval. His experience spans many therapeutic areas with an extensive focus on antithrombotic treatment and schizophrenia.

Dr. Levitan co-led technical development of the PhRMA Benefit Risk Action Team (BRAT) Framework for drug benefit-risk assessment, currently being used by several pharmaceutical companies. He serves on several PhRMA committees that help influence policy in this field. Dr. Levitan is a member of the Next Steps Working Group, a public-private partnership focused on methods and collaboration for pharmaceutical benefit-risk assessment, the Centre for Innovation in Regulatory Science (CIRS) Benefit-risk Task Force, the ISPE Benefit Risk Assessment Special Interest Group, and the Medical Device Innovation Consortium Patient Center (MDIC) Benefit/Risk Project Steering Committee.

Dr. Levitan received his B.Sc. (Electrical Engineering) from Columbia University in New York and his M.D.-Ph.D. (Bioengineering) from the University of Pennsylvania. He worked as a postdoctoral fellow at the Santa Fe Institute.  His research and consulting work have dealt with pharmaceutical benefit-risk assessment, organizational learning, evolutionary-based optimization, high-dimensional data visualization, and combinatorial chemistry.

 

Michelle_McMurryHeathMichelle McMurry-Heath, MD, PhD | U.S. Food and Drug Administration

Dr. McMurry-Heath is Associate Director for Science at FDA’s Center for Devices and Radiological Health. In that capacity, she helps manage the regulatory science programmatic portfolio for the Center. Her science cluster team includes the standards, pediatrics, medical countermeasure, and external expertise and partnership programs. Together these programs tackle many of the cross Center scientific and engineering issues.

Prior to joining FDA, she was the founding director of the Health, Biomedical Science, and Society Initiative at the Aspen Institute and Adjunct Assistant Professor of Health Policy at George Washington University. Her Aspen Institute team focused on creating new policy strategies for stimulating biomedical research, disseminating emerging healthcare technologies, and reducing healthcare disparities domestically and internationally. Her science diplomacy work has included projects from Rwanda to Cambodia. From 2001-2004, she oversaw health and social policy issues for Senator Joseph Lieberman and was the senior health policy advisor for the Lieberman for President Campaign. While on the Hill, she worked on homeland security, health disparities, healthcare quality, and translational research bills, including the American Center for Cures initiative and legislation (later enacted as the Cures Acceleration Network). After studying biochemistry at Harvard, Dr. McMurry-Heath went on to become the first African American to receive both MD and PhD degrees from Duke University.  She trained in pediatrics and molecular immunology.

 

1_Bill Murray_20Aug2013Bill Murray | MDIC

Bill joined MDIC in August 2013 as President and CEO. He has over 25 years of senior leadership experience spanning the range of privately financed start-up to billion dollar plus global businesses. Bill’s most recent experience was as CEO of Envoy Medical, a privately financed commercial stage medical device company. Prior to Envoy, he was Interim President and CEO of MTS Systems (MTSC), a public $500M industrial technology company. Bill’s small company experience spans 5 years as CEO and executive consultant to privately financed start-up medical device companies. His large company experience includes leadership as the Molecular Biology Division President of Applied Biosystems, and at Medtronic where he spent 18 years in various senior leadership positions, including President of the Pacemaker Business. Bill currently serves on the Board of MTS Systems and previously served on the Boards of LifeSync Holdings, and ReShape Medical. Bill has served on various industry association and community leadership boards.  He earned a Bachelor of Science Degree in Electrical Engineering from The University of Florida.

 

dksphoto2Diana Salditt, FRAPS | Medtronic

Ms. Salditt is a Distinguished Regulatory Affairs Advisor in Global Regulatory Affairs at Medtronic, Inc. In this position, she serves as an internal regulatory consultant to Medtronic businesses, geographies, and corporate organizations. Ms. Salditt has a broad range of product and regulatory experience including US and international regulatory submissions and compliance for combination products, implantable medical devices, in vitro diagnostics, drugs, and biologics. She is a Fellow of the Regulatory Affairs Professionals Society (FRAPS). Ms. Salditt is active in trade association activities and leads cross-company teams in the development of internal policy and in the implementation of regulations and legislation. Special areas of expertise include regulatory strategy, combination products, regulatory science, advertising and promotion, and due diligence and acquisitions. Prior to joining Global Regulatory Affairs, she held a variety of regulatory positions in Medtronic’s Neurological and Cardiac Surgery businesses and in the in vitro diagnostics industry.

 

Schiestl,RandyRandy Schiestl, PMP | Boston Scientific

Mr. Schiestl is the Vice President of Global Technology at Boston Scientific, where he leads a team at Boston Scientific to deliver computational analysis, technology roadmapping, product design, packaging & labeling, knowledge management, and lab & test services. Mr. Schiestl’s latest role is building Global Technical Community across the corporation. He has BSME, MBA and Executive MBA degrees from the University of Minnesota. Mr. Schiestl received the UMAA Alumni Service Award from the College of Science & Engineering in 2011 and the Design of Medical Device Conference Award in 2012.

 

 

Jeffrey-ShurenJeffrey Shuren, MD, JD | U.S. Food and Drug Administration

Dr. Shuren is the Director of the Center for Devices and Radiological Health (CDRH) at FDA. He previously served as Acting Center Director. Dr. Shuren has held various policy and planning positions within FDA from 1998 to 2009, including Acting Deputy Commissioner for Policy, Planning, and Budget; Associate Commissioner for Policy and Planning; and Special Counsel to the Principal Deputy Commissioner. Dr. Shuren is board certified in Neurology and served as an Assistant Professor of Neurology at the University of Cincinnati. In 1998, Dr. Shuren joined FDA as a Medical Officer in the Office of Policy. In 2000, he served as a detailee on the Senate HELP Committee. In 2001, he became the Director of the Division of Items and Devices in the Coverage and Analysis Group at the Centers for Medicare and Medicaid Services. Dr. Shuren returned to FDA as the Assistant Commissioner for Policy in 2003, and assumed his current position in September 2009. He received both his BS and MD degrees from Northwestern University under its Honors Program in Medical Education and his JD from the University of Michigan Law School.

 

Tamara Syrek Jensen, JD | Centers for Medicare and Medicaid Services

Tamara Syrek Jensen is the acting director for the Coverage and Analysis Group (CAG) at the Centers for Medicare & Medicaid Services (CMS). CAG develops, interprets, communicates, and updates evidence based national coverage policies. These policies help provide timely access to reasonable and necessary services and technologies to improve health outcomes for Medicare beneficiaries.
 Before her current position at CAG, she was the Special Assistant for the CMS Chief Medical Officer and Director of Office of Clinical Standards and Quality (OCSQ). Prior to working at CMS, she worked as a legislative assistant in the U.S. House of Representatives. Tamara is an attorney, licensed in Maryland.