The Galien Forum USA 2018

PANEL
4

Sponsored by:

Oracle Health Sciences

Chair
Mauro Ferrari, PhD
Ernest Cockrell Jr. Presidential
Distinguished Chair President
and Chief Executive Officer,
Houston Methodist Research
Institute 
Executive
Vice President,

Houston Methodist
Hospital System

Panelists
Marc M. Boutin, JD
Chief Executive Officer
National Health Council

Paula Brown Stafford, MPH
Co-Founder of Habergeon LLC.
Adjunct Professor of Public Health Leadership at the University of North Carolina at Chapel Hill
Chief Development Officer,

Novan, Inc.

Gerard G. Nahum, MD
Vice President of Global Clinical Development
for Medical Devices & eHealth

Bayer Pharmaceuticals

Steve Rosenberg
Senior Vice President and General Manager
Oracle Health Sciences

Panel Intro

What’s Holding Back the Technology Revolution in Clinical Trials?


Mauro Ferrari

Mauro Ferrari, PhD
Ernest Cockrell Jr. Presidential
Distinguished Chair President
and Chief Executive Officer,
Houston Methodist Research
Institute 
Executive Vice President,
Houston Methodist Hospital System

Mauro Ferrari, is Executive VP of Houston Methodist and the President and CEO of the Houston Methodist Research Institute where he is the Ernest Cockrell Jr. Presidential Distinguished Chair. As the Director of the Houston Methodist Institute for Academic Medicine, he oversees all research and education programs at Houston Methodist, over 1,200 research employees and credentialed clinicians executing more than 800 clinical protocols. He also serves as the Senior Associate Dean of the Weill Cornell Medical College. He is the founder of biomedical nano/micro-technology, especially in their applications to drug delivery, cell transplantation, implantable bioreactors, and other innovative therapeutic modalities.

Dr. Ferrari served as special expert on nanotechnology at the National Cancer Institute, providing leadership for the formulation, refinement, and approval of the NCI’s Alliance for Nanotechnology in Cancer. He has more than 350 publications, including seven books and is the inventor of 30 issued patents in the US and Europe. Dr. Ferrari’s degrees are in Mathematics (Padova, Italy), and Mechanical Engineering (MS, & PhD, UC Berkeley). His seminal contributions to the field of biomedical nanotechnology have been recognized through numerous awards and accolades, including: Founders Award − Controlled Release Society, the Wallace H. Coulter Award for Biomedical Innovation and Entrepreneurship, the ETH Zürich Stodola Medal, Blaise Pascal Medal in Biomedical Engineering − European Academy of Sciences, and the Shannon Director’s Award of the National Institutes of Health.

Dr. Ferrari is a Fellow of the American Society of Mechanical Engineers, American Academy for the Advancement of Science and American Institute for Medical and Biological Engineering. He began his academic career at the University of California, Berkeley, where he tenured in Material Science, Civil Engineering, and Bioengineering. Upon recruitment to the Ohio State University, he served as the Edgar Hendrickson Professor of Biomedical Engineering, Professor of Internal Medicine, Mechanical Engineering and Materials Science. He was also the Associate Vice President, Health Sciences Technology and Commercialization, Associate Director of the Dorothy M. Davis Heart and Lung Research Institute and Director of the Biomedical Engineering Center. Upon recruitment to Houston, he served as professor and chair of the nanomedicine department at the University of Texas Health Science Center.


Marc M. BoutinMarc M. Boutin, JD
Chief Executive Officer
National Health Council

He has been a leading voice for greater patient involvement at every stage of the health care continuum, starting with the development of new drugs, to regulatory oversight of health care delivery, to shared decision-making at the point of care. Boutin has a long history of board and committee service. Currently he serves as a member of the Patient-Centered Outcomes Research Institute (PCORI) Patient Engagement Advisory Panel, FasterCures Benefit-Risk Advisory Council, and the Medical Device Innovation Consortium (MDIC) Patient-Centered Benefit-Risk Steering Committee. Boutin has been actively involved in patient advocacy organization management, health advocacy, and both federal and state policy throughout his career.

He is a founding member of the international Patient-Focused Medicine Development consortium and has served on the Governing Board of the International Alliance of Patients’ Organizations as a member and treasurer. He is also a former member of the Partnership to Fight Chronic Disease Board of Directors, the Humana Cares Clinical Advisory Board, the eHealth Initiative Leadership Council, Community Health Charities Board of Directors, Healthcare Systems Research Collaboratory, and the North America Advisory Board to the Drug Information Association.


Paula Brown Stafford, MPH
Co-Founder of Habergeon LLC.
Adjunct Professor of Public Health Leadership at the University of North Carolina at Chapel Hill
Chief Development Officer,
Novan, Inc.

Paula Brown Stafford, MPH, is Adjunct Professor in the Public Health Leadership Program at the University of North Carolina at Chapel Hill Gillings School of Global Public Health and Chief Development Officer and Board member for Novan, Inc. She is also a Board member of the CRO Health Decisions, Inc. and co-founder of Habergeon LLC.

With more than 30 years of experience in biopharmaceutical services and consulting, Paula helped build the CRO industry and the preeminent CRO in the industry, Quintiles.  Her three-decade career at Quintiles culminated in serving for five years as President of Clinical Development, the largest business within Quintiles.  She was also a member of the Executive Committee, the Technology Investment Committee and a Board observer.  She also founded Quintiles Enterprise Data Council and Quintiles Women Inspired Network. She previously served as a member of the CDISC (Clinical Data Interchange Standards Consortium) Board of Directors and as an Independent Director for Bio-Imaging Technologies, Inc. Ms. Brown Stafford provided expert testimony in the U.S. Congressional hearing on the topic of modernizing clinical trials: the “21st Century Cures” bill was later approved by the House of Representatives in 2015. She has been named as one of the 10 top women in biotech by FierceBiotech.  She received the Triangle Business Journal’s Women in Business award for her contributions to Quintiles, and her dedication to making a positive difference in healthcare. She was also honored with a Distinguished Alumna Award from the University of North Carolina at Chapel Hill.


Gerard G. Nahum

Gerard G. Nahum, MD
Vice President of Global Clinical Development
for Medical Devices & eHealth

Bayer Pharmaceuticals

Gerard G. Nahum is Vice President of Global Development, Medical Devices & eHealth at Bayer Pharmaceuticals. Previously, he was Vice President of Global Clinical Development for General Medicine at Bayer HealthCare, and before that Senior Director of US Medical Affairs at Berlex/Bayer HealthCare. Dr. Nahum has also been FDA Medical Officer at the Center for Drug Evaluation and Research in the Office of New Drugs, Associate Professor at the Duke University School of Medicine, and Adjunct Professor at the Uniformed Services University of the Health Sciences. He was in private practice for 10 years, followed by six years at Duke University Medical Center.

Dr. Nahum is the first physician in the world to successfully deliver a set of surviving twins from a woman with a rudimentary horn uterus, initially by Cesarean section and then vaginally (births separated by eight days). He is BIO-approved Industry Representative to the FDA’s BRUDAC Advisory Committee, Industry Representative for the FDA Risk Communication Advisory Committee, and has authored 65 peer-reviewed articles and chapters, in addition to three books.


Steve Rosenberg

Steve Rosenberg
Senior Vice President and General Manager
Oracle Health Sciences

As a leader and industry veteran with a range of experiences in life sciences and healthcare technology and services, Rosenberg has the knowledge and experience to address and influence the changing life sciences landscape, utilizing his deep domain understanding, customer relationships, and technology vision. As senior vice president and manager of the Medical Management Division at HPR, Inc. (acquired by McKesson HBOC) and as senior vice president of Development and Client Services at W3Health, a healthcare analytic software and services technology startup, Rosenberg gained a unique healthcare perspective to broaden his holistic view of the life sciences industry. These experiences provide him with the payer and provider perspective needed to understand the end-to-end business process and the changing dynamics affecting life sciences R&D. Rosenberg’s experience also includes eight months as chief operating officer for PHT Corporation, a technology and service leader in the electronic patient-reported outcome (ePRO) market space.

He was instrumental in developing PHT’s strategy for the patient suite and the patient-centric clinical trial. Most notably, Rosenberg was the visionary and lead evangelist for the integrated clinical technology suite introduced by Phase Forward and used by 9 of the top 10 global biopharmaceutical companies. As senior vice president of Software and Services at Phase Forward, Rosenberg was an integral member of the senior management team and championed the integrated technology approach. During his tenure, Phase Forward went public in 2005, and with his technology guidance dominated the clinical R&D solutions market. In 2009, Phase Forward achieved US$213 million in revenue with approximately 1,000 employees and was the #1 clinical R&D solution provider.