Life Science Future – MedTech Speakers

Fireside Chat | 10:05 am – 11:00 am Thursday, July 16

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. From 1998 to 2003, he served as a Staff Volunteer in the National Institutes of Health’s National Institute of Neurological Disorders and Stroke Cognitive Neuroscience Section supervising and designing clinical studies on human reasoning. Dr. Shuren returned to FDA as the Assistant Commissioner for Policy in 2003, and assumed his current position in September 2009.

Fireside Chat | 10:05 am – 11:00 am Thursday, July 16

Mark Leahey is the President & CEO for the Medical Device Manufacturers Association (MDMA), the leading national trade association representing hundreds of innovative and entrepreneurial medical technology companies in Washington, DC. His responsibilities include advocating on behalf of the medical device industry to Congress, the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and other federal and state agencies. He has led efforts for more reasonable and predictable regulatory pathways for innovators, a more timely and fair reimbursement process, and worked to open access in the hospital marketplace for all medical devices. Mr. Leahey led efforts against the medical device tax when it was first proposed in 2009, and successfully advocated for multiple suspensions of the tax before securing a full repeal in 2019. He has been named one of the medical device industry’s top lobbyists and has served as one of the lead negotiators for the medical technology industry during every user fee agreement. Leahey currently serves on the Board of Directors for the Fogarty Institute, a leading medical technology incubator, and the Executive Board of EXCITE International, a global collaborative seeking to accelerate access to health technologies and the Editorial Advisory Board of Medical Product Outsourcing. He is a member of the Massachusetts Bar and a graduate of Georgetown University, the Georgetown Law Center and Georgetown’s McDonough School of Business.

Breakfast with the CEO | 9:00 am – 9:45 am Thursday, July 16

Scott Whitaker is President and CEO of AdvaMed, the world’s largest medical technology association. AdvaMed members make the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments, to help people live longer, healthier lives. AdvaMed members range from the largest to the smallest medical technology innovators and companies. 

As CEO of AdvaMed, Whitaker is the voice of the medical technology industry. He is widely recognized as a top health care advocate and policy expert with experience across multiple health policy sectors, having worked successfully with diverse stakeholder groups – including hospital, patient and physician groups, regulators, public and private payers, and global trade organizations – to advance medical technology innovation and timely patient access to next- generation treatments and cures. 

Prior to AdvaMed, Whitaker was chief operating officer of the Biotechnology Innovation Organization (BIO), the world’s largest trade association representing biotechnology companies, and president of the BIO International Convention, the world’s largest biotech conference. Having served as COO of BIO since 2005, Whitaker brings a deep knowledge of the medical technology innovation ecosystem, a wealth of health care advocacy expertise, and strong working relationships with patient groups and other industry stakeholders. 

Whitaker also previously served as chief of staff of the U.S. Department of Health & Human Services (HHS) – a cabinet agency with 67,000 employees and a budget of $550 billion – from 2003 to 2005. As HHS chief of staff, Whitaker managed the day-to-day operations of the department; led the department’s activities on all major policy and management issues and initiatives; and served as the top liaison to the White House on policy, management and political matters. He also served as assistant secretary for legislation at HHS from 2001 to 2003. Whitaker began his Washington career on Capitol Hill, where he worked for U.S. Senator Don Nickles (R- Okla.). 

Whitaker holds a master’s degree in government from Johns Hopkins University and a degree in political science from Palm Beach Atlantic University. 

My COVID-19 Diary: Direct From the Front Lines. | 9:00 am – 10:00 am Wednesday, July 15

CDR Valerio grew up in Northeastern Ohio and attended Case Western Reserve University (BS, BA, MS 1998) and Cleveland State University College of Business Administration (MBA 2000). He was commissioned as an Ensign in the Naval Reserves in 2000 and attended the University of Kentucky College of Medicine (MD, 2004) on the Health Professions Scholarship Program (HPSP). He then completed his residency in Plastic and Reconstructive Surgery at the University of Pittsburgh Medical Center (2004-2010) prior to completing additional international fellowships in craniofacial and microsurgery at Chang Gung Memorial Hospital (CGMH), Linkou, Taiwan. After completion of his graduate medical education and training, Dr. Valerio was commissioned into Active Duty service as a Lieutenant Commander (LCDR 2010) and began his tour as an attending surgeon at the National Naval Medical Center (NNMC), Bethesda, MD.

During his Active Duty tour, he was present through the joint merger of Walter Reed Army Medical Center (WRAMC) with NNMC in formation of the joint service military treatment facility – Walter Reed National Military Medical Center (WRNMMC), Bethesda, MD. At WRNMMC, CDR Valerio served as the Director of the WRNMMC/Johns Hopkins/University of Maryland Plastic and Reconstructive Surgery Residency Combined Program, the Director of Plastic Surgery Research Programs, the Co-Director of the Reconstructive Microsurgery Program, and was a founding member and Co-Director of the Center for Advancements and Innovations in Regenerative Surgery (MISSION CAIRS). Through his leadership and commitment as a dedicated surgeon-scientist, CDR Valerio was able to secure and oversee a budget of more than $50 million in competitively awarded intramural and extramural Department of Defense (DoD) funding for various regenerative medicine projects as well as basic science, translational, and clinical trials in regenerative and reconstructive surgery.

With regard to operational experience and leadership, CDR Valerio deployed as an Individual Augmentee (IA) in support of Operation Enduring Freedom (OEF). During his deployment, he was selected and served as the Department Head of Surgical Services at the NATO Role III Multinational Medical Unit, Kandahar Airfield, Afghanistan (2012-13). After his deployment, he returned to WRNMMC and successfully completed his five-year active duty tour (2010-2015).

CDR Valerio then entered the Active Reserve Component of the US Navy (2015). He was assigned to Expeditionary Medical Facility, Bethesda (EMF – Bethesda) and cross assigned to EMF- Great Lakes. During his EMF tour, he served as an Officer-in-Charge (OIC) and Senior Medical Officer (SMO) for Detachment X, NOSC Youngstown (2017-2019). In 2019, he was selected for promotion to Captain (CAPT-sel) and assumed his current duties as a Senior Medical Executive (SME) for Operational Health Support Unit, Portsmouth Headquarters, NOSC Norfolk. As SME, he directed 77 Medical Corps officers in delivery of medical services to 901 Sailors in 15 regional detachments. In 2020, CDR Valerio mobilized with the Navy Medical Support Team (NMST) as an IA during Operation Gotham in support of the joint response to COVID-19 in New York City. During this mobilization, he served as a Senior Medical Executive (SME) and as an Acting Naval Liaison Officer (LNO) in the logistics and integration of 200 Navy Medical and Nurse Corps personnel deployed to 11 regional medical centers and the 2500 bed military field hospital located at the Javits Center.

CDR Valerio is board certified in Plastic and Reconstructive Surgery and currently serves as the SME at OHSU Portsmouth. He is a physician executive, a nationally and an internationally recognized surgeon-scientist, and a subject matter expert in reconstructive and regenerative surgery. He has authored more than 150 peer reviewed professional publications, has given over 300 national and international societal presentations, and has been a recipient of numerous national academic and educational awards. In 2019, CDR Valerio was awarded the Military Health Systems Research Symposium (MHSRS) Individual/Academia Award for Excellence in Research Accomplishment. CDR Valerio holds hospital privileges at the Massachusetts General Hospital (MGH) and holds academic appointments at Harvard Medical School, the University of Pittsburgh, and the Uniformed Services University of the Health Sciences. His military decorations include a Defense Meritorious Service, two Navy and Marine Corps Commendation, a Navy Unit Commendation, the National Defense Service, an Afghanistan Campaign, the Global War on Terrorism, a NATO, Navy and Marines Overseas, and Expert designation for both the Rifle and Pistol Marksmanship Medals, respectively.

Second Wave of COVID-19 and What to Expect | 11:35 am – 12:20 pm Friday, July 17

David B. Nash is the Founding Dean Emeritus, and he remains on the full-time faculty as the Dr. Raymond C. and Doris N. Grandon Professor of Health Policy, at the Jefferson College of Population Health (JCPH). His 11 year tenure as Dean completes 30 years on the University faculty. JCPH is dedicated to developing healthcare leaders for the future.  After voluntarily stepping down as Dean, Jefferson Health asked him to take on some additional responsibilities as “Special Assistant” to the Chief Physician Executive, and a member of the board of our ACO, one of the largest in the nation, effective July 2019.

A board-certified internist, Dr. Nash is internationally recognized for his work in public accountability for outcomes, physician leadership development, and quality-of-care improvement.  More recently, he has achieved wide acclaim for his Covid19 thought leadership and has been named as the Chief Health Advisor for the Philadelphia Convention and Visitor’s Bureau.

Repeatedly named to Modern Healthcare’s list of Most Powerful Persons in Healthcare, his national activities cover a wide scope.  Dr. Nash is a principal faculty member for quality of care programming for the American Association for Physician Leadership (AAPL) in Tampa, FL.  He served for a decade on the John M. Eisenberg Award Committee for The Joint Commission.  He also is a founding member of the AAMC-IQ Steering Committee, the group charged with infusing the tenets of quality and safety into medical education.

Dr. Nash has governance responsibilities for organizations in the public and private sectors.  He has chaired the Technical Advisory Group (TAG) of the Pennsylvania Health Care Cost Containment Council (HC4) for more than 20 years and he is widely recognized as a pioneer in the public reporting of outcomes.  Dr. Nash has been a hospital trustee for 20 years.  He served on the Board of Trustees of Catholic Healthcare Partners (now Mercy Partners), in Cincinnati, OH (1998–2008), where he was the inaugural chair of the board committee on Quality and Safety.  He concluded his tenure (2009-2017) on the board of Main Line Health, a four-hospital system in suburban Philadelphia, PA, where he also chaired the board committee on Quality and Safety.  He now serves on the board of the Geisinger Commonwealth School of Medicine (GCSOM). In 2018 he joined the board of the National Investment Center for Senior Housing and Care (NIC) – a national not-for-profit to enable housing choices for elders. Finally, in 2019, he joined the AMGA Foundation Board in Arlington, VA. 

In the for-profit sector, he very recently completed nearly a decade as a member of the Board of Directors for Humana, Inc., one of the nation’s largest publicly traded healthcare companies.  In 2014 he joined the board of InfoMC, a leading information technology company in suburban Philadelphia.  He is on the health care advisory board for Arsenal Capital Partners in NYC and just joined the board of Tract Manager, a portfolio company of Arsenal.  In late 2018 he joined the board of ANI Pharmaceuticals, a publicly traded generic drug manufacturer, headquartered in Baudette, MN.  Finally, he is a board member of FOX Rehab, a portfolio company of Blue Wolf Capital.

Dr. Nash has received many awards in recognition of his achievements.  He received the top recognition award from the Academy of Managed Care Pharmacy (1995), the Philadelphia Business Journal Healthcare Heroes Award (1997), and was named an honorary distinguished fellow of the American College of Physician Executives (now AAPL) in 1998.  In 2006 he received the Elliot Stone Award for leadership in public accountability for health data from NAHDO.  Wharton honored Dr. Nash in 2009 with the Wharton Healthcare Alumni Achievement Award and in 2012 with the Joseph Wharton Social Impact Award. Also in 2012, he received the Philadelphia Business Journal award for innovation in medical education.  

Dr. Nash’s work is well known through his many publications, public and virtual appearances, and online column on MedPage Today.  He has authored more than 100 peer-reviewed articles and edited 25 books, including The Quality Solution, Demand Better, and most recently Population Health: Creating a Culture of Wellness (3rd edition).  He was the inaugural Deputy Editor of Annals of Internal Medicine (1984-1989).  Currently, he is Editor-in-Chief of American Journal of Medical Quality, Population Health Management, and American Health and Drug Benefits. He is also on the founding editorial board of TeleHealth and Medicine Today.

Dr. Nash received his BA in economics (Phi Beta Kappa) from Vassar College; his MD from the University of Rochester School of Medicine and Dentistry and his MBA in Health Administration (with honors) from the Wharton School at the University of Pennsylvania.  While at Penn, he was a former Robert Wood Johnson Foundation Clinical Scholar and Medical Director of a nine-physician faculty group practice in general internal medicine.  He has received honorary doctorates from Salus University in Philadelphia, GCSOM, and the University of Rochester.  Dr. Nash has delivered a score of endowed and named lectures across the country.

Dr. Nash lives in Ardmore, PA, with his wife of 40 years, Esther J. Nash, MD.  They have 3 adult children.  He enjoys tennis, jogging, biking, and yoga.