Life Science Future – MedTech Speakers
Learn more about the keynote speakers featured at
Life Sciences Future – MedTech 2020.
Vice President of Clinical Affairs, Intact Vascular and Vesper Medical
Managing Clinical Trials for Start-Up Companies: Making the Most of What You Have | 12:00 pm – 12:30 pm Wednesday, July 15
With more than 15 years of experience managing all phases of clinical research for medical devices, Mr. Marc Penna started with Intact Vascular in 2015 and Vesper Medical in 2016 and is responsible for creating short-and long-term clinical strategies with a focus on enhancing trial enrollment. He has held both executive and clinical data/clinical trial program management roles within the cardiovascular, endovascular and oncology therapeutic areas.
Previously, he served as the Senior Director of Clinical and Medical Affairs at AngioDynamics, where he was responsible for all global clinical activity. Earlier in his career, Mr. Penna worked on the transcatheter aortic valve replacement (TAVR) pivotal trials at Edwards Life Sciences as well as on the drug eluting stent program at Boston Scientific.
Mr. Penna holds a B.S. in Management Information Systems from Central Connecticut State University.
HHS Small Business Program Lead, SEED (Small business Education and Entrepreneurial Development), Office of Extramural Research (OER), National Institutes of Health (NIH)
The SEED and SBIR Programs – Latest Updates | 11:35 am – 12:05 pm Thursday, July 16
Ms. Stephanie J. Fertig is the new HHS Small Business Program Lead in SEED (Small business Education and Entrepreneurial Development) at the National Institutes of Health (NIH). She currently oversees the Health and Human Services (HHS) Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, which includes the NIH SBIR and STTR programs. The HHS SBIR and STTR programs are congressionally mandated set-aside programs that provide over $1.2 billion dollars per year to small business concerns. Prior to joining SEED, she managed the SBIR and STTR Programs at the National Institute of Neurological Disorders and Stroke (NINDS). During her over 15 years at NIH she has led the development and implementation of multiple programs focused on small businesses and translational research. Ms. Fertig has a Bachelor of Science degree in Chemistry with a major in Physics from the University of Virginia and a Master of Business Administration from the University of Maryland’s Robert H. Smith School of Business.
Retired US Army Staff Sergeant of the 82nd Airborne, Quadruple Amputee
Patient Spotlight | 9:15 am – 10:00 am Friday, July 17
Travis Mills’ keynote speech teaches and inspires audiences nationwide to “Never give up. Never quit.” no matter the obstacles or circumstances. Mills’ larger-than-life personality, sense of humor and incredible spirit for life engage audiences from the moment he takes center stage.
On April 10, 2012, United States Army Staff Sergeant Travis Mills of the 82nd Airborne was critically injured on his third tour of duty in Afghanistan by an IED (improvised explosive device) while on patrol, losing portions of both legs and both arms. He is one of only five servicemen from the wars in Iraq and Afghanistan ever to survive quadruple amputee injuries.
Thanks to his amazing strength, courage, an incredible will to live, the heroic actions of the men in his unit, the prayers of thousands, and all the healthcare providers at the Walter Reed Army Medical Center, near Washington D.C., Mills continues to overcome the obstacles of living life as a quadruple amputee. Every day is a battle, but Mills continues to astound everyone with his progress and with his amazing spirit. SSG Travis Mills is a genuine American hero, and for his incredible sacrifice, we are forever in his debt.
Susan Van Meter
Executive Director, AdvaMedDx
COVID-19: Testing, Testing, Testing | 11:00 am – 11:30 am Thursday, July 16
Susan Van Meter is executive director of AdvaMedDx. AdvaMedDx represents manufacturers of in vitro diagnostic (IVD) tests and technologies. AdvaMedDx member company innovations allow early detection of disease, facilitate evidence-based medicine, improve patient health and health care, and enable personalized medicine, while often lowering overall health care costs. AdvaMedDx is the only advocacy organization exclusively addressing policy issues facing diagnostics manufacturers in the U.S. and around the world.
AdvaMedDx operates as a division of AdvaMed, the Advanced Medical Technology Association. AdvaMed is the world’s largest medical technology association, with over 400 member companies that develop medical devices, diagnostic tools, and health information systems.
Prior to joining AdvaMedDx in 2018, Ms. Van Meter served as senior vice president at the Healthcare Association of New York State (HANYS), focused on hospital and health system policy, payment, quality and health information technology priorities. Ms. Van Meter has an undergraduate degree in Political Science and French from Villanova University and a MA in Political Science from Boston University.
Senior Vice President, Corporate Strategy and Business Development, Boston Scientific
Boston Scientific – Company Reverse Pitch | 10:50 am – 11:10 am Friday, July 17
Charlie currently serves as Senior Vice President, Corporate Strategy and Business Development for Boston Scientific. He joined the company in 2010 and his team is responsible for corporate strategic planning as well as coordinating the identification, assessment and execution of business development transactions including acquisitions, VC/minority investments, divestitures, licensing deals, co-development agreements and joint ventures. Boston Scientific has been amongst the most active investors in medical technology over the past 10 years, having completed over 35 acquisitions across size ranges from sub $10 million to several $ billions, as well as growing our venture capital portfolio to over 40 investments across strategic areas of interest. Prior to Boston Scientific, Charlie spent 16 years in investment banking at Credit Suisse, DLJ and BT Alex Brown – in New York, Chicago and Paris. Charlie grew up in France and attended college at Princeton University where he received a Bachelor of Arts in Economics.
President, Chief Executive Officer and Chairman of the Board of Directors
Breakthrough Device Designation for the PoNS Device – The Ups and Downs of the Process | 12:10 pm – 12:40 pm Thursday, July 16
Phil joined Helius Medical Technologies in 2013. He has more than 28 years of experience in pharmaceutical and healthcare commercialization gained at Bristol Myers Squibb (BMS) and as CEO of GSW Worldwide and, later, at MediMedia Health.
Before joining Helius, Phil led MediMedia Health Marketing Services, where he was responsible for strategic development, nurturing the company’s clients and developing nonpersonal products and services in the healthcare industry.
As GSW’s president and CEO, Phil was responsible for worldwide operations in 15 major global markets and a turnover of $160 million with 700 employees globally. His primary work included global marketing, commercialization and new business model development for pharmaceutical, device and diagnostics companies.
Phil’s role as director of neuroscience marketing at BMS saw him serve as a member of several prelaunch global marketing teams in the neuroscience and pain therapeutic areas. He also held marketing positions in the neuroscience, pain, and metabolic therapeutic areas.
He is a leader in developing new global business models for the healthcare industry, including outsourcing solutions that seek to increase commercialization effectiveness and increase resource flexibility while reducing risk and driving efficiency and cost reduction. His experience as a global healthcare commercialization expert will guide Helius in its development and acquisition of non-invasive treatments designed to help patients affected by neurological symptoms caused by disease or trauma.
Phil graduated from the University of Ottawa with a degree in Chemistry. He is fluent in French and English. He resides in Newtown, PA, with his wife Nicole and two children. Learn more about Phil on LinkedIn.
Gerard Honig, PhD
Associate Director of Research Innovation, Crohn's & Colitis Foundation
Crohn’s & Colitis Foundation – Company Reverse Pitch | 11:50 am – 12:10 pm Thursday, July 16
Speaker details coming soon.
Ibraheem T. Badejo, PhD
Senior Director - New Ventures (Med Devices), Johnson & Johnson Innovation Center, Boston
Johnson & Johnson Innovation – Company Reverse Pitch | 11:40 am – 12:o0 pm Wednesday, July 15
Ibraheem (Ib) leverages his expertise in smart materials and biomaterials to support the medical device sector of Johnson & Johnson. From 2010 to 2013, Ib was a Research Fellow at Global Surgery Group of Johnson & Johnson, where he was responsible for external and front-end innovations and intellectual property for Ethicon Biosurgery. From 2006 to 2010, he was the Director of Applied Research & New Technology Assessment of novel biomaterials. Prior to that, he was the Chief Scientist of Closure Medical Corp (acquired by Johnson & Johnson in 2005). Ib has held various positions at Bayer, North Carolina State University, and the College of Charleston. He currently serves as an Adjunct Professor of Biomedical Engineering at Drexel University.
During his career, Ibraheem has led teams in the development of commercialized biomaterials-based products and new technology / products licensed or acquired. Ib received his PhD in organic chemistry from the University of Toledo, where he was the Robert Whiteford Memorial Scholar for Outstanding Graduate Research and a Petroleum Research Fund Fellow. Ib received the Science Alumni Award, Avila University in 2014. Ib is also the recipient of 24 US patents, he’s also well published in many peer review journals.
Partner, Morgan Lewis
Leading From Within: How Meditation Can Make you a More Effective Leader | 12:35 pm – 1:05 pm Wednesday, July 15
Chair of the firm’s emerging business and technology practice, Steven M. Cohen represents entrepreneurs, private equity investors, and venture capital funds. He advises clients in such industries as technology, life sciences, chemicals, consumer products, digital health, and fintech. Steve counsels mid-Atlantic region investors and emerging growth companies in a variety of business transaction including equity financing transactions, mergers and acquisitions (M&A), divestitures, initial public offerings (IPOs), joint ventures, and international strategic partnerships.
With a knack for creating connections between investors and entrepreneurs, Steve helps develop and implement growth strategies, working with companies throughout their entire lifecycle.
Widely recognized on the East Coast for his knowledge and skill, Steve lectures frequently on planning profitable exit strategies, obtaining angel and venture capital financing for early-stage companies and business leadership. Steve is also managing partner of the firm’s Princeton office.
David Dalessandro, PMP
Technology Transfer Director, 3D Printing Innovation & Customer Solutions, Johnson & Johnson
Supply Chain Innovation: 3D Printing | 12:45 pm – 1:15 pm Thursday, July 16
David Dalessandro is a new product development leader who developed and commercialized over 20 medical devices in the cardiovascular, surgical, orthopedic, diagnostics and consumer markets. He was a pioneering member of the Johnson & Johnson startup venture that developed the first cardiovascular stent changing the standard of care in cardiac revascularization and becoming the fastest medical device to achieve $1B in sales.
During his 30+ year career with J&J David held several leadership positions in R&D, Project Management and Supply Chain across the medical device, pharmaceutical and consumer sectors of J&J. He is currently the Technology Transfer Director with J&J Supply Chain Strategy Innovation & Deployment, responsible for the application of 3D printing technologies.
David holds a BS in Mechanical Engineering and an MS in Engineering Management, both from New Jersey Institute of Technology. He is a Certified Project Management Professional (PMP) and holds a Certification in Innovation and Entrepreneurship from Stanford University.
Ian L. Valerio, MD, MS, MBA, FACS, Commander (CDR), Medical Corps, US Navy
Plastic and Reconstructive Surgeon at Harvard Medical School and Massachusetts General Hospital
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.
Vice President, Global Commercial of DSM Biomedical
Company Reverse Pitch – DSM | 11:15 am – 11:35 am Friday, July 17
As Vice President, Global Commercial, Eric Shelton leads the sales and marketing operations of DSM Biomedical’s global business.
Mr. Shelton joined DSM from Nypro Healthcare, where he led their business development efforts in expansion of sales and services to major and emerging pharmaceutical and biotech companies. Before joining Nypro, Eric was the Executive Vice President, Global Sales & Marketing at SteriPack Group and held other leadership positions at Smith & Nephew, Phillips-Medisize and BASF. Eric is a highly accomplished senior leader who excels at analyzing lucrative global operational needs, identifying multimillion-dollar growth opportunities, defining methods for capturing new customers and retaining existing clientele, and attaining competitive market leverage.
Stephen Pitt, Ph.D.
Head of Johnson & Johnson Innovation, JLABS US North East
JLABS Update | 11:00 am – 11:30 am Thursday, July 16
Stephen Pitt, Ph.D. is the Head of Johnson & Johnson Innovation, JLABS US North East which includes the JLABS @ NYC, JPOD @ Boston, JLABS @ LabCentral, JLABS @ M2D2 and JPOD @ Philadelphia. He is responsible for external engagement, innovation sourcing, company onboarding, portfolio management, operational excellence, educational programming and P&L. He catalyzes and supports the translation of science and technology into valuable solutions for patients and consumers across the pharmaceutical, medical device, consumer and healthtech sectors.
Steve joined JLABS from GlaxoSmithKline, where he was Senior Director of Emerging Science Innovation and Head of the Digital Innovation Hub R&D Team. At GSK, Steve led externally focused R&D teams that shifted pipeline strategies from basic symptom relief to holistic disease management to transform self-care. He also created partnerships with academic institutions, start-ups, corporate partners, hospital systems, and other novel outsourcing collaborators with the aim to build breakthrough technology platforms and products.
Prior to GSK, he continually increased his responsibility as an R&D leader over 15 years in drug discovery, pharmaceutical development and consumer healthcare at Johnson & Johnson, Pfizer, Bayer, and in biotech. His experiences include drug discovery and advancing compounds to clinical trials, pharmaceutical development and commercialization of novel Rx Drugs, and consumer health product development in upstream innovation groups to shape and launch new external technologies.
Steve earned his Ph.D. in Molecular Pharmacology from Cornell Medical School and Memorial Sloan Kettering Cancer Center in New York City. At Cornell, Steve pioneered computational molecular dynamic drug discovery approaches. He also holds several patents and has published in top scientific journals.
President and CEO, Advanced Medical Technology Association
Breakfast in the C Suite | 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.
Chairman and CEO, ALung Technologies, Inc.
Emergency Use Authorization in COVID-19 Era | 10:50 am – 11:20 am Wednesday, July 15
Pete DeComo has served as Chairman and CEO of ALung Technologies, Inc. since 2010. ALung has developed a revolutionary artificial lung for patients suffering from Acute Respiratory Failure. He has raised in excess of $100MM to complete development of ALung’s technology. Prior to ALung he was founder, Chairman and CEO Renal Solutions, Inc. (RSI). RSI developed a revolutionary dialysis technology system for patients suffering from kidney failure. In late 2007 RSI was acquired by Fresenius Medical Care Holdings for a total consideration of $200MM. Mr. DeComo is the past Chairman and is a current Director on the Board of the Pittsburgh Life Sciences Greenhouse. He is the past Chairman of the Community College of Allegheny County Educational Foundation Board and has served on the Boards of numerous early stage medical device companies. He is the recipient of the Ernst & Young and Pittsburgh Venture Capital Association “Entrepreneur of the Year Awards” in 2008.
Dr. Shante P. Williams, MBA
CEO, Black Pearl Global Investments
Creating the Future: Investing in Life Sciences | 12:45 pm – 1:15 pm Thursday, July 16
Dr. Shante Williams is currently the CEO of Black Pearl Global Investments, a $25M venture capital fund. She is a distinguished Venture Capitalist, business owner, Inventor, Intellectual Property Strategist, and Private Investor. In her career years, she has used her wealth of scientific knowledge as well as her passion for innovation to solve multiple complex problems across the industries of health, finance, and real estate. Best known for her creative problem-solving approach, Dr. Williams’ impressive professional qualities and ethics make it easy for her to transition into various career paths seamlessly. Her proven track record of excellence and leadership has been an integral part of growth for many individuals and businesses. She is a proud graduate of Winston-Salem State University (BS, Chemistry), The Ohio State University (PhD, in Integrated Biomedical Science specializing in Neuro-Oncology and Pharmacology), Queen’s University of Charlotte (MBA). Dr. Williams has received numerous awards for her business and entrepreneurship efforts.
Justin Klein, MD, JD
Co-Founder and Managing Partner, Vensana Capital
Funding and Investments: What I’m Seeing Right Now – Key Considerations in Light of COVID-19 | 10:15 am – 10:45 am Wednesday, July 15
Justin Klein, MD, JD is a co-founder and Managing Partner at Vensana Capital, a leading venture capital and growth equity firm dedicated to medtech innovation. Justin was previously a partner and leader of the medical technology investing practice at NEA, one of the largest and most active venture capital firms in the world. Justin also worked at the Duke University Health System where his experience included roles in strategy, finance and operations as Duke built one of the nation’s first integrated healthcare delivery systems. Justin currently or previously served on the board of directors of Cartiva (acquired), ChromaCode, CV Ingenuity (acquired), Epix Therapeutics (acquired), FIRE1, GPB Scientific, Intact Vascular, Metavention, Personal Genome Diagnostics, PhaseBio Pharmaceuticals (IPO), Relievant Medsystems, Senseonics (IPO), Topera (acquired), Ulthera (acquired), Vertiflex (acquired), Vesper Medical, and VytronUS (acquired).
Justin currently serves as a member of the Board of Directors of the Medical Device Manufacturers Association and that of AdvaMed Accel, where he is the Chair of its MedTech Investment Working Group.
Justin graduated with an AB in Economics, a BS in Biological Anthropology & Anatomy, and a Minor in Chemistry from Duke University. He also concurrently earned his MD from the Duke University School of Medicine and his JD from Harvard Law School.
David B. Nash, MD, MBA
Founding Dean Emeritus at Jefferson College of Population Health, Thomas Jefferson University
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.
Jeffrey Shuren, MD, JD
Director of the Center for Devices and Radiological Health (CDRH), U.S. FDA)
Fireside Chat | 10:05 am – 11:00 am Thursday, July 16
Jeffrey Shuren, MD, JD 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. 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.
President & CEO Medical Device Manufacturers Association (MDMA)
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.
Gert Bos, PhD, FRAPS
Executive Director & Partner, Qserve Group
The Impact and Implications of 1 Year Delay in EU MDR Date of Application | 10:50 am – 11:20 am Wednesday, July 15
Gert is an expert in European regulations based on 18 years hands-on working in the field, as auditor, product reviewer, regulatory specialist, Head of notified body and strategic consultant. He has been leading the Notified Bodies in Brussels for many years, and has strongly supported the regulatory debate with the EU Commission, EU Parliament and the EU Council of Ministers. He combines strong experience in quality, compliance and regulations with a pragmatic, result driven approach at both operational and strategic level. From his PhD in Biomaterial Sciences, and PostDocs in controlled release of drugs
and gene therapy, he has dealt as technical reviewer and consultantwith a large range of devices mostly in the non-active device area. For his contributions to the regulatory profession he has been awarded as Fellow of RAPS. Gert is president-elect of RAPS, and serves as board member of RAPS Europe.
Project Officer Division of Detection, Diagnostics, and Devices Infrastructure (DDDI), Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response, US Department of Health and Human Services
BARDA and Medical Devices: How We Approach Platform Development | 12:10 pm – 12:40 pm Thursday, July 16
Ms. Bonnie is a Project Officer from Biomedical Advanced Research and Development Authority (BARDA) a component of the Office of the Assistant Secretary for Preparedness and Response in HHS. BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. Ms. Shen joined BARDA in November 2010 focusing on product development specifically for Medical Devices and Diagnostics. Since joining BARDA, Ms. Shen has successfully lead multiple products from early stage development through FDA clearance/authorization, and eventual acquisition into the Strategic National Stockpile, including an all hazard ventilator for pandemic use, a ZIKA blood screening diagnostic, and a COVID-19 point of care diagnostic. Ms. Shen’s current portfolio includes respiratory masks and devices, point of care influenza, COVID 19 diagnostics, and biothreat diagnostics. Prior to joining BARDA, Ms. Shen focused on product development for global health in Africa and Asia. Ms. Shen has a Bachelor of Arts in Economics from University of Michigan and Masters of International Health from Brandeis University.
Marla A. Phillips, Ph.D.
Director, Xavier Health, Xavier University
COVID-19 Impacts on Supply Chain | 10:15 am – 10:45 am Wednesday, July 15
Marla founded Xavier Health in 2008 at Xavier University, where she advances the industry with FDA officials and Pharmaceutical and Medical Device professionals. Marla began working in the pharmaceutical industry for Merck in 1996 where she took on roles of increasing responsibility, culminating in the position of Head of Quality Operations at the Merck North Carolina facility. Additionally, Marla is the Founder, CEO and President of Pathway for Patient Health, leading the implementation of a Quality Science Education program that is free for undergraduate and graduate students around the world, and is working with Chief Quality and Operations Officers to Mobilize Enterprise-wide Effectiveness. Marla holds a B.S. in Chemistry from Xavier University, and a Ph.D. in Organic Chemistry from the University of North Carolina – Chapel Hill.
John H. Rundback, MD
Managing Partner, Advanced Interventional & Vascular Services LLP and Partner, New Jersey Endovascular & Amputation Prevention
Accessing Clinicians in the New Normal: Education and Industry Collaborations | 10:15 am – 10:45 am Friday, July 17
John H. Rundback, MD, is the Managing Partner of Advanced Interventional & Vascular Services and Partner at New Jersey Endovascular & Amputation Prevention. He is a graduate of SUNY Downstate Medical Center, and completed his fellowship in Interventional Radiology at Washington Hospital Center in Washington, DC. He is a member of the Board of Directors of VIVA Physicians, and has served as Principal Investigator of multiple trials evaluating new device and drug therapy for peripheral arterial disease. Dr. Rundback has authored or contributed to nearly 100 scientific manuscripts and has been an invited speaker at numerous medical meetings world-wide. His primary research activities are in the area of complex endovascular interventions, and amputation prevention.
Elective Surgeries: Impact on Patients and the Industry | 12:00 pm – 12:30 pm Wednesday, July 15
As a thought leader on enterprise strategy, Jeff helps both health system and life sciences and industry clients understand the implications of emerging macro- and microlevel trends impacting health care. He plays a key role in the development of Sg2 Intelligence resources and educational offerings and is a frequent presenter and educator on multiple topics, including health care reform, consumerism and patient engagement, ambulatory strategy, value-based care, and leading practices in care redesign.
Jeff has more than 25 years of health care advisory and consulting experience, with specific areas of expertise including strategic planning, process improvement, operational effectiveness and organizational change.
Before joining Sg2, Jeff was the vice president of assessments at Cardinal Health in Dublin, OH, where he identified opportunities for improvement and recommended specific strategies to client organizations. He also led health care consulting projects focused on improving profitability, quality and service for both specific departments and entire organizations. During his tenure, Jeff helped identify opportunities that yielded an average of 12% operating improvement. In his last 5 years, he participated in or led an average of 15 assessments per year. He was integral to the development of Cardinal Health’s “patient throughput” product in 2002.
Prior to his work at Cardinal Health, Jeff served as a project director for West Hudson, Inc (now part of Cardinal Health). There, he facilitated the implementation of hospital-based quality-, service- and cost-related process improvements both inter- and intradepartmentally. Jeff received an MS in organizational psychology from Springfield College in Massachusetts and a BS with a double major in economics and psychology from Texas Christian University.
President and Chief Executive Officer, OraSure Technologies, Inc.
OraSure Technologies – Company Reverse Pitch | 11:15 am – 11:35 am Thursday, July 16
Steve Tang became President & CEO of OraSure Technologies, Inc. (NASDAQ: OSUR) on April 1, 2018. Dr. Tang previously served as Chairman of the Board of Directors (2016-2018) and was first elected to the Board in 2011. Prior to April 2018, Dr. Tang served as President and CEO of the University City Science Center, the nation’s first and largest urban research park, from 2008-2018. During that decade, Tang initiated, led, and implemented a strategic plan designed to transform the Science Center from a traditional real-estate focused research park to an innovation powerhouse. From 2005-2008, he was a senior executive with Olympus America, including leading their Life Science Group of business. Prior to that, he was an energy technology entrepreneur and a senior executive at two leading global management consulting firms.
Amy Brouhle, RN, BSN, MBA, MHA
Vice President, Business Development, Sg2
Elective Surgeries: Impact on Patients and the Industry | 12:00 pm – 12:30 pm Wednesday, July 15
As a vice president at Sg2, Amy is responsible for driving new business for Sg2 in the supplier segment of the market, which includes pharmaceutical, medical device and life science companies. She focuses on identifying emerging trends, industry disruption and partnership opportunities for life science organizations to leverage for growth, and she helps prioritize IDN segmentation and innovation. Previously at Sg2, she was accountable for growing new sales in the Western region of the United States, including California and Texas.
Amy has over 25 years of experience in the health care arena and has held positions spanning a variety of consulting, operational and clinical services. Prior to joining Sg2, she worked with Press Ganey Associates, Inc, and most recently served as vice president of ambulatory services, where she was responsible for the strategic direction, revenue growth, product development, regulatory alliance, sales messaging and marketing of the ambulatory service lines. She also managed product development and collaborated with marketing and sales as vice president of client enterprise solutions, and she provided marketplace and regulatory expertise to large medical practices seeking to grow market share as director of medical services, among other Press Ganey Associates duties and roles.
Additionally, Amy has held positions with GE Healthcare, Per-Se Technologies and the TriZetto Group, Inc. She has extensive consulting experience in medical practice start-ups, physician compensation planning and revenue cycle reengineering. She began her career as a registered nurse.
Amy holds a master of business administration and a master of health administration from the University of Colorado Denver, and she has a bachelor of science in nursing from the University of Virginia.
Assistant Clinical Professor at Drexel LeBow College of Business
Supply Chain Globalization or Localization in a Post-Pandemic Era? | 10:15 am – 10:45 Friday, July 17
Mr. Albert DeRitis is an Assistant Clinical Professor at Drexel LeBow College of Business. He brings over thirty-five years of unique & diversified experience in accounting, finance, and supply chain in the healthcare industry. He has an in-depth understanding of domestic and international marketplace dynamics across Supply Chain, Commercial Sales & Marketing, and R&D organizations.
Most recently, he served as Worldwide Supply Chain Product Management Director for Johnson & Johnson, where he was responsible for all aspects of Life Cycle Management and End-to-End (E2E) supply chain for J&J’s top selling pharmaceutical product across 111 markets, impacting 2.7 million patients worldwide.
Mr. DeRitis previously served as Worldwide Financial Controller for a French Pharmaceutical company. He possesses knowledge in both Chemical (small molecule) and Biologic (large molecule) API business models, and has manufacturing plant experience in both environments.
- Executive Faculty Member for LeBow College of Business
- MBA from St. Joseph’s University Haub School of Management
- Certified Public Accountant (CPA), Certified Supply Chain Professional (CSCP), and Chartered Global Management Accountant (CGMA).
- Courses include: Essentials of Financial Reporting for MBA/EMBA, Operations & Supply Chain Management, Cost Accounting, Advanced Cost Accounting, Strategic Cost Management, Integrating Supply Chain with Financial Management, and Strategy & the Master Budgeting Process
Shawn Patrick O’Brien
Genomind – Company Reverse Pitch | 10:30 am – 10:50 am Wednesday, July 15
Shawn currently serves as the CEO and Director of Genomind Inc., a private personalized mental health business based in King of Prussia, which improves the lives of many around the globe through insights provided from its world class genetic lab and medical team.
A biotech and big pharma executive leader with over 35 years’ experience in building highly successful global enterprises. Shawn has extensive international experience in business development, marketing, selling, licensing, researching & developing both small and large molecules, with over 7 multi-Billion dollar product launches.
Since leaving big pharma 15 years ago, Shawn has been a serial entrepreneur leading 4 biotech companies before his current role at Genomind. In addition he has broad healthcare provider experience in USA, UK and Canada.
Shawn is the Chairman of Alto Pharma, Co-Chair of the Hubert Schoemaker Classic, Advisory Board member of both; The Greater Philadelphia Life Sciences Congress and Life Sciences Cares Philadelphia.
Supply Chain Virtual Audits: Temporary Change or Permanent Impact? | 11:25 am – 11:55 am Wednesday, July 15
Jim Fries is a success based executive with over 25 years of experience building medical device and diagnostic companies. He became CEO of Rx-360 in February of 2018. Jim’s dedication to healthcare supply chain security and patient safety has always been his personal mission. In 2020 Rx-360 also founded the Rx-360 Education and Research Foundation (501c3) that is dedicated to bringing awareness of patient safety to everyone worldwide through educational programs and research. His personal vision coupled with the Rx-360 mission brings a wealth of awareness and success to all Rx-360 members and the industry as a whole.
Kate M. Shay, Esquire
Partner, Duane Morris LLP
Moderating: Closing Speaker – Fireside Chat | Second Wave of COVID-19 and What to Expect | 11:35 am – 12:20 pm Friday, July 17
Kathleen M. Shay, a partner at the law firm of Duane Morris LLP, is a corporate and securities lawyer who focuses her practice on the life science industry, representing public and private biopharmaceutical, medical device and diagnostic companies, healthcare information technology and services companies, venture capital funds and other investors in the life science and healthcare industries, academic and research institutions, and life science industry collaborators and service providers. Ms. Shay represents both established and emerging businesses in a wide range of legal transactions and issues, including debt and equity financings, structuring transactions, licenses and strategic relationships, mergers and acquisitions, governance matters, and employment and compensation issues.
Ms. Shay serves on the Boards of Directors and Executive Committees of Life Sciences PA and University City Science Center and the Board of Consultors of Villanova Law School, and she is a Director Emeritus of the Philadelphia Alliance for Capital and Technologies (PACT) and a Trustee Emeritus of the Academy of Notre Dame de Namur. Ms. Shay previously served as a director of the Philadelphia Chapter of the Association for Corporate Growth and as the Chair of the Executive Committee of the Business Law Section of the Philadelphia Bar Association, and she is a past-Chair of the Securities Regulation Committee. She is an Advisory Board member and former director of the Alliance of Women Entrepreneurs (AWE) and has served as AWE’s counsel since its inception.
Ms. Shay received her B.A. from Villanova University and her J.D. from Villanova University School of Law, where she served as Editor-in-Chief of The Villanova Law Review.
Duane Morris LLP, among the one hundred largest law firms in the nation, is a full service firm of approximately 750 lawyers. The firm represents clients across the United States and around the world through its offices in the United States, London and Asia, and relationships with two international networks of independent law firms. For more information, visit the firm’s website at www.duanemorris.com.
Daniel K. Fitzpatrick
Partner, Duane Morris LLP
Moderating: Breakfast with the CEO | 9:00 am – 9:45 am Thursday, July 16
Daniel K. Fitzpatrick, a commercial banking executive with more than 30 years of experience, is President of Citizens Bank’s Mid-Atlantic Region and Head of its National Industry Verticals.
He serves on Citizens Financial Group’s Executive Leadership Group, the company’s senior leadership team. Citizens Financial Group is headquartered in Providence, R.I.
Fitzpatrick, a native of Northeast Philadelphia, is a former chairman of the Greater Philadelphia Chamber of Commerce and serves on its executive committee, its Greater Philadelphia Energy Action Team, and its CEO Council for Growth. As chairman of the CEO Council’s Human Capital Working Group, Fitzpatrick has focused on collaborating with public, private and nonprofit partners to provide workforce development solutions and opportunities to disadvantaged populations. Fitzpatrick is also a member of the Board of the Allegheny Conference on Community Development and a member of the Heinz History Museum Board in Pittsburgh.
Fitzpatrick serves as vice chairman of Philadelphia Works, Philadelphia’s workforce development corporation, and is a member of the board of directors of the Philadelphia Convention & Visitors Bureau, The Wistar Institute and The Union League. Fitzpatrick serves on the board and executive committee of The Satell Institute. He is also a member of the executive board of Elementary Education for the Archdiocese of Philadelphia, and serves on the University of Pennslyvania’s Abramson Cancer Center Innovation Advisory Board and is a member of Children’s Hospital of Philadelphia’s Corporate Council. Fitzpatrick is a former member of the board of trustees of La Salle University and served on the advisory board of Drexel University’s College of Engineering.
As a result of Fitzpatrick’s community efforts, he and Citizens Bank have received numerous community awards from such organizations as the Police Athletic League Award, Philadelphia Academies Inc, the Greater Philadelphia YMCA, the Philadelphia Mural Arts Program, the Philadelphia Chinatown Development Corporation and the Welcoming Center for New Pennsylvanians. In 2016, Fitzpatrick was named an Emerging Icon in Financial Services by The Philadelphia Inquirer.
Fitzpatrick earned a bachelor’s degree in business administration from La Salle University and an MBA from Drexel University. He is a CPA and a Chartered Financial Analyst. Fitzpatrick lives in Philadelphia, Pa., with his wife Beth and their four children.
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