Ed, and the teams he led, have improved medical care for countless individuals, worldwide. Over a span of 30 years in the medical device field, he has focused on the advancement of global healthcare via applied innovation. He was formally Senior Director – Diabetes Care Division of Becton Dickinson and has over 15 years of business experience in diabetes care and surgical devices. He has led a number of large multi-national business teams, formed two new business units and was responsible for development and implementation of strategies that led to industry leading growth and share-of-category positions for a number of multi-billion-dollar enterprises.
Recently retired, Larry Hirsch was Vice President, Global Medical Affairs for BD Diabetes Care (DC) since 2006. Dr. Hirsch provided medical perspective to the business, engaged widely with KOLs and professional societies, designed and reported DC clinical trials, worldwide. He initiated the first modern, published studies on injection site anatomy, and essentially taught the global medical community the resulting implications for insulin delivery device design. He also studied the performance of the world’s first 4mm x 32G insulin pen needle, and the impact of other product innovations on intramuscular injection risk, pain, ease of use, and patient preference. Larry co-authored several studies on injection-related fat enlargement (lipohypertrophy) diagnosis, prevalence, and impact on insulin absorption, action and costs. He did the same for the 2016 New Recommendations for insulin injection technique, and initial studies of a dual-ported insulin pump infusion set catheter. Larry also provided medical direction to development programs in BD for novel devices and technologies for diabetes. Dr. Hirsch has given > 250 presentations worldwide – many of them invited at prominent academic medical centers and teaching hospitals, as well as in plenary sessions at regional, national and international conferences. He interacted with many leading KOLs and professional societies on behalf of DC including the ADA (American Diabetes Association), EASD, AADE, AACE and others.
Dr. Hirsch previously spent nearly 18 years at Merck (MSD), where he oversaw quantitative coronary angiography and clinical outcome studies with statins (including the practice-changing “4S” trial with simvastatin), and led the global product development team for alendronate (Fosamax®), presenting the original NDA to the FDA Endocrine-Metabolic Disease Advisory Committee in 1995. Alendronate became the first non-hormonal treatment for osteoporosis approved by the FDA, with multiple additional indications. At its peak, Larry managed a clinical team of ~ 50 persons, with annual operating budget > $8 million, and clinical trial expenditures > $13 million.
Dr. Hirsch has a strong interest in clinical research, trial registration, ethical publication practices, peer-reviewed publication and editorial conduct. He has written several Commentaries on these matters, and was a co-founder and third President of ISMPP (International Society of Medical Publication Professionals), for those working in industry organizations supporting trial publication. He started and expanded the “publications department” from 15 to > 50 staff at Merck, 2001-2006. The group annually published > 125 peer-reviewed articles in major medical journals, and > 200 abstracts/posters in his last two years in the role. Larry authored publication policies at both Merck and at BD. He was awarded Fellowship status in the American College of Physicians, received the Edward Ill Foundation Award for Outstanding Clinical Scientist in New Jersey, and the BD Wesley J. Howe Lifetime Achievement Award, BD’s highest scientific award – all in 2017.
Dr. Hirsch graduated from Harvard Medical School, and is board-certified in Internal Medicine and in Endocrinology & Metabolism. He has lived a very active life with type 1 diabetes, taking insulin > 61 years. Larry is a recipient of the Joslin Clinic’s 50-year Medal, and a participant in the Medalist Study of diabetes-related complications in long-term T1D survivors.
Mark S. Andrew, MD
Dr Andrew is the Founder and Chief Scientific Officer of Medality Medical, LLC. He is the co-inventor of Tissue Liquefaction Technology® (TLT). Medality Medical’s’ HydraSolve® is the second clinical application of TLT, the first being the AquaLase® Liquefaction Device, a small-incision cataract removal technology on Alcon’s premier cataract machine, the INFINITI® Vision System, used routinely in more than 50 countries. Dr Andrew, a Fellow of the American Academy of Ophthalmology, is a board-certified ophthalmologist with more than 25 years’ experience. He received his medical degree from Jefferson Medical College (Sidney Kimmel Medical College) in Philadelphia, PA, and served his residency at Hahnemann University Hospital in Philadelphia. His scientific background includes basic science research in biochemistry, endocrinology, and immunology, as well as research in fluid dynamics at: the National Eye Institute of the National Institutes of Health (NIH), Drexel University School of Biomedical Engineering, Jefferson Medical College (Sidney Kimmel Medical College), Wills Eye Hospital and the Penn State Health Milton S. Hershey Medical Center. Dr Andrew holds 10 issued US patents, 27 issued foreign patents, with more pending. Dr. Andrew’s inventions have led to 6 FDA clearances, 25 peer-reviewed journal articles and numerous surgical textbook citations.
Mr. Murray established BV Murray & Co. Inc., a boutique investment bank in 1996 after 17 years at Bear Stearns in the corporate finance department where he was a Senior Managing Director. Prior to joining Bear Stearns in 1978, he was a partner at HC Wainwright & Co, an institutional Wall Street research firm. Over his career, Mr. Murray has obtained extensive worldwide experience in mergers and acquisitions, valuations and public and private debt and equity of offerings. Mr. Murray holds a B.S. degree in Economics from Villanova University, an MBA with honors (majoring in finance and international business) from the University of Chicago and is a Chartered Financial Analyst (“CFA”).
Suzy is a marketing strategist with extensive business management experience. She has developed and led successful teams for DuPont, Pfizer, Inamed and Allergan. Her 25-year career has been focused on building and reviving brand value for the professional and consumer segments in the health and beauty, cardiology and plastic surgery markets. Suzy successfully spearheaded the reintroduction of Allergan’s silicone breast implants in the US market. She actively participated in the development and launch of Project Beauty now Smart Beauty guide, ASAPS proprietary consumer website and The Plastic Surgery Channel theplasticsurgerychannel.com (plastic surgeons owned video based consumer website). She has also been invited to speak at ASAPS annual meeting in 2010 and 2011 on the importance of social media for plastic surgery practices. Suzy holds an MBA in Healthcare from St-Joseph’s University and a bachelor’s degree in chemistry from Laval University.
Herbert serves as Vice President of Regulatory Affairs and Quality Assurance for Andrew Technologies, LLC. He has 25 years’ experience in Quality Control, Quality Engineering, Quality Assurance, and Regulatory Affairs in medical device companies producing 510(k) and PMA regulated products. He began his career at STAAR Surgical, an innovator in minimally invasive ophthalmic vision products. As Director of Quality Assurance he led the creation of quality controls and quality assurance systems for the production of collagen based devices at the Nidau, Switzerland facility. Later as Director of Regulatory Affairs he led the successful US and global registration activities of collagen based intraocular and phakic lenses. He was subsequently recruited to Nobel Biocare the world’s leading manufacturer of dental implants and accessories. As Director of Global Regulatory Affairs for Nobel Biocare he led global regulatory efforts and successfully cleared more than sixty 510(k) submissions with the US FDA including industry unique devices and indications. Herbert earned a BA degree from the University of La Verne, and Quality Engineer Certification from the American Society for Quality.