With his broad and deep knowledge and “molecule-to-patient” perspective, Mr. Serafin has work in and assisted clients of all sizes from early stage/premarket to Fortune 10 companies across five continents. He specializes in the development and execution of business and risk strategies that create, protect, and transform value, improve operational efficiency and achieve process excellence, as well as sustained regulatory compliance. His expertise also includes business process transformation and technology enablement including advanced manufacturing, enterprise systems, digital technology, cloud computing, intelligent automation, and advanced analytics.
He has demonstrated domestic and international regulatory compliance experience including ANVISA, CMS, DEA, EMA, FDA, GCP/PV, GxP, HC, HIPAA, ICH, ISO, MHLW, MHRA, NMPA, PDMA, and PIC/S including product submission/approvals, site registrations, 483/Warning Letter/Consent Decree, response and remediation program development and execution. He is internationally recognized for his subject matter knowledge and experience concerning regulatory, quality systems, compliance, and risk management.
Mr. Serafin is a strategic advisor to the FDA, having assisted them in various areas, including product quality, patient safety, data integrity, cloud computing, and digital health. For the last several years, he has been co-leading a collaboration effort between FDA, the Medical Device Innovation Consortium (MDIC), and the medical device industry that has developed a program that leverages CMMI (Capability Maturity Model Integration) as the standard maturity model by which medical device organizations may measure their capability to produce high-quality devices and improve patient safety.
Previously, George was a national managing director at Deloitte and a senior managing partner at Grant Thornton where he was the Industry Leader as well as the healthcare and life sciences leader across their advisory, audit, and tax businesses.
Prior to consulting, Mr. Serafin worked for Novartis, Roche, and Fresenius Medical Care, starting in research and development as an R&D engineer, and then progressing across the value chain with increasing levels of responsibility in engineering, manufacturing, operations, quality, and regulatory. He also worked for SAP and led the development of SAP’s Life Sciences solution and served as its life sciences solutions leader as well as assisting companies around the globe with implementing SAP.
Mr. Serafin received an M.S. in technology management and a B.E. in biomedical engineering with a double minor in electrical engineering and computer science from Stevens Institute of Technology.
Jeff is the CEO of Embody, a sports medicine medical device company developing collagen-based implants for the treatment of tendon and ligament injuries. Embody has been funded by DARPA with over $20 million in non-dilutive funding and has previously raised $9.3 million in Series A financing.
Jeff is the Managing Director of Buenaventura Advisors structuring licensing partnerships for life science companies. Since 2012, Jeff served as the Head of Corporate Development for Especificos Stendhal S.A. de C.V., a Latin American specialty pharmaceutical company. Previously, Jeff was the President of TissueNet, an AATB-accredited tissue bank.
Jeff is an Independent Director of Cingulate Therapeutics, a CNS company developing ADHD therapeutics, and Odyssey Group International (ODYY), a medical device technology holding company.
Jeff holds a B.S. in Business from Providence College. Jeff lives in Vienna, Virginia with his wife Jennifer and daughters Maddy and Mary.
Throughout his executive career, Dr. Steinfels has held executive and CXO positions at both large and small, and public and private companies in both the biotechnology and service provider arena. Dr. Steinfels has had tremendous success over the years and has served as a key contributor and value creator for all organizations where he has served.
Currently, he is President of EMS Development Group, a company he founded, that provides development and commercialization expertise for medical technology companies, and corporate development and marketing consulting for service providers in the life science area. Before that, he was the Vice President of Clinical Operations at Sancilio & Co. where his team successfully completed a Phase 2 study for a pediatric orphan indication that met its primary clinical endpoint and surpassed industry metrics for clinical trial execution in that therapeutic area.
He was responsible for increasing portfolio valuation of Rexahn Pharmaceuticals as Chief Business Officer and Sr. Vice President Clinical Development. There he advanced the clinical development of Rexahn’s oncology portfolio and increased the Company’s portfolio valuation through in-licensing efforts that resulted in the acquisition of a novel portfolio of compounds with anxiolytic/antidepressant activity.
Previous to that he was a Vice President at Quintiles Consulting in his role as the leader in the New Product Development Group where he led a team that created marketing and product development plans for several client products that generated revenues in excess of a billion dollars.
He began his career at DuPont Pharmaceuticals, which later became DuPont Merck Pharmaceuticals, as a bench scientist and eventually managed a team of multidisciplinary scientists, including several extramural research programs with the goal of identifying new chemical entities for the treatment of central nervous system disorders.
Dr. Steinfels has written and published extensively and has spoken at business conferences on various topics in the medical technology industry. Dr. Steinfels received his Bachelor of Science in Biology from The Johns Hopkins University, his Master of Business Administration in Management and Finance from The Wharton School, and his Master of Science and PhD in Pharmacology from the University of Maryland. As an expert and leader in his industry, he is highly respected by peers and partners and has served in several advisory roles. He has served as a Board Member at several for profit and not-for-profit entities.
Dr. Korner has experience across novel pathways including gene therapy, vaccines, small molecules, peptides, and biologics across all development phases and multiple therapeutic areas including rare disease, CNS, women’s health, gastroenterology, nephrology, musculoskeletal/inflammation/orthopedics, and urology. He also serves on the Accreditation Council for Medical Affairs Scientific Advisory Board, and CEO of Korner BioPharma Advisors, LLC, providing strategic and operational clinical consulting services to small to biotech companies. Over the course of his career, he has authored forty-nine publications across multiple disease states.
Dr. Korner is a board-certified obstetrician and gynecologist who was in private practice in Glencoe Illinois and Riverdale Georgia prior to joining industry in 1998. He received his B.S. in Biology from the University of Illinois (Champaign/Urbana), M.D. from Loyola University, Stritch School of Medicine in Maywood Illinois. He also holds an M.B.A. from the Michael J. Coles College of Business at Kennesaw State University in Georgia.
Dr. Callahan has received philanthropic and UN support for his work in highly dangerous pathogen outbreak response and field trials in austere medical care settings. In 1988, Callahan, co-founded with colleague disaster medical assistance team members the disaster and expatriate medical service, Rescue Medicine. In this role he has most recently responded to assist stranded cruise ships struck by COVID-19 outbreaks.. Dr. Callahan has clinical teaching appointments at Chulalongkorn Medical University and is guest faculty at Infectious Disease Hospital, Jakarta, and Montebello Medical University in Kaduna, Nigeria.
Dr. Callahan is the recipient of numerous international awards including the Secretary of Defense Award for National Service, The DARPA National Service Award, the Edward M. Kennedy Award for Advancement in Health Care, and the 2018 International Society of Travel Medicine Award for his work in Zika convalescence. Dr. Callahan is a member of the National Disaster Medical System (NDMS) executive counsel . He divides his clinical and drug development time between Boston and Washington, DC.
Artificial Intelligence Team
Prior to starting her companies, she was Arthur F. Thurnau Professor (UM’s highest teaching honor) at the University of Michigan, for 17 years. Tenured and promoted early, Sastry was recognized with some of the highest honors in her scientific fields, including the ASME Frank Kreith Energy Award (2011) and NSF’s Presidential Early Career Award for Scientists and Engineers (1997). She has co-authored over 100 publications and 100 patents and filings, and has delivered over 100 invited lectures and seminars globally (NIH, NSF, NAE, MIT, Stanford, UC Berkeley, Oxford, Cambridge, etc.).
Sastry is active in business mentorship and philanthropy, with emphases on education, environment, and poverty alleviation. She serves on the Boards of the International Council on Clean Transportation (ICCT), the Alpha House Family Homeless Shelter, Greenhills School and the Oxford Company, among others. She holds PhD and MS degrees from Cornell University, and a BS from the University of Delaware, all in Mechanical Engineering.
Investment and Ops Committee
Dr Tony N. Hodges is currently Chief, Transplant Services; Director, Center for Infusion Medicine and Physician Executive Director of Revenue Cycle Operations at Banner University Medical Center in Phoenix. He holds the rank of Professor of Medicine at The University of Arizona College of Medicine. He has held these leadership positions since April 2016.
Prior to this he was co-founder and Director of the Center for Thoracic Transplantation and Medical Director of Lung Transplantation at the Norton Thoracic Institute at St. Joseph’s Hospital and Medical Center in Phoenix. He held that leadership position 2006 to 2012.
Prior to relocating to Phoenix, Dr Hodges was an Associate Professor of Medicine and Cardiothoracic Surgery at the University of Southern California Keck School of Medicine in Los Angeles. He also served as the Medical Director of Lung Transplantation, Medical Director of Lung Volume Reduction Center, Director of Interventional Pulmonology and Director of the Advanced Lung Disease Center at USC University Hospital.
Dr Hodges received his medical degree from Louisiana State University in New Orleans. He performed his Internal Medicine residency and served as Assistant Chief of Medicine at Wake Forest University/Baptist Medical Center. He then matriculated to the University of Colorado Health Sciences Center / National Jewish for fellowship training in Pulmonary Science and Critical Care Medicine where he also spent two years in a specialty Lung Transplant fellowship. Dr Hodges was on faculty at the University of Colorado Health Sciences Center as the Associate Medical Director of Lung Transplantation before assuming his leadership role at USC.
He is a fellow in the American College of Chest Physicians, American College of Physicians and Infectious Disease Society of America. Active in the American Thoracic Society, American Society of Microbiology, the International Society of Heart and Lung Transplant and American Society of Transplantation.
He has been included in the prestigious Best Doctors in America list yearly since 2001. Dr Hodges’ research and clinical interests are primarily in the area of the immunomodulatory effects of viral infections in transplantation and their role in acute and chronic allograft dysfunction. He is internationally recognized for his expertise in issues related to pneumonia syndromes, community acquired respiratory viruses, lung transplantation, advanced lung diseases and infectious complications of transplantation, the immunocompromised host and the business development of successful transplantation programs.
Dr. Shriver has built scientific organizations from scratch and led scientific teams as well as established laboratory operations for biotech companies. Notably, he made significant contributions to solving the 2008 heparin crisis and has advised the United States Pharmacopeia on biologics-based medicines. His research has led to development of 10+ drug candidates, with six INDs and two approved products: enoxaparin sodium and Glatopa (glatiramer acetate). In addition, he is an author on 100+ scientific publications and is an inventor on 60+ patents.
Dr. Shriver is expert in identifying and managing critical manufacturing aspects of biotechnology businesses. He has been involved in everything from working with partners/vendors to utilize their manufacturing capabilities to optimize product development for specific companies to guiding their scientific teams on potential ways to reduce program risk, shorten timelines, and better prepare for various regulatory submissions.
Mr. Zook served or continues to serve on several boards, including the boards of AltheRx, Inhibikase, Rib-X Pharmaceuticals, the National Pharmaceutical Council, PhRMA, the Pennsylvania Division of the American Cancer Society and his alma mater, Frostburg State University. Mr. Zook earned a B.S. degree from Frostburg State University and an A.A. degree in chemical engineering from Pennsylvania State University.