Scientific Team

George Serafin
George Serafin

George Serafin serves as FTI Consulting’s life sciences industry leader responsible for the integrated delivery of services and solutions focused on assisting life sciences and healthcare clients with solving their most complex problems and achieving their strategic and operational objectives. He has 30+ years of experience in the areas of R&D, engineering, manufacturing, supply chain, quality control/laboratory, quality assurance, regulatory, compliance, corporate/operations, and information technology across pharmaceutical, biotechnology, medical technology, nutraceuticals, and consumer healthcare.
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 Conroy
Jeff Conroy

Jeff is an operating and business development executive with over 30 years in the life science industry.
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.
George Steinefls, PhD, MBA
George Steinefls, PhD, MBA

George Steinfels, PhD, MBA, is a seasoned Senior Executive and Board Member with demonstrated success across the medical technology industries. Leveraging extensive experience in clinical product development and commercialization, he has proven to be a valuable asset for biotech companies seeking to engage in their first clinical studies or provide leadership and guidance to more mature clinical stage companies. His broad areas of expertise include product development from inception to commercialization, clinical trial operations, and general corporate operations and development. Dr. Steinfels scientific expertise is equally extensive as he has prepared clinical development strategies, including clinical protocols for drugs, biologics, devices, and diagnostics in all major therapeutic areas.

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.

Jeffrey A. Gelfand, MD
Jeffrey A. Gelfand, MD

Dr. Jeffrey A. Gelfand is an infectious disease specialist in Boston, Massachusetts. He received his medical degree from Tufts University School of Medicine and has been in practice for more than 20 years. Dr. Gelfand’s specializes in infectious disease. He is also a Clinical Professor of Medicine, where he has developed a novel approach for targeting (tumor) antigens whose sequence may not be known or structure even identified.
Jeff O'Donnell
Jeff O'Donnell

Mr. O’Donnell has extensive experience in the Healthcare industry, merging a solid, traditional corporate background with emerging growth experience. Jeff adds significant medical device expertise to the board. He also has deep senior management experience in both IPO’s and strategic transactions. Jeff has started and sold a number of healthcare companies. Jeff brings more than 20 years of Board and Chief Executive experience running emerging medical device firms. Businesses under his direct leadership have achieved over $1.5 Billion in value creation from initial public offering of stock or mergers and acquisitions. Most recently, Mr. O’Donnell served as the Chief Executive Officer and a Director of Trice Medical from 2013 until June 2019. Trice is an emerging growth medical device company developing optical needles used by orthopedic surgeons to diagnose soft tissue damage of joints. In 2008, Jeff started and ran Embrella Cardiovascular, a medical device startup company, which was sold in 2011 to Edwards Lifesciences (NYSE: EW). Prior to Embrella Cardiovascular, Jeff served as President and CEO of PhotoMedex (NASDAQ: PHMD) from 1999 to 2009. Prior to PhotoMedex, Jeff was the President and CEO of Cardiovascular Dynamics. His team took CCVD public on NASDAQ in June of 1996 and purchased Radiance Medical Systems and Endologix (NASDAQ: ELGX). From 1994 to 1995 Jeff held the position of President and CEO of Kensey Nash Corporation (NASDAQ: KNSY). Additionally, he has held several senior sales and marketing management positions at Boston Scientific Corporation, Guidant Corporation and with Johnson & Johnson’s Orthopedic Division. In 2005, Jeff was named LifeSciences CEO of the Year by Price Waterhouse Coopers. In 2011, Jeff was named the Greater Philadelphia Emerging Entrepreneur of the Year by Ernst & Young. In 2017, Jeff assumed the role of Chairman of the Board of Directors for SpectraWave, a cardiology device company. He joined the AdvaMed Accel Board of Directors in 2016 and serves as an observer on the Membership, Ethics, and Technology and Regulatory committees of the AdvaMed Board. Previously, Jeff served as Chairman of the Board of Strata Skin Sciences (NASDAQ: SSKN) (2 years) as well as Director on the Board at Cardiac Science (7 yrs.) and Endologix (12 yrs.). Jeff is a graduate of LaSalle University in Philadelphia.Mr. O’Donnell brings his experience in the healthcare industry and cardiovascular space, along with his experience with emerging growth companies, which will make him a valuable member of our board of directors.
Paul Korner, MD, MBA
Paul Korner, MD, MBA

Dr. Paul Korner is the Chief Medical Officer of Agile Therapeutics, Inc, an innovative commercial-stage women’s health company. He has over 21 years of pharmaceutical and biotech industry experience, having served in senior medical leadership positions within organizations such as Ferring Pharmaceuticals, Ardelyx Inc., Sarepta Therapeutics and Axovant Gene Therapies. He has been responsible for multiple INDs/CTAs and more than 50 clinical trials (phase 1-4), leading to marketing authorization/approvals of 10 products including VYONDYS 53® (golodirsen), NOCDURNA® (desmopressin), PREPOPIK® (sodium picosulfate), EUFLEXXA® (1% sodium hyaluronate), and YAZ® (EE/drospiranone).
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.
Mark Poznansky, PhD
Mark Poznansky, PhD

Director of the Vaccine and Immunotherapy Center (VIC) and Physician at Massachusetts General Hospital and an Associate Professor of Medicine at Harvard Medical School. Dr. Poznansky will serve as both scientific founder and scientific advisory board member to help advise on the early clinical research and implementation of testing in the hospital setting and to help gather additional academic and clinical KOLs to serve on the SAB.
Michael V. Callahan, MD, MSPH, DTM&H (U.K)

Dr. Michael Callahan is a Staff Physician at Massachusetts General Hospital (MGH) in internal medicine and infectious disease and the Director, Clinical Translation and Mass-Casualty Therapeutics at the Vaccine and Immunotherapy Center, MGH. He is also a Special Advisor for COVID-19 clinical response to the Assistant Secretary of Public Health Preparedness (ASPR) of the Dept. of Health and Human Services, Washington, DC. In both capacities, he has responded to infectious disease outbreaks, and worked on development of therapies for highly dangerous pathogens, including Ebola and Marburg outbreaks in DRC and West Africa, Bird flu and SARS in Asia and to the initial hotspots for COVID-19 outbreaks including international deployments to the Diamond Princess cruise ship outbreak in Yokohoma and the Grand Princess cruise ship off the California coast. Dr. Callahan has conducted federal-funded basic science and clinical research in tropical infectious disease, sepsis and immune therapies since 1986. He has worked with the Defense Advanced Research Projects Agency (DARPA), the U.S. Agency for International Development (USAID)

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.

Patrick Reeves, PhD
Patrick Reeves, PhD

Team Leader at VIC. Additionally, he is an Instructor at the Harvard Medical School. Dr. Reeves has authored and contributed to many publications regarding cancer, immunology and virology. Dr. Reeves also has expertise in high dimensional immunology techniques including imaging mass cytometry.
Ruxandra Sîrbulescu, PhD
Ruxandra Sîrbulescu, PhD

Instructor in Medicine at Harvard Medical School, and an Instructor in Investigation at Massachusetts General Hospital. Dr. Sîrbulescu’s work at the Vaccine and Immunotherapy Center, Massachusetts General Hospital focuses on developing immunotherapies for tissue regeneration and neuroprotection. Dr. Sîrbulescu’s areas of expertise and research interest include mass spectrometry imaging with a focus on Immunology and Cell Biology.

Artificial Intelligence Team

Ann Marie Sastry
Ann Marie Sastry

Ann Marie Sastry is President and CEO of Amesite, an award-winning artificial intelligence software company focused on improving learning, and one of Metropolitan Detroit’s Best and Brightest Companies to Work For (2019). Dr. Sastry was previously President, CEO, Board Director and co-Founder of Sakti3, recognized as one of MIT’s 50 Smartest Companies (2015), and as a Crain’s Detroit Business Cool Places to Work winner (2017). The company was acquired by Dyson in 2015 for $90M. Sastry was invited to the White House in 2015 to be recognized for her technology entrepreneurship, and meet with President Barack Obama. Her technology and business work have been featured in WSJ, Fortune, Forbes, The Economist, USA Today, The New York Times and on the cover of Inc.
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.
Selvara Senthamilarasu

Deep expertise in Information retrieval, Machine Learning, Artificial Intelligence, Deep Learning, Keras, Scikit, NLP Frameworks, python Frameworks.
Dr. Selvaraj extensive experience has afforded him the opportunity to work with top clients like VMware, AT&T, Atlassian, Veritas, Fetchr, DHL