Dr. Lavin is an internationally well-known drug developer and Biostatistician with a long history of supporting clinical trials. He was a member of the Biostatistics faculty at the Harvard School of Public Health and a member of the Department of Surgery at Harvard Medical School where he was affiliated for over 25 years. He co-founded Boston Biostatistics which became Aptiv Solutions before being acquired by ICON plc.
Dr. Lavin has authored or co-authored 160 peer-reviewed publications in the medical and statistical literature. Dr. Lavin has been the Lead Biostatistician for 64 FDA approvals to date including 39 PMAs (16 orthopaedic, 7 cardiovascular).
Dr. Lavin has continuously worked on various device projects in cardiovascular, orthopaedics, periodontal indications plus In-vitro diagnostics, and imaging. Dr. Lavin received his Ph.D. in Applied Mathematics at Brown University in 1972. He is the only person to be elected a Fellow of the American Statistical Association and the Regulatory Affairs Professional Society reflecting his many pioneering contributions to statistics, regulatory approvals, and medicine. He has been associated and working with the Genpro International team for over 10 years.
Dr. Sachin Marulkar is a drug development professional with 20 years of clinical, data analytics, and biometrics work experience. He currently is the clinical lead on hematology indications. He has previously held varied roles in Harvard clinical research, Genzyme, and Sanofi, providing strategic inputs in clinical development, study designs, statistical methodology, regulatory strategy, operational planning, budget planning, and product life cycle management.
Dr. Marulkar has a passion for healthcare technology which can facilitate data-driven decision-making within patient-centric healthcare organizations. He is involved in mentoring start-ups in the healthcare space. Dr. Marulkar holds MD degree, master’s in public health (Drug Epidemiology and Biostatistics) from Boston University, and an MBA from Massachusetts Institute of Technology (MIT) Sloan school of business.
Dr. Mark Chang has over 20 years of experience as a statistician and, he is the founder of AGInception for Artificial General Intelligence Research. Previously, He served as Sr. Vice President, Strategic Statistical Consulting at Veristat, Vice President of Biometrics at AMAG Pharmaceuticals and, director and scientific fellow at Millennium/Takeda Pharmaceuticals.
Dr. Chang is a fellow of the American Statistical Association and an adjunct professor of Biostatistics at Boston University. He is a co-founder of the International Society for Biopharmaceutical Statistics, co-chair of the Biotechnology Industry Organization (BIO) Adaptive Design Working Group, and a member of the Multiregional Clinical Trial (MRCT) Expert Group. He has published 11 books, including Artificial Intelligence for Drug Development, Precision Medicine and Healthcare, Innovative Strategies, Statistical Solutions and Simulations for Modern Clinical Trials, and many more.
Mr. Babu Sivadasan is a serial entrepreneur and executive with more than 25 years of experience in product engineering, operations, mergers and acquisitions, and corporate leadership. Mr. Sivadasan has co-founded two public companies that are Envestnet and Stamps.com and, he was also instrumental in building early-stage start-ups and large enterprise software companies. Mr. Sivadasan is an alumnus of Stanford University SEP and has a B.S in Computer Science and Engineering from the University of Kerala.