Debapriya Dutta, PhD is the Counselor S&T, Indian Embassy, Washington DC, where he provides guidance to US public and private organizations regarding India’s initiatives in the Science and Technology fields. Prior to his current position, Dr. Dutta worked at the Dept of Science and Technology, Govt of India as an Advisor.

 

Yaun Lin, PhD is the founder and President of Marco Polo Technologies (MPT), which provides services to companies on regulatory aspects of product development and clinical trials in the U.S. and Asia. Prior to founding MPT, Dr. Lin worked at the FDA, in various capacities from 1988 to 1997 Prior to working at the FDA, Dr. Lin worked at E.I. du Pont de Nemours. Dr. Lin obtained her Ph. D. in biochemistry at University of California Davis. She was one of the first women to do research in Antarctica under the National Science foundation’s Antarctic program.  

 

 Edward Tab, MD is the VP and Head of Global Regulatory Strategy at Quintiles Consulting since 2005. He had been Associate Director for Medical Affairs in the Office of Blood Research and Review at the FDA from 1999 to 2005, and a Division Director of two FDA divisions prior to that. At FDA, Dr. Tabor was a Division Director in both CBER and CDER, where he led the review and approval of numerous products. Dr. Tabor obtained his undergraduate degree from Harvard University, his M.D. from Columbia University, and did a residency in pediatrics at Columbia University.

 Larry Tamarkin, PhD, RAC is the CEO and founder of CytImmune Sciences, Inc. Dr. Tamarkin has lead CytImmune from its founding as a diagnostic company to its current focus on cancer therapeutics. Dr. Tamarkin is the co-inventor of the colloidal gold-based, tumor-targeted nanomedicine platform technology, which is covered in 35 allowed and 46 pending patents both domestically and internationally. Dr. Tamarkin was graduated from SUNY at Stony Brook receiving a B.S. degree and received his Ph.D. degree from the University of Connecticut.

 Ashok Srivastava, MD is Chief Medical Officer of DiverseLynx Clinical and also Chief Medical Officer of CareBeyond. He has more than 15 years of experience in clinical drug development for oncology, CNS, and cardiovascular diseases. He is the recipient of numerous National and International prestigious medical awards and recognitions.Dr. Srivastava received his education at All India Institute of Medical Sciences, Czechoslovak Academy of Sciences, University of Nagasaki School of Medicine and Pharmaceutical Business, Rutgers University.

 

 Rita Khanna, PhD, JD is the General Counsel for Aeras Global TB Vaccine Foundation. She is an expert on issues of global health, especially diseases affecting developing countries. Her previous positions include Director of Technology Transfer at the University of MD Biotechnology Institute. Dr. Khanna has published extensively, including most recently as co-editor of a book titled “Technology Transfer in Biotechnology”.  She received her PhD from the University of Illnois and her JD from the University of MD.

  

 Mukesh Kumar, PhD, RAC is the Head of Regulatory Affairs and Quality Assurance at Amarex Clinical Research and is on the Board of Amarex Biosciences India, a pharmaceutical and services company based in India. His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He is a well knows expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India.

  

 A.B. Ramteke, M.sc is the Joint Drugs Controller (India). As a senior drug regulatory officer he has worked for more than 20 years leading Indian regulatory processes related to new drug development, import and export of drugs, biologics and medical devices to and from India, and clinical trial oversight. He played a key role in the recent amendments of Indian regulations such as Drugs & Cosmetics Act of India, Good Clinical Practices, and clinical trial approval. Recently, he was involved in creating Indian regulations and guidelines for medical devices. Prior to working at CDSCO, he worked for 11 years at the Central Research Institute, Himachal Pradesh, India. He holds a MS in biochemistry and a post-graduate degree in microbiology. 

 

 Shoibal Mukherjee, MD, DM is the Senior VP for Clinical Development at GVK BIO, India. Dr Mukherjee joined Pfizer, in Mumbai, in 1990 as Associate Medical Director and was promoted to Senior Director and Head of the Medical & Research Division in 1997. He joined Ranbaxy Laboratories Limited in 2007. He received a Master’s degree in Pharmaceutical Medicine from Hibernia College, Ireland, in 2007 and a Post-Doctoral degree in Clinical Pharmacology from the Postgraduate Institute of Medical Education and Research in Chandigarh.

 

 Felix Khin-Maung-Gyi, PharmD, MBA, CIP, RAC is the CEO and founder of the Chesapeake Research Review. Dr. Gyi is a recognized leader in human subject protection both in the US and abroad. Dr. Gyi has provided consultation and professional development to clients domestically and globally for more than 20 years. Dr. Gyi received the Doctor of Pharmacy degree from Duquesne University; and the M.B.A. from Loyola (MD) College. He has completed Clinical Pharmacy residencies in both pediatric and adult medicine and post-graduate studies in bioethics, drug development, regulations and medical research. His undergraduate work in Pharmacy from the University of Maryland included a concentration in Microbiology.

 

 

  Ekopimo Ibia, MD, MPH, FWACP, FRCP (Glasgow) is the Director and US Regulatory Policy Lead, Global Regulatory Strategy, Policy, and Safety at Merck & Co., Inc, and an adjunct faculty at Johns Hopkins University, where he teaches graduate level international regulatory affairs. Prior to joining Merck & Co., Dr. Ibia was a lead review medical officer at the FDA and attending pediatrician at Suburban Hospital, Bethesda, Maryland. He holds a Masters in Public Health degree in international health policy from  George Washington University and a Clinical Pharmacology certificate from NIH.

 

 Jan Pierre, MPH is a Principal Consultant with Quintiles Consulting. Ms. Pierre has over 12 years of experience working in the clinical research arena, with a unique combination of expertise in inspections, regulatory compliance, auditing, quality assurance, and training. Ms. Pierre was an FDA Investigator with over 6 years of experience auditing/inspecting sponsors, IRBs, clinical investigators, and non-clinical laboratories against FDA regulations and compliance programs, ICH guidelines and company SOPs. Ms. Pierre holds an M.P.H. in International Health Policy.