Archives: Speakers

James J. Krupa, Pharm.D.,  Director, Clinical Supply Team Lead, Operations at Takeda in Lexington, MA. In this position, I am responsible for providing the leadership and strategic direction in terms of planning, budget, coordination, scheduling, resources and tracking of global clinical trial materials. I have over 42 years of industrial pharmaceutical experience in multiple dosage form drug development. Building upon experience as a bench pharmacist in clinical and non-clinical supplies, formulations, process development, and technical services, I  have contributed to the success of early and late stage development programs intended for regulatory approvals in women’s health, pain, oncology, CNS disorders, anti-inflammatory diseases, metabolic disorders, anti-infectives, cardiovascular, gastroenterology, gene therapy, and rare disease therapeutic areas.

David Sokoloff is the Director of Global Logistics & Materials Management for Novavax, Inc. He manages the storage and transportation of Novavax’s products through its global network. David founded For Granted, Inc. in 2006, a nonprofit supporting community driven programming in education, water and sanitation, micro-finance, and child health.

David has managed supply chains for emergency relief efforts across the Globe. He ran operations in the field for several years with Doctors Without Borders, prior to working in Washington, D.C., leading logistics operations for the U.S. Office of Foreign Disaster Assistance. At the onset of the COVID-19 outbreak, David joined Novavax, Inc. He supports their global supply chain to deliver products preventing a broad range of infectious diseases. Novavax produces vaccine candidates in response to both known and emerging disease threats, including the company’s CoVID-19 vaccine.

Dr. Isaac R. Rodriguez-Chavez is a biomedical and regulatory leader with expertise in decentralized clinical trials (DCTs) and Digital Medicine Tools applied to multiple therapeutic areas including Infectious Diseases, Viral Immunology, Viral Oncology, and Vaccinology. Currently, he is an independent consultant for Scientific-, Clinical-, Regulatory-affairs, and digital medicine for modern trials such as DCTs enabled by Digital Health Technologies (DHTs). Past positions in the last 20+ years include: Senior Vice President for Scientific, Clinical Affairs, leading the Strategy of the Global Center of Excellence for DCTs and Digital Medicine at PRA Health Sciences and ICON plc; FDA, CDER Senior Officer for Clinical Research Methodology, Regulatory Compliance and Policy Development modernizing clinical research through Real World Evidence and DCTs enabled by DHTs and electronic Clinical Outcome Assessments (eCOAs); CEO and Founder, 4Biosolutions Biomedical Consulting Firm; Vice President, Research, Texas Biomedical Research Institute; Director of HIV Clinical Research Programs at National Institute of Allergy and Infectious Diseases (NIAID) and National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH); Senior Clinical Scientist, Schering Plough Corp. – Merck & Corp.; Scientist, Columbia University; Scientist, Polar Biotechnology Company and Venezuelan Institute for Scientific Research (IVIC). He has a PhD in Virology and Immunology; a MS in Microbiology; a MHS in Clinical Research and Health Sciences; and a B.S. in Biology. He also has 5 years of postdoctoral specialty experience in Clinical Research (phases 1 & 2 trials) linked to AIDS Malignancies, Immuno-Oncology and Viral Immunology (Infectious Diseases) done at the U.S. NIA and NCI, NIH. Dr. Rodriguez-Chavez is a Founding Board Member of the Digital Medical Society (DiME). He is also a co-chair of the DiME’s Research Committee, driving digital medicine globally. He is an Advisory Board Member of BlueCloud by HealthCarePoint; a regulatory Advisor and Vice-Chair of the Institute of Electrical and Electronics Engineers (IEEE) fostering industry standards on DCTs and DHTs. He is a former Leadership Council Board Member of the Decentralized Trials & Research Alliance (DTRA). He is a Board Member of the Hypertrophic Cardiomyopathy Association (HCMA) and a Health Equity Board Council Member for equity, diversity and inclusion in rare diseases at the Global Genes. He is a global content editor for regulatory science and an Editorial Board Member of the DIA Global Forum Magazine. He is also an active member of sixteen professional associations, including the Infectious Disease Society of America, American Federation for Medical Research, American Association of Immunologists, American Society for Virology, American Society of Microbiology, Society of Quality Assurance, Association of Clinical Research Professionals, New York Academy of Sciences, International AIDS Society, International Association for Dental Research, American Association for Dental Research, and Regulatory Affairs Professional Society.

LinkedIn: https://www.linkedin.com/in/isaacrc/

Dr. Debashish Niyogi is currently Vice President, Product Management at Anju Software, where he is responsible for the vision, strategy, and roadmap for the company’s eTMF and CTMS solutions. Debashish has over 18 years of experience in the life sciences / clinical trials industry, including several leadership roles in Product Management. His expertise is in regulated content management, and he is a member of the TMF Reference Model Project Team. Debashish has previously managed successful eTMF products at Veeva and Medidata, as well as clinical trial imaging tools at Synarc (now part of Clario). Debashish earned a PhD in Computer Science from the State University of New York at Buffalo, specializing in the application of AI techniques in document analysis.

Caroline Cooper is the Director of Clinical Operations at CymaBay Therapeutics, Inc. with over 10 years of experience in clinical research. Caroline is experienced in the planning and execution of global clinical drug trials in the European, North American, Latin American, and Asia Pacific regions. She is currently managing a Ph3 program in rare liver disease.