Dr. Vassileva has decades of experience with managing complex multi-stakeholder biomedical research programs. She spent most of her career in the nonprofit sector, leading the Science Team at the Arthritis Foundation, and working at the Foundation for NIH and the American Association for the Advancement of Science. She was also on the leadership teams of two health research organizations, serving as project director on multiple government contracts. Her areas of expertise include musculoskeletal, metabolic, immunity and inflammation disorders, as well as patient engagement. She received her PhD in Biochemistry and Cell Biology from Johns Hopkins.

Tamei Elliott, MS, serves as the Associate Director of Scientific Programs for the Americas region at DIA. In this pivotal role, she is responsible for identifying and prioritizing content areas and topics crucial to DIA constituents. Tamei assesses the implications of significant regulatory and health policy changes, seamlessly integrating relevant content into the development and advancement of DIA conferences and courses. Her responsibilities extend to overseeing content development and strategy within the Americas region.

Prior to joining DIA in 2023, Fathallah was the Operating Officer and EVP at Ortho Clinical Diagnostics, accountable for Operations, Post Market Product Science and Engineering, Regulatory, Quality, Medical, Clinical, Scientific Affairs, and Process Excellence. Before joining Ortho, he held Executive and Senior Leadership roles in Research and Development, Operations, and Regulatory Medical and Clinical Affairs at Avantor, Danaher, Pfizer, Hospira, and Abbott Laboratories. Fathallah holds a Master’s and Bachelor of Science degrees in Mechanical Engineering from the Univ. of Wisconsin-Madison and an MBA from the Kellogg School of Management at Northwestern University.

Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in January 2016. He is a Fellow of the American College of Physicians and in 2022 he was elected to the National Academy of Medicine.

Michael has over 20 years of R&D experience in biomaterials, medical devices and regenerative medicine. He has led product development teams for class II devices, human cell and tissue-based products, and drug/device combination products. He is a creator and an inventor with multiple U.S. patents to his name. Michael has a MSc in /Biomedical Engineering, with a focus on tissue engineering, from Drexel University. Michaels areas of expertise include cell-based tissue engineering, bioceramics, biodegradable polymers, project management, strategic pipeline development, and business development.

Maria Paula offers expert scientific content guidance and project management support for DIA's global consortium initiatives and specialty meetings. She is dedicated to ensuring the development and delivery of impactful, patient-centric scientific content that generates evidence to facilitate the integration of innovation in medical product development. She brings experience in public health, patient engagement, and research management. She holds a Master of Science in Health Care Management from Marymount University and a Bachelor of Science in Microbiology and Bioanalysis from Universidad Industrial de Santander, Colombia.

James Wabby is the Global Head, Regulatory Affairs - (CoE) Emerging Technologies, Devices, and Combination Products at AbbVie in Irvine, California. He has 22 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment pertaining to Nutritional, Cosmetic, Branded Pharmaceutical, Generic, Biologic, Medical Device and Combination Product areas. James received his undergraduate and graduate degrees from Duquesne University and received his Health Care Compliance Certificate from Seton Hall University Law School. He is a member of various regulatory and quality work groups including RAPS, OCRA and the ASQ Orange Empire Section.

Lesbeth Rodriguez, Director, Regulator Policy and Science at Bayer, is a regulatory policy leader specializing in advanced therapies and Chemistry, Manufacturing, and Controls (CMC) across all modalities. She represented PhRMA in the ICH Q13 Implementation Working Group, and currently represents PhRMA in the ICH Cell and Gene Therapy Discussion Group. In addition, she is an active member of the PhRMA Global Quality and Manufacturing Work Group, the BIO Manufacturing/Quality and Distribution Committee, and the IFPMA Quality/Manufacturing Working, the Co-Chair of BIO Regenerative Medicine Committee and a member of the ARM US Policy Advisory Group driving harmonization efforts, regulatory efficiency, and policies that enhance patient access.