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.

I hold a degree in Biology from the University of Brasília, where I also completed my master’s degree. I work as a health specialist at Anvisa since 2005, in the office of blood, tissues, cells, and advanced therapy medicinal products.

Dr. Kishioka is a Review Director of the Office of Cellular and Tissue-based Products, PMDA. In this role, he is responsible for the assessment of regenerative medical products (gene/cell therapy products). Since joining PMDA in 2008, Dr. Kishioka has been involved in various international activities including ICMRA (collaborative assessment pilot under PQKMS), ICH (Q12 and M4Q(R2)), WHO, APEC, and IPRP (Biosimilar WG). He also served as ICH Technical Coordinator (2019-2020) and MHLW/PMDA international liaison official at EMA (2020-2022). He obtained a Ph.D. from Hokkaido University in Meat Science with emphasis in Molecular Biology.

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.

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.

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.

Dr. Verdun joined FDA in 2012, first in the Office of Hematology Oncology Products as a medical officer and a liaison for sickle cell therapeutics and anticoagulants, and then Therapeutic Biosimilars. She was appointed as the Deputy Director of the Office of Blood Research and Review in the Center for Biologics Evaluation and Research (CBER) in October 2016 and was promoted to Office Director in 2018. In 2023, Dr. Verdun was selected as the Super Office Director of the Office of Therapeutic Products, overseeing 6 Offices dedicated to the regulation and approval of Cell and Gene therapies in the United States. She overseas both a research and regulatory portfolio in CBER. She is also on staff at Children’s National Medical Center.

Dr. Sandra Blumenrath is the Executive Editor of Scientific Publications & Sr. Scientific Program Manager at DIA, where she oversees the organization's publications portfolio and leads research projects in rare neurological disorders. She collaborates with regulators, industry leaders, non-profits, academia, and patient advocacy groups. Dr. Blumenrath holds a Ph.D. in Biology from the University of Maryland, College Park, and an M.S. from the University of Copenhagen, Denmark. With international experience working across the U.S., Denmark, and Germany, she specializes in science communication, open science advocacy, strategic publication management, and interdisciplinary collaboration to share scientific knowledge and advance global health.

Evdokia joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which includes Quality, GxP Compliance, Referrals and PhV. She is the EMA lead of the EU Network's strategic priority to facilitate the uptake of advanced manufacturing approaches. She is also representing the Agency at the ICMRA PQKMS core group. She has trained as a pharmacist in the School of Pharmacy of the University of Athens and has received a M.Sc. and a Ph.D. in Pharm. Technology from the same Faculty.

James Wabby is the Global Head, Regulatory Affairs - (CoE) Emerging Technologies, Devices, and Combination Products at AbbVie in Irvine, California. He has 25 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.

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.

Sara is currently Senior Manager, Scientific Programmes at DIA. In the EMEA region, she is responsible for engaging with external stakeholders and advancing the scientific content strategy by creating opportunities to integrate scientific and regulatory changes of interest in DIA initiatives. Additionally, she is responsible for the regional patient engagement and learning design initiatives, being the liason for the Middle East and SEE regions. Previously, she was Public Health Promotion Projects Manager at the Portuguese Pharmaceutical Society. Sara is a Master of Pharmacy since 2015 and a Soft skills Trainer since 2012, having delivered over 300h of Training internationally primarily focused on creating impactful interactions.