CASSS – Sharing Science Solutions is excited to announce the election of Markus Blümel, Carmilia Jiménez Ramírez, and Yasuhiro Kishioka to the Board of Directors. CASSS board members are elected by the Associate Directors of the organization, a group of volunteers who have contributed significantly to the association.
As a returning Director, Carmilia shared that her main priorities include, “Maintaining relevance and superior content in [CASSS] meetings and symposia offerings, engaging the next generation of scientists and regulatory professionals, and staying at the forefront of emerging technologies and trends to positively influence regulatory agencies and industry innovators."
Reflecting on why he chose to seek a seat on the board, Markus shared, “The most crucial success factor for CASSS remains staying ahead of changes in the evolving regulatory landscape and offering guidance on how to navigate them effectively.”
In reflecting on his goals for being a CASSS Director, Yasuhiro shared, “[We need to] continue to provide a place of knowledge management for creating wisdom and promote diversity and inclusion for fostering knowledge [which] are top priorities and challenges facing CASSS."
Markus Blümel currently holds the position of Director, Science & Technology, and Global Lead of Analytical Standards at Novartis Pharma AG. Blümel earned his master’s degree in chemistry from Justus Liebig University Giessen and his Ph.D. in biochemistry from Goethe University Frankfurt.
With a career spanning over twenty-five years in the biopharmaceutical industry, Blümel’s fascination with proteins marked the beginning of his journey at Novartis. Regular attendance at WCBP meetings since 2004 provided him with the opportunity to exchange ideas with senior experts on best practices for an effective biologics CMC development strategy, from early development to commercialization. Since 2011, he has been a member of the WCBP organizing committee and he has served as a co-organizer for multiple workshops and CMC Strategy Fora in North America.
Carmilia Jiménez Ramírez is currently the Owner and Chief Consultant of Miliar BioPharma Solutions. Prior to consulting, she has held various leadership and individual contributor roles at BioMarin Pharmaceutical Inc., Ajinomoto Bio-Pharma Services, Gilead Sciences, Merck & Co., Inc., and Amgen Inc. She earned her Bachelor of Science degree in biology from the University of Puerto Rico-Mayaguez and her Ph.D. in microbiology and immunology from Temple University’s Lewis Katz School of Medicine.
Jiménez Ramírez has been serving on the CASSS Board of Directors since 2022. Her tenure has been marked by a dedication to technical innovation, technical development, and quality control in biopharmaceuticals to ensure patient access to superior medical treatment. Over the last 10 years, she has contributed to multiple committees, including WCBP and the CMC Strategy Forum for Latin America (Co-chair in 2015) and North America. She recently joined as a scientific organizing committee member of CASSS’ new Symposium on mRNA Therapy Products: Manufacturing, Quality, and Regulatory Considerations, taking place in May 2025.
Yasuhiro Kishioka is currently a Review Director in the Office of Cellular and Tissue-based Products at the Pharmaceuticals and Medical Devices Agency (PMDA). He earned his Ph.D. in meat science, with an emphasis on molecular biology, from Hokkaido University.
Since joining PMDA in 2008, he has over 15 years' experience in the area of biologics, including the assessment of biosimilars, gene therapy products, quality of biotechnological/biological products. He also has joined several international initiatives such as WHO, APEC, ICMRA, ICH, and IPRP.
Since 2012, Kishioka has been actively involved in planning Japan CMC Strategy Forums. He has also participated as a speaker at CMC Strategy Forums in North America, Europe, Japan, and China, as well as at WCBP.