About

biomatria is founded and led by Basak Clements, PhD. Basak is a seasoned biopharmaceutical development leader with over 15 years of experience driving innovation in cell and gene therapy (CGT), biologics manufacturing, and materials science. As a Senior Scientific Advisor at biomatria, Basak provides strategic materials science and management consulting for advanced therapy and biopharmaceutical companies, research institutions, and CDMOs, and suppliers - specializing in raw material management for biologics and advanced therapies

Basak previously served as Global Head/Senior Director of Cell and Gene Therapy Materials Science at Roche/Genentech, where she implemented material sciences strategy for a multi-billion dollar CGT pipeline and established an industry-first risk-based material control framework. She led large global teams of scientists and engineers across multiple sites while serving on the Senior Leadership Team influencing strategic decisions for the Roche CGT Process Development and Manufacturing organization. Before that, at Janssen Research & Development, Basak worked for enabling commercial approval of Carvykti™, the company's first CGT product, while managing support for the materials science portfolio of 60+ novel molecular entities including other clinical cell & gene therapy assets, antibodies, and vaccines. Basak also worked at Amgen in Materials Science and Raw Materials and Devices organizations in process development/SME, specification management, data management/PLM roles.

Recognized for creating transformative solutions that reduce costs while maintaining quality and compliance in complex regulatory environments, Basak has deep expertise in QbD-based material control strategies, specification management, and supplier relationship excellence programs. She has a track record of implementing innovative systems that achieved significant improvement in material data management and reduction in material-related investigations, and keen interest in technical detail and excellence.

Basak's academic background includes a Ph.D. in Pharmaceutical Sciences/Chemical Engineering, which focused on non-viral gene delivery to primary bone marrow stromal cells. This was followed by an extensive postdoctoral research period at Rutgers University's New Jersey Center for Biomaterials where she led cutting-edge research in peripheral nerve regeneration, resulting in a patent for biocompatible implants. During her career, Basak published numerous peer-reviewed papers in leading journals and actively contributed to industry guidelines (USP, EP) and consortia (Biophorum). She is a regular speaker and chair at industry conferences including ASGCT, CASSS, and BPI, sharing expertise in raw materials and process development.

Basak is passionate about knowledge sharing, collaboration and community building. She also believes strongly that we can accelerate the development of therapies and make them accessible to more patients when we help one another through sharing publicly available best practices and tools and collaborate within confines of companies' confidentiality boundaries.

Please drop a line for any consulting requests, questions, ideas or detailed information.