- Discussing the most important new technologies in biomanufacturing today, with a special emphasis on what we want to do as our industry matures
- Debating how talent and workforce development in our industry is changing, and what we should do about it
- Listing the current factors affecting speed of development and efficient manufacturing. How do we continue to improve in a changing business landscape with special reference to IRA and the BIOSECURE Acts?
- Understanding the current Regulatory environment with an eye for how things are going to evolve into the future
- How can we improve the access of biologic medicines?
Alison Moore
Chief Technical Officer
Codexis
Alison Moore brings to Codexis significant experience as a biotechnology and pharmaceutical executive, including an extensive background in biomanufacturing. She is former Chief Technical Officer of Allogene Therapeutics, a pioneering clinical-stage company advancing CAR-T therapies. Prior to Allogene she spent a total of 20 years at Amgen, most recently as Senior Vice President, Process Development, and including roles in Supply Chain and Manufacturing. Dr. Moore also has experience at Genentech as a Director in Chemistry, Manufacturing and Controls, and Regulatory Affairs. Dr. Moore holds a bachelor’s degree in Pharmacology with Honors and a Ph.D. in Cell Biology from Manchester University, England.
Kawa Chiu
Chief Technical Officer
Abdera Therapeutics
Kawa Chiu is the Chief Technical Officer at Abdera Therapeutics, a biopharmaceutical company leveraging antibody engineering to design and develop next-generation precision radiopharmaceuticals for cancer. Kawa joined Abdera in 2022 and built out Technical Operations organization and CMC capabilities. During her tenure, Kawa and her team developed Abdera’s lead program, ABD-147, a targeted radiopharmaceutical biologic therapy designed to deliver Actinium-225 (225Ac) to solid tumors expressing delta-like ligand 3 (DLL3) with high affinity. The FDA cleared the IND for the treatment of SCLC and LCNEC in May 2024 and recognized the potential of ABD-147 to become a transformative treatment option in areas of high unmet medical need by granting fast track designation in extensive-stage SCLC in June 2024, and an orphan drug designation for the treatment of neuroendocrine carcinoma in August 2024.
Prior to Abdera, Kawa served as the vice president of CMC supply chain at Lyell Immunopharma, a cell therapy company focused on solid tumors. At Lyell, Kawa oversaw CMC programs that enabled three IND approvals, established the company’s autologous patient supply chain, and implemented a progressive cloud based, integrated manufacturing systems. Prior to Lyell, Kawa spent 14 years at Genentech in South San Francisco and at Roche in Basel, Switzerland in roles including head of Oceanside drug substance manufacturing, global head of technical operation strategy, global head of biologics operational excellence and global head of supply planning. Kawa started her career and held a number of manufacturing positions at Merck & Co., Inc.
Kawa holds a B.S. in operations from The Ohio State University, a M.Sc. in Engineering from University of Pennsylvania, an MBA from New York University, and a Master in Public Health from U.C. Berkeley.
Rainer Müller
Senior Vice President Global Technical Development
BioNTech
Rainer Müller, Ph.D., is Senior Vice President Global Technical Development at BioNTech, a position he has held since May 2024. Together with his team, he is providing BioNTech’s Technical & Chemistry, Manufacturing, and Controls (“CMC”) Development strategy across its portfolio.
Rainer joined BioNTech in May 2022 as Vice President Operations Projects, where he led key initiatives to optimize operations and development processes. He was later promoted to Vice President Global Technical Development & Operations Projects, further expanding his responsibilities to support BioNTech’s internationalization. Prior to joining BioNTech, Rainer spent 17 years at Roche, where he held roles of increasing responsibility within Technical Operations and Development. Most recently, he served as their Global Technical Development Head for Individualized and Cell Therapies.
Rainer started his career in the biopharmaceutical industry in 1998 at Medigene AG after completing his Ph.D. in Biochemistry and Cell Biology at the Max-Planck Society and the University of Tübingen, Germany.
Alex Cooke
CEO
Phase 3
Alex Cooke is the founder & CEO of Phase 3 Search- a boutique executive search firm driven by their mission to accelerate drug development through building and supporting the world’s life sciences leadership teams.
Alex’s expertise lies in building out executive teams in early stage companies, working with PE & VC backed biotechs to accelerate their growth and development. He provides much more than placement, acting as a trusted advisor to his clients.
With 11 years industry expertise placing biotech executives at home and abroad in Europe, Alex is a visionary and active member of the FORBES Business Council.
Dr. David Chang, PhD
Chief Executive Officer
TBMC
Dr. David Chang is a seasoned leader with over three decades of experience in the biopharmaceutical and biotechnology sectors, specializing in cell therapy and biologics manufacturing. As CEO of TBMC, Dr. Chang brings a wealth of expertise in leading advanced therapeutic development and operations on a global scale.
Prior to joining TBMC, Dr. Chang served as President and CEO of WuXi Advanced Therapy Unit from June 2020 to February 2024. He also held key leadership positions at renowned organizations, including Corporate Vice President and Head of Cell Therapy Manufacturing at Celgene (now Bristol Myers Squibb), Corporate VP and Global Head of Technical Operations at Roche, and Senior Director of Biologics Manufacturing Science and Technology at Genentech. His strategic vision and deep technical knowledge were pivotal in advancing therapeutic manufacturing capabilities across these roles.
Earlier in his career, Dr. Chang led cell culture process development at Biogen and contributed to groundbreaking research as Senior Scientist of Cell Culture at BASF Research and Senior Chemical Engineer at Schering-Plough Research Institute.
Dr. Chang holds a PhD in Biochemical Engineering from MIT (1992) and a B.S. in Chemical Engineering from National Taiwan University (1985).
