Our team is experienced in gene therapy, rare disease drug development and commercialization, and biologics manufacturing.
Don Mather serves as Senior Vice President for BioPharma Manufacturing within Astellas. He is responsible for Clinical and Commercial GMP Manufacturing at five (5) global sites across the Astellas organization including: Sanford, NC and South San Francisco, CA for Gene Therapy (AGT); Westborough, MA for Cell Therapies (IRM); and Toyama and Tokodai, Japan for monoclonal antibodies and antibody drug conjugates (mAb/ADC).
Prior to April 2023, Don was Head of Manufacturing & Site Operations for Sanford, NC and served as a member of the Astellas Gene Therapies RTO Leadership Team since May 2020. Prior to his work at Astellas, Don held various leadership roles at Grifols in Validation, Manufacturing, and Process Development for various Biologic Modalities including Capital Project design, build, qualify, validate, licensure and operation for four facilities up to $340MM scale, including a 2014 ISPE Facility of the Year.
Prior to Grifols, Don held numerous leadership positions in Development & Manufacturing at Human Genome Sciences.
Mr. Mather earned his M.Sc. in Biotechnology from Johns Hopkins University and B.Sc. in Biochemistry from the University of Washington.
Amy Pott is Division Head of Gene Therapy, Commercial for Astellas Gene Therapies, and is responsible for leading commercialization of our Gene Therapy business. She joined Astellas Gene Therapies (formerly Audentes Therapeutics) in January 2021 and brings an impressive amount of experience and expertise around rare disease therapies.
Ms. Pott joined Astellas Gene Therapies from Swedish Orphan Biovitrum (SOBI), where she was President, North America, and oversaw rare disease and specialty programs. Prior to joining SOBI, Ms. Pott was Group Vice President, US Franchise Head, Internal Medicine & Oncology at Shire, where she was responsible for four rare disease businesses. She joined Shire when the company acquired Baxalta and stayed on to build the US commercial operations group handling the US franchises.
Ms. Pott earned her B.A. in History from the University of Bristol and her M.Sc. in European Policy & International Relations from the London School of Economics.
Carolyn Sasse is the Development Division Head of Cell and Gene Therapy for Astellas and is responsible for providing strategic direction and leadership for the development of all compounds across the cell and gene therapy primary focus areas. She has more than 20 years of experience in research, development and the launch of small molecules and biologics.
She joined Astellas in 2011 and has held numerous roles within the organization. She led the Clinical Operations Team responsible for the successful global and US registration of oncology and anti-infective products. Most recently she has served as Executive Director, Global Development Project Lead in Oncology where she led the development team to the successful global launch of the first therapy approved for patients with locally advanced or metastatic urothelial cancer who had received prior treatment with a platinum-based therapy and a PD-1/PD-L1. While leading this team she maintained oversight accountability for several program development teams. Prior to joining Astellas, Carolyn was Manager of Clinical Operations at PAREXEL International and a Senior Clinical Research Associate at Paragon Biomedical.
Ms. Sasse earned her B.A. in Human Biology at the University of Dayton. Carolyn has a passion for learning and finding solutions to the challenges that exist within the medical industry, and she is focused on bringing life changing therapies to patients with high unmet need.
Jason Schwartz, MD, is the Vice President of Medical Affairs for Astellas Gene Therapies and is responsible for leading development and execution of the Medical Affairs strategy. He joined Astellas Gene Therapies in June 2022 after helping to overcome several mission-critical challenges in both industry and academia.
Dr. Schwartz is a multi-organ transplant surgeon by training, joining Astellas in 2014 from academic practice where he was associate professor and head of the kidney transplant program at the University of Texas, Southwestern. Prior to that, he co-founded the multi-organ transplant and liver oncology programs at the University of Utah, where he was also director of translational research. At Astellas, he has held positions of increasing responsibility, first leading the U.S. Medical Affairs activities for transplant / immunology and then helping to establish and grow the global Early Stage Medical Affairs function, leading teams that seek to optimize the value of Astellas products early in their life cycle. He has an extensive clinical background in the surgical and medical management of end-organ disease and was involved in some of the earliest efforts to transplant across HLA and ABO barriers. Over the years, his research interests have focused on liver and kidney pathologies, hepatic and biliary malignancies, and immunosuppressive management.
Dr. Schwartz earned his B.S. in biochemistry from the University of Illinois Urbana-Champaign and his MD from the University of Illinois at Chicago College of Medicine. After completing his five year general surgery training at the University of Texas, Southwestern, he completed a two year NIH-sponsored research fellowship in burns, trauma, and critical care. This was followed by 2 years of additional training at the Mayo Clinic, Rochester, where as a surgical transplant fellow, he earned certification in liver, kidney, and pancreas transplantation, as well as that of living donation.
David Smethurst is the Head of Regulatory for Cell and Gene Therapies at Astellas with accountability for global regulatory strategy for the pipeline of Cell and Gene Therapies as well as responsibility for Astellas’ Regulatory Policy and Intelligence group. Mr. Smethurst joined Astellas Gene Therapies in August 2021, transitioning from a leadership role in Astellas’ global regulatory organization.
A global leader with over 25 years of experience in regulatory affairs, Mr. Smethurst has held leadership roles in both regional and global regulatory affairs that have led to more than 10 NDA/BLA/MAA and international regulatory submissions and approvals under his leadership.
Mr. Smethurst has diverse experience across multiple therapeutic areas, including Respiratory Diseases, Anti-Infectives, Inflammation and Immunology, Cardiovascular Disease, Neuroscience, Pain, and Psychiatry in orphan and larger chronic diseases for small molecules, vaccines, monoclonal antibodies, other biologics, and gene therapies.
Prior to joining Astellas, Mr. Smethurst held regulatory leadership roles at Pfizer as well as Boehringer Ingelheim.
David earned his B.Sc. (Honors) Pharmacology from the University of Liverpool, United Kingdom and completed post-graduate research work at the School of Pharmacology and Therapeutics, University of Liverpool.
Morten is responsible for advancing the company’s pipeline from discovery through to IND-enabling preclinical development including Discovery Biosciences, Integrative Biology, Strategy & Project Management, non-GMP CMC (Tech Development), Research Engineering and Facilities. Morten also is overseeing gene therapy technology and early stage partnerships.
Prior to joining Astellas Gene Therapies in May 2022, Morten was Head of Target Sciences at Pfizer and served as a member of the global R&D Leadership Team. Morten also held various leadership roles at Pfizer in Diagnostics, Genomics, Genetics and Computational Capabilities, as well as External R&D for Platform Technologies and Oncology.
Prior to Pfizer, Morten led Immuno-Oncology research at Pharmacia, headed the Global Enabling Technologies and Research Informatics at Boehringer Ingelheim, and oversaw Molecular Sciences research at AstraZeneca.
Morten has a Ph.D. in Biochemistry with a focus on protein engineering from the University of Copenhagen.
Richard Wilson is currently the Senior Vice President, Primary Focus Lead of Genetic Regulation at Astellas Gene Therapies and is responsible for setting and leading the gene therapy strategy for Astellas’ Primary Focus Genetic Regulation. Richard joined Astellas Gene Therapies (formerly Audentes Therapeutics) in April 2020 as Vice President, Program Management.
Richard has over 30 years of experience in research, development, and commercialization of small molecules, biological and gene therapies. Prior to Astellas Gene Therapies, he served as Executive Director, Product Portfolio Development at BioMarin Pharmaceutical Inc. where he held a number of roles including portfolio Core Team leader for BioMarin’s PKU franchise, overseeing the approval and global launch of the first enzyme substitution therapy for PKU.
Prior to BioMarin, Richard held leadership positions in GlaxoWellcome, BioChem Pharma, Theravance and Innoviva, where he was involved in the development and commercialization of a range of products in COPD and Asthma, and led R&D programs in anti-infective, cardiovascular, rheumatology, and urology disease areas.
Richard holds a BSc (Hons) in Chemistry from the University of Manchester and an MBA from the Haas School of Business at the University of California, Berkeley.
Under construction and scheduled to be fully operational by the Summer of 2024, our new South San Francisco West Coast hub for Cell and Gene Therapy research will unite 20+ geographically-dispersed teams comprised of Research, Technical Development, Medical & Development, Commercial, Business Development, and relevant administrative support functions in one location. This state-of-the-art 154,000 square foot facility will provide ample laboratory and office space to accommodate the future growth of our staff researching rare diseases and cancer for patients with limited or no treatment options.
As part of our unique end-to-end global infrastructure capabilities, our state-of-the-art manufacturing facilities, which originally began on Oyster Point in South San Francisco in 2017, now comprise over 52,000 square feet of Good Manufacturing Practice (GMP)-compliant drug substance and drug product clinical- and commercial-scale manufacturing capabilities, QC labs, warehousing, and office space for our pipeline of AAV gene therapies.
Completed in 2022, our manufacturing facility in Sanford, North Carolina reflects a $100 million investment in the development and future commercialization of life-changing gene therapies for people around the world. This 135,000 square foot, GMP-compliant facility expands Astellas' manufacturing capacity, enabling the production of materials for multiple gene therapy programs and studies in parallel. Its design provides clinical and commercial manufacturing capabilities for our pipeline of AAV gene therapies, including GMP manufacturing of the AAV portfolio and Quality Control testing.