MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--SanBio, Inc., a leader in stem cell based therapeutics, today announced the appointment of Jay Stout , PhD, as Senior Vice President of Manufacturing. In this role, Dr. Stout will be responsible for all production-related operations, from process development, production and quality control, to clinical cell preparation and final quality assurance.
Dr. Stout is a distinguished industry veteran with 25 years of experience in biologicals development and commercialization. He previously served as Global Process Team Lead for Enbrel, Amgen’s blockbuster anti-TNF product; and as Global Technical Lead for Keytruda (pembrolizumab), Merck’s antibody targeting the Programmed Cell Death 1 (PD-1) receptor. Keytruda was awarded Breakthrough status by the FDA and was the first anti-PD-1 therapy approved in the United States.
“I’m eager to roll up my sleeves to prepare SanBio’s promising cell therapies for scaled-up production and rapid rollout,” said Stout. “The clinical results are exciting, and bringing a breakthrough technology to commercialization is a challenge I’ve met several times before.”
A PhD biochemist, Stout most recently served as Executive Director of Merck’s Center for Biopharmaceutical Manufacturing, and previously was Executive Director of Amgen’s Manufacturing Sciences and Technology Group. Earlier in his career he initiated and directed Pfizer’s Biologics Development Group.
“We’re delighted to welcome Jay aboard,” said Keita Mori, SanBio’s Chief Executive Officer. “He is perhaps the individual with the greatest experience in the world in manufacturing scale-up of biologics similar to SanBio’s SB623 stem cell therapy. He fills out what is a genuinely world-class development and operations team.
“We’ve always considered production of completely uniform, commercial-scale quantities to be a critical element in bringing the enormous promise of stem cell medicines to large patient populations,” continued Mori. “It’s why we have always focused on allogeneic cell lines, which are much more readily produced in quantity. It’s also why we spent years solving scale-up challenges that the rest of the industry is only now starting to address.
“Having an executive of Jay’s caliber to execute scale-up moves our program even farther into a position of global industry leadership.”
About SanBio, Inc. (SanBio)
SanBio is a regenerative medicine company with cell based products in various stages of research, development and clinical trials. Its proprietary cell based product, SB623, is beginning Stage 2b clinical trials for treatment of chronic dysfunction resulting from stroke. SanBio also began Stage 2 clinical trials for treatment of disability resulting from traumatic brain injury in late 2015. More information about SanBio, Inc. is available at www.san-bio.com.
Contacts
For SanBio, Inc.
Meredith Gallagher, 612-455-1724
Meredith.Gallagher@padillacrt.com
