Charles River Laboratories

John is the General Manager of APAC for Dark Horse Consulting. Before joining DHC, John served as CTO of Tessa Therapeutics. Tessa Therapeutics is a clinical-stage biotechnology company based in Singapore that was developing a portfolio of autologous and allogeneic cell therapy assets.

Tim has more than 20 years of life sciences strategy, business development, product development, and commercialisation experience in Europe, Asia and Australia. He has more than 10 years of experience in cell and gene therapies. Tim is currently CEO and Managing Director of AdAlta Ltd which is building a pipeline of clinical stage CAR-T cell therapies for solid cancers originating from across Asia (and particularly China) and providing them with a pathway to Western patients and markets via Australia. He is also Non-Executive Chair of Skin2Neuron Pty Ltd, a new company developing regenerative cell therapies for neurological diseases such as Alzheimers. He was previously CEO and Managing Director of Cell Therapies Pty Ltd, Australia's leading contract manufacturer of cellular therapies in Asia Pacific and was a Director of the Alliance for Regenerative Medicine. Other roles include President of Asia Pacific for Hospira, Inc., senior EMEA roles with Mayne Pharma Ltd prior to its acquisition by Hospira and Non-Executive Director at BioMelbourne Network.

Dr Kerstin Brack has been a Scientific Director at Charles River since 2018 and a subject matter expert for biosafety testing of biologicals. She holds a Diploma in Biology from the University of Bremen (Germany) where she subsequently also earned her PhD in Virology. In 2001 Kerstin joined NewLab BioQuality AG (now Charles River Laboratories Germany GmbH) as a Study Director for virus and prion validation studies. She was also responsible to establish analytical test methods for biosafety testing of biologicals as well as cell-based potency assays. Between 2004 and 2018 Kerstin managed the departments for biosafety and bioassay services at Charles River Laboratories Germany.

Dr. Smith has 40+ years of experience in the cell therapy and gene therapy field with experience in a wide variety of cell types and viral vector platforms. He has extensive experience in research, process development, GMP manufacturing, quality control, quality assurance, analytical and assay development, GMP facilities design, construction and operation and GMP supply chain/procurement. 

He most recently served as Chief Technology Officer of Ambys Medicines, Inc. Prior to his time at Ambys Medicines, Dr. Smith served as Chief Technology Officer at Akouos, Inc., a gene therapy company focused on cures for genetic hearing defects (acquired by Lilly), and was Executive Vice President, Technical Operations at Bellicum Pharmaceuticals, Inc. Dr. Smith previously served as Vice President of Research & Development and Cellular Therapeutics for LifeNet Health, Inc. and its wholly owned subsidiary, The Institute of Regenerative Medicine. He also operated a successful consulting company serving the cell and gene therapy field for a number of years. Earlier in his career, Dr. Smith served as President and CEO of Cognate BioServices (now part of Charles River Laboratories); Chief Operating Officer and Senior Vice President of R&D for Osiris Therapeutics; led the R&D functions for Aastrom Biosciences and Genetic Sciences; and served as Director of Cell Separations R&D at Baxter Healthcare and Director of Biochemistry at HyClone Laboratories (now Thermo Fisher). 

Over the course of his career, he has been a material contributor to more than 25 successful regulatory applications for human cell therapy clinical trials and medical devices. Dr. Smith has previously held adjunct professor appointments at Eastern Virginia Medical School, California State University, Long Beach and Utah State University and has served in a number of academic advisory panel positions. He holds a B.S. in Chemistry from Southern Utah University and a Ph.D. in biochemistry from Utah State University.