CMC Team

CMC Team

Kathleen Leach, PhD - Head of CMC

Dr. Leach became the head of CMC at Aruvant in May of 2020. She is responsible for the process and product development for our lead product candidate, ARU-1801, a one-time potentially curative gene therapy for patients with sickle cell disease administered with reduced intensity conditioning. Dr. Leach is charged with developing and implementing CMC strategies for process control, specifications, stability, raw materials, residuals for both the lentiviral vector as well as the cell product. She also oversees the commercial process and analytical method development at the contract manufacturing organizations and contract test laboratories. Prior to working with Aruvant, Dr. Leach was the director of CMC quality and analytics at Juno Therapeutics. There she defined the global quality strategies for cell therapy and lentiviral vector products, including product and raw material specifications, analytical method lifecycle, stability and product quality attributes. She played a key role in authoring the CMC sections and representing quality for global health authority interactions. Before Juno, she worked in process and product development at Amgen for 12 years and as a staff scientist at Immunex for three years. She received her bachelor’s degree from MIT in Chemical Engineering and her Ph.D. from Brown University.

Amitabha Deb, PhD - Head of Vector Development

Dr. Deb joins Aruvant with over 19 years’ experience in transitioning pharmaceutical drug candidates into clinical development, and leading multiple commercial and IND approved products into market. In the recent past, Dr. Deb served as VP of Bioprocess Development & Manufacturing at Ring Therapeutics, a Flagship Pioneering Company. Dr. Deb also served in different leadership roles in Technical Operations at Sanofi/Bioverativ related to hemophilia Gene Therapy and Gene editing programs. Prior to joining Bioverativ, Dr. Deb also served as Director of the Lentiviral development group for KYMRIAH®. Dr. Deb obtained his PhD in Molecular Biology from the Indian Institute of Chemical Biology with the Presidential award and conducted his postdoctoral training in Cancer Biology at Cleveland Clinic, researching the JAK-STAT pathway and RNA dependent protein kinase. Outside of his professional life, Dr. Deb is an accomplished vocal singer of Indian Classical Music, a Certified Yoga trainer, and an avid traveler.