From vein to vein: how starting material quality impacts the manufacturing and success of next-generation therapies

I am a T cell biologist. I am currently the SVP of Process Development at PACT Pharma Inc, supporting the development of personalized TcRs to tumor neoAgs as a therapy for solid cancers. From February 2018 to September 2019, I was the VP of Technical Operations at Poseida Therapeutics, leading the process development and manufacturing teams supporting their non-viral process for developing autologous and allogeneic CAR-T programs.

I led the Process Development group in the Cell and Gene therapy unit at Novartis in generating the clinical and commercial manufacturing process for the CD19 CAR-T program (Kymirah™). The work involved the tech transfer of the academic process from the University of Pennsylvania, replicating and improving the process, process characterization, manufacturing support, and process validation. The opportunity at Novartis allowed me to “bookend” my career; from LAK cells to commercialization of the first adoptive CAR-T therapy for cancer.

Previous to Novartis, I let the CMC, Pharm/Tox, and QA/QC groups at Sangamo Therapeutics for all their gene-modification programs. This involved process and assay development for both vector (AAV, Adeno) and gene-modified cell therapies (T cells, CD34+ progenitor cells). I led the teams that set up our collaboration with a number of CDMOs to produce GMP material in support of our INDs and clinical trials.

At Cerus, I worked with Dr Tom Dubinsky to set up the cancer vaccine program, using recombinant Listeria as the vector for immunization. I led the Pharm/tox effort, by setting up animal tumor models (murine syngeneic and adoptive transfer), performing initial and pivotal IND-enabling safety studies in both mice and nonhuman primates.

My career has focused on the manipulation of the immune response to better fight cancer and infectious disease. My time at Chiron provided experience with recombinant proteins for the treatment of HIV and cancer (Proleukin™ rIL-2), MS (Betaseron™), and various vaccine adjuvants. At Triton/Berlex BioSciences, I performed basic research on suppressor factors for regulation of the immune response and explored the use of Fludara® as a therapy for rheumatoid arthritis. My tenure at the LSU medical center in New Orleans provided experience in leading the tissue typing team in support of the renal and BM transplant program. This built on my Ph.D. experience at MCV-VCU in Richmond, VA. Fellowships at Scripps in la Jolla and DNAX in Palo Alto provide a grounding in T cell regulation, with seminal work in defining the Th1/Th2 paradigm that has guided T cell research over the past 20 years.

Dr. Baghbaderani is the Global Head of Process Development, Cell and Gene Technologies at Lonza. He has over 15 years of experience in stem cells engineering, bioprocessing, and cell and gene therapy (C&GT) field. Dr. Baghbaderani holds a PhD degree in Biomedical Engineering from the University of Calgary (Calgary, Canada), where he developed bioreactor protocols for large-scale expansion of human neural stem cells for clinical applications.

He completed nearly three years of post-doctoral program including a two-year post-doctoral fellowship at the National Institutes of Health (NIH) / National Institute of Neurological Disorders and Stroke (NINDS). His post-doctoral research at the NIH focused on generation of human induced pluripotent stem cells, bioprocessing of both human embryonic stem cells and human iPSCs and controlled differentiation into neuronal lineage.

Since joining Lonza in 2011, he led a group of scientists at Lonza process development team, establishing pluripotent stem cells platform technologies and a cGMP compliant manufacturing process for human induced pluripotent stem cells. Dr. Baghbaderani then led the cell therapy development department (including process development and bioassay services), focusing on the development of cGMP compliant processes and cell characterization assays for different cell therapy applications. As the global head of process development, Dr. Baghbaderani is currently leading the development activities for viral vector and C&GT applications across Lonza Cell and Gene Technologies global network.

Philippe Parone, PhD, is the Director for Industrialization at Celyad. Prior to Celyad, Dr. Parone worked at Fate Therapeutics overseeing the development of cell therapy product candidates derived from hematopoietic stem cells and iPSCs for the treatment of autoimmune disorders.

During his time at Fate therapeutics, Dr. Parone was part of the team that filed the INDs for the first U.S. clinical investigation of an iPSC-derived cell product and the world’s first cell therapy derived from an engineered iPSC. Dr. Parone holds a PhD in Biochemistry and Cell biology from the University of Cambridge and received his B.S. in Biology from the University of East Anglia.