The first CAR-T therapies are on the market, but the commercial journey is far from over. The process requires that blood be taken from a patient, cryopreserved, shipped to a facility, reprogrammed and manufactured in the lab, and then shipped back for infusion into the patient, all in the shortest time possible to try to outrun aggressive cancers.
Manufacturing cell-based drugs is unlike anything most drug developers ever faced and requires specialized skills. Anyone with those skills is going to be in demand and expensive. One expert tip: Start your search for experienced people sooner than later.
And if you never thought you would need a real estate specialist to make cell-based manufacturing work, think again. The time constraints of producing and infusing cell-based therapies means manufacturing needs to be close to patients and close to airports.
When your manufacturing process depends on healthcare professionals working with the patients to get the front-end and back-end of the processes exactly right, those professionals need to understand your process unequivocally. That may mean having a team of trainers to make that happen.
We’ll discuss the challenges posed by this new wave of therapies and how the pioneers in the field are tackling them
Spencer Fisk is the Chief Technical Operations Officer of Rubius Therapeutics and brings more than 25 years of experience in Manufacturing and CMC product development. Prior to joining Rubius, Spencer served as VP & Global Head of Cell & Gene Technical Development and Manufacturing at Novartis where he led the CMC development and manufacturing organization to deliver the CAR-T portfolio. Under his leadership, the team successfully registered and launched the first CAR-T cellular therapy product, Kymriah, which has demonstrated transformative efficacy in patients with acute lymphoblastic leukemia. While at Novartis, Spencer also led the process development teams in support of the commercialization of Cosentyx® and the registration and approval of ErelziTM and Rixathon®. Prior to Novartis, he led manufacturing and CMC functions in support of Somavert®, Elonva®, Retavase® and Puregon® while at Merck, formerly Schering Plough, Organon and Covance. Prior to Merck, Spencer held various process development and manufacturing roles at Genentech, Genencor and Novo Nordisk.
Colleen Floreck is the Vice President of Marketing and Strategy at Catalent Cell & Gene Therapy responsible for the strategic, competitive and tactical marketing across the cell and gene therapy business. Colleen joined Catalent in April 2019. She has held several sales, marketing and communications positions at previous companies including Lonza, EMD Biosciences and Becton Dickinson. Colleen has a Masters in Cell and Molecular Biology from Penn State College of Medicine and has over 20 years of experience in the biotech and pharmaceutical industry.