Education Program 1: Operational Excellence presented by 2021 FOYA Category Winner ElevateBio
3:00 PM – 4:00 PM | South End Zone, Red Level, Press Box
2021 FOYA Category Winner ElevateBio talks Operational Excellence
ElevateBio is a technology-driven company built to power the development of transformative cell and gene therapies. ElevateBio was awarded the 2021 ISPE FOYA Award for Operational Excellence for their BaseCamp facility in Waltham, MA. BaseCamp is a purpose-built facility offering process innovation, process sciences, and current Good Manufacturing Practice (cGMP) manufacturing capabilities. It was designed to support diverse cell and gene therapy products, including autologous, allogeneic, and regenerative medicine cell products such as induced pluripotent stem cells, or iPSC, and viral vector manufacturing capabilities.
In this session, hear from a diverse group of panelists representing BaseCamp’s process development, technology transfer, manufacturing, quality, automation, and supply chain groups as they discuss the systems in place driving operational excellence. Attendees will hear insights on how ElevateBio has embraced novel ways of thinking to create efficient, flexible and industry leading processes to manufacture cell and gene therapies. This session will be a panel discussion followed by audience Q&A.
Moderator:
Jon Bairam, AD, Cell Therapy Manufacturing
Panelists:
Pete Gelinas, VP, Head of Manufacturing and Technical Operations
Todd Hiser, Sr. Director, IT Systems and Infrastructure
Andreas Kouri, SVP, Supply Chain Strategic Operations
Mercedes Segura, VP, Process Development
Josh Sorafine, SVP, Quality and Analytics
Speaker / Panelist Bios:
Jon Bairam has over 7 years of Cell and Gene therapy experience in manufacturing focusing primarily on product technical transfer into routine clinical manufacturing. At ElevateBio, Jon is an Associate Director of the Cell Therapy Manufacturing team, concentrating on routine, right first time manufacturing and Technology Transfer. He has been with ElevateBio for nearly 2 years and has supported facility start up and organization build out. Prior to joining ElevateBio, he was a Supervisor of Cell and Gene therapy manufacturing at Lonza Biologics, where he held several roles of increasing responsibility, accountable for multiple client product technical transfers into Portsmouth, NH and Walkersville, MD locations.
Pete Gelinas has over 10 years of Cell and Gene therapy experience in manufacturing and CMC product development from candidate nomination to commercialization. At Elevate bio, Pete heads up Manufacturing & Technical Operations which overseeing aspects of Technology Transfer, CMC strategy, and oversite of routine clinical manufacturing for the Elevate bio portfolio and strategic partners. HE has been with elevate bio for nearly 4 years and has helped with the facility and system buildouts. Peter has led both the Drug Product MS&T group and CMC team for the Eli-Cel program for the Treatment of Cerebral Adrenoleukodystrophy (CALD) at bluebird bio for more than four years. In his MS&T role, he completed multiple late-phase global technology transfers and led the drug product process validation efforts instrumental to filing the Marketing Authorization Application (MAA) for Zynteglo. Peter also held various roles at the Connell O’Reilly Cell Manipulation Core Facility (CMCF) at Dana Farber Cancer Institute (DFCI), assisting in the development and manufacturing of multiple gene and cell-based therapies.
Todd Hiser joined ElevateBio in 2019 as Head of Automation initially supporting the Basecamp buildout. He quickly expanded his role as Senior Director of Infrastructure and Operations to include all IT & OT operations from the service desk, infrastructure, and IT projects to shopfloor systems and CSV/A. Todd brings 20 years of automation experience and strategic leadership in the biotech industry. He was previously Site Head of Automation, MES, & IT at Sanofi Genzyme in Framingham, where he oversaw a diverse team of IT and OT professionals supporting a multi-building commercial manufacturing campus. Prior to Sanofi Genzyme, Todd worked at Lonza and at a local engineering company in the Boston area as a controls engineer and served in the US Navy on submarines. His hands-on experience deploying and operating digital systems has been critical in the successful implementation of ElevateBio’s own digital strategy. ElevateBio was ‘born’ digital, but maturing digitally is a never ending process that Todd continues to lead.
Andreas Kouri joined ElevateBio in 2021 as Senior Vice President, Supply Chain Strategic Operations. He brings 20 years of operational & strategic experience in cell and gene therapy, biotech, technical operations, and global supply chain. Prior to joining the Company, he was Senior Vice President of Global Supply Chain & External Manufacturing at AVROBIO, where he was accountable for design, build, scale, oversight, and leadership of their end-to-end supply chain and external manufacturing network. Before that Mr. Kouri was Vice President of Global Supply Chain at bluebird bio, Inc., where he held several roles of increasing responsibility and was the functional head of global supply chain supporting the European approval for ZYNTEGLO®, a transformational gene therapy for Transfusion dependent Thalassemia. Earlier in his career, he held positions of increased responsibilities at Shire, BMS, Pfizer and Pharmacia, spanning all aspects of global clinical and commercial supply chain across multiple geographies, including Sweden, Ireland, and the United States.
Mercedes Segura is a senior executive with extensive experience on Advance Therapy Medicinal Products. Her interests are on all aspects of pharmaceutical development for cell and gene therapies. She has worked on all phases of clinical development from pre-IND to marketing application (BLA and MAA) and helped grow start-up companies to medium size. Mercedes completed her undergraduate studies in pharmacy and a MSc in Biotechnology at the Universidad de Buenos Aires, Argentina. She enrolled to a PhD program at l´Université Laval in Quebec and conducted research studies at the Biotechnology Research Institute of the National Research Council Canada (BRI-NRC). Her thesis focused on the production and purification of gamma-retroviral and lentiviral gene therapy vectors. Mercedes pursued post-doctoral studies at the Universitat Autònoma de Barcelona, Spain, where she mainly focused on bioprocessing and analytical characterization of AAVs, adenoviral vectors, and VLP vaccines. In 2013, Mercedes joined bluebird bio, a gene therapy company located in Cambridge, MA. During her 7 years at bluebird, she helped build the company’s infrastructure to advance pre-clinical and clinical gene therapy programs throughout different stages of development. She led several scientific teams including Vector Manufacturing, Process Characterization and Analytical Characterization, mRNA Process and Analytical Development, and Cellular Process Development for both HSC and T cell-based gene therapy programs. Mercedes joined AVROBIO in 2020, where she helped develop early- and late-stage CMC strategies for AVROBIO portfolio of lysosomal storage disorder (LSD) programs and brought drug product process and analytical development capabilities in house. Currently, Mercedes leads the Process Development group at Elevate bio where she is responsible for executing on the high-level strategy and day-to-day operations for a wide variety of cell and gene therapy process platforms.
Josh Sorafine is the Senior Vice President of Quality and Analytics for Elevatebio. Josh has worked in the biotechnology and pharmaceutical industry for over twenty years and has significant experience building Quality functions and systems. Previously, Josh worked at New England Biolabs where he established a quality control testing laboratory for GMP-grade enzymes. Prior to that, Josh was the Associate Director of Quality Control Operations at bluebird bio. In this role, he was responsible for testing, as well as the validation and transfer of associated test methods at various global test sites. Josh worked for Momenta Pharmaceuticals for eight years, where he was integral in building the Quality Control function to support the complex generics and biosimilars programs, including successful FDA inspections and launch of a generic version of Lovenox. Josh also held positions within the Quality organizations of Millennium Pharmaceuticals and Biogen. Josh received his bachelor’s degree in biology from the University of Massachusetts at Amherst.
