7:15am – 8:45am | BlueRock Therapeutics Ballroom
Sponsored by Thermo Fisher Scientific
INDUSTRIALIZATION OF CELL THERAPY MANUFACTURING – LESSONS LEARNED FROM BIOLOGICS WORKSHOP
The transformative impact that cell therapies have is evident from the observed efficacy of FDA-approved therapies to date. However, as an increasing number of drugs move from early discovery to commercialization, manufacturing innovations have moved to the forefront of the discussion. We have reached an inflection point that requires us to move from small scale, open workflows to robust, closed and automated manufacturing processes. In this session we will discuss and reflect on the various lessons that we have learned from biologics manufacturing and how they can be applied to advance the industrialization of the cell therapy manufacturing process. Join this session to hear from experts on:
- Innovation in “fit for purpose” closed cell therapy manufacturing equipment
- Controlling critical process parameters with digital integration utilizing a distributed control system (Delta V)
- Supply chain considerations
- Characterization and QC analytics for standardization
Chair:
Betty Woo, Ph.D., Vice President and General Manager, Cell and Gene Therapy, Thermo Fisher Scientific
Speakers:
Jerry Cacia, Chief Technical Officer, Graphite Bio
Andy Lin, Ph.D., Principal Technical Development Leader, Pharma Technical Development, Genentech
Sophia Sharp Donaldson, Executive Director, Supply Chain, Global Strategic Sourcing and Procurement, Kite, a Gilead company
7:15am – 8:45am | Aviara Salon A
Sponsored by IQVIA
DEMOCRATIZATION OF TRANSFORMATIVE CELL & GENE THERAPIES WORKSHOP
Recent years have seen dramatic success with gene therapy, even apparent cures for serious medical conditions (e.g., spinomuscular atrophy, sickle cell disease). Yet, for several of the diseases being cured with gene therapy, the vast majority of patients who could potentially benefit reside in low- and middle-income countries (LMIC), where such therapies are not available. The reasons underlying inaccessibility are multifold, and both near-term and long-term solutions need to be devised and implemented by the regenerative medicine industry. Near and next-term solutions come from disparate areas from utilizing information technology with patient databases/registries, to improving efficiencies and cost of manufacturing and distribution. The challenges of gene therapy implementation in LMIC span several functional areas including education and communication, regulatory, clinical preparedness, and technical / logistical aspects. Looking at the longer-range and worldwide aspirations, one initiative called the Global Gene Therapy Initiative (GGTI) includes diverse stakeholders covering broad areas of expertise from all sectors. The GGTI has set an aspirational goal of launching Phase I gene therapy clinical trials in each of two LMIC, Uganda and India, by 2024.
Chair:
Eugene Brandon, Ph.D., Head, Cell and Gene Therapy Translation, IQVIA
Speakers:
Jennifer Adair, Ph.D., Associate Professor, Clinical Research Division, Stem Cell and Gene Therapy Program, Fred Hutchinson Cancer Research Center
Boro Dropulic, Ph.D., Executive Director, Caring Cross
Eric Faulkner, Vice President, Global Real World Evidence, Novartis Gene Therapies
Mike McCullough, Chief Information Officer, National Marrow Donor Program (NMDP)/Be The Match
7:15am – 8:45am | Aviara Salon B
Sponsored by Cell One Partners
OVERCOMING CHALLENGES TO GENE THERAPY MANUFACTURING THROUGH STANDARDIZATION & AUTOMATION WORKSHOP
Gene therapy clinical trials pose interesting challenges in GMP manufacturing. Plasmids and vectors often cannot be produced by the same vendors, may have different stabilities, and may require different storage conditions. Furthermore, some gene therapies require additional processing of the vector with target cells ex vivo. This expert-led session will explore innovations and best practices that are shortening timelines, lowering costs, and standardizing processes when manufacturing gene therapies.
Chair:
Anthony Gringeri, Ph.D., Strategic Advisor, Cell One Partners
Speakers:
David Backer, Chief Commercial Officer, Oxford Biomedica
Michelle Berg, President, GMP Nucleic Acids, Aldevron
Fabian Gerlinghaus, Co-Founder and CEO, Cellares
Judith Koliwer, Ph.D., Lead Consultant Software, Körber Business Area Pharma