Many companies in the cell therapy regenerative medicine market including Roche, Genzyme, Athersys, Miltenyi Biotec, Hospira, Lonza and Life Technologies will join International Society for Cellular Therapy (ISCT) to launch a series of new initiatives that will create greater strategic alignment within the industry and drive late stage clinical development.
The ISCT Industry Task Force (ITF), comprising these major corporations along with internationally renowned clinicians and academics in cell therapy translation, rolled out a series of recommendations to re-charter the ISCT Commercialization Committee to drive the creation of forums for discussion of shared concerns on process and product development, business models, and clinical development, and to catalyze the development of consensus standards.
"Working in partnership to develop standards around cell characterization and potency as well as treatment approaches and trial endpoint design we aim to facilitate entry into the cell therapy space for large healthcare and pharmaceutical companies, those members of the industry most reliably able to initiate and maintain advanced phase clinical trials. Ultimately, this will expedite the maturation of the field and bring cell therapy treatments to patients faster," said Ed Horwitz, M.D., president of ISCT.
These companies remain engaged with ISCT as members on the commercialization committee to drive this agenda forward and are participating in the roll out of the first initiative to add value in the relationship between ISCT and Industry - the new ISCT Industry Community.
The community offers access to key opinion leaders in cell therapy translation including regulatory, scientific, process development and clinical experts through focus group participation, and will drive priorities on the development of resources and initiatives to remove key obstacles to commercialization.
"ISCT is the logical home base for industry stakeholders in the translational medicine space. The commercialization committee is a consortium of institutional, technology, regulatory and industry thought leaders trying to move therapies out of phase I and II. It is poised to be very influential in driving out standards for that process," said Robert Deans, senior VP Regenerative Medicine Athersys, and Chair of the ISCT Commercialization Committee.
ISCT is a global association driving the translation of scientific research to deliver innovative cellular therapies to patients. Established in 1992, its membership and leadership comprises world-class scientists, clinicians, technologists, biotech/pharma and regulatory professionals from around the world focused on pre-clinical and translational aspects of developing cell therapy products.