Register Today!
ARM’s Science & Technology Committee Workshop on Cell & Gene Therapy Standards
Join the Alliance for Regenerative Medicine for an in-depth half-day workshop discussing the requirements needed to promote the development and improvement of advanced therapies standards. Participants will include leading clinicians and scientists, manufacturing quality specialists from the cell and gene therapy industry as well as regulators and policy experts. Join the discussion and weigh in on ways to promote higher quality practices, identify critical areas of need in regard to standards and ways to address them, and hear the FDA’s perspective directly on how this sector can improve its current methods.
*Attendance is complimentary but registration is required.
AGENDA
Monday, June 15, 2015
1:00pm | WELCOME
1:15pm | STANDARDS GAPS & NEEDS
1:45pm | CELL & GENE THERAPY STANDARDS: FDA’S PERSPECTIVE
2:00pm | STANDARDS TOPICS: UPCOMING AND UNDER DEVELOPMENT
ISO TC276 WG4 strategies and plans for developing bioprocessing standards
Cell counting
Gene Therapy – AAV working group activities
– Nomenclature
– Reference standards
Raw materials
Cell characterization
Cell therapy manufacturing equipment selection and other topics being considered
3:00pm | BREAK
3:15pm | STANDARDS CENTER OF EXCELLENCE (CoE)
3:35pm | ROUNDTABLE DISCUSSION
Standards CoE and key stakeholders
Standards gaps, needs and prioritization
Next steps, planned activities and suggestions
4:50pm | CONCLUSION
Location:
University of Pennsylvania
Bodek Room, Houston Hall
Philadelphia, PA
Questions?
Please contact:
Chelsey Hathaway
Coordinator, Events & Committees
chathaway@alliancerm.org
