Science and Technology
Standards Coordinating Body - overview slides (May 2016)
- A multi-stakeholder initiative proposed by ARM to bring together sector stakeholders, including standards development organizations already addressing some aspects of standards requirements for cell therapy/gene therapy/other regenerative medicine product development, to support the establishment, development and implementation of uniform technical and process standards and other best practices.
- The creation of this SCB will support a more coordinated and refined regulatory submission review, reducing the time and financing resources necessary for the development and approval of advanced therapy products.
ARM Standards Worshop on Cell & Gene Therapy: View the presentations and summary here
White Paper: Critical elements in the development of cell therapy potency assays for ischemic conditions. Written in conjunction with the International Society for Cellular Therapy and published in the journal Cytotherapy.
Pharma and Biotech Survey: download here
White Paper: Key Tools and Technology Hurdles in Advancing Stem Cell Therapies. Written in conjunction with the California Institute for Regenerative Medicine and Cell Therapy Catapult.
Science and Technology Overview
The Science and Technology initiatives taken on by the Alliance for Regenerative Medicine (ARM) are run through and organized by the Science and Technology (S&T) Committee. The S&T Committee serves as a forum for ARM members to exchange ideas, information and data on different science and technology issues within the regenerative medicine field. One of the principal responsibilities of the committee is to consider issues relating to process and research standards in the context of regulatory science that could be adopted by the industry after consultation with other interested and qualified organizations and the appropriate federal agencies.
Some ongoing initiatives taken on by the S&T Committee include:
- White paper: Critical Elements in the Development of Cell Therapy Potency Assays for Ischemic Conditions
- White paper: Immune Modulation and Cell Content
- White paper: Practical Considerations in Development and Selection of Cell Content and Viability Assays for Novel Cell Therapies
- Conducting a survey to gain a clearer understanding of how mid-large pharma and biotech companies to assess the potential for regenerative medicine and envision use of these approaches for the development of new therapeutics.
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