Establishing Standards for Experimental Assays and Bioinformatics Protocols Aim at Accelerating Development and Availability of New Cell and Gene Therapies for Patients
Embleema Inc. and CDISC have announced a collaboration to develop new standards for experimental assays and bioinformatics protocols to facilitate monitoring the activity of Cell and Gene Therapy Products (CGTP).
CGTP involves inoculating patients with active ingredients such as proteins, genes, attenuated viruses, altered cells and other live tissues. Their activity inside patients is difficult to control, and the lack of standards for monitoring and analyzing this activity makes it difficult for sponsors to demonstrate the safety and efficacy of their products and impedes regulatory review.
The collaboration will cover standards development in three areas:
- Protocols for experimental assays and bioinformatics pipelines for evidence generation and submission to the regulation bodies
- Provenance and privacy with relation to the patient CGTP datasets
- Longitudinal data linkage and patient engagement
These new standards are intended to drive operational efficiencies, expediting the regulatory review process and reducing the time it takes to bring safe and effective treatments to market.
“Through this partnership with CDISC, we are creating opportunities to accelerate drug development in personalized medicine and bring associated costs down,” said Vahan Simonyan, PhD, Chief Science Officer, Embleema. “We are hopeful patients will benefit greatly from this collaboration that will standardize approaches for cell and gene therapy evidence generation and expedite new treatments for patients.”
“We are grateful for the opportunity to partner with CDISC Platinum Member Embleema in developing standards that will meet a crucial need,” said Rhonda Facile, VP, Partnerships and Development, CDISC. “Embleema’s innovative work, combined with CDISC’s established processes and procedures, will benefit the clinical research community and, ultimately, patients greatly.”
Next steps include CDISC and Embleema working together to dimension and support development of standards for the three specified areas. Once released, the standards will be freely available via the CDISC website.
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