Embleema and CDISC Partner to Develop Standards for Cell and Gene Therapy Product Monitoring

Establishing Standards for Experimental Assays and Bioinformatics Protocols Aim at Accelerating Development and Availability of New Cell and Gene Therapies for Patients

METUCHEN, N.J. & AUSTIN, Texas–(BUSINESS WIRE)–#cleardataclearimpact–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.

About Embleema

Embleema’s standard technology platform accelerates personalized medicine by expediting evidence generation and regulatory reviews of new treatments. From establishing trusted real-world and clinical data networks to making complex data sets regulatory grade, Embleema helps its clients from life sciences, academia, regulatory agencies, and patient advocacy build a healthier world. For more information, please visit www.embleema.com.

About CDISC

CDISC creates clarity in clinical research by convening a global community to develop and advance data standards of the highest quality. Required by the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), recommended by the China National Medical Products Administration (NMPA) and adopted by the world’s leading research organizations, CDISC standards enable the accessibility, interoperability, and reusability of data. With the help of CDISC standards, the entire research community can maximize the value of data for more efficient and meaningful research that has invaluable impact on global health. CDISC is a 501(c)(3) global nonprofit charitable organization with administrative offices in Austin, Texas, and Brussels, Belgium and thousands of employees, volunteers, and member organizations around the world. https://www.cdisc.org/

Contacts

Ann P. White

+1.512.363.5826

awhite@cdisc.org

Robert Chu

+1.914.572.8108

rchu@embleema.com