Le Lézard
Classified in: Health, Science and technology
Subjects: Photo/Multimedia, Contract/Agreement, Product/Service, Nonprofit

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


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:

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/


These press releases may also interest you

at 07:30
Aptose Biosciences Inc. ("Aptose" or the "Company") , a clinical-stage precision oncology company developing highly differentiated oral kinase inhibitors to treat hematologic malignancies, today announced the appointment of Mr. Fletcher Payne to the...

at 07:30
Jushi Holdings Inc. ("Jushi" or the "Company") , a vertically integrated, multi-state cannabis operator, announced that Chief Executive Officer, Chairman, and Founder, Jim Cacioppo, has purchased 100,000 Class B Subordinate Voting Shares ("Shares")...

at 07:20
The "Cell Counting Market Research Report by Product (Consumables, Instruments, and Microscopes), Application, End User, State - United States Forecast to 2027 - Cumulative Impact of COVID-19" report has been added to ResearchAndMarkets.com's...

at 07:20
Lenica Research Group is pleased to announce the launch of a new strategic partnership with Allegori, a pioneering neuroscience innovation company based in Port of Spain, Trinidad and Tobago. "We're very pleased that Allegori chose Lenica as the...

at 07:20
A new market study published by Global Industry Analysts Inc., (GIA) the premier market research company, today released its report titled "Cerebrospinal Fluid (CSF) Management Devices - Global Market Trajectory & Analytics". The report presents...

at 07:14
RaySearch Laboratories AB (publ) will exhibit at PTCOG 60, to be held in Miami, Florida, USA, during June 27-July 1. The latest news in treatment planning system RayStation®*, oncology information system RayCare®* and oncology analytics system...



News published on 24 may 2022 at 08:20 and distributed by: