CAR T-Cell Immunotherapy
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Biosimulation company Certara announced on Thursday that is has entered a two-year collaboration with Memorial Sloan Kettering Cancer Center (MSKCC) to develop new biosimulation software aimed at improved CAR T-cell therapy dosing for multiple myeloma patients.

“We are very pleased to work with MSK, a leading cancer hospital and research institution, to accelerate innovative solutions and deliver meaningful impact to cancer patients,” said Piet van der Graaf, senior vice president of Quantitative Systems Pharmacology at Certara in a press release. “After CAR T-cell therapy is infused into the body, the altered T-cells multiply and proliferate, so a precise and personalized dosing approach is essential. We are excited to use biosimulation to identify optimal therapeutic strategies using in silico, computer-based trials to guide precision dosing in virtual and actual patients.”

To develop and train the software to provide information on optimal dosing for multiple myeloma, MSKCC will provide Certara with de-identified clinical data through its MSK Innovation Hub. In time, Certara intends to expand the capabilities of its biosimulation software to include analysis and clinical decision support for combination therapies and to enhance the manufacturing learning process for next generation CAR T-cell therapies.

“While approved CAR T products for multiple myeloma are effective, relapses are common and additional efforts are needed to optimize these treatments,” said Dr. Sham Mailankody, an MSK medical oncologist and one of the project’s collaborators. “We are hopeful that this effort will provide important insights into improving the efficacy of these treatments, including identifying factors associated with durable response, and understanding future direction in terms of combination strategies.”

Princeton, NJ-based Certara is a biotech company that works with pharmaceutical companies and biotechs to help optimize their drug development programs via the application of if proprietary biosimulation software.

The company says that it works with more than 2,000 biopharmaceutical companies and academic institutions in more than 62 countries. It provides software and services from pre-IND stage through to regulatory approval in the areas of pharmacodynamics ranging from clinical pharmacology, pharmacokinetics and pharmacodynamics, first-in-human dose prediction, and biosimulation programs that can predict drug efficacy in virtual patient populations, among others.

The MSK Innovation Hub brings together innovative, digitally focused companies with MSK’s community of researchers, clinicians, and digital health professionals through a program designed to establish innovative collaborations that can have a tangible impact on treatment or management of cancer.

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