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Premier Research, InSilicoTrials partner to leverage in silico modelling and simulation and optimize regulatory pathways for rare disease therapies

Morrisville, North Carolina
Wednesday, March 15, 2023, 16:00 Hrs  [IST]

Premier Research, whose mission is to help the most innovative biotech and device companies take their best ideas from concept to commercialization, and InSilicoTrials, a leader in the use of AI and computational modelling and simulation (CM&S) to accelerate development of new therapies and medical devices, have partnered to create safer, faster, and more efficient pathways to regulatory approval for rare disease treatments.

Premier Research VP, statistical consulting, Abie Ekangaki, Ph.D., notes that recent CM&S advances have made possible the full or partial substitution of virtual patients in clinical trials. The FDA supports this as part of the body of evidence required for regulatory submissions in specific circumstances.

As part of the R&D lifecycle, in silico trials enable simulated synthetic control or treatment arms, inform strategies for patient enrollment, and more efficiently predict the safety and efficacy of novel drugs and medical devices. Synthetic control arms (SCA) generated using in silico CM&S techniques represent a powerful tool for enabling preclinical and clinical research that otherwise might not be feasible, particularly in rare disease research.

Having managed more than 240 rare disease studies across numerous indications in the past five years alone, Premier Research has a long-term commitment to orphan drug development. Partnering with InSilicoTrials, whose in silico study design will result in faster submission-ready studies and more effective preclinical review of trial design parameters, is a continuation of Premier Research’s ongoing investment in rare disease trials.

“The in silico option can transform trials for which it is difficult to recruit or retain patients, such as with rare or imminently life-threatening diseases, with no or inadequate standard of care treatments,” Ekangaki said.

“For clinical trials in small patient populations,” he added, “in silico models that leverage biological, molecular, or genetic data to characterize the disease can generate synthetic control arms, which, together with Premier Research’s expertise in preclinical and clinical development, execution, and regulatory aspects of small population trials, can shrink the time it takes to develop effective rare disease therapies.”

Ekangaki noted that one huge advantage of in silico simulation is the ability to investigate ‘what if’ scenarios, such as in rare disease, where a larger patient population does not exist.

The partnership between Premier Research and Italy-based InSilicoTrials will emphasize smarter in silico study design resulting in more effective pre-clinical review of trial design parameters and faster submission-ready studies.

“Modeling and simulation combined with AI is the most effective way to innovate the R&D process in drug development,” InSilicoTrials CEO Luca Emili said. “Computational models and AI are true game changers because they enable sponsors to dramatically accelerate the development of new medicinal treatments, improve the safety of medical products, and significantly cut R&D costs.”

Premier Research, a clinical research, product development, and consulting company, is dedicated to helping biotech, specialty pharma, and device innovators transform life-changing ideas and breakthrough science into new medical treatments.

InSilicoTrials is an emerging startup founded by a team of life science, cybersecurity and digital innovation experts, which aims to revolutionize Healthcare through an innovative digital simulation platform.


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