FDA outlines Cures implementation, touts in silico clinical trials

By Melissa Fassbender

- Last updated on GMT

The 21st Century Cures Act was enacted by the US Congress in December 2016. (Image: iStock/ismagilov)
The 21st Century Cures Act was enacted by the US Congress in December 2016. (Image: iStock/ismagilov)

Related tags Food and drug administration Fda

The US FDA has revealed its work plan for implementing aspects of the 21st Century Cures Act, including an investment in in silico tools for use in clinical trials.

In a recent blog post, Scott Gottlieb, M.D., Commissioner of the US Food and Drug Administration (FDA) addressed the ways in which the agency plans to help consumers “capitalize on advances in science​.”

Gottlieb writes that the FDA is investing in and expanding on – as part of the broader Innovation Initiative – the use of in silico tools​ in clinical trials “for improving drug development and making regulation more efficient​.”

The Innovation Initiative is soon to be announced, according to the Commissioner, who said it will be aimed at ensuring the regulatory processes are modern and efficient.

Also to be expected are additional, updated guidances on how in silico tools can be advanced and incorporated into drug development.

FDA is actively working to expand the agency’s capabilities in high performance computing, and to explore modeling approaches and enhance their regulatory impact, through an effort enabled by the work of the agency’s Scientific Computing Board​,” said Gottlieb.

The Science Board​ provides advice to the Commissioner and others as it pertains to “complex scientific and technical issues​.” The committee consists of 21 voting members.

Delivering Cures

The initial list of Cures deliverables, which was posted​ earlier this month, will eventually serve as a progress-tracking tool for the public.

The list includes additional deliverables such as novel qualification of drug development tools, clinical trial designs, and real world evidence guidances.

Virtual Imaging Clinical Trials for Regulatory Evaluation

By leveraging modeling and simulation, in silico clinical trials provide several benefits, such as the development of “virtual patients​” for testing.

Research into the use of virtual patients in medical device clinical trials has been advancing the past five years​,” an FDA spokesperson told us.

The FDA hopes that continued advances will lead to a reduction of the number of patients needed in clinical trials at some point in the future​.”

Recently, the FDA has established a new research initiative to investigate the use of in silico trials for the regulatory evaluation of imaging products.

The research project, VICTRE (Virtual Imaging Clinical Trials for Regulatory Evaluation)​, is in its final stages of development and should be finalized by the end of the year.

The FDA has already implemented several important Cures provisions, Gottleib said, including the “Plan for Issuance of Patient-Focused Drug Development Guidance​” which was released in May.

Additionally, Section 1002 of Cures​ authorized $500m in new funding over nine years to help the FDA cover costs of implementing the law.

We’re at the beginning of a transformative era in science and medical technology​,” concluded Gottlieb. “Through our implementation of Cures, and our efforts to build on its provisions through a new Innovation Initiative, we hope that our collective efforts will help consumers benefit from this new progress​.”

Industry encouraged

Commenting on the FDA Commissioner’s blog post on the advancement of in silico tools, Certara CEO Edmundo Muniz, MD, PhD, said the company is extremely pleased to read about the agency’s commitment to modeling and simulation as a step in implementing the 21st Century Cures Act.

The fact that Commissioner Gottlieb highlighted this pivotal technology as his example of ‘an appropriate step to facilitate access to safe and effective new innovation,’ affirms the increasingly important value that modeling and simulation brings to the drug development process​,” said Muniz.

According to Muniz, the success of modeling and simulation is underscored in the Commissioner’s statement:

FDA’s Center for Drug Evaluation and Research (CDER) is currently using modeling and simulation to predict clinical trial designs, support evidence of effectiveness, optimize dosing, predict product safety, and evaluate potential adverse event mechanisms​,” said Gottlieb.

Simulations Plus, Inc. Chairman and CEO, Walt Woltosz, echoed this sentiment and told us the new director’s emphasis on simulation and modeling is encouraging.

The bang for the buck is so much greater than any other technology, but of course we need experimental results from other technologies for validation​,” explained Woltosz.

So we can't eliminate experiments, but we can guide them so that when they are run, we get the most useful data from them and we avoid unnecessary experiments that do nothing to advance a specific project or the science in general​."

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