TransCelerate BioPharma’s subsidiary, BioCelerate, is collaborating with the US Food and Drug Administration (FDA), launching a joint working group to examine methods that will enable more effective analysis of nonclinical studies.
BioCelerate will work with the FDA’s Office of Computational Science (OCS) to evaluate and publish findings related to the use of study datasets using the Clinical Data Interchange Standards Consortium’s Standard for Exchange of Nonclinical Data (CDISC SEND).
The working group also will evaluate methods, tools, and common templates, which could potentially improve the analysis or use of nonclinical research data.
Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER), called the collaboration “another step forward as part of the FDA’s longstanding commitment to advancing a more efficient and data-driven decision-making processes.”
The project builds on BioCelerate’s past work, which includes the delivery of more than 30 pragmatic solutions over the past six years, said Janice Chang, executive vice president of TransCelerate.
As part of this, the organization is “thoughtful in identifying areas where we can further optimize the impact of building blocks we’ve already put in place to achieve our future state of research and development,” Chang told us.
Identifying pragmatic opportunities
TransCelerate also recently kicked off three new initiatives focused on clinical and drug safety, the development of which required an extensive prioritization process, said Chang.
The organization’s three strategic priorities – serving as the foundation of the new initiatives – include: improving the patient and site experience, enhancing sponsor efficiencies and drug safety, and harmonizing process and sharing information.
“With these three strategic priorities in mind, our goal is to identify pragmatic opportunities where we can tackle as a group of sponsor companies to enhance the research and development ecosystem,” said Chang, adding that the new initiatives will help address a unique challenge or capitalize on an opportunity to improve efficiency in clinical development and drug safety.
The first of these is the Common Serious Adverse Events (SAE) Fields Initiative, which aims to address the variations in fields within and across sponsors, she explained. “Relevant case information can become masked or may be missing when collection is not executed in an optimal way, which often creates uncertainty,” Chang added.
“By developing best practices to identify the most critical SAE fields and working with industry standard-setting organizations to propagate standards in this area, this initiative will help increase the quality of what is reported and create greater efficiencies for sites, CROs, and regulators,” she explained.
Second, the Modernization of Analytics Initiative will consider novel ways in which to include newer open source technologies in clinical trials. Long-term, Chang said this will allow the industry to leverage “the most advanced data analytical capabilities available.”
The third of the new initiatives is the Interpretation of Guidances and Regulations Initiative, which Chang said “seeks to clarify substantive ambiguities in health authority guidances and regulations, which may result in, among other things, difficulties in interpreting and adhering to these regulations and guidances.”
The first deliverable as part of this will be a Quality Tolerance Limits Framework to help facilitate clinical trial compliance. “At present, there is a need for improved clarity on how to construe and operationalize expectations about this concept,” said Chang.
The goal of releasing new deliverables is to enhance the impact of the organization’s portfolio roadmap. TransCelerate aims to ultimately advance improve efficiency for sites, patients, and sponsors – and is experiencing what Chang said is “tremendous support and interest” from regulators, as adoption of its work grows globally.
At present, TransCelerate is engaging with approximately 15 health authorities across the globe.
Said Chang, “Our new initiatives will further enhance this collaborative relationship, engage key groups across the research and development landscape and expand our global presence so that we can progress towards our shared mission of getting innovative therapies to patients faster.”
