Challenge

A U.S. biopharmaceutical company had an extremely short timeline to submit data for an innovative cell therapy product for FDA approval. It needed to submit the product in the electronic Common Technical Document (eCTD) submissions format to the FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). The company called on Accenture to meet the tight timeframe.

The right direction

The biopharmaceutical company deliberated on whether or not to include legacy data for two older studies that were performed on a different but similar product acquired by another pharmaceutical company. It considered making the submission without converting the older data to the updated CDISC requirements, as the time needed to convert the data might result in a missed submission deadline. Additionally, there were some questions surrounding the necessity of integrating all four studies.

Working in partnership on the decision, the company asked Accenture to prepare the submission without integrating the older data, with the understanding that there was a risk the FDA would decline to review the application if it did not include both the updated and integrated data. Drawing on our extensive experience, we collaborated on a strategic data plan, tackling the decisions as one team to drive toward a successful application.

What Accenture did

In addition to the shortened timeline, we worked with the company throughout the process to help it understand what needed to be done with the data and why. Based on Accenture’s past FDA interactions under similar circumstances, we recommended the company return to the agency to clarify the submission data plan. The agency’s response was not definitive regarding the data integration, resulting in confusion about what to do.

Moving forward

After some discussion, Accenture proposed a data strategy that would accelerate the process of converting the old formats into the newly required SDTM/ADaM compliant format, while still meeting the company’s submission deadline.

Our combined team agreed to err on the side of caution and implement a back-up plan in case the FDA requested the integrated data package of all four studies after the original application submission.

Although the legacy studies would not be integrated into the initial FDA submission, this proactive approach would ensure the company was ready if the data was requested by the FDA.

A cross-functional Accenture team prepared the initial submission while working on the integrated statistical analysis in parallel for later submission, if required.

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People and culture

Our experience with FDA submissions and the most recent data standardization requirements guided the company to a successful submission under extremely tight deadlines. The FDA approved the new application for the innovative new product, which is now in therapeutic use.

Value delivered

With Accenture’s help, the company is bringing the latest cell therapies to market to help improve patient outcomes.



Submitting a successful FDA application

In addition to data packages encompassing legacy, SDTM and ADaM data, we submitted:

4

clinical study reports.

75

thousand pages across hundreds of case report forms.

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