A Case Study on the Delivery & Management of a Large Oncology IND Submission
Highlights
A small, consistent team of highly experienced medical writers with oncology, vaccine and IND experience
Documents written and reviewed in parallel rather than sequentially - expedited timelines
Patients seamlessly enrolled in the US due to our assistance, expertise and effective communication
Background
Morula Health helped a UK biotechnology company obtain IND approval from the FDA to initiate phase 1 clinical studies in the US, to reposition an approved COVID-19 vaccine into an oncology therapeutic vaccine.
Challenge
The IND submission from the client comprised 21 clinical studies conducted by different sponsors. The studies aimed to provide strong evidence supporting the safety profile of the therapeutic vaccine; the underlying technology platform has been successfully used in an already approved COVID-19 vaccine.
However, the source documents for these clinical studies varied in format and quality. Adding to the complexity, many nonclinical studies were still ongoing and awaiting readout. This information had to be written accurately and concisely, to ensure the FDA reviewers could understand the safety profile of the therapeutic vaccine's technology platform to avoid confusion and time-consuming questions.
Solution
A small team of highly experienced medical writers was assigned, each taking responsibility for specific documents. All medical writers had oncology, vaccine, and IND writing experience and were located in the US and Europe. One writer was assigned to write CTD Module 2.7.2, 2.7.4, and 2,5. These were written and reviewed in parallel instead of sequentially to reduce timelines. The other writer was assigned to write the Investigator's Brochure (IB). All documents, including the Clinical Trial Protocol, underwent thorough review and extensive quality control by a third Morula Health medical writer, who had a
deep understanding of IND submissions, as well as the context.
This approach ensured consistency in documents and made the process efficient by conducting document work and quality control in parallel.
Effective communication was crucial for the project's success, in addition to experience. Weekly team meetings were held with all medical writers and the sponsor's project team. Strict comment resolution meetings, quality control, and document management processes ensured a standardized and streamlined delivery process.
Results
The IND submission was a resounding success, paving the way for the commencement of the phase 1 clinical study. Patients were seamlessly enrolled in the US, marking a significant milestone in the client's research journey.