Background
After a biotech/pharma company receives drug approval, the FDA issues reporting requirements catered to the approved drug that must be carried out in order to maintain ongoing market approval. These post-marketing requirements (PMRs) often entail safety monitoring including collection, summary, and review of data on adverse events, abuse, misuse, diversion and drug utilization. The biotech or pharma company is responsible for conducting these studies and routine monitoring activities, assembling and reporting the results to the FDA within mutually agreed upon timelines, and reporting any potential safety signals to the FDA immediately.
Situation
A multi-billion dollar U.S. pharmaceutical client was asked by the FDA to conduct several studies as part of their PMR. Though formal prospective epidemiologic studies will be required in coming years, the FDA first requested that the client demonstrate full market adoption of their approved drug before pursuing prospective studies, and to monitor abuse, misuse, diversion, overdose and death using retrospective database studies.
Solution
Third-party vendors who maintain large databases focused on abuse, misuse, diversion, overdose and resulting death data conducted several retrospective analyses on behalf of the client. Venebio was tasked with assembling these disparate reports into a single cohesive and comprehensive work product that both synthesized the respective sets of results and provided context and interpretation in a formal FDA submission. Venebio also completed a thorough evaluation of the study protocols, statistical analysis plans, and completed study reports against FDA requests made in communications between the FDA and the client to ensure compliance.
Additionally, Venebio’s analytics team was asked to perform a drug utilization study on the client’s compound and several relevant comparator drugs. A detailed assessment of drug utilization and market penetration was completed, a detailed standalone report was prepared, with the results and interpretation incorporated into the FDA submission.
Venebio’s quality control specialists conducted an extensive review including all relevant cross-comparisons to ensure report accuracy and FDA-compliant formatting and referencing.
Outcomes
The completed deliverable included more than 1,000 pages of submission-ready materials encompassing six post-marketing studies and single integrative summary on abuse, misuse and diversion as well as drug utilization of the client’s compound. The client was able to complete their submission under an aggressive timeline without disturbing their company workflow.
How Venebio addressed the challenge
PMR reports often require considerable effort and a multidisciplinary team that can table data analytics, interpretation, scientific writing, and regulatory review. As such, meeting PMR-related milestones can pose a substantial logistical burden for a company’s internal R&D team who needs to also balance day-to-day business obligations. Outsourcing such commitments to experienced consulting firms ensures a high-quality submission with limited disruption to the company workflow.
Preparing reports for regulatory authorities differs from scientific manuscript submissions in writing style, organization, and presentation of data. Venebio’s expertise in epidemiologic and biostatistical methods as well as regulatory engagement allowed us to prepare this PMR submission with appropriate scientific accuracy and rigor, while also maintaining awareness of the FDA’s specific requests to ensure that they were addressed comprehensively and in an intuitive, concise manner.