Choosing a partner that is a true extension of your team will provide the options you need when faced with an aggressive submission timeline
Situation
Submitting preclinical study data to regulatory agencies is a critical step prior to starting first-in-human studies, and the initiation of clinical development is a milestone investors and potential partners look for when assessing companies for investment. In addition, for those therapeutic areas focusing on aggressively progressing diseases, the need to start clinical development becomes even more urgent as, frequently, patient advocacy organizations are clamoring for experimental therapies. Timeline delays can significantly hinder development of new therapies, which can disappoint advocates and undermine credibility with investors and potential partners.
Challenge
A California, mid-sized pharmaceutical company with an aggressive preclinical timeline wanted to submit data to the U.S. FDA just six months after the initiation of IND-enabling studies with WuXi AppTec. The quick turnaround was U.S. FDA driven and non-negotiable, and the client was very concerned that any delays would significantly hinder development of their new therapy and consequently the drug to the patient population. This of course is not unique, however, in this instance the submission plan hadn’t been conveyed to the laboratory prior to study initiation. The submission deadline was made known during the site visit for the observation of day one of dosing for the studies.
Solution
Faced with the realization that the client needed the data from its studies far earlier than anticipated, our team stepped up and quickly developed a reporting schedule to meet the aggressive submission plan, by eliminating numerous weeks from the original plan.
Results
The project team, consisting of Study Directors, Pathologists, Quality Assurance, Scheduling Managers, and Report Managers ensured timely communication with the client so that the project’s status was well understood. In addition, the team was flexible, proactive and prioritized resource allocation according to the project needs. The team demonstrated the capability and willingness to accommodate the client’s aggressive U.S. FDA submission plan as well as the ability to maintain the integrity of the study and ensured valuable pathology SEND data was obtained.
The client was able to meet their timelines and goals. They filed their submission to the U.S. FDA and initiated their follow-up studies on time.
Conclusion
While WuXi AppTec has the scientific, regulatory and strategic expertise to execute our clients’ studies, our team is committed to going the extra mile to meet their needs. In this case, we recognized how important the U.S. FDA submission timeline was for our client, and we made the necessary changes to ensure we were positioned to meet the company’s expectations.
Choosing the right partner that provides strategic solutions for aggressive submission timelines is a true partner and extension of your team. Contact us today to discuss your timelines.
