Meeting drug development timelines are highly important and the building blocks of success for drug development companies. Frequently, financing tranches are connected to the achievement of milestones, and potential strategic partners may be evaluating multiple competitive programs in a specific therapeutic area. Having the ability to move quickly through development can generate the critical data needed to provide the superior advantage in signing a partnership rather than losing it to the competition.
For companies focusing on rapidly progressive diseases, the need to start clinical development becomes even more urgent. Well-organized advocacy groups are clamoring for experimental medicine, and mission-driven biopharma, biotech and pharmaceutical companies are committed to accelerated development timelines. Development delays can undermine relationships with patients, potentially affecting clinical trial enrollment and complicating eventual commercialization.
Open Communication Ensures Expectations are Clear
To achieve success in a drug development program, an outsourcing partner needs to adopt its clients’ sense of urgency. In addition, it needs to double down on communication regarding milestone commitments so that everyone understands expectations.
WuXi AppTec recently and successfully engaged with a mid-sized pharmaceutical company focusing on a rapidly progressing disease. This company set an aggressive preclinical timeline and needed to submit data to the U.S. FDA just six months after the initiation of IND-enabling studies to meet its internal development goals.
Prior to study initiation, the submission plan hadn’t been conveyed to WuXi AppTec – it arrived only as the study commenced. Faced with the realization that the client needed the data earlier than anticipated, the WuXi AppTec team stepped up and quickly developed a reporting schedule to meet the submission plan. The first step was, of course, ensuring timely communication with the client so that the project status was well understood.
Partner with a Proactive and Committed Team
The project team, consisting of Study Directors, Pathologists, Scheduling Managers and Report Managers demonstrated the capability and willingness to accommodate the client’s U.S. FDA accelerated submission plan. The team flexibly and proactively prioritized resource allocation according to the project needs providing uninterrupted support throughout the client’s program.
A strong collaboration is rooted in complementary expertise, communication and trust. While WuXi AppTec has the scientific, regulatory and strategic expertise to execute clients’ studies, the team is also committed to going the extra mile to meet clients’ needs. Read the full Case Study today.
Providing Solutions to Meet Aggressive US FDA Submission Timelines