In a new whitepaper, cell and gene therapy experts across Medpace’s medical, operational, and regulatory groups come together to give insights from past trials. With extensive and recent hands-on experience, this team has learned a lot about the growing space of cell and gene therapies and shares important lessons-learned and best practices.
Cell and gene therapies hold tremendous potential to advance patient care but many do not complete the journey from laboratory bench to commercialization. These treatments need an integrated approach that ensures efficiency across medical, regulatory and operational considerations and requirements. Each of these areas is critical to successful product and each faces a unique set of challenges.
As advanced therapy clinical development becomes more complex, a holistic, multidisciplinary team working in unison offers the best advantage to biopharma sponsors who want to bring their scientific advances to trial and ultimately to patients.
Gene therapy companies often benefit from the assistance of experienced clinical partners. The right partner can help accelerate clinical trials and plan for long-term goals, such as marketing product approval.
This paper provides insight into some of the challenges faced in developing cell and gene therapies, as well as guidance for overcoming these hurdles such as:
- Medical challenges: Making the leap from lab to clinic
- Operational challenges: Planning, practicing and communicating
- Regulatory challenges: Engage early and plan for the long term
Learn from experts with recent and relevant experience in conducting trials in this space. Download the white paper to gain insight on the challenges in developing cell and gene therapies and potential, novel solutions.