The complexities of cellular therapy programs present scientific and technical challenges. They are highly customized and vary greatly based on product attributes. Now, because of tremendous promise to cure many types of diseases, there is a lot of pressure to move these programs through regulatory approval faster than ever so it is crucial to find a single partner of choice who offers access to a deep scientific and regulatory network and integrates the various elements of your program to achieve your milestones and make it to market on time.
Diane, head of R & D at a small biotech, is working on an exciting cellular therapy targeting cancer and wants to share early data with the FDA. Can she find the right partner to meet her deadline?
- Gene and Cell Therapy – An Overview of the Current and Changing Regulatory Requirements and Study Design for Nonclinical Safety Evaluation (Available in The Source℠)
- Stem Cell Therapies – How Targeted Delivery and Molecular Imaging Benefit Study Designs (Available in The Source℠)
- Scientific Advisory Services