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?
Speaker 1 (00:00) Diane is the Head of Research and Development at Promising Therapeutics and she's working on an exciting new cellular therapy. She knows that cell therapies might eradicate cancers, but suspects that customized preclinical studies will be needed to show efficacy and safety. (00:21) Diane needs a CRO that can not only test the efficacy of the modified human cells in specialized disease models, but one that can also conduct all the safety testing to meet regulatory requirements. (00:35) Diane makes some calls and finds that CROs that focus on GLP safety assessment don't normally have the experience or infrastructure to create and work with efficacy endpoints or specialized disease models. And CROs that focus on discovery don't normally have the experience and infrastructure to conduct the definitive IND-enabling studies. (01:00) The first CRO Diane talked to about her project would be able to help with safety assessment, but they couldn't engraft her own therapeutic cells in the mice. She then spoke to a niche pharmacology CRO. They were able to engraft her therapeutic cells in the mouse models, but they don't operate under GLP and had never prepared an IND package. (01:21) Diane realized that her specialty program needed broader expertise. She contacted Charles River because of their reputation for both discovery and safety assessment. A quick check on their website confirmed this, and she also learned they provide strategic help from regulatory experts. (01:41) The scientific advisors at Charles River recognized the issues Diane was facing and seamlessly combined subject matter experts in discovery pharmacology and traditional toxicology assessments to create an IND-enabling package that meets both scientific needs and regulatory expectations. (02:02) Now, because of the tremendous promise of cell therapies, there's a lot of pressure to move these programs faster than ever. In fact, Diane's boss wanted to file the IND before the end of the year. Diane wanted to share early data with FDA to get scientific advice, but it required submitting that data much earlier than Diane expected. (02:25) Again, Diane consulted her scientific advisors at Charles River. They leveraged their regulatory experience to meet the new FDA timelines, even suggesting some translational immune endpoints that might predict patient response and models that might expand the therapy's clinical use, allowing Diane to take advantage of early FDA advice and meet the end of year deadline. (02:49) From optimizing her lead, through success in clinical trials, Charles River was able to meet all of Diane's needs with speed, efficiency, and accuracy. (02:58) To learn more, contact a Charles River advisor today at criver.com, through email at [email protected] or call 877 C-RIVER1.