OPTIC will work closely with clinicians to evaluate single or combination therapies in pre-phase I studies to validate new targets, drugs or devices, as well as inventors and Columbia startup ventures seeking adequate cancer models to de-risk their IP through pre-clinical and IND enabling studies. Each study will be conducted with the assistance of a highly experienced team of science researchers, including cell biologists, chemists and bio-engineers.
For each project, OPTIC will provide consultations on experimental design and compliance with institutional, state and federal regulations. The timeline for project execution will be determined between OPTIC and the primary investigator (PI) in advance, since PDX development takes a significant amount of time — up to six months. Arrangements for IRB and IACUC protocol submission are also initiated early on to ensure that tissue procurement, PDX establishment, and implementation of proposed experiments are completed within the expected time frames. Since the success rates depend upon many parameters including the type of cancer, quality of tissue, and site of transplantation, the number of tissue samples to be procured and mice implanted will be determined based on the tumor type and the specific needs of the project.
Once the logistical details are finalized, the OPTIC team will implement the proposed study and assist the Investigator with data presentation, interpretation.
OPTIC strictly follows SOPs developed by the NCI Patient Derived Models Repository (PDMR) best practices for tissue collection, tumor model generation, and model quality control. The goal is to have standardized methods for generation, maintenance, and analysis of personalized tumor models. This will enhance the clinical relevance of generated models and facilitate collaboration between OPTIC and other PDX centers to form consortia and apply for funding.
All PDX work involving animals is conducted in dedicated housing and surgical suites in a fully AAALAC accredited animal care and housing facility. The facility is administered by the Institute for Comparative Medicine, which also provides full veterinary care, administrative and regulatory oversight, and assistance with animal husbandry.
Quality assessment and quality control are strictly implemented, and data safety and confidentiality managed using the most up to date security and backup systems.