Email introduction

Dear NCI Grantees:

Grantees of the National Cancer Institute (NCI) continue to make exciting discoveries that result in the identification of novel anti-cancer agents. Many have successfully advanced agents to the later stages of preclinical development and towards the filing of an Investigational New Drug application (IND) with the Food and Drug Administration (FDA), to authorize use in humans in clinical trials. Navigation through the pre-IND stage requires specialized knowledge of what constitutes IND-enabling studies, and importantly when such studies should take place and the strategic planning required. Given the limited resources available to grantees and higher expenses associated with this stage of product development, an investigator will need to identify additional resources/partners in order to advance their agent. To do so effectively and improve the chances of a successful path forward, is predicated on having a proficient knowledge of later stage preclinical studies and processes that can support product development.

The program staff at the NCI’s Developmental Therapeutics Program is planning to organize an educational series of workshops focusing on the later stages of preclinical product development. The goal of the workshop is to help our grantees gain an enhanced knowledge of late stage preclinical product development, in order to be better positioned in obtaining resources necessary to allow the development of their candidate agents for clinical evaluation, such as from funding programs administered by the National Institutes of Health (NIH), e.g. from the Small Business Innovation Research (SBIR) program and the NCI Experimental Therapeutics (NExT) Program, or for attracting other resources , e.g. academic-industrial partnerships, funding support from venture capitalists or pharmaceutical companies.

To help us design an effective workshop tailored to your needs, please kindly respond to the brief survey (click to access the survey) which entails a series of topics that generally need to be addressed for the development of cancer drugs. Further, if you have any other topics you want to have considered, please list these in the comments field. Having this information will help us identify potential knowledge gaps and topics of special interest to you.

Please note that the term "agent” is defined as small molecule, biological product, or specialized molecules (e.g. PROTACs, ADCs).

We appreciate your helps.

Best regards,

DTP Educational Workshop Planning Team