Drug Development Support for the Cancer Therapy Evaluation Program   4

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL BE ISSUED ON A LATER DATE.

This synopsis follows a Sources Sought Notice that was posted on May 11, 2021 as HHS-NIH-NCI-SBSS-ETSB-00043-16 with responses due on May 26, 2021.

Title: Drug Development Support for the Cancer Therapy Evaluation Program (CTEP)

Background:

The mission of the Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) is to improve the lives of cancer patients by finding better ways to treat, control and cure cancer. The Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) is responsible for the administration and coordination of an extensive extramural clinical oncology drug development program. CTEP, DCTD currently sponsors 195 active Investigational New Drug Applications (INDs) with the Food and Drug Administration (FDA). The sources of investigational agents are typically internally developed NCI agents and those co-developed with pharmaceutical industry collaborators. There are currently approximately four hundred (400) clinical studies conducted under these INDs that run the gamut from pilot studies through licensing studies. In addition to single-agent trials, CTEP sponsors multi-agent trials, with either combinations of investigational drugs or biomarker-driven strata of unique agents, special protocol assessments, master protocols and precision medicine studies. CTEP studies span the purview across FDA Offices including the Office of Oncologic Diseases (CDER), Division of Cellular and Gene Therapy (CBER), and Office of In Vitro Diagnostics and Radiological Health (CDRH), requiring expertise in investigational drugs, biologics and assays.

The Government is seeking a Contractor to provide support for the evolving health agency regulations, NCI, NIH, and HHS policies to fulfill the role of clinical trial sponsor.

The Drug Development Support for the Cancer Therapy Evaluation Program (CTEP) contract is responsible for:

1. Providing support for the preparation, tracking, submission and distribution of FDA submissions and CTEP drug development related activities.
2. Monitoring and Supporting Adverse Event Reporting.
3. Tracking information regarding investigational anti-cancer agents.
4. Providing technical and general administrative support for investigational agent development and regulatory activities.
5. Providing a Quality Control Program.

In 2002, the Drug Development Support for the Cancer Therapy Evaluation Program contract was awarded to Technical Resources International, Inc. The services are currently being performed by Technical Resources International, Inc. under the contract number HHSN261201500006C titled Drug Development Support for the Cancer Therapy Evaluation Program.

Please see the attached for further details.