Presolicitation Notice 75N91021R00043 - Drug Development Support.pdf

PRE-SOLICITATION NOTICE

75N91021R00043

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.”

Project Requirements:

Independently, and not as an agent of the Government, the Contractor shall supply all the necessary services as needed to perform the work including licenses, labor, qualified personnel, materials, supplies, equipment, and facilities not provided by the Government.

To assist the CTEP in fulfilling its regulatory responsibilities as an IND sponsor and to assure compliance with protocols, regulatory requirements and source data verification, the Contractor shall perform the activities including, but not limited to the following:

1. Provide support for the preparation, tracking, submission, and distribution of Food and Drug Administration (FDA) submissions and CTEP drug development related activities

• Assist in the preparation, submission and tracking of amendments for active

Investigational New Drug Applications (INDs), filing of new INDs, Pre-IND/End of Phase 2 (EOPh2) submissions and IND related correspondence. Route documents for review to CTEP staff on the CTEP SharePoint site via Contractor developed SharePoint workflows.

• Operate and maintain an eCTD software application and obtain a security-based authorization to operate in coordination with the NCI entity hosting the software application. Prepare and submit eCTD IND submissions compatible with FDA and NCI requirements.

• Assist in the preparation, submission and tracking of filings to the Office of In Vitro

Diagnostics and Radiologic Health Center for Radiological Health (CDRH), FDA and other Offices as needed. Support the complete lifecycle of CDRH applications and filings in conformance with the requirements of CTEP.

• Draft NCI Master Files (MFs) updates from data provided by the RAB (e.g., clinical protocols, preclinical, toxicology, chemistry, and manufacturing information).

• Maintain files, correspondence and documentation generated under the Statement of Work (e.g. regulatory submissions, correspondence to/from the FDA, drug development documents, agreements, collaborator correspondence) and CTEP regulatory documents in CTEP databases and/or CTEP shared drive.

• Arrange for the storage of CTEP paper documents determined to be temporary records, convenience copies and media files in either a secure non-water-based fire suppression room or an off-site NARA compliant location.

• File and maintain collaborative research agreement related records and route appropriate documents to collaborators via a Contractor developed document portal.

• Prepare, for IDB staff on a quarterly basis, or in some cases on an ad hoc basis, summary tables and reports from information in CTEP informatics databases.

• Prepare either an IND Annual Report for each active IND or a DSUR based on an investigational agent for submission to FDA in accordance with FDA requirements (21 CFR.312.33) or ICH guidelines.

• Prepare, as needed, Investigator’s Brochures from information within CTEP databases and/or provided by the NCI.

• Assist in preparation and tracking of clinical trial solicitations and responses to investigators.

• Prepare and update agent-specific and specialized protocol (e.g. organ dysfunction studies) templates as needed.

2. Monitor and Support Adverse Event Reporting

• Provide a telephone helpdesk for the CTEP adverse event reporting (Adverse Event MD) Monday through Friday from 8:30 am to 5 pm EST except holidays. Provide an e-mail AE helpdesk.

• Receive, triage, organize, and prepare an initial assessment of all expedited AE reports from information received via electronic safety reporting modules in conformance with IDB and RAB instructions and FDA requirements.

• Provide a written review of the adverse event reporting requirements section of new clinical protocols or sub-protocols scheduled for review at the Protocol Review Committee (PRC).

• Abstract protocol-specific exceptions from each new protocol and enter into the electronic safety reporting modules, CTEP-Adverse Event Reporting System (CTEP-

AERS).

• Prepare safety related protocol amendment Action Letter requests and assist in adverse events reconciliation requests, etc.

• Draft new and update existing tables of agent specific adverse events, i.e.

Comprehensive Adverse Event and Potential Risks (CAEPR) and Specific Protocol

Exceptions to Expedited Reporting (SPEER) according to Adverse Event (AE) incidence and severity for each CTEP investigational IND agent according to CTEP approved processes.

3. Track information regarding investigational anti-cancer agents

• Track current information regarding CTEP clinical trials utilizing investigational agent combinations, noting the pharmaceutical collaborator for each agent. The information shall be in a searchable and organized format.

• On an ad hoc basis maintain investigational agent information in designated CTEP shared drive folders. Update information regarding pivotal non-NCI studies performed by pharmaceutical collaborators on an annual basis or as directed by the

COR.

• On an ad hoc basis, prepare project plans for investigational agents in development.

Project plans shall include summary information on each stage of drug development (preclinical studies, anti-tumor activity, toxicity, mechanism of action, Phase 0, Phase 1 trials with status, toxicities, Phase 2 and 3 trials with response rates, status, etc.).

4. Provide technical and general administrative support for investigational agent development and regulatory activities

• Forward approved information that is relevant to investigational agent development to the PIO for distribution to investigators (e.g. PTMA, Pre-solicitation Letters and Notice of Availability).

• On an ad hoc basis, perform technical writing, editing, formatting, graphics design and text editing for presentation slides or manuscripts/abstracts in a program compatible with those in use by NCI. This includes the CTEP Investigator Handbook.

• Participate in the development of live or online training modules and assist in knowledge acquisition phase and beta-testing for the ongoing database/technology development.

• Assist NCI in the preparation for inspections from regulatory agencies on an ad hoc basis. (approximately one every other year) and provide onsite support during these occurrences.

• Provide support and expertise in monitoring of clinical testing labs associated with

CTEP sponsored clinical trials. Assistance shall include preparation of a monitoring plan, site visit checklist and on-site monitoring (approximately 4 per year requiring travel).

• Provide courier services with delivery confirmation, regulatory materials and files that are not suitable for electronic transmission to the FDA, other NIH Offices and other local sites. Courier pick-up and delivery shall be available within the same federal business day between the hours of 8:30 AM and 5 PM EST.

5. Maintain a Quality Control Program

• The Contractor shall develop and implement procedures to allow effective continuation of work in the event of change in personnel or absence of personnel for any reason.

• The Contractor shall maintain the current version of correspondence templates in a

CTEP Shared drive folder, as directed by the COR.

• The Contractor shall establish and maintain updated procedural documents to include Standard Operating Procedures (SOPs), Project Specific Procedures and Work Instructions for quality management.

• The contractor shall prepare a contingency plan and develop and implement a plan for assessment of data and document accuracy.

Other Important Considerations

Mandatory Qualification Criteria:

1. The Contractor must have experience related to a 21 CFR Part 11 (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11) electronic common technical document (eCTD) application for electronic submissions to the Food and Drug Administration (FDA) and the completion of an eCTD system validation, specifically:

a) Publish FDA submissions in eCTD format acceptable for submission through the

FDA Electronic Submission Gateway (ESG) and the capability to act as an eCTD technical contact.

b) Validation of an eCTD application within the user environment.

2. The Contractor must provide a non-water-based fire suppression file room located within a two-hour driving distance (during 8 AM to 6 PM business days, including rush hour) to the address below to deliver documents. The fire suppression file room must have a minimum of 750 cubic square feet available for CTEP files, have secure access measures and utilize a non-water-based fire suppression system with a minimum of NFPA 2001 standards and pass, at minimum, an annual inspection.

The CTEP Program Office is located at the following address:

National Institutes of Health National Cancer Institute https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

9609 Medical Center Drive Rockville, Maryland 20850

Additional Information:

These Research & Development services will be acquired through Full and Open Competition.

It is anticipated that one (1) cost reimbursement, level of effort type contract will be awarded with a one (1) year base plus nine (9), one (1) year option periods beginning on or about July 1, 2022. It is also anticipated that the resultant contract may include Phase-In and Phase-Out Transitions and Options for Increased Capacity. The NAICS Code for the requirement is 541715.

The Solicitation will be available electronically on or around October 13, 2021 and may be accessed through the Contract Opportunities at https://beta.sam.gov/. IT IS THE OFFERORS’

RESPONSIBILITY TO MONITOR THE AFOREMENTIONED SITE FOR THE RELEASE

OF THE SOLICITATION AND ANY AMENDMENTS. WE ENCOURAGE ALL

RESPONSIBLE SMALL BUSINESSES TO SUBMIT A PROPOSAL WHICH WILL

BE CONSIDERED BY THE AGENCY.

This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile or email transmissions will be accepted.

Contact Information:

Contracting Office Address:

9609 Medical Center Drive Rockville, Maryland 20850

Primary Point of Contact:

DeChanta Vaughan Contract Specialist dechanta.vaughan@nih.gov

Secondary Point of Contact:

Pooja Rathore Contracting Officer pooja.rathore@nih.gov https://beta.sam.gov/ mailto:dechanta.vaughan@nih.gov mailto:pooja.rathore@nih.gov