Drug Development Support for the Cancer Therapy Evaluation Program

Introduction This is a Small Business Sources Sought Notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; women-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This requirement is assigned the NAICS code 541715, and the SBA size standard for such a requirement is 1,000 employees. This Small Business Sources Sought Notice (SBSS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Cancer Institute (NCI). The NCI does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted. The Capability Statements submitted in response to this notice should include an indication of current certified business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address) along with the eligible business concern's name, point of contact, address, and DUNS number. Background 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. 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 purpose of this acquisition is to assist the NCI in fulfilling its regulatory responsibilities to the Food and Drug Administration (FDA) per 21 CFR 312 and 21 CFR 812.36. The Drug Development Support for the Cancer Therapy Evaluation Program 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 and Maintaining a Quality Control Program. In 2002, the initial 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. Purpose and Objectives The scope of this contract is to: 1) provide a wide range of drug development support activities for CTEP and perform select tasks for other NCI Programs, and 2) provide a technical and administrative infrastructure to ensure the efficient planning, initiation, implementation, and timely completion of all tasks set forth in the Statement of Work. These resources and services shall be used to support FDA regulatory compliance, fulfilling the terms of pharmaceutical collaborator agreements and the solicitation of clinical trials. Project Requirements To assist the Cancer Therapy Evaluation Program (CTEP) Regulatory Affairs Branch (RAB) and Investigational Drug Branch (IDB) in fulling its responsibilities in providing a spectrum of services to support drug development activities, the Contractor shall be responsible for the work described in the sections below: 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. Anticipated Period of Performance It is anticipated that one cost reimbursement term (level-of-effort) contract will be awarded with one (1) base year plus nine (9) option years for a total of ten (10) years, beginning on or about July 1, 2022. Since the Government anticipates awarding a cost reimbursement contract for this requirement, in accordance with the requirements of FAR 16.301-3, the awardee will need to have an adequate accounting system prior to the award. It is also anticipated that the resultant contract may include options for Increased Capacity, Phase-In and Phase-Out Transitions. Other Important Considerations Mandatory Qualification Criteria: Capability Statements must clearly explain your ability in the following areas: 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 9609 Medical Center Drive Rockville, Maryland 20850 Capability Statement/Information Sought The Government encourages interested, qualified small business organizations to submit a tailored capability statement for this requirement which will be considered by the agency. Tailored Capability Statements submitted in response to this notice should supply pertinent information in sufficient detail to demonstrate the offeror's ability to perform the required services. Capability Statements should clearly convey information regarding the offeror's capabilities, including: (a) staff expertise, experience, and formal and other training; (b) awareness of project's needs and ability to perform the tasks; (c) organizational experience and management capabilities; (d) Facilities and Equipment available to perform the required services; and (e) examples of similar, prior completed contracts. The capability statement shall not exceed 15, single-sided pages (including all attachments, charts, etc.), must be presented in single-spaced formatting and using minimum 12-point font size, and shall clearly detail the ability to perform the aspects of the notice described above. Capability statements must include the following: 1. Company's DUNS number 2. Company Name and Address 3. Primary Business Point of Contact 4. Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.), as validated via the System for Award Management (SAM). All offerors must be registered in the SAM, located at http://www.sam.gov/. 5. Please indicate if your organization will need to utilize the expertise and resources of subcontractors and specialized consultants to perform the full spectrum of requested activities. The Capability Statements must be submitted no later than May 26, 2021, 4:00 PM EST. All responses must be received by the specified due date and time in order to be considered. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. The capability statements shall be submitted electronically (via e-mail) to DeChanta Vaughan, Contract Specialist, at dechanta.vaughan@nih.gov and Pooja Rathore, Contracting Officer, at pooja.rathore@nih.gov. These statements should be submitted in Adobe Portable Document Format (PDF). The e-mail subject line must specify the notice number: HHS-NIH-NCI-SBSS-ETSB- 00043-16. Facsimile responses will not be accepted. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in beta.sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.