This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement.
This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only.
The Government is especially interested in determining (1) the availability 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; woman-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.
Background:
The Therapeutic Development Branch (TDB) within the Division of Preclinical Innovation (DPI) at National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH) conducts translational research in the area of human therapeutics development by moving small molecule and biologic drug candidates forward in the drug development pipeline. Upon reaching predetermined milestones, TDB hands off clinical candidates to external partners to bring these novel therapies to patients. In addition to developing new candidate drugs, TDB seeks to advance the entire field of drug discovery and development by encouraging scientific and technological innovations aimed at improving success rates in the crucial preclinical stage of drug development. The TDB model is to operate as a comprehensive small molecule and biologics drug development organization, moving therapeutic candidates through each phase of the preclinical development process until an Investigational New Drug (IND) application is filed with the US Food and Drug Administration (FDA). TDB conducts drug development as collaborations, with therapeutic candidates originating from academia, industry, non- profit foundations, or internally from NCATS and other NIH institutes. TDB’s operational strategy is to combine the capabilities of in-house staff and collaborative partners with complementary support from contract research organizations (CROs). Each development program operates in a multi-disciplinary matrix team environment, with NCATS responsible for the overall planning and execution.
Project requirements:
Contract Administration
The Contractor shall perform activities related to the overall administration of the contract. This includes fulfilling administrative reporting and deliverable requirements, ensuring contract terms and conditions are adhered to, and communicating with the Contracting Officer’s Representative (COR) and Contracting Officer (CO) as needed.
Project Management
The Contractor shall provide project management for its own core team to ensure effective project planning, execution, delivery of reports, and accurate and timely communication with the COR, CO, and other stakeholders. The Contractor shall provide and implement overall project management to coordinate and integrate activities for each task order. The Contractor shall provide sufficient project management staff to ensure management and monitoring of all task order activities and shall identify for each task order a lead individual who will serve as a primary point of contact for the Government.
The Contractor shall provide qualified multidisciplinary staff to fulfill the requirements of each task order award. For each discipline, the staff shall have all the required and customary training, experience, and licensure or certification needed to fulfill their assigned role.
Collaboration and Communications
The Contractor shall provide effective collaboration and communication with the COR, CO, and other stakeholders as needed to support successful task order performance and project outcomes. This includes providing status updates and technical information when requested and providing information as needed to ensure the Government is sufficiently informed in accordance with the needs of the project. This also includes collaboration on deliverables, technical approaches, or other areas.
The Contractor shall participate in regularly-scheduled and ad hoc meetings with the Government and other stakeholders as needed. The Contractor will generally be required to provide meeting support such as logistics and arrangements, facilitation, graphics and video support, materials preparation and distribution, and translation, as well as meeting notes, minutes, summaries and/or summary reports. Such meetings may include:
Task Order Initiation / Kick-Off Meetings. These meetings are to review the applicable requirements and timelines, discuss technical plans/Project Management Plan and approaches, and identify any anticipated problems/obstacles to completing the requirements.
Progress Review Meetings. These meetings are to review and discuss ongoing and planned activities, protocols and associated data; timelines for task initiation and completion, submission of data and other information; any problems or deficiencies identified with respect to the accuracy, timeliness, and completeness of research, trials and studies, including outcomes such as data submission; and any other matters relevant to the task order performance or administration.
Ad Hoc Meetings. These meetings may be required to address issues or questions that arise related to performance or administration. They may also include investigator, protocol, working group, strategic planning, and network meetings.
Quality Management
The Contractor shall ensure that all work performed under this contract, including by any subcontractors, meets the highest levels of quality, as appropriate for the task. All management and operational systems used must be sufficient to monitor, maintain, and document quality.
One or more domestic or international regulations may apply to task orders issued under this IDIQ. These include, but are not limited to, US FDA current Good Manufacturing Practice (cGMP), Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) regulations, and/or International Council for Harmonisation (ICH) and International Organization for Standardization (ISO) regulations. When one or more regulations apply, the Contractor shall:
Provide a Quality Assurance Unit (QAU) that is independent of other operations of the Contractor to assure that all products and services meet quality requirements and comply with international, federal, state and local government regulations, as applicable.
Provide a Quality Assurance/Quality Control (QA/QC) infrastructure for the awarded Contract including SOPs for establishing and maintaining the QA/QC processes and approaches/methods to document, identify the source(s) of and address any problems and deviations as they occur, as well as provide recommendations for the resolution of problems and correction of deviations. The Contractor shall have a Quality Management Plan (QMP) that shall include management responsibilities, resources, assessment and training, oversight of outsourced operations, defined metrics, and accountability for identification and remediation of errors as well as communication processes and timelines.
Arrange and/or accommodate independent audits of any Contractor or subcontractor sites. The Government may require an independent audit of any Contractor and/or subcontractor sites to ensure that all facilities satisfy the quality requirements set forth for successful performance of the work. During such an audit, the Contractor shall ensure that staff, facilities, and relevant documentation are available. The Contractor shall prepare updates to the QMP and provide updated plans including corrective actions and preventative actions (CAPA) as needed.
Facilities, Equipment and Other Resource Management
The Contractor shall provide and maintain facilities, equipment, space, and other resources as needed that comply with all local, domestic, in-country, state, federal and NIH regulations. The Contractor shall maintain QA documentation to support adherence to these areas. This includes submitting a floor plan of the relevant facilities and providing safe and secure operation of /access to those facilities; establishing processes and procedures limiting access to only approved and qualified staff to physical sites, systems, equipment, technology, internet, and/or data; and providing biohazard, environmental and occupational health safety, emergency management/preparedness, security, transportation and logistics services. All work with hazardous biological materials shall comply with all local, domestic, in-country, state, federal and NIH regulations. Contingency and catastrophic event plans shall be developed and documented to protect project-related work.
The Contractor shall provide for overall management and conduct of the receipt, storage, retrieval, custom clearance, packaging and shipping of materials, including obtaining appropriate licenses and permits and developing SOPs for processes and procedures. All storage, packaging, and shipping shall comply with all local laws and all applicable regulations. As appropriate, material shall be inventoried and tracked to ensure chain of custody. Plans shall be developed and documented to identify and mitigate against supply chain or other delays to ensure steady access to critical resources.
Data Access and Technology Transfer
The Contractor shall fully support submission of technology transfer packages to the Government or a designated third party when directed by the COR and/or at the completion of the Task Order. Technology transfer packages will include information, technology, and documentation created with sufficient detail, clarity, and completeness to enable the receiving party to fully understand, and if needed, repeat activities of the Task Order. In certain cases, the Contractor may be required to provide training to the Government or designated third parties to utilize or operate a subject technology. The Contractor will support NCATS regulatory affairs processes by providing authorization to the Government and/or any relevant third parties identified by the Government to access and cross reference relevant prior data generated by the Contractor, including but not limited to, Drug Master Files (DMFs) or other previous regulatory filings, as needed.
Site Visits
The Contractor shall arrange and/or accommodate site visits and independent audits as needed. Site visits may be necessary to ensure that all required equipment is available and in good working order and to review the training records of all key technical staff, as available. Audits may be needed to assure Contractor and subcontractor facilities and all planned procedures meet regulatory (e.g., GMP, GLP) or other quality control standards. The Contractor shall ensure all Contractor and subcontractor records and staff are available in response to site visits or study-specific audits, and provide interim and final audit reports to the COR. All data generated by the Contractor to support manufacture of cGMP material shall have a strict quality system review of raw data and transcription, technical supervisor approval, and quality assurance (QA) release.
Project Closeout
The Contractor shall ensure an orderly, secure, and efficient transition at the conclusion of each task order. This may include preparing and submitting a Transition Plan; transferring and/or disposing of contract-related materials, supplies, and information / data; and retaining documents in secure storage (up to five years).
Technical Requirements
Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, materials, equipment, and facilities not otherwise provided by the Government to provide the services described in this Statement of Work and subsequent task orders.
Area 1: Bioanalytical Method Development for Novel Biologic Drugs
The Contractor shall: (1) develop and/or qualify bioanalytical methods for quantitative analyses of novel therapeutic biologics in plasma/serum, tissue homogenates, and other biological fluids from animal species used in efficacy and toxicity studies (e.g., mice, rats, dogs, and monkeys) and from human clinical trials; and (2) develop assays to measure anti-drug antibodies (ADAs), including neutralizing antibodies (nAbs), and to assess treatment-emergent cytokine-secreting immune cells in rodent and non-rodent animal species and humans. For gene-based therapies, this includes developing methods to assess antibodies against the carriers (e.g., vector capsids) and the gene-of-interest (GOI) protein product. The Contractor will not be responsible for obtaining clinical samples from patients directly, and all clinical samples will be deidentified prior to being sent to the Contractor.
Anticipated activities include, but are not limited to:
Develop robust (accurate, precise, specific/selective and reproducible) methods to detect the relevant attribute (e.g., biologic drug, anti-drug antibodies) at a wide range of concentrations. Standard curves should contain a minimum of six non-zero concentration points. Cell-based assays are the Government’s preferred format for detection of neutralizing antibodies (nAbs).
Verify or validate methods for appropriate accuracy and precision, specificity and selectivity using low, medium and high concentration Quality Control (QC) samples. Assays must be suitable for measurement of a novel biologic drug and any ADAs, including nAbs, in concentration ranges expected to be present in study samples.
Perform method characterization studies to define the stability of representative samples under various storage and handling conditions (e.g., room temperature, multiple freeze/thaw cycles, and long-term storage at -20°C or -80°C).
Determine the stability of a novel biologic drug in blood/plasma/serum, tissues or other biologic fluids to guide sample collection processes in animal studies or clinical trials.
Provide instructions on precaution(s) or method(s) necessary to prevent degradation of a novel biologic drug in blood/plasma/serum, tissues or other biologic fluids during sample handling.
Assess the extraction efficiency of an assay in the biologic matrices of interest, which may include the utilization of a radiolabeled biologic.
Establish cut-points for distinguishing positive control (PC) and negative control (NC) samples.
Include screening, confirmatory/specificity, and titer components in the clinical assay for detection of ADAs, including nAbs.
The Contractor shall deliver assay development plans, development reports (outlining experiments conducted in the development phase), validation plans, and validation reports. These reports and plans must be reviewed and approved by the COR. The Contractor may not proceed to subsequent phases until approval is received from the COR (e.g., a validation protocol must be approved before the validation run may commence).
Area 2: Bioanalysis of Novel Biologic Drugs in Biologic Matrices
The Contractor shall provide bioanalytical support for biologic drug concentration and anti-drug antibody (ADA) measurement, including neutralizing antibodies (nAbs), for samples collected from animal pharmacokinetic and efficacy studies as well as from human clinical trials. The Contractor will not be responsible for obtaining clinical samples from patients directly, and all clinical samples will be deidentified prior to being sent to the Contractor.
The assays used may be developed by the Contractor or transferred to the Contractor from a third party. All assays used should be validated in accordance with current regulatory guidelines and expectations. The Contractor shall document any assay deviations from the validated methods to support the precision and accuracy of measurements established with the Quality Control samples. The Contractor shall perform incurred sample re-analysis (ISR) on samples derived from GLP toxicology and/or clinical studies.
Upon completion of an assay, the Contractor shall deliver bioanalytical reports for drug and anti-drug antibody (ADA) concentrations in biologic matrices. These documents must be reviewed and approved by the COR. The Contractor shall clearly document sample receiving conditions, sample ID, and sample storage conditions and duration needs.
For toxicokinetics (TK) in GLP toxicity studies and pharmacokinetics (PK) in human clinical trials, the Contractor shall calculate important TK/PK parameters, which include, but are not limited to, area under the concentration-time curve (AUC), maximum drug concentration (Cmax), time to reach Cmax (Tmax), clearance, half-life (t1/2), volume of distribution, and bioavailability. Furthermore, the Contractor shall calculate and report TK/PK parameters for each individual subject, when possible, and the standard deviation for each treatment group. The Contractor shall use FDA-approved software for such analyses using the non-compartmental approach. The Government recommends validated Phoenix WinNonlin software (Certara, Radnor, PA).
The Contractor shall provide bioanalytical reports for clinical samples, and shall clearly document sample receiving conditions, sample ID, and sample storage conditions and duration needs.
Capability statement /information sought. Respondents must be registered in the System for Award Management (SAM), and address the following questions:
- Provide your DUNS number, organization name, address, and point of contact. If your business is a small business, include your size and type of business (e.g., 8(a), HubZone, etc., SDVOSB, etc.) pursuant to the applicable NAICS code
- Provide a capability statement that addresses the project requirements listed above, with particular attention to the description of your commercial solution and general estimates regarding the length of time required to implement the solution.
- Provide any other information that may be helpful in developing or finalizing the acquisition requirements.
The information submitted must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required.
The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone numbers, and e-mail addresses.
All responses to this notice must be submitted by email to Nick Niefeld, Contract Specialist, at nick.niefeld@nih.gov, and reference sources sought notice number 75N95025R00006.
The response must be received on or before Friday, November 8, 2024 at 11:00 a.m. Eastern time.
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 synopsis and solicitation may be published in SAM.gov Contract Opportunities. 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(s).
