Draft Statement of Work.pdf

Parent IDIQ Contract Statement of Work

CRO Support for NCATS Regulatory Affairs Support and Related Services

I. Background and Introduction

The Division of Preclinical Innovation (DPI) at the National Center for Advancing Translational Sciences (NCATS) conducts translational research in human therapeutics development and aims to move small molecule and biologic drug candidates forward in the drug development pipeline. At predetermined milestones, DPI will hand off the drug candidate to external partner(s) to bring the novel therapy to patients. In addition to developing new candidate drugs, DPI 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 pre-clinical stage of drug development.

DPI’s model is to operate as a full range small molecule and biologics drug development organization, moving drug candidates through each phase of the pre-clinical drug development process until an Investigational New Drug (IND) is filed with the US Food and Drug Administration (FDA), and, on a case by case basis, to continue into clinical development studies.

DPI conducts drug development as collaborations through programs such as the Therapeutics for Rare and Neglected Diseases (TRND), Helping to End Addiction Long-term (HEAL) Initiative and the Bridging Interventional Development Gaps (BrIDGs) programs. DPI drug development programs originate from academia, industry, non-profit foundations, or internally from NCATS and other NIH institutes. The R&D operational strategy is to combine the capabilities of DPI in-house staff and DPI partners, who may be the drug originators. Each drug program operates in a multi-disciplinary, multi-partnership matrix team environment, and a DPI program officer is responsible for the overall planning, execution, and reporting of the program.

Contract research organizations (CROs) and contract manufacturing organizations (CMOs) provide DPI with manufacturing, pharmacology, toxicology, regulatory, and clinical operations services to assist with drug development. Planning and execution of each individual drug development program includes identification of scientific and regulatory areas best suited for utilization of CROs and CMOs to conduct some or all parts of a given drug development program.

DPI has a need for both preclinical and clinical regulatory support so that projects can meet the regulatory requirements of the FDA and other non-US regulatory bodies. Therapies under development can cover a wide range of modalities, such as small molecules and biologics (e.g.

antibody, proteins, and cell and gene therapy), and can be at different stages of pre-clinical or clinical development that requires varying levels of support.

II. Scope and Objectives

The objective of this contract is to support the DPI drug development programs by providing regulatory affairs services that can fully support drug development projects from pre-clinical through clinical phases. This may include drugs, medical devices used in drug delivery, or drug-device combinations. While this contract will be primarily in support of the NCATS DPI drug development programs, the Government reserves the right to allow other drug development programs at NIH to solicit task order proposals. As such, this contract is not limited to requirements under the TRND, HEAL or BrIDGs programs, or under NCATS as a whole.

Small Business Sources Sought: 75N95021R00008

III. Requirements

A. General Requirements

The following requirements are applicable to every task order issued under this contract:

1. Project Management

The Contractor shall provide project management for its own core team to ensure planning, execution, delivery of reports, and accurate and timely communication with the Contracting Officer’s Representative (COR), Contracting Officer (CO), and other stakeholders.

The Contractor shall organize, and conduct teleconferences as required in individual task orders. These teleconferences may include but are not limited to the Contractor’s core team, the COR, the CO, and other stakeholders. The Contractor shall prepare and submit pre- and post-meeting reports in accordance with the task order deliverables and reporting requirements section of subsequent task order awards.

The Contractor shall immediately contact the COR if there are any adverse results or difficulties with the regulatory activities that would impact the project or timeline. The communications shall include proposed solutions.

2. Standard Operating Procedures

The Contractor shall follow all site-specific standard operating procedures (SOPs). If a deviation from an SOP is required, the Contractor shall notify the COR of the deviation and document as appropriate. At the request of the COR, the Contractor shall submit to the Government any SOPs, method descriptions, and references used in the implementation of studies. The Government will treat Contractor SOPs as confidential.

3. Record Retention

The Contractor shall document and provide all data, information, and records required for the writing of any documents (related to regulatory submissions or otherwise) used to support NCATS related programs.

Upon study completion, the Government may require all study documentation be placed in secure storage for a period of up to seven years. During this period, the Contractor shall be responsible for the integrity and organization of the material and its confidentiality. At the end of the period, all such documentation will be transferred or disposed of at the direction of the COR.

4. Task Order Transition

At least 45 days prior to task order expiration, the Contractor shall prepare and submit a proposed Transition Plan for an orderly and complete transition/relocation of the task order resources to a successor Contractor or to the Government. The plan shall include details on the relocation/disposition of all materials developed under the task order, including but not limited to dossier of all interactions with the Agency on behalf of NCATS, meeting briefing package(s), other regulatory submissions and communications, reports, plans, studies, Government-furnished material and data. The plan shall also include a description of transition activities, timelines, and assigned staff. The Contractor will submit a Draft Transition Plan for review before submission of the Final Transition Plan. Both plans will be submitted in accordance with the Task Order Deliverables and Reporting Requirements section of subsequent task order awards.

5. Government-Furnished Data

The Contractor will have access to any data and materials available at NCATS or the NCATS partner related to each task order that the Government deems necessary to successfully perform under the task order. The Contractor will relocate/dispose of any Government-furnished data and materials at the end of each task order in accordance with the approved Final Transition Plan.

B. Specific Requirements

The Contractor shall provide services related to regulatory affairs support and strategies for therapeutics under development in the following areas: pre-IND regulatory activities;

preparation and filing of IND; regulatory services for clinical studies; regulatory filings for other designations and expedited pathways; regulatory and scientific consulting services and subject matter expertise; and regulatory support for medical devices and/or drug-device combination products. Although referred to as an IND in the United States, the equivalent filing in other countries may have different name(s). Both the IND and its equivalents are captured by the scope of this IDIQ, and reference to the IND includes the IND-equivalents in other countries.

Examples of activities in these areas are provided below. Task orders may include activities in one or more areas.

The Contractor shall work closely with the Contracting Officer’s Representative (COR) and other NIH staff, as applicable, during the performance of these services. The Contractor shall also work closely with other key stakeholders, which may include but are not limited to the U.S. Food and Drug Administration (FDA) (including the Centers for Drug Evaluation and Research (CDER), Biologics Evaluation and Research (CBER), and Center for Devices and Radiological Health (CDRH)), the European Medicines Agency (EMA), Health Canada, and regulatory agencies worldwide.

The following requirements apply to every task order issued under this IDIQ as applicable.

1. Defining a regulatory strategy and providing support to the drug development plan that is clearly aligned to meet project goals, including a Target Product Profile (TPP) and gap analysis as requested.

2. Optimizing preclinical and clinical regulatory timelines and costs, providing risk mitigation plans.

3. Ensuring that all key studies required for regulatory filings are included and strategically planned at the appropriate stage of development.

4. Ensuring compliance with all regulations, policies, and protocols.

5. Providing proven SOPs, templates, and industry best practice for regulatory services.

6. Conducting appropriate communication with regulatory agencies and different stakeholders that is accurate and timely.

7. Submitting documents to appropriate regulatory body(ies) in the required format (e.g.

electronic Common Technical Document (eCTD)).

8. Adhering to the requisite quality control for all documents and activities.

B. Area 1: Pre-IND Regulatory Activities

The Contractor shall provide services related to the pre-IND process. Anticipated activities under this area include but are not limited to:

1. Obtaining and reviewing preclinical and clinical information needed for the IND submission.

2. Preparing, drafting, reviewing, and/or submitting the pre-IND meeting request and briefing package and other supporting documentation as needed.

3. Managing pre-IND meeting rehearsal, as necessary, to include but not limited to requesting meetings and preparing documentation and/or presentations.

4. Managing post-meeting responses and communications.

5. Conducting a debriefing meeting.

C. Area 2: Preparation and Filing of IND

The Contractor shall provide services related to the preparation and filing of IND. Anticipated activities under this area include but are not limited to:

1. Conducting IND kick-off meeting.

2. Defining IND filing strategy, scope, timeline, and responsibilities.

3. Preparing all modules of the IND, which includes tasks such as:

a. Collecting all study reports, summaries, synopses, and other required documentation.

b. Drafting and writing regulatory documents of the submission, including Investigator’s Brochure.

c. Preparing all forms necessary for submission.

4. Providing post-IND filing support, including formal responses and maintenance activities as needed.

D. Area 3: Regulatory Services for Clinical Studies

The Contractor shall provide services related to clinical studies. Such studies may be human clinical trials, natural history studies, patient finding studies, or others.

Anticipated activities under this area include but are not limited to:

1. Planning, requesting, and preparing materials for additional types of informal and formal meetings (e.g., End of Phase I or End of Phase 2 meeting).

2. Tracking and managing study-related regulatory documentation (e.g., protocol amendments, 1572s, Investigator Brochures, cross-references and letter of authorization, severe adverse event [SAE] reporting).

3. Supporting clinical protocol(s) and clinical trial(s) to ensure compliance with Good Clinical Practice (GCP). This may include tasks such as reviewing study regulatory files and subject specific documents such as informed consent, case report forms, medical records, and communication with the regulatory agency and Investigational Review Board (IRB).

E. Area 4: Regulatory Filings for Other Designations and Expedited Pathways.

The Contractor shall provide services related to other designations, such as orphan drug designation, and expedited pathways for US and non-US regulatory bodies (i.e., EU EMA, Health Canada, etc.). Such expedited pathways may include Breakthrough Therapy (BT) Designation, Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Pediatric or Neglected Disease Voucher, and/or Accelerated Approval.

Anticipated activities under this area include but are not limited to:

1. Obtaining and reviewing information needed for the designation and/or expedited pathway.

2. Preparing, drafting, reviewing, and/or submitting documentation to the appropriate regulatory body.

3. Providing post-submission filing support including communications, responses, and maintenance activities.

F. Area 5: Regulatory and Scientific Consulting Services and Subject Matter Expertise

The Contractor shall provide scientific and technical consultants and subject matter experts as needed. Areas of expertise include but are not limited to: Pharmacology; Toxicology; Chemistry, Manufacturing and Controls (CMC); Clinical; Statistical services; and Medical Devices. The level of education and/or expertise required will be determined at the task order level. Anticipated activities under this area include but are not limited to:

1. Designing studies

2. Writing protocols

3. Providing technical guidance

4. Overseeing studies at CROs

5. Reviewing data

6. Preparing and reviewing study reports and summaries

G. Area 6: Regulatory Support for Medical Devices and/or Drug-Device Combination Products

The Contractor shall provide regulatory services related to medical devices used in drug delivery, and/or drug-device combination products. Services may support any aspect or stage of the regulatory process.

Anticipated activities under this area may include but are not limited to:

1. Determining the regulatory requirements, such as the appropriate medical device compatibility testing.

2. Preparing and filing the necessary documentation such as IND, investigational device exemption (IDE), pre-submissions, etc. with appropriate regulatory body.

3. Providing post filing support, including formal responses and maintenance activities as needed.

4. Providing technical guidance and subject matter expertise, which may include tasks such as writing protocols, reviewing data, overseeing studies at CROs, and preparing and reviewing study reports and summaries.