Interventional Agents Chemistry Services

The aim of this solicitation is to create a multiple award Indefinite Delivery/Indefinite Quantity (IDIQ) type contract. The development and introduction of new therapeutic products against potential agents of bioterrorism, drug-resistant pathogens, emerging and re-emerging infectious diseases, as well as infectious diseases prevalent in resource-limited countries remains a public health priority.

To assist in filling these public health gaps, the NIAID requires a nontraditional, proactive, and product development-oriented program to provide preclinical development support for promising therapeutic candidates that emerge from academia, the private sector, or other sources.

The full suite of services, of which the services in this solicitation are a part, will encompass those activities commonly associated with the development of interventional products for infectious disease required for New Drug Application (NDA), Biologic License Applications (BLA) and/or Investigational New Drug (IND) applications.

Consequently, NIAID recognizes that to obtain the full spectrum of expertise or facilities required to perform all activities set forth in this solicitation, individual organizations will likely need the expertise and resources of other organizations or persons through consortia agreements, partnerships, subcontracts, or consultants.

Chemistry underpins all stages of product development by providing the materials required at each stage of development for studies supporting advancement to the next stage of development. The Interventional Agents Chemistry Services resource is intended for case-by-case support of diverse interventional agent product candidates rather than for carrying a single program through multiple stages of the preclinical development pathway.

These services are intended to help a large number and variety of investigators to obtain critical data needed to attract additional funding, gain prospective partnerships (either for further development or to support clinical trials), fulfill regulatory requirements, and complete necessary studies to satisfy regulatory requirements. Investigators work with NIAID program officers to access the services through an online request portal.

Through these interactions the program officers develop requirements in conjunction with the investigators that reflect the program development needs at the time. These requirements become the basis of the Statement of Work (SOW) of a Request for Task Order Proposal (RTOP) which is issued as a solicitation to all awardees (the contractor “pool”) of the Task Area to which the RTOP is issued.

Contractors in the pool then submit technical and cost proposals against the work in the RTOP and these proposals are evaluated by the responsible NIAID staff. The proposal determined to be the best value to the government is awarded, provided funds are available. Contractors in the pool are not involved in the development of the requirements, however, they may receive inquiries from the Contracting Officer (CO), in the form of a Request for Information (RFI) in regard to technical capabilities in some cases.

For the purposes of this contract an Interventional Agent is a chemical or biological agent for control of an infectious disease caused by a pathogen or toxin (e.g., botulinum toxin). The provided services shall be directed at the following:

Diseases caused by pathogens and toxins on the NIAID Emerging Infectious Diseases/Pathogens list (https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens) Emerging and re-emerging infectious diseases Antimicrobial resistant and multi-drug resistant infections Other bacterial infections Fungal infections Viral infections Parasitic diseases.

NIAID anticipates awarding multiple Indefinite Delivery, Indefinite Quantity (IDIQ) contracts to organizations that demonstrate capability to fulfill the technical requirements of at least one (1) of the technical Task Areas listed below plus required Task Area A. A contract may be awarded to an organization proposing to fulfill either or both of the technical Task Areas plus Task Area A. The Government anticipates making awards to those organizations with the best qualifications in each Task Area.

Subpar evaluation in one technical Task Area will not exclude the organization from or negatively impact consideration for award in another Task Area. Organizations will be considered for contracts only in the Task Area(s) they include in the proposal. Task areas and the scope of each are as follows:

Task Area A – Contract Kick-Off Meeting Task Area A will support the planning and participating in the parent contract kick-off meeting. Task Area B – Non-GMP Chemistry Task Area B will support activities required for the route optimization, process development, and synthesis of a synthetic intermediate, lead, or preclinical candidate, and may include acquisition or purchase of compounds from a third-party source, such as a commercial vendor.

Activities under this Task Area include technology transfer of synthesis schemes and procedures between third party facilities and contractors as specified in each Task Order.

Task Area C – GMP Manufacturing, Formulation, Fill and Finish Task Area C will support the formulation development for clinical or advanced preclinical studies; current Good Manufacturing Practices (cGMP)-compliant synthesis of Drug Substance (DS), cGMP-compliant manufacturing of Drug Product (DP) consistent with relevant FDA guidelines; provision of all required documentation including documentation required for IND filing; product release testing required for human clinical use; and DP stability testing required during clinical trials.

The Contractor shall be responsible for directing and ensuring the successful technology transfer of all materials, assays, methods and procedures as required for the successful performance of the activities. The focus of this task area will be for discrete small molecule drugs, including those derived from fermentation. Biological drugs and complex or poorly defined mixtures are excluded.