A7_Additional_Technical_Proposal_Instructions.pdf

ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS

The Offeror shall submit a proposal that addresses all performance activities in the Statement of Work (SOW). Only proposals from prospective offerors who demonstrate the capability to perform all aspects of the performance activities in the SOW will be considered for contract award.

Performance Activity 1 (PA1) – Kickoff Meeting:

The contractor shall ensure and participate in a one-day contract initiation meeting. The meeting will be scheduled by the contracting officer’s representative (COR) and will take place within two months following the effective date of the base contract award. For additional details, please see Attachment 3 – Sample Task Order #0001 SOW.

Performance Activity 2A - General Project Administration and Technical Support:

Work under Performance Activity 2A, the contractor (Project manager/ principal investigator) shall provide general administration, coordination, and management of contract activities, participate in LDT, ad hoc meetings and teleconferences (for example pre-IND meeting, IND meetings, and additional FDA updates); prepare and submit reports as required by the terms of the contract or specified timeframes to the COR and CO and provide the necessary technical support for information technology and information systems security staff and timely submission of information systems reports as required.

Performance Activity 2B – API Scale Up and Manufacture/ Formulation and Dosage Form Manufacture/ Analytical Methods Development and Stability Testing:

Performance Activity 2B shall incorporate one or more of the following activities:

• API Scale Up and Manufacture: The contractor shall have adequate infrastructure to perform scale up and manufacturing of API from approximately small scale (≈25 g) up to typically 1-2 kg but large scale (10 kg) should be accessible as needed. API scale up and manufacture shall support preclinical studies, IND enabling studies, and clinical studies, which will be performed by other components of the BPN. The contractor should have the ability to conduct API manufacturing and qualification under cGMP/GLP conditions as appropriate on request. The contractor shall also provide chemistry expertise to perform process development to transition from medicinal chemistry routes to establish synthetic methodologies and processes amenable to scale up, and quality control. The contractor will be required to have adequate personnel, equipment, and space to perform approximately 1-2 API scale up and manufacture campaigns simultaneously. The contractor must have the capability to ship samples and provide adequate facilities for the storage of raw, intermediates, final materials, and products according to regulatory requirements, and including controlled substances for the length of the individual task order.

• Formulation and Dosage Form Manufacture: The contractor shall conduct studies to support the development of suitable formulations and dosage forms manufacture of potential therapeutics for clinical testing (typically for Phase I testing). Targeted formulations may include, and are not limited to, oral (through the mouth), parenteral (intravenous or intramuscular or subcutaneous), topical (skin) forms (cream, ointment, gel, paste or powder), intraocular, transmucosal (intravitreal, nasal, buccal/sublingual, vaginal, and rectal), inhalation, and others. The contractor shall also package, label, store, and ship materials intended for evaluation in preclinical studies, IND enabling studies, and clinical studies. Activities shall be performed in compliance with cGMP/GLP guidelines as necessary. Formulations shall be manufactured as sterile products as necessary.

• Analytical Methods Development and Stability Testing: The contractor shall conduct suitable analytical methods development in a stage appropriate fashion to provide qualification and if required validation studies to support API and dosage form manufacture of potential therapeutics. The studies shall support documentation of the identity, strength, quality, purity, potency and stability of drug substances and drug products. The contractor shall have capabilities in assembling information, submitting samples, and presenting data to support analytical methodologies for drug substances and drug products in a form acceptable to the FDA for an IND or NDA submission. The contractor shall also conduct stability studies to collect up to 5-year stability data to ensure product stability during preclinical/clinical studies. The stability studies will be conducted under long-term (usually 60 months), accelerated (6 months), intermediate (12 months), and/ or under photo-stability conditions.