Additional_Technical_Proposal_Instructions.pdf

ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS

The Offeror shall submit a proposal that addresses all three (3) performance areas in the Statement of Work (SOW). Only proposals from prospective offerors who demonstrate the capability to perform all aspects of the SOW will be considered for award.

1. Performance Area 1

a) Demonstrate evidence of experience in conducting in-house animal studies evaluating small molecules and/or biologics and/or natural products and/or devices in rat and/or mice models of pain.

b) Demonstrate through subcontracting activities or in-house capacity including technical staff, laboratory, animal and surgical facilities and equipment to handle capacity for concurrent testing requirements and expertise to perform the following screening tasks within a performance period of 12 months:

i. Demonstrate capability to screen up to 50 investigational agents per year in rat acute pain model, rat inflammatory pain model and rat neuropathic pain models; (Vehicle, 3 dose levels and positive control)/agent

ii. Demonstrate capability to screen up to 30 investigational agents per year in rat or mice migraine model; (Vehicle, 3 dose levels and positive control)/agent

iii. Demonstrate capability to screen up to 10 investigational agents per year in rat chemotherapy-induced pain model, rat Diabetic neuropathy model, rat Visceral pain model, rat post-surgical pain model, rat Fibromyalgia model, rat bone cancer pain model, rat osteoarthritis pain model, rat orofacial pain model; (Vehicle, 3 dose levels and positive control)/agent.

iv. Demonstrate capability to screen up to 40 investigational agents per year in rat rotarod assay, rat locomotor activity assay and rat modified Irwin Test;

(Vehicle, 3 dose levels and positive control)/agent

v. Demonstrate capability to screen up to 40 investigational agents per year in rodent Conditioned Place Preference (CPP) abuse liability model (Vehicle and 1 dose) and up to 10 investigational agents in self-administration abuse liability model; (vehicle and 1 dose)/agent.

2. Performance Area 2

a) Demonstrate capabilities to screen up to 50 investigational agents (1 concentration) and up to 10 concentration-response curve within a performance period of 12 months, whether in house or through subcontracting activities to perform in-vitro pharmacological profiling in either binding and/or functional assays to assess interaction with opioid receptors (Mu-opioid, Delta-opioid, and Kappa-opioid receptors) and/or interaction with other molecular targets as proposed in the SOW.

3. Performance Area 3

b) Demonstrate capacity and capabilities in executing up to 50 ADME/Formulations studies, up to 50 Pharmacokinetic studies in rat and/or large animals and up to 50 Bioanalytical studies during a performance period of 12 months. For each investigational agent, Pharmacokinetics studies are aimed to determine brain and plasma exposure at one or multiple doses including oral and other routes of administration.