Pharmacology and Toxicology for Therapeutics Program (PTTP)

Added: Mar 04, 2016 3:43 pm THIS IS NOT A REQUEST FOR PROPOSALS (RFP). THIS IS A PRE-SOLICITATION
ANNOUNCEMENT ONLY. A REQUEST FOR PROPOSALS (RFP) NO. NIH-NINDS-16-01,
ENTITLED: "PHAMACOLOGY AND TOXICOLOGY FOR THERERAPEUTICS PROGRAM
(PTTP)" WILL BE ISSUED VIA FEDBIZOPPS ON OR ABOUT March 18, 2016.

The National Institute of Neurological Disorders and Stroke (NINDS) and the NIH Blueprint Neurotherapeutics Network (BPN) (http://neuroscienceblueprint.nih.gov/bpdrugs/index.htm) have established a ‘virtual pharma' network of contract service providers and consultants with extensive industry experience to enable therapeutic (e.g., small molecule, peptide, biologic) development in the NIH research community. The Network and similar NINDS and NIH programs offer researchers access to a range of industry-style therapeutic development services and expertise, including medicinal chemistry, IND-enabling studies, and Phase I clinical trial infrastructure, with the goal of supporting efforts to advance compounds successfully through Phase I clinical testing.

The goal of the PTTP contract will be to assess the pharmacokinetics, toxicology and safety of promising candidates to support their eventual use as therapeutics. It is anticipated that NIH-approved samples will be submitted from a variety of sources including NIH-funded research programs, pharmaceutical companies, biotechnology companies, or other sources. Pharmacology, toxicology and safety data generated from this program may be used by investigators in support of an Investigational New Drug (IND) application.

Studies to be performed may include, but are not limited to:
• Development and validation of the analytical methods for quantitating drug/biologic concentrations in dosing solutions, biological fluids, and tissues, as required
• In vivo pharmacokinetic studies through various routes of administration
• Preclinical acute toxicity evaluations on lead compounds or therapeutics.
• Subacute, subchronic, and/or long-term toxicity evaluations in rodents and non-rodent species
• Safety Pharmacology Studies in rodent and non-rodent species (e.g., cardiovascular, pulmonary, CNS)
• Genotoxicity assessments using a battery of appropriate assays and carcinogenicity assessments
• In vitro predictive ADMET assays, including metabolic stability studies, hepatotoxicity, permeability studies, cytochrome P450 assays, plasma protein binding, and cytotoxicity assays

The NINDS anticipates requiring non-GLP ADMET services (e.g., in vitro ADMET, pharmacokinetic studies, dose range finding toxicity studies) for up to 10 projects in the lead optimization stage per year and GLP IND-directed ADMET services (e.g., toxicity and safety pharmacology studies) for up to 5 projects per year. Multiple studies may be required for each project. It is anticipated that multiple projects and studies will be conducted simultaneously (e.g., concurrent studies for 2-3 lead optimization stage projects and 2-3 IND-stage projects).

In addition to the above, offerors must also meet the following certification/compliance criteria:
(1) A laboratory facility fully compliant with the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) Regulations;
(2) Facilities accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International as indicated by providing your organization's latest accreditation report. Information about AAALAC accreditation is available at www.aaalac.org.
(3) Organization must have an Animal Welfare Assurance indicating compliance with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, information for which is available at http://grants.nih.gov/grants/olaw/olaw.htm.; and
(4) The organization is expected to be able to conduct in vivo studies in the following species: rodents (rats and mice), dogs (purpose bred Beagle dogs), rabbits, non-human primates (Cynomolgus, Rhesus), and other animal models (as appropriate), obtained from an AAALAC accredited registered breeder (Association for Assessment, Accreditation, and Laboratory Animal Care, U. S. Department of Agriculture (USDA).

The NINDS anticipates awarding multiple Indefinite Delivery/Indefinite Quantity (IDIQ) type contracts under this program with a ten year ordering period. It is also anticipated that the IDIQ awards will be made in the fourth quarter of Fiscal Year 2016.

This is NOT a Request for Proposals (RFP). Request for Proposals (RFP) No. NIH-NINDS-16-01 will be available electronically and may be accessed through the FedBizOpps (URL: http://www.fedbizopps.gov) approximately 15 calendar days after the issuance of this synopsis. THIS SOLICITATION WILL BE AVAILABLE ELECTRONICALLY ONLY. OFFERORS ARE RESPONSIBLE FOR ROUTINELY CHECKING THE FEDBIZOPPS WEBSITE FOR ANY POSSIBLE SOLICITATION AMENDMENTS THAT MAY BE ISSUED. NO INDIVIDUAL NOTIFICATION OF ANY AMENDMENTS WILL BE PROVIDED. All responsible sources may submit a proposal, which shall be considered by the agency.