Pharmacologic Characterization Support Services

Agency: Department of Health and Human Services
State: Maryland
Type of Government: Federal
FSC Category:
  • R - Professional, Administrative and Management Support Services
NAICS Category:
  • 541690 - Other Scientific and Technical Consulting Services
Posted Date: Sep 18, 2017
Due Date: Sep 25, 2017
Solicitation No: HHS-NIH-NIDA-SSSA-NOI-17-484
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Solicitation Number :
HHS-NIH-NIDA-SSSA-NOI-17-484
Notice Type :
Presolicitation
Synopsis :
Added: Sep 18, 2017 7:09 am
PRE-SOLICITATION NOTICE OF INTENT
NON-COMPETITIVE

Solicitation: HHS-NIH-NIDA-SSSA-NOI-17-484


Title: Pharmacologic Characterization Support Services


INTRODUCTION
PURSUANT TO FAR Subpart 5.2-Synopses of Proposed Contract Actions, THIS IS A PRE-SOLICITATION NOTICE OF A PROPOSED CONTRACT TO ACTION.


THIS IS A PRE-SOLICITATION NON-COMPETITIVE NOTICE OF INTENT TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).


The National Institute on Drug Abuse (NIDA), Station Support Contracts and Simplified Acquisitions Branch (SS/SA) on behalf of the National Institute on Aging (NIA) intends to negotiate and award a contract for the Pharmacologic Characterization Support Services with Dr. Barbara Slusher of Johns Hopkins Drug Discovery Program, Rangos Building Suite 279, 855 North Wolfe Street, Baltimore, MD 21205.


NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE
The intended procurement is classified under NAICS code 541690 - Other Scientific and Technical Consulting Services with a Size Standard of $15.0 Million.


REGULATORY AUTHORITY
The resultant contract will include all applicable provisions and clauses of the Federal acquisition Requlation (FAR) in effect through the Federal Acquisition Circular (FAC) 05-95, January 19, 2017.


STATUTORY AUTHORITY


This acquisition is conducted as non-competitive under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302-1 - Only one response source and no other supplies or services will satisfy agency requirements.


DESCRIPTION OF REQUIREMENT


Project Description
Clinical/preclinical studies indicate that basal inflammatory status increases as a function of normal aging, and development of a mild pro-inflammatory state closely associates with major degenerative diseases in the elderly. Accordingly, levels of brain pro-inflammatory cytokines become elevated with age in rodents and humans, and several regulatory molecules and anti-inflammatory cytokines decline. Microglia cells within the brain, as a source of these pro- and anti-inflammatory molecules, are thereby implicated as the major culprit of this neuroinflammation. Hence, correcting the overproduction of pro-inflammatory cytokines by microglia may mitigate a broad number of neurodegenerative disorders prevalent in the elderly. Engaging an appropriate drug target to effectively achieve this has proved difficult, and likely underpins the numerous past and recent failures of clinical trials of anti-inflammatory agents in neurodegenerative disorders, and particularly in Alzheimer's disease (AD) and Parkinson's disease (PD). Tumor necrosis factor-a (TNF-a), a vital pro-inflammatory cytokine, is generated and released by microglial cells during their activated M1 (pro-inflammatory) state as part of the innate immune system response to initiate healing following a physiological insult. If elevated TNF-a production is not appropriately time-dependently reduced by microglial transition to a M2 (anti-inflammatory) phase, dysregulated TNF-a synthesis initiates a self-propagating cycle of unchecked inflammation. The pharmacological inhibition of this cycle may benefit disorders with a neuroinflammatory component. To achieve this, the Drug Design & Development Section within the Intramural Research Program of NIA has synthesized a broad series of TNF-a synthesis inhibitors as both pharmacological probes to understand the role of TNF-a in disease processes such as AD and PD, and as drug candidates to treat them.


Purpose and Objectives
The purpose of this acquisition is to procure commercial support services to aid in the pharmacological characterization of the TNF-a synthesis inhibitors that have been generated within the Drug Design & Development Section of the Intramural Research Program of NIA. Support is required to define which specific compounds, among the many dozens of novel agents generated, have appropriate features to effectively provide anti-inflammatory actions in both animal and ex vivo models predictive of human activity.


Delivery Schedule
The period of performance shall be made up of a base year and a one year-long optional period of performance:


Base Year September 30, 2017 - September 29, 2018


CLOSING STATEMENT
This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice.


Responses to this solicitation must include clear and convincing evidence of the offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria. The price proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount.


Specific Requirements:
The Contractor will undertake a series of pharmacological assays on compounds provided by the Drug Design & Development Section, Intramural Research Program of NIA. Results from such assays will be used by scientists within the Drug Design & Development Section of the Intramural Research Program of NIA to select which agents should be moved forward in the drug development process.


In addition to demonstrating proficiency with the 3 Assay types defined below, the Contractor MUST MEET the following specific five (5) Requirements:


(i) To meet with Dr. Greig (NIA) three times yearly in Baltimore, MD, USA, to go through data and interpret results


(ii) Have a degree Chemistry and a Ph.D. in Pharmacology


(iii) Have a demonstrated background in the pharmaceutical industry with senior leadership in relation to Translational Drug Development (>10 years), AND must have a demonstrated background in academic drug development with senior leadership in Drug Discovery, and with experience of US regulatory issues.


(iv) Have a demonstrated background in successfully developing experimental drugs from preclinical in to clinical development (with examples).


(v) Have a demonstrated background in neurological drug development (with publications).


A. Assay 1: Ex vivo drug metabolism assay


Phase 1: Specific in vitro techniques/assays are incorporated into the drug discovery process. With regards to optimizing pharmacokinetic parameters (e.g., bioavailability and clearance), the metabolic stability of new experimental drugs (sometimes termed new chemical entities (NCEs)) can be determined from in vitro incubations with hepatocytes or microsomes. This provides a measure of metabolic stability: a key feature of a NCE that can be defined as the percentage of parent compound lost over time in the presence of the test metabolic system. Cellular (in vitro) metabolic systems are widely used throughout the pharmaceutical industry to assist with the identification of whether or not a NCE has sufficient stability to be active when administered to an animal model or human - to identify likely candidates to take forward for further evaluation as potentially useful experimental drugs.


As a majority of drug metabolism occurs in the liver, in vitro liver preparations have been established to evaluate metabolic stability. Such systems use either hepatocytes (plated or suspended cells) or microsomes, which are prepared from liver homogenates. In this regard, the goal is to isolate the endoplasmic reticulum, as cytochrome P450 (CYP) metabolizing enzymes are located within the endoplasmic reticulum. These CYP enzymes are responsible for the majority of drug metabolism.


Typically, metabolic stability assays are designed to follow the time-dependent loss of the NCE in the presence of the test system. For microsomes, the NCE is added at a low micromolar concentration to a buffer system (usually phosphate or Tris buffer), containing 0.1 to 1 mg/mL microsomal protein and either NADPH or an NADPH-regenerating system. The incubation is maintained at 37C either in a shaking or static water bath and the reaction stopped by the addition of methanol, acetonitrile, or an acid, such as trichloroacetic, resulting in precipitation of the proteins (including CYPs involved in phase 1 and 2 drug metabolism). Samples are then centrifuged and prepared for analysis via high-performance liquid chromatography (HPLC) with tandem mass spectrometry (LC/MS/MS). Appropriate controls (inactivated microsomes and benchmark compound) are typically added to the assay to assist with the interpretation of the results. For specifics see: Rais R.; Thomas A. G.; Wozniak K.; Wu Y.; Jaaro-Peled H.; Sawa A.; Strick C. A.; Engle S. J.; Brandon N. J.; Rojas C.; Slusher B. S.; Tsukamoto T. Pharmacokinetics of oral D-serine in D-amino acid oxidase knockout mice. Drug Metab. Dispos. 2012, 40, 2067-207310.1124/dmd.112.046482.


Microsomes can be prepared from a number of species (i.e., mice, rats, dogs, non-human primates and humans) to predict the stability of the NCE across species. Such studies are highly desirable to allow cellular screening of NCEs to select out which agents should be evaluated further - potentially in animal studies.


Studies are routinely undertaken in triplicate and provide an analysis of:
(i) Time-dependent loss of compound vs. a reference agent in microsomes derived from a specific species (i.e., mouse, rat, do, non-human primate or human)
(ii) Studies may provide a metabolic profile of potential metabolite(s) generated from the parent compound.


B. Assay 2: Ex vivo plasma half-life characterization.


Phase 2: for certain types of drugs, metabolism can occur outside the liver within the plasma compartment consequent to the high concentrations of unspecific esterases and peptidase present.


To evaluate this, NCEs can be time-dependently measured following their addition to plasma obtained from different species (i.e., mice, rats, dogs, non-human primates and humans) to predict the stability of NCEs.
Characterization of major metabolites in drug discovery has important objectives: (1) identifying potent metabolites with better "drug-like" properties; (2) understanding the metabolism fate of drug candidates; and (3) using metabolism information to guide new synthesis to generate more stable compounds for use as experimental drugs in human disease.
Typically, such studies are undertaken as in Phase 1 liver microsome studies - with the notable difference that plasma samples are used in lieu of microsomes. Incubation is time-dependently undertaken at 37C either in a shaking or static water bath and the reaction stopped by the addition of methanol, acetonitrile, or an acid - resulting in precipitation of the proteins. Samples are then centrifuged and prepared for analysis via high-performance liquid chromatography (HPLC) with tandem mass spectrometry (LC/MS/MS). Appropriate controls (inactivated plasma and benchmark compound) are typically added to the assay to assist with the interpretation of the results. Appropriate controls aree evaluated (in which no drug is administered) to allow evaluation of background levels for assay procedures, etc.

C. Assay 3: Animal drug absorption, distribution, metabolism and elimination studies.


DMPK, or Drug Metabolism and Pharmacokinetics, is an important part of drug development studies, and is often referred to as ADME (Absorption, Distribution, Metabolism, and Elimination).
- Absorption (how much and how fast, often referred to as the absorbed fraction or bioavailability) ?
- Distribution (where the drug is distributed, how fast and how extensive) ?
- Metabolism (how fast, what mechanism/route, what metabolite is formed, and whether they are ?active or toxic) ?
- Elimination (how fast, which route). ?In the drug discovery process, early in vitro ADME screening and in vivo PK profiling provide a basis for choosing which NMEs and lead compounds have desirable features (re: drug metabolism, PK or safety profiles) necessary for drug candidate selection and provide a basis to select agents for evaluation in late?stage preclinical development. The ADME properties of a drug allow the drug developer to understand which agents should be moved forward to gain safety and efficacy data required for regulatory approval. ?
ADME studies can be undertaken by different routes of administration, depending on how the finalized drug would be considered delivered to humans (i.e., by the oral route vs. intravenous or subcutaneous routes), and can be undertaken in different species (mice, rats, dogs, non-human primates) depending on the animal that the experimental drug will be evaluated in for efficacy and/or safety/toxicity.


Typically, an animal species is selected based on how the drug will be developed in further efficacy/toxicity studies, and a route of drug administration selected based on final envisaged human administration route. In early preclinical drug development, this animal species is generally a rodent (most often mice). Animals are dosed with an intermediate concentration of drug - considered well tolerated from preliminary studies (undertaken by scientists within the Drug Design & Development Section of the Intramural Research Program of NIA). At times ranging from 5 min to 24 hr following dosing, animals (n=3 per time point) are euthanized, a blood sample is rapidly taken (centrifuged for collection of plasma) and tissues of interest to the mechanism of action of the drug (such as brain, liver, etc.) are collected and immediately frozen to -80 C.


Analytical chemistry is thereafter undertaken on such samples, including sonification of tissue in appropriate buffer/solvents to extract the experimental drug of interest, and the quantification of the drug by LC/MS/MS.
Studies are routinely undertaken to provide an analysis of:
(i) Time of peak plasma concentration following administration and time-dependent loss of compound from the plasma compartment
(ii) Distribution of compound to the primary site of the drug target (for example, brain), and time-dependent disappearance.


LEVEL OF EFFORT:
The contractor shall provide expertise in performing all three scientific assays described in SOW.


GOVERNMENT RESPONSIBILITIES
The Government will provide the compounds of interest (NCEs) for evaluation in Assays 1, 2 and 3. The Government will provide reference compounds of interest - as comparators. In some cases, the Government will provide plasma and tissue samples for analyses (re: Assay 3 studies). The Government will provide details relating to the chemical structure and chemical characterization of compounds for analysis to support development of LC/MS/MS assays by contractor. The Government will provide input as to selected doses for evaluation.


DELIVERY OR DELIVERABLES
The contractor shall provide copies of the Results and Analyses as assays are completed.


This information shall be submitted to the NIH Scientist, Dr. Nigel H. Greig, Ph.D., via email (Greign@mail.nih.gov / phone 410-558-8278) on periods of performance. Dr. Greig will also be the point of contact for any questions relating to which NCEs will be evaluated.


The contractor will have regular (once every 4 month) meetings with Dr. Greig to go through data. These meeting will be in Baltimore, MD.


REPORTING REQUIREMENTS
The contractor shall provide copies of the Results and Analyses as assays are completed.


This information shall be submitted to the NIH Scientist, Dr. Nigel H. Greig, Ph.D., via email (Greign@mail.nih.gov / phone 410-558-8278) on periods of performance. Dr. Greig will also be the point of contact for any questions relating to which NCEs will be evaluated.


The contractor will have regular (once every 4 month) meetings with Dr. Greig to go through data. These meeting will be in Baltimore, MD.

See attached Statement of Work (SOW) for further information.


In addition the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov."
A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.


All responses must be received by Monday, September 25, 2017 at 10AM, Eastern Standard Time, and reference number HHS-NIH-NIDA-SSSA-NOI-17-484. Responses may be submitted electronically to Danielle R. Brown, Contract Specialist, at Danielle.brown2@nih.gov.


Fax responses will not be accepted.


Please contact Danielle R. Brown, Contract Specialist, at Danielle.brown2@nih.gov or (301) 594-1928 with any questions.



STATEMENT OF WORK (SOW) - SERVICES


GENERAL INFORMATION
Title of Project:
Pharmacologic Characterization Support Services


Statement of Need, Purpose, and/or Objective:
The purpose of this acquisition is to procure commercial support services to aid in the pharmacological characterization of the TNF-a synthesis inhibitors that have been generated within the Drug Design & Development Section of the Intramural Research Program of NIA. Support is required to define which specific compounds, among the many dozens of novel agents generated, have appropriate features to effectively provide anti-inflammatory actions in both animal and ex vivo models predictive of human activity.


Background Information:
Clinical/preclinical studies indicate that basal inflammatory status increases as a function of normal aging, and development of a mild pro-inflammatory state closely associates with major degenerative diseases in the elderly. Accordingly, levels of brain pro-inflammatory cytokines become elevated with age in rodents and humans, and several regulatory molecules and anti-inflammatory cytokines decline. Microglia cells within the brain, as a source of these pro- and anti-inflammatory molecules, are thereby implicated as the major culprit of this neuroinflammation. Hence, correcting the overproduction of pro-inflammatory cytokines by microglia may mitigate a broad number of neurodegenerative disorders prevalent in the elderly. Engaging an appropriate drug target to effectively achieve this has proved difficult, and likely underpins the numerous past and recent failures of clinical trials of anti-inflammatory agents in neurodegenerative disorders, and particularly in Alzheimer's disease (AD) and Parkinson's disease (PD). Tumor necrosis factor-a (TNF-a), a vital pro-inflammatory cytokine, is generated and released by microglial cells during their activated M1 (pro-inflammatory) state as part of the innate immune system response to initiate healing following a physiological insult. If elevated TNF-a production is not appropriately time-dependently reduced by microglial transition to a M2 (anti-inflammatory) phase, dysregulated TNF-a synthesis initiates a self-propagating cycle of unchecked inflammation. The pharmacological inhibition of this cycle may benefit disorders with a neuroinflammatory component. To achieve this, the Drug Design & Development Section within the Intramural Research Program of NIA has synthesized a broad series of TNF-a synthesis inhibitors as both pharmacological probes to understand the role of TNF-a in disease processes such as AD and PD, and as drug candidates to treat them.


Period of Performance:
September 30, 2017 - September 29, 2018



Background Information:
A cost-type purchase order is anticipated. The contractor will invoice as various individual Assays (whether 1, 2 or 3) are completed and accepted (by Dr. Greig, NIA) on compounds of interest - on a continuing basis, and payment shall be made via Electronic Funds Transfer (EFT).


SCOPE OF WORK
General Requirements:
Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:


Specific Requirements:
The Contractor will undertake a series of pharmacological assays on compounds provided by the Drug Design & Development Section, Intramural Research Program of NIA. Results from such assays will be used by scientists within the Drug Design & Development Section of the Intramural Research Program of NIA to select which agents should be moved forward in the drug development process.


In addition to demonstrating proficiency with the 3 Assay types defined below, the Contractor MUST MEET the following specific five (5) Requirements:


(i) To meet with Dr. Greig (NIA) three times yearly in Baltimore, MD, USA, to go through data and interpret results


(ii) Have a degree Chemistry and a Ph.D. in Pharmacology


(iii) Have a demonstrated background in the pharmaceutical industry with senior leadership in relation to Translational Drug Development (>10 years), AND must have a demonstrated background in academic drug development with senior leadership in Drug Discovery, and with experience of US regulatory issues.


(iv) Have a demonstrated background in successfully developing experimental drugs from preclinical in to clinical development (with examples).


(v) Have a demonstrated background in neurological drug development (with publications).


A. Assay 1: Ex vivo drug metabolism assay


Phase 1: Specific in vitro techniques/assays are incorporated into the drug discovery process. With regards to optimizing pharmacokinetic parameters (e.g., bioavailability and clearance), the metabolic stability of new experimental drugs (sometimes termed new chemical entities (NCEs)) can be determined from in vitro incubations with hepatocytes or microsomes. This provides a measure of metabolic stability: a key feature of a NCE that can be defined as the percentage of parent compound lost over time in the presence of the test metabolic system. Cellular (in vitro) metabolic systems are widely used throughout the pharmaceutical industry to assist with the identification of whether or not a NCE has sufficient stability to be active when administered to an animal model or human - to identify likely candidates to take forward for further evaluation as potentially useful experimental drugs.


As a majority of drug metabolism occurs in the liver, in vitro liver preparations have been established to evaluate metabolic stability. Such systems use either hepatocytes (plated or suspended cells) or microsomes, which are prepared from liver homogenates. In this regard, the goal is to isolate the endoplasmic reticulum, as cytochrome P450 (CYP) metabolizing enzymes are located within the endoplasmic reticulum. These CYP enzymes are responsible for the majority of drug metabolism.


Typically, metabolic stability assays are designed to follow the time-dependent loss of the NCE in the presence of the test system. For microsomes, the NCE is added at a low micromolar concentration to a buffer system (usually phosphate or Tris buffer), containing 0.1 to 1 mg/mL microsomal protein and either NADPH or an NADPH-regenerating system. The incubation is maintained at 37C either in a shaking or static water bath and the reaction stopped by the addition of methanol, acetonitrile, or an acid, such as trichloroacetic, resulting in precipitation of the proteins (including CYPs involved in phase 1 and 2 drug metabolism). Samples are then centrifuged and prepared for analysis via high-performance liquid chromatography (HPLC) with tandem mass spectrometry (LC/MS/MS). Appropriate controls (inactivated microsomes and benchmark compound) are typically added to the assay to assist with the interpretation of the results. For specifics see: Rais R.; Thomas A. G.; Wozniak K.; Wu Y.; Jaaro-Peled H.; Sawa A.; Strick C. A.; Engle S. J.; Brandon N. J.; Rojas C.; Slusher B. S.; Tsukamoto T. Pharmacokinetics of oral D-serine in D-amino acid oxidase knockout mice. Drug Metab. Dispos. 2012, 40, 2067-207310.1124/dmd.112.046482.


Microsomes can be prepared from a number of species (i.e., mice, rats, dogs, non-human primates and humans) to predict the stability of the NCE across species. Such studies are highly desirable to allow cellular screening of NCEs to select out which agents should be evaluated further - potentially in animal studies.


Studies are routinely undertaken in triplicate and provide an analysis of:
(i) Time-dependent loss of compound vs. a reference agent in microsomes derived from a specific species (i.e., mouse, rat, do, non-human primate or human)
(ii) Studies may provide a metabolic profile of potential metabolite(s) generated from the parent compound.


B. Assay 2: Ex vivo plasma half-life characterization.


Phase 2: for certain types of drugs, metabolism can occur outside the liver within the plasma compartment consequent to the high concentrations of unspecific esterases and peptidase present.


To evaluate this, NCEs can be time-dependently measured following their addition to plasma obtained from different species (i.e., mice, rats, dogs, non-human primates and humans) to predict the stability of NCEs.
Characterization of major metabolites in drug discovery has important objectives: (1) identifying potent metabolites with better "drug-like" properties; (2) understanding the metabolism fate of drug candidates; and (3) using metabolism information to guide new synthesis to generate more stable compounds for use as experimental drugs in human disease.
Typically, such studies are undertaken as in Phase 1 liver microsome studies - with the notable difference that plasma samples are used in lieu of microsomes. Incubation is time-dependently undertaken at 37C either in a shaking or static water bath and the reaction stopped by the addition of methanol, acetonitrile, or an acid - resulting in precipitation of the proteins. Samples are then centrifuged and prepared for analysis via high-performance liquid chromatography (HPLC) with tandem mass spectrometry (LC/MS/MS). Appropriate controls (inactivated plasma and benchmark compound) are typically added to the assay to assist with the interpretation of the results. Appropriate controls aree evaluated (in which no drug is administered) to allow evaluation of background levels for assay procedures, etc.

C. Assay 3: Animal drug absorption, distribution, metabolism and elimination studies.


DMPK, or Drug Metabolism and Pharmacokinetics, is an important part of drug development studies, and is often referred to as ADME (Absorption, Distribution, Metabolism, and Elimination).
- Absorption (how much and how fast, often referred to as the absorbed fraction or bioavailability) ?
- Distribution (where the drug is distributed, how fast and how extensive) ?
- Metabolism (how fast, what mechanism/route, what metabolite is formed, and whether they are ?active or toxic) ?
- Elimination (how fast, which route). ?In the drug discovery process, early in vitro ADME screening and in vivo PK profiling provide a basis for choosing which NMEs and lead compounds have desirable features (re: drug metabolism, PK or safety profiles) necessary for drug candidate selection and provide a basis to select agents for evaluation in late?stage preclinical development. The ADME properties of a drug allow the drug developer to understand which agents should be moved forward to gain safety and efficacy data required for regulatory approval. ?
ADME studies can be undertaken by different routes of administration, depending on how the finalized drug would be considered delivered to humans (i.e., by the oral route vs. intravenous or subcutaneous routes), and can be undertaken in different species (mice, rats, dogs, non-human primates) depending on the animal that the experimental drug will be evaluated in for efficacy and/or safety/toxicity.


Typically, an animal species is selected based on how the drug will be developed in further efficacy/toxicity studies, and a route of drug administration selected based on final envisaged human administration route. In early preclinical drug development, this animal species is generally a rodent (most often mice). Animals are dosed with an intermediate concentration of drug - considered well tolerated from preliminary studies (undertaken by scientists within the Drug Design & Development Section of the Intramural Research Program of NIA). At times ranging from 5 min to 24 hr following dosing, animals (n=3 per time point) are euthanized, a blood sample is rapidly taken (centrifuged for collection of plasma) and tissues of interest to the mechanism of action of the drug (such as brain, liver, etc.) are collected and immediately frozen to -80 C.


Analytical chemistry is thereafter undertaken on such samples, including sonification of tissue in appropriate buffer/solvents to extract the experimental drug of interest, and the quantification of the drug by LC/MS/MS.
Studies are routinely undertaken to provide an analysis of:
(i) Time of peak plasma concentration following administration and time-dependent loss of compound from the plasma compartment
(ii) Distribution of compound to the primary site of the drug target (for example, brain), and time-dependent disappearance.


LEVEL OF EFFORT:
The contractor shall provide expertise in performing all three scientific assays described in SOW.


GOVERNMENT RESPONSIBILITIES
The Government will provide the compounds of interest (NCEs) for evaluation in Assays 1, 2 and 3. The Government will provide reference compounds of interest - as comparators. In some cases, the Government will provide plasma and tissue samples for analyses (re: Assay 3 studies). The Government will provide details relating to the chemical structure and chemical characterization of compounds for analysis to support development of LC/MS/MS assays by contractor. The Government will provide input as to selected doses for evaluation.


DELIVERY OR DELIVERABLES
The contractor shall provide copies of the Results and Analyses as assays are completed.


This information shall be submitted to the NIH Scientist, Dr. Nigel H. Greig, Ph.D., via email (Greign@mail.nih.gov / phone 410-558-8278) on periods of performance. Dr. Greig will also be the point of contact for any questions relating to which NCEs will be evaluated.


The contractor will have regular (once every 4 month) meetings with Dr. Greig to go through data. These meeting will be in Baltimore, MD.


REPORTING REQUIREMENTS
The contractor shall provide copies of the Results and Analyses as assays are completed.


This information shall be submitted to the NIH Scientist, Dr. Nigel H. Greig, Ph.D., via email (Greign@mail.nih.gov / phone 410-558-8278) on periods of performance. Dr. Greig will also be the point of contact for any questions relating to which NCEs will be evaluated.


The contractor will have regular (once every 4 month) meetings with Dr. Greig to go through data. These meeting will be in Baltimore, MD.


OTHER CONSIDERATIONS
Travel:
No travel is required.


Key Personnel:
The contractor shall provide all key personnel.


Information System Security Plan:
No information security is required.


Data Rights:
The contract will not have any data rights.


Section 508-Electronic and Information Technology Standards:
The contractor is not required to develop, procure, maintain, or use Electronic and Information Technology (EIT) in the performance of the SOW.


Publications and Publicity:
The contract will not publish the data produced under the SOW.


Confidentiality of Information:
The government will not provide the contractor with any personal information.


Contracting Office Address :
6001 Executive Boulevard
Room 4211, MSC 9559
Bethesda, Maryland 20892-9559
United States
Place of Performance :
251 Bayview Boulevard
Baltimore, Maryland 21224
United States
Primary Point of Contact. :
Danielle R. Brown,
Contract Specialist
Phone: 301 480 2385

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