D1 PD Purchase Description.pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

PURCHASE DESCRIPTION

1. Name of Item or Project Title: Purchase of sixteen (16) boxes of 48-well and (16) boxes of 96-well Axion CytoView microelectrode array plates (Brand-name or equal) for electrophysiological experiments required for toxicity screening as part of the N=1 ASO project.

2. Statement of Need and Purpose: The Therapeutic Development Branch (TDB) within the National Center for Advancing Translational Sciences (NCATS) Division of Preclinical Innovation (DPI) seeks to purchase multi-well microelectrode array (MEA) plates for electrophysiological experiments required for toxicity screening as part of the N=1 antisense oligonucleotides (ASOs) project.

3. Background Information and Objective: The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people’s health and save lives.

NCATS is one of 27 Institutes and Centers at the NIH and its mission is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.

The NCATS DPI plans, conducts and uses both internal and contract resources to advance collaborative research projects across the preclinical phases of the translational science spectrum.

The goal of the NCATS DPI TDB is to help close the gap between basic research and preclinical testing of new small-molecule and biologic drugs, as well as cell-based and gene therapies. Work spans the entire preclinical development pipeline, including medicinal chemistry, toxicology, formulation, and other studies required to support an Investigational New Drug (IND) application to the U.S. Food and Drug Administration

(FDA)

The NCATS DPI TDB requires multi-well microelectrode array (MEA) plates to meet the needs of the N=1 ASO project.

An ASO is a single-stranded, synthetic RNA (or DNA) sequence. ASOs are designed to selectively bind via complementary base-pairing to messenger RNA (mRNA) and are the basis for one type of RNA-based therapeutics being explored to treat cancer and genetic disorders. RNA-based therapeutics are catagorized as a type of gene therapy.

An integral part of this project is developing assays for predictive neurotoxicity of ASOs to facilitate streamlining the safety approval process of ASO treatments for rare diseases. MEAs are used for recording electrical signals from neuronal networks and are composed of a grid of planar metal microelectrodes dispersed across a small surface, typically incorporated into flat bottom wells of “cell culture”-like plates. Neurons seeded and cultured directly onto MEAs plates allows for the measurement of changes in extracellular voltage as neurons spontaneously produce action potentials and generate network connections between cells. Neurotoxic MEA screening assays with ASOs permit the testing of both acute and chronic toxicity by measuring alterations in neuronal network signaling over the course of hours, days, and weeks after compound dosing.

MEAs have been successfully used by NCATS scientists to characterize neuronal toxicity by measuring changes in electrical signaling between neurons after exposure to ASOs of different toxicities. 48-well MEA plates have a total of 16 electrodes per well, allowing for high resolution data, but limits scientists by the number of ASOs that can be screened. 96-well MEA plates only have 8 electrodes per well, cutting the data resolution in half, but allows scientists to screen double the number of ASOs per plate. MEA plates with 96-wells will be used for first pass screening, and subsequent “hits” will be further evaluated in the 48-well MEA plates. Combining the benefits of both plate formats into the assay will significantly increase the screening capacity required for this project.

NCATS DPI TDB requires the MEA plates to have transparent bottoms, allowing for additional toxicity parameters such as cell morphology that can also be assessed throughout the experiment. These plates must also be compatible with Axion Biosystem Maestro Pro MEA reader for measuring the electrical activity and is analyzed with Axion software previously purchased by NCATS.

Thus, without acquisition of the sixteen (16) boxes of 48-well and (16) boxes of 96-well Axion CytoView microelectrode array plates (Brand-name or equal), NCATS will be unable to perform electrophysiological experiments required for toxicity screening as part of the N=1 ASO project.

4. Generic Name of Product: multi-well microelectrode array plates

5. Purchase Description: For reference purposes, the multi-well microelectrode array plates that meets the need of this requirement is the Axion CytoView microelectrode array plates, as follows:

Part Number Description Quantity M768-tMEA-48W CytoView MEA 48-White plate 16 boxes with 5 plates each M768-tMEA-96W CytoView MEA 96-White plate 16 boxes with 5 plates each

6. Salient characteristics The salient characteristics of the multi-well microelectrode array plates include:

48-well format:

o 16 recording electrodes/well allows for high resolution data.

96-well format:

o 8 recording electrodes/well

Each box with a minimum of five (5) plates, or equivalent overall quantity.

Transparent well bottom allowing visualization of neurons throughout culture/experiment.

Compatible with pre-existing Axion Biosystems “Maestro Pro multiwell microelectrode array and Impedance system” and associated Axion data analysis software suite.

Plates contain barcode identifiers for sample and data management.

Handling and Shipping to NCATS, FOB Destination.

7. Quantity: Total of thirty-two (32) multi-well microelectrode array boxes, being sixteen

(16) boxes of 48-well and (16) boxes of 96-well, as provided in the Purchase Description.

8. Delivery Date: Delivery is required within thirty (30) days after receipt of order (ARO), Delivery shall be made to the below address with FOB Destination, in accordance with quantities described in the Purchase Description:

National Center for Advancing Translational Sciences (NCATS) Building and Room to be determined at time of award.

9800 Medical Center Drive Rockville, MD 20850.