NMRC JA Rohan BioCAM DupleX_Shipman_Rohan (002).pdf

NMRC (template)

JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Research Center (NMRC), Silver Spring, MD, on behalf of the Navy to meet Naval Medical Research and Development mission as required by Naval Medical Research Unit Dayton (NAMRU-D).

2. Nature and/or description of the action.

The proposed action is for the sole source purchase of a complete high density microelectrode array (HD-MEA) system with 3D microelectrode arrays capable of generating functional images to be used for neuro-toxicology assessments and research.

This BioCAM DupleX system will be purchased from our project money.

This system can stimulate and record from >4000 3D penetrating microlectrodes and generate a functional image from recorded electrical activity.

Proposed source:

ALA Scientific Instruments 60 Marine Street, Suite 1 Farmingdale

NY 11735

US

+1 631 393 6401 http://alascience.com/ sales@alascience.com

This action needs to be performed through Award of Contract. We request a Sole Source Contract be awarded to the manufacturer listed above.

3. Description of Supplies or Services:

This high density microelectrode array system (HD-MEA) is an advanced high-resolution system for in-vitro and ex vivo electrophysiology that can further be translated to functional imaging, equipped with 4096 fully bidirectional planar as well as 3D (penetrating) microelectrodes. The system is comprised of:

- Advanced high resolution platform compatible with multiple HD-MEA chips that can deliver electrical current stimulus as well as record synaptic potentials

- Necessary upgrade to enable compatibility with high density (>4000) 3D or penetrating microelectrodes

- Laptop workstation

- Microelectrode array membrane covers to prevent tissue drying and allow gas exchange

- Microelectrode array covers with perfusion ports for in vitro exposures

- Mini incubator box to provide connection to O2/CO2 enabling long term recordings (for days)

- 3D (penetrating) high density CMOS-MEA chips

- Planar high density MEA chips

- Standard licensing to Brainwave – for data acquisition and analysis

4. Identification of the statutory exceptions permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 10 U.S.C. 2304(c)(1), Only one responsible source (ALA Scientific Instruments) and FAR 6.302-1 sole source (including brand name) acquisitions

5. Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

ALA Scientific Instrument, Inc. is the sole source supplier in North America for BioCam Duplex system which satisfies all required specifications described above. The BioCam Duplex system is unique and there are no other competitors carrying similar system in the world.

We have added brain slice electrophysiology to our repertoire for neurotoxicity assessments.

This system will complement our existing system which comprised of 65 planar (2D) microelectrodes in generating critical data as to effects of environmental exposures on brain function. Its unique features are:

(1) High density 3D microelectrodes: 4096 penetrating microelectrodes capable of recording beyond the surface of brain slice and ideal for dissociated neurons, stem cell derived-neurons, as well as brain organoids

(2) Bidirectional microelectrodes: not only can we record from all 4096 microelectrodes, we can deliver electrical current to any of the 4096 microelectrodes to evoke and record synaptic potentials.

(3) Functional imaging capability: system and software can convert electrical activities recorded from all 4096 microelectrodes into a functional image; system can overlap tissue image (taken with any standard light microscope) with electrical signals to evaluate brain signal propagation and effects on brain network circuitry.

Thus far, we have had at least 12 funded projects, of which at least 5 are currently active and ongoing, as well as 2 pending proposals that require the use of a microelectrode array system.

Our current microelectrode array system is capable of recording from only 16 microelectrodes simultaneously from a brain slice (or other tissue/cell sample). The microelectrodes are 2D or planar and do not penetrate the tissue. Furthermore, our current system cannot generate functional images to efficiently assess signal propagation across brain slice. One of our pending proposals involve brain organoids and a high density (>4000 microelectrodes) 3D or penetrating microelectrode system that can generate functional images is required. We have at least 3 trained PhD level neuroscientists with extensive electrophysiology experience. The acquisition of this advanced system is appropriate for our research missions and will position NAMRU Dayton as a prominent contributor in the field of environmental health effects research.

Our research has found no other contractor capable of providing the system sufficient to address our research needs. Not acquiring a system or purchasing a less capable system would be detrimental to the Government as the inability to acquire research data could potentially delay research progress. A secondary problem involves the credibility of NAMRU Dayton as a reliable, knowledgeable, and proficient source for this type of research and could result in the loss of our future funding considerations.

A total of 5 vendors were contacted for information and evaluated. In person discussions took place at the Society for Neurobiology Meeting in October 2019.

1. 3Brain – in person meeting, email, telephone conversations. They have several HD-MEA systems.

The BioCAM DupleX system has 4096 3D penetrating microelectrodes, can deliver electrical stimulations as well as record from all 4096 3D microelectrodes, and can overlay and generate functional images from recorded electrical activity. Company is based in Switzerland.

2. ALA Scientific Instruments, Inc. – in person meeting, email, telephone conversations. They carry the identical HD-MEA system as 3Brain (BioCAM DupleX) and found out that ALA Scientific is the sole US distributor for 3Brain.

3. Automate Scientific, Inc. (Berkeley, CA) – in person meeting. They do not have HD-MEA systems.

Unable to meet government’s requirements, eliminated from further consideration.

4. Multichannel Systems – in person meeting. Their HD-MEA system works only with planar (2D) microelectrode arrays (non-penetrating). They do have penetrable microelectrode array but not at high density. Unable to meet government’s requirements, eliminated from further consideration.

5. Maxwell Biosystems – contacted company via their website. Their HD-MEA system works only with planar microelectrode arrays (non-penetrating). Unable to meet government’s requirements, eliminated from further consideration.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

The independent research performed by in-house NAMRU Dayton staff constitutes the equivalent of Market Research. This independent survey has been ongoing since the inception of proposals of studies for which it was determined that there was a need for a high density 3D microelectrode array system. In total, the research constitutes attendance at a Society for Neuroscience annual meeting where discussions with > 5 electrophysiology vendors occurred, hours of web browsing, and emailing with manufacturers of this line of system inquiring about the availability of this product. We found one product (BioCam Duplex) that meets our research needs.

Based on our independent research for complete high density 3D microelectrode array system equipped with functional imaging, NAMRU Dayton feels that justification for this sole source meets the requirement for 10 U.S.C. 2304(c)(1), Only one responsible source and FAR 6.302-1, Only One Source (>$150K) (Warner Instrument LLC) (Listed in Section 4) and therefore a FEDBIZOPPS notice will not be published.

7. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made. In addition, the Government anticipates that the negotiated contract price will reflect a discount from the ALA Scientific Instruments, Inc. commercial price list and will be determined fair and reasonable.

8. Description of the market survey conducted and the results, or a statement of the reasons a market survey was not conducted.

Market research was conducted by a NAMRU-D’s electrophysiology expert in the October 2019

– November 2019 timeframe. This research consisted of reviews of previous procurements and quote requests as well as one on one meetings with several vendors at Society for Neuroscience annual meeting held on Oct 19-23, 2019. Web searches using assorted search engines of open market contractors were employed. The conclusion was that ALA Scientific Instruments, Inc.

was the sole supplier of a high density 3D microelectrode array system with functional imaging capability that can meet the Government’s requirements. The results of the market research are attached.

9. Other facts supporting the use of other than full and open competition.

The requirement listed was not competed in open competition.

(i) Technical data packages, specifications, engineering descriptions, statements of work, or purchase descriptions suitable for full and open competition have not been developed because NAMRU Dayton feels that the FAR 5.202 only one responsible source applies.

(ii) 6.302-1 has not been cited for a follow-on acquisition. There is no duplication of costs to the Government because NAMRU Dayton has not purchased nor does it already possess a high density 3D microelectrode array system with functional imaging capability.

(iii) 6.302-2 has not been cited.

10. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest.

A FEDBIZOPPS notice will not be published because NAMRU Dayton feels 10 U.S.C.

2304(c)(1), Only one responsible source and FAR 6.302-1, Only One Source (>$150K) (ALA Scientific Instruments, Inc) apply based on our marketing research.

11. Statement of actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

For the reasons set forth in Paragraph 5, NAMRU Dayton has no plans at this time to compete future contacts for the types of supplies/services covered by this document. If another potential source emerges, (NMRC) will assess whether competition for future requirements is feasible.

NAMRU-Dayton scientists are researchers working in the field of toxicology and environmental health effects. We regularly read scientific literature and attend national and international symposia where products of this nature are advertised and displayed; at which time we evaluate their strengths and weaknesses in relation to our organizational research. Procurement of these products from ALA Scientific Instruments Inc. is imperative for us to continue to provide our customers with the best possible research in the most efficient manner. The proposed sole source is the only known source able to satisfy the government’s requirement(s). This is a one-time purchase.

12. Point of Contact.

The point of contact at the Naval Medical Research Center, Silver Spring, MD, regarding the contents of the sole source justification is , Deborah M. Sharpe, who may be reached at (301) 319-6471 or Edilberto Calma 301-319-6481.

TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY NAVSUP 4200.83 series

I certify that the facts and representations under my cognizance which are included in this justification and approval and which form a basis for this justification are complete and accurate.

Technical Cognizance

937-904-9440 3 Feb 2020 Name: Joyce G. Rohan Phone Date Title: Research Physiologist Department/Command: Environmental Health Effects Laboratory, Naval Medical Research Unit Dayton

Requirements Cognizance

937-904-8640 3FEB2020

Name: LCDR Matt Shipman Phone Date Title: Technical Research Support Dept Head Department/Command: Environmental Health Effects Laboratory, Naval Medical Research Unit Dayton

CONTRACTING OFFICER CERTIFICATION

I certify that this justification is accurate and complete to the best of my knowledge.

Deborah M. Sharpe Phone Date Contracting Officer

Edilberto P. Calma Phone Date Contracting Officer

Technical Cognizance