SOLE SOURCE JUSTIFICATION_CDER-2026-135969_Redacted.pdf

SOLE SOURCE JUSTIFICATION

DOCUMENTATION OF DECISION TO RESTRICT COMPETITION

ALP Number: CDER-2026-135969 Requirement: Human iPSC-Derived Hindbrain Organoid Functional Assay Services Proposed Contractor: OrganoTherapeutics SARL Estimated Value: $252,742.50 Acquisition Type: Commercial Service Anticipated Contract Type: Firm-Fixed-Price Purchase Order Authority: RFO FAR 12.102(a), Restricting Competition

1. Description of the Requirement

The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Division of Applied Regulatory Science (DARS), requires specialized scientific services to support preclinical research concerning the effects of drugs on respiratory function and the assessment of potential pharmacological reversal agents.

The principal purpose of this acquisition is to obtain functional assay services using human induced pluripotent stem cell (iPSC)-derived hindbrain organoids. Associated organoids, culture media, shipping, and other materials necessary to perform and support the assays are integral to the required service.

The contractor shall provide human hindbrain organoids and conduct functional testing using three-dimensional multi-electrode array (3D MEA) technology to assess changes in electrophysiological activity in response to drugs known to affect respiratory function. The vendor's proposed service encompasses organoid production, drug treatment, MEA measurements, data analysis, study reports, and assessment of batch-to-batch reproducibility.

The planned experiments include evaluation of FDA-identified drug and reversal-agent combinations, with testing performed over multiple organoid batches. The proposed approach includes four experiments, four batches per experiment, eight organoids per experiment per batch, and 16 MEA measurement runs.

The contractor will also provide analysis files, raw data, and written study reports to FDA.

Performance of the applicable experiments requires access to a laboratory licensed to work with the controlled substances included in the study.

2. Authority for Restricting Competition

This acquisition will be conducted as an acquisition of a commercial service pursuant to RFO FAR Part 12, Acquisition of Commercial Products and Commercial Services.

Pursuant to RFO FAR 12.102(a), for acquisitions valued at or below the Simplified Acquisition Threshold, the Contracting Officer shall document the decision that only one source is available and the basis for that decision.

The estimated value of this acquisition is $252,742.50, which is below the current Simplified Acquisition Threshold of $350,000. Accordingly, the Government is documenting its decision to restrict competition to one source under RFO FAR 12.102(a).

Based on the Government's market research and the specialized scientific requirements described below, OrganoTherapeutics SARL is the only source identified as capable of satisfying the Government's complete requirement.

3. Unique Technical Requirements

DARS requires human iPSC-derived hindbrain organoids suitable for studying the effects of drugs known to affect respiratory function. The required organoids must demonstrate characteristics associated with human hindbrain tissue and must be suitable for obtaining electrophysiological data.

The Government's research requirement includes organoids demonstrating expression of genes and biological markers associated with hindbrain function, including DBX1, SLC17A6 (VGLUT2), TACR1 (NK1 Receptor), SST, OPRM1, KCNJ6, ARRB2, ADRA2A, SLC6A2, NALCN, SCN8A, and CACNA1H.

In addition to providing the required organoids, the contractor must be capable of conducting functional characterization to assess the organoids' responsiveness to drugs known to affect respiratory function. The functional assessment requires baseline recordings, sequential drug applications, stabilization between applications, MEA measurements, data analysis, and written reporting.

The proposed contractor's quotation confirms its capability to perform these functional assays using human hindbrain organoids and 3D MEA technology. The studies include testing drug and reversal-agent combinations specified by FDA and conducting the work across multiple organoid batches to assess reproducibility.

4. Market Research and Basis for the Sole-Source Decision

The Government conducted market research to identify commercially available sources capable of providing human hindbrain organoids meeting DARS's scientific requirements and the associated functional assay services.

The IGCE documents that the Government conducted internet research using the search term “hindbrain organoid COMPANY” and investigated six potential sources. The Government's research determined the following:

STEMCELL Technologies indicated that it could provide midbrain organoids but not hindbrain organoids. The company's available product also did not demonstrate certain hindbrain-specific markers required for the Government's research.

Fujifilm offers commercially available midbrain dopaminergic neurons but did not offer a hindbrain-fate product capable of satisfying the Government's requirement.

AcceGen Biotech was identified as having offered a human neural hindbrain stem-cell product;

however, the product has been discontinued.

28bio and Creative-Biolabs did not offer ready-to-use human hindbrain organoids meeting the Government's requirement.

OrganoTherapeutics SARL confirmed that it could provide human hindbrain organoids after reviewing the genes and biological characteristics identified by FDA. Following confirmation of the organoid characteristics, the Government also inquired regarding functional characterization of the organoids in response to drugs known to affect respiratory function. OrganoTherapeutics confirmed its capability to perform the required functional assessment.

The contractor's quotation further demonstrates that the proposed service includes the required human hindbrain organoids, MEA functional assays, controlled drug treatments, MEA measurement runs, data analysis, raw data, analysis files, written reports, and performance in a laboratory licensed to work with the applicable controlled substances.

Based on this market research, no other source identified by the Government was determined capable of satisfying the complete requirement.

5. Basis for Selection of OrganoTherapeutics SARL

OrganoTherapeutics SARL is the only source identified through the Government's market research that demonstrated the capability to provide the required human iPSC-derived hindbrain organoids meeting DARS's identified biological characteristics and perform the associated functional characterization required by the Government.

The contractor has proposed a complete scientific service covering the production and preparation of the organoids, drug treatment, MEA measurements, data analysis, and preparation of study reports. The service is also designed to demonstrate batch-to-batch reproducibility, which is necessary to support FDA's assessment and future experimental design.

Upon completion of each experiment, the contractor will provide FDA with the study results, analysis files, and raw data.

No alternative source identified during market research demonstrated the ability to provide the Government's complete technical requirement.

Accordingly, restriction of competition is based on the Government's minimum scientific and technical requirements and documented market research, and not merely on a preference for a particular contractor.

6. Efforts to Promote Competition

The Government will publicize the acquisition in accordance with RFO FAR 12.202, as applicable. RFO FAR 12.202 requires commercial acquisitions to be publicized in accordance with the applicable publicizing requirements.

The notice will identify the Government's intent to procure the requirement on a sole-source basis from OrganoTherapeutics SARL and provide sufficient information regarding the requirement to permit other responsible sources to respond.

Any timely capability information or quotation received demonstrating that another responsible source can satisfy the Government's complete requirement will be considered by the Contracting Officer prior to award.

7. Determination of Fair and Reasonable Price

The estimated value of the acquisition is $252,742.50.

Prior to award, the Contracting Officer will determine that the proposed price is fair and reasonable. RFO FAR 12.204(a) requires the Contracting Officer to make a fair-and-reasonable-price determination for commercial acquisitions.

The Government's price analysis will consider the Independent Government Cost Estimate, the contractor's quotation, the proposed quantities and services, discounts offered, available market information, and any additional information determined necessary by the Contracting Officer.

The price reasonableness determination will be documented in the contract file prior to award.

8. Actions to Increase Future Competition

For future acquisitions involving human hindbrain organoids and related functional assay services, the Government will continue to conduct market research to identify new or emerging commercial sources capable of satisfying DARS's scientific requirements.

If additional technically capable sources become commercially available, the Government will consider those sources when developing the acquisition strategy for future requirements.

9. Contracting Officer Determination

Based upon the foregoing facts and the results of the Government's market research, I determine that OrganoTherapeutics SARL is the only source identified as capable of satisfying the Government's complete requirement for human iPSC-derived hindbrain organoid functional assay services.

Accordingly, restricting competition to OrganoTherapeutics SARL is justified pursuant to RFO FAR 12.102(a).

The restriction is limited to the extent necessary to satisfy the Government's requirements. Prior to award, the Contracting Officer will consider any timely response received from another responsible source demonstrating the capability to satisfy the complete requirement and will determine that the final price is fair and reasonable.

Contracting Officer: Iris Johnson, Warranted Contracting Officer, OAGS/DAP/FSB

Signature: Date: 9/11/2026