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This Pre-Solicitation opportunity was posted on June 25, 2018. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

Parathyroid Hormone (PTH) Aptamer Probe Development

Closed
75D301-18-Q-68645Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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NAICS: 541714
New
Federal
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The Capability Program Executive for Chemical, Biological, Radiological, and Nuclear Defense (CPE CBRND) is establishing the Chemical, Biological, Radiological, and Nuclear (CBRN) Medical Countermeasure (MCM) Participant Basic Agreement (PBA) ecosystem. This continuous, open announcement seeks to build a network of pre-qualified partners to accelerate the development, testing, and fielding of next-generation medical defense solutions. The program focuses on two primary pillars: host-targeted resilience, which targets critical host systems like neurological and respiratory pathways to enhance physiological protection, and threat-targeted neutralization, which focuses on broad-spectrum countermeasures for prophylaxis and acute treatment. Priority is given to candidates designed for austere environments, featuring environmental stability without cold-chain reliance and simplified administration routes such as oral or intranasal delivery. The government is inviting two types of participants: MCM Development Collaborators, ranging from Phase I products through FDA licensure, and MCM Development Support Collaborators, such as CROs and CDMOs specializing in preclinical testing, cGMP manufacturing, and regulatory submissions. Interested parties must submit a white paper of no more than five pages detailing their product descriptions, efficacy data, regulatory status, and manufacturing capabilities. Acceptance into the PBA enables the subsequent award of project orders under the authority of 10 U.S.C sections 4021, 4022, and 4023. These agreements are not subject to the Competition in Contracting Act of 1984. All prospective awardees must be registered in the System for Award Management (SAM) database to receive payment.
W6QK Acc-Apg

POSTED

1 day ago

DEADLINE

N/A
NAICS: 541714
New
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AJ12--Development/Production - Kidney GEC-Specific AAV Vector
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The Department of Veterans Affairs is issuing a Sources Sought notice to identify capable vendors for the development and production of a kidney glomerular endothelial cell specific adeno-associated virus AAV vector. This project, funded by a VA ORD Merit award, aims to create a homing peptide enabled vector platform to target the glomerular endothelium to treat kidney injury and disease while reducing off target transduction. The scope of work is divided into three primary tasks: the engineering and incorporation of targeting peptides into the AAV capsid, testing vector binding and internalization in kidney tissue slices, and evaluating the specificity and efficiency of the modified vector through bioluminescence imaging and in vivo biodistribution studies. Qualified contractors must possess extensive onsite resources, including BSL 2 laboratories, specialized DNA and RNA facilities, and advanced instrumentation such as the Agilent Fragment Analyzer and various qPCR platforms. Vendors must demonstrate proven success in animal and human cell vector delivery and maintain full compliance with AAALAC and FELASA health standards. The government requires quarterly reporting, weekly videoconferences, and biannual face to face meetings. All generated data will be subject to Government Purpose Rights, and contractors must adhere to strict federal records management and information security protocols. Interested parties must submit a capability statement, relevant literature, and socio economic status details under NAICS 541714 by November 4, 2026.
Rpo East (36C24E)

POSTED

1 day ago

DEADLINE

in 13 days
NAICS: 541714
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Translational Centers Using Microphysiological Systems for Infectious Diseases (U54 Clinical Trial Not Allowed)
Solicitation # RFA-AI-28-012
The National Institute of Allergy and Infectious Diseases (NIAID) has issued solicitation RFA-AI-28-012 to establish a consortium of Translational Centers Using Microphysiological Systems for Infectious Diseases (TCMID). The primary objective is to refine and validate human tissue models using Microphysiological Systems (MPS) to a level consistent with regulatory qualifications, thereby promoting their adoption by product developers and reducing reliance on laboratory animals. This initiative aligns with NIH and FDA guidance on New Approach Methodologies (NAMs) to accelerate the development of safer medical interventions by capturing human variability and patient-specific characteristics. The program is structured around an Administrative Core, a Qualification Core, and Scientific Cores, with a heavy emphasis on technical readiness, reproducibility, and regulatory acceptance. Key deliverables include the validation of assays for specific endpoints and the submission of regulatory packages. Applicants must be domestic entities, as foreign organizations and foreign subawards are strictly prohibited. Required personnel must possess deep expertise in infectious diseases, MPS platforms, bioinformatics, and FDA submission processes. Applications are due by January 29, 2027, and must be submitted via the NIH ASSIST system or approved institutional system-to-system solutions. Evaluation is based on an overall impact score considering the project's significance, the suitability of the investigators, and the quality of the institutional environment. Mandatory application components include a Data Management and Sharing Plan and a Benchmarks and Timeline PDF not exceeding six pages. Awardees must also adhere to strict cybersecurity incident reporting guidelines, notifying HHS within 48 hours of any discovery.
National Institutes Of Health

POSTED

3 days ago

DEADLINE

in 3 months
NAICS: 541714
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Immune Tolerance Network (UM1 Clinical Trial Required)
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The National Institutes of Health, under the Department of Health and Human Services, is seeking applications through solicitation RFA-AI-28-005 to continue the Immune Tolerance Network (ITN). This cooperative agreement aims to develop tolerogenic therapies for immune-mediated disorders, specifically focusing on autoimmune diseases, allergic diseases and asthma, and the immune-mediated consequences of transplantation. The network operates through four integrated functional areas: Leadership, Clinical Operations, Core Laboratory, and Bioinformatics. Its primary objectives include designing and conducting clinical trials, performing integrated mechanistic studies, and sharing research results. Eligible applicants include small businesses and other for-profit organizations, though non-domestic entities are ineligible. Applications are evaluated based on scientific and technical merit, with a primary focus on significance and the likelihood of exerting a sustained influence on the research field. Key requirements include maintaining active registrations in SAM.gov, eRA Commons, and Grants.gov, as well as adhering to strict cybersecurity incident reporting and human subject protection protocols. The project requires a minimum effort of 3.6 person months per year for the PD/PI and mandates participation in a kick-off meeting in Bethesda, Maryland, and bi-annual steering meetings. Applications must follow specific page limits for the research strategy subsections and include detailed plans for clinical trial implementation, data management, and biorepository services.
National Institutes Of Health

POSTED

3 days ago

DEADLINE

in 3 months

General Info

Agency

N/A

NAICS

541714 - Research and Development in Biotechnology (except Nanobiotechnology)

Place of Performance

Base Pair Biotechnologies, Inc 8619 Broadway Street Suite 100, PEARLAND, TX, 77584-9765, USA

Set-Aside

NONE

Documents

0

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Timeline

PhaseClosed
Posted

Presolicitation

Response Deadline

Deadline has passed

Submission Closed

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Organization & Contact Information

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AgencyN/A
Contacts1 person available
OfficeN/A
Organization / Agency
N/A
Office AddressN/A
Contacts
Tonya S. JusticeContracting Officer

Full Description

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This is a notice of intent to award a sole source contract and is not a request for competitive proposals. The Centers for Disease Control and Prevention (CDC), National Center for Environmental Health (NCEH) hereby announces its intent to award a sole source contract to Base Pair Biotechnologies, Inc., 8619 Broadway Street, Suite 100, Pearland, TX 77584-9765 for the acquisition of Parathyroid Hormone (PTH) Aptamers Probe development. The statutory authority for this sole source acquisition is 10 U.S.C. 2304(c)(1) in accordance with FAR Part 6.302-1, only one responsible source and no other supplies or services will satisfy the agency requirement. The NAICS code for this acquisition is 541714, Research and Development in Biotechnology (except Nanobiotechnology). The period of performance for this procurement is four (4) months. The purpose of this procurement is to purchase Parathyroid Hormone (PTH) Aptamers Probe development from Base Pair Biotechnologies, Inc. The aptamer probe development project consists of four phases: initial aptamer candidate selection, high throughput sequencing and bioinformatics, affinity screening and aptamer-based enrichment screening, and delivery of material. PTH is a polypeptide hormone synthesized by the parathyroid gland through a conversion of pre-pro-PTH to pro-PTH via a 25 amino acid N-terminal cleavage and pro-PTH to PTH via a 6 amino acid N-terminal cleavage. PTH is a key biomarker in patient diagnosis and treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD), as well as hypo/hyperparathyroidism, hypercalcemia and renal osteodystrophy. There is an obvious clinical need for the harmonization of PTH testing. Several other companies can provide aptamer development. However, Base Pair Technologies is the only company that provides the following unique services, including: (1) library screening against 1015 unique single stranded oligonucleotides, (2) multiplex SELEX which determines the best candidates that bind to the target, (3) sequencing by next generation sequencing which distinguises aptamers that bind to single targets, multiple targets and unwanted molecules and (4) high-throughput screening/characterization to generate 2-20 potential candidates. Other companies with the ability to provide aptamer development were researched. However, they could only implement antibody libraries with 109 molecules (which may result in a lower probability of generating an applicable PTH aptamer sequence), could only bind one target at a time and only screen targets iteratively instead of in a multiplexing process. This results in processes that take much longer compared to Base Pair's process and will impact end results. Base Pair Technologies, Inc. is the only source for this instrument that can meet our specific needs and fulfill the requirements of the aptamer development that the Protein Biomarker Laboratory needs for this project. As a result of this synopsis, no competitive solicitation will be posted on FedBizOpps.com. We will only issue a solicitation to Base Pair Technologies, Inc. However, all responsible sources who believe they can meet these requirements, may submit their capabilities and/or qualifications to Tonya S. Justice, Contracting Officer, via email to TJustice@cdc.gov, no later than 10:00am eastern standard time on July 10, 2018. Reference solicitation number RFP #75D301-18-Q-68645 in the subject line of the email. A determination by the Government not to compete this proposed action will be based on responses to this notice and is solely in the discretion of the Contracting Officer. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.

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