Piflufolastat F-18 injection drugs (Pylarify) from Sofie Co. (Notice of Intent to sole source)
ID: NOI-CC-25-000073Type: Presolicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTES OF HEALTH - CCBETHESDA, MD, 20892, USA

NAICS

Pharmaceutical Preparation Manufacturing (325412)

PSC

DRUGS AND BIOLOGICALS (6505)

Original Source

https://sam.gov/opp/d83a8d1f1f934c2d937d82443ebb5f4e/view
Timeline
    Description

    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), intends to negotiate a sole-source contract with Sofie Co. for the procurement of Piflufolastat F-18 injection drugs (Pylarify) essential for clinical nuclear medicine procedures at the NIH Clinical Center. This acquisition aims to secure compounded, patient-ready doses of the radiopharmaceutical, which is critical for diagnosing and treating diseases in accordance with patient care protocols. The drugs are FDA-approved and must be compounded and delivered on a time-sensitive basis due to their rapid radiation decay, making Sofie Co. the only authorized provider capable of meeting these specialized requirements. Interested parties may submit capability statements by September 18, 2024, to Lu Chang at lu-chang.lu@nih.gov, as this is not a request for proposals.

    Point(s) of Contact
    Lu Chang
    lu-chang.lu@nih.gov
    Files
    No associated files provided.
    Similar Opportunities
    Notice of Intent to Sole Source; Siemens Medical Solutions
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), intends to award a sole source contract to Siemens Medical Solutions for the maintenance and support of the Syngo Dynamics application. This acquisition aims to activate a software maintenance agreement for the proprietary Syngo Dynamics General Ultrasound software, which is critical for daily operations in patient care at the NIH Clinical Center. The contract will be awarded under the Federal Acquisition Regulation (FAR) Part 13, allowing for a sole source procurement due to the unique nature of the software. Interested parties may express their interest and capabilities to Kristin Nagashima at kristin.nagashima@nih.gov by November 15, 2024, at 10 AM EST.
    Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health (NIH), is soliciting proposals for Chemistry, Manufacturing, and Control (CMC) services related to the development of drug substances under RFP number 75N95024R00094. The primary objective is to secure high-quality drug substances to support preclinical and Investigational New Drug (IND)-enabling studies, ensuring compliance with current Good Manufacturing Practices (cGMP) and federal regulations. This initiative is crucial for advancing therapeutic innovations and facilitating collaborations in drug development, with a total funding amount of up to $49.7 million over the contract period from September 1, 2025, to May 14, 2031. Interested parties must submit their proposals by December 3, 2024, and can direct inquiries to primary contact Samson Shifaraw at samson.shifaraw@nih.gov or secondary contact Valerie Whipple at valerie.whipple@nih.gov.
    PREPARATION AND DISTRIBUTION OF RESEARCH DRUG PRODUCTS
    Active
    Health And Human Services, Department Of
    The National Institutes of Health (NIH), specifically the National Institute on Drug Abuse (NIDA), is seeking proposals for the "Preparation and Distribution of Research Drug Products" under solicitation number 75N95024R00003. The primary objective of this procurement is to acquire, analyze, create, and distribute a variety of drug compounds essential for drug abuse and addiction research, including controlled and uncontrolled substances, while ensuring compliance with DEA regulations. This contract, structured as an indefinite delivery, indefinite quantity (IDIQ) agreement for a five-year period, aims to enhance research capabilities in the field of drug abuse, with proposals due by November 15, 2024, at 1:00 PM (Eastern Time). Interested parties should contact Scott Duernberger at scott.duernberger@nih.gov or Josh Lazarus at josh.lazarus@nih.gov for further information.
    Renewal of Mediso Multiscan LFER 150 software license and PC hardware component upgrades
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking to renew the software license for the Mediso Multiscan LFER 150 and upgrade associated PC hardware components. This procurement aims to ensure the continued functionality and efficiency of critical software used in biomedical research and diagnostics. The renewal and upgrades are vital for maintaining the operational capabilities of NIH's research initiatives in Rockville, Maryland. Interested vendors can reach out to Dana Monroe at dana.monroe@nih.gov or call 406-375-9814 for further details regarding this presolicitation opportunity.
    Reagent Generation for Bioanalytical Method Development on Biologics
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking qualified sources for a potential contract focused on reagent generation for bioanalytical method development related to biologics. The primary objective is to obtain information on the availability and capability of companies to generate and deliver reagents, including anti-drug antibodies, that support the quantification of novel biologic drugs in various biological matrices. This initiative is crucial for advancing drug development processes and improving success rates in preclinical stages, with the Therapeutic Development Branch (TDB) at NIH playing a pivotal role in moving therapeutic candidates through the drug development pipeline. Interested parties must submit their capability statements by November 8, 2024, to Nick Niefeld at nick.niefeld@nih.gov, referencing sources sought notice number 75N95025R00007.
    Notice of Intent to Sole Source Invetech GMP Korus SUS Kits
    Active
    Health And Human Services, Department Of
    The National Institutes of Health (NIH) intends to award a fixed-price purchase order for GMP Korus SUS Kits to Invetech Inc., as part of a sole source procurement. The kits are essential for the Department of Transfusion Medicine, Center Cellular Engineering, which manufactures human cells and tissue-based products for clinical protocols in transplantation and gene therapy. Invetech Inc. is the only known source capable of providing these proprietary kits that are compatible with the Invetech Korus™ Counterflow Elutriation System, which is critical for the department's operations. Interested parties may submit capability statements to Sheri Eiri at sheri.eiri@nih.gov by November 14, 2024, at noon EST for consideration in this procurement process.
    NOI Cytiva Sepax C-Pro Cell Processing Systems Software Upgrade
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking to award a firm fixed price contract for a software upgrade on two Cytiva Sepax C-Pro Cell Processing Systems. The objective of this procurement is to enhance the functionality of these systems, which are critical for the Department of Transfusion Medicine, thereby reducing the need for alternative devices and associated maintenance costs. This sole source acquisition is justified as Cytiva-Global Life Sciences Solutions USA LLC is the original equipment manufacturer and the only qualified provider for the proprietary software required for the upgrade. Interested parties must submit capability statements by November 14, 2024, at 12:00 PM EST to Sheri Eiri at sheri.eiri@nih.gov for consideration.
    NIAID CLINICAL PRODUCTS CENTER (CPC)
    Active
    Health And Human Services, Department Of
    The National Institutes of Health (NIH), specifically the National Institute of Allergy and Infectious Diseases (NIAID), is seeking proposals for a contract to provide pharmacy and pharmaceutical oversight for clinical trials, both nationally and internationally. The primary objective of this contract is to ensure the integrity of study products, participant safety, and compliance with pharmacy and pharmaceutical regulations throughout various NIH-funded clinical trials. This opportunity is critical for maintaining high standards in public health research, as it encompasses a wide range of services including product management, regulatory document maintenance, and clinical laboratory testing. Proposals are due by January 17, 2025, with the contract expected to commence on April 1, 2026, and run through March 31, 2027, potentially extending through 2033. Interested parties can contact Deborah Blyveis at blyveisd@niaid.nih.gov or Emily Bannister at emily.bannister@nih.gov for further information.
    Qiagen LLC QIAsymphony DSP DNA Midi Kits, filter tips and supplies
    Active
    Health And Human Services, Department Of
    The National Institutes of Health (NIH) intends to issue a sole source firm fixed-price purchase order to Qiagen LLC for QIAsymphony DSP DNA Midi Kits, filter tips, and related supplies, essential for the Microbiology Service section of the Department of Laboratory Medicine. This procurement aims to acquire reagents and supplies necessary for the efficient extraction of nucleic acids from clinical samples, which is critical for timely detection of infectious agents and supporting ongoing clinical testing. The items will be utilized with existing QIAsymphony SP and QIAgility instruments, which are vital for the laboratory's operations and the development of novel tests. Interested parties may submit their capability statements to Shasheshe Goolsby at shasheshe.goolsby@nih.gov by November 14, 2024, at 2:30 PM EST, as this is not a request for proposals.
    INTENT TO SOLE SOURCE - CAREFUSION for Pyxis rental with full support
    Active
    Health And Human Services, Department Of
    Special Notice: HEALTH AND HUMAN SERVICES, DEPARTMENT OF intends to negotiate a sole source contract with CareFusion Solutions for Pyxis rental with full support. Pyxis is a drug automated distribution system that controls the availability, access distribution, and patient safety. The contract will be in effect from the date of award to March 31, 2025. This is a non-competitive procurement based on exclusive licensing agreement. Other potential sources may submit a capability statement by July 24th, 2024.