Piflufolastat F-18 injection drugs (Pylarify) from Sofie Co. (Notice of Intent to... Tender

Procurement Summary

Country : USA

Summary : Piflufolastat F-18 injection drugs (Pylarify) from Sofie Co. (Notice of Intent to sole source)

Deadline : 14 Mar 2025

Other Information

Notice Type : Tender

TOT Ref.No.: 116023526

Document Ref. No. : NOI-CC-25-004297

Competition : ICB

Financier : Self Financed

Purchaser Ownership : Public

Tender Value : Refer Document

Purchaser's Detail

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Tender Details

Description

Acquisition Description:

This is a Notice of Intent, not a request for proposal. The National Institute of Health, Clinical Center (NIH-CC) intends to negotiate on an other than full and open competition basis with Sofie Co. (a.k.a. Sofie Biosciences Inc.).



The National Institute of Health, Clinical Center (NIH-CC)-s has the Nuclear Pharmacy (CC NP) department (collectively “Program”) that purchases and compounds radiopharmaceuticals (radioactive drugs) on a daily basis for life-saving clinical nuclear medicine procedures. This is essential for the NIH Clinical Center to achieve optimal patient care. These radiopharmaceuticals are United States Food and Drug Administration (FDA) approved drugs for use in patients. They are also radioactive materials that are regulated by the United States Nuclear Regulatory Commission (US NRC) through the NIH radioactive material license (RAM) administered by the NIH Radiation Safety Office (RSO). Only RSO certified Nuclear Medicine personnel can order these radiopharmaceuticals directly for patient use. Each radiopharmaceutical is time sensitive because of the rapid radiation decay. Because of their short useful half-lives, they cannot be ordered in advance for storage. They must be properly compounded, dispensed, calibrated and delivered for a specific patient at a specific time on a specific date on a daily basis.

The purpose is to procure compounded piflufolasta F-18 in patient ready unit doses (UDs) from an authorized nuclear pharmacy (Sofie Nuclear Pharmacy) for the use by the NIH Nuclear Medicine, Department of Radiology and Imaging Sciences to diagnose and treat diseases as required by necessary patient care protocols at the NIH Clinical Center. This new radioactive drug is vital to the NIH Clinical Center mission.

The product is owned and developed by Lantheus Medical/Progenics Pharmaceuticals (now merged as one company). Sofie Co. has been authorized by Lantheus to manufacture and dist...
Active Contract Opportunity
Notice ID : NOI-CC-25-004297
Related Notice
Department/Ind. Agency : HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier : NATIONAL INSTITUTES OF HEALTH
Office: NATIONAL INSTITUTES OF HEALTH - CC
General Information
Contract Opportunity Type: Presolicitation (Original)
Original Published Date: Mar 10, 2025 07:53 pm EDT
Original Response Date: Mar 14, 2025 11:00 am EDT
Inactive Policy: 15 days after response date
Original Inactive Date: Mar 29, 2025
Initiative: None

Classification
Original Set Aside:
Product Service Code: 6505 - DRUGS AND BIOLOGICALS
NAICS Code: 325412 - Pharmaceutical Preparation Manufacturing

Place of Performance: Bethesda, MD 20814 USA

Documents

 Tender Notice