Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF SEPTEMBER 15, 2024 SAM #8328
SOLICITATION NOTICE

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

Notice Date

9/13/2024 12:14:33 PM
 

Notice Type

Presolicitation
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

NATIONAL INSTITUTES OF HEALTH - CC BETHESDA MD 20892 USA
 

ZIP Code

20892
 

Solicitation Number

NOI-CC-25-000073
 

Response Due

9/18/2024 8:00:00 AM
 

Archive Date

10/03/2024
 

Point of Contact

Lu Chang
 

E-Mail Address

lu-chang.lu@nih.gov
(lu-chang.lu@nih.gov)
 

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 distribute the product and is allowed to use Lantheus� Federal Supply Schedule contract on contract 36F79719D0170. This requirement will be sole sourced to Sofie Co. under FAR 8.405-6 (b): Only one source is capable of providing the�supplies�or services required at the level of quality required because the�supplies�or services are unique or highly specialized. Lantheus Medical Imaging (a company of Lanntheus Holding, Inc.) is the developer and intellectual property owner of Piflufolastat F-18 injection drugs (Pylarify) in the United States. More specifically, Progenics Pharmceuticals had been developing this drug and Lantheus merged Progenics Pharmaceuticals. Sofie Nuclear Pharmacy (known as Sofie Co.) is the only local authorized commercial nuclear pharmacy authorized by Lanthesus Medical Imaging to compound, prepare, delivery and invoice for these drugs. Sofie Co. is allowed to use Lantheus� Federal Supply Schedule contract on contract 36F79719D0170, and they are the designated authorized vendor for our area. Only this drug can be used for Program�s patient care and research and Program has been using these drugs for years in ongoing projects and patient care. Only qualified vendors that meet the FDA and US NRC regulations can provide these radiopharmaceuticals for compounding and dispensing at NIH Nuclear Pharmacy to NIH Clinical Center patients. Thus, only Sofie Co. is the sole authorized provider of these drugs. Requirement: 60x Qty for PYLARIFY piflufolastat F-18 injections 3x Qty for PYLARIFY unused doses fees Place of Performance or Delivery: The contract period of performance is 10/01/2024 to 09/30/2025 This requirement will be awarded on GSA Contract #36F79719D0170.� Place of Performance: NIH Clinical Center in Bethesda, MD The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL.� All responsible sources that could provide the required may submit a capability statement that will be considered by email (subject line to reference NOI-CC-25-000073) by 11:00 AM eastern standard time on 09/18/2024 to: lu-chang.lu@nih.gov All responses received by the closing date of this synopsis will be considered by the Government.� A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/d83a8d1f1f934c2d937d82443ebb5f4e/view)
 

Place of Performance

Address: Bethesda, MD 20814, USA

Zip Code: 20814

Country: USA
 

Record

SN07211114-F 20240915/240913230122 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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