Acquisition of Services for cGMP Testing of PEN-866 Drug Conjugate

The Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Pediatric Oncology Branch (POB) plans to procure, on a sole source basis, for the generation of a new Certificate of Analysis (CoA) for the drug conjugate PEN-866 from: PPD Development LP (PPD) 929 N Front St Wilmington, NC 28401 The response close date of the notice for this requirement is in accordance with FAR 5.203(b). This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR Part 13.106-1 (b)(1) and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 541380 (Testing Laboratories and Services) and the business size standard is $19.0 Million. PEN-866 is a HSP90 inhibitor-drug-conjugate which effectively regresses tumors and improves survival in multiple models of pediatric sarcoma. The National Cancer Institute (NCI) currently holds the existing drug supply, and the open clinical trial is being conducted without an industry partner with NCI as the sponsor. To stay in compliance with federal regulations, samples of the drug production batch used in the clinical trial must be regularly tested for their stability for the duration of the trial. NCI originally obtained its supply of PEN-866 from Tarveda Therapeutics which is no longer in business. After production of the initial PEN-866 batch, PPD then developed and validated protocols for stability and purity testing for PEN-866 during the initial phases of clinical trials. As such, PPD is the only vendor with established and validated protocols for testing PEN-866. For that reason, PPD is the only vendor who can meet the Government's need for ongoing stability and purity testing of PEN-866 without significant delays or duplicated cost to the Government. For those reasons PPD is the only vendor who can perform the necessary testing in a timely and cost-effective manner. This notice is not a request for competitive quotations. However, if any interested party, especially a small business, believes it can meet the Government's needs it may submit a capability statement, proposal, or quote for the Government to consider. The response and any other information furnished must be in writing and must contain sufficient details to allow NCI to determine if the party can perform the requirement. Responses to this notice shall be submitted via email to Contracting Officer, John Russell, at John.Russell3@nih.gov no later than 10:00 A.M. EST on Friday, July 18, 2025 (07/18/25). A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered for the purpose of determining whether to conduct a competitive procurement. The Government reserves the right to use the information provided by respondents for any purpose deemed necessary and legally appropriate. To receive an award, Contractors must be registered and have valid certification through SAM.GOV. Please reference the notice number 75N91025Q00045 on all correspondence. ***Please reference attached Statement of Work for more details pertaining to the nature of the work to be performed. ***