AN11--Intent to sole source - Cancer Prevention Study - Imiquimod and Placebo

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The Department of Veterans Affairs, VA Cooperative Studies Program, Clinical Research Pharmacy Coordinating Center (CRPCC) in Albuquerque, NM, intends to negotiate on a sole source basis, pursuant to FAR 6.302-1, with Societal CDMO provide ACTIVE Imiquimod 5% cream and matching PLACEBO products to be used in a VA clinical study.. The vendor is also required to develop required formulations and analytic methods related to successful manufacturing of the product which will be submitted to the FDA as part of the Investigational New Drug (IND) request. Societal CDMO was the only vendor identified who was a FDA-approved Manufacturer and could formulate, manufacture, and supply the CSPCRPCC with active Imiquimod (IMQ) 5% topical cream with a therapeutic equivalence evaluation and a matching placebo and the vendor. Therapeutic equivalency requires that the active IMQ 5% cream be classified as a pharmaceutical equivalent, expected to have the same clinical effect and safety profile when administered to study participants under the conditions specified in the official prescribing information. Societal CDMO will develop active and placebo formulations and provide it to user for submission in FDA Investigational New Drug (IND) application. This requirement is supporting a cancer prevention clinical study intending to use imiquimod 5% cream and matching placebo as the drug intervention. This trial will study the effects of chemoprevention on the recurrence of basal cell carcinoma. This is a notice of intent and is not a request for competitive proposals; however, any responsible source who believes they are capable of meeting the requirement may submit a capability statement to the contracting office no later than February 28th, 12PM, EST. Interest/capability statements may be sent to Lynn Portman at lynn.portman@va.gov. No telephone responses will be accepted. A determination not to compete the proposed requirement based upon the responses to this notice is solely within the discretion of the Government.