Support Services for Clinical Trials of Therion Produced Vaccines

Note'this synopsis follows a Sources Sought Notice that was released on July 28, 2009 under Sources Sought Notice No. N02-RC-01010-03. The National Cancer Institute (NCI), Laboratory of Tumor Immunology and Biology (LTIB), located in the Center for Cancer Research (CCR) is proposing to contract for consulting and professional services to support on-going and future clinical studies of recombinant poxvirus vaccines manufactured by the former Therion Biologics Corporation (Therion). These vaccines were developed jointly by LTIB and Therion under a longstanding Cooperative Research and Development Agreement (CRADA) to treat various cancers, including prostate cancer. Therion was responsible for (1) the generation and analysis of the recombinant viruses, (2) the manufacture and testing of virus stocks and vaccine product lots under Current Good Manufacturing Practices (CGMP), and (3) the preparation, submission, and maintenance of regulatory submissions containing all Chemistry, Manufacturing, and Control (CMC) information required by the Food and Drug Administration (FDA) for approval to conduct clinical trials of these vaccines. Therion closed abruptly in November, 2006. A new CRADA has been set up with Bavarian Nordic Immunotherapeutics (BNIT), to provide the CMC support necessary to continue the clinical research in the prostate cancer program; transition to this new CRADA partner is in progress. Additional CRADA(s) will also be established to continue the other Therion vaccine programs. At the same time, the integrity and stability of the vaccine materials must be continuously preserved and monitored, and the Investigational New Drug Applications (INDs) and related Master Files (MFs) filed by the Cancer Therapy Evaluation Program (CTEP) with the FDA must be supported and updated as required. This contract provides the scientific and regulatory expertise necessary to maintain the CMC status of the Therion vaccines in good standing with the FDA and enable the continuation of the associated clinical studies sponsored by CTEP. The Contractor shall provide the following tasks: monitoring of stability testing of vaccines, vaccine inventory management, maintenance of regulatory documentation including, Investigational New Drug applications for vaccines developed under a CRADA with Therion and assistance in transitioning vaccine development to a third party partner. Any Contractor performing this work must have knowledge of assay procedures and Investigational New Drug applications. In addition, the Contractor must monitor transfer and inventory of current vaccines from a third party contractor to a Government repository; this requirement will allow the continuity of the vaccine clinical trials within the NCI and to continue with the current schedule of these clinical trials. The Contractor shall provide technical assistance in the preparation of any new lots of vaccines produced using the original seed stocks developed at Therion. The anticipated period of performance, inclusive of all options, for this proposed contract is 03/01/2010 through 02/28/2013. The contract will consist of a one (1) year base period (03/01/2010 - 02/28/2011) and if exercised, a one (1) year option period (03/01/2011 - 2/29/2012) and two (2), six (6) month option periods (03/01/2012 - 08/31/2012) and (09/01/2012 - 02/28/2013). It is anticipated that the Request for Proposal will be available on or about October 2, 2009 with responses due within 30 calendar days following the actual date of issuance of the RFP. POTENTIAL OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. Full electronic copies will not be accepted, but portions of the proposal may be provided on disc. The reference number to be used for this announcement is RFP N02-RC-01010_03. All correspondence must cite the reference number as provided.