To support the commercial development plan for our ACT, we engaged four leading consultants to provide key services in cell therapy bioprocess engineering, clinical trial design, biostatistics, regulatory affairs and FDA compliance. This dynamic team has been instrumental in developing our clinical strategy to advance our ACT on a regulatory pathway toward approval.
One of the prerequisites for a successful IND filing is confirmation of our ability to manufacture our investigational ACT treatment in accordance with good clinical practice ("GCP"). Our goal is to ensure our GCP process will be consistent with the approach we propose to take for the manufacture of commercial product As previously reported we entered into a process development and scale-up agreement relating to the manufacture of Contego with Lonza, which is one of the world's leading suppliers to the pharmaceutical, healthcare and life science industries. Over the past months we have made significant progress in taking the Standard Operating Procedures (SOPs) currently used by the institutions conducting the physician-sponsored studies, and replicating them to build scaled-up bioprocesses that can support the commercial manufacture of Contego. Our goal is to complete the technology transfer to Lonza and obtain FDA certification for a commercial-scale TIL manufacturing processes to be ready to commence Registration trails in late 2013.
We are very satisfied with the progress we've made to date, and expect the remainder of 2012 to be an equally productive time. We are delighted to be working with several of the world's leading oncologists and clinical cancer-care institutions to bring our ACT through the regulatory process with the goal of expanding access to this life-saving therapy to the thousands of patients with late-stage melanoma who have no other treatment options.
On behalf of my colleagues and our Board of Directors, tha
|SOURCE Genesis Biopharma, Inc.|
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