On January 30, 2017 PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, officially reported that PharmaCyte has retained Facet Life Sciences, Inc. (Facet) to guide PharmaCyte through its pancreatic cancer therapy development lifecycle with the U.S. Food and Drug Administration (FDA) (Press release, PharmaCyte Biotech, JAN 30, 2017, View Source [SID1234517605]). Facet has been working with PharmaCyte and Translational Drug Development (TD2) since September 2016 and was instrumental in expediting PharmaCyte’s pre-IND meeting with the FDA.
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The Chief Executive Officer of PharmaCyte explained retention of Facet, "After we completed much of the Chemistry, Manufacturing and Control (CMC) work for PharmaCyte’s pre-IND submission to the FDA, we decided that PharmaCyte needed to retain a life sciences consulting firm that could guide it in a broad spectrum of areas that will be required for the successful development of PharmaCyte’s therapy for pancreatic cancer.
"Facet’s initial efforts to date have included assembling all of the preclinical and clinical data available on PharmaCyte’s therapy for pancreatic cancer and submission to the FDA as a ‘pre-IND package.’ Subsequently, Facet made arrangements with the FDA for the pre-IND meeting with the FDA and played a significant role in the meeting. We are extremely pleased with Facet’s performance and are convinced, based upon the results of the FDA meeting, that we made the right selection in retaining Facet."
The Facet Life Sciences team is comprised of drug development, regulatory affairs and regulatory writing experts who have scientific degrees and over 100 years of combined experience in the pharmaceutical, biologics, biopharmaceutical and medical device industry. The services offered by Facet span the full spectrum of services that PharmaCyte will need for regulatory approval of its therapy for pancreatic cancer. Facet is the U.S. Agent for PharmaCyte before the FDA and will assist with regulatory and clinical strategy, preparation and support for regulatory meetings, regulatory submission leadership, gap analyses, product labeling, risk management and medical writing in a number of areas.
The President and CEO of Facet, Ken VanLuvanee, commented on Facet’s retention by PharmaCyte saying, "We are extremely pleased to have been selected to work with PharmaCyte on its novel live-cell encapsulation therapy for pancreatic cancer. This is cutting edge technology that presents one of the most complex regulatory product candidates on which we have ever worked. In spite of its complexity, when compared to a single chemotherapy drug for example, we believe that successful development of PharmaCyte’s therapy may change the way tumors of the pancreas and other solid tumors are treated in the future. It’s truly an exciting time for us and PharmaCyte alike."
Facet development experts work closely with client teams to successfully reach their corporate and product goals. Facet has created and managed critical development aspects for some of the industry’s fastest growing life sciences companies. Its specialists deliver expert services and cutting-edge technologies that are designed to help small life science companies with big goals optimize their product research and development efforts.