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Replies to post #206488 on Avid Bioservices Inc (CDMO)
DR. ROBERT GARNICK (HEAD OF REGULATORY AFFAIRS):
”Thank you, Steve, and thank you everyone for joining this call. I am really very pleased to be here with you today, since I’ve been working with Peregrine for only a few months. In this call, I’d like to focus on sharing with some general observations that I have made on Peregrine and its product pipeline.
Let me start by telling a little bit about myself. I’ve spent all of my professional career working in the area of drug development, focusing on the rigorous scientific, clinical, and regulatory assessments that must be completed before any potential new product or medical device can be marketed. As you know, this is typically a very long complex and challenging process. However, the rewards for both drug developers, investors, and most importantly the patients who so desperately need these new products, can be quite substantial. In my own career, I’ve had the good fortune to spend over 32 years in the pharmaceutical industry, 24 years of which were at Genentech, where I was part of the birth of the biotechnology industry. I joined Genentech in 1984, and had the unique opportunity to literally grow up with the company, and played a significant role in the development of its products. At Genentech, I was deeply involved in obtaining marketing approval for 17 drug products and 3 manufacturing facilities, including such anticancer blockbusters as Rituxan for non-Hodgkin Lymphoma, Herceptin for breast cancer, Avastin for colorectal cancer and non-small cell lung cancer, and Lucentis for age-related macular degeneration. After heading up Genentech’s formal regulatory efforts for 15 years and growing my own department to over 1,300 people, in 2008 I decided it was time to retire from the corporate life of a large company and form the biotechnology specialty consulting company through which I was very fortunate to meet the excellent folks here at Peregrine.
After carefully studying the company’s Phosphatidylserine-Targeting Antibody platform and its lead product candidate bavituximab, I became extremely excited and agreed to work with Steve and his team to help guide the drug’s development, focusing specifically on how we might accelerate its progress towards marketing approval.
I’d like to say that bavituximab reminds me a great deal of a similar and very important monoclonal antibody, Rituxan, because of the biological elegance of its mechanism of action. Because of the similarity, the regulatory approach I’m recommending to Peregrine for bavituximab is very consistent with the approach we took at Genentech for obtaining the approval of Rituxan. I’m extremely optimistic that bavituximab may represent a unique and valuable new approach to the treatment of advanced refractory cancer in combination with chemotherapy or radiation, and based on its mechanism of action may potentially be useful in anti-viral and other indications as well. In addition to my personal scientific interest in the potential Peregrine’s technology, I’ve also been very impressed with the Peregrine team and the mix of professionalism, enthusiasm and commitment that are so reminiscent of my early days of Genentech.
As Steve mentioned, this is a very exciting time for Peregrine’s drug development programs. We have recently completed patient enrollment in 3 signal seeking bavituximab Phase II cancer trails, as well as an earlier-stage bavituximab cancer & Cotara brain cancer studies, and we eagerly anticipate having data starting to come in from these studies in the next few months. This sets the stage for planning our next set of bavituximab cancer trials and we are actively embarking on that progress. Our goal is to implement a clinical and regulatory strategy, that will maximize our chances of getting that bavituximab approved and to do so in the shortest feasible timeframe.
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