MasterL, Barnett Inst. Director profiles Robert L. Garnick… Nice to hear he’s a “nice man” too… BTW, he ended up with 1300 people working for him.
12-6-07: ”Rob Garnick appointed Adjunct Professor at Barnett Institute” I am pleased to report that Dr. Robert Garnick, Senior Vice President, Regulatory, Quality and Compliance at Genentech has accepted my invitation to be appointed an Adjunct Professor of the Barnett Institute. We are indeed fortunate to have the affiliation of Dr. Garnick, given his broad background in the biopharmaceutical field and his great success in bringing 18 protein therapeutic products to market. In his role as Adjunct Professor, he will provide continuous advice as we move ahead to establish a GMP/GLP laboratory. In addition, he will visit Northeastern several times yearly and meet with students to discuss future career paths in the biotechnology industry. Rob Garnick received his Ph.D. under the direction of Dr. Philip Le Quesne. After working for Armour, he moved to Genentech in 1984, where he began a most successful career. His broad knowledge of the biotech industry was on display in his presentation of the Hoehn Lecture. He is a loyal alumnus who serves on the Advisory Board of the Barnett Institute. All of us at Northeastern are proud that he is an alumnus.
The Barnett Institute welcomes Dr. Garnick as an Adjunct Professor and looks forward to close interaction in the years ahead.
Barry L. Karger Director, Barnett Institute James L. Waters Chair in Analytical Chemistry Northeastern University Boston, MA 02115 http://www.dac.neu.edu/barnett/BInews_2007/GarnickAdjunctprof.htm THE BARNETT INSTITUTE: http://www.northeastern.edu/barnett The Barnett Institute is a center of excellence in the development and application of technologies for proteomics and systems biology [at Northeastern University].
= = = = = = = = = = = = = = = BusinessWeek EXECUTIVE PROFILE Robert Garnick Ph.D. Head of Regulatory Affairs, Peregrine Pharmaceuticals Inc. Age: 60 -- BACKGROUND Robert L. Garnick, Rob, Ph.D., has been Head of Regulatory Affairs at Peregrine Pharmaceuticals Inc., since October 19, 2009. Dr. Garnick is responsible for overseeing Peregrine's interactions with the U.S. FDA and regulatory agencies around the world, and leads the development of the Peregrine Pharmaceuticals's regulatory strategies for advancing its novel monoclonal antibody-based treatments for cancer and infectious diseases. Dr. Garnick has over 30 years of experience in drug and biologic pharmaceutical development, including 24 years at Genentech helping to build the biotechnology industry. He served as Senior Vice President of Regulatory, Quality & Compliance at Genentech Inc. since February 2001. During his 24-year career at Genentech, he was responsible for 17 new product approvals including most of the Genentech's top selling monoclonal antibody therapeutics such as Rituxan®, Herceptin®, Avastin® and Lucentis®. Previously, Dr. Garnick served as Vice President, Regulatory Affairs from February 1998 to February 2001, Vice President, Quality from April 1994 to February 1998, Senior Director, Quality Control from 1990 to 1994 and Director, Quality Control from 1988 to 1990. He joined Genentech in August 1984 from Armour Pharmaceutical, where he held various positions. After leaving Genentech in 2008, Dr. Garnick founded Lone Mountain Biotechnology and Medical Devices Inc., a successful company specializing in drug and device consulting where he remains as President and CEO. Dr. Garnick has also been extensively involved with the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). He has extensive experience in analytical methodology, process validation, and the regulatory review process in the U.S. and Europe. Dr. Garnick has authored numerous scientific papers and is a frequent keynote speaker at pharmaceutical Industry conferences and events.
= = = = = = Genentech 10-K iss. 2-23-2007: Robert L. Garnick, Ph.D. was appointed Senior Vice President, Regulatory, Quality and Compliance of Genentech in February 2001. Previously, he served as Vice President, Regulatory Affairs from February 1998 to February 2001, Vice President, Quality from April 1994 to February 1998, Senior Director, Quality Control from 1990 to 1994 and Director, Quality Control from 1988 to 1990. He joined Genentech in August 1984 from Armour Pharmaceutical, where he held various positions. http://www.gene.com/gene/ir/downloadDoc.do?id=3461
= = = = = = = = = = = == = = = = = 12-10-09 Peregrine’s Qtly CC: ( http://tinyurl.com/y9tr3q3 ) 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 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. . .” *snip*
= = = = = = = = Peregrine’s CEO Steve King, 5-18-10, R&R, on Recent Additions: Slide5: “3 of the key hires in the last 9 mos. or so include Robert Garnick as the Head of Reg. Affairs. Rob was formerly the Head of Reg. Affairs at Genentech - he was there for 17 years, and directly oversaw the approval of such successful drugs as Avastin, Herceptin, Rituxin, Lucentis. Clearly, no one in any company has a better track record than he had during his time at Genentech, so he really brings a lot of regulatory leadership to the company. Marvin Garovoy came on board as the Head of Clinical Science in January – he was involved on the medical side in the approval of Raptiva, where he worked with Rob on that project. In addition, as our Mfg. business has grown, as we look to transition toward commercial production for our own products as well as our clients’ products, we brought on board Truc Le as COO Officer of our Mfg. Business (Avid Bioservices) – he brings a lot of mfg. experience to the table, and the ability to implement a lot of lean mfg. techniques as we move into, again, advancing that business.” http://tinyurl.com/23wqam9
= = = = = = = = = = = = = = 10-19-09: Dr. Robert Garnick (former DNA Exec) appointed Head/Reg.Affairs http://tinyurl.com/yga7z4x ...examples of Dr. Garnick's work at Genentech on Avastin (bevacizumab) approvals: http://tinyurl.com/yg7vtqa ...All of Dr. Garnick's comments (thru 12/2009) re: his new assoc. with PPHM: http://tinyurl.com/yjd3ucc
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