Peregrine Pharmaceuticals Appoints Former Genentech Senior Executive Dr.Robert Garnick as Head of Regulatory Affairs
Mon, 10/19/2009 - 6:34am
PeregrinePharmaceuticals, Inc. today announced that Dr. Robert Garnickhas joined the company as the head of regulatory affairs. Dr. Garnick wasformerly the senior vice president of regulatory, quality and compliance atGenentech. During his 24-year career at Genentech, he was responsible for 17new product approvals including most of the company's top selling monoclonalantibody therapeutics such as Rituxan, Herceptin, Avastin and Lucentis.Dr. Garnick will be responsible for overseeing Peregrine's interactions withthe U.S. FDA and regulatory agencies around the world, and will lead thedevelopment of the company's regulatory strategies for advancing its novelmonoclonal antibody-based treatments for cancer and infectious diseases. . "Rob has an unparalleled track record in the biotechnology andpharmaceutical industry, having led the regulatory, quality and compliancestrategy for developing many of the most successful monoclonal antibodytherapeutics currently on the market representing multiple disease areas,"said Steven W. King, president and CEO of Peregrine. "His profoundunderstanding of every aspect of the regulatory process and how it impactsclinical design and drug development is already proving invaluable as weprepare for the next stage of clinical development for our innovative drugcandidates bavituximab and Cotara. We have made considerable progress overthe past few years in our clinical programs and bringing Rob's expertise andexperience on board at this critical time is a significant development for thecompany.". . Dr. Garnick has over 30 years of experience in drug and biologicpharmaceutical development, including 24 years at Genentech helping to buildthe biotechnology industry. Dr. Garnick joined Genentech in 1984 and after aseries of promotions, he became vice president of quality in 1994 and waslater promoted to senior vice president of regulatory, quality and compliancein 2001. In this role, Dr. Garnick was responsible for all the regulatedaspects of Genentech's business including drug development, commercialproduction and promotional and labeling compliance. After leaving Genentechin 2008, Dr. Garnick founded Lone Mountain Biotechnology and Medical DevicesInc., a successful company specializing in drug and device consulting where heremains as president and CEO.. . "Peregrine's bavituximab and Cotara products represent the kind ofinnovation that made my drug development work so exciting and fulfilling atGenentech," said Dr. Garnick. "Peregrine's PS-targeting antibodies such asbavituximab represent an entirely new mechanism that has already shownconsiderable promise for the treatment of cancer and infectious diseases,while Cotara has shown promising survival benefits in patients suffering fromthe worst form of brain cancer. I welcome the opportunity to work with thePeregrine team to help advance these promising candidates through the clinicaland regulatory process.". . Dr. Garnick has also been extensively involved with the InternationalConference on Harmonisation of Technical Requirements for Registration ofPharmaceuticals for Human Use (ICH), a project that brings together regulatoryauthorities and pharmaceutical industry experts from Europe, Japan and theU.S. to discuss scientific and technical aspects of product registration froma global perspective. 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 keynotespeaker at pharmaceutical Industry conferences and events.. . Joseph Shan, vice president of clinical and regulatory affairs atPeregrine added, "Rob is a welcome addition to the team at Peregrine, joiningat an opportune time as we have just recently completed enrollment in allthree of our ongoing bavituximab Phase II cancer trials, as well as abavituximab Phase I cancer trial. He brings a tremendous amount of enthusiasmand experience across many different areas that will be very valuable as wecontinue to advance our clinical and preclinical programs.".