AI
Tuesday, October 20, 2009 11:12:56 AM
Examples of Dr. Robert Garnick’s work at Genentech…
12-4-03: FDA ACCEPTS BLA FOR GENENTECH'S AVASTIN
A Biologics License Application for Genentech's Avastin (bevacizumab) has been accepted by the FDA. As part of the Avastin BLA filing, Genentech requested and has been granted, priority review designation from the FDA. Based on the priority review designation, the FDA has 6 months from the submission date, or by the end of March 2004, to take action on the BLA filing. The final portion of the BLA was submitted under the FDA's Fast Track designation as a treatment for first-line metastatic colorectal cancer in combination with chemotherapy. 'This priority review designation puts us one step closer to delivering a potential new therapy to metastatic colorectal cancer patients and we will continue to work with the FDA as they review our Avastin BLA filing," said Dr Robert Garnick, Genentech's senior vice president, regulatory, quality and compliance.
http://www.manufacturingchemist.com/story.asp?storycode=22663
2-26-04 - ATTACHMENT D – AVASTIN APPROVAL LETTER
From: FDA, To: Dr. Robert Garnick
http://investorshub.advfn.com/uimage/uploads/2009/10/20/pptxoFDA-Feb2004-Garnick2.jpg
FOLLOWED BY AVASTIN EXPANSION APPROVAL AS 2ND-LINE VS. MET. COLORECTAL CANCER:
6-20-06: From: FDA
Dear Dr. Garnick:
…
http://www.genentechaccesssolutions.com/docs/av/FDA_approval_letter_Avastin_Colorectal_2nd_line.pdf
= = = = = = = = = 10-19-09:
“Peregrine Pharmaceuticals Appoints Former Genentech Senior Executive Dr. Robert Garnick as Head of Regulatory Affairs”
• During a 24-Year Career at Genentech, Dr. Garnick was Responsible for the Approval of 17 Products Including Rituxan(R), Herceptin(R), Avastin(R) and Lucentis(R)
• Dr. Garnick to Direct Regulatory Operations, Strategy and Commercial Development Planning as Peregrine Advances its Oncology and Infectious Disease Clinical Programs
…Dr. Garnick will be responsible for overseeing Peregrine's interactions with the U.S. FDA and regulatory agencies around the world, and will lead the development of the company'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…
"Peregrine's bavituximab and Cotara products represent the kind of innovation that made my drug development work so exciting and fulfilling at Genentech," said Dr. Garnick. "Peregrine's PS-targeting antibodies such as bavituximab represent an entirely new mechanism that has already shown considerable promise for the treatment of cancer and infectious diseases, while Cotara has shown promising survival benefits in patients suffering from the worst form of brain cancer. I welcome the opportunity to work with the Peregrine team to help advance these promising candidates through the clinical and regulatory process." …
http://tinyurl.com/yga7z4x
= = = = = = = = = = =
And don’t forget, Dr. Garnick will be working with this fellow:
8-31-09: Renouned Oncologist Dr. Bruce Chabner added as Advisor
…Dr. Chabner will serve as a clinical advisor to the company on the design of clinical trials for the Bavi cancer program…
"Bavituximab's novel mechanism that enables the patient's immune system to attack tumors more effectively combined with its natural synergy with chemotherapy make it an intriguing and promising new approach to treating solid tumors," said Dr. Chabner. "The early clinical data on bavituximab is encouraging and I look forward to assisting Peregrine as they advance the bavituximab cancer program into later-stage trials [Ph IIB & III] in a number of indications."
http://tinyurl.com/lma24x
12-4-03: FDA ACCEPTS BLA FOR GENENTECH'S AVASTIN
A Biologics License Application for Genentech's Avastin (bevacizumab) has been accepted by the FDA. As part of the Avastin BLA filing, Genentech requested and has been granted, priority review designation from the FDA. Based on the priority review designation, the FDA has 6 months from the submission date, or by the end of March 2004, to take action on the BLA filing. The final portion of the BLA was submitted under the FDA's Fast Track designation as a treatment for first-line metastatic colorectal cancer in combination with chemotherapy. 'This priority review designation puts us one step closer to delivering a potential new therapy to metastatic colorectal cancer patients and we will continue to work with the FDA as they review our Avastin BLA filing," said Dr Robert Garnick, Genentech's senior vice president, regulatory, quality and compliance.
http://www.manufacturingchemist.com/story.asp?storycode=22663
2-26-04 - ATTACHMENT D – AVASTIN APPROVAL LETTER
From: FDA, To: Dr. Robert Garnick
http://investorshub.advfn.com/uimage/uploads/2009/10/20/pptxoFDA-Feb2004-Garnick2.jpg
FOLLOWED BY AVASTIN EXPANSION APPROVAL AS 2ND-LINE VS. MET. COLORECTAL CANCER:
6-20-06: From: FDA
Dear Dr. Garnick:
…
http://www.genentechaccesssolutions.com/docs/av/FDA_approval_letter_Avastin_Colorectal_2nd_line.pdf
= = = = = = = = = 10-19-09:
“Peregrine Pharmaceuticals Appoints Former Genentech Senior Executive Dr. Robert Garnick as Head of Regulatory Affairs”
• During a 24-Year Career at Genentech, Dr. Garnick was Responsible for the Approval of 17 Products Including Rituxan(R), Herceptin(R), Avastin(R) and Lucentis(R)
• Dr. Garnick to Direct Regulatory Operations, Strategy and Commercial Development Planning as Peregrine Advances its Oncology and Infectious Disease Clinical Programs
…Dr. Garnick will be responsible for overseeing Peregrine's interactions with the U.S. FDA and regulatory agencies around the world, and will lead the development of the company'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…
"Peregrine's bavituximab and Cotara products represent the kind of innovation that made my drug development work so exciting and fulfilling at Genentech," said Dr. Garnick. "Peregrine's PS-targeting antibodies such as bavituximab represent an entirely new mechanism that has already shown considerable promise for the treatment of cancer and infectious diseases, while Cotara has shown promising survival benefits in patients suffering from the worst form of brain cancer. I welcome the opportunity to work with the Peregrine team to help advance these promising candidates through the clinical and regulatory process." …
http://tinyurl.com/yga7z4x
= = = = = = = = = = =
And don’t forget, Dr. Garnick will be working with this fellow:
8-31-09: Renouned Oncologist Dr. Bruce Chabner added as Advisor
…Dr. Chabner will serve as a clinical advisor to the company on the design of clinical trials for the Bavi cancer program…
"Bavituximab's novel mechanism that enables the patient's immune system to attack tumors more effectively combined with its natural synergy with chemotherapy make it an intriguing and promising new approach to treating solid tumors," said Dr. Chabner. "The early clinical data on bavituximab is encouraging and I look forward to assisting Peregrine as they advance the bavituximab cancer program into later-stage trials [Ph IIB & III] in a number of indications."
http://tinyurl.com/lma24x
