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Rob Garnick Announced as CASSS Hancock Award Winner for 2018

Monday, March 12, 2018   (0 Comments)
Posted by: Amy Cano
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CASSS President Wassim Nashabeh , left, presents
Hancock Award to 2018 recipient Robert Garnick, right.


CASSS has honored Rob Garnick, PhD, a former Senior Vice President of Regulatory, Quality and Compliance at Genentech, Inc., with its prestigious Hancock Award for Outstanding Achievements in CMC Regulatory Science.

This annual award recognizes outstanding and sustained contributions in the field of regulatory science. Garnick was announced as the 2018 honoree during CASSS’s 22nd Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products (commonly referred to as WCBP), held in Washington, D.C., January 30 – February 1.

“I am very honored to receive this award and see it as a reward for all the years I spent in ICH working with very talented people on very difficult issues,” Garnick said after accepting the award, “I am very pleased that my colleagues in industry, the global regulators and the CASSS directors have honored me. CASSS has done a fantastic job of building on and continuing the spirit of Well Characterized Biological Products and its annual meetings are some of the best in the industry."

In his comments to introduce this year's honoree, CASSS President Wassim Nashabeh shared highlights of Garnick's long career in biologics. Among his achievements:

      • He joined Genentech in 1983 as its 300th employee.

      • He was significantly involved with the approval of every Genentech Biotech product from Human Growth Hormone through, Rituxan, Avastin and Lucentis.                Approximately, 17 different drugs over his tenure. 

      • He was involved with the FDA in planning for the very first FDA sponsored meeting in 1995 where the basic concept of a well characterized Biological Product            was derived. This later became the CASSS WCBP Symposium.

      • In the early days of biotech evolution, Rob immediately recognized the need to focus on the challenges facing both industry and regulators. Ultimately,                        impacting product safety and efficacy in a transparent way as information was rapidly evolving. This mentality set the standard to help foster a trusted and                respectful collaboration with industry and regulatory authorities. An algorithm that nowadays is practiced as a matter of course. 

"Rob was famous for saying, '...we don't yet have all the data, but as soon as we do, you will be the first to know before we proceed,'" Nashabeh said. 

"I have always been interested in the entire Regulatory process and my career in regulatory allowed me to use my scientific background in molecular structure elucidation to provide insight into how biologics can and should be regulated on a global basis. I found regulatory affairs to be a perfect fit for my talents," Garnick said.

Garnick continues to support the biotech community through his consultancy on drug development and regulatory affairs called Lone Mountain. He also is focused on the future of this industry through his investing in biotech start-ups.

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