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Gene Murano Announced as CASSS Hancock Award Winner for 2016

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This annual award recognizes outstanding and sustained contributions in the field of regulatory science. Murano was announced as the 2016 honoree during CASSS’ 20th Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products (commonly referred to as WCBP), held in Washington, D.C., January 26 through 28.

“The Hancock Award represents the dedication and commitment that is required in order to achieve success in the production, control and approval of the highest quality medicines, worldwide,” Murano said. “I am humbly honored having been selected as a recipient this year.”

In his comments to introduce this year’s honoree, CASSS Vice President Wassim Nashabeh said that Murano “exemplifies the true mission of what we are here for, in terms of driving the establishment of science-based regulations for biotech products and relentlessly advocating for the adoption of such regulations in a harmonized way globally.”

Nashabeh also noted that Murano “has distinguished himself by a unique style: personable, welcoming and with a truly elegant approach to policy and regulatory activities.”

Murano has had a long career in the field of biotechnology both as a regulator and industry participant. His FDA tenure spanned 20 years, ending as the Associate Director for Science, Office of Therapeutics Research and Review, and Deputy Director, Division of Hematological Products.

Following his FDA career, Murano was the Director of the Division of Biologics and Biotechnology at USP. In 2000, he joined Genentech, where he was the first to establish the Regulatory Policy Office in Washington, D.C., eventually moving to San Francisco as Vice President of Regulatory Affairs.

Murano shared what he has enjoyed about his long career in regulatory science —“The ability and privilege to routinely interact with very smart people, to share points of interest and diverse views, to learn about the latest scientific breakthroughs, to solve serious problems that impact the practice of medicine and health care delivery.”

While the Hancock Award honors a long career, it does not mark an ending.

“In the autumn of my career, one of my goals is to share with young people my incredibly satisfying and exciting experiences working in this field of developing high quality pharmaceuticals with particular emphasis on the fact that whether in academia, in industry, in government service, the net value is the same,” Murano said.

In his comments to WCBP attendees, Murano remarked on CASSS’ crucial role in regulatory science.
“The CASSS/WCBP membership can and should continue to play a role in fostering an innovative environment, advocating and facilitating the practice of sensible science-based regulation,” Murano said.

“Your habits and practices are well-honed and your contributions to date remarkable. ... With the past as prologue, I envision the future is very bright.”

A nominee for the CASSS Hancock Award must have made significant contributions to the advancements of scientific principles, applied technologies and /or science-based regulations in the areas of manufacturing, process/technology development, characterization, analysis and/or quality of biotechnology-derived pharmaceuticals. The awardee’s achievements must have been instrumental in enabling the availability of high quality medics derived from recombinant technology on a global basis.

This is the fifth time that this honor has been awarded, starting with the WCBP conference in 2012. Previous awardees are:
  • 2015 – Takao Hayakawa
  • 2014 – Kathryn C. Zoon
  • 2013 – Yuan-yuan Chiu
  • 2012 – Ken Seamon