FOR IMMEDIATE RELEASE

February 2, 2016

Contact: Stephanie Flores, CAE

Executive Director

CASSS – An International Separation Science Society

510-428-0740

Gene Murano Announced as CASSS Hancock Award Winner for 2016

CASSS has honored Genesio “Gene” Murano, PhD, principal/partner with Bioscope Associates, LLC, with its prestigious HancockAwardfor Outstanding Achievements in CMC Regulatory Science.

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.”

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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 ofdriving 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 byaunique style: personable, welcoming and with a truly elegant approachto policy and regulatory activities.”

Murano has had a long career inthefield ofbiotechnologyboth as a regulator and industry participant. His FDA tenure spanned 20 years, ending as theAssociate Director for Science, Office of Therapeutics Research and Review, and Deputy Director, Division ofHematological 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.

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“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 ofbiotechnology-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.

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This is the fifthtime 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

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About CASSS

CASSS is a not-for-profit professional scientific society made up of over 4,000 industry, academic, and regulatory professionals. CASSS is dedicated to facilitating the sharing of resources, information, and best practices to advance scientific knowledge for the benefit of its members and the public at large. Membership is complimentary and is open to all who support the objectives of the Society and are willing to contribute to the achievement of those objectives.

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