This website uses cookies to store information on your computer. Some of these cookies are used for visitor analysis, others are essential to making our site function properly and improve the user experience. By using this site, you consent to the placement of these cookies. Click Accept to consent and dismiss this message or Deny to leave this website. Read our Privacy Statement for more.
Print Page   |   Contact Us   |   Sign In   |   Register
Community Search
William S. Hancock Award 2019
Share |

2019 Hancock Award Winner Tom Layloff

 

Bill Hancock, left, and CASSS President Wassim Nashabeh, right, present 
Hancock Award to 2019 recipient Tom Layloff, middle.

 

CASSS has honored Tom Layloff, PhD 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. Layloff was announced as the 2019 honoree during CASSS’s 23rd Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products (commonly referred to as WCBP), held in Washington, D.C., January 29-31.

“I am honored, but I don’t need an award,” Layloff said after accepting the award, “Being here at the meeting today, I see many of those young investigators who came up through the FDA, now as leaders in their companies. WCBP has been an integral part of their careers."

In his comments to introduce this year’s honoree, CASSS President Wassim Nashabeh shared highlights of Layloff’s long career. Among his achievements:

- Served as professor of Analytical Chemistry at the University of Kansas.

- Worked as a scientific advisor and eventually director of the National Center for Drug Analysis in St. Louis for over 20 years. He is largely credited for developing the center into the FDA’s leading pharmaceutical testing laboratory in the nation.

- Director of Regulatory Standards at FDA, CDER.

- US Pharmacopeia Vice President and Director of the Pharmaceutical Standards Division. He was elected to serve two five-year terms on the USP Committee on Revisions. He chaired chapter subcommittees and was a member of the reference standards committee.

Tom also served on the key FDA advisory committee including the Manufacturing Advisory Sub-Committee and was Past Chair of the Pharmaceutical Analytical Technology Sub-Committee. These committees were advisory to FDA, CDER in their development of guidance documents which address the incorporation of new technologies into the approval and inspection processes.

He has vast knowledge on supporting non-profit organizations in enabling access to safe and affordable medicine.  He was part of MSH (Management Sciences for Health) as a Principal Program Associate in the Center for Pharmaceutical Management on the Bill and Melinda Gates funded SEAM projects for Tanzania.

Tom participated as a Senior Environmental Advisor, Partnership for Supply Chain Management (PFSCM) and technical advisor for FHI 360 (Family Health International) Product Quality and Compliance Division. His work resulted in timely availability of critical and affordable medicines to patients worldwide, in many instances, for unmet medical needs.

“You always know where you stand with Tom.” Nashabeh said, speaking of both interactions within the context of executing the WCBP Symposium and issues related to the current state of CMC/Regulatory. 

“At the time, our inspectors were seeing unbelievable things in the early biologics labs. I saw WCBP as an opportunity to educate industry on FDA expectations,” Layloff said.

Dr. Layloff continues to play an important role in bringing medicines to those who need them through work as Technical Advisor, FHI 360 Product Quality and Compliance Division (fhi360.org); Senior Environmental Advisor, Partnership for Supply Chain Management (PFSCM, pfscm.org); and Principal Technical Advisor, Pharmaceutical Health Technologies Division, Management Sciences for Health (MSH, msh.org). 


 



 

Membership Software Powered by YourMembership  ::  Legal