CASSS – Sharing Science Solutions has honored Wassim Nashabeh, PhD with its prestigious William S. Hancock Award for Outstanding Achievement in CMC Regulatory Science. The annual award recognizes outstanding and sustained contributions in the field of regulatory science. Nashabeh was announced as the 2024 honoree during CASSS’ Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products (WCBP), held in Washington D.C. on January 23-25.
Julia Edwards, who served as CASSS President (2022-2023) and has been a longtime mentee and friend of Nashabeh, presented the award. She shared, “He has inspired and shaped my thinking and my career. He supported me in almost every crazy idea I have had, and he provides me feedback and put effort into making me better. The thing about Wassim, I am not even a unique story. There are many of us here in the room, online and beyond, that have had similar experiences. It is in these experiences in what has become and aligned collective vision that has really advanced the biopharmaceutical industry forward. Wassim’s contribution to CMC regulatory science, his vision, and lessons he has taught us will continue to advance our thinking as a biopharmaceutical community and sustain us for years to come.”
(Left to right: Jamie Moore, Gilead Sciences, Inc., Wassim Nashabeh, Roche Pharmaceutical Group, and Julia Edwards, Genentech, a Member of the Roche Group at WCBP 2024)
When accepting the award, Nashabeh reflected on two aspirations of the community, “We want science-based regulations because this is the only way innovation can strive. We want the regulatory system to support innovation rather than hinder it. This is an area over the years where we have made significant progress in terms of the product modalities and the technologies used in how they are manufactured and controlled. The second aspiration, we want these regulations to be the same everywhere and implemented in the same way globally. Everything we have done over the last 30 years has been for these two simple aspirations…The second aspiration has proved more difficult to achieve but has been greatly accelerated from learnings of the pandemic. This period when we all became patients, showed us that no one can do it alone—and the incredible power of global collaboration…and the essential need to drive this harmonization in a global basis.”
Career Overview
Nashabeh is currently the Vice President and Global Head of Regulatory Policy & International Operations for the Roche Pharmaceutical Group. In this capacity, Nashabeh has oversight of all technical outreach activities with global health authorities, industry associations, and scientific organizations.
Nashabeh has a PhD in analytical chemistry from Oklahoma State University and a post-doctoral fellowship in bioanalytical from The Barnett Institute, Northeastern University, and is the author of over 30 scientific publications, reviews, and patents in the fields of separation science and biotechnology.
Some of Nashabeh’s career accomplishments include:
International Committee on Harmonization (ICH)
- Expert member of the ICH responsible for development of global guidelines for Pharmaceuticals. Served as an expert working group member of ICH Q11 and Q3D and ICH Q12.
- Member of ICH General Assembly on behalf of Biotechnology Innovation Organization (BIO) since 2017.
- Elected to ICH Management Committee in 2018 and reelected to a second term in 2021 and served as a member of the ICH industry Executive Council since 2018.
APEC
- Core member of the APEC RHSC (Asia Pacific Economic Cooperation, Regulatory Harmonization Steering Committee) responsible for advocacy and oversight of regulatory convergence activities within the 21 APEC economies.
- Member of the APEC Harmonization Center (AHC) Advisory Board supporting AHC regulatory capacity building and strategic planning.
Academic Appointments
- Visiting Expert at Duke-National University of Singapore Medical University Centre of Regulatory Excellence.
- Member of Northeastern University Bioanalytical Research Centre Advisory Board, an ICH Training Centre of Excellence.
- Member of Northeastern University College of Science Dean's Advisory Council.
Contributions to CASSS
Nashabeh has been essential to the growth and creation of multiple CASSS Symposia and Fora, including the CMC Strategy Forum global expansion in Europe, Latin America, and Japan. He was also one of the founding members of the CE in the Biotechnology & Pharmaceutical Industries Symposium (CE Pharm) and won the CE Pharm Award for Sustained and Significant Contribution to the Practical Application of CE to the Analysis of Biotechnology and Pharmaceutical Products in 2008.
He served on the CASSS Board of Directors for 14 years, including the roles of Vice President from 2016-2018 and then President from 2018-2020. In addition, he was awarded the CASSS Distinguished Fellows designation in 2020 for his outstanding contributions to CASSS, our community, and industry overall.