This FDA award recognizes new reviewers who have demonstrated an extraordinary grasp of the public health objectives of the Agency’s review process and through their efforts have made an impact or contribution to a significant regulatory decision of their review unit. To be considered, the individual must have begun employment at FDA in the previous 5 years.
Achievements that may be used to support a nomination may include:
- Independent review of a complex application
- Presentation of the primary review of a complex matter to an Advisory Committee
- Original scientific contribution that impacts a regulatory decision
- Publication or invited presentation of review related research
- Significant contribution to the development of a new guidance document (particularly a regulatory science guidance as opposed to a procedural guidance) or improvement of a current guidance document.
- Significant leadership on standards committee or authorship of new FDA-recognized standard.
Joshua A. Young, Ph.D. (Staff Fellow - CDRH)
For independent review of complex applications involving chemical characterization and detailed feedback to support justifications by the review team.
Christa Johnson, DVM (CVM)
For outstanding contributions to protect human and animal health by ensuring appropriate disclosure in owner consent forms for animal studies and exceptional animal drug review.
Xiajing (Jean) Gong, PhD (CDER) (Staff Fellow)
For exceptional contributions in developing advanced data analytics capacity including quantitative modeling & simulation, and machine learning methodologies and data management to support OGD's missions.
Brittany W. Schuck, PhD
For innovative regulatory approaches to improve the availability of safe and effective genetic in vitro diagnostic tests.
Kimberly Schultz, PhD
For exceptional contribution to the regulatory review of chimeric antigen receptor (CAR) T cell-based gene therapy products.
Shruti V. Kabadi, PhD
For outstanding review and analysis of pharmacokinetic data using computational methods to ensure the safe use of food additives and resolve public health issues.
Lian Ma, PhD
For exceptional contribution towards personalized medicine in the area of medical countermeasures and oncology through optimal dose selection and dose individualization.
Michelle L. McClure, PhD
For outstanding achievement in device review, leading to development of guidance on infectious disease screening and testing for donors of human cells and tissue-based products.
Maura C. O’Leary, M.D.,
For outstanding review of cell and gene therapies for the treatment of pediatric malignancies.
April Neal Kluever, Ph.D., D.A.B.T.,
For outstanding performance as a new reviewer in the Division of Food Contact Notifications, OFAS, CFSAN
Eric Dollins, Ph.D.,
For outstanding contributions to improving the regulation of innovative products in cellular therapies.
Scott Winiecki, M.D.,
For outstanding epidemiologic investigation and analysis of thromboembolic events following the use of intravenous immune globulins, leading to improved safety of currently available medications.
Christopher Breder, M.D., Ph.D.,
For development and application of unique methods of analysis and for systematic and innovative review of original data in a complex application
Qiang Xu, Ph.D.,
For outstanding contributions in regulatory review work and scientific research work related to science-based decision making process.
Jennifer Catalano, PhD,
For outstanding contribution on the complex issue of review of application with new ‘genomics technologies and International Conference on Harmonization genomics guidance formation 2012