Pictured: the three Certara-Monash Fellows (L-R): Dr. Yu-Wei Lin, Dr. Zheng Liu and Dr. Katrina Hui).
This fellowship program was designed by Certara and Monash University to help prepare the next generation of industry-experienced drug development scientists through training in clinical pharmacology, pharmacometrics and regulatory science.
Based at the Monash Institute of Pharmaceutical Sciences, the program provides a combination of academic coursework, hands-on industry training, international industry/academic placements, and research. The fellowship program is designed to address the industry growth and increased need for global talent in drug development and regulatory sciences. The fellows will contribute to the planning, execution and analysis of pre-clinical and clinical drug development and pivotal clinical trials leading to regulatory submission in Australia.
Underscoring the need for this advanced training program, Australia’s Therapeutic Goods Administration, the China National Products Administration, European Medicines Agency, Japan’s Pharmaceuticals and Medical Device Agency, the UK’s Medicines and Healthcare Products Regulatory Agency, and US Food and Drug Administration are all increasing their use of modeling and simulation to evaluate new drug submissions. In fact, there are now more than 200 label claims on FDA-approved drugs that have been made using physiologically-based PK modeling alone, in lieu of a clinical study.
Outcomes: All five postdoctoral fellows have now been appointed. Feedback from academic and industry mentors is positive with respect to the skills being learnt by the fellows and their impact on the projects they are involved in. One fellow was recruited from the program to work within industry.
|Consoritum Partners||Monash University|
|Project Duration||April 2019 - October 2021|
Craig Rayner, President | Intergrated Drug Development, email@example.com