Gáborik, Zsuzsanna
(SOLVO Biotechnology, a Charles River Company)
Why drug development takes so long and how
to help it?
The COVID-19 pandemic presented new challenges but also new opportunities for companies in the pharmaceutical sector. It also highlighted the importance of readily available capabilities which help respond quickly to new diseases. The pharmaceutical and biotechnology sector has the highest intensity of Research and Development, with an average cost of two billion USD for developing a new drug. This can take 10-15 years to marketing a synthesized compound as a new drug. With such high cost and no promise of reward, there is an increasing importance of minimizing risk and avoiding failure especially before the long and most costly clinical study part. In this process precise and timely prediction of drug safety and efficacy is of high importance. The trend to minimize human risk and animal experiments highlights the importance of computer simulation models and predictions using complex mathematical models. In the pharmaceutical industry, mathematics‐based models can be applied at all stages of development, starting with formulation design, continuing through the preclinical pharmacokinetic studies, clinical study planning and evaluation, scale‐up, and extending into process monitoring. In my presentation I review the stages of drug development from lead identification to approval with a focus on examples of mathematical models and simulations used to improve safety and efficacy prediction quality.
The talk is held in Hungarian!
Az előadás
nyelve magyar!
Date: Nov 9, Tuesday
4:15pm
Place: BME, Building „Q”, Room
QBF13