SGS Early Phase Drug Development Course, 9 May 2017, Antwerp
The course aims to provide participants with a strong insight in how drugs are developed, and how you can successfully make the transition from lab to clinic. This meeting encompasses a theoretical plenary morning session with expert lectures and discussions, and in the afternoon, practical workshops where the participants will apply the lessons learned on actual case studies.
This meeting will address:
- The common hurdles and challenges in early phase drug development
- Which regulatory aspects you need to take into account when moving through the different phases of drug development
- How early data analysis through pharmacokinetic and modeling & simulation can optimize decision making
Dr. Katrien Lemmens (MD) will open the session by introducing new approaches for early phase trials. Narine Baririan (PharmD) will follow up by showing how clinical pharmacology and pharmacokinetics expertise can support drug development. Afterwards, Ruben Faelens (MSc Ir.) will present how PK/PD M&S can help in target selection, by predicting and quantifying the drug development process. Finally, Bruno Speder (MSc Ir. MBA) will summarize what regulators expect from applicants, and show how each consultancy approach can help optimize this process.
In his talk, Ruben Faelens from SGS Exprimo will show how we can make better decisions in drug development, through the use of Modeling & Simulation. Strategic decisions in drug development can be of vital importance to a company. In 2006-2015, the Likelihood of Approval from Phase 1 was only 9.6%. Only 1 in 10 promising drugs get approved for use in humans. The attrition rate for Phase 2 is the highest, with 69.3% of Phase II trials failing. To fix this, we need to make better decisions. We need better information. Authorities agree, and promote Model-Informed Drug Development as one of the tools to discover early on if compounds will fail in later phases.
We present a concrete case study for Phase 2 trial design in Parkinson’s Disease. Using publicly available information, we show how we designed the study, and how we optimized information discovery during the trial. Afterwards, a practical session will allow you to simulate several trial design options for yourself, using a demo compound. Together, we will decide the next step for your compound, allowing you the best chances of market approval.
The training is free of charge, however registration is mandatory. Register yourself by sending an email to Christina.Abts@sgs.com before 1 May.