Panel Discussion: Building the bridge from preclinical to clinical studies

Panel Discussion: Building the bridge from preclinical to clinical studies

In the current global economic environment, companies need to become even more efficient to get their drugs through the development process. The transition from preclinical studies to human clinical trials is challenging in many ways - scientifically, regulatory and organizationally. Therefore, understanding the complexity of this step and the issues that arise can help streamline the process and minimize the risks and pitfalls.

Our speakers are proven experts in the field of preclinical and clinical development and have been working in a managerial and/or advisory capacity nationally and internationally for many years:

- Jens Hoffmann, Managing Director of Experimental Pharmacology & Oncology (EPO), Berlin-Buch GmbH,
- Michael Firgens, Managing Director at MF Biotech, Berlin,
- Virgilio Garcia Lerma, Executive Director, Regulatory Strategy at Worldwide Clinical Trials, Madrid, Spain,
- Uwe Lohmeier, Head of Gläsernes Labor Akademie (GLA), Campus Berlin-Buch GmbH (Moderation).

Key Topics:
- to reflect clinical problems in preclinical models such as pharmacodynamic activity, safety and biomarker translational research,
- to weight ethical aspects in planning in vitro versus animal versus human experimentation,
- to continuously comply with all applicable regulatory requirements (at least such as ICH, EMA or FDA Guidelines and regulations),
- and nonetheless …. to consider the costs for preclinical and clinical development in order to be and to remain also financially successful.

Don't miss the opportunity to join in the discussion and exchange ideas with each other and our experts over snacks and drinks at the subsequent get-together and networking event. 

Organizers