SPARK Educational Forum: Regulatory Compliance

Dr. Jens Hoffmann, EPO

 

The developmental process in a translational project has one goal: to reach the patient. To this end, it is extremely important to know what proof regulatory authorities are expec­ting in terms of efficacy and safety in order to approve your approach and drug.

Once the decision to develop the compound and drug candidate is made, the preclinical program is designed following a strict and logical stepwise manner. The lead compund needs further testing and relevant experiments can and should be performed and assem­bled into a full dossier.

Since these experiments are relevant for the submission process, it makes sense to be aquainted with what regulatory authorities are expecting to see. Also, an academic pro­gram usually is following a research oriented workflow rather than a regulatory compliant workflow.

This leads us to the topic of this forum: What is the right time to start thinking about re­gulatory comliance? What animal experiments need to be carried out and how should they be documented? What animal models are being selected and why is it important to be selecting for those that will strictly prove the pre-set clinical end point?

We will be hosting Jens Hoffmann, epo and cpo GmbH, who has profound experience in this area and in dealing with regulatory when it comes to sharing pre-clinical data and animal experiments for drug testing. Jens will give us an overview of the topic, and in the discussion following his talk we will focus on the differences between research and drug development programs, and what this difference can tell us about how your work is im­pacted by the decision to start a drug development program.