Simultaneous Data Generation Connects Early Data to the Clinic
Safety aspects have increasingly become an outstanding issue in the drug discovery and development arena with the FDA and the EMEA placing a clear emphasis on their importance.
The point is illustrated in the book Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays, co-authored by Dr. Franz Hock, CorDynamics European Business Development Director.
Sequential Development: The Paradigm of the Past
Up until 15 years ago, drug discovery and evaluation was a single, sequential process starting with the selection of the most active compound from a series of newly synthesized agents by means of special pharmacological assays.
• Safety aspects were addressed by pharmacological testing of the selected compound in high doses in assays directed at targets other than the intended indication of the new compound.
• These tests were followed by pharmacokinetic studies, which were mainly aimed at confirming a suitable half-life and oral activity.
• Safety aspects relied mostly on toxicity studies, which however gave information on changes of organ structure rather than on organ function.
• Toxicological and pharmacokinetic studies were adapted to the progress of studies in clinical pharmacology and clinical trials.
Simultaneous Data Generation: Today’s Paradigm
The sequential way of working has been replaced by simultaneous generation of data.
• Concurrent safety, pharmacodynamic and pharmacokinetic data is generated.
• If need be, bench-to-bedside and bedside-to-bench approaches can be facilitated to connect preclinical and clinical data as early as possible.
• Rather than a separation into toxicology, pharmacokinetics and clinical applications, a connectivity between all these disciplines is embraced.
This new paradigm is seen as mandatory in the eyes of regulatory bodies as well as among academic thought-leaders and drug development executives.
The industry as a whole has come to understand there is no real safety evaluation possible without combining toxicological, pharmacodynamic and pharmacokinetic data both from a preclinical and from a clinical environment.
To learn more on the topic or to order Dr. Hock’s book, click here.