Apocalyptic Clinical Pharmacology: A Comprehensive Approach to Drug Development
Imagine a virtual biological world with all of the exquisite features of physiology, biochemistry and anatomy of our “wonderfully made” human bodies. Candidate drugs are inserted into this biological system. The interaction between our investigational drug and the biological system is fixed by the chemistry of the drug and the system into which it is placed. If we knew everything about the biological system, drug development would be complete before we started!
The problem is that we don’t.
Our task in drug development is to uncover this drug-system interaction to discover the risk-benefit profile investigational drugs offer to patients. The drug-system interaction is exceedingly complex, but the variables open to the uncovering process are surprisingly few. On the drug side, we can vary the dose, the frequency of administration, the route of administration, and the formulation. On the system side, we can vary the disease population, the demographics of that population, and some features of the patient’s environment.
When the clinical pharmacology experts at regulatory agencies review submissions, they approach the task by asking four questions:
- To what extent does the available clinical pharmacology information provide pivotal or supportive evidence of effectiveness?
- Is the proposed dosing regimen appropriate for the general patient population for which the indication is being sought?
- Is an alternative dosing regimen and/or management strategy required for subpopulations based on intrinsic factors?
- Are there clinically relevant food-drug or drug-drug interactions, and what is the appropriate management strategy?
One approach to this uncovering process would be to test every possible dose, at every possible frequency, to every possible patient group including every possible demographic feature (large, small, young, old, black, white, etc.) under every possible environmental condition (eg, co-administration with every other drug possible, every possible meal combination for oral drugs, etc.). Such an approach would uncover all we would need to know, but it would hardly be practical.
So what’s the answer?
To find out, watch this webinar with Dr. Graham Scott, Senior Director of Clinical Pharmacology at Certara Strategic Consulting to learn why you should invest in “apocalyptic clinical pharmacology.” “Apocalypse” is derived from the Greek apokálypsis (ἀποκάλυψις)—a combination of ἀπό and καλύπτω, which literally means “uncovering.”
An investigational drug is exactly the same compound at the candidate selection stage as it is when the development program is complete. If this is the case, then it begs the question as to what development actually is. Clinical Pharmacology is fundamentally a discipline that is all about uncovering; it really is apocalyptic!
In this webinar, Dr. Scott presented case studies that illustrate how sponsors can benefit from a clinical pharmacology strategy that uses model-informed approaches to inform and “fill in the gaps” of clinical trials.