A House Divided—The Interplay of Bioanalysis and Pharmacokinetics

Drug discovery and development is key to meeting the world’s unmet medical needs. However, bringing a drug to market is a risky, labor intensive, time exhaustive, and expensive endeavor. And for every single drug that reaches the market, over 10,000 have failed (success rate of 0.01% or less).

A key piece to understand during a drug’s development is not only the drug concentration in the body but also how this concentration impacts safety and efficacy. Bioanalysis is the science of measuring both exogenous (drugs) and endogenous (biomarkers) molecules in biological samples.

The clinical pharmacologist is responsible for getting the right drug into the right patient at the right time. Accurate and precise measurement of drug and biomarkers are key for the correct interpretation of drug pharmacokinetics, drug safety, and drug effect. Proper bioanalysis and efficient communication of results enables the clinical pharmacology group to provide timely and thorough data interpretation.

To overcome limited resources, limited capacity, or a gap in the capabilities of the in-house scientific staff, bioanalysis is often outsourced by companies of all sizes: from large global pharma companies to virtual biotech. But, treating a key compound of your clinical pharmacology deliverable as a commodity has led to a disconnect between these two functional areas. This disconnect can often result in delays, clinical holds, loss of potential revenue, expensive requirements to repeat clinical trials, and unnecessary risk to patients.

This webinar introduced the importance of bioanalysis and its downstream effects on clinical development and clinical pharmacology. By watching this webinar, you will gain an appreciation of the following:

  • The importance of bioanalysis in the drug discovery and drug development process
  • The interdependence of robust bioanalytical data and clinical pharmacology
  • An in-depth case study illustrating where bioanalysis went awry:
    • how this effected the clinical program
    • key warning signs that went undetected
    • strategies to overcome these challenges
    • ways this could have been avoided from the beginning
    • examples where things went right
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