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 will introduce the importance of bioanalysis and its downstream effects on clinical development and clinical pharmacology. By attending 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
About Our Speakers
Dr. Stephanie Pasas-Farmer is the President and Founder of BioData Solutions, LLC, a consulting firm that offers R & D, regulatory, and commercial consulting services to early stage pharmaceutical and biological drug development organizations in the field of bioanalysis. With more than 14 years of industry experience, Dr. Pasas‐Farmer specializes in discovery and regulated bioanalysis of pharmaceutical, biologics, and biosimilars. Dr. Pasas-Farmer is a frequent contributor to industry conferences and peer-reviewed publications on current bioanalytical and pharmaceutical industry topics. She also is an adjunct Professor as well as a member for Board of Advisors for the Division of Pharmacy Professional Development (DPPD) of the University of Wisconsin’s School of Pharmacy.
Dr. Frank Engler is a Clinical Pharmacologist and Consultant at Certara with both preclinical and clinical drug development experience. Dr. Engler obtained his PhD from the University at Buffalo, followed by working in the pharmaceutical industry as a clinical pharmacologist. In addition to constructing clinical pharmacology development plans and designing studies, he has authored study reports, Investigator’s Brochures, protocols, SOPs, and INDs. His areas of expertise include pharmacokinetics (PK) and pharmacodynamics (PD), population-based, and physiologically-based PK/PD modeling and simulation. Dr. Engler’s work has focused mainly in oncology, where he has experience with multiple therapeutic drug platforms, including monoclonal antibodies, antibody-drug conjugates, and small molecules.