Application of Tracer Kinetics in Drug Development: A Valuable but Underused Tool in Clinical Pharmacology

Speaker(s): Pau Aceves
Date: August 7, 2018
Time: 11 am EDT
Duration: 1 hour

Clinical pharmacology has generally involved the study of pharmacokinetics/pharmacodynamics (PK/PD) under reasonably controlled experimental conditions including:

  • Known dose/concentration/volume of study drug (extent of input)
  • Known infusion duration into a given bodily compartment (rate of input)
  • Accessible compartments for sampling: Blood, Urine, CSF, etc.
  • The drug and its metabolites are distinguishable from endogenous compounds
  • Rapidly changing biomarkers following drug administration
  • Ability to determine routes of elimination using “hot” drug (ADME study)
  • Use of healthy volunteers to ease the feasibility of PK/PD assessments

Quantitative PK/PD analyses tools using drug/metabolite/biomarker static concentration data have become a cornerstone in drug R&D.

But what other quantitative tools are available when we face less controlled conditions?

Tracers can be substances such as dyes or drugs labelled with radioactive or stable isotopes. Tracer kinetics analysis allows the study of more than one form of a compound simultaneously thereby opening new opportunities such as tracing two isoforms of the same drug given by two routes or obtaining rates of production, pool size, and half-life of endogenous substances.

Tracers have been mostly relegated to nutrition and sport sciences, but there are instances where this technique could prove powerful in drug development. In this webinar, Pau Aceves, Associate Director of Consulting Services at Certara, will present case studies on how tracer kinetics were used to inform development of new drugs for lung, CNS, and liver diseases. By attending this webinar, you will learn how tracer kinetics can be leveraged for PK, PD, and in silico modeling applications.

Who should attend?

  • Clinical pharmacologists
  • Bioanalysts
  • Pharmacokineticists

About Our Speaker

Pau Aceves joined Certara Strategic Consulting in February 2017. Pharmacist by training, and with previous work experience in diverse aspects of the Pharmacy practice—including Community, Clinical and Production Pharmacy—Pau focused his professional career path in the field of Quantitative Clinical Pharmacology (QCP) and PK/PD Modeling & Simulation, since 2006.

Pau Aceves holds a Master’s Degree in PK/PD Modeling & Simulation from the University of Manchester in the UK. His MSc project was on an Exploratory Quantitaitve Systems Pharmacology Model (QSP) of the Squalene Synthase Inhibitor Lapaquistat Acetate.

In addition to having worked on QCP-type studies (ie, food effect, bioavailability, DDIs), Pau also has a wide range of experience on other modalities, including: First-in-human (SAD/MAD), Proof-of-mechanism (PoM), Proof-of-concept (PoC), Positron Emission Tomography (PET), and highly complex combination (or umbrella-type) protocols; as well as experience interacting with regulatory agencies (FDA, EMEA) at various stages of drug development.

He brings to Certara a total of 11 years of QCP experience in the design, analysis and reporting of studies in a wide range of therapeutic areas across all phases of drug development. Pau always enjoys devising innovative strategies to streamline and maximize the value of clinical development programmes by combining efficient clinical strategies with fit-for-purpose PK/PD analysis methods, eg, Population PK/PD, Physiologically-based Pharmacokinetic modeling, and Quantitative Systems Pharmacology approaches.

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