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First-In-Human Studies An Examination of the Evolving Regulatory and Clinical Practices


Date: Thursday, November 9, 2017

Time: 11am EST / 4pm GMT (UK) / 5pm CET (EU-Central)

Duration: 60 minutes

Featured Speakers:

  • John Oldenhof, PhD, Executive Director, Clinical Pharmacology, Early Phase, INC Research/inVentiv Health
  • Richard Larouche, VP Medical Affairs, Early Stage Clinical Operations, INC Research/inVentiv Health
  • Clark Williard, Executive Director, Bioanalysis, Early Stage Bioanalytical Labs, INC Research/inVentiv Health

In this webinar, INC Research/inVentiv Health experts will discuss the evolving regulatory and clinical requirements to ensure safety and compliance when conducting First-in-Human studies.

First-in-human studies are a key milestone in drug development. In such studies, a drug already tested in a preclinical setting (in vitro, animals) is tested in humans for the first time. Study participants, who are often healthy volunteers, face an element of risk as the ability to predict the effects in humans is limited. In recent history, albeit in rare cases, study subjects have experienced serious harm in such trials. Regulatory guidelines have evolved following such events to ensure the safety and well-being of study subjects. Most recently in 2017, the European Medicines Agency (EMA) has revised its guidance on first-in-human trials. The revised guidance includes additional strategies to mitigate and manage risks for study subjects, including guidance for the calculation of the starting dose, rules for subsequent dose escalation and the criteria for establishing the maximum dose. The guidance also provides criteria to stop a study, review emerging data and handling of adverse events in relation to the study stopping rules.

Over recent years, first-in-human studies have become increasingly complex, focusing on multiple parts such as single-dose ascension, multiple-dose ascension, food interactions, different age groups or gender, proof of concept, or relative bioavailability of different formulations. While most first-in-human studies are conducted in healthy volunteers, other populations such as patients may need to be considered. As such, data generated during the course of the trial should be carefully reviewed and used to inform the decision to initiate a subsequent study part or to inform the selection of the doses to be evaluated.

This session will discuss the evolving requirements for conducting first-in-human studies and will focus on the key regulatory and clinical considerations in ensuring subject safety.

Learning Objectives:

  • Learn about the updated EMA guidelines on first-in-human studies and how they may impact your clinical trials
  • Discover strategies to optimize data review for safe dose escalation
  • Understand best practices in dose selection and risk mitigation

Keywords: First-in-Human Studies, EMA, Clinical Trials


    John Oldenhof, PhD, Executive Director, Clinical Pharmacology, Early Phase, INC Research/ inVentiv Health

    Dr. John Oldenhof is Executive Director, Clinical Pharmacology at INC Research/inVentiv Health - Toronto, where he is responsible for the oversight of the Pharmacokinetic/Pharmacometric, Pharmacy, Compliance and Clinical Documentation teams. Dr. Oldenhof obtained his MSc and PhD in pharmacology from the University of Toronto in the areas of behavioral pharmacology and molecular neuropharmacology. Prior to joining INC Research/inVentiv Health in 2003, Dr. Oldenhof worked in the biotechnology sector. In this role, he was involved in the design and analysis of phase II and III studies and was responsible for the management and scientific oversight of non-clinical research programs at the Virginia Commonwealth University and the University of Western Ontario. At INC Research/inVentive Health, Dr. Oldenhof has been involved in more than 300 Phase I clinical studies, including numerous first-in-man (FIM), single ascending dose (SAD) and multiple ascending dose (MAD). His experience is across a wide range of disease conditions with a variety of therapeutic strategies. He has more than 30 published research papers and conference abstracts.

    Richard Larouche, VP Medical Affairs, Early Stage Clinical Operations, INC Research/inVentiv Health

    Dr. Larouche oversees the medical team in the Quebec, Canada unit and is the leading investigator in various early phase clinical trials in healthy volunteers and patients such as: first in human, SAD-MAD, drug-drug interaction, TQT, renal impaired, insulin clamp, PK-PD, and phase IIa. He has been involved in design and conduct of all innovator compound studies and biologics/biosimilars studies performed at inVentiv Health for the last 16 years and he continues to work as a family physician in a community medical clinic.

    Clark Williard, Executive Director, Bioanalysis, Early Stage Bioanalytical Labs, INC Research/inVentiv Health

    Mr. Williard has more than 23 years of experience in the mass spectrometry bioanalysis field of research supporting the pharmaceutical industry. In 1994, Mr. Williard joined Taylor Technology, Inc., a start-up lab of 7 employees, focusing efforts in methods development and validation utilizing LC-MS/MS and GC-MS/MS techniques. Mr. Williard's other interests included the development and deployment of Taylor Technology's laboratory automation program.

    At INC Research/inVentiv Health, Mr. Williard has held such laboratory positions as Senior Scientist and Research Scientist. He has functioned as bioanalytical Principal Investigator in regulated studies for 16 years. As Executive Director, Mr. Williard has overseen daily operations of the company's bioanalytical mass spectrometry-based laboratories in Princeton, New Jersey and Quebec City, Canada consisting of 240+ highly skilled professionals. His responsibilities include financial performance, resource allocation, and new business development. He functions as GLP Manager and Site Head of the laboratories.

    Mr. Williard holds a bachelor's degree from Penn State University. He has authored various articles in peer-reviewed journals and book chapter contributions on bioanalysis supporting the oncology, biomarker, and medical device fields of research.


    Senior professionals from pharmaceutical and biotechnology companies working in early phase drug development, including the areas of:

    • Preclinical Development
    • Toxicology
    • Clinical Pharmacology
    • Toxicology
    • Clinical Operations
    • Data Management
    • Regulatory Affairs

    INC Research/inVentiv Health (Nasdaq:INCR) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to address new market realities where clinical and commercial share expertise, data and insights to accelerate biopharmaceutical performance. With more than 22,000 employees and the ability to support customers in more than 110 countries, our global scale and deep therapeutic alignment enables INC Research/inVentiv Health to help customers successfully navigate an increasingly complex environment. For more information on our Raleigh, N.C.-based company, visit incresearch.com or inventivhealth.com.

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