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

John Oldenhof, PhD, Executive Director, Clinical Pharmacology, Early Phase, Syneos Health

Dr. John Oldenhof is Executive Director, Clinical Pharmacology at Syneos 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 Syneos 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 Syneos 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.

Dr Richard Larouche Vice-President, Medical Affairs, Syneos 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 Syneos 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, Syneos 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 Syneos 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.