On-Demand Online Seminar: "Mode of action studies and label texts in the metabolic field"

 

 In this online seminar, Dr. Hans de Vries of Profile discusses the importance and application of mode of action studies within the metabolic field, specifically how these studies generate clinical data for drug labels. Using a tirzepatide study as a primary case study, the presentation details various methodologies, including hyperinsulinemic euglycemic clamps to measure insulin sensitivity, hyperglycemic clamps for insulin secretion, mixed meal tolerance tests, and ad libitum energy intake assessments. Dr. de Vries examines how these technical outcomes translate into specific regulatory label texts for both the FDA and EMA, noting differences in how agencies accept subjective data like satiety. The session also explores emerging technologies such as fMRI and PET-MRI imaging that could provide more precise organ-specific data for future drug labeling. 

On-demand online seminar: Mode of action studies and label texts in the metabolic field by Dr. Hans de Vries. Fill out the form to get insights into this topic.

 

You will benefit by learning about:

  • The role of mode of action studies in metabolic drug development
  • The tirzepatide mode of action study conducted at Profil and its label-relevant findings
  • The selection of relevant clinical trial endpoints
  • New methods with the potential to generate additional label-relevant evidence
  • Key design considerations for mode of action studies and early phase clinical trials

 

Online seminar synopsis

Understanding how a drug achieves its clinical effects is an important part of modern drug development. Well-designed mode of action studies can provide valuable insights into pharmacological effects, support the characterization of a drug candidate, and generate evidence that may ultimately contribute to the product label.

In this online seminar, Dr. Hans de Vries, Lead Scientist at Profil, will discuss the role of mode of action studies in metabolic drug development, with a particular focus on obesity and diabetes drug development. Using a tirzepatide mode of action study conducted at Profil as a real-world example, he will examine the methodologies and endpoints used to investigate its metabolic effects, and which outcomes ultimately contributed to the product label.

Beyond the tirzepatide case study, Dr. de Vries will address key design considerations for early phase clinical trials investigating a drug’s mode of action. The seminar will cover the selection of meaningful pharmacodynamic endpoints, the integration of established and emerging methodologies into clinical study designs, and new approaches with the potential to generate label-relevant evidence.

The seminar provides practical insights into the design and conduct of mode of action studies in metabolic clinical research and demonstrates how appropriate study designs, endpoints, and specialized methodologies can help address important questions in clinical drug development.

 

Who should attend?

This online seminar is designed for professionals in pharmaceutical and biotechnology companies involved in the development of metabolic therapies, particularly in obesity and diabetes. It is especially relevant for professionals working in clinical development, clinical pharmacology, translational medicine, medical affairs, and regulatory affairs, as well as scientists and decision-makers responsible for early clinical development strategies and study design.

 

Meet the presenter

Dr. Hans de Vries obtained board licenses in Internal Medicine and Endocrinology at the VU University Medical Centre, Amsterdam. He was a professor of Internal Medicine at the University of Amsterdam's Faculty of Medicine. He joined Profil in 2017 and maintains an outpatient clinic for people with diabetes one day per week. Dr. de Vries has been Principal Investigator in numerous clinical trials and has published more than 250 peer-reviewed scientific publications. He is a frequently invited speaker at international diabetes meetings, and has been a editorial board member of Diabetes Care, the Journal of Diabetes Science and Technology, and International Associate Editor of Diabetes Technology & Therapeutics.  

 

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