WEBINAR: Model-Informed Drug Development

Efficient Clinical Programs and Decision Making through Model-Informed Drug Development (MIDD)

This webinar will cover MIDD as a concept, discuss the approach and associated methodologies with usage cases, with a focus on early clinical development.

MIDD involves the use of pharmacological, biological, medical and statistical principles and data. It is quantified using mathematical models and simulation to inform clinical dose selection, trial design and analysis, program development and decision making. The major goals of MIDD are to accelerate and streamline clinical programs, maximize probability of technical success, and ultimately obtain an approved product for patients and prescribers.

The methodologies commonly grouped together under the MIDD umbrella are pharmacometrics, typically population pharmacokinetic (PK) and PK/pharmacodynamic (PD) modelling and simulation, physiologically-based pharmacokinetic (PBPK) modelling, model-based meta-analysis (MBMA) and quantitative systems pharmacology (QSP). All have application for analysis and simulation of clinical trials and all have their merits for enabling efficient trial and clinical development design and execution.

At the end of this webinar attendees will understand:

●        The concept of MIDD and it’s key methodologies

●        Applications to clinical drug development focused on early clinical trials, program progression and decision-making

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Speaker: Alex MacDonald

Alex MacDonald is VP of Model-informed Drug Development at Allucent.  He is an engineer and quantitative pharmacologist by training, studying for a PhD in physiologically-based pharmacokinetics and pharmacodynamics at the University of Sheffield, UK. He has over 20 years of cross-Pharma experience in modelling, clinical pharmacology and pharmacometrics and joined Allucent from AstraZeneca, where he was most recently Global Head of Respiratory and Immunology Clinical Pharmacology and Pharmacometrics. Alex is well-published across multiple therapeutic areas with different modalities including respiratory and immunology medicine, oncology, and metabolic diseases. He has been involved in numerous successful global regulatory filings including Nirsevimab for the prevention of severe respiratory syncytial virus infection, Tezepelumab for severe asthma, and Anifrolumab for systemic lupus erythematosus.