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Our CEO, Peter Milligan, has been interviewed by the Pharma Tech Outlook magazine. Read more about how cutting-edge methods and tools help change the model-informed drug development landscape of the pharmaceutical industry, from early clinical trials to drug approval.

Regulatory authorities have accepted concentration-QT modeling as the primary basis to classify the risk of proarrhythmic effects of a drug. For concentration-QT modeling to replace the thorough QT (TQT) study there are regulatory expectations, ranging from high-quality ECG data and study design
features to best modeling practices. Here Angela Äbelö and Jurgen Langenhorst share their experiences on implementing model-based concentration-QT analyses as part of cardiac safety programs for nonantiarrythmic drugs and describe their daily work with various clients in the pharmaceutical industry.

There is a demand to develop new drug therapies for pediatric indications. As children cannot merely be seen as small adults, proper dose selection for pediatric programs may require special attention. Meet Mats Magnusson and Siv Jönsson, sharing their experiences about supporting clients with the planning, implementation, and reporting of drug development programs in pediatric populations.

Pharmacometrics has gained increasing importance in drug development and most medium and large-sized pharmaceutical companies have significantly large departments dedicated to such work. Ultimately, pharmacometric models, built upon observed data from clinical studies, are used to inform the next emerging study and the overall drug program. Meet Marcus Björnsson and Elodie Plan, further describing how that can be achieved.

Pharmacometrics and quantitative clinical pharmacology are now almost routinely integrated in the process of drug development in many pharmaceutical companies. Nevertheless, this research area is continuously evolving and shows increasingly high impact in supporting both in-house and regulatory decision-making. Meet Céline Sarr and Jakob Ribbing, sharing their experiences about implementing pharmacometrics in a variety of projects across many different therapeutic areas and organisations.

Pharmacometrics and quantitative clinical pharmacology are now almost routinely integrated in the process of drug development in many pharmaceutical companies. Nevertheless, this research area is continuously evolving and shows increasingly high impact in supporting both in-house and regulatory decision-making. Meet Céline Sarr and Jakob Ribbing, sharing their experiences about implementing pharmacometrics in a variety of projects across many different therapeutic areas and organisations.

Physiologically based pharmacokinetic (PBPK) models and quantitative systems pharmacology (QSP) models are built on prior knowledge, including (patho-)physiology, and pharmacology. The independent representations of drug and system specific parameters allow for extrapolation to scenarios beyond observation. This can help decision makers with informing biomarker strategies and early prediction of clinical outcome. Meet Erik Sjögren and Tobias Kanacher, with long experiences as consultants in this area. After defining how these modeling techniques work, they describe how they are now supporting clients in their daily work.

Effective feedback and feedforward of information across and within compounds can promote an environment of “joined-up thinking” within organizations. This is an important element of model-informed drug development (MIDD) as we obtain insights on a compound’s properties by efficiently leveraging accumulated data. These insights can be used to frame the most impactful compound-related risks and shape contingency plans that enable these risks to be managed/mitigated appropriately. MIDD can greatly aid the ability of decision makers to arrive at strategy and/or study design achieving a favorable outcome. Meet Peter Milligan and Richard Anziano, sharing their experiences from implementing this type of collaborative quantitative framework within a top pharmaceutical company and how they currently support clients with MIDD-related questions.