The COVID-19 pandemic has upended all our lives in ways big and small with the ability to attend in-person scientific conferences being no exception. Fortunately, many conferences have become virtual events which have allowed participants to share the latest research findings and trends while maintaining safety for everyone.
Last month, I virtually attended the annual meeting of the American Society for Clinical Pharmacology and Therapeutics (ASCPT). It was a valuable opportunity to see some truly innovative scientific approaches to the toughest challenges in drug development.
In this blog post, I’ll discuss four presentations highlighting our latest research on modeling and simulation presented by my colleagues at the meeting.
Presentation #1: Software and services overview with a focus on RsNLME and Simcyp
Speakers: Dr. Keith Nieforth and Dr. Hannah Jones
Summary: A successful drug product must demonstrate drug substance viability, clinical viability, and economic viability. Drug developers typically use a range of software tools to help demonstrate the viability of their products in these domains. In this product theatre, Drs. Hannah Jones and Keith Nieforth explained how Certara’s products and services can help accelerate the drug development process from discovery to patient access. They also gave a deeper look into two tools- R speaks NLME and the Simcyp Simulator. The latter was then highlighted in a case study demonstrating how using this tool helped inform and streamline clinical development for a novel treatment for sickle cell disease.
Presentation #2: From Epidemiology to Health Economics: Linking Outcomes of COVID-19 Epidemiology to Health Economics Outcomes within the US Population
Speaker: Dr. Patrick Smith
Summary: The COVID-19 pandemic is an urgent health crisis. We simply don’t have the time to run sufficient experiments to address all the key questions regarding the pharmacoepidemiology and pharmacoeconomics of potential treatments for COVID-19. By contextualizing the outputs of epidemiology models into health economic terms, policy makers can be better poised to make critical decisions as to how best use antiviral treatments in combination with non-pharmaceutical interventions like masking, handwashing, and social distancing.
Presentation #3: Use of PBPK modelling to inform dose selection in children and pregnant women in developing countries
Speaker: Dr. Karen Rowland Yeo
Summary: Historically, children and pregnant women have been excluded from clinical trials of investigational drugs. Physiologically-based pharmacokinetic modeling can help inform dose selection for these special populations. In this presentation, Dr. Rowland Yeo explained how the Simcyp Simulator’s Global Health repository of compound files can be used to assess the disposition of anti-infective drugs including anti-malarial treatments. The PBPK model is comprised of the drug-dependent component (data from the compound files which use in vitro data) and a drug-independent component that reflects the intrinsic and extrinsic factors causing variability within a population. This model can then be used to perform simulations to identify the dose adjustments from the non-pregnant adult dose for both pregnant women and children.
Presentation #4: Quantitative Systems Pharmacology in Neurodegenerative Diseases
Speakers: Dr. Viji Chelliah and Dr. Piet van der Graaf
Summary: While quantitative systems pharmacology can be applied to drug development in many therapeutic areas, it can have a particularly large impact on neurodegenerative diseases (NDD). This is because NDDs are complex and usually involve dysregulation of multiple biochemical pathways. QSP simultaneously integrates multiple pathways/scales of biological organization into a model-informed drug development framework. Some of the key questions that QSP can address pertain to dose selection and optimization, target identification and validation, and biomarker determination. In this presentation, Dr. Chelliah shared a case study on using QSP to inform the development of an HDAC6 inhibitor for amyotrophic lateral sclerosis (ALS), an NDD where axonopathy has been shown to be an early indicator of disease pathogenesis. The QSP model was developed to assess whether inhibition of HDAC6 could improve axonal transport and delay ALS progression. The model’s findings supported the hypothesis that this was a valid drug target, and that oxidative stress could be the mechanism regulating axonal transport.
Looking ahead to next year!
It was great to be able to learn so much at the virtual ASCPT meeting. I’m really looking forward to their annual meeting in 2022 where I hope to be able to attend in person and see my colleagues and collaborators!
To find out more about how we’re reimagining how drugs are developed with a focus on global health, watch this minisode with Drs. Patrick Smith and Karen Rowland Yeo.