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ASCPT 2021

ASCPT 2021
Speakers and Posters
Ask Me Anything: ASCPT Editors-in-Chiefs
Piet van der Graaf, SVP Quantitative Science Services, Certara, France Mentre, Professor of Biostatistics, Univ Paris Diderot, John Wagner, CMO Cygnal Therapeutics |
Join ASCPT's three Editor-in-Chiefs for a live Ask Me Anything Session.
Live Q&A/Panel Discussion: Model-Informed Dosing: Ready for Implementation in Clinical Care
Karen Rowland Yeo, SVP, Client and Regulatory Strategy, Certara, J. Steven Leeder, Deputy Director, CMRI, Jeffrey Barrett, Sr Advisor, Critical Path Institute, Saskia de Wildt, Professor of Clinical Pharmacology, Radbound Univ Med Ctr |
In the COVID-19 pandemic, doses for repurposing of drugs, also for special populations, were rapidly established using modeling and simulation approaches. This was, however, an exceptional action. During drug development, the FDA and EMA support the use of modeling and simulation, including PBPK modeling, for special populations such as children, pregnant women, and patients with liver and kidney failure. Some pediatric labels are now solely based on extrapolation from adult data. In contrast, doses for off-label prescribed drugs are most often still derived from small, low quality trials and expert opinion. To establish best-evidence doses, dosing simulations based on existing PK data or PBPK models should be included. Some examples of local implementation are available. However, most (inter)national committees in charge of dosing guidelines are unaware of these techniques or consider such dosing simulations as insufficient evidence. Considering that off-label use remains wide-spread, especially in special populations, there is a need to provide prescribers with the best-evidence doses available when a medical need exists to prescribe the drug.
Use of PBPK Modelling to Inform Dose Selection in Children and Pregnant Women in Developing Countries
Karen Rowland Yeo, SVP, Client and Regulatory Strategy, Certara |
A practical approach to dose selection for orphan drugs in children and pregnant women in developing countries will be presented. Examples of application of PBPK modelling for the repurposing of drugs during the COVID-19 pandemic will be shown. For COVID-19 and future outbreaks, it is important to have the right tools and the best data in place to provide a rapid response to help tailor therapies for special populations.
Challenging the Status Quo: Innovating the Landscape for Drug Development for Neurodegenerative Diseases
Kevin Krudys, Sr Clinical Analyst, US FDA, Nitin Mehrotra, Senior Principal Scientist, Merck, Vijay Chelliah, Principal Scientist, Certara, Josh Cosman, Director, Digital Health Strategy, Abbvie, S. Aubrey Stoch, VP & Head of Pharmacology, Merck & Co |
Neurodegenerative diseases continue to represent an area of great unmet medical need. While the health and economic burden of neurodegenerative disease remain high, the pipeline attrition rates also remain high with a general lack of new effective therapies in this area. Several reasons have been put forth to explain the failure to develop drugs in this area, such as incomplete understanding of the pathogenic mechanisms underlying the complex nature of neurodegenerative diseases, lack of validated biomarkers, uninformative trial design, improper patient selection, insensitive clinical endpoints, and lack of predictive animal models and translatable biomarkers. Regulatory agencies have been quite forthcoming to help drug sponsors develop a successful drug development path and time is opportune to challenge the status quo and embrace new and innovative ideas to transform drug development in this space. This session will focus on the following themes that will encourage drug developers, researchers and regulatory scientists to pave a path that fosters drug development for neurodegenerative disorders: Predictive neurological endpoint in early clinical development, Critical need to invest in digital measures to assess clinical outcomes, Development of “fit for purpose” and “decision-focused” Quantitative Systems Pharmacology (QSP) models, Data sharing initiatives, and Innovating the regulatory landscape.
Interdisciplinary Model Informed Drug Development (I-MIDD)
Mohamad Shebley, Director, AbbVie Inc., Stephanie Chiuve, Director Global Epidemiology, AbbVie Inc., Michael Maitland, Professor of Medicine, Inova Schar Cancer Inst, Craig Rayner, President iDD, Certara. David Strauss, Division Director, US FDA |
Model-Informed Drug Development (MIDD) has been championed by the discipline of quantitative clinical pharmacology in recent years. The U.S. FDA took on an initiative to increase the applications of MIDD by launching a Pilot Program as a performance goal agreed to under the sixth iteration of the Prescription Drug User Fee Act (PDUFA VI), included as part of the FDA Reauthorization Act of 2017. The FDA’s Pilot Program is envisioned to facilitate the development and application of exposure-based, biological, and statistical models derived from preclinical and clinical data sources. Since drug development is an interdisciplinary process, various disciplines that employ quantitative methodologies have an unrealized opportunity to collaborate and join forces to boost the success of interdisciplinary MIDD (i-MIDD). For example, infectious diseases with potential for pandemics (i.e. COVID-19, influenza and others) demonstrate an opportunity for such i-MIDD approach, where PKPD (i.e. viral load suppression), epidemiological projection models (i.e. disease transmission), and health economics models (i.e. payer perspective) can come together to provide a quantitative framework for rational selection of drug/vaccine dosing and affordable treatments. Drug induced adverse events with future risk such as bone fracture risk in post-menopausal women, which usually are not fully evaluated during randomized controlled clinical trials due to the limited duration, would benefit from integration of real-world data (RWD) (i.e. post marketing surveillance of fracture incidence) and epidemiological models that describe the natural history of bone development and incidence of fractures due to natural causes (i.e. menopause) or medical treatments (i.e. corticosteroids, GnRH analogues). In such scenarios, joining models across disciplines under the umbrella of i-MIDD is envisioned to enhance drug development decisions and optimize success. In this session, speakers from various quantitative disciplines within the pharmaceutical industry, academia and regulatory and government agencies will present case examples in a TED Talk presentations to inspire collaboration.
Innovative Pharmacology to Health Economics Approach Using A Multi-Scale COVID-19 Transmission Model
Hazem Hassan, Assoc Director, Clinical Pharmacology, Regeneron, Nidal Huniti, Exec Director, Regeneron, Roman Casciano, SVP, Certara, Mohamed Kamal, Director Clinical Pharmacology, Regeneron, Andreas Kuznik, Executive Director, HEOR, Regeneron, Patrick Smith, SVP, iDD, Certara |
The global impact of COVID-19 has been profound, and the public health threat it represents is the most serious since the 1918 H1N1 influenza pandemic. Current influenza and SARS-CoV-2 epidemiological models vary in sophistication, ranging from simple susceptible-infectious-recovered (SIR) models to multi-scale approaches (Ferguson et al, Strategies for mitigating an influenza pandemic, Nature, 2006) that incorporate antiviral and vaccine interventions, non-pharmaceutical interventions (e.g. school closure, home isolation of cases), population movement patterns, social behaviors, and social contact networks. The objective of this session is to discuss a novel agent-based multiscale transmission model for COVID-19 that links drug pharmacology, epidemiology and health economics for better assessment of the pandemic. The speakers will discuss how drug pharmacology data (e.g., emerging data from novel therapeutic modalities such as anti-spike mAb cocktail for COVID-19 treatment and prevention, and remdesevir for treatment), epidemiology data (e.g., real-time data from WHO, CDC, and US state-level pandemic surveillance databases), and health economics data (e.g., emerging literature and clinical trial data on mortality/hospitalization) can be leveraged for a more efficient allocation of an anticipated finite supply of COVID-19 therapeutics. For example, the number of infected patients in the US population and the key epidemiological outcomes would enter an analytic decision tree assessing cost of health care utilization and effectiveness of various interventions (Kamal et al, 2017) . The session would conclude by providing various simulated pandemic mitigation and suppression scenarios (with and without a pharmaceutical intervention) to evaluate key questions such as: 1) What is the transmission trajectory of the pandemic and associated healthcare outcomes; 2) How is the finite supply of anti-COVID-19 drug strategically deployed and allocated within the population (e.g., by age, or use as a treatment vs. prophylaxis) and 3) What is the value of COVID-19 therapy/prophylaxis and the implications on pricing therapeutic interventions.
Join Patrick and Karen on the Road to Global Health
Karen Rowland Yeo, SVP, Client and Regulatory Strategy, Certara, Patrick Smith, SVP, Commercial Strategy & Innovation, COS-IDD |
Diseases affecting developing nations continue to be areas of large unmet medical need. Collaborations between academics, CROs, industry, and non-profit organisations can have a large impact on Global Health. Specifically, clinical pharmacologists are uniquely positioned to improve global health by ensuring that we get the right drug dose to the right patients to give them the best possible outcome. In this minisode, Drs. Karen Rowland Yeo and Patrick Smith will briefly discuss their experiences working on global health project and explain why a multi-disciplinary approach is crucial for helping address these unmet  needs.
Welcome & Preview Sponsored by Certara
Presenter: Craig Rayner, President of Integrated Drug Development | President, COS-IDD
Welcome & Preview Sponsored by Certara
Re-Cap: Highlights & Preview Sponsored by Certara
Presenter: Craig Rayner, President of Integrated Drug Development | President, COS-IDD
Re-Cap: Highlights & Preview Sponsored by Certara
A Drug Development Software and Services Overview with a Focus on rsNLME and Simcyp
Keith Nieforth, Senior Director, Pharmacometrics Software, Certara, Hannah Jones, PhD, Vice President, Head of PBPK Consulting Services |
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 will explain how Certara’s products and services can help accelerate the drug development process from discovery to patient access. They will also give a deeper look into two tools- R speaks NLME and the Simcyp Simulator- as well as share a case study demonstrating how using them has helped inform and streamline clinical development.
Farzaneh Salem | Research Scientist, Certara
Posters: Farzaneh Salem | Research Scientist, Certara