Two-day workshop underscores NIH’s increasing interest in applying QSP methods to facilitate development of CNS therapies
PRINCETON, NJ – July 25, 2017 – Certara®, the global leader in model-informed drug development and regulatory science, today announced that Professor Piet van der Graaf, PharmD, PhD, vice president and head of Certara QSP, is co-chairing the NIH workshop entitled “QSP and Drug Discovery: Filling the Gaps in Current Models of the R&D Process for Neurotherapeutics.” This workshop will be held at the Bethesda North Marriott Hotel & Conference Center in Bethesda, MD from July 26-27.
“Central nervous system (CNS) diseases tend to be complex, involving multiple molecular targets. As a result, progress in increasing scientific knowledge in this area has been slow, and CNS drug development costs have been high with low success rates,” said Professor van der Graaf.
“This NIH workshop will explore whether combining systems biology and systems pharmacology methods can enhance the drug discovery and development process for CNS diseases. Participants will also help to identify any potential roadblocks or gaps in this approach and propose ways to address them,” Professor van der Graaf added.
The potential marriage of systems biology and systems pharmacology was previously proposed in a 2011 NIH white paper stemming from a National Institute of General Medical Sciences QSP workshop.
It noted that systems biology can help to identify a network of relevant genes, proteins or neural pathways and then model the network’s responses to environmental, chemical or genomic changes. That data can then be used to identify therapeutic targets and biomarkers for the disease.
Systems pharmacology enables the systems biology data to be vertically integrated at the cellular, tissue and whole organism level. That approach permits better drug target identification, more efficient prediction of pharmacokinetic/pharmacodynamic responses, and more accurate human dose projections. By combining “omic” or phenotypic screening data with animal data, systems pharmacology can also better predict toxicity. Furthermore, improved biomarker identification can lead to better patient stratification in clinical trials.
Professor van der Graaf’s workshop co-chairs are Mary Ann Pelleymounter, PhD, program director in the Office of Translational Research at the National Institute of Neurological Disorders and Stroke, and Suzana Petanceska, PhD, health scientist administrator in the Division of Neuroscience at the National Institute on Aging.
In addition to providing an introduction to and summary of each day’s proceedings, Professor van der Graf will co-present the session entitled “QSP: History, Relationship to Systems Biology and Applications to CNS Drug Discovery,” and chair the panel discussion about the “Importance and Feasibility of QSP to Neurotherapeutics.”
Furthermore, highlighting Certara’s commitment to QSP, the company is also co-sponsoring this event.
Certara is a leading decision support technology and consulting organization committed to optimizing drug development and improving health outcomes. Certara’s solutions, which span drug discovery through patient care, use the most scientifically-advanced modeling and simulation technologies and regulatory strategies to increase the probability of regulatory and commercial success. Its clients include hundreds of global biopharmaceutical companies, leading academic institutions, and key regulatory agencies.
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