Applied BioMath, the industry-leader in applying mechanistic modeling to drug research and development, today announced that they have been awarded a grant for development of a quantitative systems pharmacology model of amyloid beta and tau pathways for clinical trial design and decision making in Alzheimer's Disease and Dementia. Applied BioMath's approach will be a unique integration of mechanistic, physiological, and clinical pharmacological aspects of Alzheimer's disease (AD) and existing therapeutics into one model, increasing the likelihood that this model will impact AD research and development (R&D).
"This is a very exciting project, and the work being pursued by Applied BioMath holds the potential for substantial impact on Alzheimer's Disease therapeutic approaches," said Douglas A. Lauffenburger, PhD Ford Professor of Biological Engineering, Chemical Engineering, and Biology, as well as, head of the Department of Biological Engineering at Massachusetts Institute of Technology. "Applied BioMath's modeling approach is uniquely suited to develop a versatile systems pharmacology computational modeling platform integrating the complex processes involved in this terrible disease."
In 2017, more than 5 million Americans are living with Alzheimer's Disease, at an annual healthcare cost of $259 billion (Alzheimer's Association 2017). Despite significant effort in R&D, from 2002 to 2012, 99.6% of the clinical trials for AD failed (Cummings, 2014). In most cases it could not be conclusively decided why these trials failed. There is an urgent need for tools and techniques that improve clinical decision making and decrease the extremely high failure rate.
"We have a very good chance at helping out pharmaceutical and biotechnology companies, to help them help patients and save money, if we work hard, and have a little luck!" said Mark W. Albers, MD, PhD, Frank Wilkens and Family Endowed Scholar in Alzheimer's Disease Research, Department of Neurology, Massachusetts General Hospital and Assistant Professor of Neurology, Harvard Medical School. Dr. Albers will participate as a consultant for the grant along with Bradley T. Hyman, M.D., PhD, Director, Massachusetts Alzheimer's Disease Research Center & John B. Penney Jr. Professor of Neurology, Harvard Medical School. "I'm excited by the expertise Applied BioMath brings to bear to address one of the major problems in the field: How to sort out, in a quantitative fashion, the pharmacology of anti-Alzheimer agents," added Dr. Hyman. "Given how expensive and complicated clinical trials are, I believe that biotechnology and pharmaceutical companies will be excited to work with the Applied BioMath team by obtaining access to quantitative systems pharmacology approaches to use data to better model the interactions involved in AD research."
Robert Rissman, PhD, Associate Professor of Neurosciences and Neuropathology Core Director of the Shiley-Marcos Alzheimer's Disease Research Center at the University of California, San Diego will also serve as a consultant on this grant. "New quantitative strategies and tools for refining enrollment and biomarkers in Alzheimer's clinical trials are critically needed and I am excited to be working with the Applied BioMath team on this project," says Dr. Rissman. "We have learned a great deal from prior trials on defining patient populations and timing of treatment but yet methods for reducing the number of individuals screened and screen failures for large trials is desperately needed."
"We envision the final product of this project being a validated QSP model where a user can select the patient population of interest, drug or drugs of interest, desired dosing regimen, and then simulate the effects of the Aβ and Tau changes over time," explained John Burke, PhD, Co-Founder, President, and CEO of Applied BioMath. "It is our mission to help reduce the cost and duration of drug R&D, and in this particular case, specifically for AD."
The grant referenced in this press release is supported by the National Institute On Aging of the National Institutes of Health under Award Number R44AG058411. The content is solely the responsibility of Applied BioMath, LLC and does not necessarily represent the official views of the National Institutes of Health.
About Applied BioMath
Applied BioMath (www.appliedbiomath.com), the industry-leader in applying mechanistic modeling to drug research and development, helps biotechnology and pharmaceutical companies answer complex, critical Go/No-go decisions in R&D. Applied BioMath leverages biology, proprietary mathematical modeling and analysis technology, high-performance computing, and decades of industry experience to help groups better understand their candidate, its best-in-class parameters, competitive advantages, and the best path forward. Our involvement shortens project timelines, lowers cost, and increases the likelihood of a best-in-class drug. We provide clarity to complex situations, answer otherwise unanswerable questions, and our approach, when validated in the clinic, is 10x more accurate than traditional methodologies.
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