Significant biological events can take different shapes and sizes, from disease to intentional poisons and anywhere in between. The Defense Department (DOD) is adapting to this new reality by developing capabilities that could rapidly produce medical countermeasures (MCM) and other solutions to address and combat the threat regardless of the specific threat source.
The Generative Unconstrained Intelligent Drug Engineering (GUIDE) program leverages integrated computational and experimental capabilities to accelerate drug development for the warfighter by harnessing the power of advanced simulation and machine learning.
GUIDE is stewarded by the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) Joint Project Lead for CBRND Enabling Biotechnologies (JPL EB), working with interagency, academic and industry partners.
Traditional drug development requires a “try and fail” process to evaluate effectiveness, safety, and ultimately manufacturing at scale. Using robust integration of computational and experimental design, GUIDE evaluates these variables and potential liabilities upfront, prior to extensive and costly product development.
READ ALSO: The Need for Speed in Biodefense: How JPEO-CBRND is Positioning for Rapid Response Aug 2023
Within the systems-of-systems in which GUIDE falls, the moonshot goal of GUIDE is to do this evaluation (up to Phase 1 clinical trials) in 100 days or less: a seismic departure from the traditional timeline and cost which is usually estimated to be ~$1.5B and 10 years of product development per drug candidate.
Ultimately GUIDE will yield reduced developmental risk, time, and cost.
In the current wave of advancement in artificial intelligence and machine learning the computational prowess of GUIDE’s high-performance computing (HPC) capabilities may seem like the program’s standout capability, however the real power of GUIDE is the tight integration with experimental design and validation. GUIDE’s integration of HPC capabilities with experimental validation allows for an iterative cycle of computational design-to-experimental validation to quickly generate a plethora of highly effective drug candidate designs under an aggressive timeline.
“The difference with GUIDE and other programs that utilize computational design is the purposeful integration of computational design with rapid experimental methods so that the system can be operationally relevant to Warfighter needs,” said Chris Earnhart, Ph.D. Chief Technology Officer for JPL EB. “Computational drugs can be produced and tested in a dedicated rapid response lab and then manufactured in a facility that gives the government priority access. This program is incredibly robust and enables us to move fast and honor our commitment to rapid response.”
That integration is made possible through the many partnerships formed between interagency, academia, DoD and the Department of Energy. Each entity brings a critical asset to the table to create a process that challenges the norm of drug development to create better solutions faster.
GUIDE is just one element of a larger strategic plan to develop rapid response capabilities within EB and accelerate the medical development timeline. Other projects in that strategic plan include the Accelerated Antibodies program and the Rapid Access to Products in Development (RAPID) program. While GUIDE is just in its second year as a program, it’s demonstrating promising impact to the future of MCM development and CBRN defense.
Sources: JPEO-CBRND, Lawrence Livermore National Laboratory, adapted