Translating Ideas into Medical Treatments
For more than a century, chemical and biological weapons have posed a threat to warfighters and civilians alike. Whether used on the battlefield or in an act of terrorism, cases of severe exposure can result in medical conditions that can potentially lead to fatality. This prompts the significant clinical need for safe and effective medical treatments to address these threats and help ensure the health and safety of people everywhere. To help combat this problem, MRIGlobal tests and evaluates the safety and efficacy of medical countermeasures in response to these threats, including therapeutics to address conditions that currently do not have an FDA-approved therapy. Ultimately, this work saves the lives of those impacted.
Before such countermeasures can be used in humans and/or tested in human clinical trials, they must first go through pre-clinical toxicology trials. Our team has the depth of experience testing and evaluating therapeutics for use against such chemical agent threats, including examining a drug’s pharmacokinetics, effectiveness, and safety in animal models. Pre-clinical testing aims to spot any possible safety issues and helps establish the optimal safe dose and dosing schedule in humans for the compound in question.
Coupled with our world-class laboratories, we are uniquely positioned to work with a variety of chemical agents, including nerve agents, vesicants, toxins, and pharmaceutical based agents. This ability to work with a broad range of agents supports therapeutics testing and development for commercial and government clients in need of guidance, experience navigating government regulatory agencies, and established best practices.
To learn more about our multidisciplinary approach to provide scientific and subject matter expertise for development of these medical countermeasures through pre-clinical toxicology research, we spoke with Phil Beske, Senior Director and Brad Wahle, Principal Scientist, both of our Translational Development division.
What is the process for initiating a pre-clinical toxicology research study?
Based on our many years of expertise and flexibility in research study design, we work in partnership with our clients to clearly understand precisely what they’re trying to accomplish. And because we are invested in the client relationship and with their goals in mind, we offer guidance on how to best approach the science involved and then develop a tailored study design that meets their specific needs. This can’t always be accomplished by performing a standard study, so we modify study designs to answer more specific questions or address issues related to the test article, such as the dosing route. To learn more about how we design research studies that best meet client goals, read “Six Questions to Ask Your CRO When Designing a Research Study.”
What differentiates MRIGlobal from our competitors in this area?
In addition to the U.S. government, small and virtual pharma companies look to MRIGlobal as a trusted partner to advance their technologies. They call on us because of our long-standing track record of success. We design customized research studies that meet their needs, providing laboratories and expertise they cannot access elsewhere, while effectively navigating the regulatory process to support their market access. In all that we do, we emphasize the need to provide our clients with customized solutions and best-in-class services.
What types of research scientists are on the team?
Our technical staff includes experienced toxicologists (DABT;PhD); clinical veterinarians (DVM, board-certified surgeon); registered veterinary technicians (RVT); and AALAS accredited animal care personnel (ALAT, LAT, LATG). When appropriate, we also integrate broader multidisciplinary expertise, engaging researchers and even engineers from across our capabilities to ensure a comprehensive solution. And because we run small teams that remain consistent throughout performance of the research, our team becomes intimately familiar with our clients’ ever-evolving needs. Too, we provide clients with a single point of contact for the duration of their project, giving clients ready access to our technical experts. We can even lead the client’s project team, if requested.
And what types of research studies do they perform?
MRIGlobal has experience and in-depth knowledge to perform a wide variety of studies and project work.
Our toxicology services include:
- Maximum Tolerated Dose – Through escalating or deescalating dose levels, MRIGlobal will determine the maximum tolerated or maximum feasible dose of a target drug or biologic.
- Dose Ranging Finding Studies – Characterize the toxicity and toxicokinetic profile of a target drug or biologic via any route of exposure and frequency; Bioanalysis and TK analysis; Determination of desired dose levels for pivotal GLP studies
- Repeat Dose Definitive Subacute and Subchronic Studies Under GLP Compliance – Evaluation of toxicity via in-life parameters including, but not limited to, clinical observations, body weight, food consumption, ophthalmology, ECG/EKG, etc.; Clinical pathology (clinical chemistry, hematology, coagulation, and urinalysis parameters); Histopathology services; TK profile with WinNonlin analysis/results
- Animal Models and Multiple Routes of Exposure
- Complete Bioanalytical and Chemistry Support – Method development and validation; Impurities isolation and identification; Materials characterization and release; Short-term and long-term stability assessment
- Pharmacokinetics and Toxicokinetics (PK/TK) – MRIGlobal has bioanalytical capabilities to perform test article concentration analysis of blood samples. Analysis is conducted using WinNonLin software. PK parameters include but are not limited to Cmax, Tmax, T1/2, AUC, etc.
- Customized Study Designs and Animal Models – Ask us how we can customize and develop a specific animal model for your test article application.
After the research is completed, how do we help customers navigate regulatory approvals?
We provide not only the research study data, but also ongoing support to help navigate FDA approvals through continuous access to our Study Director and other MRIGlobal scientific experts. Further, as the customer develops their Investigational New Drug application that relies upon this data, our Study Directors and researchers continue to be available to answer any questions or help reconcile any questions between pre-clinical and clinical research steps.
Too, our experience with IND-enabling services provides clients with an extensive range of services and unmatched expertise to facilitate the initiation and successful completion of IND-enabling programs. To learn more about our support for Investigational New Drug applications, read “Developing Investigational New Drug Applications.”
Innovating solutions to address the world’s important challenges is what we do. Every single day, our commitment to our customers is to provide unsurpassed technical expertise, world-class laboratories, and a partnership to find customized solutions to your specific challenges.
GETTING STARTED AT MRIGLOBAL
Contact MRIGlobal for further information about our work with chemical and biological threat agents. Through an interdisciplinary approach, we provide scientific and subject matter expertise for development of medical countermeasures research against these threats.
To discuss how we can help your project be successful, contact us today.
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