Preclinical Research

  • Preclinical Research

    • Coast-to-Coast Specialized Preclinical Solutions


    Four Preclinical Sites to Support Your Program

    With four purpose-built preclinical facilities across the U.S., we conduct over 700 safety assessment studies annually in rodent and non-rodent species. Our small and large molecule solutions include pivotal toxicology, safety pharmacology, and PK/PD studies, with comprehensive bioanalytical services to ensure your IND submissions meet global regulatory requirements.

    Our specialties include:

      Therapeutic Indications
    • ophthalmology
    • dermatology
    • CNS research
      Therapeutic Products
    • cell and gene therapy
    • oligonucleotides
    • monoclonal antibodies
    • antibody-drug conjugates

    Learn more about the specific capabilities provided at each of our preclinical facilities.

    Questions on how we can support your drug development program? Consult with one of our experts.

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    Metabolic Drug Development: A to Z Solutions


    In the complex and dynamic field of metabolic drug development, partnering with an accomplished contract research organization is essential.

    Altasciences has over 25 years of experience in metabolic diseases and supports every stage of the development process, from the initial discovery phase and preclinical studies to clinical trials and beyond.

    Here are a few highlights:

    • The teams at our four preclinical sites are proficient in obesity and metabolic models, and both GLP and non-GLP studies in rodents, dogs, minipigs, and NHPs.
    • Our clinical teams have completed over 50 early-stage trials involving anti-diabetic and hypoglycemic agents, such as insulin, GLP-1, SGLT-2, and DPP-4, with 75 type I and type II diabetic patients enrolled in a single-center trial over four weeks.
    • Our clinical database includes over 400,000 participants to more quickly qualify for inclusion/exclusion criteria based on pre-existing conditions, demographics, medication use, and BMI.
    • Our scientists have developed bioanalytical assays for exenatide, glucagon, insulin glargine (M1, M2), insulin aspart, and metformin.
    • We can develop additional assays tailored to your program.
    • We’ve conducted numerous pharmacodynamics and immunogenicity assessments, including high-glycemic load challenge/tolerance tests, glucose clamps, insulin-induced hypoglycemic events in type 1 diabetes, and anti-drug antibody evaluations.
    • We support data management both at our clinics and at external sites.
    • Our pharmacokinetic, pharmacodynamic, and statistical experts support the analysis of drug concentration, biomarker, subjective measure, and immunogenicity data.
    • Our medical writers and scientists have designed thousands of studies and are accustomed to preparing clinical protocols and high-quality reports.

    Ready to get started? Speak with one of our experts.

    You may also be interested in the following resources:


    When is the Right Time to Connect With a CDMO?


    Timing is Everything

    Early collaboration with an experienced CDMO is crucial in drug development to mitigate manufacturing risks and ensure the efficient formulation of your API for preclinical and clinical testing.

    For over 25 years, we’ve been providing manufacturing and analytical testing services for solid and liquid dosage forms in most therapeutic areas.

    You benefit from:

    • optimized processes
    • insights into scaling production to reduce costs
    • assured regulatory compliance
    • accelerated timelines

    What's more, our manufacturing site is strategically located near our preclinical and clinical facilities, for seamless transitions from one phase to the next.

    Contact us today to discuss the next stage of your drug development journey.

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    Tips on How to Select the Right Species for Your Preclinical Studies


    In this webinar, we dive into the scientific rationale driving species selection and how it can impact your study designs. We also focus on how in vitro species comparison studies can help determine the right species for your in vivo programs.

    START WATCHING!

    How do I select the right species for my toxicology program?

    Deciding which animal model to utilize for your preclinical program is not always obvious. Speak with one of our experts who can help identify the appropriate species to generate the most relevant safety data needed to progress your program to Phase I clinical trials.

    ​​Related resources that may interest you:

    Whole Genome Sequencing, Proteomics, and Function Characterization of the Sinclair Nanopig™ for (Bio)Pharmaceuticals Safety Assessment

    Inside The Altascientist: How to Achieve Optimal Preclinical Formulation and Drug Product Manufacture

     

     

    Strategies to Minimize Number of Animals Used in Toxicology Studies


    Optimizing Preclinical Study Designs to Reduce Animal Use

    Our latest webinar is now available on-demand―watch it at your leisure.

    This webinar focuses on the methods employed to minimize the number of animals used in toxicology studies while ensuring scientific integrity and reproducible findings. Drawing from our extensive experience spanning decades, we analyze the advantages and limitations of each method.

    WATCH IT NOW!

    Social media webinar Preclinical 3Rs mouse on demand

    Questions? Speak with one of our experts today and let's get your program underway.

    ​​Related resources that may interest you:


    CNS-Targeted Therapies Delivery Strategies and Sampling in Non-rodent Preclinical Species: Considerations During Early Phase Discovery to IND-Enabling Regulatory Studies

    The Next Generation of Non-Rodent Species for Nonclinical Studies


    Embracing Change

    If you missed our latest webinar in collaboration with Sinclair Bio Resources, The Next Generation Non-Rodent Model for (Bio)Pharmaceuticals Safety Assessment, it’s not too late! The on-demand version is now available.

    You’ll learn about the increasing role of miniature swine in drug development and the distinct advantages offered by the Sinclair Nanopig™ model—from availability across all ages to comparable toxicological data with Göttingen™ minipigs and other non-rodent species.

    Watch it now!

    ​​​​

    Sinclair Nanopig

    If you have questions about your nonclinical studies, speak with one of our experts.

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