Preclinical Research

  • Preclinical Research
  • Establishment of Historical Control Reference Values of Cambodian Cynomolgus Macaque Blood Gases

    Evaluating Cytokine Data in Nonhuman Primate Safety Assessment Studies: A Correlation to Toxicity Outcomes

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    Meet Dr. Simone Iwabe, DVM, PhD, DACVO
    Senior Veterinary Ophthalmologist

    A Unique Approach to Project Management

     

    The Benefits of Altasciences’ Unique Approach to Project Management

    When you partner with Altasciences, you are assigned a dedicated
    cross-functional project manager to seamlessly guide you from one milestone to the next — keeping your studies on track, throughout the lifecycle of your project.

    In this complimentary webinar, learn about the benefits of Altasciences’ unique program management offering, including case studies and client testimonials. 

    Watch now

    You may also be interested in the following:  

    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single service or a synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.

    WEBINAR — Adversity Level Determination in Nonclinical Studies

     

    Adversity Level Determination in Nonclinical Studies

    This complimentary webinar offers expert insight into how data is interpreted on toxicology studies. More specifically, we provide you with an insider’s view on common practices and guidances followed by contract research organizations to characterize adversity. 

    Case studies included:

    • Overt toxicity, exaggerated pharmacology, and changes in various markers of toxicity in the context of other safety endpoints
    • How to approach data interpretation on toxicology studies to classify adverse vs. non-adverse effects

    Watch now

    You may also be interested in the following:


    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.

    In drug development, toxicology evaluates and examines adverse effects of an investigational product on a living organism to determine its initial safety and dose-specific effects. But did you know that toxicology is not limited to drug development? Toxicology is a branch of science that deals with toxins and poisons, and their effects and treatment; other types of toxicology include forensic toxicology, environmental toxicology, food toxicology, and veterinary toxicology.

    Take this quiz to discover how much you know (or don’t know) about toxicology.

    A Solution to Drive Your Drug Development Forward

     

    Nonclinical and Clinical Research Services — Phase I to IV

    Whether you are looking for a full-service solution or a stand-alone offering, Altasciences will help guide you along the way. We are accustomed to managing complex projects with different partners, and have robust communication and operational processes in place to ensure efficient integration.

    We offer a range of services for early phase and late phase studies, including:

    • Program Management
    • Clinical Monitoring
    • Scientific Publication Development and Review
    • Protocol Development and Medical Writing
    • PK/PD Analysis and Interpretation
    • Data Management
    • Biostatistics and Statistical Analysis
    • Support Services for Non-Clinical Studies

     

    Have 5 minutes? You may be interested in this:

    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.

    Faster Start to Nonhuman Primate Studies to Meet Planned IND Filing Timelines

     

    Many of you are experiencing significant delays (up to 12 months!) in initiating nonhuman primate (NHP) studies. With Altasciences, the time-to study initiation can be as short as two to three months following contracting, thanks to our steady supply of NHPs.

    At Altasciences, we do not rely on a single-source NHP supply chain. We remove the stress of sourcing research animals so that you can start your studies faster, with:

    • dedicated and diversified Cynomolgus monkey supply agreements in place to allow for faster start-up timelines
    • a continuously maintained and backfilled population of hundreds of naïve NHPs at our preclinical facility 

    You can schedule newly contracted NHP studies to start in late Q1 and early Q2 2022 immediately.

    Contact us to schedule your NHP studies today.

    You may also be interested in the following:


    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated, synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.

    A Step-by-step Guide for Meeting Your Safety Assessment Start Dates

     

    Careful planning and financial commitment can make the difference between starting your safety testing studies on time or experiencing significant delays.

    Once you have determined your desired safety assessment start date, we recommend taking the following steps to ensure you start your studies on time, and on your terms.

    • 12-18 months before: 
      • Schedule a meeting with the FDA to go over your safety assessment plan.
    • 9-12 months before: 
      • Get quotations from your preferred CRO partners. 
      • After receiving the proposals, discuss your program with an expert toxicologist to ensure you captured all the required studies.
    • 6-12 months before (depending on research animal species and study type):
      • Choose a CRO partner and sign a contract. 

    Reach out to us today so we can go over these steps together and ensure your study starts on time.

    Top Scientific Resources of 2021

    Top Scientific Resources of 2021

    With the year coming to an end, we rounded-up some of our most insightful scientific resources from 2021. Check out what you may have missed, discover more about our areas of expertise, and learn how we can help you accelerate your drug development program.

    Preclinical
    1.





     
    The Altascientist: Planning your Preclinical Assessment for a Successful Regulatory Submission
    A thorough review of IND requirements and preclinical program considerations, including a guide to help you estimate small molecule and biologic timelines.
    Read More
     
    2.



     
    The Altascientist: Safety Pharmacology Guidelines and Practices – A Review
    How to reduce the use of test animals, save time, and ensure quality data. Read More
     
    3.




     
    Podcast: Consultant Series ― A chat with Dr. John Atkinson, Founder of Atkinson Toxicology Consulting
    Dr. Atkinson’s journey in the drug development industry, his experience as the former president of the American College of Toxicology, what to look for in a CRO partner, and much more. Listen Now
    Clinical
    4.


     
    The Altascientist: Planning your First-in-Human Trial
    A thorough review of the first-in-human clinical trial process, including planning and conduct. Read More
     
    5.



     
    Blog: Ethnobridging Supports Global Clinical Development
    Historical background on ethnobridging and how it developed into a mainstream strategy. Learn More
     
    6.




     
    Webinar: The Brain on Drugs: The Strategic Use of Cognitive Measures and Biomarkers in Early-Phase CNS Drug Studies 
    Key clinical and bioanalytical considerations when it comes to pharmacokinetics and pharmacodynamics data specific to biologics. Watch Now
    Manufacturing
    7.




     
    E-Book: Liquid-Filled Capsules: Getting Your Drug to the Clinic – FAST
    How liquid-filled, hard-shell capsules can help accelerate drug development programs and entry into clinical trials. Read More
     
    8.




     
    The Altascientist: Terminal Sterilization of Pharmaceutical Products
    Why regulatory agencies, such as the FDA and EMA, prefer terminal sterilization over aseptic processing. Learn More
     
    9.


     
    Webinar: Overcoming the Challenges of Manufacturing and Clinical Trials
    An overview of our pharmacy and manufacturing services, including a recent case study. Watch Now
    Bioanalytical
    10.





     
    Webinar: Patient Centricity and the Evolving Role of Microsampling
    An in-depth bioanalytical and clinical exploration of microsampling technology and its significance in supporting patient-centric healthcare initiatives, along with case studies to demonstrate.  Watch Now
     
    11.




     
    Insert: Flow Cytometry Solutions to Support your Preclinical and Clinical Studies
    An overview of our flow cytometry services, on-site equipment, flow markers, and NHP panels to support your preclinical and clinical studies. Read More
     
    12.



     
    Infographic: The Key To Selecting The Right Bioanalytical Platform For Your Molecule
    How to expedite your research goals by proactively selecting the best pathway for your unique molecule. Learn More
    Research
    13.




     
    Quick Chat: A Seamless Experience, Thanks to Expert Scientific Project Management
    An inside look at Altasciences' Scientific Project Management team, our company culture, and how we assign project and program managers. Watch Now
     
    14.


     
    Webinar: Demystifying the CTA Process in Canada
    Benefits of conducting FIH trials in Canada for biopharmaceutical companies. Watch Now
     
    15.



     
    Interview: Five Things to Know About Scientific Affairs
    Catherine Dussault, Director of Scientific Affairs, discusses how her team is able to design and conduct the most appropriate study for each unique development program. Read More

    Have five more minutes? You may be interested in:


    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated, synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.

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