It's Been a Minute, See What You Missed! Top 10 Life Science Resources


 

Top 10 Life Science Resources 

Your time is precious. Therefore, we’ve curated a selection of recently published expert insights, tips, case studies, and scientific and regulatory information, just for you. 

Nonclinical Resources

  1. eBook: Safety Assessment for Ophthalmic Products

    Learn about the considerations and assessments necessary for performing nonclinical research on ophthalmic therapies, from species selection and routes of administration to preparing for first-in-human trials. Read it now.
     
  2. ​​The Altascientist: Issue No. 36 – Nonclinical Studies in Cell and Gene Therapy: Key Considerations and Regulatory Guidance

    Find out what the key factors are when developing nonclinical cell and gene therapies–including expert approaches to mitigating complex challenges, improving study efficiency, and maximizing translational opportunities to first-in-human (FIH) trials.​​​​​ Read or listen now.
Clinical Services
  1. Video: Think Canada: The Team Behind Your Clinical Trials

    Learn about the inner workings of our clinical pharmacology unit in Montréal, and meet the dedicated team of experts driving the many trials conducted there, in this fun behind-the-scenes look. Watch the video.
     
  2. Podcast: FDA Guidance for Industry Psychedelic Drugs

    Listen to an in-depth discussion on the FDA’s recent draft guidance on clinical investigation of psychedelic drugs with Altasciences’ expert doctors, Denise Milovan, Debra Kelsh, and Beatrice Setnik. Listen to the podcast.
Bioanalytical Services
  1. Fact Sheet: Bioanalytical Expertise for Immunomodulatory Drugs 

    See how Altasciences’ bioanalytical experts can provide support for your immunomodulatory drugs, and advance your drugs from preclinical to early phase clinical trials.​​​​​ Read the fact sheet.
     
  2. Blog: Choosing the Best Bioanalytical Platform for Your Program

    Explore how we determine the most appropriate and effective bioanalytical platform for your molecule. Read the blog.
    ​​​
Manufacturing and Analytical Services
  1. The Altascientist: Issue No. 35 – Critical Considerations for the Safe and Compliant Manufacture of Highly Potent Drugs

    How the demand for manufacturing highly potent active pharmaceutical ingredients (HPAPIs) has increased, and the intricacies involved in manufacturing them safely. Read or listen now.
     
  2. Podcast: Successful Manufacturing of Clinical Trial Supply

    Uncover secrets from our formulation and pharmacy experts for effectively completing clinical trials, and resolving potential issues that could hinder your drug development timeline. Listen here.
Research Support Services
  1. Educational Video: The Benefits of Conducting a Clinical Trial in Canada

    Gain valuable insights into Health Canada's Clinical Trial Application (CTA) submission and review process, along with answers to some of your most common questions. Watch it now.
     
  2. The Altascientist: Issue No. 34: Toxicokinetics, Pharmacokinetics, and Pharmacodynamics 

    Take a closer look at the collection and use of pharmacokinetic (PK) and pharmacodynamic (PD) data in early phase drug development, as well as the critical role of nonclinical toxicokinetic (TK) studies in guiding early phase clinical trials. Read or listen now.
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Recent Regulatory Updates:

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.


Altasciences has been recognized as a 2023 CRO Leadership Award Champion in the Capabilities category, as voted by you in ISR’s annual CRO Quality Benchmarking survey.


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Say Goodbye to Clinical Trial Delays!

 

Your Passport to Success 

At Altasciences, we understand the importance of streamlining your drug development process and ensuring the highest quality results. We provide a comprehensive, North American solution that significantly enhances the clinical trial phase, from design and conduct to compiling data for regulatory submission.

Here's why Altasciences is your ideal CRO partner:

  1. We conduct trials in both Canada and the U.S.
    You can experience expedited timelines by conducting trials in Canada, giving you a competitive edge right from the start. Our expertise in navigating Health Canada's CTA process ensures smooth and efficient approvals. Discover more: An Overview of Health Canada's CTA Process
     
  2. We have optimized workflows for efficient bioanalytical sample processing.
    Save time with our optimized workflows that ensure timely processing, transport, and analysis of your samples. Our co-located clinics and labs in both Canada and the U.S. work seamlessly to accelerate your data. Watch how: Accelerate Your Data With Our Canadian Co-located Clinic and Lab
     
  3. We can prevent repeated Phase I studies for drugs intended for the Asian market.
    Speed up approval of your drug in Asian markets by conducting your trials at our clinical site in L.A., one of the most ethnically diverse regions in the U.S. Our expertise in ethnobridging trials can pave the way for your global market access. Learn more: Shortening Drug Development Timelines With Asian Ethnobridging Trials
     
  4. We have driving simulators on-site.
    For CNS drugs that need assessment of their impact on driving ability, start your study faster and with lower costs thanks to our on-site driving simulators in Montréal. 13,000+ simulated drives completed to date! Learn how: Studying the Effects of Drugs on Driving
     
  5. We specialize in human abuse potential assessments.
    Benefit from experience at our Kansas City clinical site—we have successfully conducted over 60 HAP studies, including for stimulants, opioids, and sedative-hypnotics. Read more: Assessing Human Abuse Potential to Limit the Misuse and Abuse of Prescription Drugs
     
  6. We offer specialized ophthalmology expertise.
    Benefit from combined clinical and scientific expertise specific to ophthalmology and our co-located ophthalmic clinic. See how: Co-located Canadian Ophthalmology Center for All Your Early Phase Development Needs

     

Schedule a chat with our experts to learn more about how Altasciences can be your only North American clinical trial solution. Contact Us to get started.

 

Infographic―Discover the Optimal Dosage Form for Your Molecule

 

A Quick Guide 

We’ve received a lot of questions about drug formulation and development over the years, but these are the most common:

•    What’s the best dosage form for my molecule? 
•    Which will yield data from clinical trials faster? 
•    Which will safely get my product to market fastest?

The answer to all is “It depends on your molecule!”. Take a look at this infographic for help determining whether tablets or liquid-filled, hard-shell capsules are most suitable for your specific molecule, and let’s plan the next step.   

Have questions? Speak with one of our experts.

Related resources that may interest you:
eBook: Applications of Liquid-Filled Capsules in Drug Development
Podcast: Ensuring the Successful Manufacture of Clinical Trial Supply
Webpage: Comprehensive Manufacturing and Analytical Testing Solutions

Drug Development for Cell and Gene Therapy

 

In this scientific journal, we review considerations for nonclinical cell and gene therapy development, including expert approaches to mitigating complex challenges, improving study efficiency, and maximizing translational opportunities from nonclinical to first-in-human trials.

Learn about: 
•    the ICH S-12 Guideline on nonclinical biodistribution studies 
•    species selection criteria per the FDA
•    choosing the appropriate vector
•    immunogenicity evaluations
•    findings from two case studies

Read the issue HERE.

Nonclinical Studies in Cell and Gene Therapy

 

Ready for the next step? Contact one of our experts to discuss your study needs.

You may also be interested in the following:  
•    Webinar: Cell and Gene Therapy―Enhanced CNS and Ocular Delivery in NHPs
•    Poster: Gene Therapy Utilizing Adeno-Associated Viral (AAV) Vectors―Historical Data Review
•    Webpage: Preclinical Research Services

Development of a Novel Canine Prostatectomy Model

Choosing the Optimal Dosage Form for Your Molecule

PCR's Key Role in Therapeutic Advancements

Cell and gene therapies are revolutionizing medicine with personalized treatments; PCR analysis plays a crucial role in their development.

In this issue of The Altascientist:

- explore the different approaches and applications of qPCR and ddPCR analysis for nonclinical and clinical studies;
- discover the unique advantages they offer; and
- review two case studies demonstrating how these methods are shaping the future of gene therapy research.


Have questions? Speak to a scientist.

READ NOW

​​​​​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.​​​​

Getting to the Heart of Science With Natasha Savoie

Natasha Savoie, Senior Director of Quality Assurance at Altasciences, has an undeniable passion for science, a passion that drives her to ensure that the data we generate for our clients is reliable and precise.

Watch this video to experience Natasha's unwavering dedication to science. 

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