Top 10 Life Science Resources - July 2023

There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for you. Catch up on what you may have missed below!

Top Nonclinical Scientific Resources

1. The Altascientist Issue 32: A Changing Paradigm for Non-rodent Species in Nonclinical Safety Studies 
   Though historically used predominantly in dermal and wound healing research, an increasing body of evidence supports the use of miniature swine as a viable non-rodent option for your nonclinical safety studies. Discover the unique advantages of this large animal model alternative. Read or listen. 
    
2. Webinar: Gene and Cell Therapy: Enhanced CNS and Ocular Delivery in Nonhuman Primates 
   With the new modalities, early drug discovery may require more specialized and focused delivery options for animal disease models. Using recent case studies, Dr. Makori and Dr. Menodza share essential approaches and techniques to help you accurately administer drugs to an organ of interest. Watch it now. 
    

Top Clinical Scientific Resources

3. The Altascientist Issue 31: The Advantages of Conducting Early Phase Clinical Research in Canada  
   Is conducting early phase clinical studies in Canada the right solution for you? There are several reasons why choosing Canada for your clinical trials can be beneficial. The FDA’s Investigational New Drug (IND) submissions can be put on hold for an undefined period during the application period and, as such, Canada’s clinical trial applications (CTA) can save you time and cut down costs.

   Read this issue of The Altascientist to discover the other ways your clinical trials could benefit. Read or listen.

4. Ask an Altascientist: Q&A With Lisa Sanford on First-in-Human Trials  
   Do you need an IND before beginning a first-in-human trial within Canada? Altasciences’ expert Lisa Sanford is here to answer that question. Watch the Q&A. 
    

Top Bioanalytical Resources

5. Poster Presentation: Application of Mitra Microsampling for the Quantitative Bioanalysis of Antisense Oligonucleotides (ASOs) 
   Using research conducted at Altasciences, Dr. Chen discusses how the use of volumetric absorptive microsampling (VAMS) has recently emerged as an alternative to venous sampling, and provides insight into the first application of VAMS with the Neoteryx microsampling device. Watch the presentation. 
    
6. Podcast: Coupling Hybridization LC-MS Workflows With Microsampling for the Analysis of Antisense Oligonucleotides  
   Altasciences’ bioanalytical experts Dr. Chen and Jeff Plomley share with you their insights on workflows for the quantitative bioanalysis of antisense oligonucleotide (ASO) therapeutics. Find out how these breakthrough novel LC-MS-based strategies can be applied to your nonclinical studies. Listen here. 
    

Top Manufacturing and Analytical Resources

7. Ask an Altascientist: What Our Recent CDMO Facility Expansions Mean for You 
   Altasciences is constantly looking for ways to improve your drug development and manufacturing needs. In this video, Ben Reed, General Manager of CDMO services, explains how doubling the square footage of our CDMO campus has increased cGMP manufacturing bandwidth—and how your projects will benefit. Watch the video. 
    
8. Podcast: Tips to Ensure Successful Formulation for Nonclinical Safety Testing 
   Do you find yourself facing challenges during formulation development stages for nonclinical testing? In this podcast, our drug formulation and safety assessment experts share tips on how you can avoid and mitigate those challenges to facilitate your IND applications. Listen here.

Top CRO Research Support Services

9. Video: Accelerate Your Data With our Co-located Clinic and Lab 
   Did you know that our Canadian clinical facility is only a 15-minute drive from our bioanalytical lab? Get a look into our workflow, and see how our operations are optimized to collect, process, and transport your samples for expedited go/no-go decision-making. Watch it now. 
    
10. Video: Inside Look at Ophthalmic Early Clinical Research with Dr. William Foster 
    At Altasciences, we have a fully integrated ophthalmology department, led by an experienced team of specialists. In this video, Dr. Foster explains how our state-of-the-art equipment and processes make us the perfect partner for your ophthalmic clinical trials. Watch it now. 
     

Recent Regulatory Guidances and Updates

• FDA: Final Guidance Revision – Use of Whole Slide Imaging in Nonclinical Toxicology Studies
• FDA: Guidance Draft – Psychedelic Drugs: Considerations for Clinical Investigations
• FDA: Guidance Draft – E6(R3) Good Clinical Practice (GCP)
• FDA: Guidance Draft – Decentralized Clinical Trials for Drugs, Biological Products, and Devices
• FDA: Guidance Revision – Clinical Drug Interactions Studies With Combined Oral Contraceptives

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