Top 10 Life Science Resources - October 2023

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. 

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.

3. 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.
    
4. 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   Listen to an in-depth discussion on the FDA’s recent draft guidance on clinical investigation of psychedelic drugs with Altasciences’ expert doctors, Denise Milovan, Debra Kelsh, and Beatrice Setnik.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.

5. 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.
    
6. 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.
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7. 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.
    
8. 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.

9. 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.
    
10. 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.

Recent Regulatory Updates:

• FDA: Guidance Final Revision – Benefit-Risk Assessment for New Drug and Biological Products
• FDA: Guidance Final Revision – Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors
• FDA: Guidance Draft – Demonstrating Substantial Evidence of Effectiveness With One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence
• EMA Draft – Guideline on Clinical Investigation of Medicinal Products in the Treatment of Depression
• ICH Draft Revision – E6(R3) Good Clinical Practice (GCP)

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.