Top 10 Life Science Resources - October 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. eBook: Safety Assessment for Ophthalmic Products
   Designing preclinical studies for ocular therapies take a lot of deliberation. Discover the considerations and assessments necessary for performing preclinical research for ophthalmic therapies in this new eBook, that covers everything you need to know, 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
   With an estimated 6,000 monogenic diseases affecting over 350 million people worldwide, the advantages of cell and gene therapy can be a ray of hope—but development of complex, leading-edge therapies requires careful planning. Find out what the key factors are when developing nonclinical cell and gene therapies, including expert approaches to vindicating complex challenges, making your studies more efficient, and maximizing translational opportunities to first-in-human (FIH) trials. Read or listen now.
    

TOP CLINICAL RESOURCES

3. Video: Think Canada: The Team Behind Your Clinical Trials
   Learn more about the inner workings of our clinical pharmacology unit in Montréal, and meet the dedicated team of experts driving the many trials conducted there each year, in this fun look behind-the-scenes, presented by Lisa Sanford, Vice President of Business Development. Watch the video.
    
4. Podcast: FDA Guidance for Industry Psychedelic Drugs
   Extensively studied for potential therapeutic efficacy, psychedelic drug development comes with its own set of clinical development requirements. In this in-depth discussion on the FDA’s June draft guidance on clinical investigation of psychedelic drugs, Doctors Denise Milovan, Debra Kelsh, and Beatrice Setnik share insights into the potential need for additional methodological adaptations for study designs, in order to evaluate the safety and effects. Listen to the podcast.
    

TOP BIOANALYTICAL RESOURCES

5. Fact Sheet: Bioanalytical Expertise for Immunomodulatory Drugs 
   Immunomodulatory drugs play a crucial role in maintaining the balance and efficiency of the immune system's responses. See how Altasciences’ experts can provide support for your immunomodulatory drugs, including our common monitoring platforms, and how we are positioned to advance your drugs from preclinical to early phase clinical trials. Read the fact sheet.
    
6. Blog: Choosing the Best Bioanalytical Platform for Your Program
   There are four points to consider when choosing the best bioanalytical platform for your molecule. This informative blog lists crucial points to keep in mind, and details how Altasciences’ experts can help you choose the right platform for you. Read the blog.
    

TOP MANUFACTURING AND ANALYTICAL RESOURCES

7. The Altascientist: Issue No. 35: Critical Considerations for the Safe and Compliant Manufacture of Highly Potent Drugs
   Mainly driven by oncological research, the demand for highly potent active pharmaceutical ingredients (HPAPIs) has increased over the past 10 years—with over 25% on the market formulated with HPAPIs. Learn about the intricacies involved in manufacturing them safely, in this issue of The Altascientist, which examines the guidances, systems, and processes that we put in place, and how to maximize safety for your projects. 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, with Altasciences’ Senior Formulation Scientist, Andrew Buis, and Dr. Kevin Kirkcaldy, Director of Pharmacy Operations. Listen here.
    

TOP RESEARCH SUPPORT SERVICES

9. 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.
     

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RECENT REGULATORY GUIDANCES

The regulatory landscape is constantly evolving, and staying  up to date with these changes can be challenging. To ensure you're in the know, we've put together a summary of recent revisions, drafts, and new guidance releases from the FDA, EMA, Health Canada, and ICH.

• 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)