Top 10 Life Science Resources for Summer 2024

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 your convenience. Catch up on what you might have missed below!

TOP NONCLINICAL SCIENTIFIC RESOURCES

• Webinar:  Best Practices to Reduce Animal Use in Toxicology Studies
  Drawing upon decades of experience, Altasciences’ experts take a deep dive into some of the advantages and limitation of the methods for minimizing the number of animals used in toxicology studies, while still maintaining robust, high-quality, and reproducible findings. Watch it now.
   
• The Altascientist: Issue No. 39 Key Considerations for Nonclinical Dermal Studies—Advancing to Phase I
  An increasing number of advanced methods for dermal drug delivery can contribute to successful 505(b)(2) applications and extend the patent life of a drug for its sponsor. Discover some of the nonclinical requirements for moving dermal studies into Phase I clinical trials, including formulation considerations, species selection, and ideal candidates for transdermal drug delivery systems (TDDS). Read or listen now.

TOP CLINICAL SCIENTIFIC RESOURCES

• Webinar: CNS-Active Compounds—The Importance of Cognitive and Pharmacodynamic Testing During First-in-Human Trials
  Pharmacodynamic (PD) and cognitive testing is used to characterize CNS profiles of novel drugs in order to provide vital data on safety and proof-of-concept (POC) endpoints. This in-depth webinar reviews some of the most common cognitive and PD test batteries, including their applications and limitations in first-in-human (FIH) studies. Watch the webinar.
   
• eBook: Regulatory Comparisons for Starting First-in-Human Clinical Trials
  Initiating FIH studies in the EU and UK has become a more complex and resource-intensive process. Because of this, considering other regulatory pathways is necessary. In this eBook, discover the different requirements, procedures, and timelines based on where you choose to conduct your studies—whether in Canada, the U.S., the UK, or the EU. Read the eBook.

TOP BIOANALYTICAL SCIENTIFIC RESOURCES

• Webinar: Nonclinical Adeno-Associated Virus (AAV) Gene Therapy Development 
  Explore pre-existing immunity challenges, vector targets, biodistribution, and the role of PCR analysis in assessing therapy efficacy and safety, including case studies highlighting the delicate balance between innovation and regulatory compliance. Watch the webinar.
   
• Poster: Sensitive Quantitation of Antisense Oligonucleotides (ASOs)
  Discover the complex workings of the novel finger-stick-derived capillary collection method (such as that supported by the Capitainer® qDBS microsampling device), which has recently emerged as an alternative to traditional venipuncture in combination with hybridization LC-MS/MS. Watch the poster presentation.

TOP MANUFACTURING AND ANALYTICAL SCIENTIFIC RESOURCES

• Podcast: Successful Manufacturing of Clinical Trial Supply
  Join our formulation and pharmacy experts as they share insider secrets for overcoming clinical trial challenges and resolving issues that could impact your drug development program's timeline. View the podcast.
   
• The Altascientist: Issue No. 38 Ensuring Successful Formulation and Drug Product Manufacture for Preclinical Testing 
  Preclinical manufacturing involves various critical sub-processes, from formulation development and manufacturing, to stability studies and process validation. In Issue 38 of The Altascientist, you will explore some of the key considerations for drug formulation, biopharmaceutical assessments, drug manufacturing, and more. Read or listen here.

TOP CRO SCIENTIFIC RESOURCES

• Fact Sheet: Clinical Trial Site Selection and Management
  At Altasciences, you have the option to utilizing one or more of our three clinical sites, one of our affiliate sites, or both for a hybrid approach. In this fact sheet, learn how we ensure on-time and on-budget completion of your clinical trial projects, and leverage our extensive data and experience to place your study where it makes the most sense. Read the fact sheet.
   
• Video: Connecting the Dots—So You Don’t Have To
  Discover a simpler drug development journey—one solution seamlessly connecting to the next. Watch the video.

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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 final guidances from the FDA.

• FDA: Guidance Draft – Data Integrity for In Vivo Bioavailability and Bioequivalence Studies
• FDA: Guidance Revision – Controlled Correspondence Related to Generic Drug Development
• FDA: Final Guidance – Clinical Pharmacology Considerations for Antibody-Drug Conjugates
• FDA: Guidance Draft – Early Alzheimer’s Disease: Developing Drugs for Treatment
• FDA: Final Guidance – Human Gene Therapy Products Incorporating Human Genome Editing