Top Life Science Resources for Fall 2024
There’s a lot of life science content out there, so for your convenience, we’ve curated a selection of expert insights, tips, case studies, and scientific and regulatory information. Catch up on what you might have missed below!
TOP NONCLINICAL SCIENTIFIC RESOURCES
- Webinar: Innovative Surgical Solutions in Safety Assessment Studies
Explore how innovative surgical solutions are enhancing nonclinical safety assessments. This webinar dives into the latest techniques and methods designed to improve toxicology and safety pharmacology studies, showcasing how these advancements help streamline procedures and move your compounds one step closer to approval. Watch it now.
White Paper: Whole Genome Sequencing, Proteomics, and Function Characterization of the Sinclair Nanopig™
Discover how the Sinclair Nanopig™ is transforming nonclinical safety assessments. This comprehensive white paper provides an in-depth look at genome sequencing, proteomics, and functional characterization of the Sinclair Nanopig™, offering key insights for pharmaceutical and biopharmaceutical safety evaluations. Read the white paper.
TOP CLINICAL SCIENTIFIC RESOURCES
- Video: The True Meaning of Moving in Unison
Watch how collaboration and precision ensure seamless clinical trial implementation. Experts from Altasciences provide their insights provide their on the importance of synergy between clinical and bioanalytical teams, and how you will benefit from an integrated CRO solution. Watch the video.
- Blog: Case Study: How to Evaluate Human Abuse Potential (HAP) for CNS Drugs
Explore how Altasciences evaluated the human abuse potential of mirogabalin, a CNS drug, by comparing it with diazepam and pregabalin in clinical trials. The study used a double-blind, crossover design with recreational drug users to evaluate subjective effects and likability. Read the blog.
TOP BIOANALYTICAL SCIENTIFIC RESOURCES
- The Altascientist: Issue 41—Immunomodulation Assessments for Clinical Trials: Sophisticated Bioanalytical Approaches to Support Complex Modalities
Uncover the complexities of immunomodulation. Issue 41 of The Altascientist focuses on bioanalytical testing for immunomodulatory drugs. This resource provides valuable insights into optimizing drug development while ensuring regulatory compliance and innovative solutions for immunotherapy. Read or listen now.
eBook: Key Considerations for Nonclinical AAV Gene Therapy Development
Explore the ins and outs of AAV gene therapy development. This eBook offers a detailed roadmap, from preclinical research to bioanalytical testing and manufacturing, equipping you with the knowledge needed to navigate the complexities of gene therapy smoothly. Read the eBook.
TOP MANUFACTURING AND ANALYTICAL SCIENTIFIC RESOURCES
- The Altascientist: Issue 40—Analytical Testing: Accurate and Complete Characterization of Your API
Discover how precise analytical testing ensures your drug products' proper absorption and therapeutic effect. This issue of The Altascientist dives into methods for identifying and characterizing your API, common techniques to determine particle size distribution (PSD), formulation approaches to maximize bioavailability, and a nanosuspension case study. Read or listen now.
- Infographic: Nanomilling—Enhancing Drug Solubility and Bioavailability
Learn how nanomilling, a cutting-edge manufacturing technique, addresses the critical challenge of poor water solubility and bioavailability in drug development. This infographic provides an overview of how nanomilling works, offering a practical solution for improving the formulation of poorly soluble drugs. View the infographic.
TOP CRO SCIENTIFIC RESOURCES
- Video: An Integrated CRO/CDMO
Discover how Altasciences breaks down organizational silos, streamlines project management, and provides effortless communication. In this video, leaders from across Altasciences come together to discuss how we safely accelerate your early-phase drug development journey using a seamless and integrated approach. Watch the video.
- Fact Sheet: Clinical Trial Site Selection and Management
Learn how Altasciences identifies, selects, and manages clinical trial sites to optimize patient enrollment, and ensure high data integrity throughout the study. This fact sheet highlights how our expertise in site selection directly contributes to your clinical trials. Read the fact sheet.
Want to see more? Access the full resource center!
RECENT REGULATORY GUIDANCES
The regulatory landscape is constantly evolving. To ensure you're in the know, we've put together a summary of recent revisions, drafts, and final guidances.
- FDA Draft Guidance — Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice
- FDA Final Guidance — Conducting Clinical Trials With Decentralized Elements
- FDA Final Guidance — Providing Regulatory Submissions in Electronic Format | Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry
- FDA Final Guidance — ANDA Submissions | Amendments to Abbreviated New Drug Applications Under GDUFA
- EMA Guideline — Reflection Paper on Establishing Efficacy Based on Single-Arm Trials Submitted as Pivotal Evidence in a Marketing Authorization Application
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.