Top 10 Life Science Resources

We’ve curated a selection of recently published expert insights, tips, case studies, and scientific and regulatory information, just for you.

1. Webinar: Innovative Surgical Solutions in Safety Assessment Studies

Explore the latest advancements in surgical techniques for your toxicology and safety pharmacology studies. This webinar dives into innovative methods and techniques for new dose routes and procedures that help move your compounds one step closer to approval. Watch it now.

2. ​​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 details the genome sequencing and functional characterization of the Sinclair Nanopig™, offering key insights for pharmaceutical and biopharmaceutical safety evaluations. Read now.

3. Video: The True Meaning of Moving in Unison

See how collaboration and precision ensure seamless clinical trial implementation. Experts from Altasciences provide their insights on the importance of synergy between clinical and bioanalytical teams, and how you will benefit from our integrated CRO solution. Watch the video.

4. 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 case study.

5. The Altascientist: Issue 41—Immunomodulation Assessments for Clinical Trials: Sophisticated Bioanalytical Approaches to Support Complex Modalities

Uncover the complexities of immunomodulation in this issue of The Altascientist. This resource provides valuable insights into optimizing drug development while ensuring regulatory compliance and innovative solutions for immunotherapy. Read or listen now.

6. 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 through to bioanalytical testing and manufacturing, equipping you with the knowledge needed to smoothly navigate the complexities of gene therapy. Read now.

​​​

7. The Altascientist: Issue 40—Analytical Testing: Accurate and Complete Characterization of Your API

Discover how precise analytical testing ensures the proper absorption and therapeutic effect of your drug products. This issue of The Altascientist dives into methods for identifying and characterizing your API, common techniques to determine particle size distribution (PSD), and formulation approaches to maximize bioavailability. Read or listen here.

8. Infographic: Nanomilling—Enhancing Drug Solubility and Bioavailability

Learn how nanomilling, a cutting-edge manufacturing technique, can be used to tackle 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.

9. 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.

10. Fact Sheet: Clinical Trial Site Selection and Management

Learn how Altasciences can identify, select, and manage clinical trial sites to optimize patient enrollment, and ensure high data integrity throughout your study. Read the fact sheet.

Recent Regulatory Updates:

• FDA Guidance Draft – 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

Get ready for some fun! Join Lisa Sanford as she introduces you to our amazing clinical teams in Kansas and Los Angeles. Thinking about early-phase studies? Think Altasciences!

Book a visit, we’d love to host you.

Did you miss our last video in this series? You can still watch it here:

• Think Canada: The Team Behind Your Clinical Trials

You may also be interested in these resources:

• Webpage: Clinical Research Services
• eBook: Altasciences’ Facilities – Moving in Unison

Altasciences’ Chief Scientific Officer Selected as a PharmaVoice 100 Honoree

Dr. Beatrice Setnik, Chief Scientific Officer at Altasciences, has been named a 2024 PharmaVoice 100 honoree. Known as a dedicated and hands-on leader, Dr. Setnik has nearly 20 years of experience in clinical drug development, and was selected by the PharmaVoice team from nominations submitted by industry peers.

"Thank you very much to PharmaVoice for this honor, which would have been impossible without the support of my colleagues, the clients at Altasciences, and of course, my peers and collaborators over the years,” said Dr. Setnik. “To be included in a list of such incredible innovators and trailblazers is extremely humbling."

​​

You may also be interested in these resources from Dr. Setnik

• Scientific Poster: Development of the Subject-Rated Comprehensive Drug Withdrawal Scale (CDWS) to Evaluate the Physical Dependence Potential of Investigational Drugs
• Webinar: CNS-Active Compounds–The Importance of Cognitive and Pharmacodynamic Testing During First-in-Human Trials
• Webinar: Demystifying the Conduct of Clinical Trials in Canada
• Podcast: The Many Faces of Recreational Drug Use—Episode 1
• Interview: Dr. Beatrice Setnik: Boldly Navigating the Future of Drug Development-Insights Care
• Feature: Medicine Maker’s Power List 2024