'Tis the season for a little extra joy, and we're thrilled to present "Questions From a Stocking: Holiday Edition!" in which Altascientists fully embrace the holiday spirit as they answer rapid-fire questions pulled from our new favorite stocking.

As we share these lighthearted moments, we're filled with deep gratitude for the ideas, discoveries, trials, and successes you've shared with us this year. Your partnership has been invaluable, and we're honored to support your efforts in bringing life-saving therapeutics to our global community.

From our stocking to your inbox, we wish you and your loved ones a very happy holidays.

Watch "Questions From A Stocking: Holiday Edition"

The Stories That Inspire

Meet Yosuke Izumi, one of our Directors of Business Development at Altasciences. From Japan to L.A., his career demonstrates his adaptability, an attribute that he uses in his personal life as well as in surfing. Each day presents new challenges—whether it’s helping you find your drug development solutions or mastering the ocean on his surfboard. Even with the best planning, unexpected things may happen, but Yosuke relies on his philosophy of always being solutions-oriented and knowing how to ride the waves.

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.

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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

The Stories That Inspire

Meet Talita Conte, one of our dedicated scientific project managers. From São Paulo to Montréal, her journey is a testament to the power of passion and innovation in science. After making a breakthrough in myotonic dystrophy type 1 published in Nature Communications, she transitioned to project management at Altasciences, where she continues to drive fast-paced, impactful clinical trials.

WATCH VIDEO

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:Best Practices to Reduce Animal Use in Toxicology Studies

   Explore the advantages and limitations of various methods for minimizing the number of research animals used in your toxicology studies, while maintaining robust, high-quality, and reproduceable findings. Watch it now.

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2. The Altascientist: Issue No. 39 Key Considerations for Nonclinical Dermal Studies—Advancing to Phase I

   Find out more about 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. Read or listen now.



3. Webinar: CNS-Active Compounds—The Importance of Cognitive and Pharmacodynamic Testing During First-in-Human Trials

   Enjoy this comprehensive review of well-known cognitive and pharmacodynamic test batteries, including their applications and limitations in first-in-human studies. Watch the webinar.

4. eBook: Regulatory Comparisons for Starting First-in-Human Clinical Trials

   Delve into the different regulatory 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.



5. 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 now.

6. Poster: Sensitive Quantitation of Antisense Oligonucleotides (ASOs)

   Hear about the complex workings of the novel finger-stick-derived capillary collection method, which has recently emerged as an alternative to traditional venipuncture. Watch the poster presentation.



7. 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.

8. The Altascientist: Issue No. 38 Ensuring Successful Formulation and Drug Product Manufacture for Preclinical Testing

   Uncover the key factors in effective formulation development and manufacturing for safety assessments. Read or listen here.



9. Fact Sheet: Clinical Trial Site Selection and Management

   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, either at one of our clinical sites or at a partner site (or both). ​​Read the fact sheet.

10. 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.

Recent Regulatory Updates:

• 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

On June 12, Altascientists at all nine of our facilities took time to celebrate each other and the important work that we do as your partners. Altasciences Day, as we like to call it, is a testament to our journey with you—a journey defined by collaboration, dedication, and moving in unison.

I want to extend my heartfelt gratitude for your ongoing trust and partnership, and for giving us the opportunity to help you bring better drugs to the people who need them, faster.

Here’s to many more remarkable accomplishments, and even more reasons to celebrate.

Cheers,

Chris Perkin
CEO, Altasciences

Connecting the Dots With Comprehensive CRO Solutions

When you CONNECT THE DOTS, you open a world of possibilities.

At Altasciences, we connect the dots, so you don’t have to. With you in mind, we establish a clear and consistent path from drug discovery to delivery—one solution seamlessly connecting to the next. All you have to do is reach out and get the conversation started.

Ready for a simpler drug development journey? Contact us today.

You may also be interested in these resources:

• Webpage: Clinical Research Support Services
• Video: Clinical Trial Site Identification, Selection, and Management
• Fact Sheet: Integrated Research Support Services