Disrupting the CRO Model:
A 2024 Global Health Summit Documentary

Can the drug development industry change for the better?

In a short documentary for the 2024 Global Health Summit, your partners at Altasciences lead the conversation on change in a slow-to-change industry. We dive into the obstacles and inefficiencies of the traditional outsourcing relationship between CROs and sponsors, and how Altasciences has broken from tradition to offer an alternative outsourcing model that can help you bring better drugs to people who need them, faster.

Watch Altasciences in "The Shape of Progress"

Shaping Progress in the Drug Development Industry: A Short Documentary for the 2024 Global Health Summit

Be a part of driving change in global health by safely accelerating your early-phase drug development with Altasciences’ integrated model. Contact us to get started!

What is the Global Health Summit?

The Global Health Summit will be hosted alongside the WHO’s 77th World Health Assembly in Geneva this May. Leading up to the Summit is a series of interviews and documentaries about how the private sector can help drive global health in a positive direction. The campaign highlights several organizations pioneering developments within the healthcare sector. Altasciences is proud to participate in this year’s campaign.

Discover the series.

Top 10 Life Science Resources

Your time is precious. Therefore, we’ve curated a selection of recently published expert insights, tips, case studies, and scientific and regulatory information, just for you.

1. Blog: Q&A With Dr. Norbert Makori and Pierre Jolicoeur: The Benefits of Combining Preclinical and Bioanalytical Solutions for Your Gene Therapy Studies

Discover how integrated preclinical and bioanalytical services can benefit your gene therapy requirements, what platforms are available, and what advancements in gene therapy treatments our experts are anticipating. Read the blog.

2. ​​Webinar: Sinclair Nanopig™–The Next Generation, Non-Rodent Model for (Bio)Pharmaceuticals Safety Assessment

Learn about the advantages of factoring miniature swine into your species selection considerations, from cost-efficiency to lower body weight, and comparable toxicological data to beagles and Göttingen minipigs. Watch the webinar.

3. eBook: First-in-Human Solutions for Small and Large Molecules

Explore the benefits of a customized and integrated approach to your first-in-human (FIH) clinical trials. Read the eBook.

4. Webinar: On the Edge of Dermatology Early-Phase Trial

Innovaderm invited Altasciences for a roundtable discussion on the current landscape in early-phase dermatology clinical trials. Discover how these trials are instrumental in shaping innovative treatments and therapeutic strategies for dermatological conditions. Watch the webinar.

5. Fact Sheet: Flow Cytometry Services

Uncover the scope of flow cytometry services available to you when partnering with Altasciences for your immunology and cell-based research. Read now.

6. Podcast: Sparking the Evolution of Microsampling with the Mitra® VAMS® Device

Jeff Plomley, Scientific Director, Method Development, discusses the history and evolution of microsampling with guest Dr. James Rudge, the co-inventor of the Mitra® VAMS® device, and Microsampling Technical Director of Neoteryx. Listen to the podcast.

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7. Infographic: Choosing the Optimal Dosage Form for Your Molecule

Discover the advantages of liquid-filled, hard-shell capsules (LFHCs), and tablets, as well as which factors come into play when selecting the appropriate oral dosage form for your active pharmaceutical ingredients (APIs). View the infographic.

8. Ask an Altascientist: The Benefits of Nanomilling

Andrew Buis explains the valuable techniques and equipment utilized in nanomilling—a sophisticated process that breaks down API particles into smaller sizes to enhance their surface area and dissolution rate. Watch here.

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

FIH trials are a critical first step for your drug development program. This eBook will show you how conducting Phase I research in North America can shorten timelines by as much as six weeks, in comparison to the EU and UK. Read the eBook to learn more.

10. Case Study: Streamlining Clinical Trial Start-up for Accelerated Drug Development

Learn how Altasciences was able to condense the start-up timeline for a Phase I study from the typical 12 weeks to three and a half, by emphasizing effective communication, strategic planning, and delegation of responsibilities. Read the case study.

Recent Regulatory Updates:

•   FDA: Guidance Draft – Early Alzheimer’s Disease: Developing Drugs for Treatment
•   FDA: Guidance Final Revision – Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products
•   FDA: Guidance Final Revision – Clinical Pharmacology Considerations for Antibody-Drug Conjugates
•   FDA: Guidance Final Revision – Gene Therapy Products Incorporating Human Genome Editing
•   FDA: Final Rule – Biologics License Applications
•   FDA: Guidance Draft – Race and Ethnicity Data Terminology in Clinical Trials
•   EMA: Guideline – ICH Q14 Analytical Procedure Development
•   EMA: Guideline Revision – Clinical Evaluation of Medicinal Products Intended for Treatment of Hepatitis B

Thank You for Being You

Here’s to you… who forge new paths into the unknown and shape the future of medicine for generations to come.

To show our appreciation for the rich tapestry of perspectives and experiences that you bring to drug development, we made you this video:

Thank you for entrusting Altasciences as your partner in helping you create novel ways to fight disease.

For Your Reading Pleasure

Our authors publish new blog posts multiple times a month, so there is always something to discover. Browse articles on a variety of topics and get to know the experts running your studies more personally!

Drug Development Topics

Whether it’s advice for choosing the best bioanalytical platform for your studies, the advantages of using miniature swine in your small and large molecule studies, or exploring the advantages of Canadian CTAs, there is something for every part of your early-phase drug development journey.

Human Stories

Get to know the experts that make up the Altasciences team! Like in this Q&A with Angel Reyes, General Manager of CDMO Services, or in this interview with Marta Rodriguez, Director of Clinical and Study Operations, on what inspired her to pursue a career in clinical research.

Life Science Resources

Receive regular recaps on the top life science resources in preclinical and clinical research, bioanalysis, manufacturing, and CRO services, curated by our experts for your convenience.

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.

Best Practices for a Successful, Multi-Step Data Journey

In this issue of The Altascientist, we guide you through the complex, multi-step data journey for Phase I clinical trials, from study conceptualization and protocol development, to data collection and analysis, through to final regulatory submission. We highlight best practices and approaches to mitigate challenges, and show how integration and collaboration build the strongest datasets for your drug development program.

Speak with an expert to learn more about our service offering.

Have a few more minutes? Check out these insightful resources:

•   The Altascientist—CDISC Data Standards
•   Fact Sheet—Comprehensive Research Support
•   Blog—Data Management Excellence