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.

​​​

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.

Optimizing Drug Development With Biomarkers

The strategic integration of biomarkers into the drug development process empowers sponsors with critical information at every stage.

Altasciences’ biomarker services provide insight into a drug’s efficacy, safety, and mechanism of action, where we can translate findings into clinical applications and beyond, resulting in reduced timelines.

Our Laboratory Sciences team has the scientific, operational, and regulatory acumen to offer pre-existing validated assays in multiple species and matrices, and can develop new methods to meet your needs.

Is the assay you are looking for missing? Contact us to discuss how we can support your specific needs.

You may also be interested in the below resources:

Fact Sheets

•   Flow Cytometry Services
•   Immunogenicity Testing
•   Immunomodulatory Drugs

eBooks

•   Key Biomarkers of Immunomodulation
•   Altasciences' Proactive Drug Development Solution: Large Molecules

Poster Presentation

•   Immunogenicity Target Interference: A Novel Blocking Approach

Accelerate your drug development timelines by up to 40% with an integrated CRO/CDMO by your side, from lead candidate selection to clinical proof of concept, and beyond.

Our scientific and operational teams move in unison to provide a seamless and synchronized drug development roadmap with research activities running in parallel. With nine strategically placed research and manufacturing facilities across North America, Altasciences has the capacity to help you get better drugs to the people who need them, faster.

With multiple points of entry, Altasciences' integrated, full-service solutions help you make educated and more complete early phase drug development decisions. When you choose the right partner, you only need one.

Get a glimpse of the unique expertise at each of our nine facilities:

You may also be interested in the following:

•   Digital Brochure: Our Expertise at a Glance
•   Video: Accelerate Your Data With Our Co-Located Clinic and Lab
•   Webpage: Proactive Drug Development
•   Video: Quick Chat With CEO Chris Perkin: One Operational Structure

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