How Mitra® Vams® Microsampling Device Redefines Sample Collection
From Concept to Application
Delve into the fascinating evolution and revolutionary advancements of the Mitra Vams microsampling device and its applications within life sciences with Dr. James Rudge, Microsampling Technical Director at Neoteryx, and Jeff Plomley, Scientific Director at Altasciences.
Listen now!
Speak with one of our bioanalytical experts today.
Related resources that may interest you:
Microsampling Podcast Series:
Episode 1: When Small Steps Lead to Big Outcomes
Episode 2: Coupling Hybridization LC-MS Workflows With Microsampling
The Altascientist: Microsampling in Drug Development
Webpage: Microsampling in Early Drug Development
Don’t Miss the Latest Life Science Resources
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.
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
Up Close and Personal With Eryn Corriveau, MSc, Senior Director, Drug Development and Regulatory Strategy
Here at Altasciences, Eryn is responsible for guiding regulatory strategies, conducting gap analyses, and leading interactions with regulatory agencies dur
ing early drug development.
Streamlined Clinical Trial Solutions
A Solution for Every Trial
Altasciences’ comprehensive clinical trial solutions, supported by over 25 years of CRO expertise, ensure a streamlined process—from study design to site identification, selection, and management.
Benefit from:
• Global Reach: A network of 100+ active sites worldwide.
• Therapeutic Expertise: Specialization in multiple therapeutic areas with access to a large pool of patient populations.
• Innovative Approach: Hybrid model combining our clinical sites with partner sites for efficient recruitment.
• Regulatory Excellence: Expert regulatory and scientific guidance throughout your project.
• Seamless Collaboration: Close collaboration and communication, from site qualification to closure.
• Project Precision: Comprehensive project plans and timelines for on-time, on-budget delivery.
Discover how Altasciences turns clinical trial challenges into solutions. View the insert.
You may also be interested in the following webpages:
• Clinical Trial Site Identification and Selection
• Clinical Trial Site Management
Three Platforms Used to Monitor Cytokines and the Complement System
Monitoring both cytokines and complement factors in drug development has become increasingly important, as the movement toward personalized treatments for cancers and genetic diseases has spurred research and development into biologics, vaccines, and small molecules that can have unintended consequences due to their immunomodulatory effects.
Must-Read Scientific Posters Presented by Our Preclinical Experts
LATEST SCIENTIFIC POSTERS PRESENTED BY OUR PRECLINICAL EXPERTS
Hot off the press! We're excited to showcase our latest collection of 11 new scientific posters, unveiled at the
63rd Annual Society of Toxicology (SOT) Meeting.
Dive deep into a series of preclinical findings:
• Sinclair Nanopig™: From Multi-Omics Characterization to Pharmacology and Toxicology Validation: Underline Drug Metabolism and Immune System Presented by Yafei Chen, Senior Research Fellow, Pathology Services
• Cross-Comparison of Immunophenotyping Assay Performance in Naïve Filipino, Mauritian, and Cambodian Nonhuman Primates Presented by Derek Hanson, Principal Scientist
• Historical Background Data in Juvenile Cynomolgus Monkeys: Comparative Immunotoxicology and Pathology of Different Origins Presented by Narine Lalayeva, Associate Director, Safety Assessment
• Cross-Comparison of Biomarker Assay Performance in Naïve Philippines, Cambodian, and Mauritius, and Non-Naïve Mauritius Cynomolgus Macaque Nonhuman Primates Presented by Catherine Schilffarth, Associate Director, Operations, Laboratory Sciences
• 28-Day Intranasal Toxicity Study of MMS019 in Sprague Dawley Rats and Dogs Presented by Kyle Klepner, Senior Scientist, Study Director, Safety Assessment
• Tissue Biopsy Collections in Nonhuman Primates During Toxicology Studies: A Comparison of Findings with Animals Not Sampled Presented by Narine Lalayeva, Associate Director, Safety Assessment
• Incidence of Neutralizing Adeno-Associated Viral Antibody Subtypes in Cynomolgus Monkeys of Cambodian, Mauritius, and Philippines Origins Presented by Julie Forget, Senior Director, Safety Assessment
• Development of a Novel Early Intervention Stabilization for Abdominal Aortic Aneurysms Presented by Timothy J. Madsen, Associate Scientific Director, General Toxicology
• Development of a Canine Prostatectomy Model for Use in the Toxicity Evaluation of Oncology Drugs Presented by Ahmed Abdalla, Associate Scientist, Study Director
• Comparison of Safety Pharmacology End Points Used on Toxicology Studies Across Differing Cynomolgus Monkey Origins Presented by Jean-Christophe Queudot, Associate Director, Safety Pharmacology
• Clinical Pathology Reference Data for the Philippine Cynomolgus Monkey for Preclinical Toxicology Studies Presented by Dr. Johanna Rigas, Veterinary Clinical Pathologist
Questions? Speak with one of our experts about your small or large molecule preclinical projects. We can get your study started within the next two months!
Top 5 Scientific Resources in CNS Clinical Trials - March 2024
CNS Center of Excellence Resource Library
Altasciences has an extensive understanding of psychiatric and neurologic disorders, stemming from our decades of conducting complex studies in various therapeutic indications impacting the central nervous system.
Here are some of our most insightful scientific resources in the area of CNS drug development:
Webinar: A Square Peg in a Round Hole–Navigating the Unique Attributes of Psychedelic Drug Development
Altasciences’ panel of experts discuss the FDA’s recently published guidelines for early-phase clinical development of psychedelics and the assessment of abuse potential. Watch Now
The Altascientist: Central Nervous System
Early-phase development of CNS-acting drugs is a complex, challenging undertaking.
In this article, we provide a detailed overview of the multiple facets you need to consider during the planning and conduct of your CNS-active drug development. Learn More
The Altascientist: CNS, Psychedelics, and Other Schedule I Drugs
In this scientific journal, we uncover the regulatory environment and challenges, the required preclinical and clinical studies specific to Schedule I or Class I (CI) drugs, and the manufacturing considerations for CNS-active drugs. Learn More
The Altascientist: Studying the Effects of Drugs on Driving
Driving simulation studies are required by the FDA when preclinical and early clinical studies show that a drug may cause somnolence or impair cognition. Discover the challenges of driving simulation clinical testing. Learn More
The Altascientist: Human Abuse Potential Studies
The 2017 FDA guidance states that a broad range of CNS drugs require human abuse potential (HAP) studies to evaluate the abuse liability of drugs in development before a drug reaches the market. The complicated regulatory pathway for HAP requires individualized consulting for each type of study. Watch Now
Speak with an expert today to learn more about our CNS solution.
Have five more minutes? Check out these webpages:
• CNS Clinical Trials
• Human Abuse Potential<
• Driving Simulation<
We Want to Say Thanks!
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.