You Won’t Want to Miss This Video!

Watch as, Dr. Michael R. Gralinski, CEO of CorDynamics, reviews the results of three GLP safety pharmacology validation studies.

The studies were conducted using telemetered dogs with well-characterized hemodynamic, electrocardiographic, and respiratory positive controls. All three studies demonstrated the ability to detect expected effects of positive controls with a high degree of reliability.

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The studies were conducted in Altasciences' purpose-built, isolated telemetry facility, with data review and interpretation by CorDynamics.

Speak with one of our experts today.

You may also be interested in: 
•    The Altascientist: Scientific Journal Issue 13 — Safety Pharmacology Studies, a Review
•    Fact Sheet: Safety Pharmacology
•    Webpage: Safety Pharmacology Overview and FAQs

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.

Robust Sample Management

Read our latest issue of The Altascientist to better understand how we deliver reliable study results through robust sample management for your preclinical and Phase I to IV clinical studies, including:

• Customized processes
• Controlled environments  
• Standardized workflows for risk management
• Capability to handle a wide variety of matrices
• Stability testing

Download your copy, or listen to the audiobook today.

You may also be interested in the following:

Webinars:

• Sample Collection Kits and Lab Manual
• Bioanalytical Project Management
• Critical Sample Handling Processes for Clinical and Preclinical Studies

Podcast:

• Transitioning Novel Scientific Workflows to Routine Bioanalysis 

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.

Altasciences Tackles the Issues and Challenges Associated with Schedule I Therapeutic Development

Schedule I, or Class I (CI) drugs are currently restricted to research in the U.S., meaning that they are not approved for medical use, and are deemed at highest risk for abuse. Recent research on psychedelics and entactogens, of which are schedule I, is beginning to demonstrate potential therapeutic effects of these drugs for various medical indications. Approvals of such drugs for medical or therapeutic use will inevitably result in the rescheduling of these drugs from their current CI status. 

In this issue of The Altascientist, we uncover the following:

• Regulatory environment and challenges — DEA 
• Required preclinical and clinical studies specific to Schedule I or Class I (CI) drugs 
• Manufacturing considerations

Download your issue

For novel CNS-active Schedule I drugs, partner with Altasciences and benefit from our Schedule I licenses across every stage of early phase drug development. Our knowledge and operational expertise across preclinical, clinical, and manufacturing stages ensures complete continuity, data transfer, information sharing, and efficient timeline management... in real-time. 

Speak with an expert today for more information or to review your specific program requirements. 

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.​​​​

Want to Start Your Nonhuman Primate Studies in Q3 2022? Here’s How.

Are you experiencing delays initiating your nonhuman primate (NHP) studies? We have the capacity, at our three preclinical sites, to start your studies two to three months following contracting, thanks to our steady supply of NHPs.  

At Altasciences, we do not rely on a single-source NHP supply chain. We remove the stress of sourcing research animals so that you can start your studies faster, with:

• Dedicated and diversified cynomolgus monkey supply agreements in place to allow for faster start-up timelines
• A continuously maintained and backfilled population of hundreds of naïve NHPs at our preclinical facility 

You can schedule newly contracted NHP studies to start in Q3 2022 immediately.

Contact us to schedule your NHP studies today.

Have five minutes? Discover our extensive site capabilities:

• Webpage: Preclinical Testing Facilities
• Fact Sheet: Preclinical Services Capabilities
• The Altascientist: Planning Your Preclinical Assessment

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.

Miniature Swine Considerations for Your Next Nonclinical Program

Did you know that miniature swine is often a viable option for your nonclinical program?

This complimentary webinar discusses the scientific rationale for miniature swine model selection for your non-rodent, nonclinical programs. In addition, we present the different miniature swine strains which may affect your species selection process.

Speak with an expert to learn more about the possibility of utilizing miniature swine for your upcoming nonclinical drug development program.

Refer to these two guidance documents which can help with your species selection:

• Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals S6(R1)
• M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals

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.

We are pleased to share with you the four scientific posters that were presented by our nonclinical experts at the annual SOT meeting.

Detection of Plasma Cells and their Precursors in Bone Marrow and Peripheral Blood 
Plasma cells are antibody-producing B cells that play a major role in conferring immune protection, but can also contribute to the pathogenesis of autoimmune diseases like multiple sclerosis, and hematologic cancers like multiple myeloma. Read more.

Evaluating Cytokine Data in Non-human Primate Safety Assessment Studies 
Cytokines are cell-signaling small proteins classified as either pro-inflammatory or anti-inflammatory. With the increasing number of biologics and immune-modulating drugs being developed, the evaluation of cytokine levels as potential biomarkers in safety assessment studies has become more common. Read more.

Historical Control Reference Values of Cambodian Cynomolgus Macaque Blood Gases 
Measuring blood gases can be useful in identifying drug-related respiratory changes like blood changes in the diffusion of gases from the lungs into the bloodstream. For small molecule pharmaceuticals, ICH S7 identifies hemoglobin oxygen saturation (sO2) as a potential part of the core respiratory battery, while other blood gases (e.g., pO2 and pCO2) can be used for supplemental assessment. Read more.

Multiplexed Cytokine Comparison Across Two Species Dosed with the Same Drug
Questions often asked include which assay platform to use (Meso Scale Discovery or Luminex xMAP^®), and how relatable are the results between small animals (e.g.,rats) and large animals (e.g., non-human primates)… Our analysis revealed commonalities and differences in cytokine responses across species. Read more.

Book a consult with one of our experts to discuss how we can support your program.


You may also be interested in the following:

• E-book: Preclinical Assessment Planning Guide
• Webpages:
  • Preclinical Solutions
  • Bioanalytical Solutions
  • Early Phase Drug Development Solutions

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.

Three Strategically Located Preclinical Sites

Our three preclinical sites work in unison with our clinical, bioanalytical and manufacturing sites to offer an integrated drug development solution from lead candidate selection to clinical proof of concept. We offer a full range of in vivo non-GLP and GLP preclinical studies in both rodent and non-rodent species to thoroughly assess the safety of your molecules.

Our purpose-built:

• 550,000 sq.-ft.
• 260 custom-designed animal rooms, including North-American and European housing
• Capacity to house 3,320 NHPs, 965 canines, 920 swine, 27,320 rodents, 2,480 rabbits
• Barrier facilities for small animals
• Archive facility and services on site
• Laboratory services on site

Let’s chat!

You may also be interested in the following:

• Preclinical Services
• Bioanalytical Services
• Clinical Services
• Manufacturing and Analytical Services

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.

Seamless Bioanalytical Transition

Altasciences’ scientists move in unison with you, collaboratively, accurately, and efficiently, from preclinical to clinical, and beyond. Our team of over 260 bioanalytical scientific veterans is strategically located across North America, and has experience with a wide spectrum of biological matrices in both animal and humans.
 
Driven by your assay requirements, our program support includes LC-MS/MS, LBA OR HYBRID LBA/LC-MS/MS ASSAY platforms for:

Speak with a scientist

Have 5 minutes? You may also be interested in the following:

• Assay List — Over 685 Assays covering 650 Molecules
• The Altascientist — Validation of Immunogenicity Assays
• Webinar — Development of a Cell-Based Assay for Dual Purposes: to Support Drug Potency and Immunogenicity Characterization

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.