[Video] Watch and Smile – Our Canadian Team in Action
Think Canada!
If you have yet to visit our Montréal clinical facility to learn about the advantages of conducting trials in Canada or had the pleasure of meeting the friendly, uniquely talented, and experienced team working on your studies, you will want to watch our latest video.
You may also be interested in the following:
• Webpage: Clinical Research Services
• Scientific Journal: The Advantages of Conducting Early Phase Clinical Research in Canada
• eBook: Altasciences' Facilities: Moving in Unison
The Nonhuman Primate Model of CNS Therapies and Utility of Adeno-Associated Viral (AAV) Vectors in Gene Therapy: From Discovery to IND-Enabling Studies
Hot off the Press!
| |||||||
| |||||||
Copyright © 2023, Altasciences, All rights reserved. |
Save Time. Choose the Right Regulatory Pathway.
Advantages of Conducting Early Phase Clinical Research in Canada
Given the regulatory constraints in Europe, Altasciences' Montréal facility continues to be an ideal choice for clinical research. Discover the benefits of conducting early phase research in Canada, such as time and cost savings.
This issue of The Altascientist examines the advantages of conducting early phase clinical research in Canada, including 76 days in time savings, and a predictable regulatory review.
In this on-demand webinar, Leslie Dowling and Roland Jbeily walk you through different regulatory pathways available to safely get your drug to market as quickly as possible.
Altasciences’ Canadian clinical facility consists of seven Phase I units, at which we conduct over 100 trials every year. We support the full range of first-in-human studies, specialty studies, and therapeutic areas, such as ophthalmology, CNS, and substance abuse.
We can help get you into the clinic faster—schedule a chat today!
Take five minutes to explore these insightful resources:
Podcast: The Benefits of Conducting a Clinical Trial in Canada
Drug Development Timelines: How Health Canada’s 30-Day Regulatory Review Process Could Provide an Advantage
Mastering Drug Safety: Your Passport to Successful Pharmacology
Navigating the Depths of Safety Pharmacology
Altasciences can help you assess the impact of your therapeutic entity on vital organ systems before first-in-human trials begin. Our experts conduct the core battery of safety pharmacology tests required by international regulatory guidelines, which include cardiovascular function, respiratory function, and central nervous system behavior, as well as combined and supplemental studies, if needed.
You can expect a robust program suited to your unique needs to support your IND submission and minimize potential risks, so you can transition smoothly from preclinical to clinical pharmacology.
Explore our full range of safety pharmacology capabilities here, and read this issue of The Altascientist on Safety Pharmacology Guidelines and Practices to learn more about:
• the benefits of combining safety pharmacology studies (i.e., cardiovascular and
respiratory); and
• safety pharmacology endpoints in general toxicity studies.
QUESTIONS? SUBMIT AN INQUIRY.
You may also be interested in the following:
• Fact Sheet: Safety Pharmacology Studies
• Podcast: Altasciences’ Scientific Experts Discuss Safety Pharmacology
• ICH Guidance for Industry: S7A Safety Pharmacology Studies for Human Pharmaceuticals
Altasciences Chosen by Virpax to Support the Development of a New Drug to Prevent Spread of Flu-like Viruses
Laval, Québec, September 21, 2023 - Altasciences is pleased to have been chosen by Virpax Pharmaceuticals, Inc. (NASDAQ:VRPX) (“Virpax”), a company specializing in developing non-addictive products for pain management, PTSD, central nervous system (CNS) disorders, and viral barrier indications, to conduct preclinical studies in support of their development of quaternary ammonium palmitoyl glycol chitosan (GCPQ, under the trade name of AnQlar™). AnQlar is a nanoparticle intended to help prevent the spread of negatively charged viruses such as COVID-19 and influenza via intranasal spray, and has been shown to inhibit the ability of the virus to replicate at non-toxic concentrations.
In development since 2022, the project has so far seen the completion of safety assessment utilizing intranasal administration at Altasciences’ preclinical site in Columbia, MO. A cardiovascular study was also completed at Altasciences’ preclinical facility in Scranton, PA.
Bioanalytical sample analysis for the GLP studies is currently ongoing. “We are very pleased to be working with Virpax again and are satisfied with the trajectory our studies have taken. The final step for this program will be a bioanalytical sample analysis. Once samples are validated, this will conclude the IND package” said Kyle Klepner, Senior Scientist, Study Director, Safety Assessment, at Altasciences.
Steve Mason, Co-Chief Operating Officer, Altasciences, added: “The creation of AnQlar as a treatment, if successful, could be a huge leap forward in preventing the spread of influenza and similar viruses. We look forward to further collaboration with Virpax in the near-future.”
Sheila Mathias PhD, Chief Scientific Officer, Virpax, also said of the project: “Our work with Altasciences over the last year has been both exceedingly productive and rewarding demonstrating tangible results, and the preclinical support provided has been vital in ensuring the progress of this project."
About Altasciences
Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster. To learn more about Altasciences, visit altasciences.com.
About Virpax
Virpax is developing branded, non-addictive pain management product candidates using its proprietary technologies to optimize and target drug delivery. Virpax is initially seeking FDA approval for two prescription drug candidates that employ two different patented drug delivery platforms. Probudur™, a single injection liposomal bupivacaine formulation being developed to manage post-operative pain, and Envelta™, an intranasal molecular envelope enkephalin formulation being developed to manage acute and chronic pain, including pain associated with cancer.
Virpax is also using its intranasal molecular envelope technology (MET) to develop two other product candidates. PES200, is a product candidate being developed to manage PTSD, and NobrXiol™, a product candidate being developed for the nasal delivery of a pharmaceutical-grade cannabidiol (CBD), for the management of rare pediatric epilepsy.
Having recently acquired global rights to NobrXiol, Virpax has competitive cooperative research and development agreements (CRADAs) for all three of its prescription drug candidates, two with the National Institutes of Health (NIH) and one with the Department of Defense (DOD).
Virpax is currently seeking approval of two nonprescription product candidates: AnQlar, which is being developed to inhibit viral replication caused by influenza or SARS-CoV-2, and Epoladerm™, a topical diclofenac spray film formulation being developed to manage pain associated with osteoarthritis.
For more information, please visit virpaxpharma.com or follow on Twitter, LinkedIn, and YouTube.
Virpax Media Contact:
Robert Cavosi
RooneyPartners
+1 646 638-9891
rcavosi@rooneypartners.com
Julie-Ann Cabana
Altasciences
+1 514 601-9763
jcabana@altasciences.com