A Changing Paradigm in Nonclinical Studies
In this issue of The Altascientist, we cover the changing paradigm for non-rodent species selection in nonclinical safety studies, and how the miniature swine is a viable option in small and large molecule studies.
We discuss:
Miniature swine size considerations
Species selection criteria and processes
Four case studies
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You may also be interested in the following:
Webpage: Miniature Swine in Nonclinical Studies
Webinar: Downsized Miniature Swine: A New Spin on the Oldest Model
Educational Video: How Do I Select the Right Species for My Toxicology Program?
Expanding to Meet Your Needs
In our latest Ask an Altascientist video, General Manager of CDMO Services, Ben Reed, explains how doubling the square footage of our Philadelphia facility has increased our cGMP manufacturing bandwidth and ability to take on additional clients and projects, including programs involving highly potent compounds.
Need drug formulation, development, or manufacturing services for your upcoming preclinical and clinical studies? Contact our experts today.
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Related Resources That May Interest You:
- Webpage: Global CDMO for Manufacturing and Analytical Services
- Press Release: Altasciences Continues Expansion With Client-Dedicated Building
- Podcast: Key Considerations as You Move From Discovery to Preclinical to Clinical
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.
Altasciences Completes Clinical Portion of Alzamend Neuro's Phase IIa Multiple Ascending Dose Clinical Trial for Treatment of Dementia Related to Alzheimer's
Laval, Québec, April 18, 2023 – Altasciences is proud to support Alzamend Neuro, Inc. (Alzamend) in advancing a novel treatment for dementia related to Alzheimer’s disease (Alzheimer’s). In addition to having conducted Alzamend’s Phase IIa multiple ascending dose (MAD) clinical trial in healthy subjects, Altasciences is continuing to provide clinical monitoring, project management, biostatistics, pharmacokinetics (PK), bioanalysis, and medical writing solutions as the product candidate is evaluated in Alzheimer’s patients.
The purpose of the MAD study conducted at Altasciences’ Montréal clinical pharmacology unit, was to evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions; to determine the maximum tolerated dose in healthy young and elderly study participants; and to allow Alzamend to proceed to the next step: dosing in planned subsequent Phase IIa clinical trials involving Alzheimer’s, bipolar disorder, major depressive disorder (MDD) and post-traumatic stress disorder (PTSD) subjects.
“Our Phase I study was successfully conducted with Altasciences and we are excited to continue this partnership with our Phase IIa MAD study,” said Stephan Jackman, Chief Executive Officer of Alzamend. “We strongly believe that AL001’s patented ionic cocrystal technology may constitute a means of treating over 40 million Americans suffering from Alzheimer’s, bipolar disorder, MDD, and PTSD. We look forward to reporting topline data in June 2023 and further advancing clinical development of this promising potential therapeutic.”
The clinical and PK data generated during the clinical portion of the MAD study are undergoing evaluation by Altasciences to characterize the safety and drug exposure in healthy subjects, as well as Alzheimer’s patients.
“Altasciences’ mission is to help sponsors bring promising novel treatments, like AL001, to the people who need them, faster,” says Marie-Hélène Raigneau, Co-chief Operating Officer. “Our team takes immense pride in the role we play to help improve lives through drug development, and is delighted to continue our valued partnership with Alzamend.”
Altasciences has decades of experience with early phase drug development, supporting sponsors with an end-to-end solution, from preclinical studies to clinical proof of concept, and beyond.
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 Alzamend Neuro
Alzamend is a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s, bipolar disorder, major depressive disorder and post-traumatic stress disorder. Their mission is to rapidly develop and market safe and effective treatments. Their current pipeline consists of two novel therapeutic drug candidates, AL001, a patented ionic cocrystal technology delivering lithium via a therapeutic combination of lithium, proline and salicylate; and ALZN002, a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient’s immunological system to combat Alzheimer’s. Both of our product candidates are licensed from the University of South Florida Research Foundation, Inc. pursuant to royalty-bearing exclusive worldwide licenses. To learn more about Alzamend, visit alzamend.com.
Julie-Ann Cabana
Altasciences
+1 514 601-9763
jcabana@altasciences.com
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- Blog: Data Management Excellence–What it Takes
- Webpages:
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.
Your Expert Guide to Developing Psychoactive Substances
Practical Approaches to Conducting
Early Clinical Trials with Psychedelics
Watch this on-demand webinar on the development of psychedelics. Altasciences’ experts, Dr. Setnik and Dr. Milovan, provide an overview of the pragmatic and cost-effective approaches to conducting early-phase clinical trials with psychedelics, including adequate setup of the clinical pharmacology unit.
Speak with our experts to discuss your drug development needs.
You may also be interested in the following:
Webpages:
Scientific Journal: Challenges Associated with Schedule I Therapeutic Development
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.
Four Key Steps to Optimizing a Large Molecule Bioanalytical Program
Biologics are large, complex molecules that can undergo structural changes during the manufacturing process, storage, or administration to patients. This means bioanalysis of biologics is a critical aspect of the drug development process, and one that requires sensitivity, specificity, and selectivity.