ghp News: Best Global CRO/CDMO 2023 (Biotechnology Awards)
Altasciences Receives 2023 CRO Leadership Award for Capabilities
Laval, Québec, May 9, 2023 – Altasciences announced today that it has been recognized for excellence in contract research with a 2023 CRO Leadership Award for Capabilities. This marks the eighth year that Altasciences, a fully integrated drug development solution company, has been deemed a top performer.
Clinical Leader and Life Science Leader teamed up with ISR Reports to assess 46 CROs on more than 20 performance metrics in ISR’s annual Quality Benchmarking survey.
“Survey participants are asked to evaluate CROs that they have had hands-on experience working with over the past 18 months,” explains Kevin Olson, CEO at Industry Standard Research. “Experiential data, as opposed to perceptual data, enable users of ISR’s market research to feel confident in their business decisions based on learnings from the recent experiences of their industry peers.”
The Capabilities category assesses respondents on a CRO’s ability to deliver a wide range of services, expertise, and resources across multiple therapeutic areas. For more than 25 years, Altasciences has been transforming the traditional outsourcing paradigm by building a one-stop outsourcing solution with end-to-end services that simplify and accelerate the early phase drug development process for its partners.
“We are thrilled to be recognized by our peers in the industry, and are proud to have exceeded the expectations of small and large pharmaceutical companies,” says Chris Perkin, CEO at Altasciences. “Our ability to innovate and deliver a broad range of high-quality, integrated solutions for our clients is what sets us apart, and this award is a testament to the breadth of expertise our team brings to client projects and science each and every day.”
With nine strategically placed research and manufacturing facilities across North America, Altasciences helps safely speed its partners lead candidate selection 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.
Julie-Ann Cabana
Altasciences
+1 514 601-9763
jcabana@altasciences.com
Drug Development Timelines: How Health Canada’s 30-Day Regulatory Review Process Could Provide an Advantage
We want novel therapies to be approved fast, while being safe for us. Regulatory agencies around the world strive to balance the critical elements of speed and safety; at the same time, a rigorous review process is a must.
Application of Mitra Microsampling for the Quantitative Bioanalysis of Antisense Oligonucleotides
Current Strategies for Using Commercial LBA Kit in Regulated Bioanalysis
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
ISSUE NO. 33 — End-to-End CNS Drug Development Solutions
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.
Get Ahead of the Game with Flexible Phase 1 Study Timing
Development of a Flow Cytometry Phospho-STAT5 Assay in Nonhuman Primate T Cells