Bioanalytical Expertise in ASO Quantification
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The development of antisense oligonucleotides (ASOs) is showing promise in therapeutic applications for a number of diseases, both neurological and non-neurological. The accurate quantification of ASOs in complex biological tissues requires robust and sensitive bioanalytical assays that minimize interference, an area in which Altasciences has significant expertise. In this issue of The Altascientist we provide an overview of the evolving ASO therapeutic approach, and present two case studies demonstrating our capabilities in the field. |
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How Can We Help
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Dear Partners, Like me, you probably have an inbox full of messages about steps being taken to avoid further contamination on company premises, at home, and worldwide. First, let me assure you that COVID-19 has our full attention here at Altasciences, and the safety of our employees, clients, and study participants will always be our top priority. |
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Second, know that many here at Altasciences are accustomed to working in unprecedented situations and making the right and, often difficult, decisions. We continue to focus on helping you bring your drugs to market and providing you the quality and timelines you have come to expect from us. In line with the current public health and government sources of information, we have updated and are continuously reviewing our business continuity plan to enable proactive, flexible, and dependable delivery of our commitments, some of which includes:
At Altasciences, we care about your studies and deliverables. We have the team and safety measures in place to ensure your studies continue. These are challenging times, but we feel confident that as a company and research community, we can get through this together. Please let me know how we can help. I am here to personally discuss any of your questions or concerns. If there are any significant changes to the way we do business in the upcoming weeks, I will personally ensure you are informed. |
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Be well, 
Chris Perkin |
Bioanalytical Project Management — a Critical Function Adapted to the Study Type(s) of Your Drug Development Program
The objective of quantitative bioanalysis is to provide precise and accurate sample analysis results within the acceptable tolerance (variability), in line with the study scope, so that sponsors can make appropriate go/no-go decisions. For proactive and efficient study progression, stakeholders must fully understand the operational, logistical, technical, and scientific considerations for the bioanalytical phase of various study types within a drug development program. Webinar participants will receive insight on this framework and the relevant critical control points.
Amphetamine to Zolpidem: Navigating the ABCs of Early Phase CNS Drug and Cannabinoid Development
CNS drug development continues to evolve with changing regulations, particularly in light of prescription drug abuse and risk/benefit optimization. The uncertainty with regulations around emerging therapeutics, including cannabinoids, adds to the confusion. Navigating a successful regulatory and commercial pathway for CNS drugs can pose challenges and delays when requirements are not met. In addition to NDA-enabling phase I studies, specialty studies may be required to further evaluate your risk/benefit profile and support a drug scheduling recommendation.
SOT Virtual Poster Session
Get the most of Altasciences’ preclinical NHP expertise by attending two sessions, covering six distinct topics:
1. feasibility analysis of two locations for radio telemetry device implantation
2. spermatozoa evaluation in normal cynomolgus macaque
3. juvenile cynomolgus macaque infusion procedures
4. cytokine data vs. in-life parameters in NHP
5. major immune cell populations in peripheral blood of naïve cynomolgus macaque
6. assessment of receptor occupancy via flow cytometry
Strategic Considerations for a Successful CNS Clinical Development Pathway
Central Nervous System (CNS) drug evaluation requires the assessment of specific safety endpoints, such as the drug’s potential to cause impairing effects on driving, the likelihood that it may be abused or misused, or the risk of causing withdrawal symptoms if abruptly discontinued. Evaluation of CNS effects in Phase I studies can be very helpful in determining if dedicated driving simulator, abuse potential, and dependence studies are needed.
Altasciences and Amador Bioscience Announce Strategic Collaboration
Laval, Quebec, March 17, 2020 – Altasciences, a CRO in the U.S. and Canada specializing in a flexible, innovative approach to comprehensive early stage drug development, announced today that they have entered into an agreement with Amador Bioscience, a translational and consulting clinical research organization located in China and the U.S. This partnership aims to expand world-class capabilities and resources to promote drug development in China and North America.
“We are excited to collaborate with Amador Bioscience’s dedicated team of diverse experts, particularly in support of China’s fast-growing and innovative biotech industry,” stated Steve Mason, Executive Vice President, Altasciences.
Altasciences and Amador Bioscience will collaborate on IND-enabling preclinical studies, design and conduct of early-stage clinical programs, including first-in-human and proof-of-concept trials, as well as provide end-to-end solutions, such as laboratory services, to transpacific drug development programs.
“We are pleased to be partnering with Altasciences, offering our clients access to world-class preclinical and clinical facilities, personalized services, and 25 years’ expertise in conducting successful clinical trials,” said Xiaomin Chen, General Manager, Amador Bioscience. “Our synergistic and effective collaboration will surely expedite the development of novel therapeutics,” added Mrs. Chen.
CONTACT:
Julie-Ann Cabana
Altasciences
514 601-9763
jcabana@altasciences.com
About Altasciences
Altasciences is a forward-thinking, mid-size contract research organization 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, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster. Altasciences has strategically placed facilities in the U.S. (Seattle and Kansas City) and Canada (Montreal and Laval).
About Amador Bioscience
Amador Bioscience provides global-standard laboratory, clinical research, strategy consulting and regulatory filing services to leading biopharmaceutical companies. The laboratory services focus on bioanalysis, biomarkers and immunogenicity assessment. Amador’s clinical research unit specializes in innovative clinical development strategy, protocol design, study initiation and monitoring of clinical studies in China and the U.S. In addition to the R&D strategy and regulatory pathway, Amador’s consulting services perform global-standard data analysis and generate submission-ready study reports. Amador has successfully supported CTD filings in China and U.S. Amador Bioscience operates in the U.S. (San Francisco Bay Area, Virginia) and China (Shanghai-Hanghzou and Beijing).