Our Role in Treating Mental Health and CNS Disorders
Leading Partner in CNS Drug Development and Manufacturing
In honor of Mental Health Awareness month, we asked our CDMO Vice President and Scientific Advisor, Dennis DiBiagio, what specific expertise is required to manufacture drugs that treat central nervous system (CNS) disorders, including mental disabilities.
Watch our latest clip of Ask an Altascientist.
Speak with Dennis today about the unique and most advantageous reason drug sponsors choose to partner with us for their CNS drug development!
SEND DENNIS A MESSAGE
You may also be interested in these related resources:
• Webpage: Global CDMO for Manufacturing and Analytical Services
• Interview: Manufacturing of Highly Potent APIs and Controlled Substances
• 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.
Scientific Journal on the Intricacies of CNS Drug Development
In this issue of The Altascientist, we detail the complexities of central nervous system (CNS) drug development programs. In addition, we share how partnering with an integrated CRO/CDMO can reduce your timelines by up to 40% as your compound advances through each study phase.
Topics covered include:
- Preclinical safety and toxicity testing
- Formulation and manufacturing for nonclinical and clinical studies
- Maximizing early phase clinical trials
- Bioanalytical considerations
Questions? Consult with our experts and tell us how we can support your program.
Related resources that may interest you:
- Podcast: High Potency Manufacturing Solutions
- Webinar: Practical Approaches When Conducting Clinical Trials With Psychedelics
- Educational Video: Development Strategies for Neurological Drugs
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.
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.
What Makes Our Pathologists Unique?
A Chat With Dr. Wendell Davis
Altasciences’ team of in-house pathologists has expertise with different test articles, drug modalities, and species. With close to 30 years of experience each, our pathologists can support your toxicology studies and help to set safety margins for your clinical trials.
Watch Dr. Wendell Davis, Vice President of Pathology, explain what makes Altasciences' pathology team unique.
Learn more about our pathology capabilities:
Podcast: Digital Pathology―Establishing the Capability
Press Release: Altasciences Selects Proscia to Accelerate the Development of Life-Saving Drugs
Application of Mitra Microsampling for the Quantitative Bioanalysis of Antisense Oligonucleotides
Current Strategies for Using Commercial LBA Kit in Regulated Bioanalysis
Get the Facts: NDA-Enabling Studies
We’ve Got Your NDA Study Needs Covered
The development of an NDA submission plan can sometimes be unclear. Partnering with the right CRO early on can increase your chances of success and ensure you meet your milestones. With over 25 years of experience across the spectrum of therapeutic areas, Altasciences' specialists apply their knowledge in designing, conducting, analyzing, and reporting on trials for regulatory submissions.
Our complimentary fact sheet guides you through the different types and features of NDA-enabling clinical pharmacology studies, and how we can support you.
Want to learn more about the requirements for each study? Explore these insightful resources:
Breaking Ground: A Novel Method for Whole Blood Linearity Assessments
Achieving precise and relevant dilutions while mitigating variations in sample preparation poses a significant challenge.
In this study, we assessed:
- the impact of four different linearity sample preparation methods, including fixed FMX, fixed unconjugated, fresh FMX, and fresh unconjugated.
- the accuracy of quantifying low-abundance cell populations (T regulatory cells and CD14-CD16+ monocytes) using a lyse/no wash method for whole blood staining.
Our results demonstrate that one of the novel sample preparation methods showed superior performance compared to the industry-standard approach, leading to a marked improvement in linearity assessment quality.
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