Clinical Trials
Inside the Pharmacodynamic Toolbox: How Questionnaires, Models, and Tests of Cognition Can Accelerate the Development of CNS-Active Drugs
Your Scientific Resources in CNS‑Drug Development
CNS Center of Excellence
Are you working on a CNS-active drug? With over 25 years of conducting preclinical and clinical studies, Altasciences’ CNS Center of Excellence experts have developed an extensive resource library, including webinars and scientific journals, to guide you through all phases of early drug development, from lead candidate selection to clinical proof of concept, and beyond.
How is Partnering With Altasciences for Your First-in-Human Clinical Trials Different?
Advancing your molecule to first-in-human (FIH) clinical trials is a major milestone in your drug development program. Altasciences is here to help you get there, conduct your study, and provide you with a full range of complementary services.
- Regulatory Expertise: Our regulatory advisors have extensive experience navigating complex regulatory processes, ensuring your IND and CTA applications are submitted and processed swiftly and efficiently.
- Scientific and Operational Expertise: You can trust our team to deliver high-quality, customized solutions for your clinical trial needs.
- Pharmaceutical Manufacturing: We offer a wide range of manufacturing services to support your preclinical and clinical trials.
- Bioanalysis: With over 260 highly trained specialists and a capacity of over 60K study samples per month, Altasciences has the capacity to process your data quickly.
- Project Management: A single, dedicated project manager, along with a proprietary information-sharing database, means you only have to Tell Us Once™. Learn more about Altasciences' FIH solutions.
Optimizing Drug Formulations for Successful First-in-Human Clinical Trials
Ensure a Smooth Transition from Formulation to Clinical Trials
Altasciences supports your formulation and drug development needs for preclinical safety testing, from discovery through first-in-human (FIH) clinical trials, for all dosage forms, such as oral liquids, powders, capsules, and injectables.
Our integrated approach combines formulation development, cGMP manufacturing and release testing, as well as clinical testing functions/workflows. One of the biggest benefits of this seamless offering is that our clinical trial teams work closely with the scientists involved in the formulation and manufacturing process, and are able to evaluate and optimize new formulations in the clinic, based on real-time human data. This collaboration and data sharing between our teams leads to shorter timelines, less risk, reduced costs, and improved flexibility.
Learn more about our expertise with both simple and complex formulation development, including those with highly potent APIs and solubility/bioavailability challenges.
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Questions? Speak with one of our experts.
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.
Going Beyond the Science of Drug Abuse and Dependency
Opioid medications offer important benefits for pain management. They also have significant risks for abuse, dependency, and cognitive impacts. At Altasciences, we have leading-edge expertise in the scientific and clinical aspects of human abuse potential (HAP) evaluation, dependency assessment, and cognitive testing. We also devote significant time and resources to understanding the human behavioral elements of drug use, from recreational to abuse.
View the podcast series that takes a deeper look at the users behind the behavior, moderated by Dr. Beatrice Setnik, Chief Scientific Officer, and featuring Dr. Debra Kelsh, Psychiatrist and Principal Investigator at Altasciences:
- Trailer—The Many Face of Recreational Drug Use
- Episode 1—Introduction and interview with male, 30, opioid user
- Episode 2—Brief introduction and interview with female, 46, opioid use disorder
- Episode 3—Brief introduction and interview with male, 24, recreational poly-drug user
We seek to understand the genesis of the human story so that we can better influence the evolution, applying our expertise in opioid trials including HAP evaluation, driving simulation, abuse-deterrent formulations, and more, to this complex issue.
Quick Chat with Denise Milovan
Exploring Altasciences' Expertise in CNS Drug Development
You won't want to miss this 5-minute Quick Chat video!
Dr. Denise Milovan explains how Altascience's expertise in pharmacodynamic assessments for CNS drug development benefits both sponsors and study participants.
Altasciences has the specialized facilities and highly trained experts to conduct a comprehensive battery of assessments, including:
- Visual analog scales
- Cognitive measure of attention, memory, etc.
- Drug liking
- Pain perception
- Sense distortion
Our Altascientists can provide a thorough understanding of the cognitive impacts of your CNS-active drug. Contact us today.
Have a few more minutes? Check these out:
- The Altascientist—CNS Drug Development
- Fact Sheet—CNS Drug Development
- Webinar—Inside the Pharmacodynamic Toolbox
Start Your Driving Trial Quickly—Simulators on Site
Driving simulator studies are a safe, efficient, and effective alternative to on-the-road driving trials for CNS-active drugs. The Altascientist dives into the requirements and technicalities of driving studies, and explains how driving simulation offers…
Faster study startup • Lower cost • No risk of property damage • No risk of injuries
… including a case study whose results were described as “reassuring” by the FDA.
Altasciences has conducted over 13,000 simulated drives in support of drug development.
Download as a PDF or listen to the audiobook, the choice is yours.
You may also be interested in the following:
Still Using Tablets in Your Clinical Trials? Consider Changing to a Better Option.
Accelerate Your Clinical Trials With This Dosage Form
With tablets presenting numerous drawbacks, liquid-filled capsules (LFCs) are becoming the optimal choice for clinical trials. Their benefits include:
- Ease of scalability from preclinical to clinical to commercial volumes
- Quick dose adjustments
- Faster dissolution and absorption
- Less required stability studies
LFCs are most suitable for drugs with complex formulations, low-dose requirements, poor solubility, or highly potent active pharmaceutical ingredients (APIs). Clients with such drug profiles substantially accelerated their drug development process using LFCs for early phase clinical trials, resulting in reduced costs.
Where Do We Come In?
Altasciences’ state-of-the-art cGMP manufacturing and analytical facility in Philadelphia has a team of experienced scientists to support you through your entire drug development process, from pre-formulation to clinical trials and beyond. Our advanced equipment includes cutting-edge liquid-filling, binding, and sealing machines, ensuring an impressive 97% right-first-time (RFT) batch release success rate.
Consult our resources for further details on how you can benefit from using LFCs in your clinical trials.
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Ready to accelerate your drug development? Speak with one of our experts.
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.
Don't miss this issue of The Altascientist
Shortening Drug Development Timelines with Asian Ethnobridging Trials
Developing drugs for the Asian market may require that Phase I studies be repeated in regions outside North America and Europe. Altasciences has the clinical capabilities to demonstrate biosimilarity of drug products between Asian and non-Asian populations by comparing pharmacokinetics of the investigational drug in both ethnic groups, providing a safe strategy to save time and money.
In our latest issue of The Altascientist, using case studies, we discuss how ethnobridging can prevent the necessity of regional-specific development programs, helping you achieve commercial milestones safely and more efficiently.
Download your copy today! Listen to the audio recording!
Speak with an expert today to discuss your next study!
Got a few more minutes? You may also be interested in the following 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.