CNS DRUG DEVELOPMENT SOLUTIONS
Altasciences’ CNS Center of Excellence offers decades of experience, having completed over 200 neurological studies. Our in-house preclinical, clinical, bioanalytical, and manufacturing teams ensure your compound advances seamlessly from discovery to market.
Engaging at the outset with Altasciences, a fully integrated and experienced drug development
partner, ensures timely data sharing at every step of drug development, and facilitates agile and flexible
decision-making. This could mean up to 40% in
OUR END-TO-END CNS SOLUTIONS
CNS DRUG FORMULATION, MANUFACTURING, AND ANALYTICAL SERVICES (CDMO)
Altasciences’ cGMP, FDA-registered, and inspected manufacturing facility is DEA-licensed for drugs Schedule I-V, and equipped with R&D and formulation laboratories for all analytical testing. In addition, our Grade C and D manufacturing suites allow for the handling of highly potent compounds and controlled substances.
Our scientific experts have extensive experience formulating and developing CNS pharmaceutical products, using advanced techniques such as nanomilling to resolve solubility and bioavailability issues that often arise with CNS drug compounds. Our team also produces a vast range of dosage forms to support your preclinical and clinical studies, including sterilized injectables, topicals, powder-filled capsules, liquids and suspensions, as well as hard-shell, liquid-filled capsules, which are often the optimal choice of dosage form in early phase CNS drug development.
Our specialties include:
- Seamless transition from prototype formulation to clinical proof-of-concept
- Development and manufacturing of complex formulations, highly potent APIs, and controlled substances (including cannabinoids)
- Micro and nanoparticulate formulations
- Method development for low-concentration formulations
- Scale-up and process optimization of low-concentration formulations of potent and controlled substances
- Clinical supply manufacturing for Phase I to IV
- Finished dosage form manufacturing and packaging
- Commercial batch manufacturing
- Drug product characterization
- Analytical testing, including ICH stability testing and drug product release testing
- Transport and distribution of controlled substances from site to site
Listen to our Vice President, Scientific Advisor, detail our expertise in CNS drug development and manufacturing.
CNS PRECLINICAL SAFETY TESTING
Altasciences has over 25 years of experience conducting CNS safety assessments. Our nonclinical CRO solutions include the full range of in vivo GLP and non-GLP studies, in multiple species, to thoroughly assess the safety profile of your molecules. We provide IND-enabling and BLA/NDA-enabling toxicology, safety pharmacology, and bioanalytical services that meet global regulatory requirements for both small and large molecules.
Altasciences’ preclinical CNS expertise encompasses all pivotal toxicology and safety pharmacology studies, including 24-hour video monitoring and the performing of functional observation battery tests to assess behavioral changes. Our full range of CNS nonclinical research covers:
- exploratory primate surgical models
- exploratory primate CNS research
- lead optimization
- acute toxicology
- dose range finding/maximum tolerated dose
- repeat-dose toxicity testing
- safety pharmacology
- sub-chronic/chronic toxicity
Altasciences' preclinical team also specializes in the safety assessment of psychedelics with extensive experience in all species and routes of administration. In addition to the standard toxicology studies for psychedelics, we provide:
- early efficacy signals
- optimized pharmacokinetics
We partner with industry and key opinion leaders, such as Sygnature (for non-GLP early toxicology) and DevelRx (to help design nonclinical abuse liability studies), to complete the preclinical phase of your drug development program. Our preclinical and clinical teams then work together to ensure a rapid and smooth transition from safety testing to first-in-human trials, providing briefing documents and support for all types of global regulatory meetings along the way.
CNS CLINICAL RESEARCH SERVICES
CNS drug development often requires specialized clinical assessments, such as cognitive function, EEG, specialized imaging, CSF collection, neuropsychiatric evaluations and questionnaires, pain models, dependence evaluation, abuse potential, and the evaluation of driving impairment. Altasciences’ CNS Center of Excellence has the expertise to advance your clinical program with the most rigorous attention to quality and safety while offering regulatory guidance.
Our three strategically located clinical pharmacology units hold all the appropriate DEA/Narcotics licenses and are designed for multifaceted pharmacodynamic and safety monitoring assessments of studies. They have been adapted for psychedelic trials, varying patient populations, and are fully customizable for complex CNS-related procedures and the evaluation of CNS drug effects. Our clinical sites also include a fully dedicated driving simulation unit.
Altasciences’ core team is comprised of in-house research pharmacists, principal investigators/psychiatrists, senior clinical scientists/neuropsychologists, and highly trained personnel that ensure the safety and comfort of all study participants.
We have extensive experience in preparing and dosing substance abuse, CNS, and HAP studies via oral, sublingual, intranasal, and parenteral routes.
Our clinical team has completed CNS/neurological studies in:
CLINICAL TRIALS COMPLETED ANNUALLY
PARTICIPANTS IN OUR COMBINED DATABASE
Our robust participant database has allowed us to perform proof-of-concept studies using pain models in specialty patients and healthy participants, and investigate sleep in patients with different forms of insomnia. We are proficient in substance abuse, insomnia, Parkinson’s, Alzheimer’s, ADHD, depression, and social anxiety. Our expertise also includes the testing of abuse potential for opioids, stimulants, sedative-hypnotics, and cannabinoids. And finally, we are highly regarded for testing the cognitive effects of centrally acting drugs, including driving simulation studies which are required for many drugs that may affect cognition.
SIMULATED DRIVES CONDUCTED
DRIVING SIMULATORS ON-SITE
Altasciences’ skilled staff has industry-leading expertise in the conduct of first-in-human and clinical pharmacology trials with psychedelics. Our three clinics have an optimized Phase I facilitation set-up which includes private and semi-private rooms, stimuli reduction, and soundproofing. Their flexible design also allows for increased participant-to-facilitator ratio, where appropriate, and for clinical pharmacology trials later in development.
Discover the flexible selection of pharmacodynamic measures to enhance the pharmacology, safety, and efficacy evaluation of a CNS-active drug in early phase clinical trials.
Altasciences’ bioanalytical scientists work in tandem with our preclinical, clinical, and research support services groups to ensure the accurate collection, dissection, and handling of CNS samples, ensuring alignment with the bioanalytical method in development.
Our team of more than 300 dedicated scientists supports small and large molecules, and performs bioanalysis for drug quantitation and assessment of systemic exposure, biomarkers, and immunogenicity. Our state-of-the-art instrumentation and assay platforms (LC-MS/LBA) help us achieve low quantitation limits for systemic exposure and provide the ultra-low sensitivity necessary for plasma or serum TK/PK samples for CNS drug development.
We are an industry-recognized leader in the bioanalysis of small molecules using mass spectrometry. We develop, transfer, and optimize methods with innovative workflows to meet your needs through a tiered approach of selecting a screening, qualified, or validated assay.
The most common approach to generating CNS PK data for clinical trials is drug sampling in cerebrospinal fluid (CSF). View our validated list of bioanalytical assays, including those for CSF.
With a well-established record of conducting rigorous, high-quality research on large or small molecules, Altasciences can help move your CNS compound through the early phases of drug development seamlessly and efficiently.
Read this issue of The Altascientist to learn about the complexities of CNS drug development programs and how our comprehensive offering can reduce your timelines by up to 40%.