Altasciences Tackles the Issues and Challenges Associated with Schedule I Therapeutic Development

Schedule I, or Class I (CI) drugs are currently restricted to research in the U.S., meaning that they are not approved for medical use, and are deemed at highest risk for abuse. Recent research on psychedelics and entactogens, of which are schedule I, is beginning to demonstrate potential therapeutic effects of these drugs for various medical indications. Approvals of such drugs for medical or therapeutic use will inevitably result in the rescheduling of these drugs from their current CI status. 

In this issue of The Altascientist, we uncover the following:

• Regulatory environment and challenges — DEA 
• Required preclinical and clinical studies specific to Schedule I or Class I (CI) drugs 
• Manufacturing considerations

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For novel CNS-active Schedule I drugs, partner with Altasciences and benefit from our Schedule I licenses across every stage of early phase drug development. Our knowledge and operational expertise across preclinical, clinical, and manufacturing stages ensures complete continuity, data transfer, information sharing, and efficient timeline management... in real-time. 

Speak with an expert today for more information or to review your specific program requirements. 

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.​​​​

Altasciences’ New eSource Platform ⁠— ClinSpark^®

We are pleased to share that we have adopted the eSource platform ClinSpark^®, created by Foundry Health, to support our never-ending focus on compliance, efficiency, and oversight in data collection.

From recruitment to database lock, ClinSpark^® software will provide you, our valued clients, with access to your data in a fully validated system, compliant with 21 CFR Part 11.

We have successfully deployed the administrative recruitment portion of ClinSpark^®, as well as validated and deployed the clinic module. Ongoing trials being conducted in the clinic with a live database will still be performed by transcribing data from paper source documents into Medrio. Upcoming studies will be handled in ClinSpark^® as eSource and/or eCRF. Our study team will be in touch regarding any changes to your study.

A Frequently Asked Questions document is available here for your convenience.

The validation package is available electronically for client review and audit purposes, upon request. Please contact your Altasciences Project Manager should you wish to coordinate access to the validation documentation.

We are very excited to share this important milestone with you, and look forward to our continued partnership!

Sincerely,

The Altasciences Clinical Team


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.

Clinical Sample Kit Management

From trial sites to our labs, Altasciences’ Material Management Team has over 25 years of experience supporting clinical trials around the globe. We make it easy with efficient collection, preparation and shipment of clinical samples.

Each kit is adapted to your specific study needs, and allows for the storage and shipping of different matrices, such as plasma, urine, serum, and whole blood.
        
Download our fact sheet to learn more about our capability or send us an e-mail and we will connect you with an expert within 24 hours.

Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining 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.

You may also be interested in the following:

• Webpages:
  • Clinical Trial Facilities
  • Bioanalytical Services
• Fact Sheet:
  • Pharmacy On Demand

Scientific Resources in CNS Clinical Trials

Altasciences has an extensive understanding of psychiatric and neurologic disorders, stemming from our decades of conducting complex studies in various therapeutic indications impacting the central nervous system.

Here are some of our most insightful scientific resources in the area of CNS drug development: 

1. The Altascientist: Central Nervous System
   Early phase development of CNS-acting drugs is a complex, challenging undertaking. In this article, we provide a detailed overview of the multiple facets you need to consider during the planning and conduct of your CNS-active drug development. Learn More
    
2. The Altascientist: CNS, Psychedelics and Other Schedule I Drugs
   In this scientific journal, we uncover the regulatory environment and challenges, the required preclinical and clinical studies specific to Schedule I or Class I (CI) drugs, and the manufacturing considerations for CNS-active drugs. Learn More
    
3. The Altascientist: Studying the Effects of Drugs on Driving
   Driving simulation studies are required by the FDA when preclinical and early clinical studies show that a drug may cause somnolence or impair cognition. Discover the challenges of driving simulation clinical testing. Learn More
    
4. Webinar: Navigating the Abuse Potential Evaluation of CNS-active Drugs for EU and U.S. Submissions
   In this on-demand webinar, we discuss the key considerations for delivering an integrated preclinical and clinical abuse potential drug development evaluation that meets EMA and FDA regulatory requirements. Watch Now
    
5. Webinar: Inside the Pharmacodynamic Toolbox: How Questionnaires, Models, and Tests of Cognition Can Accelerate the Development of CNS-active Drugs 
   This session explores the flexible selection of pharmacodynamic measures to enhance the pharmacology, safety, and efficacy. Watch Now

Speak with an expert today to learn more about our CNS solution.

Have five more minutes? Check out these webpages:

• CNS Clinical Trials
• Human Abuse Potential
• Driving Simulation

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.

Seamless Bioanalytical Transition

Altasciences’ scientists move in unison with you, collaboratively, accurately, and efficiently, from preclinical to clinical, and beyond. Our team of over 260 bioanalytical scientific veterans is strategically located across North America, and has experience with a wide spectrum of biological matrices in both animal and humans.
 
Driven by your assay requirements, our program support includes LC-MS/MS, LBA OR HYBRID LBA/LC-MS/MS ASSAY platforms for:

Speak with a scientist

Have 5 minutes? You may also be interested in the following:

• Assay List — Over 685 Assays covering 650 Molecules
• The Altascientist — Validation of Immunogenicity Assays
• Webinar — Development of a Cell-Based Assay for Dual Purposes: to Support Drug Potency and Immunogenicity Characterization

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.

PODCAST — How Novel Data-Driven Treatments Are Improving Patient Care

Special guest Dr. Michael Winlo, Managing Director at Emyria, joins us for a very insightful conversation about their unique programs and new patient care models. Emyria is a biotech company that brings together patients, clinicians, researchers, and medical innovators to develop data-driven, novel treatments for patients in need, including cannibidiol formulations.

Listen now!

Have 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.