HAP Capabilities at Our Kansas City Clinical Facility

Altasciences is a CNS Center of Excellence for research from discovery to preclinical to clinical. We have experience in a diverse range of human abuse potential (HAP) studies, such as for stimulants, opioids, and sedative hypnotics; and have conducted over 60 HAP trials over the last decade. 

Sponsors choose our Kansas City Research Campus for their HAP studies for our:

• Experienced physicians who understand how to work with recreational drug users
• 36-bed specialty clinical unit in Kansas City for sequestering patient populations
• Upscale facilities that contribute to industry-leading retention rates for up to 60 days of consecutive confinement
• Pharmacies with USP 797 clean room with Class II biological safety cabinet
• Database of over 400,000 active participants including 45,000 at our Kansas City site alone.  The database includes recreational abusers of opioids, stimulants, sedative hypnotics, and cannabinoids

Discover more!


You may also be interested in the following:

• Webpages:
  • CNS Clinical Trial Capabilities
  • Human Abuse Potential Capabilities
  • Our Early Phase Clinical Facilities
• Video:
  • Quick Chat with Dr. Kelsh — Leader in CNS and Human Abuse Liability Studies

Join our upcoming webinars:

• Inside the Pharmacodynamic Toolbox: How Questionnaires, Models, and Tests of Cognition Can Accelerate the Development of CNS-Active Drugs
• Ethnobridging in Phase I Clinical Trials: Strategy for Enhancing Asset Value and Accelerating Global Drug Development

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.

Key Considerations for Developing
Cell-Based Assays 

In this complimentary webinar, Dr. Danielle Salha, Senior Director, Immunochemistry and Immunology, Ligand Binding Assays, discusses key parameters to consider during method development to support drug potency and immunogenicity characterization. 

Topics covered:

• Reducing development timelines and management of critical reagents
• Important parameters to consider for NAb method development and for the development of potency assays
• Management of critical reagents to support long-term clinical studies
• Advantages of using the same method for both immunogenicity assessment and product characterization
• Challenges that may be encountered when developing cell-based assays

Watch now

You may also be interested in the following:

• Ligand Binding Capabilities
• Bioanalytical Assay List
• The Altascientist — Validation of Immunogenicity Assays

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.

Adversity Level Determination in Nonclinical Studies

This complimentary webinar offers expert insight into how data is interpreted on toxicology studies. More specifically, we provide you with an insider’s view on common practices and guidances followed by contract research organizations to characterize adversity. 

Case studies included:

• Overt toxicity, exaggerated pharmacology, and changes in various markers of toxicity in the context of other safety endpoints
• How to approach data interpretation on toxicology studies to classify adverse vs. non-adverse effects

Watch now

You may also be interested in the following:

• Preclinical Drug Development Solutions
• Podcast — Overcoming Drug Development Pathway Challenges with Dr. Ghatnekar
• Safety Pharmacology Capabilities

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.

Partnering for the Development of Psychedelics, Cannabidiol (CBD), and Other Scheduled Drugs

Altasciences can help develop and commercialize first- and second-generation novel therapeutics for the treatment of mental health, addiction, and CNS disorders. We are a recognized CNS center of excellence, specializing in the formulation, development, analysis, testing, and manufacturing of controlled substances for clinical trial supply all the way through to commercialization.

When partnering with us, you benefit from our state-of-the-art facilities and advanced expertise, including:

• DEA license for drug Schedules I-V for manufacturing and analytical services
• FDA-registered and inspected facilities, including cGMP manufacturing suites, segregated Grade C/D clean rooms, warehouses, and cold storage 
• cGMP-compliant analytical laboratory for drug product release and ICH stability testing
• Expertise with small molecule APIs, simple and complex formulations of highly potent compounds, and controlled substances
• Experience with formulation development and optimization of cannabinoids
• Experience developing methods for low concentration formulations often used for psychedelics
• Experience with all aspects of drug product characterization
• Clinical supply and commercial manufacturing, packaging, and shipping
• Regulatory and technical guidance and support 

Get in touch with our experts today to discuss your project’s needs.

Got a few more minutes? You may also be interested in the following:

• Webpage: Pharmaceutical Contract Manufacturing and Analytical Services
• Webinar: The Many Facets of Early Phase Evaluation of Psychedelics in Psychiatry
• E-Book: The Benefits of Liquid-Filled Capsules in Pharmaceutical Development

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’ Clinical Facilities Move in Unison

Altasciences provides strategically located clinical pharmacology facilities and access to over 500 beds across North America. We have over 1,000 employees dedicated to clinical pharmacology research who conduct over 285 trials per year. 

Operations at our clinical teams in Los Angeles, Kansas City, and Montreal follow the same set of standard operating procedures to offer you a scientifically sound, quality experience, every time — for both your single-site or multi-site studies.  

In addition, our clinical teams work in unison with our preclinical, bioanalytical, manufacturing, and research support teams at our five other sites, to offer an integrated drug development solution, from lead candidate selection to clinical proof of concept, and beyond.

Altasciences provides customized solutions that fit your needs, and innovative in-house recruitment call centers for quick study startup.

Let’s get started!

You may also be interested in the following:

• Video: Fully Integrated Drug Development Solutions
• Webpage: Phase 1 Clinical Trial Units 
• E-book: First-in-Human Solution 

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.

It’s All About ASOs!

Antisense oligonucleotides (ASOs) offer an exciting pathway to targeting the source of a disease’s pathogenesis. In this e-book, we take a deep dive into the bioanalytical development for the analysis of ASOs.

Topics covered: 

• Benefits and challenges of novel ASO bioanalytical approaches.
• Case studies examining how best to align a bioanalytical technique with the goals of a particular ASO drug development program. 

Download the FREE e-book now

Speak with an expert.

Have 5 minutes? Take a look at these:

• Comprehensive Bioanalytical Services
• Altasciences' Proprietary Bioanalytical Assay List
• Three Laboratories – One Vision (PODCAST)

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.

40% of marketed drugs and 90% of active pharmaceutical ingredients (APIs) are poorly water-soluble, BCS Class II or IV. Nanomilling is a proven technique that can overcome solubility challenges and ensure your molecules are developed successfully into life-saving therapies. 

In our latest ​​​​​​ issue of The Altascientist, learn about:

• Solubility classifications (consult the checklist to see if your API qualifies)
• How nanomilling works
• The advantages of nanomilling
• Maximizing formulations
• A case study

Download your copy today, or listen to the audio recording.
 

Questions? Speak with our experts.

Moving in Unison to Bring Your Vision to Life 

Trust is an important factor in any relationship. And we know trust is earned. 

That’s why at Altasciences, our focus is on you. We build strong relationships with each client through quality science and  proactive, responsive, and transparent communication that ensures you only have to Tell Us Once™. 

When you choose us, you are choosing a partner that will work as an extension of your team — who treats you like colleagues and your projects as our own. We’ll work side by side, getting to know your goals and understanding your needs. From preclinical to clinical proof of concept, and beyond, we’ll advance your molecule in one integrated, seamless process, celebrating your milestones together. 

Why? Because drug development isn’t a transaction — it’s a journey. Speak with an Altasciences expert to start your journey.
 

Watch this video to discover what it means to partner with Altasciences:

Have five minutes? Take a look at these: 

• Check out our new interactive brochure
• Discover our Proactive Drug Development solution
• Read this blog article: Moving Your Drug Forward to Preclinical Trials
• Explore our customizable and flexible early phase solution offering
• Read this Q&A featuring Marie-Hélène Raigneau, our Co-Chief Operating Officer​​​​​

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.