With expertise in non-clinical and clinical development, and safety pharmacology assessments, that has been demonstrated through the registration of 16 new drugs, we have the expertise to provide our pharmaceutical and biotech clients the support to expedite, facilitate and optimise success in drug development.
Examples include supporting the development of lisdexamfetamine as a treatment for binge-eating disorder, and the abuse/dependence evaluations of this prodrug and of cannabidiol.
Our services include:
- Evaluations of abuse and dependence potential and controlled drug scheduling
- Computational assessment of structural similarities between drug candidates and controlled drugs including similarity matching by Tanimoto analysis (in collaboration with ).
- 8-factor analyses
- Abuse potential assessment waiver submissions for CNS drug-candidates which may not require non-clinical abuse and dependence assessment.
- Regulatory safety pharmacology assessments including document preparation for End-of-Phase 2 meetings, preparation of GLP study plans, and negotiation with regulatory agencies
- Designing, outsourcing, and monitoring non-clinical abuse and dependence studies including drug discrimination, intravenous self-administration and withdrawal-induced physical dependence studies, analysis and interpretation of data. Preparation of regulatory-standard reports
- Designing, outsourcing and monitoring experimental projects to provide complementary evidence to support findings from non-clinical abuse and dependence testing eg microdialysis, microdialysis combined with behaviour and ex vivo binding
- Strategic evaluations for additional therapeutic indications for drugs in development and the design, outsourcing, and monitoring of experimental programs to evaluate these opportunities
- Designing non-clinical programs to differentiate clients’ drug-candidates from market competitors based on efficacy and safety end-points. Analysis and interpretation of data. Preparation of regulatory-standard reports.
- Participation in scientific, clinical and strategic advisory panels to support drugs in clinical development
- Advice and guidance on clinical development programs
- Ensuring compliance of studies with FDA or EMA regulatory guidelines
Drug abuse and dependence
We have advised more than 50 clients on abuse/dependence evaluations for US, European and Japanese drug registrations. Our consultant scientists produce regulatory briefing documents, negotiate with regulators, and develop innovative experimental programs to assess abuse/dependence potential. We have performed regulatory abuse/dependence studies on more than 40 compounds.
We have over 30 years of experience in the development of treatments for psychiatric and neurological disorders including binge-eating disorder, ADHD, depression, anxiety, schizophrenia, epilepsy, pain, anaesthesia, and Parkinson’s and Alzheimer’s diseases.
We have extensive pre-clinical expertise in the development of treatment for obesity and its co-morbidities, and type 2 diabetes.
Get in touch to find out how we can help you.