With expertise in non-clinical and clinical development, and safety pharmacology assessments that has been demonstrated through the registration of 12 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.
- Evaluations of abuse and dependence potential and controlled drug scheduling
- Regulatory safety pharmacology assessments including document preparation for End-of-Phase 2 meetings, preparation of GLP study plans, and negotiation with regulatory agencies
- Design, outsource, and monitor non-clinical abuse and dependence testing, analyse and interpret data. Preparation of regulatory-standard reports
- Design, outsource and monitor experimental projects to provide complementary evidence to support findings from non-clinical abuse and dependence testing
- Conduct strategic evaluations for additional therapeutic indications for drugs in development. Design, outsource, and monitor experimental programs to evaluate these opportunities
- Design non-clinical programs to differentiate clients’ drug-candidates from market competitors based on efficacy and safety end-points. Analysis and interpretation of data. Prepare regulatory-standard reports.
- Participation in scientific, clinical and strategic advisory panels to support drugs in clinical development
- Advice and guidance on clinical development programs
- Ensure 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 use novel adjunctive testing procedures to complement drug discrimination, intravenous self-administration and withdrawal-induced physical dependence studies eg microdialysis, microdialysis combined with behaviour and ex-vivo binding to evaluate drug abuse liability and dependence.
CNS and Neurological Disorders
We have over 30 years of experience in the development of treatments for CNS 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.
- Risk assessments for abuse and dependence liability
- Treatments for substance use disorders
- Binge-eating disorder
- Parkinson’s disease
- Alzheimer’s disease
Smith SL, Dean RL, Todtenkopf MS, Heal DJ. Investigation of the reinforcing potential of samidorphan and naltrexone by fixed and progressive ratio intravenous self-administration testing in heroin-maintained rats. J Psychopharmacol. 2019, 33:383-391.
Heal DJ, Gosden J, Smith SL. Evaluating the abuse potential of psychedelic drugs as part of the safety pharmacology assessment for medical use in humans. Neuropharmacol. 2018, 142:89-115.
Vickers SP, Goddard S, Brammer RJ, Hutson PH, Heal DJ. Investigation of impulsivity in binge-eating rats in a delay-discounting task and its prevention by the d-amphetamine prodrug, lisdexamfetamine. J Psychopharmacol. 2017, 31:784-797.
Hutson PH, Rowley HL, Gosden J, Kulkarni RS, Slater N, Love PL, Wang Y, Heal D. The effects in rats of lisdexamfetamine in combination with olanzapine on mesocorticolimbic dopamine efflux, striatal dopamine D2 receptor occupancy and stimulus generalization to a D-amphetamine cue. Neuropharmacol. 2016, 101:24-35.
Heal DJ, Buckley NW, Gosden J, Slater N, France CP, Hackett D. A preclinical evaluation of the discriminative and reinforcing properties of lisdexamfetamine in comparison to D-amfetamine, methylphenidate and modafinil. Neuropharmacol. 2013, 73:348-358.
Heal DJ, Cheetham SC, Smith SL. The neuropharmacology of ADHD drugs in vivo: insights on efficacy and safety. Neuropharmacol. 2009, 57:608-18.