Expert advice and support for early-stage discovery programs seeking new treatments for drug addiction, psychiatric and neurological disorders, obesity and binge-eating disorder. All aspects of strategy, screening and project support management are performed with a strong focus on clinical success and regulatory approval.
- Design innovative non-clinical studies, prepare experimental protocols, outsource and monitor projects, analyse and interpret data, and prepare regulatory-standard reports
- Strategic assessments of therapeutic indications, including competition from current therapies, market opportunities and novel drug targets
- Screening strategies with key ”Go/No Go” decision points
- Long-term collaborations bringing our expertise into our clients’ research projects to facilitate and expedite the discovery and selection of drug candidates for clinical development
- Guidance, design and management of non-clinical efficacy and safety testing to differentiate clients’ drug-candidates from the competitors
- Early-stage abuse and dependence liability assessments to de-risk programs
- Ensure FDA and EMA compliance for the design and conduct of studies
DevelRx’s consultants each has at least 25 years of experience in R&D managing programs at Boots Pharmaceuticals, Knoll Pharmaceuticals (BASF Pharma), and in RenaSci with a range of external biotech and pharmaceutical industry clients. We have initiated clinical development of drug-candidates and supported successful development and registration of 12 new drugs for the treatment of opiate withdrawal, ADHD, binge-eating disorder, schizophrenia, opiate-induced constipation, Parkinson’s disease, epilepsy, anaesthesia, obesity and Type 2 diabetes. As globally acknowledged experts in evaluating drug abuse risks, we provide a key service in de-risking early-stage projects in therapeutic indications where regulatory approval and controlled drug scheduling are major obstacles to commercial viability.
- Risk assessments for abuse and dependence liability
- Treatments for substance use disorders
- Binge-eating disorder
- Parkinson’s disease
- Alzheimer’s disease
Heal D, Goddard S, Smith S, Cheetham S. Comparison of the physical dependence syndromes produced in rats by morphine and diazepam. J Pharmacol Toxicol Methods. 2019, 99:106595.
Heal D, Kulkarni R, Pinder L, Rowley H. Use of in vivo intracerebral microdialysis in rats to identify stimulant drugs of abuse. J Pharmacol Toxicol Methods. 2019, 99:106595.
Smith S, Holland S, Slade J, Hallam M, Heal D. Progressive ratio (PR) intravenous self-administration testing in rats to assess the relative reinforcing effects of a wide range of substances of abuse. J Pharmacol Toxicol Methods. 2019, 99:106595.
Vickers SP, Hackett D, Murray F, Hutson PH, Heal DJ. Effects of lisdexamfetamine in a rat model of binge-eating. J Psychopharmacol. 2015, 29:1290-1307.
Heal DJ, Gosden J, Smith SL. Dopamine reuptake transporter (DAT) "inverse agonism" - a novel hypothesis to explain the enigmatic pharmacology of cocaine. Neuropharmacol. 2014, 87:19-40.