Today, Discovery Park company Scitegrity, which specialises in making controlled drug and chemical regulations searchable by chemical structure and DevelRx, who provide expert support on CNS (central nervous system) drug discovery and development, announced a new partnership to streamline and improve Drug Abuse Potential assessments and submissions.
In the partnership Scitegrity will perform sophisticated and quantitative chemical similarity assessments of drugs in development to drugs and chemical space with known human abuse potential utilising the algorithms, data sets and expertise behind Scitegrity’s Controlled Substances Squared.
Scitegrity (Kent, UK), was founded in 2011 by former Pfizer Scientists and data managers and in 2014, in conjunction with several Pharma companies developed and launched Controlled Substances Squared, a market leading computational system that encodes controlled drug legislation from around the world.
The system is trusted by 5 of the world’s top 10 Pharmaceutical companies, and dozens of chemical suppliers, CROs, regulators and pharma to identify accurately and automatically if any chemical is considered controlled or regulated in over 28 countries.
DevelRx (Nottingham, UK) is an internationally recognised consultancy business founded in 2020 that provides expert support on CNS (central nervous system) drug discovery and development to all sectors of the worldwide pharmaceutical and biotech industry. Key services include drug abuse evaluations of all centrally-acting drugs (regardless of the primary site of action).
DevelRx facilitates regulatory submissions for drug-candidates by supporting preclinical drug development programs, preparing New Drug Applications (NDAs) / Market Authorisation Applications (MAAs) and abuse potential briefing documents (including 8-Factor analyses for the USA). As globally acknowledged experts in evaluating drug abuse risks, they 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.
The company team comprises Professor David Heal, Dr Sharon Smith (Co-founders and Executive Directors), Mrs Jane Gosden (Senior Consultant and Finance Officer) and Dr Helen Jackson (Business Development Officer). They each have more than 25 years of experience in research and development of CNS drugs used in psychiatry (e.g. addiction / dependence, ADHD (attention deficit hyperactivity disorder), binge-eating disorder, neurology and metabolic disorders that has been gained from successful careers in academic research, the pharma and biotech industry and as founder / senior members of a UK CRO. Their key areas of expertise include all the strategic, regulatory and technical aspects of the drug discovery process, and an innovative contribution to advancing research in this field. They are experienced at interacting with regulatory authorities including the Medicines and Healthcare Regulatory Agency (MHRA; UK), the European Medicines Agency (EMA) and the Food and Drug Administration (FDA; USA). The team at DevelRx has supported the successful development and registration of 12 new drugs for the treatment of opiate withdrawal, ADHD, binge-eating disorder, schizophrenia, Parkinson’s disease, epilepsy, anaesthesia, opiate-induced constipation, obesity and Type 2 diabetes.
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