At Scitegrity we can perform a Drug Abuse Potential chemical similarity assessment for you to include within your own regulatory submission.
However as part of our partnership with Develrx, we are also able to offer a more comprehensive regulatory submission service.
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.
The partnership combines Scitegrity’s sophisticated and quantitative chemical similarity assessments to drugs with known abuse potential with Develrx expertise in drug development in CNS. For more information on this please contact either Develrx or Scitegrity.
We are proud to work with the Pistoia Alliance a global, not-for-profit alliance of life science companies, vendors, publishers, and academic groups that work together to lower barriers to innovation in R&D through pre-competitive collaboration.
Under their BioVia brand, Dassault Systemes produce the industry leading tools Pipeline Pilot and Chemistry Direct which Scitegrity use to help power our solutions.