25 Jun DevelRx
DevelRx is a consultancy business providing strategic and scientific support on central nervous system (CNS) drug discovery and development, drug abuse evaluation and treatment to clients in all sectors of the worldwide pharmaceutical and biotech industry.
The principals at DevelRx each have more than 25 years of experience in research and development of CNS drugs used in psychiatry (eg Addiction / dependence, ADHD, binge-eating disorder) and neurology that has been gained from successful careers in academic research, the pharmaceutical and biotech industry and as founder / senior members of a CRO, RenaSci Ltd (UK). David Heal was a founder member of RenaSci Ltd at BioCity in Nottingham in 2001 after leaving Knoll Pharmaceuticals (BASF Pharma). He has been joined in DevelRx by the key members of the RenaSci Consultancy Team, Sharon Smith and Jane Gosden.
R&D strategic reviews:
DevelRx conducts strategic reviews of a therapeutic indication that includes research on the mode of action of current therapies, identifying novel approaches, market opportunities, barriers to drug entry onto the market and likelihood of success in treating a specific CNS disorder.
Design and preparation of experimental protocols:
We prepare experimental protocols for investigating the properties of new drugs in development. This may be in areas of efficacy (eg a new drug for ADHD), or to treat opiate or cocaine dependence, or in drug safety (eg evaluating the risk for human abuse and/or dependence as demanded by the drug regulatory agencies).
Regulatory support for drugs in clinical development:
DevelRx provides regulatory support in areas such as the evaluation of risks of abuse and dependence for new drugs. Before a new drug can enter the formulary of country it has to be approved as safe and effective as a medicine. We prepare documents for clients to submit to government appointed regulatory agencies, eg Medicines and Healthcare Regulatory Agency (MHRA) in the UK, European Medicines Agency (EMA) in the European Union and Food and Drug Administration (FDA) in the USA.
Participation in scientific and clinical advisory board meetings:
We provide expert advice on pathways for successful drug development, choice of therapeutic indication for a new drug, additional therapeutic opportunities for new and existing drugs and marketing opportunities / challenges.
DevelRx undertakes medical education projects including presentations to scientists and clinicians at client hosted symposia, preparation of articles for specialist journals, and participating in webinars and films.
Expert witness work:
We offer advice to legal representatives of the pharmaceutical industry, to generic drug-makers and to government agencies. We support litigation in areas including intellectual property disputes and claims relating to drug efficacy and safety by providing expert testimony as written depositions. We can also provide expert witness testimony in court.
We prepare patents to help our clients maintain intellectual property for their drug inventions.