96014 Molecule to Market

Description

This subject covers the drug development process from laboratory to patient – a high risk, high cost but high reward process. One in 10,000 screened compounds make it to market. The subject outlines the stages of the pharmaceutical research and development of a drug. The process begins with drug discovery that can take five years in assessing 10,000 compounds. Of these 10,000 compounds, 250 have pre-clinical studies conducted that can take upwards of two years. Of these 250 compounds, only five make it to clinical trials, which can take six years. This includes phase 1 to phase 3 efficacy and safety clinical studies. Of these five compounds, only one will have the necessary chemistry, pre-clinical and clinical data for a regulatory dossier to be compiled and submitted to the Therapeutic Goods Administration (TGA) in Australia. The TGA is responsible for evaluating the efficacy, safety and quality of new drugs. Access to medicines for patients involves product registration via the TGA and pricing reimbursement via the Pharmaceutical Benefits Division (PBD). This subject also outlines what is involved in successfully registering a medicine and listing it with the Pharmaceutical Benefits Scheme (PBS).