It takes 2 to 4 years to identify new compounds or substances that cure, relieve or prevent a disease
The following steps are taken for this purpose: understanding the disease, identifying a therapeutic target: Genomics / Proteomics / Bioinformatics, designing an in vitro model of the disease, chemical synthesis of compounds or natural molecules along with in-vitro testing, high throughput screening
These steps then lead to the selection of the most active compounds. Once this is done then optimising of identified compounds commence which includes, efficacy, selectivity, safety molecular modelling or crystallography. This is followed by testing the efficacy of compounds on an animal model of the disease and finally selecting the compounds with the best efficacy-to-safety ratio.
Pre-clinical Development
It then takes 1 to 2 years to improve the properties and activity identified by research
The different phases of preclinical development are carried out simultaneously in order to speed up the new drug discovery process.
Analytical chemistry
To study molecular characteristics: molecular structure, physiochemical properties and stability.
Pharmacodynamics
Includes evaluating the biological effects of the drug on animal models of the disease.
Pharmacokinetics
To determine the fate of the compound in the body after administration: distribution, bioavailability, metabolism, and elimination.
These steps again lead to selection of the most active compounds.
Toxicology
Refers to assessing the compound?s safety for organic functions (respiration, digestion, etc.) and for reproduction.
Pharmaceutical form
Is to develop a pharmaceutical form for use in human clinical trials.
All these processes then finally lead to the selection of the best compounds for human testing.
Clinical Development
It takes 6 to 8 years to test the new compound in humans
Phase I
To evaluate tolerance in healthy human subjects (a few dozen volunteers)
Phase II
To evaluate efficacy and safety in patients. To determine dosage (a few hundred patients)
Phase III
To evaluate the compound in a large number of patients. And, to compare with existing treatments and/or reference treatments (a few thousand patients)
These phases then culminate in the decision to file for registration.
Registration and market access
It takes 1 to 2 years to obtain approval from health authorities to bring the drug to market
Filing for registration and market access
A file summarising all the data collected about the compound is submitted to health authorities (FDA* in the United States, EMEA** in Europe, local health authorities, etc.). These independent authorities then assess the efficacy and safety of the drug.
New drug approval
Price setting and Access to reimbursement
The price will be determined by each country based on the added value and cost-effectiveness ratio of the drug. The level of reimbursement will also be determined based upon these factors.
Life Cycle Management
This includes
* Monitoring safety profile
* New indications