Drug Development :Drug Development


Introduction :Introduction Average time to develop new drug is 10 -12 years. On an average out of 10,000 – 30,000 potential substances only 1 could make it to the market. As per 2006 estimates, the cost of bringing a new drug could vary from 500 million to 2,000 million USD.


Life Cycle for new drug :Life Cycle for new drug


Historical Timelines :Historical Timelines 1937 No Regulatory control for Drug safety Elixir sulfanilamide disaster Federal Food and Drug Act passed


Stages in Drug Development :Stages in Drug Development Drug Discovery Pre-Clinical Testing Phase I Clinical Trials Phase II Clinical Trials Phase III Clinical Trials New Drug Application (NDA) / Biologics License Application (BLA) Phase IV and Beyond


Drug Discovery [ Stage 1] :Drug Discovery [ Stage 1] Determine the target disease. Determine each component of disease : Symptoms Target organ Biochemical pathways Search for the target drug : -Chemically synthesized compound -Biologically synthesized compound -Computer simulated compound Isolate the compound Proceed to next Stage.


Pre CLINICAL TRIALS [ STAGE 2] :Pre CLINICAL TRIALS [ STAGE 2] Evaluation of acute and short term toxicity in animals. It Involves : -Lethal dose determination. -Effect of dose at normal level for short/Long term. Assess how the drug is absorbed/distributed/metabolized and excreted in animals. Proceed to next Stage.


Phase 1 CLINICAL TRIALS [ STAGE 3] :Phase 1 CLINICAL TRIALS [ STAGE 3] Begins after 30 days of filing IND. Drug given to 20-100 healthy volunteers Duration could vary from 1 month to 1 year. Cost could vary from $100K to $1000K Following is studied here : -Drug absorption/Metabolism in human. -Effect on organs and tissues. -Side affect of different dosages. Thus early evidences on effectiveness are achieved. Proceed to next Stage.


Phase 2 CLINICAL TRIALS [ STAGE 4] :Phase 2 CLINICAL TRIALS [ STAGE 4] Drug given to 100 - 300 patient volunteers Duration could vary from 1 year to 2 years. Cost could vary from $10 - $100 million. Following is studied here : -Drug effectiveness in treating the disease. -Short term side effects in patients Less than 1/3rd of INDs survive phase 2 Proceed to next Stage.


Phase 3 CLINICAL TRIALS [ STAGE 6] :Phase 3 CLINICAL TRIALS [ STAGE 6] FDA consulted before beginning phase 3 Drug given to 1000-3000 patient volunteers Duration could vary from 3 years to 4 years. Cost could vary from $10 - $500 million Following is studied here : -Safety of Drug [ Benefits v/s risk analysis ] -Long term side effects in patients Proceed to next Stage.


NDA :NDA Refers to New Drug Application Formal proposal for the FDA to approve a new drug for sale in the U.S. Sufficient evidences provided to FDA to establish: Drug is safe and effective. Benefits outweigh the risks. Proposed labeling is appropriate.


Market Launch/Phase 4 :Market Launch/Phase 4 Drug is launched to the Market Additional post marketing testing of patients to -support the use of the approved indication. Finding new therapeutic opportunities Extending use of the drug to different classes of patients like children


Questions :Questions


Slide 14:THANK YOU