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HOW ARE NEW DRUGS DEVELOPED?

HOW ARE NEW DRUGS DEVELOPED?. Durhane Wong-Rieger, PhD Consumer Advocare Network. OVERVIEW. Examples of “innovative” and “incremental” discoveries. What are steps from discovery to regulatory submission?. What are likelihood of success and cost through the process?.

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HOW ARE NEW DRUGS DEVELOPED?

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  1. HOW ARE NEW DRUGS DEVELOPED? Durhane Wong-Rieger, PhD Consumer Advocare Network

  2. OVERVIEW Examples of “innovative” and “incremental” discoveries What are steps from discovery to regulatory submission? What are likelihood of success and cost through the process?

  3. Incremental versus breakthrough innovation • Breakthrough innovation is characterized by first-in-class, or new therapies • Examples include: Penicillin (first antibiotic); Insulin (first animal insulins); Thorazine (first anti-psychotic); first birth control pill • “A breakthrough drug product is the first one to be sold in Canada that treats effectively a particular illness or address effectively a particular indication” (PMPRB)

  4. Follow-on (incremental development) • Incremental Innovation is characterized by bit-by-bit, cumulative improvement • Examples include: modern day antibiotics (4 days, one pill/day); newer insulin therapies, modern birth control pills, etc. • Development of follow-on drugs occurs at the same time with that of the first-in-class • Therapeutic value of follow-on drugs is reflected in the percentage of priority designations, inclusion in the clinical practice guidelines, and coverage in major formularies

  5. Years 0 Discovery (2–10 Years) 2 Preclinical Testing Laboratory and Animal Testing 4 Phase I 20–80 Healthy Volunteers Used to Determine Safety and Dosage 6 Phase II100–300 Patient Volunteers Used to Look for Efficacy and Side Effects 8 10 Phase III1,000–5,000 Patient Volunteers Used to Monitor Adverse Reactions to Long-term Use 12 FDA Review Approval 14 Additional Post-marketing Testing 16 New Product Development:Risky and Expensive Compound Success Rates by Stage 5,000-10,000 Screened 250 Enter Preclinical Testing 5 Enter Clinical Testing 1 Approved by the FDA Net Cost: $1.3 billion invested over 15 years

  6. Clinical Trials • Conducted to determine the safety and efficacy of the new health technologies • Many types exist • Phases: • Pre-clinical • Phase I • Phase II • Phase III • Phase IV (Post-Market)

  7. Most products that get to market never make enough to recoup R&D Investment $0 New Products Grouped in Tenths According to Financial Success

  8. Movement of Drug Through Regulatory System • Do we have budget to fund the drug? • Health Canada • Common Drug Review • Provincial Regulators • Does the drug provide value? • Is the Drug Safe & Effective? PMPRB - Pricing

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