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pres.layout = "LAYOUT_WIDE";
pres.title = "Drug Development Process";
pres.author = "Pharmacy & Medical Education";

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// ─── BUILD SLIDES ──────────────────────────────────────────────────────────

// 1. Title
titleSlide(pres,
  "The Drug Development Process",
  "From Target Discovery to Post-Market Surveillance  |  Pharmacy & Medical Students"
);

// 2. Overview / Agenda
contentSlide(pres, "Lecture Overview", [
  { type: "heading", text: "What we will cover:" },
  { text: "1. Introduction & historical perspective" },
  { text: "2. Drug discovery — target identification & lead optimization" },
  { text: "3. Preclinical studies (in vitro & in vivo)" },
  { text: "4. IND Application (Investigational New Drug)" },
  { text: "5. Clinical Trials — Phase I, II, III" },
  { text: "6. NDA/BLA Submission & FDA Review" },
  { text: "7. Post-marketing surveillance (Phase IV)" },
  { text: "8. Challenges, costs & future directions" },
  { text: "9. Key regulatory concepts & summary" },
], { page: 2 });

// 3. Introduction
contentSlide(pres, "Introduction — Why Is Drug Development Complex?", [
  { type: "heading", text: "Historical Context" },
  { text: "Ancient empiric use of plant extracts for fever, pain & breathlessness" },
  { text: "20th century: shift to targeting fundamental biologic processes" },
  { text: "Paul Ehrlich coined 'magic bullet' — searching for selective therapies" },
  { type: "heading", text: "The Modern Challenge" },
  { text: "Average cost > $1 billion per approved drug (Katzung 16e)" },
  { text: "Only ~1 in 10,000 synthesized compounds reaches market" },
  { text: "Timeline: 10–15 years from discovery to approval" },
  { text: "Drug pricing controversies & global access inequities" },
], { page: 3 });

// 4. Timeline visual
timelineSlide(pres);

// 5. Drug Discovery
contentSlide(pres, "Step 1: Drug Discovery — Target Identification", [
  { type: "heading", text: "Common Approaches (Katzung 16e)" },
  { text: "Screening large libraries: natural products, peptides, nucleic acids, chemical entities" },
  { text: "Chemical modification of known active molecules ("me-too" analogs)" },
  { text: "Identification of a new drug target from disease pathophysiology" },
  { text: "Rational design based on receptor/enzyme structure (structure-based design)" },
  { type: "heading", text: "Modern Examples" },
  { text: "HMG-CoA reductase → statins (cholesterol biosynthesis)" },
  { text: "BRAF V600E mutation → vemurafenib (malignant melanoma)" },
  { text: "High-throughput screening (HTS): millions of compounds tested rapidly" },
  { text: "Genomics & systems biology: multi-pathway targeting for complex diseases" },
], { page: 5 });

// 6. Lead Optimization
contentSlide(pres, "Step 2: Lead Optimization & Compound Profiling", [
  { type: "heading", text: "Optimization Goals" },
  { text: "Increase potency (binding affinity to target receptor)" },
  { text: "Improve selectivity — minimize off-target effects" },
  { text: "Optimize pharmacokinetic properties: absorption, distribution, metabolism, excretion (ADME)" },
  { text: "Ensure consistent bioavailability & adequate elimination half-life" },
  { type: "heading", text: "Key Early Screens" },
  { text: "Cytochrome P450 enzyme studies (drug interactions, metabolism prediction)" },
  { text: "Agonist / antagonist / partial agonist / inverse agonist characterization" },
  { text: "Receptor binding assays: affinity constants (Ki, IC₅₀)" },
  { text: "SAR (Structure-Activity Relationship) studies guide chemical modification" },
], { page: 6 });

// 7. Preclinical Studies
contentSlide(pres, "Step 3: Preclinical Studies — In Vitro & In Vivo", [
  { type: "heading", text: "In Vitro" },
  { text: "Molecular assays: receptor binding, enzyme inhibition, cell-based assays" },
  { text: "Cytotoxicity, genotoxicity (Ames test), mutagenicity" },
  { text: "Protein binding & plasma stability studies" },
  { type: "heading", text: "In Vivo (Animal Studies)" },
  { text: "Pharmacodynamic studies: efficacy in disease models (e.g., hypertension, infection)" },
  { text: "Dose-response characterization & therapeutic window (LD₅₀ / ED₅₀ → TI)" },
  { text: "Acute & chronic toxicity: hepato-, nephro-, cardio-toxicity panels" },
  { text: "Reproductive & developmental toxicity; carcinogenicity (long-term)" },
  { text: "Route of administration studies (oral, IV, topical)" },
], { page: 7 });

// 8. IND Application
contentSlide(pres, "Step 4: IND Application — Entering Human Trials", [
  { type: "heading", text: "What is an IND? (Investigational New Drug)" },
  { text: "Sponsor submits IND to the FDA before initiating human clinical trials" },
  { text: "IND contains: preclinical data, manufacturing info, proposed clinical protocols, investigator info" },
  { text: "FDA has 30 days to respond; no response = allowed to proceed" },
  { type: "heading", text: "Institutional Review Board (IRB)" },
  { text: "Independent ethics committee at each trial site must also approve" },
  { text: "Protects rights, safety & welfare of research subjects" },
  { text: "Reviews informed consent documents, study design, risk-benefit ratio" },
  { type: "heading", text: "Good Clinical Practice (GCP)" },
  { text: "International standard (ICH E6) for designing, conducting & reporting trials" },
], { page: 8 });

// 9. Phase I
phaseSlide(pres, "I", "Phase I Clinical Trials — Safety & Tolerance",
  C.phase1,
  [
    { type: "heading", text: "Objectives" },
    { text: "First-in-human testing: assess safety, tolerability, and pharmacokinetics" },
    { text: "Determine maximum tolerated dose (MTD) and dose-limiting toxicities (DLT)" },
    { text: "Characterize PK: absorption, distribution, metabolism, elimination" },
    { type: "heading", text: "Design" },
    { text: "20–100 healthy volunteers (or patients in oncology)" },
    { text: "Open-label, dose-escalation design" },
    { text: "Duration: 1–2 years" },
    { text: "Success rate: ~63% of drugs advance to Phase II" },
    { type: "heading", text: "Endpoints" },
    { text: "Adverse events (AEs), pharmacokinetic parameters (Cmax, AUC, t½)" },
  ],
  "Phase I does NOT assess efficacy — it is purely about safety & dose finding"
);

// 10. Phase II
phaseSlide(pres, "II", "Phase II Clinical Trials — Efficacy & Dose Finding",
  C.phase2,
  [
    { type: "heading", text: "Objectives" },
    { text: "Preliminary evidence of efficacy in target patient population" },
    { text: "Identify optimal dose range and dosing interval" },
    { text: "Detect common adverse effects and drug interactions" },
    { type: "heading", text: "Design" },
    { text: "100–500 patients with the target disease" },
    { text: "Randomized controlled trials (RCT); may be blinded" },
    { text: "Duration: 2–3 years" },
    { text: "Success rate: ~35% of drugs advance to Phase III" },
    { type: "heading", text: "Biomarkers & Surrogate Endpoints" },
    { text: "Used to predict clinical benefit (e.g., HbA1c for diabetes, viral load for HIV)" },
  ],
  "Phase IIa = proof-of-concept; Phase IIb = dose-ranging"
);

// 11. Phase III
phaseSlide(pres, "III", "Phase III Clinical Trials — Large-Scale Efficacy",
  C.phase3,
  [
    { type: "heading", text: "Objectives" },
    { text: "Confirm efficacy and safety in a large, diverse patient population" },
    { text: "Compare against placebo or current standard of care" },
    { text: "Provide statistical power for regulatory submission" },
    { type: "heading", text: "Design" },
    { text: "1,000–5,000+ patients across multiple centers (international)" },
    { text: "Randomized, double-blind, controlled trials (gold standard)" },
    { text: "Duration: 3–4 years | Most expensive phase" },
    { text: "Success rate: ~58% of drugs submitted for approval are approved" },
    { type: "heading", text: "Subgroup Analyses" },
    { text: "Effect modifiers: age, sex, renal/hepatic function, genetic polymorphisms" },
    { text: "Safety data required for labelling (package insert)" },
  ],
  "Phase III failure is catastrophic given cost — thorough Phase II planning is critical"
);

// 12. NDA / FDA Review
contentSlide(pres, "Step 6: NDA/BLA Submission & FDA Review", [
  { type: "heading", text: "New Drug Application (NDA)" },
  { text: "Submitted to FDA after successful Phase III; ~100,000+ pages of data" },
  { text: "Includes all clinical, preclinical, manufacturing & labelling data" },
  { text: "Standard review: 10 months | Priority review: 6 months" },
  { type: "heading", text: "FDA Review Pathways" },
  { text: "Standard Review: 10-month target action date" },
  { text: "Priority Review: 6-month; for serious conditions with significant improvement" },
  { text: "Breakthrough Therapy Designation: intensive FDA guidance, rolling review" },
  { text: "Accelerated Approval: based on surrogate endpoints; confirmatory trial required" },
  { text: "Fast Track Designation: more frequent FDA meetings; rolling review" },
  { type: "heading", text: "Biologics License Application (BLA)" },
  { text: "Used for biologic drugs (monoclonal antibodies, vaccines, blood products)" },
], { page: 12 });

// 13. Phase IV
phaseSlide(pres, "IV", "Phase IV — Post-Marketing Surveillance",
  C.phase4,
  [
    { type: "heading", text: "Objectives" },
    { text: "Monitor long-term safety in real-world, large, diverse populations" },
    { text: "Detect rare adverse effects not seen in controlled trials (1:10,000+)" },
    { text: "Evaluate drug interactions, use in special populations (elderly, pediatric, pregnant)" },
    { type: "heading", text: "Tools & Methods" },
    { text: "Spontaneous adverse event reporting (FDA MedWatch, Yellow Card UK)" },
    { text: "Pharmacovigilance: signal detection from large healthcare databases" },
    { text: "REMS (Risk Evaluation and Mitigation Strategies) for high-risk drugs" },
    { text: "Post-marketing commitment studies (PMC/PMR) required by FDA" },
    { type: "heading", text: "Outcomes" },
    { text: "Black box warnings added; restricted indications; drug withdrawal (e.g., rofecoxib/Vioxx)" },
  ],
  "Phase IV is increasingly important — thalidomide tragedy reshaped drug safety monitoring globally"
);

// 14. Regulatory Concepts two-col
contentSlide(pres, "Key Regulatory & Scientific Concepts", [
  { type: "heading", text: "Pharmacokinetics (PK)" },
  { text: "ADME: Absorption, Distribution, Metabolism, Excretion" },
  { text: "Bioavailability, Cmax, Tmax, AUC, half-life (t½)" },
  { text: "Volume of distribution (Vd), clearance (CL)" },
  { type: "heading", text: "Pharmacodynamics (PD)" },
  { text: "Mechanism of action at receptor/enzyme level" },
  { text: "Dose-response curves: EC₅₀, Emax, therapeutic index (TI)" },
  { text: "TI = LD₅₀ / ED₅₀ — narrow TI = high-risk drug" },
], {
  twoCol: [
    [
      { type: "heading", text: "Pharmacokinetics (PK)" },
      { text: "ADME: Absorption, Distribution, Metabolism, Excretion" },
      { text: "Bioavailability, Cmax, Tmax, AUC, half-life (t½)" },
      { text: "Volume of distribution (Vd), clearance (CL)" },
      { type: "heading", text: "Pharmacodynamics (PD)" },
      { text: "Mechanism of action at receptor/enzyme level" },
      { text: "Dose-response curves: EC₅₀, Emax" },
      { text: "Therapeutic Index (TI) = LD₅₀ / ED₅₀" },
    ],
    [
      { type: "heading", text: "Regulatory Terms" },
      { text: "IND — Investigational New Drug" },
      { text: "NDA — New Drug Application" },
      { text: "BLA — Biologics License Application" },
      { text: "IRB — Institutional Review Board" },
      { text: "GCP — Good Clinical Practice" },
      { text: "REMS — Risk Evaluation & Mitigation Strategy" },
      { text: "Orphan Drug — <200,000 US patients/year; tax incentives" },
      { text: "Generic Drug — ANDA; bioequivalence to reference listed drug" },
    ],
  ],
  page: 14,
});

// 15. Challenges & Future
contentSlide(pres, "Challenges & Future of Drug Development", [
  { type: "heading", text: "Current Challenges" },
  { text: "Escalating R&D costs; drug pricing controversies & affordability gaps" },
  { text: "High attrition rates — ~90% of candidates fail" },
  { text: "Poor translatability of animal models to human disease (e.g., Alzheimer's, autism)" },
  { text: "Regulatory complexity & global harmonization (ICH)" },
  { type: "heading", text: "Emerging Innovations" },
  { text: "AI/ML-assisted drug discovery & target identification" },
  { text: "Genomics & pharmacogenomics — personalized medicine" },
  { text: "Drug repurposing: using genomic data to find new indications" },
  { text: "Adaptive trial designs: modify trials based on interim data" },
  { text: "Organ-on-chip & microphysiological systems replacing animal models" },
], { page: 15 });

// 16. Attrition / Success Rate
contentSlide(pres, "Drug Attrition — The Numbers Behind Development", [
  { type: "heading", text: "Key Statistics (Katzung 16e; Harrison 22e)" },
  { text: "~10,000 compounds screened → ~250 enter preclinical studies" },
  { text: "~5 compounds enter clinical trials (1 in 50 from preclinical)" },
  { text: "~1 compound gains FDA approval (1 in 10,000 from initial screening)" },
  { type: "heading", text: "Attrition by Phase" },
  { text: "Preclinical → Phase I: safety failures, poor PK/PD" },
  { text: "Phase I → II: ~37% failure rate; safety & tolerability concerns" },
  { text: "Phase II → III: ~65% failure rate; lack of efficacy (most common)" },
  { text: "Phase III → NDA: ~42% failure; efficacy or safety not confirmed at scale" },
  { type: "heading", text: "Primary Cause of Failure" },
  { text: "Lack of clinical efficacy (~56%) > safety concerns (~28%) > commercial (~16%)" },
], { page: 16 });

// 17. Summary
contentSlide(pres, "Summary — The Drug Development Journey", [
  { type: "heading", text: "Sequential Steps" },
  { text: "1. Target ID & Drug Discovery → 2. Lead Optimization → 3. Preclinical Studies" },
  { text: "4. IND Application → 5. Phase I (safety) → 6. Phase II (efficacy/dose)" },
  { text: "7. Phase III (large-scale RCT) → 8. NDA/BLA → 9. Phase IV (surveillance)" },
  { type: "heading", text: "Core Principles to Remember" },
  { text: "Benefits of therapy must always outweigh risks" },
  { text: "Smallest effective dose; minimize polypharmacy" },
  { text: "Pharmacogenomics increasingly shapes individualized therapy" },
  { text: "EHR & pharmacy systems will provide prescribing decision support" },
  { type: "heading", text: "Sources" },
  { text: "Katzung's Basic & Clinical Pharmacology, 16th Edition (2021)" },
  { text: "Harrison's Principles of Internal Medicine, 22nd Edition (2025)" },
], { page: 17 });

// ─── WRITE FILE ─────────────────────────────────────────────────────────────
pres.writeFile({ fileName: "/home/daytona/workspace/drug-dev-ppt/Drug_Development_Process.pptx" })
  .then(() => console.log("✅ Saved: Drug_Development_Process.pptx"))
  .catch(err => { console.error("❌ Error:", err); process.exit(1); });

Successfully replaced 1 instance(s) of the string in '/home/daytona/workspace/drug-dev-ppt/build.js'