Drug Hunting: The Science Of Making New Medicines

Master the Drug Discovery Pipeline: From Target ID and Medicinal Chemistry to Clinical Trials & FDA/EMA Strategy

What you'll learn

Evaluate strategies for drug target identification, validation, and hit-finding to initiate a successful discovery program.

Describe the principles of medicinal chemistry and multi-parameter optimization (MPO) required to create a preclinical drug candidate.

Analyze the role of preclinical pharmacology and toxicology studies in building the safety and efficacy case for an IND application.

Differentiate the objectives, design, and endpoints of Phase I, II, and III clinical trials, and the ethical principles of GCP that govern them.

Compare the regulatory submission and review processes for new medicines at the FDA (NDA) and EMA (MAA).

Assess the impact of patents, pricing, and payer reimbursement strategies on the commercial viability of a new drug.

Explain the importance of pharmacovigilance and Phase IV studies in monitoring a drug's lifelong benefit-risk profile after approval.

Evaluate the impact of new technologies like AI, gene therapy, and cell therapy on the future of drug discovery.

Requirements

No prior prerequisites

Description

Are you ready to unlock the complete blueprint for creating new medicines?For too long, the complex, decade-long journey of drug development has been fragmented, with scientists and professionals siloed in their specific domains. This course shatters those silos. "Drug Hunting: The Science of Making New Medicines" is a comprehensive, narrative-driven masterclass designed specifically for industry professionals, PhDs, and ambitious students who want to understand the entire pharmaceutical R&D pipeline—from the first spark of an idea to a life-saving medicine in the hands of a patient.This is not a high-level overview. This is a deep dive into the science, the strategy, and the high-stakes decisions that define modern drug discovery. We will guide you step-by-step through the entire process:Early Discovery: We begin at the source, exploring the strategies for Target Identification and Validation and the art of Hit-Finding, where we search for the initial chemical key to fit our biological lock.Medicinal Chemistry & Preclinical Development: We then enter the domain of the molecular architect. You will master the principles of Lead Optimization, Multi-Parameter Optimization, and the critical science of ADMET (Absorption, Distribution, Metabolism, Excretion, and Toxicity) that transforms a simple compound into a viable drug candidate.The Gauntlet of Clinical Trials: Journey with us through the high-stakes world of human testing. We will dissect the strategy behind Phase I, II, and III clinical trials, and explore the ironclad ethical and quality standards of Good Clinical Practice (GCP) that govern all human research.Regulatory Approval & Beyond: Finally, we tackle the ultimate hurdles. You will learn how to assemble the NDA/MAA dossier, navigate the complex review processes of the FDA and EMA, and understand the critical commercial considerations of patents, pricing, and payers. We'll conclude by looking to the future, exploring the frontiers of AI-driven discovery, gene therapy, and cell therapy.Taught in an engaging, narrative style and enriched with real-world case studies of both landmark successes and instructive failures, this course provides the strategic context that is often missing from traditional academic or specialized training. You won’t just learn what happens at each stage; you will understand the critical why behind every decision.Enroll now to transform your understanding of the pharmaceutical industry and become a complete, strategic drug hunter.

Overview

Section 1: Introduction to Drug Hunting: The Journey of a Medicine

Lecture 1 From Serendipity to Strategy: The Evolution of Drug Discovery

Lecture 2 The Drug Development Pipeline: A 10-Year, $2 Billion Gamble

Lecture 3 The Players in the Ecosystem: Pharma, Biotech, Academia, and Regulators

Lecture 4 Case Study: The Story of Penicillin - The Dawn of the Antibiotic Age

Lecture 5 Learning Toolkit: Slides and Video Scripts

Section 2: Early Discovery: Finding the Starting Point

Lecture 6 Identifying the Target: Finding the Biological "Why"

Lecture 7 Finding a Hit: High-Throughput Screening, AI, and Natural Products

Lecture 8 From Hit to Lead: The Art of Chemical "Speed Dating"

Lecture 9 Assay Development: Creating the Tools to Measure Success

Lecture 10 Learning Toolkit: Slides and Video Scripts

Section 3: Lead Optimization: Crafting a Potential Drug

Lecture 11 Medicinal Chemistry: Designing the Perfect Molecular Key

Lecture 12 ADMET 101: What the Body Does to the Drug (and Vice Versa)

Lecture 13 Introduction to PK/PD: Getting the Dose Right

Lecture 14 The "Go/No-Go" Decision: Selecting a Drug Candidate

Lecture 15 Learning Toolkit: Slides and Video Scripts

Section 4: Preclinical Development: Before the First Human Dose

Lecture 16 Proving the Concept: Testing in Lab and Animal Models

Lecture 17 Toxicology: The Science of Safety

Lecture 18 Formulation & Delivery: It's Not Just What You Make, It's How You Give It

Lecture 19 The IND Application: Getting the Green Light for Human Trials

Lecture 20 Learning Toolkit: Slides and Video Scripts

Section 5: Clinical Trials: Testing in Humans

Lecture 21 The Three Phases of Clinical Trials: Safety, Efficacy, and Confirmation

Lecture 22 Ethics and GCP: Protecting Patients and Ensuring Data Integrity

Lecture 23 Trial by Numbers: Endpoints and Statistical Analysis

Lecture 24 Case Study: Analyzing High-Profile Clinical Trial Failures

Lecture 25 Learning Toolkit: Slides and Video Scripts

Section 6: Regulatory Approval & Market Launch

Lecture 26 The NDA/MAA: Assembling the Ultimate Scientific Dossier

Lecture 27 Navigating the FDA & EMA: A Global Perspective

Lecture 28 Patents, Pricing, and Payers: The Business of Medicine

Lecture 29 The Final Mile: Manufacturing, Quality Control, and Launch Strategy

Lecture 30 Learning Toolkit: Slides and Video Scripts

Section 7: Post-Market: A Medicine in the Real World

Lecture 31 Phase IV & Pharmacovigilance: The Watchful Eye After Approval

Lecture 32 Health Economics (HEOR): Proving a Drug's Value

Lecture 33 Drug Repurposing & Generics: The Second Life of a Molecule

Lecture 34 Case Study: Landmark Drug Recalls (e.g., Vioxx, Zantac)

Lecture 35 Learning Toolkit: Slides and Video Scripts

Section 8: The Future of Drug Hunting

Lecture 36 Personalized Medicine & Pharmacogenomics

Lecture 37 AI and Machine Learning: Revolutionizing Drug Discovery

Lecture 38 The New Frontier: Gene Therapies, Cell Therapies, and RNA Drugs

Lecture 39 Tackling Global Challenges: Antimicrobial Resistance and Pandemic Preparedness

Lecture 40 Learning Toolkit: Slides and Video Scripts

Pharmaceutical & Biotech Industry Professionals: Scientists (chemists, biologists), project managers, and team members in R&D, Clinical Operations, Regulatory Affairs, or Medical Affairs who want to break out of their functional silos and understand the complete drug development pipeline to enhance their strategic contribution and career growth.,PhDs, Postdocs, & Graduate Students: Aspiring scientists in pharmacology, biology, chemistry, or related life sciences who want to bridge the gap between academic research and industrial drug development, giving them a significant competitive advantage for a career in the pharmaceutical industry.,Clinicians & Healthcare Professionals: Physicians, pharmacists, and clinical research coordinators who are involved in clinical trials or wish to understand the deep scientific and regulatory journey a medicine takes before it ever reaches their clinic or pharmacy.,Business & Commercial Professionals: Individuals in pharmaceutical marketing, business development, venture capital, or life science consulting who need a robust understanding of the scientific engine behind the assets they manage, evaluate, and commercialize.,Anyone Curious About the Science of Medicine: If you have ever wondered how a new medicine is actually made—from the first moment of discovery to the final pill in a bottle—this course provides the definitive, accessible, and comprehensive answer.