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Drug Development: From Molecule to Market

This learning journey is designed to provide a general introduction to the drug development process. It covers several key stages within the classical process, including drug discovery, non-clinical studies, clinical trials, regulatory frameworks, safety assessments, patents, and pharmaceutical marketing. The final section covers novel approaches to methods used within drug development.

Research: Identifying the Drug Product:
Target Discovery >> Target Validation >> Assay Development >> Screening >> Lead Optimization

Development: Obtaining Regulatory Approval:
Preclinical Development >> Phase I >> Phase II >> Phase III >> Phase IV

Drug Development: From Molecule to Market

Table of Contents

  1. An Introduction to Drug Discovery
  2. The Sustainability of Drug Development
  3. A Summary of Hit to Lead in Drug Discovery
  4. Antibiotic Drug Discovery and Validation
  5. Pharmacophores and Lead Optimization
  6. The Modern Drug Discovery Process and Machine Learning
  7. An Introduction to Virtual Screening
  8. Lead Identification and Virtual Screening
  9. Traditional High Throughput Screening Versus Virtual Screening
  10. High Throughput Screening Versus Fragment-Based Screening
  11. Biologics and Biosimilars
  12. Non-Clinical Safety Assessment and ICH Guidelines
  13. Non-Clinical and Toxicology Studies
  14. The Phases of Clinical Trials
  15. Phase I Clinical Trials
  16. Elements of Consent
  17. An Introduction to Clinical Trials and Randomization
  18. Phase II Clinical Trials
  19. Adaptive Clinical Trials
  20. Pre-Marketing Safety Surveillance
  21. Legal Evolution of Drug Approval and Definition of Terms
  22. Drug Approval Tracks and New Drug Application
  23. New Drug Approval Package and Activities after Submission
  24. Patents in the Pharmaceutical Industry
  25. Decentralised Clinical Trials
  26. Phases III and IV Clinical Trials
  27. An Introduction to Pharmaceutical Branding and Marketing
  28. Modern Medical Communication Channels
  29. Humanized Antibodies and Phage Display
  30. An Introduction to Antibody Engineering
  31. CRISPR-Engineered T Cells and CAR-T Therapy
  32. Novel Cancer Therapeutic Modalities

1. An Introduction to Drug Discovery

By Dr. David Swinney – Institute for Rare and Neglected Diseases Drug Discovery, USA

An excerpt from Where did drugs come from?

R&D Stages: Research (mainly Target Discovery).
Topics Covered: Challenges, approaches, and types of drug discovery.

  • Play An Introduction to Drug Discovery

2. The Sustainability of Drug Development

By Dr. Abdel-Bassett Halim – Daiichi-Sankyo, Inc.

An excerpt from Biomarkers in drug development: potential use and challenges

R&D Stages: Development (all stages).
Topics covered: Stages and attrition in drug development, and Eroom’s law.

  • Play The Sustainability of Drug Development

3. A Summary of Hit to Lead in Drug Discovery

By Dr. Michael Rafferty – University of Kansas, USA

An excerpt from Hit to lead

R&D Stages: Research (mainly Target Validation).
Topics covered: Hit to lead, hit validation, sources and selection.

  • Play A Summary of Hit to Lead in Drug Discovery

4. Antibiotic Drug Discovery and Validation

By Dr. Jonathan Cox – Aston University, UK

An excerpt from Strengths and limitations of phenotypic drug discovery

R&D Stages: Target Discovery and Target Validation.
Topics covered: Antibiotic discovery and target validation.

  • Play Antibiotic Drug Discovery and Validation

5. Pharmacophores and Lead Optimization

By Dr. John H. Van Drie – Van Drie Research LLC, USA

An excerpt from Pharmacophore methods in drug discovery

R&D Stages: Research (mainly Lead Optimization).
Topics covered: Classes of drug targets, pharmacophores, and lead optimization.

  • Play Pharmacophores and Lead Optimization

6. The Modern Drug Discovery Process and Machine Learning

By Mr. Ed Addison – Chairman of Cloud Pharmaceuticals and Adjunct Professor at North Carolina State University, USA

An excerpt from AI and big data in drug discovery

R&D Stages: Research (mainly Target Discovery).
Topics covered: Effective use of AI in drug discovery.

  • Play The Modern Drug Discovery Process and Machine Learning

7. An Introduction to Virtual Screening

By Dr. John H. Van Drie – Van Drie Research LLC, USA

An excerpt from Virtual screening

R&D Stages: Screening.
Topics covered: Virtual screening – overview and methods.

  • Play An Introduction to Virtual Screening

8. Lead Identification and Virtual Screening

By Dr. Olexandr Isayev – Carnegie Mellon University, USA

An excerpt from Accelerating drug discovery with machine learning and AI

R&D Stages: Lead Identification and Screening.
Topics covered: Finding lead and CADD.

  • Play Lead Identification and Virtual Screening

9. Traditional High Throughput Screening Versus Virtual Screening

By Dr. Douglas Houston – University of Edinburgh, UK

An excerpt from The utility of consensus approaches in virtual drug discovery

R&D Stages: Screening.
Topics covered: Approaches to screening for drug discovery.

  • Play Traditional High Throughput Screening Versus Virtual Screening

10. High Throughput Screening Versus Fragment-Based Screening

By Dr. Daniel A. Erlanson – Carmot Therapeutics, Inc., USA

An excerpt from Fragment-based lead discovery

R&D Stages: Screening.
Topics covered: Fragment-based approaches for lead discovery.

  • Play High Throughput Screening Versus Fragment-Based Screening

11. Biologics and Biosimilars

By Prof. John Isaacs – Newcastle University, UK

An excerpt from Modern management of rheumatoid arthritis - with a focus on biologic therapies

R&D Stages: Development (all stages).
Topics covered: Biosimilars – development and regulation.

  • Play Biologics and Biosimilars

12. Non-Clinical Safety Assessment and ICH Guidelines

By Dr. Claudette L. Fuller – Merck Research Laboratories, USA

An excerpt from Overview of nonclinical safety assessment

R&D Stages: Development (all stages).
Topics covered: Guidelines and regulations of ICH, EMA and FDA.

  • Play Non-Clinical Safety Assessment and ICH Guidelines

13. Non-Clinical and Toxicology Studies

By Dr. Claudette L. Fuller – Merck Research Laboratories, USA

An excerpt from Overview of nonclinical safety assessment

R&D Stages: Development (all stages).
Topics covered: Toxicology, safety assessment drug programs.

  • Play Non-Clinical and Toxicology Studies

14. The Phases of Clinical Trials

By Dr. Hannah Polson – Nucleus Global, UK

An excerpt from Medical communications: principles and best practice

R&D Stages: Phase I and Phase II.
Topics covered: Introduction to phases I and II.

  • Play The Phases of Clinical Trials

15. Phase I Clinical Trials

By Prof. Michael Kinch – Washington University in St. Louis, USA

An excerpt from Drug development: from discovery to manufacture

R&D Stages: Phase I.
Topics covered: Overview of phase I clinical trials.

  • Play Phase I Clinical Trials

16. Elements of Consent

By Prof. Dr. Christian Lenk – Ulm University, Germany

An excerpt from The history and foundations of medical research ethics

R&D Stages: Phase I.
Topics covered: Elements of consent.

  • Play Elements of Consent

17. An Introduction to Clinical Trials and Randomization

By Prof. William Rosenberger – George Mason University, USA

An excerpt from An introduction to randomization for clinical trials 1

R&D Stages: Phase II & III.
Topics covered: Introduction to randomization and assignment.

  • Play An Introduction to Clinical Trials and Randomization

18. Phase II Clinical Trials

By Prof. Michael Kinch – Washington University in St. Louis, USA

An excerpt from Drug development: from discovery to manufacture

R&D Stages: Phase II.
Topics covered: Overview of phase II clinical trials.

  • Play Phase II Clinical Trials

19. Adaptive Clinical Trials

By Prof. Yu Shyr – Vanderbilt University Medical Center, USA

An excerpt from Adaptive clinical trials: conclusion and future directions

R&D Stages: Phase II & III.
Topics covered: Adaptive trials – definition and types.

  • Play Adaptive Clinical Trials

20. Pre-Marketing Safety Surveillance

By Dr. Lothar Tremmel – CSL Behring, USA

An excerpt from A structured approach for pharmaceutical pre-marketing safety surveillance

R&D Stages: Phase I, II & III.
Topics covered: Key concepts and definitions in safety surveillance.

  • Play Pre-Marketing Safety Surveillance

21. Legal Evolution of Drug Approval and Definition of Terms

By Prof. Martin Edelman – Fox Chase Cancer Center, USA

An excerpt from Development of a cancer drug

R&D Stages: Phase I, II & III.
Topics covered: Drug laws and terminology.

  • Play Legal Evolution of Drug Approval and Definition of Terms

22. Drug Approval Tracks and New Drug Application

By Prof. Martin Edelman – Fox Chase Cancer Center, USA

An excerpt from Development of a cancer drug

R&D Stages: Phase I, II & III.
Topics covered: Drug approval – tracks and new approval.

  • Play Drug Approval Tracks and New Drug Application

23. New Drug Approval Package and Activities after Submission

By Prof. Michael Kinch – Washington University in St. Louis, USA

An excerpt from Drug development: from discovery to manufacture

R&D Stages: Phase I, II & III.
Topics covered: New drug approval – package and activities.

  • Play New Drug Approval Package and Activities after Submission

24. Patents in the Pharmaceutical Industry

By Dr. Jonathan D.M. Atkinson – Partner HGF Limited and Director, Atkinson IP Consulting Limited, UK

An excerpt from Introduction to patents in the pharmaceutical industry

R&D Stages: Development.
Topics covered: Patents – definition, requirement and filing.

  • Play Patents in the Pharmaceutical Industry

25. Decentralised Clinical Trials

By Ms. Ada Middleton – Parexel International, Canada

An excerpt from Introduction to decentralized clinical trials: benefits, challenges and solutions

R&D Stages: Phase I, II & III.
Topics covered: Definition and importance of DCTs.

  • Play Decentralised Clinical Trials

26. Phases III and IV Clinical Trials

By Prof. Michael Kinch – Washington University in St. Louis, USA

An excerpt from Drug development: from discovery to manufacture

R&D Stages: Phase III & IV.
Topics covered: Phase III and other clinical trials.

  • Play Phases III and IV Clinical Trials

27. An Introduction to Pharmaceutical Branding and Marketing

By Mr. Giles D. Moss – Founder, Pharma Brand Logic, Belgium

An excerpt from The future of branding within the pharmaceutical industry

R&D Stages: Phase IV.
Topics covered: Brand building and theories.

  • Play An Introduction to Pharmaceutical Branding and Marketing

28. Modern Medical Communication Channels

By Dr. Hannah Polson – Nucleus Global, UK

An excerpt from Medical communications: principles and best practice

R&D Stages: Phase IV.
Topics covered: Primary channels and key audiences.

  • Play Modern Medical Communication Channels

29. Humanized Antibodies and Phage Display

By Dr. Andre Frenzel – YUMAB GMBH, Germany

An excerpt from Phage display for generating monoclonal antibodies

R&D Stages: Preclinical Development & Phase IV.
Topics covered: Chimeric and humanized antibodies, and antibody phage display.

  • Play Humanized Antibodies and Phage Display

30. An Introduction to Antibody Engineering

By Dr. Ian Wilkinson – Absolute Antibody, UK

An excerpt from Antibody engineering: beginnings to bispecifics and beyond

R&D Stages: Preclinical Development.
Topics covered: Antibody engineering and humanization.

  • Play An Introduction to Antibody Engineering

31. CRISPR-Engineered T Cells and CAR-T Therapy

By Dr. Else Marit Inderberg – The Norwegian Radium Hospital, Norway

An excerpt from Latest advances in the development of CAR & TCR T-cell treatments for solid tumours

R&D Stages: Preclinical Development.
Topics covered: CRISPR T-cells and their safety.

  • Play CRISPR-Engineered T Cells and CAR-T Therapy

32. Novel Cancer Therapeutic Modalities

By Dr. Krishna Allamneni – Concarlo Therapeutics, USA

An excerpt from Toxicity testing of oncology drugs: unraveling the last 15 years of progress

R&D Stages: Preclinical Development.
Topics covered: Five pillars and novel modalities of cancer therapy.

  • Play Novel Cancer Therapeutic Modalities