The Biomedical &Life Sciences Collection

Drug Development:
From Molecule to Market
A learning journey on the process ofdeveloping a novel medicine

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, andpharmaceutical marketing. The final section covers novel approaches tomethods used within drug development.
A visual outline of the drug research and development processThis flowchart was adapted from a lecture on ‘Drug discovery: fromdiscovery to manufacture’ by Prof. Michael Kinch.

Research: Identifying the Drug ProductTargetDiscovery

TargetValidation

AssayDevelopment

Screening

LeadOptimization

Development: Obtaining Regulatory Approval

PreclinicalDevelopment

Phase lPhase llPhase lll

Phase lV

Clinical Trial Phases
Phase I: evaluating safety, maximum tolerable dosage, and route ofadministration (usually in a small cohort of healthy volunteers).
Phase II: first evaluation of efficacy and side effects (in small cohortof patients).
Phase III: evaluation of efficacy (vs standard of care), monitor safety
and side effects (in large cohort of patients).
Phase IV: post-approval evaluation of risks, benefits and use in thewider population.

01

An Introduction to Drug Discovery
Extract from:’Where did drugs come from?’
Dr. David Swinney – Institute for Rare andNeglected Diseases Drug Discovery, USA
7 mins (00:30 - 36:32)

02

Main Considerations for Promising Novel Drugs

03

The Sustainability of Drug Development

Extract from:’Drug discovery: from discovery
to manufacture’
Prof. Michael Kinch – Washington University
in St. Louis, USA
9 mins (00:26 - 09:27)

Extract from:’Biomarkers in drug development:
potential use and challenges’
Dr. Abdel-Bassett Halim - Daiichi-Sankyo, Inc.
2 mins (01:18 - 03:36)

04

Identifying a Drug Target through Research

05

A Summary of Hit to Lead in Drug Discovery

Extract from:’Drug discovery: from discovery tomanufacture’
Prof. Michael Kinch – Washington University
in St. Louis, USA
4 mins (11:00 - 17:30)

Extract from:’Hit to lead’
Dr. Michael Rafferty – University of Kansas,
USA
5 mins (01:25 - 07:39)

06

Pharmacophores and Lead Optimisation
Extract from:’Pharmacophore methods in drug discovery’
Dr. John H. Van Drie – Van Drie Research LLC,USA
14 mins (01:14 - 16:07)

07

The Modern Drug Discovery Process and Machine
Extract from:’AI and big data in drug discovery’
Mr. Ed Addison – Cloud Pharmaceuticals,USA
8 mins (01:08 - 09:21)

08

An Introduction to Virtual Screening
Extract from:’Virtual screening’
Dr. John H. Van Drie – Van Drie Research LLC,
USA
16 mins (01:32 - 18:30)

09

Traditional High Throughput Screening
Versus Virtual Screening

10

High Throughput Screening Versus
Fragment-Based Screening

Extract from:’The utility of consensus approaches invirtual drug discovery’
Dr. Douglas Houston – University ofEdinburgh, UK
10 mins (00:40 - 11:30)

Extract from:’Fragment-based lead discovery’
Dr. Daniel A. Erlanson – Carmot Therapeutics,Inc., USA
4 mins (01:25 - 05:30)

11Biologics and Biosimilars
Extract from:’Modern management of rheumatoid
arthritis - with a focus on biologic therapies’
Prof. John Isaacs – Newcastle University, UK
3 mins (28:52 - 34:20)

12

Non-Clinical Safety Assessment and ICH Guidelines
Extract from:’Overview of nonclinical safety assessment’
Dr. Claudette L. Fuller – Merck ResearchLaboratories, USA
5 mins (00:58 - 05:53)

13

Non-Clinical and Toxicology Studies
Extract from:’Overview of nonclinical safety assessment’
Dr. Claudette L. Fuller – Merck ResearchLaboratories, USA
4 mins (05:55 - 10:22)

14

Clinical Trials Overview
Extract from:’Medical communications: principles
and best practice’
Dr. Hannah Polson – Nucleus Global, UK
4 mins (14:22 - 18:50)

15

The Phases of Clinical Trials

16

An Introduction to Clinical Trials and Randomization

17

Adaptive Clinical Trials

18

Pre-Marketing Safety Surveillance

Extract from:’Drug discovery: from discovery
to manufacture’
Prof. Michael Kinch – Washington University
in St. Louis, USA
14 mins (28:46 - 43:41)

Extract from:’An introduction to randomization forclinical trials 1’
Prof. William Rosenberger – George Mason
University, USA
5 mins (00:55 - 06:30)

Extract from:’Adaptive clinical trials: conclusionand future directions’Prof. Yu Shyr – Vanderbilt University
Medical Center, USA
17 mins (02:09 - 19:56)

Extract from:’A structured approach for pharmaceuticalpre-marketing safety surveillance’
Dr. Lothar Tremmel – CSL Behring, USA
4 mins (01:40 - 05:18)

19

Patents in the pharmaceutical industry

20

Modern Medical Communication Channels

Extract from:’Introduction to patents in thepharmaceutical industry’Dr. Jonathan D.M. Atkinson – Atkinson IP
Consulting Limited, UK
8 mins (05:39 - 14:11)

Extract from:’Medical communications: principles
and best practice’
Dr. Hannah Polson – Nucleus Global, UK
13 mins (19:10 - 33:57)

Novel Approaches to Drug Development

21

Humanized Antibodies and Phage Display
Extract from:’Phage display for generating monoclonal
antibodies’
Dr. Andre Frenzel – YUMAB GMBH, Germany
11 mins (02:00 - 13:43)

22

An introduction to Antibody Engineering
Extract from:’Antibody engineering: beginnings tobispecifics and beyond’Dr. Ian Wilkinson – Absolute Antibody, UK
3 mins (06:12 - 10:10)

23

CRISPR-Engineered T Cells and CAR-T Therapy
Extract from:’Latest advances in the development of
CAR & TCR T-cell treatments for solid
tumours’
Dr. Else Marit Inderberg – The Norwegian
Radium Hospital, Norway
Prof. John Isaacs – Newcastle University, UK
4 mins (16:37 - 21:28)

Additional upcoming talks include:
Updates to the pharmaceutical marketing talks
Gene therapy development
EMA-Related regulatory challenges
In-Vivo antibody discovery and hybridoma technology
Therapeutic antibody development