PHAR40050 Drug Discovery and Development I

Academic Year 2021/2022

Topics covered:-
- High throughput screening and Hit-to-Lead in Discovery
- Pharmacokinetics in discovery and development: ADME
- Model systems in discovery: animal models and organoids
- Imaging in discovery screening: in vivo, cytometry, fMRI, reference and calibration
- Pro-drugs- Challenges in drug development
- Biomarkers: a diabetes case study
- The rise of biopharmaceuticals
- Delivery of biotech molecules by non-injected routes
- Clinical development from Phase 1-Phase 3 with case studies
- Assessing drug safety using modern toxicology methods
- Investment in biotechnology by venture capital companies
- A case study of an FDA Advisory Committee example from 2019

The module is an introduction to the processes of discovery and development in Pharma and Biotech from a pharmacological perspective. Contributors have background in industry and academia. This is an essential course for those considering a role in the pharmaceutical industry.

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Curricular information is subject to change

Learning Outcomes:

On successful completion of this module students should be able to:
-Describe the development process from discovery of a molecule to administration as a medicine to patients
-Be able to discuss rational drug design and high throughput screening
-What are the safety requirements needed before a drug can be approved?
-Understand the role of post-marketing surveillance
-Cite clinical trial case studies of recent drugs that have been approved for major diseases
-Cite examples of drug delivery technologies for non-injected delivery of biotech molecules
-Know the requirements and outputs examined for clinical trials in Phases 1-4
-Be able to write an essay on attrition causes in clinical development and possible remedies
-Understand what happens at a FDA advisory committee from the case study example presented
- Assess the role of new imaging modalities and alternative animal models in development

Indicative Module Content:

This module covers all the elements that go into a discovery programme for a new chemical entity along with its development in going from a lead to a hit. From preclinical studies in animals and cells covering toxicology and the processes of pharmacokinetics and pharmacodynamics, we then move into the clinical development phases, right through to FDA approval. We see that in 2020 the clinical development process is flexible and can expedited by parallel rather than linear movement between clinical phases where the next stage can start without full reporting of the current phase. This can be accompanied by review at breakneck speed by the Regulators in an emergency pandemic.

Student Effort Hours: 
Student Effort Type Hours
Autonomous Student Learning

90

Lectures

12

Total

102

Approaches to Teaching and Learning:
lectures; Q & A in online live lectures, private reading of an assigned text and up-to-date research article pdfs. 
Requirements, Exclusions and Recommendations
Learning Requirements:

Ideally, students should be familiar with basic pharmacokinetics and pharmacodynamics to get the most from the module. However, we will do some recapping in the event that there are attendees from non-pharmacology backgrounds.

Learning Recommendations:

Biomedical undergraduate modules in pharmacology, biochemistry and physiology taught in science, medicine or veterinary to 3rd year level. Undergraduate chemists with an interest in the drug development process would be welcome. MSc students in Biotechnology are welcome to attend. Undergrad medicinal chemists are especially welcome and usually achieve good outcomes.


Module Requisites and Incompatibles
Incompatibles:
PHAR40150 - Drug Delivery & Clinical Trial


 
Assessment Strategy  
Description Timing Open Book Exam Component Scale Must Pass Component % of Final Grade
Examination: End of Semester Written Examination 2 hour End of Trimester Exam Yes Standard conversion grade scale 40% No

100


Carry forward of passed components
No
 
Resit In Terminal Exam
Autumn Yes - 2 Hour
Please see Student Jargon Buster for more information about remediation types and timing. 
Feedback Strategy/Strategies

• Feedback individually to students, post-assessment

How will my Feedback be Delivered?

Exam writing guide to be presented to students ahead of exam. Going over scripts post-exam with individual students. Availability to meet students ahead of exam.

Rang, HR. Drug Discovery and Development, 2nd Ed. Elsevier.
Name Role
Professor Orina Belton Lecturer / Co-Lecturer
Dr Ena Prosser Lecturer / Co-Lecturer
Dr Emmanuel Reynaud Lecturer / Co-Lecturer
Timetabling information is displayed only for guidance purposes, relates to the current Academic Year only and is subject to change.
 
Spring
     
Lecture Offering 1 Week(s) - 19, 20, 21, 22 Thurs 09:00 - 09:50
Lecture Offering 1 Week(s) - 19 Tues 09:00 - 09:50
Lecture Offering 1 Week(s) - 20, 21, 22 Tues 09:00 - 09:50
Lecture Offering 1 Week(s) - 19, 20, 21, 22 Wed 14:00 - 14:50
Spring