This module begins with an introductory overview of the concepts involved in the traditional drug discovery and development process in the pharmaceutical industry and goes on to discuss why it is under pressure. We then provide selected case study examples of both small molecule and biotech molecule development from discovery to market, which are delivered by appropriate experts from academia and industry. The final part is a review of what these discoveries teach in terms of informing about the process. One of the main points is that such discoveries originate from sometimes the most unusual beginnings and that none of the stories followed the same narrative. A common feature is while luck played a role, observant and prepared scientists were needed to move a project forward. We will also see that large pharma are essential for the major development, clinical trial and regulatory work, involved irrespective of the origin of the molecule.
*Please note that Molecular Medicine Ireland has rebranded as Clinical Research Development Ireland on 02/10/2017. Further information at https://www.crdi.ie/minister-health-launches-clinical-research-development-ireland/
- Session 1: Introduction to drug discovery and development: Concepts and analysis (Prof David Brayden, UCD)
- Session 2: Rational drug discovery: Sir James’s Black’s discovery of propranolol and cimetidine (Prof. Alan Baird, UCD)
- Session 3: Aspirin: pharmacology, development and new indications (Dr.Orina Belton, UCD)
- Session 4: Denosumab®, a new biologic for treatment of osteoporosis (Dr. Will Dere, Amgen USA)
- Session 5: Kalydeco ®: An orphan drug designed for a percentage of cystic fibrosis patients (Prof. David Brayden, UCD).
- Session 6: Tyslabri (Natalizumab): Origins of a Blockbuster (Dr. Dermot Cox, RCSI)
- Session 7: Bottlenecks in the development of drugs for neurodegeneration (Julie Kelly, TCD)
- Session 8: Insulin: discovery, delivery, and devices (Prof. Sally-Ann Cryan, RCSI, Ronan McLoughlin, Aerogen)
- Session 9: Gene therapies: from failure to success (Prof Caitriona O’Driscoll, UCC)
- Section 10: Targeting the innate immune system: an academic spin-out company in a new frontier (Martin Weilshcof, Opsona; Luke O’Neill, TCD & Opsona)
- Section 11: Venture capital’s role in drug discovery: an Irish case study of a small molecule for colitis (Profs. Neil Frankish, TCD; and Dr Helen Sheridan, TCD; Dr Ena Posser, Fountain Healthcare)
Indicative Learning Outcomes
On successful completion of this module students should be able to:
- Understand the drug development process following initial molecule discovery
- Be able to describe the different manufacturing issues for small molecules and biologics
- Argue as to why the days of blockbusters are over and that drugs for cohorts of patients is the future
- Understand each phase of clinical development and causes of attrition
- Be able to discuss how academia is contributing to major drug discoveries
Date: March 2019 (tbc)
Format: two-hour duration
Coordinator: Professor David Brayden is Full Professor of Advanced Drug Delivery at UCD. He coordinates science and veterinary pharmacology-based undergraduate modules in UCD and is also a Conway Institute Fellow at UCD. His qualifications are B. Sc. Hons. In Pharmacology (1984), M.Sc. (1985) in Pharmacology at UCD; Ph.D. (1989) in Pharmacology at the University of Cambridge, UK. From 1991-2001, he was a senior scientist in Elan Biotechnology Research. Prof. Brayden is currently a co-lead PI of the SFI Centre for Medical Devices (CURAM). Other research funding is from the IRC, the Department of Agriculture and Food, and from the pharmaceutical and food industry. He is the author or co-author of over 200 research publications. He was elected as a Fellow of the Controlled Release Society (2012) an the American Association of Pharmaceutical Scientists (2017). Prof. Brayden serves on the Editorial Advisory Boards of Drug Discovery Today and Advanced Drug Delivery Reviews and is an Associate Senior Editor of “Therapeutic Delivery''.
Course Accreditation & CRDI Open Badge
The course content will be examined thereafter by online MCQ. Taking the course online examination is not mandatory and only optional.
- Please note this course bears 2.5 ECTS for eligible TCD & UCD registered students i.e. those who will be registered in TCD or UCD academic year 2018/2019.
- Students not registered with TCD or UCD should check with their own college graduate office regarding their eligibility for ECTS.
- CRDI certificates of completion and CRDI Open Badges (see below) will be awarded to all successful course participants including those eligible for ECTS.
CRDI Open Badge
- A CRDI Open Badge will be awarded to those who successfully complete the online MCQ (Date tbc). This Open Badge is provided as a measure of CPD attainment.
What is an Open Badge?
Open Badges are verifiable, portable digital badges with embedded metadata about skills and achievements. They comply with the Open Badges Specification and are shareable across the web (Social Media, e-Portfolio, Blogs or Online CVs).
Further details on CRDI Open Badges here
- CRDI Partner Institutions:
Postgraduate student, postdoctoral researcher, or member of staff in NUI Galway, RCSI, TCD, UCC, UCD, UL and affiliated hospitals: Free of charge
- Other Institutions:
Academic Rate: 200 Euros
Non-academic rate: 600 Euros
The registration charges do not include accommodation or travel. Please contact firstname.lastname@example.org for further information
Course fully subscribed