BSc Pharmacology with Industrial/Professional Experience / Course details

This new lecture unit will be delivered entirely by senior scientists from QIAGEN from their Global Development and Molecular Diagnostics division. Students will learn about current diagnostic concepts as well as how to translate advanced molecular technologies into future diagnostic techniques - as explained by commercial scientists working at the cutting edge of this process. The unit will cover both the science and the regulatory requirements necessary for such developments. Though running conventionally (i.e. in Stopford, with Podcasts, Blackboard and an internal Unit Coordinator) the unit is otherwise a unique and extremely exciting opportunity to hear directly from very senior scientists working at a major international Life Sciences company. This unit should be of special interest to the Biomedical Sciences (and related) and Biotechnology (and related) programmes as well as to those students doing an Enterprise project.

None. Helpful units include:

• BIOL21351: Molecules & Cells in Human Disease
• BIOL20902: Clinical Sciences RSM

To explore current approaches in medical diagnostics, as well as how to develop and obtain approval for future diagnostic techniques. To consider Translational Medicine and its possible impact on human healthcare.

•       Introduction to Medical Diagnostics

Why is it needed? Overview of existing diagnostics:

Patient interview (symptoms);

In vivo imaging e.g. X-ray, PET, MRI; In vitro sampling (Blood, biopsy etc)

Diagnostics performance - Sensitivity, Specificity, Precision.

Positive & negative predictive values (PPV, NPV)

•       Molecular Diagnostic (MDx) Technologies

DNA-based e.g. (q)PCR, Sequencing (Sanger, Pyro, Next Gen/NGS)

Syndromic testing

Protein-based e.g. ELISA, Immunohistochemistry

Metabolite-based e.g. Chromatography (LC-MS)

Diagnostic devices and formats; Companion diagnostics

•       Medical Diagnostics - Regulatory Environments and Requirements

Why regulation is necessary. Regulatory agencies in EU/US/CN/JP/AUS

Approval process and requirements.

Overview of US regulations - ASR, CLIA, 510k, PMA.

Example of regulatory approval process for device and assay (FDA/CE documents)

Typical development process and documentation requirements

Post-launch surveillance

Impact of regulatory processes - positive and negative on healthcare

•       Translational Medicine Overview

Rationale: translate new discoveries into clinical practice - improve human health. Definition (three pillars: benchside, bedside and community).

Combine disciplines, resources, expertise, and techniques within these pillars to promote enhancements in prevention, diagnosis, and therapies.

Future of Diagnostic Medicine

Mechanisms supporting this: Government, Commercial, Programs and organizations supporting translational science

800 word essay – 10%

Poster Presentation – 20%

2-hour written examination (70%), comprising 2 essays from a choice of 5.

• Blackboard Discussion Board - checked regularly by Unit Coordinator.

There are no specific textbooks for this unit.