BIOC40260 Biomedical Diagnostics

Academic Year 2023/2024

During the course, the students will learn how biomedical diagnostics (in vitro diagnostics, IVDs) provides information to aid the screening, detection, diagnosis and monitoring of disease.

There will be a focus on how advances, particularly in ‘omics’ approaches (especially genomics, transcriptomics, proteomics, and metabolomics), are increasing the application and range of biomedical diagnosis modalities.

Beyond the science & technology, the students will develop an understanding of how technological advances, increased expectations for medicine, longer life expectancy and legal, ethical and economic factors are all playing a role in this burgeoning billion-euro industry.

However, a crucial bottleneck has emerged in respect to translating the discovery of novel biomarkers into commercially relevant assays and devices. This is combined with the shift towards multiplex biomarkers assays and 'point-of-care' tests that are rapid, robust and cost-effective.

Therefore, this module will also outline the challenges and issues around the development of biomedical diagnostics, including challenges from research, clinical and industrial perspectives.

Some lecture topics will be complemented by workshops on areas such as IVD business start-ups and the overall regulatory domain.

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Curricular information is subject to change

Learning Outcomes:

The learning objectives of the Biomedical Diagnostics module should enable you to:
1. Develop an appreciation of how omics technologies are identifying new diagnostic biomarkers for health assessment and disease status in humans and animals.
2. Understand the role that biomedical diagnostics approaches play in drug development and translational medicine, such as in the use of companion biomarkers for optimal drug selection.
3. Describe the development process from clinical observation/scientific research and clinical trials through to the application of the biomedical diagnostic assays in patients.
4. Gain a comprehensive insight into the general technological framework underlying the biomedical diagnostics industry, with emphasis on more recent developments.
5. Analyze the role and potential of companion biomarkers in the biomedical diagnostics sphere.
6. Describe the core issues, challenges and contributors associated with the development, use, and commercialization of biomedical diagnostic assays.
7. To undertake a presentation on developments in new biomedical diagnostics (continuous assessment via the individual project presentation).

Indicative Module Content:

The following topics are covered within this module:
- The role of biomarkers in disease detection and management
- The principles of medical diagnosis, screening and monitoring
- Omics approaches used in biomarker discovery
- The application of biomedical diagnostics in translational medicine
- Principles of design and production in the diagnostics Industry
- Economics, ethics, IP, and legislation affecting biomedical diagnostics (and associated devices)
- Several case studies of biomedical diagnostics encompassing oncology, toxicology, and digital pathology
-Case studies of companion biomarkers in oncology
- Case studies of non-invasive biomarkers and their associated biomedical devices in health monitoring and disease treatment and management
- Some lecture topics will be complemented by workshops on areas such as evolution of clinical trials and the overall regulatory domain
-There will also be Industry presentations on their biomedical diagnostics and devices (e.g., Oncoassure, Biosensia)

Student Effort Hours: 
Student Effort Type Hours
Lectures

12

Small Group

6

Tutorial

5

Specified Learning Activities

30

Autonomous Student Learning

55

Total

108

Approaches to Teaching and Learning:
The primary mode of delivery of content within this module will be through lectures including instructors from scientific, business, and regulatory domains.

Case-based study exemplars from existing biomedical diagnostic (IVD) companies are included during the module to help consolidate the learning outcomes of the course.

Project work in the form of a group project and presentation on hot-topics in the subject area is also used to help promote learning and communication skills. Grades will be assigned based on an evaluation of the project presentation.
 
Requirements, Exclusions and Recommendations

Not applicable to this module.


Module Requisites and Incompatibles
Incompatibles:
BIOC40250 - Biomedical Diagnostics&Devices


 
Assessment Strategy  
Description Timing Open Book Exam Component Scale Must Pass Component % of Final Grade
Examination: two hour exam of essay type questions (generally 2 questions to be answered) 2 hour End of Trimester Exam Yes Standard conversion grade scale 40% No

60

Presentation: Group project presentation (from a topic and group assigned to the student) on a biomedical diagnostic. Week 11 n/a Standard conversion grade scale 40% No

40


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

• Feedback individually to students, on an activity or draft prior to summative assessment
• Feedback individually to students, post-assessment
• Group/class feedback, post-assessment
• Self-assessment activities

How will my Feedback be Delivered?

Group formative feedback session prior to the exit exam will provide students with a better understanding of the expectations of the exit exam. Formative Feedback individually to students by email or face-to-face meetings will be provided for queries they submit on the course content or questions over the exit exam. Formative Feedback individually to students and by group by two workshop classes, and by email or face-to-face meetings will be provided for queries they have on preparing the group project (with a tutorial also on tips for preparing the student project). Student formative feedback will be solicited as part of the tutorial on project preparation on their evaluation of previous examples of projects. Group summative feedback will be given based on their project grading and evaluation comments. Feedback to students after the exit exam can be provided upon request.

Name Role
Dr Craig Slattery Tutor
Timetabling information is displayed only for guidance purposes, relates to the current Academic Year only and is subject to change.
 
Autumn
     
Meeting Offering 1 Week(s) - 11 Mon 12:00 - 15:50
Seminar Offering 1 Week(s) - 3, 4, 6 Mon 14:00 - 15:50
Seminar Offering 1 Week(s) - 5, 9 Mon 14:00 - 16:50
Seminar Offering 1 Week(s) - 9 Thurs 14:00 - 16:50
Seminar Offering 1 Week(s) - 6 Tues 10:00 - 11:50
Lecture Offering 1 Week(s) - 11 Tues 16:00 - 16:50
Seminar Offering 1 Week(s) - 4, 5, 6, 7, 8 Wed 09:00 - 10:50
Seminar Offering 1 Week(s) - 6 Wed 15:00 - 15:50
Seminar Offering 1 Week(s) - 9 Wed 15:00 - 16:50
Autumn