Module: Biotherapeutic Pipeline

Module Specifications..

Current Academic Year 2023 - 2024

Please note that this information is subject to change.

Module Title	Biotherapeutic Pipeline
Module Code	BE561
School	School of Biotechnology
Module Co-ordinator	Semester 1: Paula Meleady Semester 2: Paula Meleady Autumn: Paula Meleady
Module Teachers	Paul Cahill Paula Meleady Denise Harold Janosch Heller
NFQ level	9	Credit Rating	5
Pre-requisite	None
Co-requisite	None
Compatibles	None
Incompatibles	None

Repeat examination

Description

The aim of the module is to provide students with a comprehensive understanding of the biotherapeutic pipeline, from initial discovery of a lead candidate, to the design and characterisation of the biotherapeutic drug, and finally to the development of production processes. Biopharmaceuticals are having a huge global impact on the treatment of challenging and previously untreatable chronic diseases. Biotherapeutic modalities such as monoclonal antibodies, fusion proteins, and new generation formats such as bispecific antibodies and antibody drug conjugates are a significant proportion of recently approved and pipeline biopharmaceuticals, providing critical new therapies for many diseases, with both life changing and life saving properties. The module will be assessed through a combination of online tests, a group assignment and an oral exam. The online tests will include multiple choice and short answer questions. The group assignment will involve development of a plan for generation of a new biotherapeutic drug, given a particular target and disease setting.. The oral exam will be an interactive oral exam assessing course content in an engaging and focused way.

Learning Outcomes

1. To identify and critically evaluate the technologies that are used to identify new biotherapeutic drug targets and lead candidates for treatment of disease indications (including the use of artificial intelligence).
2. To identify the various strategies and key considerations that are used to make, design and characterise a new biotherapeutic drug, including the use of AI and bioinformatics tools.
3. To critically evaluate the technical challenges for expression of a lead candidate in a host cell line for biotherapeutic production.
4. To critically evaluate the challenges associated with the production of next generation biotherapeutics such as difficult-to-express monoclonal antibodies, fusion proteins, antibody drug conjugates, bispecific antibodies, etc.
5. To critically review pipeline biotherapeutics from initial discovery to the clinic, and how these molecules can fail or succeed in the drug development process (e.g. at pre-clinical or clinical evaluation).

*Type*	*Hours*	*Description*
Workload	Full-time hours per semester
Lecture	12	In person lecture
Tutorial	12	In person Tutorial
Independent Study	60	No Description
Assignment Completion	40	No Description
Assessment Feedback	1	No Description
Lecture	12	No Description
Tutorial	12	No Description
Independent Study	60	No Description
Assignment Completion	40	No Description
Assessment Feedback	1	No Description
Total Workload: 250

All module information is indicative and subject to change. For further information,students are advised to refer to the University's Marks and Standards and Programme Specific Regulations at: http://www.dcu.ie/registry/examinations/index.shtml

Indicative Content and Learning Activities

Biotherapeutic Pipeline
Provide students with a comprehensive understanding of the biotherapeutic pipeline, from initial discovery of a lead candidate, to the design and characterisation of the biotherapeutic drug, and finally to the development of production processes.

Assessment Breakdown
Continuous Assessment	100%	Examination Weight	0%

Type	Description	% of total	Assessment Date
Course Work Breakdown
In Class Test	This assessment will consist of a closed book exam featuring problem- or challenge-based multiple choice and short answer questions to address the students' critical understanding of the curriculum by assessing the students' knowledge of one specific area and application in another area.	20%	Week 20
Group assignment	The group assignment will involve development of a plan for generation of a new biotherapeutic drug, given a particular target and disease setting. Students will have to present the rationale that led to the particular development and apply critical thinking in order to assess the strengths and shortcomings of their plan and ultimately propose better alternatives. Each student will be given a role (e.g. pre-clinical researcher, patient advocate, clinician, biopharmaceutical scientist, etc.) and the student's individual contributions will also be assessed.	30%	Week 28
Oral Examination	Individual oral exams (5-10 minutes) will be used to assess the deep knowledge and understanding of students covering the module content by using challenge or problem-based questions.	50%	Sem 2 End

Reassessment Requirement Type
Resit arrangements are explained by the following categories; 1 = A resit is available for all components of the module 2 = No resit is available for 100% continuous assessment module 3 = No resit is available for the continuous assessment component
This module is category 1

Indicative Reading List

Other Resources

None

Programme or List of Programmes

GCBPT	Graduate Certificate in Biotherapeutics
GDBPT	Graduate Diploma in Biotherapeutics
MBPT	MSc in Biotherapeutics

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