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Module Code - Title:

BY6021 - ADVANCED BIOTHERAPEUTICS

Year Last Offered:

N/A

Hours Per Week:

Lecture

0

Lab

20

Tutorial

0

Other

15

Private

15

Credits

30

Grading Type:

N

Prerequisite Modules:

Rationale and Purpose of the Module:

The module will provide advanced knowledge and understanding across key topics in the field of translational medicine. This will include current advances in new biologics, CRISPR technology, gene therapies, chimeric antigen receptor (CAR)-based therapies and new personalized approaches to treatment regimes including tissue profiling through single cell (scRNA-seq) and spatial multi-omics technologies alongside other modalities of Advanced Therapy Medicinal Products (ATMPs). This will be coupled with a deep understanding of processes used to extract meaningful information from large datasets and processes for validation and tests of new medicaments.

Syllabus:

Tutorials, workshops and self-directed team learning will support development of understanding and knowledge of the following topics: 1. New therapeutic developments 2. Precision Medicine 3. Cell and molecular basis of diseases 4. New biotechnologies related to Biotherapeutics 5. Drug and target selection strategies 6. Drug delivery strategies 7. Single cell sequencing and spatial biology 8. Data Analytics including advanced 'omics data analysis for health outcomes 9. How BioPharma is regulated: Governing bodies (EMA, FDA) and industry guidance (ICH, PDA, USP) relating to BioPharma 10. Critical Quality Attributes testing for protein-based biologics including Mass Determination, Binding capacity, Biological Activity, Purity testing as well as those relating to personalized cell and gene therapies Acquisition and understanding of knowledge will be supported by completion of practical laboratories covering the following topics: 1. Gene editing using CRISPR technologies 2. Protein interaction lead selection studies using Surface Plasmon Resonance 3. Cell response studies using multiplex ELISA 4. Cell response studies using Flow Cytometry 5. Protein identification using top down sequencing Mass Spectrometry 6. Protein stability assays using Differential scanning Fluorimetry 7. Protein drug binding ranking studies using Isothermal Titration Calorimetry 8. Data analytics of biological samples - genomics, transcriptomics, proteomics, metabolmics.

Learning Outcomes:

Cognitive (Knowledge, Understanding, Application, Analysis, Evaluation, Synthesis)

On successful completion of this module, students will be able to: 1. Demonstrate an understanding of the molecular basis of human non-communicable diseases including Cancer, Inflammation, Neurodegenerative diseases, metabolic insufficiency disorders. 2. Demonstrate an understanding of the molecular basis of nucleic acid based therapeutics 3. Demonstrate an understanding of the implementation of cell based therapeutics 4. Demonstrate a comprehensive knowledge of delivery systems and drug formulation 5. Demonstrate an understanding of the advances in the fast developing field of single cell and spatial multi-omics technologies and methods 6. Demonstrate an understanding of the role governing bodies (EMA, FDA) and industry guidance (ICH, PDA, USP) preform within the BioPharma industry 7. Analyze and critically evaluate large 'Omics data sets 8. Design a strategy for the treatment of a new disease

Affective (Attitudes and Values)

On successful completion of this module, students will be able to: 1. Demonstrate an appreciation of the rigors of working in a regulated environment 2. Demonstrate a strong work ethic, professionalism and respect for individuals required to successfully work as a collaborative team 3. Demonstrate an appreciation of the level of detail and intensive attention to detail required to design and execute advanced experimentation 4. Demonstrate an appreciation of the requirement to integrate multiple biological disciplines and technical expertise to answer a biological question 5. Demonstrate an appreciation of the importance of 'omics technologies and large dataset analysis in biomedical research in terms of target identification and drug development

Psychomotor (Physical Skills)

On successful completion of this module, students will be able to: Perform advanced practical/physical techniques in Molecular Biology and Cell Culture.

How the Module will be Taught and what will be the Learning Experiences of the Students:

The module will be taught through a series of workshops, flipped classrooms, demonstrations and lab practice sessions employing techniques in active learning (Bloom's Taxonomy levels). The module will use group learning focused on problem-based learning. The students will work in teams to extract information on syllabus topics, design experimentation, investigate methodologies, critique data and incorporate information into presentations for peer-learning. Workshop-style delivery of new material to the student will be used in conjunction with supervised and non-supervised group work. Use will be made of computer-based learning tools and self-testing. Laboratory practice will focus on mastery of core skills related to development of new therapeutics. Labs will be taught by small group demonstration and practice. Self-directed practical learning will be supported. Learning will involve students integrating aspects of theory, practice, coding, analytics and professional skills generating knowledgeable and responsible graduates. Analysis of real world data and design of experiment challenges will form part of the learning experience generating articulate graduates. As this block will be forward looking new material from the Research Community will be constantly reviewed and integrated into the syllabus. In this way knowledge of the current state of the art will be maintained generating curious and agile graduates. Each year the cohort will write and submit a review for publication on advancements in the field Biotherapies generating articulate and knowledgeable graduates.

Research Findings Incorporated in to the Syllabus (If Relevant):

Prime Texts:

Aranha, H., & Vega-Mercado, H. (2023) Handbook of Cell and Gene Therapy: From Proof-of-Concept through Manufacturing to Commercialization , CRC Press
Yonglun Luo (2019) CRISPR Gene Editing - Methods and Protocols , Humana New York

Other Relevant Texts:

Programme(s) in which this Module is Offered:

Semester(s) Module is Offered:

Autumn

Module Leader:

jason.bennett@ul.ie