Biopharmaceutical Development Pathway
Setting the scene for the full course, this module provides an overview of the drug development pathway, from research and development to marketed product, focusing on biologics (antibodies, vaccines, gene therapy, ADCs).
You will be introduced to the medical, scientific and economic drivers – costs, number of leads, attrition rate – associated with drug development.
The module outlines the regulatory framework for biologic drug development, including GLP, GCP and GMP, and provides a context for these through reference to landmark cases.
Biopharmaceutical Drug Discovery
This module provides an outline of the principles of drug discovery of biological molecules (as distinct from small chemical molecules) with teaching and advice from scientists working in the biopharmaceutical industry.
It considers the drug development pipeline at the preclinical stage:
- druggable target identification
- target validation
- biologic drug formats
- biological libraries and screening for target hits
- assay development
- lead identification
- hit-to-lead optimisation
- preclinical disease modelling
The module will introduce you to the team-based analytical process used by industry before commencing a drug development project.
This includes target identification and justification, a basic understanding of the path forward and the best mode of action (eg format of the biologic, naked antibody, immunoconjugate, peptide, ADC, etc.).
This module provides an in-depth introduction to biologics manufacturing.
It addresses issues related to upstream processing (cell lines and culture systems), downstream processes (product purification), analytics (chemical analysis of products), formulation, quality assurance and safety compliance.
Biopharmaceutical Development: Preclinical
This module provides an introduction to the preclinical testing requirements for biologics and how this enables clinical development and ultimately marketing application.
The different testing requirements for different biological products (eg monoclonal antibodies, recombinant proteins, gene therapy products and vaccines) are discussed and you will gain an understanding of the analytical techniques used to examine pharmacokinetics, toxicokinetics and anti-product antibodies.
You will have the opportunity to critically appraise the preclinical development strategies for a range of candidate molecules and identify go/no-go points to develop an understanding of the decision-making process on whether to continue or stop a project.
Integrated Drug Development Plan
An integrated drug development plan is submitted to the regulator (eg FDA) to gain permission to progress a drug to human clinical trial.
This module is project based, with students working in teams to produce a drug development plan. This plan integrates all the preclinical aspects of a particular biopharmaceutical product, establishing the evidence base supporting its safety and efficacy and the appropriateness of planned clinical trials.
Teams will develop a target product profile for a drug, construct an integrated development plan (manufacturing, non-clinical and clinical), take feedback from a regulatory authority and submit an investigational new drug (IND) proposal to the regulator.
Biopharmaceutical Development: Clinical
This module provides an outline to the principles of clinical trial design and conduct in the biologics development setting.
The emphasis is on understanding the practical issues that arise through real-life examples, backed up with the relevant theory.
It expands on the introduction provided in the Biopharmaceutical Development Pathway module, and link the Preclinical Biopharmaceutical Development and Commercialisation of Biopharmaceuticals modules, providing grounding in the basic specialist knowledge and skills required by the biopharmaceutical industry.
Commercialising Biopharmaceutical Products
This module explores how economic value is captured in the biopharmaceutical industry.
It focuses on salient intellectual property rights (IPR) and the external drivers that influence business decisions (economic, societal, technological and legal). Working in teams, students will take part in projects that evaluate an opportunity from the IPR perspective (freedom to operate, creative solutions), and create an opportunity business model (OBM) to exploit a particular biotechnological breakthrough.
In addition, students will formally evaluate the teamwork and leadership performance of themselves and their team whilst delivering these projects.
Practical Skills for a Regulatory Environment
Students follow a programme of experiments and analyses applying techniques used to characterise biopharmaceuticals modelled on quality guidelines such as ICH Q6B.
The module covers chromatography for protein purification, analyses of aggregation and protein stability to in vitro interaction analysis and cell-based activity assays.
You will learn about the importance of working to instruction and record-keeping for a regulatory environment.
Research Project/Placement in Industry
The course offers you the opportunity to undertake paid work and research experience in industry for 12 months or a placement based in the University research laboratories involving a collaborative project developed and co-supervised by an industry partner.
Placement opportunities will range across a variety of departments/functions (discovery, manufacturing, preclinical testing, clinical safety and efficacy).
All placements will include an original research project, which constitutes a substantial portion of the credits leading to your higher degree.
It will also give you the opportunity to experience work within the industry and identify roles that suit you best.
You will commence your project in May, seven months after the start of the course and complete it by the following April/May. Graduation is scheduled immediately thereafter, making you available for employment immediately after your placement.