PHAR40200 Biotherapeutic Pipeline I

Academic Year 2021/2022

Over the last three decades biotherapeutics have become an integral and valued part of modern medicine. For example, insulin, used by diabetics to regulate blood sugar, was the first modern medicine produced using recombinant DNA technology. It was developed by Genentech and launched in 1982 as the first biosynthetic human insulin. Since then, the vast majority of insulin used worldwide is biosynthetic recombinant insulin or its analogues. Many different biotherapeutic medicines are being developed and marketed to treat serious illnesses including cancer, heart disease, multiple sclerosis and an increasing number have entered the biotherapeutics pipeline annually.

Biotherapeutics have significant advantages over small molecule therapies since they have been shown to be even more effective due to their ability to target specific molecules within the human body. However, unlike most conventional small molecules like aspirin and antibiotics, the development , manufacturing and storage of biotherapeutics is more complex and require sophisticated production and control processes. In contrast with small molecule therapeutics, biotherapeutics depend upon the host cells of living organisms to effectively produce the active pharmaceutical ingredient.

Aims: The main focus of this module is to introduce the student to the biotherapeutic new product development process (NPD), a multistep industrial journey that begins with target identification and characterisation and continues with safety and efficacy testing and the development of appropriate manufacturing processes. Students will be introduced to the initial stages of the pipeline in this module. Students will learn about analytical research and development (R&D) programmes that identify the best target and binder combinations. Factors governing the design of production of biotherapeutic medicines and the route of a biotherapeutic from discovery in screening programmes to development as a lead candidate will be examined in detail.

Recommended Textbooks:
Principles of Biochemistry by Voet, Voet and Pratt
Protein Discovery Technologies by Renata Pasqualini, Wadih Arap

Show/hide contentOpenClose All

Curricular information is subject to change

Learning Outcomes:

Learning Outcomes:
This module is designed to help students to understand and appreciate the challenges and opportunities that the biotherapeutics industry faces in developing powerful medicines for treatment of our most difficult diseases. Students will learn:

• What are biotherapeutic molecules, their many types and applications
• How biotherapeutics are discovered, strategies and technologies
• Technical challenges in identifying a successful lead candidate and how they are overcome
• Through preparation of an in depth study of leading biotherapeutics in the clinic, how companies have succeeded and failed during development
• Focus areas in the biotherapeutics industry where companies are applying new molecular innovation to treat diseases e.g., oncology and immunology
• A detailed understanding of the holistic process of developing a biotherapeutic and the multidisciplinary nature of this activity
• Recognise and utilise the skills involved in managing a drug development team project

Indicative Module Content:

Recombinant protein therapeutics, monoclonal antibodies, antibody drug candidates, bispecifics, immunotherapy

Student Effort Hours: 
Student Effort Type Hours
Lectures

24

Tutorial

6

Seminar (or Webinar)

3

Autonomous Student Learning

83

Total

116

Approaches to Teaching and Learning:
Group poster projects, group based quiz assessment projects, formative self assessment, lecture classes 
Requirements, Exclusions and Recommendations

Not applicable to this module.


Module Requisites and Incompatibles
Not applicable to this module.
 
Assessment Strategy  
Description Timing Open Book Exam Component Scale Must Pass Component % of Final Grade
Class Test: Midterm assessment - short answer question format Throughout the Trimester n/a Graded No

25

Examination: End of semester examination 2 hour End of Trimester Exam No Graded No

60

Class Test: In class assessment based on paper review - Peer to Peer Evaluation Throughout the Trimester n/a Graded No

15


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

• Feedback individually to students, post-assessment
• Group/class feedback, post-assessment

How will my Feedback be Delivered?

Class performance in assessment will be discussed in a general feedback discussion of clear trends and examples without addressing individual performance. Individuals requesting one to one feedback will schedule appointments with the MC or lecturer at mutually agreeable times.

Name Role
Assoc Professor Siobhán McClean Lecturer / Co-Lecturer
Dr Yan Yan Lecturer / Co-Lecturer