MRes Experimental Medicine (Cancer)
Year of entry: 2018
Course unit details:
Assembling a translational medicine strategy for an anti-cancer drug
|Unit level||FHEQ level 7 – master's degree or fourth year of an integrated master's degree|
|Teaching period(s)||Summer semester|
|Offered by||Division of Cancer Sciences|
|Available as a free choice unit?||No|
Assembling a translational medicine strategy for an anti-cancer drug is a 15 credit, interactive blended learning unit which will give you a comprehensive introduction to key information and skills required to develop a translational medicine plan to inform the choice of drug schedule, disease type, mono/combination treatment, predictive and pharmacodynamics markers of activity.
The unit is a blended combination of lectures, workshops and on-line material.
Part A (Assembling a translational medicine strategy for an anticancer drug) is an introduction to the five foundational translational medicine questions
-choice of schedule (posology)
-demonstration of pharmacodynamics activity
-prioritisation of disease/tumour type
-monotherapy or combination
-identifying patients likely to respond
Part B (Pharmaceutical Translational Medicine: Putting it all together) is designed to case simulate three critical translational medicine choices drug sponsors need to address
-Should the drug proceed to human clinical trials
-Which centres should take part in the clinical study
-What comprises the accompanying translational medicine plan
The purpose of Part A is to provide a foundation and appreciation of what has to be considered in planning and designing the translational medicine plan for a new candidate drug. Students will be provided a framework to consider how to optimise the chances of success in the early clinical testing of a novel cancer drug. Despite having a potentially wonderful drug, testing it in the wrong cancer type, or at the wrong schedule or dose; or with the wrong combination of agent- could terminate a otherwise promising drug. Students will gain a foundation for considering what pre-clinical experiments can be done to inform on the optimal options for clinical testing.
The purpose of Part B is to provide real-life scenarios to the practice of translational medicine within the drug development environment. It will draw upon the formal teaching received in units 2 and 3. It will address three common, yet critical scenarios to ensure a successful transition of the drug into early clinical testing
· Should the drug enter clinical testing?
· What pre-clinical data will optimise the success of the early clinical plan?
· Where should I conduct my first in man study?
Each day of the module will be dedicated to addressing each of these scenarios, through three full-day workshops
1. Assembling a translational medicine strategy for an anticancer drug
To understand the five foundational translational medicine questions
To understand how pre-clinical experimentation can inform the preferred clinical trial to maximize success for a new anti-cancer drug
To understand the constraints to application of novel technologies into clinical testing- both from a cost and logistic perspective
To understand the strengths and weaknesses of potential pharmacodynamics biomarkers for the various hallmarks of cancer
To understand the body of evidence needed before a biomarker is “qualified” for use in clinical trials
2. Pharmaceutical Translational Medicine: Putting it all together
Understanding how various aspects of the pre-clinical package are weighted in the decision to take a new drug into human testing
Understanding of how to set a safe starting dose and dose escalation increments, and how to monitor for toxicity signals and set a safe stopping dose
To Understand how a translational medicine plan is constructed, costed and sequenced to inform decision making
To understand criteria used to audit clinical research facilities
Teaching and learning methods
A range of teaching, learning and assessments are utilised in order to assess the students’ knowledge, understanding, and developing intellectual and practical skills. Summative assessments include a variety of reports (e.g., strategies, plans, audits) literature reviews, critical appraisals/reviews of published work/government guidelines and presentation of different types of work.
The programme also places an emphasis on group work as this a vital skill for persons operating in a multi-disciplinary area such as experimental cancer medicine, and this is shown in the teaching methods and assignments. Each experimental cancer medicine specific unit has different emphasis on the group work assessment based on the nature of the material being covered; how they are to apply the knowledge and the work they are to complete.
Written assignments based on problem-solving work assess the students’ ability to gather information from a wide range of sources, evaluate and critically analyse information, make considered judgements about that information and synthesise material into logical and coherent pieces of work. Analytical assignments prepare students on practical skills gained from the course. All assignments also assess the ability of students to develop their knowledge and understanding of underpinning subjects, concepts and theories.
On-going, formative assessment and feedback to students is a key feature of the learning materials for this programme. Students will be required to engage in a wide range of interactive exercises to enhance their learning and test their developing knowledge, understanding and skills via eLearning. In addition, feedback on work is provided in the F2F workshops.
- Analytical skills
- through data intepretation and literature review
- Group/team working
- through delivering research projects to dissertation standards
- through designing a plan for clinical research projects
- taking ownership for defining, delivering, interpreting then communicating research
- Project management
- of two research projects- RP1 and RP2 at 60 credits each
- Oral communication
- by summative course assessments
- Problem solving
- through engagement with patients cancer disease
- the fundamental basis of the year programme
- Written communication
- by summative course assessments
- through awareness and engagement with life skills courses at Manchester library taught in module 2
|Written assignment (inc essay)||83%|
The students will receive feedback on their work through Turnitin.
Student feedback is the central aspect of how the programmes are organised and developed. Feedback mechanisms include the following:
I. Student representation from each year of the programmes on the MRes in Experimental Cancer Medicine Programme Committee
II. Online feedback questionnaire on which students rate the quality of teaching in terms of delivery, handouts, presentation etc.
|Scheduled activity hours|
|Independent study hours|
|Louise Carter||Unit coordinator|