MRes Experimental Cancer Medicine / Course details
Year of entry: 2018
Course unit details:
Assembling pre-clinical and early clinical development strategies for a new candidate drug
|Unit level||FHEQ level 7 – master's degree or fourth year of an integrated master's degree|
|Teaching period(s)||Semester 2|
|Offered by||Division of Cancer Sciences|
|Available as a free choice unit?||No|
Assembling pre-clinical and early clinical strategies for a new candidate drug Unit is a 15 credit, interactive blended learning unit which will give you a comprehensive introduction to key information and skills required to support entry of a drug into clinical testing and initial human trials.
The unit is a blended combination of lectures, workshops and on-line material. Part A (Assembling a pre-clinical strategy for a new candidate drug) is designed to cover topics relating to pre-clinical toxicity testing, pre-clinical pharmacokinetic testing, pharmaceutical development and regulatory requirements to support approval to conduct clinical testing. Part B (Assembling an early clinical strategy for a new candidate drug) is designed to cover topics relating to basic designs and endpoints for the early clinical development programme
The purpose of Part A is to provide a foundation and appreciation of what has to be considered in planning and designing the pre-clinical strategy for a new candidate drug. A wide range of issues has to be considered before a drug is dosed in man. Amongst these is whether the pre-clinical toxicity supports entry into man, and if so, whether the frist in man study should be performed in patients or healthy volunteers and what the initial starting dose should be?. A basic understanding of drug handling will also be provided, along with the preclinical pharmacokinetic and pharmaceutical development packages required to support an application to the regulatory authorities to gain approval to dose the drug in man
The purpose of Part B is to provide a foundation and appreciation of what has to be considered in assembling an early clinical strategy for a new candidate drug. A wide range of issues have to be considered ranging from whether the first human studies should be performed in healthy volunteers or patients, what is the safe starting dose, how to set the upper dose limit, and determination of drug pharmacokinetics, tolerability and early markers of efficacy. All of this is required if clear “go/no go” criteria for progression of the drug into further clinical development are to be put in place and adhered to.
1. Assembling a pre-clinical strategy for a new candidate drug
To understand the pre-clinical toxicology package to support entry into man
To understand how pre-clinical toxicity findings influence the design of the clinical programme
A basic introduction to drug handing- Absorption, distribution, metabolism, elimination
To understand the components of the pre-clinical pharmacokinetic package to support entry into man
To understand the components of the pre-clinical pharmaceutical (drug manufacturing) package to support entry into man
Basic introduction to the regulatory requirements to support entry into man
2. Assembling a clinical strategy for a new candidate drug
Basic introduction to the phases of clinical development
Overview of designs for the first in man administration trial
Determination of tolerability endpoints in early clinical development
Determination of efficacy endpoints in early clinical development
Determination of pharmacokinetic endpoints in early clinical development
3. Pre-clinical case studies from real life
To be able to critically analyse what are the key pre-clinical experiments to conduct when constrained by budget
To understand the findings from the Expert Scientific Committee report from the TeGenero incident
4. Clinical case studies from real life
To be able to interpret tolerability data from an ascending dose Phase I trial in cancer patients
To be able to interpret drug-concentration-time data from a Phase I trial
To understand the determinants of whether to progress a drug from Phase I to Phase II clinical testing.
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 interpretation and literature review
- Group/team working
- through delivering research project 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
|Written assignment (inc essay)||100%|
Feedback to students will be made 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|
|Andrew Hughes||Unit coordinator|