This assessment requires students to develop a written pre-clinical therapeutic development report focused on the design and evaluation of a novel therapeutic intervention for a specific disease. The report assesses students’ ability to integrate disease biology, experimental design, and pre-clinical research principles within a pharmaceutical or biotechnology context.

The report must address the following sections:

Part A: Identification of the target patient population and a detailed description of the disease characteristics that the proposed therapeutic aims to target, including relevant molecular, genetic, or biochemical features where applicable.
Part B: Proposal and justification of appropriate pre-clinical disease models to evaluate the therapeutic’s efficacy.
Part C: Design of a pre-clinical toxicity study, outlining methodology, endpoints, and considerations relevant to safety assessment.

The report must be 2,000–2,500 words in length and presented in a clear scientific format using standard word processing software. Figures, diagrams, and tables may be included where appropriate. All scientific claims must be supported by peer-reviewed literature and referenced using Harvard or APA referencing style.

In accordance with CQUniversity guidelines, the use of Gen AI is permitted for:

    - Developing literature search strategies
    - Guidance on argument structure
    - Formatting and grammar assistance
A detailed marking rubric for this assessment will be provided on the unit Moodle site.

Level of GenAI use allowed: 
Level 3: You may use Al to assist with specific tasks such as drafting text, refining and evaluating your work. You 
must critically evaluate and modify any Al-generated content you use.

Students will be assessed on the following:

1- Disease and patient population characterizations
2- Therapeutic rationale and scientific justification
3- Selection and justification of pre-clinical disease models
4- Design and scientific rigor of pre-clinical toxicity study
5- Critical analysis and integration of scientific literature
6- Structure, clarity, and scientific communication
7- Referencing accuracy and academic integrity

During the examination, students will be required to demonstrate their understanding of key laboratory concepts, including the RES protocols, techniques, safety procedures, and the scientific rationale underpinning the experiments outlined in the laboratory manual.

The oral examination will be conducted across two tutorial sessions. Each student will be allocated 15–20 minutes, consisting of a brief presentation followed by 2–5 structured questions.

Further details will be provided on Moodle.

1- Understanding of Laboratory Concepts 

     - Demonstrates clear understanding of RES protocols and experimental procedures.
     - Explains the scientific rationale behind experiments.
     - Accurately identifies key techniques and methods.

2- Demonstrating knowledge of Laboratory Safety protocols

3- Clarity and Organization of Professional Presentation 

    - Presents information logically and concisely within the allotted time.
    - Uses appropriate terminology and visual aids (if applicable).

4- Application of scientific knowledge
    - Answers questions accurately and clearly
    - Uses relevant scientific knowledge to explain responses
    - Demonstrates confidence in linking theory to practice 

During the Residential School, students are provided with a pharmaceutical agent to assess its activity against cervical cancer. The task requires students to undertake a series of cell-based experiments (as outlined in the Laboratory Manual on the unit Moodle site) to explore the anti-cancer properties and potential mechanism of action of this treatment

Students are required to complete each technique according to the Laboratory Manual, with assessment based on the quality of experimental outcomes.

If the initial attempt does not meet the minimum passing criteria, a ONE subsequent attempt is permitted for that technique.

A detailed marking rubric for this assessment will be made available on the unit Moodle site.

Students are assessed on the following:

1- Performing aseptic cell culture techniques
2- Capturing and presenting immunofluorescence microscopy images
3- Conducting quantitative real-time PCR (qRT-PCR) and interpreting the results
4- Performing an MTS assay and interpreting the results
5- Performing a TUNEL assay and interpreting the results
6- Appropriate labelling of all experimental samples

Scoring and Passing Requirements:

   - Each technique is scored according to the rubric provided on Moodle.
   - A minimum of 70% of total marks is required to pass this assessment.

This assessment requires students to present research findings on experimental data that were used during the residential school. The presentation should begin with your experimental results obtained during the residential school and progress through to the design of logical, subsequent experiments aimed at further elucidating the drug’s mechanism of action.

Students are expected to integrate peer-reviewed scientific literature to justify proposed experimental approaches and anticipated outcomes. The scope and depth of experimental findings presented (both completed and proposed) should be equivalent to that required for publication in a scientific journal (approximately 6–8 figures).

The assessment is to be delivered as a 10–15 minute recorded oral presentation, prepared using standard presentation software (e.g. PowerPoint or Keynote), and submitted via the unit Moodle site.

The presentation must include the following components:

  - Introduction outlining the discovery of the drug and the target patient population
  - Summary of experimental methods used during the residential school
  - Presentation and interpretation of experimental results generated during the residential school
  - Description of proposed subsequent experiments with anticipated results
  - Conclusions drawn from existing experimental data and proposed investigations

A detailed marking rubric for this assessment will be available on the unit Moodle site.

Level of GenAI use allowed: 
Level 3: You may use Al to assist with specific tasks such as drafting text, refining and evaluating your work. You 
must critically evaluate and modify any Al-generated content you use.

Students will be assessed on the following criteria:

1- Scientific background and context

2- Methodological understanding

3- Presentation of experimental data

4- Quality and interpretation of microscopy data

5- Data analysis and critical interpretation

6- Experimental design and scientific reasoning

7- Conclusions and scientific insight

8- Use of scientific literature