Laboratory-based (preclinical) testing of pharmaceuticals is essential to demonstrate the desired efficacy and biological activity in the treatment of various diseases. Employers within the biotechnology and medical research industries commonly use cell-based models of human disease and will be looking for graduates with a sound knowledge and practical training in such techniques. Hence, you will be assessed in this unit regarding your performance in undertaking these cell-based techniques, as described below.

During the Residential School, you will be provided with a pharmaceutical agent that has been recently discovered to have activity against cervical cancers. The hypothetical biotechnology company you are employed in has recently identified this agent from a plant that is indigenous to Australia and currently has little knowledge of how this drug works as an anti-cancer agent. Your task during the Residential School will be to undertake a series of experiments (as outlined in a Laboratory Manual provided on the Moodle site) to explore the anti-cancer properties and mechanism of action of this new potential treatment for cervical cancer. The below techniques will be used during the Residential School:

        1.        Culturing of mammalian cancer cells

        2.        Immunofluorescence microscopy

        3.        Quantitative real-time PCR

        4.        MTS assay

Sufficient training on both the practical and theoretical components of these procedures will be provided during the Residential School. You will complete each of these cell-based techniques (as outlined in the Laboratory Manual on the Moodle site for this unit) and will be assessed on the quality of the outcomes of these procedures. The assessment will be conducted as follows:

• The unit coordinator will undertake the cell-based techniques in parallel with you as a benchmark of quality of the experimental output.
• If your first attempt at the technique does not meet the minimum passing criteria, you will be allowed a subsequent maximum of (two) attempts at this technique.
• you must be deemed competent in all competencies assessed during the residential school (Competency form can be located on the Moodle page).

Gen AI Use Statement:

According to CQU guideline regarding the use of Generative AI in assessments, students are allowed to use Gen AI for:

1- Developing literature search strategies
2- Guidance on arguments
3- Formatting and grammar assistance

If you’re planning to use AI-generated content in your work, you'll need to:

1- Declaration Statement – Include the following on the front page of your submission:
"I have used (insert technology) to (insert how you used it) in accordance with this unit's requirements. The reason I used this was to (explain why). The details of how I used it are (insert how). I declare that this submission represents my individual skills and abilities to meet the task requirements."
2- Citations – Fact-check AI-generated content, cite primary sources and the AI tool used.
3- Appendix – Include AI prompts and responses. Missing this may lead to an academic integrity review.

A Pass / Fail grade will be awarded depending on the level of competency and knowledge displayed during the Practical
Assessment. If a fail grade is awarded, students will be allowed a second attempt at the practical assessment during the

You must pass the Practical Assessment to be eligible to pass the unit.

You will be assessed on the following criteria:

• Aseptic culture techniques
• Adequate labeling of experimental samples
• Quality of preparing the samples
• Quality of microscopy images
• Quality of quantitative real-time PCR results
• Analysis and interpretation of real-time PCR data
• Analysis and interpretation of the TUNEL assay results
• Analysis and interpretation of the MTS assay results

Assessment: Proposal for a Novel Therapeutic

The lecture content from Weeks 1 to 8 will provide you with foundational knowledge on how potential therapeutics are developed and translated into clinical trials within the biotechnology industry. To reinforce this learning, lectures will include specific case studies to illustrate real-world applications.

For this assessment, you will apply this knowledge by surveying existing literature on similar case studies and developing your own potential new therapeutic.

Project Overview:

You will:

1- Select a specific disease with a key “driver” that is targetable by pharmaceuticals.
This may be a disease without current treatments or one where existing treatment could be improved.
2- Confirm your disease selection with the Unit Coordinator by Thursday of Week 6.
3- Develop a written proposal addressing the following sections:

• Part A: Target Patient Population & Disease Characteristics
  1- Who is your target patient population?
  2- What are the key characteristics of the disease that your therapeutic aims to target?
  3- Identify the specific biological or genetic abnormalities relevant to your drug’s mechanism of action (e.g., gene mutations, biochemical imbalances).
• Part B: Pre-Clinical Disease Models
  1- Which pre-clinical models (e.g., cell lines, organoids, animal models) would you propose for testing your therapeutic?
       Justify your choice based on disease pathophysiology and relevance to human conditions.
• Part C: Pre-Clinical Toxicity Study
  1- Outline a pre-clinical toxicity study for your therapeutic.
  2- Consider factors such as dosage, duration, target organs, and potential side effects. 

Formatting & Submission Guidelines:

1- Word count: 2,000 – 2,500 words
2- Formatting:
    - Use Microsoft Word or another standard word processor
    - Figures, diagrams, or tables should be included where relevant with scientific legends
    - Save and submit as a PDF

3- Referencing:
   - Scientific references are essential
   - Use APA, or Harvard referencing style

This proposal should be an opportunity to demonstrate your understanding of drug development, literature research, and critical analysis of pre-clinical testing methods.

Gen AI Use Statement:

According to CQU guideline regarding the use of Generative AI in assessments, students are allowed to use Gen AI for:

1- Developing literature search strategies
2- Guidance on arguments
3- Formatting and grammar assistance

If you’re planning to use AI-generated content in your work, you'll need to:

1- Declaration Statement – Include the following on the front page of your submission:
"I have used (insert technology) to (insert how you used it) in accordance with this unit's requirements. The reason I used this was to (explain why). The details of how I used it are (insert how). I declare that this submission represents my individual skills and abilities to meet the task requirements."
2- Citations – Fact-check AI-generated content, cite primary sources and the AI tool used.
3- Appendix – Include AI prompts and responses. Missing this may lead to an academic integrity review.

The assessment of this written report will be based on the demonstrated knowledge of disease mechanisms and therapeutic targets, rationalization and justification of your arguments and ideas, support of these arguments and ideas using appropriate robust scientific literature and clarity of the proposal with accurate referencing, 

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

Presentation of your research findings at scientific meetings or conferences will ensure dissemination of your discoveries to the broader scientific community. In this assessment, your task is to present research findings on the specific anti-cancer drug that you were using during residential school. The oral presentation of your research findings will begin with your experimental results that you achieved during the residential school. You will then present a series of logical subsequent experiments and anticipated results to conclusively determine the mechanism of action of this relatively unknown anti-cancer drug. You will refer to recent scientific literature in this field to design these subsequent experiments in an effort to draw robust conclusions on the mechanism of action of this drug. It is expected that the volume of experimental findings presented (and proposed) during this presentation will be sufficient for publication in a scientific journal (approximately 6 to 8 figures).

Please note that the presentation can be between 10-15 minutes in duration. It can be recorded and uploaded into the Moodle Assessment Submission Site. It should follow the below sections:

• Introduction regarding the discovery of the drug and target patient population.
• Presentation of methods used at Residential School
• Experimental results achieved during Residential School
• Presentation of proposed subsequent experiments and anticipated results
• Conclusion drawn from existing results (from Residential School) and from proposed experiments

The presentation can be prepared using any standard presentation software (for example, PowerPoint or Keynote). Links to recording software and instructions for how to record the presentation will be available on the Moodle site.

Gen AI Use Statement:

According to CQU guideline regarding the use of Generative AI in assessments, students are allowed to use Gen AI for:

1- Developing literature search strategies
2- Guidance on arguments
3- Formatting and grammar assistance

If you’re planning to use AI-generated content in your work, you'll need to:

1- Declaration Statement – Include the following on the front page of your submission:
"I have used (insert technology) to (insert how you used it) in accordance with this unit's requirements. The reason I used this was to (explain why). The details of how I used it are (insert how). I declare that this submission represents my individual skills and abilities to meet the task requirements."
2- Citations – Fact-check AI-generated content, cite primary sources and the AI tool used.
3- Appendix – Include AI prompts and responses. Missing this may lead to an academic integrity review.

You will be assessed on the following criteria:

• Clearly introduce the background information regarding the drug and accurately identify and describe the characteristics of the target patient population.
• Accurate and clear presentation of methodology (both from existing protocols used at Residential School and subsequent proposed experiments).
• Coherent and logical presentation of results in tabular or graphical format.
• Clear presentation of microscopy images with accurate labeling.
• Logical discussion of results with accurate and definitive conclusion outlined.
• Appropriate use of referencing of scientific literature.

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