Overview
The development of new therapeutic products for the medical biotechnology industry requires comprehensive knowledge of techniques used to investigate their effects on various biological pathways at a cellular level. This unit will provide you with an opportunity to apply theoretical and practical knowledge of medical biotechnology in the development and pre-clinical testing of a new therapeutic product for industry commercialisation. You will develop new practical skills and gain experience in experimental models used to study human disease and apply these in a simulated industry environment. Your practical skills and demonstration of professional knowledge, attitude and compliance with relevant safety protocols will be assessed in a laboratory environment. Attendance at the practical activities at a compulsory residential school is a requirement of this unit. You will also develop the skills to communicate your findings to a broader audience in the medical biotechnology industry through both written reports and oral presentations.
Details
Pre-requisites or Co-requisites
Pre-requisite: BIOL12106 Molecular Biology
Important note: Students enrolled in a subsequent unit who failed their pre-requisite unit, should drop the subsequent unit before the census date or within 10 working days of Fail grade notification. Students who do not drop the unit in this timeframe cannot later drop the unit without academic and financial liability. See details in the Assessment Policy and Procedure (Higher Education Coursework).
Offerings For Term 1 - 2018
Attendance Requirements
All on-campus students are expected to attend scheduled classes – in some units, these classes are identified as a mandatory (pass/fail) component and attendance is compulsory. International students, on a student visa, must maintain a full time study load and meet both attendance and academic progress requirements in each study period (satisfactory attendance for International students is defined as maintaining at least an 80% attendance record).
Residential Schools
This unit has a Compulsory Residential School for distance mode students and the details are:
Click here to see your Residential School Timetable.
Recommended Student Time Commitment
Each 12-credit Undergraduate unit at CQUniversity requires an overall time commitment of an average of 25 hours of study per week, making a total of 300 hours for the unit.
Class Timetable
Assessment Overview
Assessment Grading
This is a graded unit: your overall grade will be calculated from the marks or grades for each assessment task, based on the relative weightings shown in the table above. You must obtain an overall mark for the unit of at least 50%, or an overall grade of ‘pass’ in order to pass the unit. If any ‘pass/fail’ tasks are shown in the table above they must also be completed successfully (‘pass’ grade). You must also meet any minimum mark requirements specified for a particular assessment task, as detailed in the ‘assessment task’ section (note that in some instances, the minimum mark for a task may be greater than 50%). Consult the University’s Grades and Results Policy for more details of interim results and final grades.
All University policies are available on the CQUniversity Policy site.
You may wish to view these policies:
- Grades and Results Policy
- Assessment Policy and Procedure (Higher Education Coursework)
- Review of Grade Procedure
- Student Academic Integrity Policy and Procedure
- Monitoring Academic Progress (MAP) Policy and Procedure – Domestic Students
- Monitoring Academic Progress (MAP) Policy and Procedure – International Students
- Student Refund and Credit Balance Policy and Procedure
- Student Feedback – Compliments and Complaints Policy and Procedure
- Information and Communications Technology Acceptable Use Policy and Procedure
This list is not an exhaustive list of all University policies. The full list of University policies are available on the CQUniversity Policy site.
- Conduct molecular or cell-based tests used to study human disease
- Display professional behaviour consistent with the safety and ethical practices of the laboratory
- Review and critically analyse current scientific literature
- Think critically to solve problems during the development and testing of therapeutics
- Effectively communicate experimental findings to industry professionals through written reports and oral presentations.
Alignment of Assessment Tasks to Learning Outcomes
Assessment Tasks | Learning Outcomes | ||||
---|---|---|---|---|---|
1 | 2 | 3 | 4 | 5 | |
1 - Practical Assessment - 0% | |||||
2 - Learning logs / diaries / Journal / log books - 0% | |||||
3 - Report - 60% | |||||
4 - Presentation - 40% |
Alignment of Graduate Attributes to Learning Outcomes
Graduate Attributes | Learning Outcomes | ||||
---|---|---|---|---|---|
1 | 2 | 3 | 4 | 5 | |
1 - Communication | |||||
2 - Problem Solving | |||||
3 - Critical Thinking | |||||
4 - Information Literacy | |||||
5 - Team Work | |||||
6 - Information Technology Competence | |||||
7 - Cross Cultural Competence | |||||
8 - Ethical practice | |||||
9 - Social Innovation | |||||
10 - Aboriginal and Torres Strait Islander Cultures |
Alignment of Assessment Tasks to Graduate Attributes
Assessment Tasks | Graduate Attributes | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | |
1 - Practical Assessment - 0% | ||||||||||
2 - Learning logs / diaries / Journal / log books - 0% | ||||||||||
3 - Report - 60% | ||||||||||
4 - Presentation - 40% |
Textbooks
There are no required textbooks.
IT Resources
- CQUniversity Student Email
- Internet
- Unit Website (Moodle)
All submissions for this unit must use the referencing styles below:
For further information, see the Assessment Tasks.
p.neilsen@cqu.edu.au
Module/Topic
Chapter
Events and Submissions/Topic
Module/Topic
Topic 2: From basic research to the pharmaceutical market
Chapter
Events and Submissions/Topic
Module/Topic
Topic 3: Drug Discovery
Chapter
Events and Submissions/Topic
Module/Topic
Topic 4: Preclinical toxicology
Chapter
Events and Submissions/Topic
Module/Topic
Topic 5: Clinical Phase I trials
Chapter
Events and Submissions/Topic
Module/Topic
Chapter
Events and Submissions/Topic
Module/Topic
Topic 6: Regulatory agencies and quality in drug development
Chapter
Events and Submissions/Topic
Module/Topic
Topic 7: Drug manufacturing
Chapter
Events and Submissions/Topic
Module/Topic
Topic 8: Clinical Phase II trials
Chapter
Events and Submissions/Topic
Module/Topic
Topic 9: Clinical Phase III trials
Chapter
Events and Submissions/Topic
Module/Topic
Topic 10: Regulatory approvals
Chapter
Events and Submissions/Topic
Module/Topic
Residential School (Monday 21st May to Sunday 27th May). This is a compulsory laboratory session held at the Rockhampton campus at Building 9, room 1.08.
Chapter
Events and Submissions/Topic
Module/Topic
Post-residential School Data Analysis Session. Monday 28th May to Wednesday 30th May. This is a non-compulsory drop-in ZOOM session that will provide you with the support in the analysis and interpretation of your data gathered during Residential School.
Chapter
Events and Submissions/Topic
Laboratory Book Due: Week 12 Friday (1 June 2018) 4:45 pm AEST
The coordinator for this unit is Dr Paul Neilsen. Please feel free to contact me anytime on p.neilsen@cqu.edu.au or on 07 4930 9108.
TEXTBOOK
There is no prescribed textbook for BMSC13014 Biotherapeutics and Industry. There will be selected reading materials provided to you on the Moodle site for this unit.
LECTURES
The lectures are delivered by Anthony Bishop, Chief Scientific Officer at Factor Therapeutics. Anthony is an industry expert, having spent his career in the pharmaceutical biotechnology industry. These lectures will be pre-recorded, and will integrate the fundamentals of pharmaceutical development with specific case studies from the biotechnology industry.
The tutorials are delivered by Dr Paul Neilsen and will re-enforce the information from the pre-recorded lectures, whilst relating the content to the assessment tasks.
RESIDENTIAL SCHOOL
There is a compulsory Residential School associated with this unit, which is held from Monday 21st May until Sunday 28th May 2018. The duration of this Residential School may be longer than those you have attended previously, however this is appropriate for the achievement of the practical skills, and demonstration of professional behaviour required, in this 12 credit unit. You will learn various new cell-based techniques during the Residential School that are highly relevant to the biotechnology and research industries. There are competency-based assessments associated with these techniques during this Residential School, so attendance is compulsory. Immediately after the Residential School, there will be an online session held from Monday 29th May until Wednesday 31st May 2018. This online session will provide support for the analysis and interpretation of data gathered during the Residential School. Attendance is non-compulsory, and it will be recorded and available on the Moodle site.
1 Report
The lecture content from Weeks 1 to 8 will provide you with knowledge regarding how potential therapeutics are developed and translated into clinical trials in the biotechnology industry. The lectures are integrated with specific case studies to support your learning with real-world examples. In this assessment, you will be tasked to use this knowledge, and survey the existing literature on similar case studies, to develop your own potential new therapeutic. Ideally, this will initially involve the selection of a specific disease which has a key "driver" that is targetable by pharmaceuticals. This may be a disease without current treatments available, or an existing disease where treatments are available, however there is scope for further therapeutic improvement. You will select this disease by Friday of Week 4 (30th March 2018) and confirm this selection with the Unit Coordinator. Upon approval to proceed, you will develop a written proposal that addresses the following sections:
Part A: Who is your target patient population? What are the key characteristics of the disease that this therapeutic is designed to target?
Part B: What pre-clinical models of the disease would you propose to use to test your therapeutic?
Part C: Describe the pre-clinical toxicity study that you may propose for your therapeutic?
Please note the following as a guide:
- The entire written proposal should be from 1,500 to 2,000 words in length.
- Accurately describe the disease that you are proposing, including the specific characteristics of the disease that your proposed drug is targeting. This may be a genetic abnormality (e.g. gene translocation or mutation), abnormality in the blood serum biochemistry (e.g. excessive protein or lipid in the blood) etc.
- The text should be prepared using a standard word processing software (e.g. Microsoft Word) with the appropriate use of figures, diagrams or tables as required.
- Specific referencing to scientific literature is essential. APA or Harvard style is acceptable, and the use of Endnote is highly encouraged.
Week 8 Friday (4 May 2018) 4:45 pm AEST
Week 10 Friday (18 May 2018)
The assessment of this written report will be based on the demonstrated knowledge of disease mechanisms and therapeutic targets, rationalisation 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 will be available on the Moodle site for this unit.
- Review and critically analyse current scientific literature
- Think critically to solve problems during the development and testing of therapeutics
- Effectively communicate experimental findings to industry professionals through written reports and oral presentations.
- Communication
- Problem Solving
- Critical Thinking
- Information Literacy
- Information Technology Competence
2 Practical Assessment
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:
- Culturing of human cervical cancer cells
- Flow cytometry
- Immunofluroescence microscopy
- Quantitative real-time PCR
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.
Week 12 Wednesday (30 May 2018) 4:45 pm AEST
Review/Exam Week Wednesday (6 June 2018)
4:45 PM
You will be assessed on the following criteria:
- Aseptic culture techniques
-
Quality and interpretation of scatterplots from flow cytometer
- Quality of microscopy images
- Quality of quantitative real-time PCR results
- Analysis and interpretation of real-time PCR data
- Adequate labeling of experimental samples
Detailed marking rubrics will be available on the Moodle site for this unit. Each technique will be scored as per the rubric, and minimum of 70% of the total marks are required to pass this assessment.
- Conduct molecular or cell-based tests used to study human disease
- Display professional behaviour consistent with the safety and ethical practices of the laboratory
- Communication
- Problem Solving
- Critical Thinking
- Information Literacy
- Team Work
- Cross Cultural Competence
3 Learning logs / diaries / Journal / log books
Biotechnology companies are required to provide adequate documentation of their laboratory activities. Laboratory records are the primary source of evidence provided when ownership of biotechnology companies IP is contested in a court of law. Hence, you will be assessed on your competency to accurately record your experimental findings during the Residential School. You will undertake the cell-based techniques as outlined in the Laboratory Manual (available on the Moodle site for this unit). You will be tasked to record your daily activities, results, observations and conclusions in this manual. This will also include information relevant to preparation for the techniques, including calculations involved in the preparation of solutions or reagents. There will also be daily worksheets provided to you regarding compliance with Standard Laboratory Practices in a PC2 Laboratory (Personal Containment Level 2 Laboratory).
You will be required to complete the Laboratory Manual in conjunction with the discussions held during Residential School and the associated reading available on the Moodle site for this unit. Submission of the completed Laboratory Manual can be performed as hard copy at the completion of Residential School, or online through the Moodle Assessment Submission Site.
Week 12 Friday (1 June 2018) 4:45 pm AEST
Review/Exam Week Friday (8 June 2018)
You will be assessed on the following criteria:
- Appropriate use of an introduction for each experiment.
- Accuracy in laboratory recording, including the methodology used and documentation of results
- Quality and appropriate use of labeling and images or tables for presentation of results
- Correct spelling and appropriate use of technical terms
- Demonstrated knowledge of the regulatory laws, government guidelines or institutional committees that govern biosafety, animal and human ethics.
Marks will be allocated within the Laboratory Manual for each section, and a detailed marking rubric will be available on the Moodle site for this unit.
- Display professional behaviour consistent with the safety and ethical practices of the laboratory
- Communication
- Information Literacy
- Team Work
- Cross Cultural Competence
- Ethical practice
4 Presentation
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.
Review/Exam Week Friday (8 June 2018) 4:45 pm AEST
Exam Week Friday (15 June 2018)
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.
- Review and critically analyse current scientific literature
- Think critically to solve problems during the development and testing of therapeutics
- Effectively communicate experimental findings to industry professionals through written reports and oral presentations.
- Communication
- Problem Solving
- Critical Thinking
- Information Literacy
- Information Technology Competence
- Cross Cultural Competence
As a CQUniversity student you are expected to act honestly in all aspects of your academic work.
Any assessable work undertaken or submitted for review or assessment must be your own work. Assessable work is any type of work you do to meet the assessment requirements in the unit, including draft work submitted for review and feedback and final work to be assessed.
When you use the ideas, words or data of others in your assessment, you must thoroughly and clearly acknowledge the source of this information by using the correct referencing style for your unit. Using others’ work without proper acknowledgement may be considered a form of intellectual dishonesty.
Participating honestly, respectfully, responsibly, and fairly in your university study ensures the CQUniversity qualification you earn will be valued as a true indication of your individual academic achievement and will continue to receive the respect and recognition it deserves.
As a student, you are responsible for reading and following CQUniversity’s policies, including the Student Academic Integrity Policy and Procedure. This policy sets out CQUniversity’s expectations of you to act with integrity, examples of academic integrity breaches to avoid, the processes used to address alleged breaches of academic integrity, and potential penalties.
What is a breach of academic integrity?
A breach of academic integrity includes but is not limited to plagiarism, self-plagiarism, collusion, cheating, contract cheating, and academic misconduct. The Student Academic Integrity Policy and Procedure defines what these terms mean and gives examples.
Why is academic integrity important?
A breach of academic integrity may result in one or more penalties, including suspension or even expulsion from the University. It can also have negative implications for student visas and future enrolment at CQUniversity or elsewhere. Students who engage in contract cheating also risk being blackmailed by contract cheating services.
Where can I get assistance?
For academic advice and guidance, the Academic Learning Centre (ALC) can support you in becoming confident in completing assessments with integrity and of high standard.