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On successful completion of this course students should be able to:

1.Understand and provide examples of commercial biotechnology related research and development.
2. Understand the nature of intellectual property, the importance and limitations of patents, the patenting process, patent infringement (freedom to operate), and IP management.
3. Understand the issues and processes involved in regulating genetically manipulated organisms and new pharmaceuticals.
4. Understand the essential information, skills and stages involved in the commercialisation of biotechnology research, including the principles of good laboratory practice (GMP), quality control (QC) and quality assurance (QA), and apply these skills to the in-house production of a product identified for development.
5. Demonstrate an ability to collect, research and integrate information from different sources and present in both written and oral forms as a research and development plan, individually and r collaboratively as part of a team.
6. Understand and critically evaluate published literature.

Workshops are a series of interactive presentations, whereby articles provided in advance to students are discussed (flip classroom), with an emphasis on critical concepts and specific terminologies.  The workshops will also include question sheets for assessment.

The workshops will allow students to experience the decision making processes a biotechnology company makes when delivering a new product to market (legal, production and costs).

Students are also required as part of their core course requirements to complete TECHCOMM 5016 Entrepreneurship & Innovation, which will complement the objectives of this subject.

Tutorials will require students to present as a group (groups of 2 or 3 depending on class size) a business proposal for a specific product.  The tutorials rely on the workshop component material to enable the students to deliver a business plan, including the business model, revenue generation, competition, production costs, and freedom to operate.

Each tutorial session will be followed by discussion on the merits and perceived disadvantages of each business plan.  The
“best” proposal chosen by students and staff will progress on to further development as part of the practical component of this course.  A distribution model limited to the School of Biological Sciences will form part of the final business model used, i.e. the
product will be available to research groups and teaching classes.

Practicals will form part of the teaching component in the second half of the course.  This component relies on the selection
process of a suitable product and the formulation of a comprehensive business plan.  The final two workshops will be scheduled for this time (second half of the semester), to allow for this planning process.

The practical component is responsible for the small scale production of the “product”.  Laboratory skills, time management, GLP, QA and QC all form a major part of this teaching mode.  Students will learn the first hand the practicalities of laboratory based production of a commodity in the biotechnology sector, and reinforce the concepts covered in the workshops.  For example, the difference and importance of the process orientated QA measures and product orientated QC procedures (testing) will be highlighted, and the necessity of GLP to produce a reliable and consistent product. Record keeping procedures in line with major accreditation agencies (such as NATA) will also form a major part of the whole process.

A student enrolled in a 3 unit course, such as this, should expect to spend, on average 12 hours per week on the studies
required. This includes both the formal contact time required to the course (e.g., lectures and practicals), as well as non-contact time (e.g., reading and revision).

Workshops – A total of 8 workshops; each session 3 hours in length.

Topics covered include: Quality management (QA, QC, GLP) Workshop 1, intellectual property (patents), and developing
a business plan.  The final two workshops will focus on processes for selection of a product, bringing the product to market, laboratory small scale production, storage & viability, and distribution.  Case studies will be used to illustrate these concepts.

Topics covered include; quality management (QA, QC, GLP), intellectual property (patents), and developing a business plan.  The final two workshops will focus on processes for selection of product, bringing the product to market, laboratory small scale production, storage & viability, and distribution.  Case studies will be used to illustrate these concepts.

All workshops require prescribed reading prior to each session. The teaching activity comes from the interactive learning mode, whereby students will also be asked to participate in key decision making steps.  Every second workshop will include a set of questions specific to the topic discussed, to be answered in small groups, within the allocated session.  This will reinforce the critical concepts covered and assess their understanding.

Tutorials – A total of 8 tutorials, each session 2 hours in length.

Topics covered are directly related to the workshop content.  Each tutorial session will be comprised of students (as part of a small group of 3), presenting a predetermined topic, i.e. quality management, intellectual property, and small scale laboratory production vs large scale commercial production (6 tutorials).  Each student group will be given a starting reference for their topic.

The students will contribute to the learning environment by presenting their specific topics as part of a group, followed by question time.  The staff member will act as a moderator, and ensure crucial areas have been presented and adequately addressed. Each tutorial session will conclude with a number of key decisions made on each topic, which relate to the final product choice.  Due to the complexity of the quality management and intellectual property topics, each will be covered as part of two tutorials.

The final two tutorials will focus on a business plan/business model for the selected product, as determined by previous workshops and tutorials.

Practicals - There are a total of 8 practicals, each session 6 hours in length.

The first two practicals will focus on general laboratory skills and safety. This will also include the principles of quality control and quality assurance, with practical examples designed to demonstrate these principles.

For example, the use of competent bacterial cells is a common procedure in research laboratories, and these are often bought commercially as frozen cells.  The quality assurance and quality control aspect of this type of product can be demonstrated by varying storage conditions of a series of competent cells and testing transformation efficiency.  Full documentation of processes (e.g. strain validation, growth conditions, media used, batch numbers) and testing procedures (e.g. transformation efficiency, contamination) in line with accreditation agency requirements (such as NATA), will also form part of the quality management protocols.

The remaining 6 practical sessions will focus on preparation of the selected product for small scale manufacture in the laboratory.

For example; if competent cells are used as the product.

Practical sessions will include - choice of bacterial strain(s) for manufacture of competent cells (check for freedom to operate), verification of strain (genotyping by sequencing), optimisation of conditions for maximum transformation efficiency, achieving required standard (transformation efficiency),testing of storage conditions and maintenance of competence, product testing in selected research laboratories, evaluate feedback, release of final product.

Students are required to attend a 6 hour laboratory practical component each week throughout the semester, for a total of 12 weeks.  
Students must attend at least 75%, i.e. 7 out of the 9 practical sessions. Attendance to each practical session is essential in achieving the main goals of this subject.  It is not possible to provide additional assessment to replace the laboratory and problem solving skills, team work & co-operation, that are part of the laboratory component of the subject.

No additional practical times will be made available to students missing more than two practical sessions.

One field trip to the Thebarton Hi-Tech Precinct (Business Incubator) is scheduled for an afternoon (approximately 4 hours).

None

Due to the current COVID-19 situation modified arrangements have been made to assessments to facilitate remote learning and teaching
Assessment task	Type of assessment	Percentage of total assessment for grading purposes	Hurdle   Yes or No	Outcomes being assessed / achieved	Approximate Timing of Assessment
Workshop question sheets (x4)	Formative & Summative	30% (7.5% for each question sheet)	No	1,2,3,4	Weeks 2,4,5,7
Tutorial Presentation	Formative& Summative	20%	No	1,2,3,4	Weeks 2- 8 (depending on who is presenting)
Practical Reports (x2)	Formative& Summative	50% (25% for each report)	No	1,2,3,4,5,6	Weeks 8, 10

Due to the current COVID-19 situation modified arrangements have been made to assessments to facilitate remote learning and teaching

Workshop Question Sheets (total of 30%):

Students will complete a total of 4 On-line question sheets with the format of questions changed slightly to include problem solving questions. Students will have had prescribed reading prior to each session. Topics are designed to determine the level of understanding and reinforce critical concepts relevant to the subject matter.  The start of each subsequent workshop will be used for formative feedback and addressing any shortcomings in understanding.

Tutorial Presentation (20%):

Groups comprising of 2 or 3 students (depending on class numbers) will be given a topic, with material which will follow on from the workshop themes.  The group will be required to present an overview of the area, and include a case study to illustrate their main points (15 minutes per student, plus a final 15 minutes question for the group, i.e. 60 minutes in total for a group of 3). The relevance of the case study to a number of selected biotechnology based products will also be presented, with audience participation used to evaluate the most promising area for further development.  The tutorial sessions will be used to determine the biotechnology related product that will be the focus of the practical component.  Two academic staff members will be present for these sessions to provide guidance in discussions and assess the presentations.

Practicals – (total of 50% for lab reports):

The first practical report will focus on the quality management aspects of the process, including appropriate methods and techniques.  The report will also include data from laboratory experiments demonstrating these principles, along with critical evaluation of the data.  The report summary should include recommendations for appropriate processes along with methods of recording them.

The second practical report will focus on the research and development phase, including the research proposal, planning and time management, and product development. 

Both reports have a 5,000 word limit, with the first report submitted as individual assignments, while the final report to be submitted as part of a group assignment. All students within a group will receive the same grade for the final assignment.

A format guide will be provided to students (groups) for both reports, as a marking guide, as well as rubrics detailing key
assessment criteria.

The main objective of the lab reports is for students to learn how to operate in a manner similar to a commercial biotechnology company.

For all Faculty courses except Level II and III SAVS courses

If an extension is not applied for, or not granted then a penalty for late submission will apply.  A penalty of 10% of the value of the assignment for each calendar day that the assignment is late (i.e. weekends count as 2 days), up to a maximum of 50% of the available marks will be applied. This means that an assignment that is 5 days late or more without an approved extension can only receive a maximum of 50% of the marks available for that assignment.