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Unit outline_

PCOL5105: Commercialising MedTech and Pharma

Semester 2, 2023 [Online] - Camperdown/Darlington, Sydney

This unit provides key business skills and related knowledge essential for the commercialisation of products in the medical device and pharmaceuticals sectors; from start-ups to large Pharma. The unit will provide students with a grounding in finance, human resources, market research and analysis, project management, risk management frameworks, regulatory and clinical strategy, freedom to operate and intellectual property. Students will learn how to develop a business case, based on market analysis, understand the process of capital fund raising and construct a development pathway for manufacturing and marketing of both medical devices and pharmaceutical products.

Unit details and rules

Academic unit Pharmacy
Credit points 6
Prerequisites
? 
None
Corequisites
? 
None
Prohibitions
? 
None
Assumed knowledge
? 

None

Available to study abroad and exchange students

No

Teaching staff

Coordinator Orin Chisholm, orin.chisholm@sydney.edu.au
Tutor(s) Orin Chisholm, orin.chisholm@sydney.edu.au
Type Description Weight Due Length
Assignment Business Case
Please see Canvas for details
40% STUVAC
Due date: 12 Nov 2023 at 17:34
3000 words
Outcomes assessed: LO1 LO2 LO3 LO4 LO5
Assignment Market Research
Please see Canvas for details
30% Week 04
Due date: 27 Aug 2023 at 23:59
1500 words
Outcomes assessed: LO1 LO2 LO4 LO5
Assignment Target Product Profile
See Canvas for details
30% Week 09
Due date: 08 Oct 2023 at 23:59
1500 words
Outcomes assessed: LO2 LO4 LO5

Assessment summary

Market Research: Students will submit a 1500 word market research paper for a proposed product. A list of suitable products will be provided. Submission prompts will be provided. 

Target Product Profile: Students will submit a target product profile of 1500 words for a given product. Submission prompts will be provided. 

Business Case: Students will put together a business case of 3000 words for a given product which would be suitable to present to a group of investors. Submission prompts will be provided. 

Detailed information for each assessment can be found on Canvas.

Assessment criteria

The University awards common result grades, set out in the Coursework Policy 2014 (Schedule 1).

As a general guide, a high distinction indicates work of an exceptional standard, a distinction a very high standard, a credit a good standard, and a pass an acceptable standard.

Result name

Mark range

Description

High distinction

85 - 100

At HD level, a student demonstrates an aptitude for the subject and a well-developed understanding of the unit material. A ‘High Distinction’ reflects exceptional achievement and is awarded to students who demonstrate the ability to apply their subject knowledge and understanding to produce original solutions for novel or highly complex problems and/or comprehensive critical discussions of theoretical concepts. 

Distinction

75 - 84

At DI level, a student demonstrates an aptitude for the subject and a well-developed understanding of the units material. A ‘Distinction’ reflects excellent achievement and is awarded to a student who demonstrates an ability to apply their subject knowledge and understanding of the subject to produce good solutions for challenging problems and/or a reasonably well-developed critical analysis of theoretical concepts. 

Credit

65 - 74

At CR level, a student demonstrates a good command and knowledge of the unit material. A ‘Credit’ reflects solid achievement and is awarded to a student who has a broad general understanding of the units material and can solve routine problems and/ or identify and superficially discuss theoretical concepts. 

Pass

50 - 64

At PS level, a student demonstrates proficiency in the material. A ‘Pass’ reflects satisfactory adequately referencing the original source of the work. 

Fail

0 - 49

When you don’t meet the learning outcomes of the unit to a satisfactory standard.

For more information see guide to grades.

Late submission

In accordance with University policy, these penalties apply when written work is submitted after 11:59pm on the due date:

  • Deduction of 5% of the maximum mark for each calendar day after the due date.
  • After ten calendar days late, a mark of zero will be awarded.

Academic integrity

The Current Student website provides information on academic integrity and the resources available to all students. The University expects students and staff to act ethically and honestly and will treat all allegations of academic integrity breaches seriously.

We use similarity detection software to detect potential instances of plagiarism or other forms of academic integrity breach. If such matches indicate evidence of plagiarism or other forms of academic integrity breaches, your teacher is required to report your work for further investigation.

Use of generative artificial intelligence (AI) and automated writing tools

You may only use generative AI and automated writing tools in assessment tasks if you are permitted to by your unit coordinator. If you do use these tools, you must acknowledge this in your work, either in a footnote or an acknowledgement section. The assessment instructions or unit outline will give guidance of the types of tools that are permitted and how the tools should be used.

Your final submitted work must be your own, original work. You must acknowledge any use of generative AI tools that have been used in the assessment, and any material that forms part of your submission must be appropriately referenced. For guidance on how to acknowledge the use of AI, please refer to the AI in Education Canvas site.

The unapproved use of these tools or unacknowledged use will be considered a breach of the Academic Integrity Policy and penalties may apply.

Studiosity is permitted unless otherwise indicated by the unit coordinator. The use of this service must be acknowledged in your submission as detailed on the Learning Hub’s Canvas page.

Outside assessment tasks, generative AI tools may be used to support your learning. The AI in Education Canvas site contains a number of productive ways that students are using AI to improve their learning.

Simple extensions

If you encounter a problem submitting your work on time, you may be able to apply for an extension of five calendar days through a simple extension.  The application process will be different depending on the type of assessment and extensions cannot be granted for some assessment types like exams.

Special consideration

If exceptional circumstances mean you can’t complete an assessment, you need consideration for a longer period of time, or if you have essential commitments which impact your performance in an assessment, you may be eligible for special consideration or special arrangements.

Special consideration applications will not be affected by a simple extension application.

Using AI responsibly

Co-created with students, AI in Education includes lots of helpful examples of how students use generative AI tools to support their learning. It explains how generative AI works, the different tools available and how to use them responsibly and productively.

WK Topic Learning activity Learning outcomes
Week 01 Module 1: Initiation Seminar (10 hr) LO1 LO2 LO4 LO5
Week 02 Module 1: Initiation Seminar (10 hr) LO1 LO2 LO4 LO5
Week 03 Module 1: Initiation Seminar (10 hr) LO1 LO2 LO4 LO5
Week 04 Module 1: Initiation Seminar (10 hr) LO1 LO2 LO4 LO5
Week 05 Module 2: Strategy Development Seminar (10 hr) LO1 LO2 LO4 LO5
Week 06 Module 2: Strategy Development Seminar (10 hr) LO1 LO2 LO4 LO5
Week 07 Module 2: Strategy Development Seminar (10 hr) LO1 LO2 LO4 LO5
Week 08 Module 2: Strategy Development Seminar (10 hr) LO1 LO2 LO4 LO5
Week 09 Module 2: Strategy Development Seminar (10 hr) LO1 LO2 LO4 LO5
Week 10 Module 3: Business Planning Seminar (10 hr) LO1 LO2 LO3 LO4 LO5
Week 11 Module 3: Business Planning Seminar (10 hr) LO1 LO2 LO3 LO4 LO5
Week 12 Module 3: Business Planning Seminar (10 hr) LO1 LO2 LO3 LO4 LO5
Week 13 Module 3: Business Planning Seminar (10 hr) LO1 LO2 LO3 LO4 LO5
Week 14 (STUVAC) Module 3: Business Planning Seminar (10 hr) LO1 LO2 LO3 LO4 LO5

Study commitment

Typically, there is a minimum expectation of 1.5-2 hours of student effort per week per credit point for units of study offered over a full semester. For a 6 credit point unit, this equates to roughly 120-150 hours of student effort in total.

Learning outcomes are what students know, understand and are able to do on completion of a unit of study. They are aligned with the University's graduate qualities and are assessed as part of the curriculum.

At the completion of this unit, you should be able to:

  • LO1. Understand and compare business models in the MedTech & Pharma sectors (e.g. start-ups, SME and large Pharma)
  • LO2. Describe & apply essential business skills including basic finance, asset management, market research & analysis, basic project managements and risk management frameworks
  • LO3. Construct a business case/proposal considering basic business skills
  • LO4. Appraise clinical and regulatory strategies in the MedTech & Pharma sector
  • LO5. Explain concepts of opportunity recognition, entering new markets, disruptive innovation, venture capital funding and corporate spin-off

Graduate qualities

The graduate qualities are the qualities and skills that all University of Sydney graduates must demonstrate on successful completion of an award course. As a future Sydney graduate, the set of qualities have been designed to equip you for the contemporary world.

GQ1 Depth of disciplinary expertise

Deep disciplinary expertise is the ability to integrate and rigorously apply knowledge, understanding and skills of a recognised discipline defined by scholarly activity, as well as familiarity with evolving practice of the discipline.

GQ2 Critical thinking and problem solving

Critical thinking and problem solving are the questioning of ideas, evidence and assumptions in order to propose and evaluate hypotheses or alternative arguments before formulating a conclusion or a solution to an identified problem.

GQ3 Oral and written communication

Effective communication, in both oral and written form, is the clear exchange of meaning in a manner that is appropriate to audience and context.

GQ4 Information and digital literacy

Information and digital literacy is the ability to locate, interpret, evaluate, manage, adapt, integrate, create and convey information using appropriate resources, tools and strategies.

GQ5 Inventiveness

Generating novel ideas and solutions.

GQ6 Cultural competence

Cultural Competence is the ability to actively, ethically, respectfully, and successfully engage across and between cultures. In the Australian context, this includes and celebrates Aboriginal and Torres Strait Islander cultures, knowledge systems, and a mature understanding of contemporary issues.

GQ7 Interdisciplinary effectiveness

Interdisciplinary effectiveness is the integration and synthesis of multiple viewpoints and practices, working effectively across disciplinary boundaries.

GQ8 Integrated professional, ethical, and personal identity

An integrated professional, ethical and personal identity is understanding the interaction between one’s personal and professional selves in an ethical context.

GQ9 Influence

Engaging others in a process, idea or vision.

Outcome map

Learning outcomes Graduate qualities
GQ1 GQ2 GQ3 GQ4 GQ5 GQ6 GQ7 GQ8 GQ9

This section outlines changes made to this unit following staff and student reviews.

We value your feedback about any aspect of the unit of study and your experience as a student of Sydney Pharmacy School. To help ensure our courses meet your needs and maintain a high standard, we welcome your feedback at any time and we ask you to complete the Mid-Semester Evaluation Survey and the unit of study Evaluation Survey at the end of the semester. You can also rate any component of the unit using our star rating system found at the bottom of many pages as you progress through the unit. Your ratings and comments are anonymous and specifying what you liked and didn’t like about any of the learning materials, assessment items, discussion forums, feedback etc will help us to target our improvement efforts. Please note that your participation in this unit of study permits de-identified information about your learning experience and interaction with learning resources to be used for the purpose of improving the student learning experience.

Disclaimer

The University reserves the right to amend units of study or no longer offer certain units, including where there are low enrolment numbers.

To help you understand common terms that we use at the University, we offer an online glossary.