BMET3990: Semester 2, 2021

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Units BMET3990 Semester 2 2021 [Normal day]

Unit of study_

BMET3990: Biomedical Product Development

Overview

Product development in the biomedical area presents unique challenges that need to be addressed to efficiently satisfy strict regulatory requirements and to successfully advance products to approval for marketing. Biomedical engineers need a broad understanding of these challenges as the main components of product development are complex and interdependent. Development of good manufacturing and quality control processes, preclinical and clinical validation of product safety and efficacy, and regulatory filings, are each progressive and interdependent processes. This UoS will provide a broad understanding of regulatory requirements for biomedical product development, with particular emphasis on the dependence of each component on the development of processes and control systems that conform to Good Manufacturing Practice. This UoS assumes prior knowledge of cell biology and chemistry and builds on that foundation to elaborate on the important aspects of biomedical product development.

Details

Academic unit	Biomedical Engineering
Unit code	BMET3990
Unit name	Biomedical Product Development
Session, year ?	Semester 2, 2021
Attendance mode	Normal day
Location	Remote
Credit points	6

Enrolment rules

Prohibitions ?	AMME4990 or BMET4990 or AMME9990 or BMET9990
Prerequisites ?	MECH2901 or BMET2901 or [MEDS2005 and (MEDS2001 or PHSI2007)]
Corequisites ?	None
Assumed knowledge ?	1000-level chemistry, 2000-level biology, and specific knowledge of cell biology at least at the 1000-level, and preferably at the 2000-level.
Available to study abroad and exchange students	Yes

Teaching staff and contact details

Coordinator	Colin Dunstan, colin.dunstan@sydney.edu.au

Type	Description	Weight	Due	Length
Online task	Quiz 1 Short answer quiz based on lecture and tutorial content in weeks 1-5	20%	Week 06 Due date: 15 Sep 2021 at 11:00 Closing date: 15 Sep 2021	60 minutes
Outcomes assessed:
Presentation	Group presentation describing a preclinical plan for a drug or device Group presentation by tutorial groups with each student participating	25%	Week 08	25 minutes
Outcomes assessed:
Assignment	Description and analysis of a drug or device withdrawal Essay analysing a drug or device failure and withdrawal	25%	Week 11	2000 +/- 200 words
Outcomes assessed:
Online task	Quiz 2 Short answer quiz based on lecture and tutorial content in weeks 6-11	20%	Week 12 Due date: 03 Nov 2021 at 11:00 Closing date: 03 Nov 2021	60 minutes
Outcomes assessed:
Participation	Participation in tutorials Engagement in weekly discussions 3 minute presentation on essay topic	10%	Weekly	weeks 2-13
Outcomes assessed:
= group assignment ?

Quiz 1 Short answer quiz based on lecture and tutorial content in weeks 1-5 held during lecture time
Quiz 2 Short answer quiz based on lecture and tutorial content in weeks 6-11 held during lecture time
Presentation Group presentation by tutorial groups with each student participating describing the preclinical program for a novel device or drug concept in Week 8
Assignment Individual essay with description and analysis of a drug or device withdrawal or recall, 2000+/-10% words due in week 10
Participation Assessment of engagement and contributions to tutorial remote or face to face discussions and a three minute presentation by each individual on the topic of the Assignment.

Assessment criteria

Result Name	Mark Range	Description
High Distinction	85-100%	Demonstrates outstanding and comprehensive knowledge and ability for critical thinking
Distinction	75-84%	Demonstrates excellent and comprehensive knowledge and ability for critical thinking. actve participation in group discussion and leadership in group presentations
Credit	65-74%	Demonstrates good understanding and comprehensive knowledge and a good level of critical thinking and participation in discussions
Pass	50-65%	Demonstrates acceptable if limited knowledge and understanding
Fail	0-49%	Unsatisfactory level of knowledge, engagement in discussion and shows little evidence of critical thinking

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.

This unit has an exception to the standard University policy or supplementary information has been provided by the unit coordinator. This information is displayed below:

Assignment: late penalty 5% per day after due date

Special consideration

If you experience short-term circumstances beyond your control, such as illness, injury or misadventure or if you have essential commitments which impact your preparation or performance in an assessment, you may be eligible for special consideration or special arrangements.

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.

You may only use artificial intelligence and writing assistance tools in assessment tasks if you are permitted to by your unit coordinator, and if you do use them, you must also acknowledge this in your work, either in a footnote or an acknowledgement section.

Studiosity is permitted for postgraduate units unless otherwise indicated by the unit coordinator. The use of this service must be acknowledged in your submission.

Weekly schedule

WK	Topic	Learning activity
Week -02	Defining the context for a decision to progress to clinical trial in humans	Lecture (2 hr)
Week 01	A brief description of the topic	Lecture (2 hr)
Week 03	Define Pharmacology studies and how they are used to validate a therapeutic target	Lecture (2 hr)
Week 03	Lecture 4 Use of Pharmacokinetics studies to define absorption, distribution, metabolism and excretion of drugs and materials in animals	Lecture (2 hr)
Week 05	Lecture 5 Toxicology Define the use of toxicology studies to define the potential of a drug or device to cause harm in an animal	Lecture (2 hr)
Week 06	Lecture 6 Manufacturing to a GMP standard with quality in accordance with ISO 13485	Lecture (2 hr)
Week 08	Lecture 8 Phase 2 studies - defining in human studies biological activity safety	Lecture (2 hr)
Week 09	Lecture 7 Planning Clinical Studies - Phase 1 studies (First in human studies) Defining safety	Lecture (2 hr)
Week 09	Lecture 9 Clinical studies 3 Phase 3 studies. Does drug or device have patient benefit relative to risk	Lecture (2 hr)
Week 10	Lecture 10 Filing for regulatory approval	Lecture (2 hr)
Week 12	Lecture 12 devices and their challenges	Lecture (2 hr)
Week 13	Lecture 11 Phase 4 studies, ongoing vigilance and market expansion	Lecture (2 hr)
Week 13	Spare lecture time allocation for presentations	Lecture (2 hr)
Weekly	Week 2 to 13 Review significant drug and device failures to illustrate the importance of the procedures outlined in lectures and defined the regulatory framework we have today. Prepare and present group presentations	Tutorial (2 hr)

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

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.

Outcomes
Graduate qualities

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

LO1. Demonstrate expertise in working in a team environment to develop a medical product concept and plan in conformity with regulatory guidelines
LO2. Demonstrate a broad understanding of biomedical product development within the regulatory framework
LO3. Present a complex plan for the development or a drug or a medical device to initial testing in human subjects
LO4. Understand and describe how previous drug and device failures have guided the evolution of the current drug and device delivery testing regimes.
LO5. Identify and understand the proceses and quality systems that satisfy the internationally agreed standards for good manufacturing practice

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
Learning outcomes

Closing the loop

The information has been upgraded include more up to date information, The tutorials will be refined so that there is more time for tutorial group interactions and more clearly defined expectations for outcomes for the tutorials

Additional information

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Delivery of the Unit of Study material will be modified as required to take into account COVID-19 constraints with details defined progressively.

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Current students

Overview

Details

Enrolment rules

Teaching staff and contact details

Assessment

Assessment criteria

Late submission

Special consideration

Academic integrity

Weekly schedule

Study commitment

Learning outcomes

Graduate qualities

Outcome map

Closing the loop

Additional information

Work, health and safety

Disclaimer

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