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BMET4990: Biomedical Product Development (2019 - Semester 1)

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Unit: BMET4990: Biomedical Product Development (6 CP)
Mode: Normal-Day
On Offer: Yes
Level: Senior Advanced
Faculty/School: School of Aerospace, Mechanical & Mechatronic Engineering
Unit Coordinator/s: A/Prof Dunstan, Colin
Session options: Semester 1
Versions for this Unit:
Campus: Camperdown/Darlington
Pre-Requisites: (MECH2901 OR BMET2901) AND (MECH3921 OR BMET3921).
Prohibitions: AMME4990.
Brief Handbook Description: 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.
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.
Lecturer/s: A/Prof Dunstan, Colin
Tutor/s: Hossain, Musharraf - m.hossain@sydney.edu.au

Poon, Christine - christine.poon@sydney.edu.au

Viray, Christina - christina.viray@sydney.edu.au
Timetable: BMET4990 Timetable
Time Commitment:
# Activity Name Hours per Week Sessions per Week Weeks per Semester
1 Lecture 2.00 1 13
2 Tutorial 2.00 1 13
3 Independent Study 1 13
T&L Activities: Tutorial: Tutorials will be used for discussion of case studies illustrating drug and medical device development issues, and for the preparation of a group presentation of a development plan for an investigational new drug application.

Independent Study: 4-5 hours per week outside of formal contact hours will be needed in order to successfully complete assignments and study.

Attributes listed here represent the key course goals (see Course Map tab) designated for this unit. The list below describes how these attributes are developed through practice in the unit. See Learning Outcomes and Assessment tabs for details of how these attributes are assessed.

Attribute Development Method Attribute Developed
To gain a broad understanding of biomedical product development within the regulatory framework. (2) Engineering/ IT Specialisation (Level 3)
Understanding the purpose and conduct of pre-clinical and clinical testing.
Spoken communication skills will be developed through the scheduled seminars.
(6) Communication and Inquiry/ Research (Level 4)
Teamwork and project management skills will be developed through the group project activities. (7) Project and Team Skills (Level 4)
Ability to develop manufacturing processes and quality systems that satisfy the internationally agreed standards for good manufacturing practice. (8) Professional Effectiveness and Ethical Conduct (Level 4)

For explanation of attributes and levels see Engineering & IT Graduate Outcomes Table 2018.

Learning outcomes are the key abilities and knowledge that will be assessed in this unit. They are listed according to the course goal supported by each. See Assessment Tab for details how each outcome is assessed.

(7) Project and Team Skills (Level 4)
1. Expertise in working in a team environment to develop a medical product concept and a plan for its implementation in conformity with regulatory guidelines
(8) Professional Effectiveness and Ethical Conduct (Level 4)
2. Achieve broad understanding of biomedical product development within the regulatory framework.
(3) Problem Solving and Inventiveness (Level 4)
3. Ability to present a complex plan for development of a drug or medical device to initial testing in human subjects
(2) Engineering/ IT Specialisation (Level 3)
4. Understand the purpose and conduct of preclinical and clinical testing.
5. Ability to develop manufacturing processes and quality systems that satisfy the internationally agreed standards for good manufacturing practice (ISO-14385).
Assessment Methods:
# Name Group Weight Due Week Outcomes
1 In session exam 1 No 20.00 Week 6 2, 3, 4, 5,
2 Presentation/Seminar Yes 25.00 Week 8 1, 2, 3, 4, 5,
3 Assignment No 25.00 Week 11 2, 4, 5,
4 In session exam 2 No 20.00 Week 12 2, 3, 4, 5,
5 Presentation and discussion No 10.00 Multiple Weeks 1, 2, 3, 4, 5,
Assessment Description: Assignment: Assignment on a product development issue.

In session exams: 30 minute open-book exam/quiz on course material.

Presentation/Seminar: Group presentation on preclinical and phase I clinical trial development for a drug or device

Presentation and discussion: Individual presentation and discusssion of a published paper describing a biomedical discovery or technical advance
Grading:
Grade Type Description
Standards Based Assessment Final grades in this unit are awarded at levels of HD for High Distinction, DI (previously D) for Distinction, CR for Credit, PS (previously P) for Pass and FA (previously F) for Fail as defined by University of Sydney Assessment Policy. Details of the Assessment Policy are available on the Policies website at http://sydney.edu.au/policies . Standards for grades in individual assessment tasks and the summative method for obtaining a final mark in the unit will be set out in a marking guide supplied by the unit coordinator.
Policies & Procedures: See the policies page of the faculty website at http://sydney.edu.au/engineering/student-policies/ for information regarding university policies and local provisions and procedures within the Faculty of Engineering and Information Technologies.
Recommended Reference/s: Note: References are provided for guidance purposes only. Students are advised to consult these books in the university library. Purchase is not required.

Note that the "Weeks" referred to in this Schedule are those of the official university semester calendar https://web.timetable.usyd.edu.au/calendar.jsp

Week Description
Week 1 Introduction to the themes in product development and the regulatory environment.
Week 2 Initial proof of principle studies (in vitro and in vivo) (pharmacology of medical products).
Week 3 Determining how medical products are distributed, degraded and cleared (pharmacokinetics).
Week 4 Determining medical product safety (toxicology)
Week 5 Good Manufacturing Practice – building a robust process.
Week 6 Good Manufacturing Practice – the importance of risk analysis and quality control
Assessment Due: In session exam 1
Week 7 Clinical Phase 1 Safety in humans.
Week 8 Clinical Phase 2 Safety, Biological activity, dose ranging.
Assessment Due: Presentation/Seminar
Week 9 Clinical Phase 3 Safety and clinical benefit.
Week 10 Phase 4 post-approval, making changes.
Week 11 Challenges in the development of gene therapy products
Assessment Due: Assignment
Week 12 Challenges in the development of stem cell based medical products
Assessment Due: In session exam 2
Week 13 Visiting lecturer on testing of materials for use in devices

Course Relations

The following is a list of courses which have added this Unit to their structure.

Course Year(s) Offered
Biomedical Mid-Year 2018, 2019, 2020
Biomedical/ Project Management 2019, 2020
Biomedical 2016, 2017, 2018, 2019, 2020
Biomedical / Arts 2019, 2020
Biomedical / Commerce 2019, 2020
Biomedical /Science 2019, 2020
Biomedical/Science (Health) 2019, 2020
Biomedical / Law 2019, 2020
Biomedical/Science (Medical Science Stream) 2019, 2020

Course Goals

This unit contributes to the achievement of the following course goals:

Attribute Practiced Assessed
(6) Communication and Inquiry/ Research (Level 4) Yes 0%
(7) Project and Team Skills (Level 4) Yes 7%
(8) Professional Effectiveness and Ethical Conduct (Level 4) Yes 25.33%
(3) Problem Solving and Inventiveness (Level 4) No 17%
(2) Engineering/ IT Specialisation (Level 3) Yes 50.67%

These goals are selected from Engineering & IT Graduate Outcomes Table 2018 which defines overall goals for courses where this unit is primarily offered. See Engineering & IT Graduate Outcomes Table 2018 for details of the attributes and levels to be developed in the course as a whole. Percentage figures alongside each course goal provide a rough indication of their relative weighting in assessment for this unit. Note that not all goals are necessarily part of assessment. Some may be more about practice activity. See Learning outcomes for details of what is assessed in relation to each goal and Assessment for details of how the outcome is assessed. See Attributes for details of practice provided for each goal.