BIO8415 Drug Development and Commercialisation
|Semester 2, 2013 On-campus Toowoomba|
|Faculty or Section :||Faculty of Sciences|
|School or Department :||Biological & Physical Sciences|
|Version produced :||13 March 2014|
Examiner: Lindsay Brown
Moderator: Mark Lynch
This course will provide an overview of how active compounds are developed into drugs and then made available to consumers as commercial entities. The regulatory and intellectual property environment in which these activities take place will be discussed.
Selection of lead compounds and the components of preclinical trials will be discussed together with potential routes of administration and subsequent clinical evaluation prior to registration. The structure of pharmaceutical industries will be examined and the regulatory and intellectual property environment within which they operate will be described.
On completion of this course students will be able to:
- Apply ethical principles associated with the use of animals for preclinical testing of drugs and ethical issues relating to clinical research,
- Understand the broad regulatory principles governing drug development, commercialisation and registration,
- Understand the principles of applying for patents, licencing and protecting intellectual property rights,
- Understand the principles governing pre-clinical and clinical testing of drugs,
- Better understand the structure of the National and International pharmaceutical industries,
- Demonstrate skills in the written and oral communication of major concepts in this course.
|1.||Selection of lead compounds and further development.||15.00|
|2.||Pre-clinical evaluation of drugs.||20.00|
|3.||Clinical evaluation of drugs.||20.00|
|4.||Management of intellectual property in the pharmaceutical industries.||10.00|
|5.||Industry codes of practice, government regulation and drug registration.||10.00|
|6.||The structure of the pharmaceutical industries.||10.00|
|7.||Ethical considerations in drug evaluation and commercialisation.||15.00|
Text and materials required to be purchased or accessed
ALL textbooks and materials available to be purchased can be sourced from USQ's Online Bookshop (unless otherwise stated). (https://bookshop.usq.edu.au/bookweb/subject.cgi?year=2013&sem=02&subject1=BIO8415)
Please contact us for alternative purchase options from USQ Bookshop. (https://bookshop.usq.edu.au/contact/)
To be advised.
Student workload requirements
|Description||Marks out of||Wtg (%)||Due Date||Notes|
|ASSIGNMENT 1||30||30||16 Jul 2013||(see note 1)|
|ASSIGNMENT 2||45||45||16 Jul 2013||(see note 2)|
|SEMINAR||25||25||16 Jul 2013||(see note 3)|
- Examiner to advise due date for Assignment 1.
- Examiner to advise due date for Assignment 2.
- Examiner to advise due date for Seminar.
Important assessment information
It is the students' responsibility to attend and participate appropriately in all activities (such as lectures, and tutorials,) scheduled for them, and to study all material provided to them or required to be accessed by them to maximise their chance of meeting the objectives of the course and to be informed of course-related activities and administration.
Requirements for students to complete each assessment item satisfactorily:
To satisfactorily complete an assessment item a student must achieve at least 50% of the marks or a grade of at least C-. Students do not have to satisfactorily complete each assessment item to be awarded a passing grade in this course. Refer to Statement 4 below for the requirements to receive a passing grade in this course.
Penalties for late submission of required work:
If students submit assignments after the due date without (prior) approval of the examiner then a penalty of 5% of the total marks gained by the student for the assignment may apply for each working day late up to ten working days at which time a mark of zero may be recorded. No assignments will be accepted after model answers have been posted.
Requirements for student to be awarded a passing grade in the course:
To be assured of receiving a passing grade a student must achieve at least 50% of the total weighted marks available for the course.
Method used to combine assessment results to attain final grade:
The final grades for students will be assigned on the basis of the aggregate of the weighted marks obtained for each of the summative assessment items in the course.
There is no examination for this course.
Examination period when Deferred/Supplementary examinations will be held:
There are no Deferred/Supplementary examinations in this course.
University Student Policies:
Students should read the USQ policies: Definitions, Assessment and Student Academic Misconduct to avoid actions which might contravene University policies and practices. These policies can be found at http://policy.usq.edu.au.
Students must retain a copy of any assignment submitted. If requested, students will be required to provide a copy of assignments submitted for assessment purposes. Such copies should be despatched to USQ within 24 hours of receipt of a request being made.