96014 Molecule to Market
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Credit points: 6 cp
Result type: Grade and marks
Requisite(s): 96002c Concepts in Pharmaceutical Sciences
The lower case 'c' after the subject code indicates that the subject is a corequisite. See definitions for details.
These requisites may not apply to students in certain courses.
There are course requisites for this subject. See access conditions.
Description
This subject covers the drug development process from laboratory to patient – a high risk, high cost but high reward process. One in 10,000 screened compounds make it to market. The subject outlines the stages of the pharmaceutical research and development of a drug. The process begins with drug discovery that can take five years in assessing 10,000 compounds. Of these 10,000 compounds, 250 are subject to pre-clinical studies that can take upwards of two years. Of these 250 compounds, only five make it to clinical trials, which can take six years. This includes phase 1 to phase 3 efficacy and safety clinical studies. Of these five compounds, only one will have the necessary chemistry, pre-clinical and clinical data for a regulatory dossier to be compiled and submitted to the Therapeutic Goods Administration (TGA) in Australia. The TGA is responsible for evaluating the efficacy, safety and quality of new drugs. Access to medicines for patients involves product registration via the TGA and pricing reimbursement via the Pharmaceutical Benefits Advisory Committee (PBAC). This subject also outlines what is involved in successfully registering a medicine and listing it with the Pharmaceutical Benefits Scheme (PBS).
Contribution to the development of graduate attributes
The purpose of 96014 Molecule to Market is to combine the knowledge, skills and attributes acquired throughout the Master of Pharmacy, tracing how all the Pharmacy disciplines are applied to discover, develop, manufacture and market a new medicinal product.
In this subject the content of previously completed subjects will be applied to the understanding of the strategic choices and the planning of essential development phases in support of the launch of a new medicinal product. Central to this subject is a semester-long project to conceive, develop, launch, market and monitor an innovative pharmaceutical product.
Teaching and learning strategies
Students apply the knowledge and skills they have learned throughout the Master of Pharmacy in an extended project. Scheduled lectures provide the theoretical underpinnings for each stage of the project.
Assessment
Assessment task 1: Project Plan
| Type: | Project |
|---|---|
| Groupwork: | Group, group and individually assessed |
| Weight: | 15% |
| Length: | Max 5000 characters excluding references |
| Criteria: | Grading criteria will be provided via UTSOnline in Week 2 |
Assessment task 2: Mid-term Exam
| Type: | Mid-semester examination |
|---|---|
| Groupwork: | Individual |
| Weight: | 20% |
| Criteria: | N/A |
Assessment task 3: Late-term MCQ
| Type: | Examination |
|---|---|
| Groupwork: | Individual |
| Weight: | 20% |
| Criteria: | N/A |
Assessment task 4: Oral Exam (Formal Presentation)
| Type: | Presentation |
|---|---|
| Groupwork: | Group, group and individually assessed |
| Weight: | 45% |
| Criteria: | Grading criteria will be provided via UTSOnline |
Minimum requirements
Students are required to attend a minimum of 85% of scheduled classes.
