96014 Molecule to Market
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Subject handbook information prior to 2018 is available in the Archives.
Credit points: 6 cp
Result type: Grade and marks
Requisite(s): 96009 Professional Services 3 AND 96010 Integrated Therapeutics 2 AND 96011 Primary Health Care
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 makes 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, it is likely 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 subsidised 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).
Subject learning objectives (SLOs)
| 0075. | Demonstrate ability to arrive at evidence-based conclusions by critical evaluation of scientific evidence |
|---|---|
| 0076. | Interpret experimental data in relation to pre-clinical and clinical investigations |
| 0089. | Explain the legislation, regulations, standards and guidelines relating to pharmacy and the distribution and use of medicines in Australia |
| 0100. | Explain the essential principles and tools of pharmacoeconomics |
| 0101. | Describe how/apply the principles of pharmacoeconomics apply to medicine registration and use |
| 0134. | Identify key qualities of an effective team |
| 0190. | Describe the stages of drug discovery and multidisciplinary approaches used in clinical drug development |
| 0222. | Describe the drug commercialisation process |
| 0532. | Trace the application of pharmaceutical science principles in the process of drug design and development |
| 0542. | Trace how R & D in Australia is driven by global considerations |
| 0543. | Explain how manufacturing and product quality strategies influence the development and commercialisation of pharmaceuticals |
| 0544. | Interpret post-marketing (pharmacovigilance) data to protect and enhance consumer safety |
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 session-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. An emphasis is placed on collaborative learning, with students engaging in investigative case study workshops in teams which are then presented and discussed with the class as a whole. Learnings are strengthened in a latter weekly workshop where students apply their understanding and tailor it to their team project as it evolves through the semester. Dedicated classroom time towards the team project also provides weekly opportunities to engage with industry professionals from the highlighted topic field in discussions and project design sessions. Prior to coming to class, students are required to go through any set pre-readings and materials which are deconstructed and discussed during class hours.
Students further develop their learning through individual quizzes and the collaborative group project in which they must submit a development plan for their product. An oral component in the form of a ‘pitch’ at the end of the project gives students experience in effectively explaining complex ideas, whilst also supporting their academic, presentation and research communication skills.
Content (topics)
Topics include:
Development and implementation of business strategy for commercialization of a pharmaceutical compound
Drug discovery and preclinical considerations
Intellectual property in pharmaceutical industry
Regulatory requirements and TGA approvals
Clinical study design
Pharmacoeconomics
Manufacturing strategy and launch
Post marketing surveillance: pharmacovigilance
Assessment
Assessment task 1: Project Plan
| Intent: | In developing the project plan, students engage with knowledge and skills they have learned throughout the course and demonstrate their understanding of risk management, resource allocation, communication, documentations and essential development phases in launch of a new medicinal product in a competitive market With an emphasis on group work, this assessment is designed to provide students with detailed feedback regarding the initial project plan and provides opportunities for project refinement. |
|---|---|
| Type: | Project |
| Groupwork: | Group, group and individually assessed |
| Weight: | 15% |
| Criteria: | Grading criteria will be provided via UTSOnline |
Assessment task 2: Mid-session Exam
| Intent: | This assessment is designed to test students’ knowledge in evaluation of scientific evidence and multidisciplinary approaches used in drug development |
|---|---|
| Type: | Mid-session examination |
| Groupwork: | Individual |
| Weight: | 20% |
| Criteria: | N/A |
Assessment task 3: Late-session MCQ
| Intent: | This exam provides the students the opportunity to review the lecture material and demonstrate their knowledge of pharmacoeconomics, interpretation of post marketing data, clinical investigations and commercialization process. |
|---|---|
| Type: | Examination |
| Groupwork: | Individual |
| Weight: | 20% |
| Criteria: | N/A |
Assessment task 4: Oral Exam (Formal Presentation)
| Intent: | This task is the last stage of the team project and comprises of submission and oral presentation of development and commercialisation plan that students have been working on throughout the semester. This authentic assessment engages students in developing a new drug from original idea to the launch of a finished product by making real-world strategic choices and plan development phases in support of the launch of new product. |
|---|---|
| Type: | Presentation |
| Groupwork: | Group, group and individually assessed |
| Weight: | 45% |
| Criteria: | Grading criteria will be provided via UTSOnline |
Minimum requirements
In order to pass this Subject, students are required to attend a minimum of 85% of classes, submit all assessment tasks and achieve a minimum overall grade of 50%.
Required texts
Policy for Assessment of Coursework Subjects
Procedures for assessment of Coursework Subjects
Graduate School of Health Policy, Guidelines and Procedures (login required)
Additional required readings will be provided via UTSOnline
