96014 Molecule to Market
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Subject handbook information prior to 2025 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)
| 008. | Critically evaluate scientific evidence to arrive at evidence-based conclusions |
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| 009. | Interpret experimental data in relation to pre-clinical and clinical investigations |
| 014. | Develop proficiency in collaborative learning by actively engaging with peers, contributing effectively to group discussions and activities, providing constructive feedback, and applying conflict resolution strategies within team learning environments. |
| 020. | Explain the legislation, regulations, standards and guidelines relating to pharmacy and the distribution and use of medicines in Australia |
| 034. | Examine how pharmaceutical sciences principles are applied in the drug discovery, design and development processes |
| 045. | Examine the stages within the product life cycle of medicines from molecule discovery to market availability, integrating knowledge of regulatory requirements, clinical trials, manufacturing, commercialisation strategies, and post-marketing phases to ensure safe and effective medication use. |
Course intended learning outcomes (CILOs)
The learning outcomes for this subject are as follows:
- Reflect on knowledge, skills and attributes required for the evaluation and integration of emerging evidence into practice, promoting the growth of personal and professional learning and the education of others (01.02)
- Analyse and synthesise knowledge of health science concepts and theory, and apply skills of scientific research and clinical reasoning to support decision-making in pharmacy practice. (01.03)
- Engage in team undertakings adopting a range of roles in diverse teams, building cohesion and maximising team contributions. (02.04)
- Integrate into daily practice knowledge of health systems and concerns in national and global communities, with awareness of the social and cultural contexts of health to meet the diverse needs of individuals and communities. (03.07)
Contribution to the development of graduate attributes
This subject contributes to the development of the following graduate attributes:
Lifelong learning:
Graduates of the Master of Pharmacy are lifelong learners, committed to and capable of reflection and inquiry in their quest for personal development and excellence in professional practice.
Professional capacity:
Graduates of the Master of Pharmacy are client-focussed, ethical practitioners with the understanding and proficiency to be leaders in their profession, capable of effectively researching and communicating solutions in a global context.
Global Citizenship:
Graduates of the Master of Pharmacy contribute to society, resolving to undertake those actions and responsibilities that will enhance their role in local, national and global communities.
Teaching and learning strategies
In this subject, students learn through face-to-face lectures, interactive workshops, collaborative quizzes, and a semester-long subject-encompassing project.
Strategy 1: Student preparation for learning: Students read articles and use online resources (provided via Canvas) to prepare for their participation in activities including collaborative discussion and group quizzes. For example technical summaries of medicinal products, or business case studies analysing the strategy of a company, which will then integrate with lecture and/or workshop material.
Strategy 2: Active lectures: Q&A sessions are a key learning resource in this subject. Attending Q&A sessions is crucial to a full understanding of the subject content. Q&A sessions are delivered by industry guests who are experts in their field, and students are encouraged to take advantage of the in-depth knowledge on offer. These sessions may include videos which are then opened up for discussion, or explore and expand upon the online pre-work for that week.
Strategy 3: Collaborative and interactive learning in workshops: Workshops provide students with an opportunity to discuss and clarify concepts from the lectures, thus providing the students the opportunity for deeper understanding. Each week students will engage in group discussion and some weeks an oral presentation will be given, with in-class feedback from the industry guest and/or tutor. Other weeks will include a collaborative quiz that is completed within groups, with feedback available online within two weeks, to inform the student of their understanding of the topic.
Strategy 4: Early and consistent feedback: Peer and self feedback regarding the project is provided individually via SPARK, with a formative and summative SPARK being executed both early and later in semester. Feedback is also given in workshops, with the first workshop per week dedicated to the weekly topic, and the second workshop per week dedicated to guiding project work for that week’s topic. The collaborative learning approach utilised in the class will enable ongoing feedback to be provided as areas of learning need are identified.
Strategy 5: Semester-long project: Running from weeks 1-14, students will be working in a large team, made up of mock pharmaceutical company positions. An assigned product is taken through its lifecycle, from the process of discovery, to market launch. The project allows students to explore the details of each week’s topic area with respect to their product, guided by industry experts within the workshops. Students develop: effective teamwork strategies to manage their groups, and research skills in acquiring and analysing information in new topic areas.
Structure:
Preparation for classes is approximately 20 minutes per week and starts in week 1. Weekly Q&A sessions commence in week 1. Q&A sessions are one hour long.
2 x weekly workshops commence in week 1. Workshops are two hours long.
Content (topics)
Molecule to Market combines students’ prior learning, builds on topics already encountered within the degree, and introduces new topics that complete the picture of a pharmaceutical product lifecycle. Knowing the interplay between regulatory bodies, commercial ventures, health professionals and patients, develops the student’s understanding of how and why a pharmaceutical product is available to the public. Knowledge learned in Molecule to Market also informs the student on many other facets of their clinical practice, such as what happens to data reported in adverse events, why patients may or may not be eligible for a clinical trial, and the strategies behind generics vs brand name pharmaceuticals. This course gives the student an insight into the industry that provides the products that are dispensed, hence a deeper understanding of what pharmacists are providing to patients on a daily basis.
Students will utilise all of their learnt teamwork skills throughout the degree to successfully complete the project.
Topics include:
- Development and implementation of business strategy for commercialisation of a pharmaceutical compound
- Drug discovery and preclinical considerations
- Commercialisation of a pharmaceutical product
- Intellectual property in pharmaceutical industry
- Project budgeting
- Regulatory requirements and TGA approvals
- Clinical study design
- People and company culture
- Pharmacoeconomics
- Manufacturing strategy
- Launch strategy, plan and implementation
- Post marketing surveillance: pharmacovigilance
Assessment
Assessment task 1: Organisation Plan
| Intent: | To allow students engage with knowledge and skills they have learned and demonstrate their understanding of risk management, resource allocation, communication, and essential development phases in launch of a new medicinal product in a competitive market. |
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| Objective(s): | This task is aligned with the following subject learning objectives: 008, 014 and 045 This task is aligned with the following course learning outcomes: 01.03 and 02.04 |
| Type: | Project |
| Groupwork: | Group, individually assessed |
| Weight: | 15% |
| Criteria: | Grading criteria will be provided via Canvas |
Assessment task 2: Active Class Participation
| Intent: | To assess the participation of students to group activities and to discuss the rationale and design of the relevant stage of a drug molecule research, development, clinical trial, manufacturing, registration and launch. |
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| Objective(s): | This task is aligned with the following subject learning objectives: 008, 020, 034 and 045 This task is aligned with the following course learning outcomes: 01.03 and 02.04 |
| Type: | Quiz/test |
| Groupwork: | Individual |
| Weight: | 40% |
| Criteria: | Presentations and quizzes will be assessed by Subject Coordinator throughout the session |
Assessment task 3: Pharmaceutical Development Plan
| Intent: | This assessment task contributes to the development of course intended learning outcomes:
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| Objective(s): | This task is aligned with the following subject learning objectives: 008, 009, 014, 020, 034 and 045 This task is aligned with the following course learning outcomes: 01.02, 01.03, 02.04 and 03.07 |
| Type: | Project |
| Groupwork: | Group, individually assessed |
| Weight: | 45% |
| Criteria: | Grading criteria will be provided via Canvas |
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
Coursework Assessments Procedures
Graduate School of Health Policy, Guidelines and Procedures (login required)
Additional required readings will be provided via Canvas