PM4PYE4: Pharmaceutical Innovation and Product Development

Module code: PM4PYE4

Module provider: Pharmacy; School of Chemistry, Food and Pharmacy

Credits: 20

Level: Level 4 (Undergraduate Masters)

When you'll be taught: Semester 2

Module convenor: Miss Sarah Needs, email: s.h.needs@reading.ac.uk

Pre-requisite module(s): BEFORE TAKING THIS MODULE YOU MUST TAKE PM3PY1 AND TAKE PM3PY2 AND TAKE PM3PY3 (Compulsory)

Co-requisite module(s): IN THE SAME YEAR AS TAKING THIS MODULE YOU MUST TAKE PM4PY1 AND TAKE PM4PY2 AND TAKE PM4PY3 (Compulsory)

Pre-requisite or Co-requisite module(s):

Module(s) excluded: IN TAKING THIS MODULE YOU CANNOT TAKE PM4PYE2 OR TAKE PM4PYE3 (Compulsory)

Placement information: NA

Academic year: 2024/5

Available to visiting students: No

Talis reading list: Yes

Last updated: 21 May 2024

Overview

Module aims and purpose

This module gives students an understanding of the innovation process “from science to person”, introducing the core topics of scientific innovation and product development (focussed on medicines and medical devices), whilst developing core skills that link science to industry. Students will learn to identify critical business development challenges that need to be addressed for science to benefit society.

Students will be introduced to core topics surrounding the societal and industrial challenge of translating science into real-world public benefit in the form of innovative healthcare products. The taught content covers the full range of innovation skills and knowledge, including a range of critical business development areas, alongside details of the product development pathway. Innovation topics include customer and market insight, intellectual property, finance, business development, and finally leadership. Students will also follow the lifecycle of a product launch, becoming aware how to effectively plan a product launch. Diverse case studies of real products and innovations, plus product concepts, will be explored by students.

The module teaches the core skills and knowledge to navigate the path “from science to person”. Students will learn by doing, gaining transferrable innovation skills. The module thus teaches the core skills and knowledge to navigate the path “from science to person”.

Aims

To give students an understanding of the process of scientific innovation, such that they can effectively plan product development from science through to patients and customers.

• To give students an understanding of the lifecycle of a product from idea through development to launch, such that they can effectively plan a launch and know the core issues that need to be addressed.
• To distinguish the detailed product development path for an individual product, from the broader innovation process
• To equip students with relevant skills through hands-on practice of vital innovation and product development activities, including project management, product-focussed research, financial planning, and market assessment.

Module learning outcomes

By the end of the module, it is expected that students will be able to:

1. Present in writing, elements from an outline business plan to develop an innovative product, describing the pathway from science through to customer/patient.
2. Define a market and research customer requirements.
3. Critically assess a product development plan, and outline how to design a product to a brief.
4. Recognise the importance of rigorous product testing, and understand the difference between experimental prototypes and manufactured product.
5. Recognise regulatory constraints, and related processes to consider when manufacturing a new product.
6. Identify and describe the key business development elements surrounding the delivery of an innovative product, including intellectual property, finance and management concepts.

Module content

The module will comprise two interlinked learning streams. A “product development” stream will be developed over the full term, taking students through the path from initial brief through to product launch. Alongside this, an overview of the broader scope of innovation of science-derived products will be developed that will cover the major areas of business development needed in addition to the product being developed.

A: Product development stream

This learning stream will cover the following stages, divided amongst 5 biweekly sections.

• Mapping steps to take a new product from science through to delivery
• Technical development (formulation, manufacturing, packaging and performance testing)
• Defining clinical and/or customer need and developing problem statements
• Regulatory and safety appropriate to the product
• Marketing, packaging, and product launch including post-sales support

B: Innovation stream:

In parallel, the innovation learning stream will incorporate the broader elements that feed into product development. It will cover topics including:

Product development, as above

• Customers. Market understanding
• Intellectual property
• Finance
• Business development including partnering and competitor analysis
• Leadership, project and people management

Whilst studying content taught within the above topic headings, core transferrable skills will be developed including independent research, presentation skills (written and verbal) and project management. These will be developed by tasks and project work, including case study and developing new product concepts, completed individually and in groups.

Student will also develop skills that will enable them to:

• Conduct independent research to contribute to building elements of a business plan
• Critically analyse a product launch and monitor the market
• Identify the major areas required to translate scientific progress into real-world benefits
• Develop teamworking and project management skills through working in multidisciplinary groups

Be aware of how the carbon footprint of pharmaceuticals is increasingly being considered in the development of new medicines.

Structure

Teaching and learning methods

The module will encourage students to study new topics rapidly and independently, in order to cover the breadth of the topic.

Significant parts of the module will incorporate problem-based and team-based learning and students will complete focussed tasks around small projects and case studies individually and in groups. By conducting these tasks and projects, students will gain understanding of new topics and at the same time develop essential innovation and product development skills.

A core series of 1 hour weekly lectures will introduce each topic or set of topics throughout the term, starting from first principles in the first week, all the way through to covering the full set of topics by the end of spring term.

Each week, a 2 hour workshop session will be used with group tasks to allow the students to work together under supervision, plan their independent study, ask questions and practice presentations. Support for assessed coursework will be provided within the workshop sessions, including organised peer and academic feedback, and opportunities to practice presenting product and business development material.

Where possible additional visiting speakers will present external commercial perspective to complement lectures and workshops.

A major focus for teamwork, workshops, and individual study is to produce presentations and business plan material to present during the end of module “Pitchfest” session that will bring the whole class together to celebrate and reflect through business plan and product development presentations, including opportunities for peer and additional feedback

Study hours

At least 30 hours of scheduled teaching and learning activities will be delivered in person, with the remaining hours for scheduled and self-scheduled teaching and learning activities delivered either in person or online. You will receive further details about how these hours will be delivered before the start of the module.

Please note the independent study hours above are notional numbers of hours; each student will approach studying in different ways. We would advise you to reflect on your learning and the number of hours you are allocating to these tasks.

Semester 1 The hours in this column may include hours during the Christmas holiday period.

Semester 2 The hours in this column may include hours during the Easter holiday period.

Summer The hours in this column will take place during the summer holidays and may be at the start and/or end of the module.

Assessment

Requirements for a pass

Students need to achieve an overall module mark of 50% to pass this module

Summative assessment

Penalties for late submission of summative assessment

The Support Centres will apply the following penalties for work submitted late:

Assessments with numerical marks

• where the piece of work is submitted after the original deadline (or any formally agreed extension to the deadline): 10% of the total marks available for that piece of work will be deducted from the mark for each working day (or part thereof) following the deadline up to a total of three working days;
• the mark awarded due to the imposition of the penalty shall not fall below the threshold pass mark, namely 40% in the case of modules at Levels 4-6 (i.e. undergraduate modules for Parts 1-3) and 50% in the case of Level 7 modules offered as part of an Integrated Masters or taught postgraduate degree programme;
• where the piece of work is awarded a mark below the threshold pass mark prior to any penalty being imposed, and is submitted up to three working days after the original deadline (or any formally agreed extension to the deadline), no penalty shall be imposed;
• where the piece of work is submitted more than three working days after the original deadline (or any formally agreed extension to the deadline): a mark of zero will be recorded.

Assessments marked Pass/Fail

• where the piece of work is submitted within three working days of the deadline (or any formally agreed extension of the deadline): no penalty will be applied;
• where the piece of work is submitted more than three working days after the original deadline (or any formally agreed extension of the deadline): a grade of Fail will be awarded.

The University policy statement on penalties for late submission can be found at: https://www.reading.ac.uk/cqsd/-/media/project/functions/cqsd/documents/qap/penaltiesforlatesubmission.pdf

You are strongly advised to ensure that coursework is submitted by the relevant deadline. You should note that it is advisable to submit work in an unfinished state rather than to fail to submit any work.

Formative assessment

Formative assessment is any task or activity which creates feedback (or feedforward) for you about your learning, but which does not contribute towards your overall module mark.

Formative feedback will be given regularly during presentations given by students during workshops, both from staff and peers. Several portfolio activities and items will be prepared to set deadlines and formative feedback provided on these tasks during the weekly progress workshops. Students will be expected to provide formative feedback throughout the term to each other through peer feedback and reflect on their own development and understanding through recording what they learned from the formative feedback that they receive.

Reassessment

Additional costs