As the pharmaceutical industry faces increasing pressure to innovate, streamline operations, and improve product quality, the adoption of Pharma 4.0 - the application of digital technology to pharmaceutical development and manufacturing workflows - has become a strategic imperative. However, the path to implementing digital transformation is fraught with challenges, including organisational inertia, competing priorities, and budgetary constraints. While the potential benefits of Pharma 4.0 are clear, successfully securing executive buy-in and the necessary resources to implement transformative technologies requires a robust, well-crafted business case that aligns with organisational goals and demonstrates measurable value.
This course delves into the critical components of building and defending a compelling business case for Pharma 4.0 initiatives. Participants will gain a deep understanding of the industry trends driving digital transformation and the current landscape of digital solutions within drug development and manufacturing. Through interactive discussions and real-world case studies, participants will learn from organisations that have successfully navigated these challenges and secured approval for transformative projects.
Whether you are championing a new technology, advocating for process automation, or driving a broader digital strategy, this course will equip you with the tools and insights needed to articulate your vision, secure funding, and pave the way for Pharma 4.0 success.
Key topics covered in this course include:
- What is Pharma 4.0?
- What is a business case?
- Industry trends driving digital transformation initiatives in drug development &
manufacturing - Current landscape of digital solutions in drug development and manufacturing
- Why digital transformation is not a foregone conclusion
- How to build and defend business cases to secure executive approval and budget
- Real world examples of successful business cases
Benefits of attending
By the end of this course, participants will be able to:
- Understand the industry trends shaping digital transformation in drug development and manufacturing
- Explore the different categories of software within pharmaceutical development and manufacturing
- Develop structured business cases that clearly articulate the value and ROI of Pharma 4.0 initiatives
- Communicate business cases effectively to secure executive approval and funding
- Leverage real-world examples of successful business cases to drive their own Pharma 4.0 initiatives
Speakers
Lewis Shipp,
Published Pharmaceutical ScientistLewis Shipp is a published pharmaceutical scientist and a recognised expert in drug development & manufacturing across a range of therapeutic modalities. Lewis currently works at the intersection of science & technology as a Digital CMC Specialist at QbDVision, helping organisations both large & small leverage digital technology to accelerate the delivery of therapies to patients.
Additionally, Lewis has contributed to ISPE's Pharma 4.0 Special Interest Group & BioPhorum's Technology Strategy Forum as an SME in the application of digital technology to solve business process challenges within the pharmaceutical industry. Lewis has also given several presentations at internationally recognised conferences on varying topics pertaining to digitally-enabled drug development and manufacturing.
Who Should Attend
This course is ideal for individuals looking to be change agents-those advocating for change through technology-within pharmaceutical and biotechnology organisations. This could include:
- Business stakeholders (development, manufacturing, quality, regulatory and technical operations)
- Technology stakeholders working in a data and/or digital capacity
This course is suitable for all levels (scientists, managers, and senior leadership). The course will focus on digital transformation within drug development and manufacturing, so may not be suitable for individuals working in drug discovery and/or in a clinical capacity.
