Judging the best technological moves

Companies need to assess the best way to make technological investments in research and development (R&D) and supply chain that will be necessary for preparedness for the future while also delivering answers to current pressing demands. As part of this process priorities will need to be considered from alternative scenarios.

• Should companies be making ‘big leap’ or small step changes?
• How can companies judge how best to prepare for future development, manufacturing strategy and infrastructure?
• How fast and far should they move?
• What are the cultural and behavioural changes that need to accompany technological change?
• How to build up the business case?
• Who makes decisions – business vs. IT?
• What governance is in place?
• How do companies manage spend and progress once decisions have been made and how do they ensure that projects run to budget?

Many companies are seeking to implement change, based on today’s competitive challenges without taking into account the overall long term perspective, often concentrating efforts in one business area. This is because decisions are not being informed by a clear vision or a broadly evaluated business case. Such a vision must address the regulatory, market, scientific and technological forces that will shape pharmaceutical R&D and manufacturing in the future. The outcome of this type of process will be a view about what type of R&D and manufacturing strategy and plant the company needs in a more medium to long term timeframe, say five to ten years time which, in turn, can frame the steps they take now. The answer may be different from plant to plant and many companies are likely to need to plan for a mix of scenarios.

The technological change roadmap needs to be shaped by calculations based on a proper assessment of the future and how that influences the assumptions built into the decision making process; this then links to ROI (return on investment) or expected net present value (NPV) and risk evaluation ensuring a route to the future destinations as well as an effective answer to the more short to medium term five, ten and fifteen year challenges along the way.

How PwC can help you
PwC’s Information Technology services practice provides a full range of services, from quality by design (QbD), process analytical technology (PAT) solutions, product lifecycle to knowledge management tools.

• Reduce costs by minimising waste and re-work
• Prepare for a future bases on live licensing
• Deliver more flexible manufacturing
• Respond to regulatory goals flagged up by the US Food and Drug Administration (FDA) and European Medical Agency (EMA)
• Bridge the gap between R&D and manufacturing
• Reduce drug development time
• Embrace the full potential of the FDA’s cGMP for the 21st initiative and new process validation guideline by identifying technological and IT changes in R&D and manufacturing.