The world as the life sciences industry once knew it has changed completely. Companies are facing new pressures to get more innovative drugs to market faster and at lower prices. This is driving an increased need for capital-efficient innovation that for life sciences is about developing innovation strategies that address key areas, such as optimizing R&D for greater productivity and better leveraging regulatory information across the organization to bring therapies to patients across the globe faster. And it is essential that these innovation strategies be complemented with cost transformation strategies. This is an issue my colleague Sharad Khusal has explored in great detail with his blog on Closing the Loop.
One of the key aspects of capital-efficient innovation for the life sciences industry is delivering value from the regulatory process. We identify three core enablers here:
- Leveraging regulatory information across the enterprise to bring innovative products to market more rapidly while mitigating risk through regulatory information management (RIM).
- Master data management, which essentially means building a centralized view of your information and which will become integral with the market-readiness of the Identification of Medicinal Products (IDMP) standards next year.
- Improving usability, which is about enabling users to access the information they need quickly and easily and from multiple devices.
I’d like to go into a bit more depth on the first of these enablers, RIM. As the industry is confronted with rapidly changing regulatory requirements, it can be a challenge to keep up to date. The point of RIM is that it has the potential to help you stay on top of your data and manage the requirements in a more agile manner, while also helping you to collaborate better with your partners and customers.
RIM is undoubtedly about the systems you have in place, which should encompass regulatory publishing tools, regulatory tracking, and content management. But that’s only part of the picture. Equally, RIM is about your processes and how you tie all those different pieces together, and that requires having a partner who can provide business process expertise to envision the best solution. And thirdly, as more companies look to focus on their core capabilities – which are to bring innovative products to the market and drive market share – the opportunity to outsource those publishing, tracking, and content management tasks becomes a very real consideration.
That brings us full circle to the topic of capital-efficient innovation: How do you achieve those end-to-end capabilities and build value for the business without adding cost? One way is through a cloud-based delivery model, targeted to delivering a flexible solution for the customer. A further way to eliminate the burden placed on your resources – both financial and personnel – is to partially or completely outsource business processes, where viable.
In our next blog, we will explore master data management and its importance in light of the rapid move toward IDMP.