The major trends in the life sciences industry are profoundly affecting the way we all work – from conducting research to distributing products, and everything in between. These major changes have made the need for an IT-enabling business strategy all the more necessary, as IT-enablement is essential to every major change occurring in the industry right now. Creating (or refreshing) and properly articulating your strategy will help your organization stay on track through all of the change, no matter how sweeping those changes turn out to be.
Industry revolution and implications
A broad view of the industry reveals little about the change underway. The drug discovery, development and commercialization processes remain the same. Companies…
- Identify commercially interesting targets (diseases)
- Research therapies and delivery mechanisms that reach the target
- Test the therapies in animals and humans for safety and efficacy
- Obtain regulatory approval in target markets
- Market and sell the drug
- Work with many third parties along way (KOLs, investigators, CROs, HCPs)
However, advances in science, changes in regulatory priorities and the resulting impact on market economics have had a profound impact on business operating models.
- Greater understanding of the genome and bio-markers is resulting in novel therapies that treat diseases more effectively for ever-smaller cohorts (micro-targeting). Advances, in some cases, have progressed to the point that we are targeting cures rather than recurring treatments, using techniques like gene-editing.
- The scientific breakthroughs have motivated the creation of a new generation of research start-ups that are disintermediating traditional Research and Development departments at traditional Big Pharma and now legacy Bio-Techs. There is a lot of money chasing the next big breakthrough.
- Pricing these new therapies has coincided – and collided – with a changing macro-economic and political environment that has put a spotlight on the cost of treatments. Regulatory agencies are now much more likely to approve only those therapies with evidence of much improved outcomes, especially with regard to quality of life. Payors (e.g. Medicare, CHIP) will only grant market access if the therapy is economic.
- These competing pressures have resulted in an ever growing desire to get the science right, earlier in the process. This requires greater end-to-end integration across departments and ever-closer collaboration with all third parties. Additionally, it demands hyper vigilance about cost control throughout the discovery and development cycles.
Everyone is seeking the Holy Grail: a patent-protected platform targeting multiple indications approved globally at desired pricing. Those that win will require a bit of serendipity and an intuitive understanding that everything about their business has changed, including science, competition, pace of execution and the required operating model. The latter often includes a never-ending cycle of M&A, divestitures, new partners and collaborators. For purposes of an analogy, we are still playing chess, but we are now on the clock and playing multiple games simultaneously.
IT evolution and what’s needed
Similarly, at a macro view, little has changed about IT-enablement. We need:
- Core departmental solutions, including: LIMS, CTMS, CDMS, AERS, eSubmissions, Sales Force Automation
- Analytics (data science) capabilities
- Collaboration capabilities
- Knowledge management to sustain our intellectual property
- Validated and secure IT operating environment
With that said, the changing operating models and increasing urgency to execute is increasing demand for IT-enablement, including:
- Tighter integration of the departmental solutions to improve process automation and information sharing end-to-end
- Significantly greater number of external partners (CROs, KOLs, payors, HCPs, regulators, …) requiring the same heightened integration
- Comprehensive data analytics capabilities enabling integrated analyses incorporating both internal and external data; research science; clinical data; market; patient outcomes; and economics
- Robust and seamless collaboration capabilities with all parties
- Ability to integrate and separate data and functions with ease as the business (operating) model changes
In short, our business strategy likely requires a conscious refresh of our IT strategy to ensure continued competitiveness. And, we need to approach the refresh with same newly found sense of urgency because the ever-changing business environment will not stop and wait for us to catch up.
Fortunately, the strategy refresh can be done quickly. A good enough strategy can be created without delay because the macro requirements are well known, and the delivery of many components can be phased. We know:
- Core department solutions exist with the requisite APIs that enable process integration and data sharing
- Analytic environments can be architected to support the requisite dimensions (views) of data
- Collaboration and knowledge management tools exist to support tagging & sharing structured and unstructured data
- Validated and secure IT environments can be sustained internally or in the cloud
While the traditional department solutions often take a year or more to implement, the analytic and collaboration environments should be architected one time and delivered in phases. Phasing should be determined by relative value and readiness (data, organization, etc.).
Keys to creating a good enough strategy that can evolve both priorities and pace include:
- Leaders appreciating the relationship between business strategy and an IT strategy. Any business strategy includes the IT-enablers. They are not separate, disconnected activities
- Leaders sponsoring a small but representative cross-functional team to develop and sustain the strategy
- Shared understanding of what a strategy is. In its simplest form, it answers the following questions:
- Where are we going? What is the relative value of each desired business capability?
- How are we getting there (roadmap)? Why are we using this sequence of activities (value and critical path)?
- What resources are required: people, money and time?
- Time-bound each iteration, and then socialize and refine until good enough to execute the initial phases
- Keep in mind that a little architecting upfront will help ensure flexibility down the road
CMK Select can help you create or refine your own IT-enabling business strategy quickly and efficiently. We’re experts when it comes to the life sciences industry, and IT-enablement possibilities. Contact us today for a consultation.