Key Challenges / Opportunities

1. Key Challenges / Opportunities • Alignment with R&D strategy: • R&D Strategic Plan – Do we know what it is? • Need capabilities move up the stack. • How can IT enable, innovate, R&D? • Still Lack insight / knowledge • Has outsourcing been tactical? • Has the business thought about the processes to support collaboration e.g. co-development? • Bringing knowledge back into the organization

2. Key Challenges / Opportunities • Business cases for “interoperability” not well expressed • Ease of use (hard to measure e.g. dropbox) • Value of speed • Value of shared assets/knowledge • Costs not expressed well • Cost hidden • Open data is tough • May expose IP or reveal proprietary methodologies • Supporting Pistoia • Some scepticism • PRISME members have significant influence/control of Pistoia

3. Key Challenges / Opportunities • Standards (data & process) • There are lost of them – hard to agree • Standards can inhibit innovation • Value of standards: decrease costs on the mundane and redeploy on the innovative • Conform business processes • Where is the “burning platform” for standards? • Annotation of data • Outsourcing • Real World Evidence (RWE)

4. Key Challenges / Opportunities • Outsourcing • Business Processes • Heterogeneity equates to cost • Define what we want -- let the outsource partners effect it • Manage the relationship not the process • Aligning Incentives • Knowledge / Intellectual Output • Reduce Costs • Ensuring quality • Trust required collaboration and mechanisms to verify • Detailed understanding of quality is required to interpret the data

5. Key Challenges / Opportunities • Creating Insight • Once we have the data how are we going to make the most out of it • Smart tools – to make decisions – in near real time • Mobile technology • Strategy for “app’ifying” pharma discovery and development. • Competition for “apps” • Discussion on patient data eHRs/eMRs • the payer will analyse the patient data and will be able to define what the medicines profile is • Enabling the “virtual desktop” / external partner portal/ application access. • Define the minimal requirements for Standard infrastructure and Security • External platform as a service • Form a consortium or external PaaS

6. PRISME Action: Benchmarking • PRISME Members conduct to benchmarking/survey virtualisation needs • Prioritize gaps or areas we can work together • Evaluate competitive advantage vs. good area for pre-competitive collaboration • Support case for action: • quantify internal costs or value and develop stronger business case for action • Differentiate “true” competitive advantage from areas where there is high value in collaborating cross-industry

7. PRISME Action: Standards • Set priority and call to action, roadmap, sponsor adoption • Prioritize need for standards and share examples of high quality “de facto” standards • Map standards across R&D • Be pragmatic: • Don’t re-invent; look at what is out there, adopt whatever is furthest ahead • Partner to answer request for a pharma declare the standard • Drive R&D awareness or value of standards