Introduction Contents The traditional business model of life sciences companies is under unprecedented stress. Demographics and technology are Leading organizations know Introduction .............................. 1 converging to drive a once-in-a-lifetime transformation: as more that the Internal Audit Impact of a changing environment ............ 2 people than ever before are receiving care and chronic illnesses in function can leverage its core Navigating the new landscape ................ 4 an aging population threaten to reach pandemic proportions, competencies and its view consumers have access to devices and data that give them ever- across the enterprise to help The audits that matter ...................... 7 increasing control over their care. identify and assess the risks Conclusion ............................... 11 Across the board, there is an urgent focus on coordinated, lower-cost care with improved that matter. To help further outcomes. Taming escalating costs is essential: in the US, health care costs are expected the discussion, we asked to reach 23% of GDP, up from 17% in 2012,1 our life sciences sector while 13% of adults in the UK and 6% of adults 2 in France face serious challenges in paying their medical bills. At the same time, countries professionals to draw on their around the world are expanding access to health care, and a growing middle class in the knowledge and experience emerging markets is demanding more — and better — care. and develop a list of audits Given the volatility of the landscape and the velocity of innovation and information, it’s to consider. more important than ever for organizations to gain visibility into everything they do. At this inflection point for the industry, organizations that know their supply chain, understand the efficacy of their products and the health outcomes that result from their use, and know their partners and influencers will be best placed for success. Internal Audit (IA) will play an essential role in helping companies gain the visibility they need to succeed. With its ability to look across the enterprise, IA can help spot emerging issues, help sharpen the organization’s focus on compliance, drive efficiencies and add value to the business — all while continuing to provide the baseline assurance the organization requires. In particular, IA can serve the organization by developing audits that focus on the risks that matter. 1 “NHE Fact Sheet,” Centers for Medicare & Medicaid Services website, September 2014. 2 “Health Affairs Web First,” The Common Wealth Survey 2013, November 2013. How Internal Audit can help life sciences companies change with the times | 1