This article provides a round-up of hot topics presented at this year’s RAPS Regulatory Convergence and includes a high level recap of innovation and technology: practical applications for regulatory, Zika, real world evidence, faster patient access to innovative and critical medicine, recent developments in off-label promotion and medical devices.

Innovation and Technology: Practical Applications for Regulatory

A panel discussion explored the topic of emerging technology applications in our regulated industry, bringing together Larry Carrier of Verily Life Sciences, Kathy Hibbs of 23andMe, Francine Ratner Kaufman of Medtronic and Bakul Patel of CDRH. On the innovation front, there was talk about the Internet of Medical Things (IoMT), which offers the possibility for continuous monitoring leading to early interventions, such as Medtronic’s continual glucose monitoring system. They also touched briefly on regulating Software as a Medical Device (SaMD) noting alignment and collaboration with the FDA are keys to success.
The main conclusion was that while these innovations bring vast tangible benefits, there is an urgent need for regulators to keep pace for patient protection. While technology in healthcare can empower and engage patients, it also can expose them to more risk for being hacked or making decisions to share data they may come to regret in the future. 

Zika

Several sessions were held on the Zika outbreak and how R&D will be critical to addressing this and future emerging diseases. An integrated public-private sector approach is needed to develop the necessary vaccines, therapeutics, diagnostics, devices and novel approaches. Policy and financial considerations must be addressed. The goal is to learn from the mistakes made in dealing with the Ebola outbreak, which exposed weaknesses in the global health system and showed the mechanisms for the establishment of public-private partnerships were lacking.{1}

Puerto Rico is as an ideal ecosystem for Zika R&D as it is endemic for the disease, covered by FDA’s authority, and is one of the top three states for share of highly specialized biopharmaceutical employment. Figure 1 shows the distribution of biotechnology, pharmaceutical, agricultural biology, and medical device employers across Puerto Rico. TransCelerate and Yale University have been key enablers of the Puerto Rico Consortium for Clinical Investigation (PRCCI). PRCCI has a pipeline of eight clinical studies for Zika-related products as of July 2016 so they are likely a group to watch in this space over the coming year.{2}

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Why Transform?

Over the next few years, Life Sciences organizations will enter a truly transformational era of technology driven finance. As we move rapidly into the digital age, finance technology is evolving to support the essential characteristics of Life Sciences organizations.

Key drivers of the digital transformation impacting finance teams include:
  1. Reducing administrative/accounting tasks related to monthly/quarterly close to free up finance resources to provide business insights that improve operations and customer satisfaction.
  2. Data security to thwart criminal efforts to harm brand, reputation.
  3. Streamlined and automated processes, strong information governance and effective policies that reduce finance costs and use assets to enable business value added activities.  
What does optimizing a Finance team mean?
  • Does it mean finance teams need to eliminate using Excel spreadsheets for analysis and the associated risk potential for spreadsheet errors?
  • Does it mean analytics technologies must be researched and implemented?
  • Does it mean change management must be incorporated to present a seamless transition to more optimized day-to-day practices?
  • Is transformation all about enhancing reporting?
  • Is the goal of transformation to shorten close cycles or deploy cost cutting measures to enable acquisition of new lines of business?
The answer to all of the above is YES.

To meet rising demands for transformation, Life Sciences organizations are striving to align financial strategy with enterprise-wide business requirements, allowing more effective management of assets, extraction of pertinent analytics from financial and operational systems and improved operational efficiency. 

Transforming the function of a finance team opens opportunities to address all of the above for Life Sciences today.