2013 FALL - Implications of Real Word Evidence for Pharmaceutical R&D IT


The fall 2013 PRISME Forum Technical Meeting was held Wednesday, October 16, 2013, and was hosted by PRISME Forum in Boston, MA, at J. B. Martin Conference Center, Harvard’s Medical School.


The meeting was preceded by a group reception on Tuesday, October 15, 2013.


PRISME Forum Technical Meeting Chair: Jason Swift, AstraZeneca

PRISME Forum Chair: Matteo di Tommaso, Pfizer

Business Meeting of the PRISME Forum 2014

Tuesday and Wednesday, the 18th and 19th of November, 2014

Meeting hosted by PRISME Forum

Implications of Real Word Evidence for Pharmaceutical R&D IT

Building on the success of the PRISME Forum sponsored meeting at AstraZeneca in May 2012 on the topic of “Patient Centred Approaches to R&D”, as well as its recent meeting at Sanofi in May 2013 on the topic of “How Is Pharma R&D Exploiting Big Data?”, the PRISME Forum has chosen to address the theme of Real World Evidence in pharmaceutical industry R&D. Working in close collaboration with the Department of Clinical Informatics at Harvard, the PRISME Forum considered this topic in Boston in October 2013.

Key business drivers that underpinned the relevance of this meeting included:

  • Strategic opportunities in Safety Pharmacovigilance, Patient Recruitment, Patient Monitoring and more
  • Advances in Sensors and Mobile Technologies
  • The explosion in the sources of “Real World Evidence”, and the need for standardised access and methodologies for secondary research
  • The emergence of powerful and scalable “Big Data” technologies including the “cloud”

To compete effectively, Pharmaceutical companies will need to develop innovative medicines that payers will recognise as delivering improved patient outcomes and differentiated products with cost-effective benefits.  To lower the high costs of pharmaceutical R&D, pharmaceutical companies will need to exploit real-world evidence and ‘omics’ data to identify patient sub-populations for whom their medicines will demonstrate value. In an increasingly collaborative R&D environment, the pharmaceutical industry will need to leverage real world data to understand and evaluate stakeholders including patient-care organisations, academic collaborators, CROs, regulatory agencies and payers.

For R&D IT groups the implications of these developments are profound. The role of R&D IT, its strategy, organization, skills and infrastructure will all have to evolve to benefit patient and the industry.

This PRISME Forum Technical Meeting focused on real-world data, integration of very large data sets to support translational science approaches, adaptive clinical trial methodologies and provision of regulatory-compliant IT platforms–perhaps in the “cloud”–to support wide collaboration.

Jason Swift (AZ) was the chair of the PRISME Forum Technical Meeting coordination team supported by Andy Gaughan (AZ), Karsten Tittman (Bayer) and Mike Montello (Shire).