The Role of Real World Data in Bringing Medication to Market and Beyond with Bruno Villetelle

In this episode of Real World Talk, host Emily Di Capua talks to Bruno Villetelle, Head of Data and Digital for Novartis. They discuss the ways real world data is being used to innovate drug development and delivery so that patients can benefit from new discoveries sooner.

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Highlights

  • [00:31] Introduction — Emily Di Capua introduces Bruno Villetelle, Head of Data and Digital for Novartis.
  • [03:28] Early stages — Real world data is being used early in the drug development process in single-arm Phase II trials with a very small number of patients. It is being leveraged to provide insight into potential new indications for novel and existing therapies.
  • [07:26] All on board — Villetelle says it’s vital to have a company-wide strategy for using real world data. Prioritize access to essential data sources and make sure software and tools are uniform across all departments.
  • [08:52] Decentralized trials — Novartis is working to normalize decentralized clinical trials (DCT), which are more accessible for patients and make it easier to follow up on a drug’s impact once it’s in the market.
  • [13:30] COVID impact — The COVID-19 pandemic accelerated the need for DCTs, as people became reluctant to visit healthcare facilities.
  • [14:00] Crucial partnerships — Partnerships are essential to helping Novartis achieve its goals. It recently partnered with Microsoft on AI models, and it’s also open to working with startups and academic institutions.
  • [15:19] The three what-ifs — Novartis breaks its data and digital goals into three questions: What if you could bring a drug to patients two years faster? What if you could do that for twice as many patients? And what if it could all happen for a better cost?
  • [16:18] Specific therapies — In addition to using real world data to improve the drug development process, Novartis studies how new technology may benefit specific medicines.
  • [19:42] The Medici effect — Villetelle believes that taking inspiration from different industries, cultures and disciplines is key to greater resourcefulness and new ideas.
  • [22:22] Diversity is good for business — Villetelle also values diversity within Novartis: When you have people from different backgrounds, you have different ways of thinking to draw on, which leads to more innovation.
  • [25:18] Aviation inspiration — Examining the way the aviation industry handles complicated data inspired the development of the Sense platform, which tracks every trial Novartis is running: 500 clinical trials in over 70 countries.
  • [27:02] Faster, better — Novartis is using AI to make its drug development process more efficient and to power up its abilities to process data, reducing the time it takes to turn data into evidence.

Key Points

  • Real world data should be used to improve patient experiences. The three main aims of Novartis’s data and digital arm are bringing medications to twice as many patients two years earlier at a lower cost. The company uses real world data and AI to analyze and update the drug development process and to study how patients on specific medications can benefit from technology such as sensors and drug delivery systems.
  • COVID-19 has reaffirmed that there is a place for decentralized clinical trials. Siteless or decentralized trials reverse the traditional clinical trial experience for patients in a way that makes it easier for them to participate — especially with social distancing requirements. Telemedicine, mobile nursing and new ways to deliver medicines bring the trial to patients. New technologies and services also make follow-up studies immediately after marketing and even further into the future more tenable.
  • The more diverse your references, the more innovative you’ll be as a company. Novartis looks at how people in other industries, cultures and disciplines work and incorporates those ideas into its practices. For example, its Sense platform was inspired by the aviation industry’s ability to manage many extremely complex systems. The company also values internal diversity for the same reason.

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