Highlights from DIA Europe 2019 – EFPIA team in the Middle of the Regulatory Buzz

Cold and sunny Vienna set the scene for this year’s DIA Europe conference (5-7th Feb 2019). The event focused on exploring the use of new technologies in medicines development. From artificial intelligence to the use of real-world data (RWD) in regulatory decision making, delegates were encouraged to think about translating the theory in to regulatory practice.
Speaking at the Regulatory Town-hall, EFPIA Director General, Nathalie Moll underlined the importance of evolving Europe’s regulatory framework. Adopting new regulatory innovations and technologies is one of the key priorities in EFPIA’s regulatory strategy plan “4e for 2023”. This 5-year strategy focuses on; ensuring a world-class regulatory framework in Europe, evolving a framework for innovation, engaging with stakeholders and expanding the global convergence. Sini Eskola, EFPIA’s Director Regulatory, Drug development and Manufacturing touched on similar themes in a later session on “Raising Europe’s Voice in Globalising Regulatory Science”. Europe has a key role to play in promoting regulatory excellence, driving global convergence and creating an innovation-friendly environment with a robust regulatory framework and the right incentives in place.
Peter Shone, Chief technology officer at Paraxel informatics, drew on his experience in the automobile and aviation industries to challenge our sector to embrace new technologies such as machine learning. It was a perspective shared by the Head of Danish Medicines Agency Thomas Senderovitz who encouraged an open mindset, learning as we go and sharing experience through early interaction and scientific advice.
Preparing the way for learning healthcare systems 
Healthcare systems are creating increasing volumes of data generated by patients, healthcare providers and researchers. But can this data be used to create learning healthcare systems? Systems that utilize data to continually improve; to predict and address needs more accurately and achieve better outcomes for individual patients and for health systems at large?
The topic was explored by Emma Du Four (Abbvie), Tom Metcalfe (Roche) and EFPIA Executive Director of Science Policy Magda Chlebus (EFPIA) in a session dedicated to examining the building blocks, experience of, and ambitions for, learning healthcare systems in Europe. Building on the success of existing initiatives and addressing the barriers to implementation requires greater partnership and new forms of collaboration. It will require political will, leadership and resource but the societal benefits are potentially significant.
The Regulatory Role in European public private partnerships
Rapidly advancing science and medical technology needs regulatory science to evolve at a similar pace. It means platforms where researchers and regulators can collaborate are more important than ever.
European institutional partnerships such as the Innovative Medicines Initiative, with clearly defined funding mechanisms and transparency rules, as well as a neutral broker to manage processes and conflicts of interest, is one way of meeting the need for shared platforms.  Showcasing examples from PPP projects such as Adapt Smart, Eupati, Protect, Prefer, and many more, Solange Rohou (AZ), David Haerry (EATG) and Magda Chlebus (EFPIA) illustrated how regulators engage with consortia as leaders, participants or advisors, to enable innovation by jointly defining the problems and creating solutions.  Without this innovator/regulator engagement, the pace of innovation will slow down. Conversely, IMI can be used more effectively to address complex and sensitive regulatory sciences challenges.
Expanding Global Convergence
The importance of convergence and collaboration between regulators was underscored in a session called “Convergence of Global Life Sciences regulation - where are we heading in 2025?” attended by EFPIA’s Deputy Director International Trade, Jana Nackberg. The session explored mechanisms to share best practices between agencies, particularly between smaller countries or countries with less mature regulatory systems and more developed ones. The discussion examined today’s complex global value and supply chains, underlining the importance of data-sharing and collaboration in order to ensure timely access to innovative medicines for patients across Europe and beyond.

At this year’s DIA meeting, two sessions focused particularly on EFPIA’s global priority markets, Turkey and Russia, organized jointly between EFPIA and our local sister associations AIFD and AIPM. A strong focus of both sessions was specifically on alignment with EU and International standards, such as ICH. The session with regulators from the Turkish Medicines Agency (TITCK) focused on their path to ICH and regulatory excellence.

Pär Tellner, Director Regulatory, Drug development and Manufacturing and ICH coordinator at EFPIA reported on developments shared by the Turkish regulatory authority, TITCK. The launch of the clinical trial portal by end of March 2019, puts Turkey more than a year ahead of Europe where the application of Clinical Trials Regulation 535/2014 is pending the establishment of Clinical Trials Information System (CTIS). The session underlined the Turkish regulators’ commitment to participating in global harmonization initiatives as well as becoming a regional reference agency.
EFPIA’s is also working closely with our Russian counterparts. Both Pär and Jana highlighted the importance of the Eurasian Union regional harmonization initiative and the implementation of the common medicines market. EFPIA will continue to support their implementation throughout the process with the proper regulatory and scientific support needed to fully and properly implement the EAEU common pharmaceutical market. 

Is it what we are doing effective for public health?
Giovanna Rizzetto, Senior Manager Regulatory, Drug development and Manufacturing at EFPIA followed the pharmacovigilance sessions at DIA. In particular, the role of pharmacovigilance in driving better public health. The Pharmacovigilance Risk Assessment Committee (PRAC) strategy presented by Valerie Strassmann (BfArM), looked at two principle areas; effectiveness of risk minimization activities and enabling effective PV and stakeholder engagement. PRAC is giving a strong focus to the effectiveness of PV and risk minimization measures by identifying which measures are effective and why. It was concluded that patient’s and HCPs views need to be incorporated to gain a better understanding on why measures are effective.
Vicki Edwards (Abbvie) gave practical, industry examples of public health impact measurement as a result of the extensive PV information collection. Examples such as a survey of impact from the revised GVP Module V and a survey and metrics collection on signal detection activities using EudraVigilance have underlined the proactive approach to data collection taken by industry over the last 18-24 months.
In the context of data collection from Patient Support Programmes, Vicki mentioned the work done by TransCelerate which looked at the quality of collected data and signal detection capabilities. She also mentioned the new ICH topic proposal submitted along with PhRMA to reopen the ICH E2D guideline and look into the definition of various sources of post approval safety reports which are no longer optimal to capture current practices. This is being evaluated by new ICH new topic subcommittee.
Like other areas of regulatory science, technology is helping to optimize pharmacovigilance. But technology alone is not the complete answer.  There is also need to improve communication with patients through education, providing easier access to information, lay-friendly language and increased focus on the important relationship between doctors and patients to improve adherence to treatments.
There was much to ponder as we left Vienna, not least the pace of technological advancement.  How we, as a regulatory community, don’t just keep pace with these changes but really harness their full  potential for patients will be the subject of many more discussion.