Early Insights into Pressing Issues


Applied Clinical Trials

DIA Europe proves to have excellent timing to learn more about the latest developments in drug development, the current status of Brexit, the plans of the National regulators and EMA, on-going discussions on pan-European HTA, and the trends for 2019.

For those of you who want to get a jumpstart on 2019, one of the first conferences of the year has a cutting-edge lineup for all issues related to the drug industry. The DIA Europe annual meeting will be held February 5 to 7 in Vienna, Austria https://www.diaglobal.org/en/flagship/dia-europe-2019. 

Thomas Bols, Senior Vice President and Managing Director for DIA Europe, Middle East, and Africa (EMEA), said that the DIA Europe meeting will feature the latest information on Brexit, EMA’s regulatory science 2015 strategy and other issues related to drug development, not in in the least the use of RWE and pan-European HTA activities. “Early February is great from a timing point of view to get up to up to speed around the events that transpired last month. We will have perspectives from regulators on what Brexit means for both the UK and the rest of Europe.” Bols also said that the DIA Europe meeting will feature the first public discussion on the EMA’s regulatory and science strategy for 2025 from its Executive Director Guido Rasi. The EMA launched a six-month public consultation in mid-December, following two multi-stakeholder meetings. Bols explained that while the EMA is on a business continuity plan, which restricts the activities and resources applied during the Brexit transition, they will still be on-hand at the DIA Europe meeting. 

Meanwhile, though known for its rich regulatory presence, the landmark meeting has numerous stakeholders outside of regulators including academia, industry and over 30 patient groups in attendance. 

DIA’s Associate Director Scientific Programmes EMEA, Inka Heikkinen noted that DIA Europe has added a Medical Affairs track for this meeting. “This is very exciting for us. The medical affairs role is changing and undergoing a transformation, so the topics we have will help guide them through that significant change.” Scheduled sessions include “The Added Value of Medical Functions: Building a Long-Term Strategy,” “Medical Functions Contribution to Benefit-Risk Assessment,” and “Dialog with Patients, Moving Forward with Digital Information” among others.

Heikkinen also noted that “newer therapies don’t necessarily fit into the randomized clinical trial framework as we know it” and that sessions within the Modern Clinical Research track seek to understand those changes. 

For 2019, both Bols and Heikkinen see trends in drug development reflected in the DIA Europe conference. Outside of that, Bols says that 2019 in Europe will see a lot of movement politically. “There is Brexit, of course, but also elections and changes at the European Commission that will affect the future of European health policy.” He also mentioned the following trends:

· The Year that EMA Really Moves. This year Amsterdam becomes the official headquarters of the EMA. While Bols did mention the continuity program is still in place, by the second half of 2019, it will be business as usual for the EMA.

· Pricing and Incentives. “The continuous debate around pricing, and how that effects regulators and industry especially around orphan drugs will go into a higher gear in 2019,” said Bols.

· Ethics and Science. With the recent events in China, with the technology around CRISPR and gene editing, Bols believes this year will bring more discussion of the ethical developments around the world. 

Heikkinen and Bols elaborated on the topic of GDPR. While 2018 put life sciences in a scrambling mode to get it implemented, 2019 will see the resulting effects and implications the rule. Heikkinen said, “GDPR has many implications in clinical trials…with patient recruitment, patient data, and that will be discussed at the meeting. While we have a push for transparency in clinical trial data, it is in a bit of conflict with the state of confidentiality alongside of transparency. So how do we achieve that balance?” 

Bols agreed: “Many parties want to use data to help the patient. But the barriers to data sharing are the rules around data protection and data privacy. GDPR doesn’t necessarily help that. The consequences and implications of GDPR are not very clear, so 2019 will see some of this sorting out around data sharing.” 


Lisa Henderson is Editor-in-Chief of Applied Clinical Trials. She can be reached at lisa.henderson@ubm.com. Follow Lisa on Twitter: @trialsonline

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