EMA Official: Data Sharing and Collaboration Can Fill Scientific Gaps in Alzheimer's

Regulatory NewsRegulatory News | 19 September 2016 |  By 

Speaking at a panel at RAPS' 2016 Convergence on Monday, Enrica Alteri, head of human medicines research and development support at the European Medicines Agency (EMA) called on drugmakers to share data to close the gaps in Alzheimer's disease (AD) research.

According to Alteri, doing so could help the scientific community not only learn from past failures in Alzheimer's research, but enable the development and validation of new targets.

Scientific Gaps

"There are gaps in the science. It's not as if everything is known," Alteri said, comparing the level of scientific understanding with better-understood diseases such as HIV/AIDs and cancer.

"There are multiple failed attempts to identify reliable biomarkers and endpoints. Without this understanding, we believe that it's very difficult to actually move from the research stage to the access to the medicine," Alteri said.

However, Alteri said that learning from past efforts is critical to more quickly advancing scientific understanding. Alteri pointed to one recent effort by EMA and other regulators to conduct a "postmortem review" with companies involved in Alzheimer's research to learn from past research to inform future efforts.

"The aim of this sort of postmortem review was to look into what could have happened—what, perhaps the company should have done and could have done better—and you learn from the failures of the development," Alteri said. The agency plans to eventually release some of the takeaways from the review while respecting the confidentiality of the data provided by the companies that participated.

Alteri said much of this must be done by companies interacting and sharing data amongst themselves. "The use of biomarkers, biomarker development, all these are areas where more sharing of information among developers would definitely benefit [Alzheimer's research]."

"We do need to learn from failures, much more than we need to learn from successes, because unfortunately we have very few successes to learn from, and therefore it's even more important to understand what went wrong. Because of the length of time put into this development effort, we cannot afford to wait another ten years to know what went wrong ten years ago," Alteri said.

Regulatory Collaboration

However, Alteri said that drugmakers are not the only ones that must work together to further developments for Alzheimer's.

According to Alteri, EMA and FDA are working together to ensure their standards and expectations for Alzheimer's treatments are aligned in order to minimize duplication of effort for industry.

"We have, as you know, an update of our guidelines in the making. We are talking to each other very collaboratively and very openly about these guidelines. We think that the guidelines as they will be finalized are very conducive to global development plans … We don't want the developers, in order to satisfy EMA needs, to do a particular set of studies so that they have to do another one to satisfy FDA," Alteri said.


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