Innovation, Regulation, R&D Productivity Headline Jam Packed DIA EuroMeeting

What will be the buzz going into the DIA’s 28th EuroMeeting? It’s hard to pick just one hot-button issue. Indeed, the association has organized more than 80 educational sessions in 14 themed tracks along with eight “Hot Topics” Sessions.

Whether your key focus is on clinical trial design, translational science and the intersection of industry and academia, gene therapy, orphan diseases, big data, innovation in medical devices, patient engagement or any number of other subjects, there will be plenty to choose from when the conference convenes April 6-8 in Hamburg, Germany.

As always with DIA, the focus is especially deep on regulatory issues.

One session that caught our eye, on the Hot Topics schedule, is the “European Regulatory Town Hall Meeting – An Interactive Discussion on the ‘EU Medicines Agencies Network Strategy to 2020.’”

The session will co-chaired by Ian Hudson, chief executive of the U.K.’s Medicines and Healthcare Products Regulatory Agency, and Guido Rasi, executive director of the European Medicines Agency.

Officials from several national agencies have been invited to speak and the audience will be asked to give live feedback through interactive voting on the themes and priorities of the strategy.

Also of acute interest will be “New Approaches to the Approval of Innovative Medicines: Do They Keep Their Promise?” in the Globalisation track.

Among the featured panelists will be Lawrence Liberti, executive director of the Centre for Innovation in Regulatory Science (CIRS). Liberti will speak on “Comparing the Characteristics and Use of Facilitated Regulatory Pathways by ICH and Maturing Agencies.” CIRS is a neutral, independent organization affiliated with Thomson Reuters that conducts novel research, convenes forums for healthcare stakeholders and provides insights to advance global regulatory and health technology assessment policies and enhance patient access to medicines.

Previewing his presentation, Liberti explained that facilitated regulatory pathways (FRPs) are alternatives to standard regulatory pathways which accelerate the development, submission, regulatory review, and patient access to important medicines with a positive benefit-risk balance for serious diseases or unmet medical need.

“Society must be willing to accept uncertainty about the benefits and harms of new medicines approved through these pathways, because of the serious risks of the disease, the lack of effective therapies and the belief that the initial data generated are reasonably predictive of clinical benefit, despite uncertainty about the true value of the therapy,” Liberti explained.

Expedited reviews made up 58% and 50% of all new active substance approvals at the U.S. FDA, and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in 2014, and 13% at the European Medicines Agency, Liberti said.

“The importance of FRPs has increased for emerging national regulatory authorities because of an expanding portfolio of products for neglected diseases and, along with the World Health Organization, these agencies are expanding their commitment to new treatments for local populations,” he added.

David Jefferys, senior vice president, EFPIA, Eisai Europe, will chair the “New Approaches” panel, which will also feature Tomas Salmonson, of the Medical Products Agency in Sweden, speaking on “New Approaches to the Approval of Innovative Medicines: The EMA Perspective,” and Toshiyoshi Tominaga, of the PMDA in Japan, discussing the “PMDA’s Approaches to the Approval of Innovative Medicines: How Does Sakigake Work?” Alastair Kent, of the Genetic Alliance in the U.K., will lead a patient perspective discussion, as well.

Among the EuroMeeting’s clinical offerings, there can be no more compelling topic than “Improving Productivity in R&D.”

This Clinical Research track offering will include a presentation by Ke Zhang, segment lead, business development & licensing and regulatory at Thomson Reuters. Zhang will be speaking on “An Analysis of Attrition Rates in Late-Stage Drug Development.”

Zhang said her presentation will focus on “the challenges of measuring productivity in our industry” and offer “an interesting analysis” based on attrition rate.

“What’s the definition of productivity? Productivity can be measured using units of output divided by units of input. People use the same principle to measure productivity for different industries, for countries, and also the biopharmaceutical industry,” Zhang said.

But, she added, “measuring productivity can be very difficult for our industry, mainly due to the long time span of the R&D development process, and many factors that would impact the research outcome.”

There are a few common productivity analyses used in the industry, Zhang said, but they all have some problems associated with them, which she will demonstrate in her talk.

Looking at success/attrition rate across development phases may be a way around these problems, Zhang said. She’ll show data from the Thomson Reuters Cortellis and Integrity products that focuses on 155 late-stage failures from 2013 to 2014. The reason for the attrition was identifiable in 130 of the cases – with 51% of the entities failing due to lack of efficacy and 28% attributable to safety issues.

“We think success across late development is increasing over time due to various reasons,” Zhang said. “It is a reflection that the approach to drug development is changing. And we believe companies focusing on rare disease are less likely to terminate.” The R&D productivity panel will be chaired by Milan Zdravkovic, corporate project vice president at Novo Nordisk in Denmark.

Also joining the panel will be Cornelis Van Den Bogert, of Utrecht University in the Netherlands, who will speak on “Does Partnering Have an Influence on Subsequent EMA Marketing Authorisations?”, and Martin Moller, at McKinsey & Company in Denmark, on “Improving R&D Productivity.”