Embracing disruption: Convergence plenary stresses compassion, innovation

Regulatory NewsRegulatory News | 13 September 2020 |  By 

Live Q&A during the kickoff Convergence plenary panel.

The COVID-19 pandemic has turned daily life upside down around the globe and presented unique challenges for regulatory affairs professionals. In the kickoff plenary session of RAPS 2020 Convergence, regulatory experts and business leaders shared how they have coped with the unprecedented disruption and offered insights about how the pandemic may be accelerating industry-wide changes.

The conversations were facilitated by Kimberly Belsky, vice chair for Convergence and executive director for regulatory policy and intelligence at Mallinckrodt Pharmaceuticals and Sarah Michel of Velvet Chainsaw Consulting. 

Succeeding while remote
Megha Deviprasad Iyer, global director for regulatory affairs for Thermo Fisher Scientific, leads a London-based division of regulators. She described how during COVID-19 the company has rapidly ramped up production and distribution of its specialized viral transport medium that allows global transport of patient specimens. Before COVID-19, the company was manufacturing up to 50,000 tubes per week. After March, they ramped up production to 1 million tubes per week. A successful bid for a subsequent contract meant Thermo Fisher faced even greater demand, pushing production up to 8 million tubes per week.

Meeting the additional demand required new facilities and manpower. Thermo Fisher acquired a 120,000 square foot facility and hired 300 new employees in the span of 8 weeks, Iyer said.

“Obviously, when you are called upon to do this kind of work, it instills a massive sense of fulfillment,” she during the plenary session. “Personally, for me, I felt pride in my team because we were able to respond to this humanitarian crisis.”

In addition to facing an increased workload, Iyer’s whole team has been working remotely throughout the crisis. With so many new employees coming aboard, that has meant a transition to a completely remote onboarding process and trying to build a cohesive team among members who have never met in person.

“In this situation, one can’t wait traditionally for a person to earn that trust and credibility,” Iyer said. “When you start to bring trust to the table, my strong opinion is that you get the trust back. The leader has to come with trust up front.”

Iyer’s advice for other regulatory leaders during COVID-19 is to be a human first. That could mean asking about a colleague’s family at the start of a call, understanding that a team member needs to switch off their webcam some days or making time to celebrate project milestones.

“It’s important that this pandemic teaches us to be just that little bit more patient… a little bit more compassionate to our fellow human beings,” she said.

Accelerating trends
Rabia Khan, PhD, the managing director of the discovery sciences division at Oxford-based Sensyne Health, pointed out how COVID-19 has accelerated some healthcare technology trends.

The pandemic has sped up the move to redesign clinical trials to include the use of real-world data for synthetic control arms and the use of remote patient monitoring for clinical endpoints, she said, and has accelerated the push to use artificial intelligence to predict patient outcomes.

“COVID has really accelerated” the trends, Khan said, “whether that’s remote patient monitoring, AI for patient outcomes and clinical decision support, or clinical trial design. I think all of these are going to be very much part of the regulatory conversations moving forward.”

But there are still a lot of challenges remaining, she said. For starters, data sets used in AI will not be able to predict patient outcomes appropriately unless they include data that are diverse in terms of age, gender, genetics, and ethnicity. Another area of work is to create and regulate data interoperability and data standards, specifically figuring out how to transfer patient data and how to govern the process, Khan said.

“We’ve been propelled into a world where everyone has gone remote. We’ve been propelled into a world where now we have track-and-trace applications on our phone,” Khan said. “Data is being shared and we now don’t have a choice.”

Interoperability fuels innovation
David Fischel, CEO and Chairman of Stereotaxis, a firm focused on robotics in endovascular surgery, described what he sees as a “golden period” of innovation in the development of drugs, devices, diagnostics, and delivery systems.

In the area of drug development, Fischel pointed to the ability to engineer molecules and cells to create immunotherapies, RNA- and DNA-based drugs, and genetically modified cellular therapies. On the diagnostic side, he said advances in liquid biopsy have the potential to improve early diagnosis of cancer. Meanwhile, robotics and digitization are changing the operating room environment, and telemedicine is revolutionizing the delivery of medicine. But most importantly, he said, these advances are being used in tandem, not in isolation.

Regulators are playing a central role in all these healthcare changes, Fischel said. But he cautioned that current regulatory requirements may serve as a barrier to interoperability. To encourage innovation, he said regulators can encourage, or even require, open standards on interoperability. He pointed to the U.S. Food and Drug Administration’s work encouraging insulin pump manufacturers and glucose monitoring companies to develop interoperability standards.

“They have been ahead of the game in recognizing how impactful that will be for patients, for physicians, for the healthcare system as a whole,” he said.

Coping with dual disruptions
When it comes to disruption, Noël Wathion, deputy executive director of the European Medicines Agency (EMA), is a bit of an expert. Before COVID-19, Wathion and his team had just finished moving their entire agency from London to Amsterdam in reaction to Brexit. That involved relocating more than 1,000 employees and their families and working in a temporary headquarters, he explained.

Though EMA’s en bloc move to Amsterdam occurred in response to the political circumstances of Brexit, the agency’s response still held lessons for how EMA could cope with the public health crisis stemming from COVID-19.

Wathion urged regulators always to be prepared for disruptions due to external events and have systems in place ahead of time. Those generic systems can then be adapted to the specific crisis. “You have to show flexibility and agility,” he said.

Some of the keys to success in the EMA’s Brexit response that have carried over include strong internal and external communication, informed decision-making, and going through a real-time process of learning from mistakes and making adjustments. “If you wait too long, the next disruption is there and you are not better prepared,” Wathion said.
RAPS Convergence 2020


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Tags: coronavirus, EMA, FDA, US

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