Big Pharma Puts Patients First in Response to COVID-19 Challenges; Collaboration with Regulators is Essential Going Forward

When early signs of a potential pandemic appeared and national border closings became a distinct possibility, many big pharma companies mobilized to move medicines from their warehouses into local warehouses in countries around the world to ensure that their patients in those countries would have access to the medicines they need when they need them.

The challenges to pharma companies from COVID-19 and how they continue to respond was a topic raised at the FDA/Xavier PharmaLink conference, which was held March 17-20, 2020. For the first time in the annual conference’s eleven-year history, this year it was held virtually.

The question regarding the virus was raised at the end of a session titled, “Chief Quality Officers Mobilizing Enterprise-wide Effectiveness.” Speakers for the session were AstraZeneca Global Quality Head Anthony Mire-Sluis and Thermo Fisher Scientific Global Quality Assurance and Regulatory Affairs VP Peter Shearstone.

Mire-Sluis and Shearstone are members of the Chief Quality Officers Team that was brought together through the efforts of Xavier Health Director and former head of quality for Merck’s North Carolina facility Marla Phillips.  The team includes the most-senior quality executives from each of more than a dozen participating companies. The team has recently begun to add their operations peers and has re-named itself the Chief Quality & Operations Team (see Figure 1).  The multinational, cross-industry composition of the team was consciously designed to get the most thorough, in-depth thinking and solutions from industries where quality departments operate similarly. More on the team and its efforts can be found here.

Figure 1

Ensuring Uninterrupted Supplies of Medicines

Regarding the challenges to the pharmacy industry from COVID-19, Mire-Sluis commented, “As a manufacturer, the number one thing we were doing was accelerating getting product that was made out globally. Of course, we have warehouses where we store inventory. Why would we want to keep it in our warehouses with the possibility that transport could go down and borders could get closed?”

The “first thing” AstraZeneca did “a couple of months ago” was to essentially empty its warehouses. “We moved all product out to the individual countries that we serve to get as much out for patients as humanly possible. The other step was to get product that wasn’t packed yet packed and get it out the door as well,” he said.

“The number one thing we were doing was accelerating getting product that was made out globally.”

The current situation “has been tough on the quality organization,” the AstraZeneca quality head noted. “We have had to have more vigilance over what is being done. We are accelerating product release, which we have never done before. We are working harder and trying to release as much product as we possibly can. The routes that we are using are starting to change over time depending on where countries are. The logistics organization and the quality associated with that is challenging.”

Mire-Sluis also addressed the measures his company is taking to safeguard the health of its employees. He said those who can work from home are doing so. However, there are also people who must be at work to run manufacturing plants and release product.

“Shift patterns have changed. People are no longer crossing over on shifts, to avoid cross-contamination. The type of cleaning that we are doing has accelerated. There are many things that we are doing,” Mire-Sluis explained.

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Updating Risk Management Plans and Finding Novel Solutions Imperative

Thermo Fisher Scientific VP Shearstone noted that his company engaged in similar activities to those Mire-Sluis described as the potential pandemic unfolded. In addition, “there are learning opportunities every minute of every day. As a company with over 200 plants globally—many in the areas that are under the most challenging conditions—we have had to adjust on the fly. For example, we have had to update our business continuity plans and our risk management plans because we never anticipated such a global impact with a virus.”

“There are learning opportunities every minute of every day… we have had to adjust on the fly.”

On the regulatory side, he said, “there has been learning around how to negotiate in a collaborative, rigorous way with regulators. They have a job to do, which is to ensure there are safe and effective products on the market.” As a pharmaceutical Contract Development and Manufacturing Organization, Thermo Fisher is working to figure out how to collaborate with regulators to keep products safe but also get them distributed quickly.

While the quality group at Thermo Fisher is having challenges similar to those Mire-Sluis mentioned are taking place at AstraZeneca, in addition, Thermo Fisher’s R&D teams, regulatory affairs teams, and clinical affairs teams “are working fifteen and seventeen hour days right now trying to find ways to do things like clinical studies. For example, how can we do a clinical study for a test in a week when normally it takes months?”

Shearstone noted that, “FDA and many of the agencies have been spectacular to work with, breaking down long-standing rules and allowing us to do things that still maintain safety and effectiveness—which is obviously most important—but still get the data that we can stand behind collectively.”

He maintained that pharma companies need to find innovative solutions to problems or challenges that are different than approaches taken in the past. “If a 510K or a PMA (premarket approval) takes X amount of time with X amount of documentation, in this situation that goes out the window and we must deal with emergency use authorization, which is completely different. It has been and is an enormous challenge for us.”

Industry/Regulator Relationships in Focus

Session moderator Marla Phillips asked Mire-Sluis and Shearstone if regulators are reaching out to work with pharma companies to find solutions.

“Yes,” Shearstone replied. “When things started heating up about six or eight weeks ago, we took a proactive step—our head of government relations and myself—to go to FDA to see what our company could do to help. We had a test in development at the time. We wanted to let them know we were there.”

“There is a lot of mutual respect going on right now collectively.  It has been remarkable.”

He explained that he has always maintained good relationships with the agency and commented that, “If you don’t have those relationships, it is going to be a bumpy ride—you will be playing catch up.”

Shearstone provided advice to other pharma companies. “I cannot emphasize enough working collaboratively with regulators just so they know who you are. Because when the phone rings—and trust me, it has been and still is—they know you are going to be there. They know you are going to pick up. And they know you are going to help them. There is a lot of mutual respect going on right now collectively. It has been remarkable.”

Are Animal Trials Necessary?

Mire-Sluis explained that his firm is also working with government bodies. AstraZeneca reached out to government officials to let them know that their company had created an antibody that could be used prophylactically against the COVID-19 virus.

With the many years’ experience AstraZeneca has working with monoclonal antibodies, he suggested that early phase testing might be skipped.

“As you may have seen in the news, a couple of products are skipping the animal part and going straight into humans based on interactions with the agency and the knowledge we have about them. So, it really is the time for collaboration, good science, and risk-based approaches to really speed up development in a way we have never seen before,” Mire-Sluis emphasized.

[Editor’s Note: Our series on the FDA Center Directors’ presentations from FDLI will continue after this post with coverage of CDRH’s Erin Keith’s presentation on her Center’s recent reorganization and current priorities.]

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