Industry Responds to COVID-19: Janssen Pharmaceutical Companies
In response to the COVID-19 pandemic, Janssen Pharmaceutical Companies of Johnson & Johnson, “has been collaborating with regulators, healthcare organizations, institutions and communities worldwide to help ensure our research platforms, existing science and outbreak expertise can be maximized to stem the COVID-19 public health threat,” says David M. Lee, MD, PhD, Global Immunology Therapeutic Area Head for the company.
“Within my team, Janssen Immunology, COVID-19 has certainly highlighted our agility in adapting to change. We’ve worked together to find creative solutions to problems we’ve never faced before. For example, we had to safely accommodate our laboratory staff, who were classed as essential workers so that we could keep the important bench science work of discovery, research, and development marching forward. This required monitoring and understanding changing needs across a variety of locations and nimbly implementing new safety measures as COVID conditions changed. I’m so proud of the scientists that came together to keep programs moving, while minimizing time in the labs and covering for each other.”
Dr. Lee notes the company has maintained focus on strategic growth initiatives, acquiring Momenta Pharmaceuticals, Inc. in October 2020. The company has adapted to the needs of its workforce, attempting to “understand and accommodate employees’ family obligations while keeping our work moving forward, Dr. Lee says. “Immune disease doesn’t wait nor does our responsibility to deliver new and better solutions for patients. Our flexibility has helped us navigate this unprecedented time while continuing to inspire and support our people and deliver on our commitment to patients,” he adds.
One area of impact from the pandemic has been clinical development. In response, Dr. Lee says, the company’s clinical development team assembled an operations task force, “with representation from early and late phase clinical development, medical safety, medical affairs, clinical operations, regulatory, quality, quantitative sciences (biostats), project management, and other functions. They joined with the goal of coordinating the Immunology team’s approach to clinical trial activities in the context of the pandemic. The task force adapted conduct of our studies to prioritize patient wellbeing and study integrity, while maintaining compliance with regulatory, Good Clinical Practice, and other applicable standards. Adaptations included use of remote visits, direct-to-patient provision of study drug, and exclusion of subjects with recent COVID infection from study enrollment. Communication was key, and the team worked hard to stay in close touch with investigators and regulators, and to remain current with evolving external guidance and other news relevant to trial conduct.” The task force continues its work, recently adapting study guidance to address use of approved COVID vaccines by subjects enrolled in studies.
With the absence of live meetings in 2020, Janssen, “certainly missed the special connection that in-person communication and education creates,” observes Michael Plotnick, MD, Vice President, Global Medical Affairs for the Immunology Global Commercial Strategy Organization of Janssen Global Services. “Our experience with virtual booths has been positive, and we’ve also had positive feedback on some of the innovative tools we’ve used to accommodate different learning styles, for example, podcasts and social media. One positive aspect of all-virtual medical congresses is eliminating concerns about space and time—in the past, symposia or talks at congresses had limited seating capacity, and attendees may have had to choose between conflicting sessions. Now, with these session available virtually and as replays, we’ve found audience reach has significantly expanded. In fact, we’re seeing record numbers in terms of reach.”
A challenge for Dr. Plotnick’s team—and what he deems their biggest success over the last year—was around the FDA approval of TREMFYA® (guselkumab) for use in adult patients living with active psoriatic arthritis (PsA). The approval, “required a speedy pivot to using all virtual tools to launch this important new indication and educate physicians about the science of IL-23 in PsA.”
Looking ahead, Dr. Plotnick says, “dermatologists can expect to see more digital communication this year with information and education tailored to their needs. They will also see Janssen’s leadership and commitment to patients with immune-driven skin disease expand as we apply scientific learnings from psoriasis and PsA to more complex immune-driven skin conditions.”