Editor’s note: This story is part of our 2022 PharmaVoice 100 feature.
Dr. Henrietta Ukwu didn’t step into her role at Novavax during a quiet period for the company. It was January 2021 and Novavax had thrust itself into the pursuit of a COVID-19 vaccine based on its recombinant nanoparticle technology. As the chief regulatory officer, Ukwu had the unique and daunting task of working to guide the company through an unprecedented period of regulatory changes.
In December 2021, the efforts paid off when the EMA approved the shot. Then in July, the FDA followed suit, announcing the approval of Novavax’s COVID-19 vaccine, which the company says uses protein antigens “arranged around a nanoparticle core and then formulated with Matrix-M adjuvant.” Although the mRNA vaccines from Pfizer/BioNTech and Moderna already have a strong foothold in the market, public health experts hope that because Novavax’s technology was developed using a more traditional protein-based approach, it will be appealing to the roughly 20% of Americans who are still unvaccinated.
While the regulatory approvals are impressive accomplishments for the company, which also has vaccines in development for seasonal influenza, respiratory syncytial virus and more, this was not Ukwu’s first rodeo. A physician who first earned her medical and surgical degrees in Nigeria, Ukwu is also an infectious disease expert, a fellow of both the American College of Physicians and the Regulatory Affairs Professional Society and a “pioneer professor” at Temple University, according to her nominator. She is also a stalwart of the pharma industry, with regulatory experience that goes all the way back to 1992 when she got her start at Merck before continuing on at Pfizer and Otsuka Pharmaceutical.
Here, Ukwu discusses the leadership skills she leaned on to lead Novavax to regulatory success, how she’s paying it forward and why the current regulatory environment mirrors the dawn of the HIV/AIDS era.
PharmaVoice: What leadership skill have you acquired in the last two years that you will continue to bring forward?
Dr. Henrietta Ukwu: The leadership skill I have come to appreciate and drive is balance of work and life with GRACE: gratitude, resilience, attitude, contribution and excellence. This past year and half at Novavax have been fast and furious with nonstop, lightning-speed work, shifting strategies and pivots as we raced to get the first protein-based COVID-19 vaccine to authorization across the globe. We worked day and night for months on end — a truly extraordinary experience and time. It was therefore crucial to help each other find the balance to ensure mental and physical health, and balance in our work and personal lives. I started what I called walk-meetings by taking my morning meetings — from 7 to 9 a.m. — walking. Walking and talking in these early morning meetings allowed me to stay engaged while enjoying nature and staying physically fit. In addition, it became a good model for my teams.
GRACE, because we must recognize that we are imperfect beings. We get up each day and do our best. Sometimes that means getting a product across the finish line, and sometimes missing a deadline or realizing we don’t have the answers. But after what we have all been through the past two years, I think I’ve honed my ability to manage stress with GRACE.
What initially drew you to the life sciences industry?
I completed my fellowship training as a physician and infectious disease specialist at Vanderbilt University Medical Center in 1991 and had become interested in pursuing a career in the pharmaceutical industry because I believed the work we do has a broad and far-reaching impact on humanity. This has borne out as true.
“At my core, I am extremely passionate about everything I do. I dive into my personal and professional mission with everything I have.”
Dr. Henrietta Ukwu
Executive vice president, chief regulatory officer, Novavax
I started my pharmaceutical medicine career at Merck in 1992 working on anti-infectives and vaccines including two high profile programs — a varicella vaccine (Varivax) and an HIV protease inhibitor (Crixivan). These programs were approved for use in 1995 and 1996, respectively, and both had significant impact on humanity around the world.
Since then, I have 30 original products developed and approved by global regulatory agencies under my belt, including the recent Novavax COVID-19 vaccine.
How would you describe your leadership style?
I describe my leadership style with three C-lettered words: communication, collaboration and contribution. Constructive, courteous and effective communication through well-established channels and mechanisms are the hallmark of good leaders. Collaboration fosters a positive and productive environment with engagement and participation from teams and peers, and finally, I am a strong believer in productivity. Tangible contribution, creating solutions and actively adding value are the expectations set and managed by effective leaders.
None of us can do everything nor know everything, so we need each other to find solutions together, and that makes those solutions better, as a TEAM: Together Each Achieves More. We inspire and motivate others when we are constructive and acknowledge others’ contributions. Being positive as we deliver feedback, brainstorming approaches or even getting bad news, is more productive. People always remember how we make them feel.
What is your key piece of leadership advice?
Feedback is a gift. We all need feedback to grow, so receive both complimentary and constructive feedback with gratitude. None of us sees ourselves clearly, so we rely on others to help us see the blind spots and the strengths. I am grateful that I had mentors who pointed out my blind spots and helped me along my leadership journey. Of course, we always like being told what we do well, but we all have blinders, therefore 360 reviews are instructive and, when received well, can help refine leadership behaviors.
How are you paving your success forward?
I spend a significant amount of time actively mentoring others to develop them as current and future leaders. Effective leaders create more leaders. Leaders who develop leaders become magnets for talent from within and outside of the organization because they are considered inspirational. Seeing my many proteges assume the leadership mantle is certainly one of my proudest accomplishments.
What’s the single most important trend you see impacting the industry?
Through the pandemic we have experienced remarkable and impactful partnership with global regulatory agencies to drive quality and speed in the development and registration process of bringing new products to patients through emergency-use regulatory pathways. Working in unison to achieve the laudable public health goal of finding a solution for the pandemic has brought a new level of partnership we trust can be carried forward beyond the pandemic.
Akin to the HIV/AIDS era where diverse accelerated regulatory mechanisms were introduced, we trust that collaboration will lead to paradigm shifts to more efficient engagement with the regulatory agencies.