Kathy Fernando, the senior vice president, head of Pfizer Ignite and Pfizer CentreOne, has had a professional trajectory marked by pivotal serendipities. One occurred when attending a seminar at the University of Pennsylvania, where she met Dr. Drew Weissman, a prominent immunologist and RNA vaccine researcher. Weissman, along with Katalin Karikó, recently received the Nobel Prize in medicine for discoveries that led to the development of mRNA vaccines against COVID-19.
Hearing Weissman first speak, Fernando recalls being “just blown away” by his scientific creativity. “He just took things to the next level,” she said. She would go on to study under his tutelage, eventually co-authoring a paper with him on HIV that was published in the journal Blood in 2007. The paper explored the potential of mRNA in an HIV vaccine, and the challenges associated with triggering an unintended immune response from the approach. “When you gave mRNA, the body mounted an immune response to the mRNA itself, and you didn’t want that to happen,” she said. A year later, Fernando and Weissman collaborated again on another study, examining how HIV proteins impact certain immune cells.
Know when to explore new opportunities for development
After graduating, she transitioned to management consulting, but ultimately wanted to focus her work more on a single company. In 2014, she applied to Pfizer. “It was a great coincidence that they had an opening in R&D strategy,” she recalled.
While at Pfizer, she has held a string of senior roles, including a stint as vice president, head of mRNA scientific strategy and head of worldwide research and development operations. “It was just an incredibly impactful role just thinking about how to manage the R&D portfolio from discovery to proof of concept,” she said.
The power of focus
In her role managing R&D, Fernando said one of the top takeaways was the significance of maintaining focus. For instance, Pfizer has prioritized a handful of therapeutic areas, but focus can also involve identifying new opportunities. During the height of the pandemic, Fernando approached Dr. Michael Dolsten, Pfizer’s chief scientific officer, emphasizing the broader potential of mRNA beyond COVID-19. Recognizing the potential of the platform, she expanded her role to explore mRNA applications in other disease areas.
The theme of focus would be instrumental in her role leading Pfizer Ignite, which began in September 2022. “I think the time is ripe for a model like Pfizer Ignite,” she said. In essence, the model involves offering Pfizer’s R&D horsepower to accelerate biotech innovation. “Every biotech company has a secret sauce that they do better than anyone else, but they never build out end-to-end capabilities,” she said “We offer complementary services to help them advance their innovation. In exchange for that we get a fee.”
Pfizer is selective when choosing collaborators for the program. Every partnership under the Ignite initiative undergoes close scrutiny. The chief scientific officer, along with other key scientific team members, gauge the potential of each project, ensuring collaborations are mutually beneficial and align with Pfizer’s broader goals.
One company that made the cut is Cardiff Oncology, which has announced the advance of its lead program targeting the first-line setting of metastatic colorectal cancer (mCRC). Another Ignite partner is Mabylon, which is developing MY006, an anti-peanut allergy antibody product. Another example of a firm that has made the cut includes CellCentric, a UK-based biotech firm developing an oral p300/CBP inhibitor known as inobrodib. The oral drug candidate targets specific protein parts, providing a unique method to treat cancer. In June 2023, the FDA granted CellCentric both orphan drug and fast track designation statuses for inobrodib,
Building foundational relationships
Fernando shed light on Ignite’s approach. “Our primary goal is not the revenue,” Fernando said. “It is standing side by side with these companies, through the ups and downs that are inherent in R&D and problem-solving through those challenges.” This joint problem-solving approach forges a foundational relationship. Consequently, Pfizer expects that participants in the program will view it as a top-of-mind partner for future collaborations. “Almost every company that we signed up in the first wave has pursued follow-on work with us,” she said.
As for an example of a tangible outcome from the program, Fernando shared an anecdote where an Ignite partner approached it with a question about clinical trial design, and its team helped the biotech “shave a full two years from their timeline,” Fernando said. “That’s the kind of impact we really want to deliver. That’s a sample size of one, but that makes you feel good. A patient can potentially get that therapy two years earlier.”
Extending pandemic collaboration and innovation on a broader scale
Formally launching in spring 2022, Pfizer Ignite is the brainchild of Pfizer CEO Albert Bourla, who observed the value of its pandemic alliance with the German biotech BioNTech. The two firms would jointly develop what would become one of the most popular COVID-19 vaccines. “I don’t think either company could have achieved, in isolation, what we ended up doing together,” Fernando said.
The aim of Ignite then was to “replicate such partnerships on a far greater scale,” Fernando said. While Pfizer has traditionally partnered with scores of companies, Ignite represents a more proactive approach in which it actively assists partners in generating the required data for drug development.
Redefining what ‘fast’ means
Traditional drug development efforts can often feel like a slog. Ignite aims to be the opposite. In a landscape where “six months is not the standard for a project,” Pfizer’s Ignite initiative embodies the agile development principles that the tech industry has long championed. The launch of Ignite itself was something like the sprint review phase of agile development in which products or features are quickly rolled out to stakeholders to get immediate feedback. “There was no pilot, there was no soft launch,” Fernando said. Instead of getting bogged down in the planning phase, the approach was direct: “Let’s go and sell this to companies. Let’s see what happens. Let’s scale this.”
The team at Pfizer Ignite has actively learned from the process. “I talk to biotech partners all the time to understand what’s working, what’s not and we evolve,” Fernando said. The approach has enabled the program to iteratively redefine timelines and “redefine what fast means.”
But the program also considers the limitations of pursuing speed at all costs. “You can’t go super fast on everything or people get burnt out,” Fernando said.
Another consideration is maintaining the quality of innovation and service to its partners.
Ultimately, Pfizer sees Ignite as a source of innovation for the Pfizer pipeline. The goal is to pick the right companies, and help them succeed and succeed sooner. “We shape the innovation in a way that we think maximizes impact to patients,” Fernando said.
Fernando is optimistic about the program’s future over the next few years. “The true test is going to be whether the company can use the program to incorporate innovative programs [from Ignite] into its broader offerings. “That’s the end goal, and the leading indicators are trending there,” Fernando said, “but we’ll have to wait and see in a few years.”
Filed Under: Biologics, Cell & gene therapy, clinical trials, Drug Discovery, Infectious Disease, Women in Pharma and Biotech