Dr. Katie Abouzahr, Johnson & Johnson’s new head of late-stage immunology development, draws on her NHS clinical roots and 11 years at Boston Consulting Group to tackle drug R&D’s most complex challenges. Having recently stepped into the role about a month ago, she oversees a portfolio that includes the newly FDA-approved nipocalimab for myasthenia gravis, a drug that emerged from J&J’s $6.5 billion acquisition of Momenta Pharmaceuticals in 2020 and represents what executives call a “pipeline in a product” with potential across more than 10 autoimmune conditions, and the promising first-in-class oral peptide JNJ-2113, viewing the process as a high-stakes collaborative effort.
“I do genuinely think that drug development, in and of itself, is one of the most complex team sports that you can play,” she said in a recent interview.
Breaking down disease silos
Katie Abouzahr
Johnson & Johnson is advancing its immunology pipeline by targeting disease pathways that cut across organs, from skin to gut to muscles. The portfolio includes blockbusters Stelara and newer Tremfya, the recently approved nipocalimab for myasthenia gravis, and the investigational oral peptide JNJ-2113 (icotrokinra), which is showing strong results in Phase 3 psoriasis trials. Prior to her current role, Abouzahr led Stelara in the IBD space and later shepherded the Momenta acquisition program through to its recent approval.
Abouzahr’s path to leading immunology development didn’t follow the usual trajectory. She initially joined J&J in a ‘strategy and operations role’ before moving to immunology R&D. “I initially came in, like all good management consultants, to a strategy and operations role, because that’s the classic entry when you’re a management consultant,” she explained. “But I was really fortunate to find my way into immunology R&D pretty quickly, and I’ve been there ever since.”
By leaning into a pathway-centric model rooted in deep immunology expertise, Johnson & Johnson is deliberately evolving from traditional disease silos to a system-level strategy to create multi‑indication platforms. “We tend to take a sort of pathway-centric, deep expertise and experience approach to immune-mediated diseases,” Abouzahr explained, describing J&J’s immunology strategy.
Here, J&J prioritizes unmet medical needs and actionable science over traditional therapeutic boundaries. “The thing that really, truly guides us is the unmet need and the actionable science,” she explained.
The company’s approach relies on core principles. “When we think about portfolios and what drugs to develop, we think about one, unmet need; two, do we have the actual science to fulfill that unmet need; and then finally, value creation,” Abouzahr said.
Addressing gender disparities in autoimmune disease
Autoimmune diseases disproportionately affect women in many cases. Lupus and Sjögren’s syndrome, for instance, strike females at rates up to 90%, while psoriatic conditions and inflammatory bowel disease show more balanced gender distributions. Abouzahr highlights that pregnancy-related autoimmunity is a critical unmet need, given not only the hormonal and immunological shifts during gestation but also the increased risks of complications such as miscarriage, pre-eclampsia and fetal growth restriction in women with autoimmune conditions. Abouzahr identifies pregnancy-related autoimmunity as a critical unmet need in the field.
“Why women have more autoimmune diseases remains an open question with multiple theories,” she explained. One relates to X-chromosome inactivation: how the body manages having two X chromosomes without both being fully active. The issue is “probably connected to hormones, genetic makeup and the immune system’s need to tolerate pregnancy, which makes women’s immune systems potentially more complex,” Abouzahr said.
The industry’s response to these disparities has been encouraging. “I’m thrilled to say that it’s competitive for the greater good, that there are lots of companies looking at being able to develop medicines in these spaces,” she noted, citing lupus, Sjögren’s disease and myasthenia gravis as areas of intense focus.
“The one area that I would say there’s a lot more to do generally… is the autoimmune diseases of pregnancy,” she emphasized. Historically, about 95% of clinical trials excluded women. “When you go into studying pregnant populations, you have to do it with care, with caution, with the science. You have to listen to patients and providers, and you have to do it in partnership with health authorities.”
A 10,000-foot view of the science
The science underlying J&J’s approach has roots. The company has spent decades focused on fundamental immunology research to create a new class of therapies. And nipocalimab, acquired via its treatment of Momenta in 2020, targets the FcRn (neonatal Fc receptor). The drug works by blocking FcRn’s ability to recycle pathogenic IgG autoantibodies, effectively reducing their levels in circulation and dampening autoimmune attacks across multiple conditions.
The discovery of FcRn itself emerged from basic science questions that researchers were asking decades ago. “Way back in the 70s and 80s, there were researchers trying to understand why IgGs live for so long in your blood,” Abouzahr explained.
Abouzahr recounts that IgGs are the most common antibodies in blood, produced by B cells, a type of white blood cell. Researchers were puzzled by why these antibodies persist so long in circulation. “They discovered, actually, in pregnant rats, that there was a receptor recycling the IgG and allowing it to continue to live. And the receptor was called the Fc neonatal receptor.”
From FcRn to IL-23
A significant portion of Johnson & Johnson’s immunology work centers on IL-23 inhibition, with the investigational oral peptide icotrokinra (JNJ-2113) leading the charge. The drug recently posted strong phase 3 data in plaque psoriasis and psoriatic arthritis, with a recent New Drug Application (NDA) submission for plaque psoriasis and expansion trials underway for inflammatory bowel disease.
Key milestones on the horizon include potential icotrokinra approval in 2026 as well as FcRn-focused nipocalimab’s expansion into pregnancy-related conditions through the ongoing AZALEA, FREESIA-1, and FREESIA-3 trials.
“We do have nipocalimab as an investigational treatment in hemolytic disease of the fetus and newborn (HDFN), and fetal neonatal alloimmune thrombocytopenia (FNAIT),” Abouzahr noted. “Nipocalimab is the only therapy under development for the treatment of these diseases.”
“What are we ultimately trying to do? Especially if you’re newer to it in immunology, you’re trying to reach durable immune balance, meaningful outcomes, reach remission for patients with unmet need,” Abouzahr explained.
Filed Under: Immunology
