Showing Up Every Day for People with PAH: David Jimenez, Janssen Pharmaceuticals

David Jimenez has been with Johnson & Johnson his entire career, starting as a sales rep for medical devices in Madrid, Spain, after becoming a pharmacist. From there, he moved around the world as he grew into different roles — general manager of the Middle East and Africa, running infectious diseases in the US, and, as of summer 2020, president of the US pulmonary hypertension (PH) therapeutic area within Janssen Pharmaceuticals.

Speaking to Pharm Exec, Jimenez talks about how the Janssen PH therapeutic area became one of the fastest growing divisions of Janssen, how the company is putting patients first, and how he is delivering on the company’s mission to support clinicians in diagnosing people with pulmonary arterial hypertension (PAH) earlier.

Pharm Exec: PAH is a rare disease. Could you tell us more about it?

David Jimenez: Pulmonary arterial hypertension is a rapidly progressive, life-threatening disease with no known cure. PAH is a specific form of pulmonary hypertension (PH) in which the pulmonary arteries become narrowed. About 500–1,000 new cases of PAH are diagnosed in the US each year. Patients with connective tissue disease (CTD) and congenital heart disease (CHD) are known to be at a greater risk of developing PAH. Of the CTDs, PAH occurs most commonly in systemic sclerosis (SSc). For individuals with PAH, continuous risk assessment is necessary to evaluate disease progression and inform treatment decisions based on patients’ prognosis.

David Jimenez

For PAH, ensuring that patients who are considered high-risk (meaning risk of one-year mortality) are diagnosed early is critical. This is why Janssen is focused on finding ways to detect PAH earlier, with the aim of decreasing time to diagnosis.

We also develop innovative therapies that slow disease progression and reduce risk of PAH-related hospitalization. It’s so important for people with PAH to stay consistent with their treatments, or to include double- or triple-combination therapy, when necessary, as this can help slow disease progression. For example, the GRIPHON* clinical trial (the first and only completed PAH outcomes trial that included patients treated with triple-combination therapy) showed a 40% risk reduction in hospitalization and disease progression. GRIPHON was a multicenter, long-term, double-blind, randomized, placebo-controlled, parallel-group, event-driven phase 3 study in patients with symptomatic PAH. There were 1156 patients who participated, making it the largest outcomes trial ever conducted in patients with PAH.

How are Janssen’s current product pipeline and other innovations poised to further help people living with PAH?

We are advancing more than 21 active projects across the R&D pipeline for new disease-modifying treatments and novel therapeutic devices related to PH. We’ve been working on ways to help patients stay connected to healthcare professionals and providing HCPs with the scientific research, tools and education they need to make earlier diagnoses and informed treatment decisions for their PAH patients.

One example of what we’re working on, beyond the product pipeline, is our DETECT screening tool. We have funded and developed this screening tool app to assist physicians in screening patients for PAH associated with connective tissue disease (referred to as PAH-CTD). People with CTD, particularly systemic sclerosis (SSc.), are known to be at a greater risk of developing PAH. The DETECT screening tool aims to help provide physicians with a recommendation on which patients should be referred to echocardiography (ECG) as a first step, and if applicable, referred for right heart catheterization (RHC) as a second step, for potential diagnosis of PAH.

Another tool Janssen funded and supported is the REVEAL Lite 2 risk calculator. Coupled with the original REVEAL 2.0 calculator, an analysis showed that REVEAL Lite 2 offers a simplified method of risk assessment in using six noninvasive and modifiable variables that may be implemented routinely in clinical practice and helps differentiate PAH patients among low, intermediate and high risk of one-year mortality. Risk calculators such as REVEAL Lite 2 that assess fewer, non-invasive variables may help physicians expedite and enhance their strategic decision making.

Can you tell us about your newest role at Janssen and your experiences over the past year? What makes you so passionate about your work?

I always wanted to work in healthcare. Having the ability to focus on work that makes a difference for patients is what makes our work so impactful. This year, I’m extremely proud of how Janssen is bringing the community together to advance our most ambitious goal of improving the lives and survival of PAH patients. Having started with the Janssen PH therapeutic area during the early stages of COVID-19, it was more vital than ever to keep our focus on patients’ needs. Through the past year and a half, we’ve made decisions that reflect the J&J credo by keeping our patients and our people top of mind with every decision. We have been agile and flexible in the solutions we offer and how we engage with all stakeholders throughout the pandemic, and we continue to strive for results that support the larger community of healthcare providers, patients, employees and consumers.

What were the most recent growth numbers for the business? To what to you attribute the growth within the Janssen PH therapeutic area?

In Q2 of this year, we’ve seen the PH division deliver 8.7% in operational growth and almost $870M in total sales. UPTRAVI® and OPSUMIT® are some of the most widely prescribed and relied upon PAH treatments in the world.

We attribute this growth to our steadfast dedicated to patient and HCP needs. We continue to drive transformation and collaboration within the PAH community by developing tools that we hope will lead to greater awareness of and screening for PAH and more timely and regular risk assessment for those living with PAH.

You recently led Janssen PH through the FDA approval of a new indication. Could you elaborate on that?

The FDA’s recent approval of an intravenous formulation of UPTRAVI® (selexipag) for the treatment of PAH in adults who are temporarily unable to take oral therapy is an important regulatory milestone for both Janssen and the PAH patient community. This new formulation will help patients avoid short-term treatment interruptions, representing a solution for a previously unmet need for PAH patients on UPTRAVI who face temporary interruptions in their ability to take UPTRAVI tablets.

You’ve had roles across the globe, all while employed at J&J. What are some of your biggest takeaways from these experiences?

My global, culturally diverse experiences have helped me shape and lead teams. I've learned how to make decisions that take multiple perspectives into account. Through working in so many different geographies, I've learned the value of diversity. People bring unique skillsets, differing points of view, and individual personalities to their work. I’m such an advocate for diversity and inclusion because I've learned that you can get the best of everybody and create something bigger through a more diverse team. My leadership style is really focused on listening to different opinions, identifying the strengths of every individual and learning how these strengths connect with the major business objectives. I also have learned the importance of bringing a growth mindset; it’s imperative to find a way for the team to see the hidden opportunities, not just the obvious challenges.

*GRIPHON = Prostacyclin (PGI2) Receptor Agonist In Pulmonary Arterial HypertensiON