Looking Back & Moving Forward With J&J's Global Development Leader For Immunology

A conversation with David Gordon, M.B., Ch.B., global development leader, immunology, Johnson & Johnson Innovative Medicine

Clinical Leader recently chatted with Johnson & Johnson Innovative Medicine Global Development Leader, Immunology, David Gordon, M.B., Ch.B. In this Q&A, Gordon recounts lessons learned from past clinical trial challenges and shares current-day strategies, like figuring out how to run a study that’s both scientifically sound and actually doable for patients and doctors. Gordon also shares his thoughts on the promising trends in clinical research and how these advancements will ultimately help more people get the treatments they need.

CLINICAL LEADER: How does patient need influence Johnson & Johnson Innovative Medicine’s strategy in the clinical research process?

GORDON: Patient need is at the core of our strategy — from the earliest stages of discovery through every aspect of development. Connecting patient need with our distinctive understanding of immune pathway science allows us to identify and focus on the highest impact research.

We know that there are more than 30 million people living with immune mediated diseases who are still waiting for solutions that will allow them to live healthier lives. And even though many current advanced therapies produce robust response in meaningful portions of patients, many patients are still not well.

 At J&J Innovative Medicine, our ambition in Immunology is to make big improvements in efficacy and reject approaches which result in small incremental steps. This is why we focus our time and resources on pursuing potential best in disease treatments, with a strategy of either defining cohorts of patients who will best respond, or by carefully combining mechanisms to achieve better efficacy. This requires a great understanding of the biology of disease and the pharmacology of our drugs.  As an example, we are studying the impact of a combination therapy that targets two distinct immune pathways in Rheumatoid Arthritis (RA). In this case we are combining an FcRN inhibitor with an anti-TNF, on the basis that they work on two distinct but complementary pathways in RA. The trial will treat patients who have inadequate response to advanced therapies and our aim is remission in a higher number of patients than has previously been observed. If we don’t see that in our proof-of-concept study, we will not continue.

Can you describe an example when you encountered a challenge in the clinical research process? How did your team address it, and what were your key takeaways from that experience?

Prior to joining J&J, I led a team focused on a treatment for severe asthma. We faced a common challenge within drug development: the program was scientifically great, but completely impractical to run.

Our initial recruitment approach involved a time-consuming, multi-step specimen process that would have been a burden on patients, as well as the staff at the investigator sites. And, it would never have worked – not in the study, and certainly not as a tool to use in the clinical setting. We needed to find a pragmatic way to deliver this clinical study that would achieve meaningful clinical outcomes, provide a more convenient process for patients and clinicians, and be true to the science underpinning patient selection.

Fundamentally, we aligned on not making “perfect” the enemy of good. Essentially, we established a pragmatic way to recruit the right patients, which may not have been 100% aligned with the original vision but was close enough. It was still based on good science and was manageable for patients and clinicians.

Without our new approach, I’m sure the study would not have been delivered and a drug that has had a big impact for patients with severe asthma would not have been approved. I continue to apply the learnings from that experience today. My goal is for our teams to be in lock step with the clinicians who treat patients living with these conditions, and that allows us to build effective clinical programs.

What are some of the most common hurdles you've encountered in your career, and what advice would you share with individuals facing similar hurdles?

Innovation is essential to our success, but it introduces the unknown and new risks. Often, it can be met with some form of a response which says: “This is not how we do things here.”

Overcoming resistance to change and embedding new ways of working takes commitment, stamina, and tenacity. I think these are some of the most underappreciated qualities of success in our job as drug developers. Having the idea is one thing, but getting people fully on board is another. As leaders, we need to create a vision and consistently show support as the team adapts to the change. You need to share your vision in a way that explicitly shows how it can make things better for everyone impacted by the change. Change for the sake of change is not enough. For it to be embedded, people need to believe it will improve outcomes.

I think it’s helpful to recognize that implementing significant change can be hard, so that we embrace the challenge and not give up before it’s given a fair chance to succeed. We hire talented, highly educated professionals and empower them to deliver. Combining that with support and strategic alignment allows us to deliver innovative change.

In your opinion, what are the most promising trends or advancements in clinical research that individuals should pay attention to?

I’m very excited about the impact that molecular biology and data analysis are having on the drug development process, and ultimately, our ability to help patients.

We design our trials based on detailed knowledge of the molecular biology and I firmly believe that will lead to better outcomes. What’s more, we are privileged to have an unprecedented amount of data at our disposal, with experts skilled at identifying the most relevant information and actioning on its value for our trials and beyond.

These are tools that are defining the next wave of drug development, as well as the next standard of care — a standard that will see more patients achieve durable, symptom-free remission.

What is your personal philosophy when it comes to motivating teams to operate with the patient, and other stakeholders, in mind?

I started my career in medical affairs, and it’s given me an important perspective that drives how I think about R&D. I am always thinking about the, “So what?” Specifically, what does this mean for patients? Does this help a prescribing decision? What does this mean in terms of accessibility? I have to consider the needs of our diverse stakeholders in every activity that we fund or resource, in addition to how to differentiate based on the science. This was the case in the earlier example I shared about the patient recruitment issue we faced. “So what if we had the most precise scientific method of identifying the best patients for the study if we were never going to be able to operationalize it?”

How do collaborations with academia and industry partners contribute to overcoming challenges in clinical research?

In J&J Innovative Medicine R&D, we have about 15,000 people. The scientific community is magnitudes greater! There’s no way all the best ideas and science happen to lie within the 15,000 that exist at J&J, so we need to collaborate.

Collaborative agreements between the academic community and industry partners can lead to innovation and successful outcomes for all involved, often bringing an idea to life that otherwise would have been impossible to achieve on our own. The drug I discussed earlier was struggling in other indications before an academic investigator had the vision for asthma. He was the one who proposed and ran the proof-of-concept study, which triggered our full development. This collaboration is what shifted an idea into reality.

Our collaborative work spans from molecular biology to population health, with each partner tapping into unique skills or resources to further the research.

About The Expert:

David Gordon, M.B., Ch.B., is global development leader, immunology, at Johnson & Johnson Innovative Medicine (J&J IM). In this role, he is responsible for the implementation and execution of the development portfolio for immunology. He will advance the immunology strategy to develop new and different mechanisms and treatment modalities to help patients achieve immune homeostasis and ultimately remission from symptoms.

Prior to his role at J&J, David served as chief medical officer at Aclaris Therapeutics. Before that, he spent more than 18 years with GlaxoSmithKline where he held a variety of roles. David received his medical degree and Bachelor of Medical Biology from the University of Aberdeen in Aberdeen, U.K., and a Diploma in Anaesthetics from the Faculty of The Royal College of Anaesthetists in London. He is accredited as a specialist in pharmaceutical medicine by the Faculty of Pharmaceutical Medicine in London and is a Fellow of the Faculty.