Two of Johnson & Johnson’s OCMO leaders, Steve Lin, who is with the company’s Innovative Medicine segment, and Richard Mayer, with the company’s MedTech segment, discuss patient-centered safety science at the company and the future of safety innovations in medicines and medical devices.
Q:
How does Johnson & Johnson prioritize medical safety throughout the product lifecycle?
A:
Lin: Johnson & Johnson approaches decisions with a focus on the people who use our products every day. Our guidance in medical and clinical safety is grounded in science and evidenced-based decision-making, as well as an ethics- and values-based approach that spans the entire product lifecycle to optimize benefit-risk for patients.
Our First-in-Human Early Development Committee for our medicines reviews early development plans to ensure appropriate risk mitigation plans are in place when an investigational therapy is first used in a person, and that the compound being studied will address unmet needs and benefit the people who ultimately will use it. Post-launch, our active safety surveillance—which includes review of medical literature and spontaneous safety reports—identifies safety signals so we can assess and, if necessary, address the potential risk as quickly as possible.
Mayer: In addition to the common approach across both segments (First-in-Human, Safety Management Teams, Development Committee, and Medical Safety Council), in MedTech we aim to use closed-loop systems to enhance safety proactively. This allows us to leverage usability evidence to capture safety insights and learnings and incorporate them back into development, leading to continuous device use safety improvement. We also provide safety and risk management education programs to surgeons and clinicians to help optimize device safety and performance in a clinical setting for better patient outcomes.
Q:
How does Johnson & Johnson involve patients in their safety processes and why is this important?
A:
Mayer: Patient input is an innovative component of our safety processes. We have recently tapped into this space to further enhance our benefit-risk evaluation methodology, as it helps us understand patient priorities and evaluate the potential benefits and risks of a device through their perspective.
We recently rolled out a quantitative benefit-risk assessment framework that not only will help our Safety Officers better assess the risk profiles of our products in the pipeline and on the market, but also provide a point of reference and relative measure when comparing to predicate devices, or a device already on the market. We are collaborating closely with our regulatory partners to advance the application of such assessments in regulatory decision-making for medical devices globally.
Lin: J&J Innovative Medicine has been a pioneer in structured benefit-risk assessments, including the incorporation of patient perspectives to understand how patients value the benefits of our medicines against potential risks. In other words, we learn what trade-offs study volunteers and patients may be willing to accept in terms of intended and potential unintended consequences of taking an investigational drug or approved medicine. We have a structured approach to capture their feedback, ensuring that we can gather insights rather than anecdotes, and that those insights are used effectively to inform our decisions, as well as educational materials for physicians and patients.
Q:
What new technologies are helping to optimize safety science at Johnson & Johnson? How will these developments benefit patients?
A:
Mayer: Artificial Intelligence (AI), natural language processing and robotic automation are transforming the safety landscape at Johnson & Johnson MedTech. AI has the potential to help us more quickly identify safety signals and improve the usability of our devices, specifically focusing on where boundaries of comprehensibility of systems and devices increase exponentially. It could facilitate further how we capture learnings from the operating room and translate those learnings to inform professional education in their safe use and back into the early development stages of future devices.
Lin: In parallel, Johnson & Johnson Innovative Medicine is leveraging robotic processes and intelligent automation to analyze data faster and help us generate insights on the safety of our products more quickly. We are also using AI-enabled technologies in the clinical development setting to inform safe dose selection in clinical trial programs and facilitate safety signal management and detection. The more rapidly we can identify potential product safety challenges, the faster we can do something about it. Finally, we’re piloting generative AI to improve our efficiency, enabling our team members to focus less on administrative work and more on high value-added activities.
Q:
Looking ahead, what excites you most about safety science innovation?
A:
Lin: In Innovative Medicine, new technologies are helping to expedite drug discovery, delivery and safety. Translational safety is an emerging area that serves as a bridge between laboratory research and real-world application to identify and mitigate potential risks associated with medical interventions and better predict clinical outcomes. For example, we are leveraging safety information from currently marketed medicines and examining how to improve preclinical models before they advance to clinical development.
Mayer: Changing patient needs, new technologies and greater collaboration require flexibility to be responsive and maintain our high safety standards. Our focus remains on addressing unmet needs and achieving optimal patient outcomes through rigorous science and care to keep patients as safe as possible.