Sujith Kallur Mallikarjuna wants to change the way we talk about combination products

RAPS Convergence is where the world’s regulatory affairs community gathers to share expert insights and create meaningful connections. We’re talking to the speakers behind this year’s event to get the inside scoop on the topics everyone will be talking about and their tips for making the most of your week. Next up: Sujith Kallur Mallikarjuna, associate director, regulatory affairs at BD.

What is your career background? How did you get to where you are now?

After college, I worked for a market research organization, where I reviewed patent and clinical trial databases to better understand how drugs enter the market. As I examined clinical trial information, I found myself asking a wide range of questions: How does an organization decide which trial to conduct? How is the objective of a trial determined? What is required for a drug to reach the market?

Those questions led me to apply to the regulatory science program at USC, which became my formal entry point into regulatory affairs. While many people discover the profession by chance, my introduction to regulatory affairs was intentional, and I was immediately drawn to the field. Since then, I have worked across orthopedic implants, diagnostics, human cells and tissue products, and combination products, with additional experience in robotics along the way.

What has it been like to transition between different product types?

That variety has been one of the most rewarding aspects of my career. Although my initial interest was in pharmaceuticals, most of my professional experience has been in medical devices, before I eventually returned to combination products and moved closer again to the pharmaceutical space.

Much of my experience has been in medical devices and in vitro diagnostics. One advantage of medical devices is their comparatively shorter lifecycle relative to drugs. An organization can identify an idea, complete development, obtain 510(k) clearance, launch the product, and begin generating postmarket surveillance data within approximately three to five years. That pace has allowed me to move across product lines and understand them from concept through launch.

What does your current role at BD entail?

I lead the regulatory affairs function for a billion-dollar platform under BD Specimen Management. A significant portion of this work involves lifecycle management, including product changes, manufacturing transfers, supplier transfers, supplier changes, material changes, renewals, certificate maintenance, audits, along with new product development to bring next-generation devices to market. My role also includes early ideation, development of regulatory strategies and pre-submissions, and mentoring my team. I have developed a competency model — based on the RAPS Regulatory Competency Framework and BD’s own competency model — to support the professional growth of team members.

Where did the inspiration for your session come from?

The inspiration came from a desire to connect my experience in medical device change management with my experience in drug change management.

Although the language used by CDER and CDRH can differ significantly, the underlying regulatory principles are often closely aligned. As someone who is multilingual, I am familiar with the challenge of recognizing when the same concept is described in several different ways.

My goal is to distill change management to its first principles from both the device and drug perspectives, and to help create a more cohesive framework that can be applied consistently while still respecting the terminology used by regulators.

You write that postmarket changes for combination products require manufacturers to reconcile distinct FDA frameworks for drugs and for devices, and “this regulatory divergence often necessitates a heavy reliance on subjective critical thinking.” What’s one example of this subjective critical thinking that can benefit from more systematic rigor?

Consider a change to the device constituent part of a combination product. If you are approaching the issue from a medical device perspective, and the product were a 510(k) device, you might begin by consulting FDA guidance or EU MDR guidance on significant changes. From there, you would work through a decision framework to determine whether the change relates to labeling, technology, materials, or another category. You would then evaluate the associated risk and determine whether the change raises new questions of safety or effectiveness.

However, 510(k) change guidance cannot be applied directly to a combination product. When working with a drug-led combination product, it is necessary to understand CDER guidance. When working with a biologic-led combination product, CBER guidance may be relevant. Each framework uses distinct terminology, even when addressing similar underlying regulatory considerations. That distinction is one example of where systematic rigor can help reduce reliance on subjective interpretation.

You write that, "by thoroughly reviewing the requirements of relevant FDA regulations and guidance, we will examine a proposed framework grounded in first principles and visualized through logic-based flowcharts.” What does this framework entail?

The framework begins with the foundational principles of both device and drug change management. From the device perspective, key questions include whether the change raises new questions of safety or effectiveness and whether the benefit-risk profile has changed. From the drug perspective, an important consideration is whether the change affects the identity, strength, quality, purity, or potency of the drug.

The objective is to show how these concepts can be integrated while also exploring key terminology such as critical quality attributes, critical process parameters, and essential drug delivery outputs. These terms may be familiar to professionals from the drug side but less familiar to those from the device side. Conversely, professionals from the drug side may be less familiar with design controls and device risk management. The session is intended to help both communities better understand each other’s language and then build a practical framework from that shared foundation.

What keeps you coming back to RAPS Convergence as an attendee?

I value the opportunity to engage with experienced professionals, receive thoughtful feedback on presentations, and build meaningful connections. RAPS Convergence also provides a valuable view into emerging topics in regulatory affairs, including areas I may not have considered previously.

How do you prepare for an event like this?

I prepare by reviewing the broader program in detail and identifying opportunities to make my participation more meaningful while I am there. I also plan to attend networking events so I can connect with new colleagues and reconnect with longtime professional contacts.

What's one piece of advice you'd give someone who is attending this event for the first time?

Bring a notebook and take as much notes as possible. Also, be prepared to share your contact information, whether through a business card or a link to your LinkedIn profile, so you can continue conversations and maintain connections after the event.