Magazine Article | March 1, 2016

Insights For Creating A Combo Products Centre of Excellence

Source: Life Science Leader

By Doug Roe, Chief Editor

The Centre of Excellence (CoE) business model has gained a lot of momentum over the last few years. Today’s companies are looking for strategic long–term solutions, not just temporary fixes or tactical course corrections. An effective CoE can offer standardization of systems and processes across multiple businesses and disciplines throughout the company.

It becomes a centralized knowledge hub that develops best practices and governance, which facilitates repeatable and sustainable improvement. The CoE leadership become the company advocates of change. Their horizontal visibility, which reaches across all projects and teams, allows for consistent alignment with corporate directives.

If you are thinking about implementing a CoE, what are the real considerations? All companies will start in somewhat different places, and the development will take different paths to fruition. But one thing will stay the same: To have success, you will need to overcome some similar challenges.

There are some basic issues that have been summed up as the three Ps: people, product, and process. Does the current employee talent pool contain the required skills and technical expertise? Is there one clear company vision for current and future product strategy? How significant are the variations of existing systems and processes? Now, add in some complexities — senior management buy-in, earning/maintaining confidence from development and manufacturing teams, ego considerations, and cultural clashes, just to name a few.

Other than that, seems easy … right? Now here’s the curve ball. What does it take to build that CoE structure in a life sciences company that also produces combination products? Talk about your culture clash. Historically, these two groups — drug and device — have existed autonomously. Each has its own regulatory path, quality standards, design and manufacturing controls, R&D obstacles, employee skillsets, department structure and career path, internal and external value proposition — and, of course — culture.

Even if you can overcome these systemic barriers that represent significant inequities, can you then bring the teams together and get them to play nicely in one very new, and very large, sandbox? Seems like a tall order.

I had the chance to discuss those issues with Susan Neadle, head of The Janssen Combination Products Centre of Excellence (a Johnson & Johnson Company). We discussed the reasons behind the 2014 launch of the CoE, some of the Centre’s early challenges, the current improvement experience, and potential next steps in the Centre’s evolution.

Can you describe the general scope and purpose of the Janssen Combination Products Centre of Excellence?

We established the CoE about a year and a half ago. Combination products at Janssen make up a good part of our portfolio. For a combination product, the critical aspects of the drug — to deliver the required therapeutic effect — and then the critical attributes of the device — to administer that drug effectively — are both key to overall patient outcomes. The Combination Products CoE was created to develop and implement the best practices and broad structure needed to be able to be strong in devices, not just pharma, ensuring we have the required resources and the skillsets, at all levels, to effectively be a pharma company and a device company.

What were the internal drivers that led to its creation?

I started at Janssen about two years ago. I transitioned in from another J&J Company (Device Sector). The timing was perfect. It was shortly after the time when the FDA released the final rule for combination products. I had just enough time to get my feet wet and realized we had an opportunity to improve our focus and core competencies for delivery devices.

I saw that the primary focus of the pharmaceutical company was about the therapeutic effects of the drug and making sure that those therapeutic effects were doing what they were supposed to do. Historically, it was less about making sure the device met the user needs for administering the product, as long as the drug was efficacious.

That was a key driver for the CoE’s creation — it is about a pharmaceutical company learning that it needs to be a device company, too.

I also wear another hat; I head up the Design to Value (DtV) efforts at Janssen. DtV is a strategic initiative across all of the J&J companies. I lead the pharmaceutical sector, in addition to our combination products. DtV is an end-to-end life cycle methodology enabling customer-centric, high-quality products, made efficiently and reliably. DtV is built on five pillars: Customer Value, Quality by Design, Technology Platforms, Knowledge Management, and Governance. Customer Value is where it all starts, capturing, analyzing, and integrating customer insights to make sure that the products you are delivering and the services you are providing are customer-centric. When applying DtV to combination products, focusing on the customer need, the focus on ensuring the quality of the drug, is of course critical, because customers need to realize the therapeutic effect of the drug. From a customer value perspective, though, the device is equally important, because the device being used to administer the drug is the thing that the customer is seeing, touching, feeling, and interacting with.

We need to focus on understanding what specifically our customer needs — from a human factors and usability perspective and from a complete supply chain perspective — as well as who is administering care, be it the patient, or a caregiver. We need to determine what they care about when it comes to the device administering the drug and then build those things into the combined product.

Again, it comes back to the requirement to have the skillsets and core competencies that enable us to effectively deliver device constituents or combination products, not just the drug.

"There are cross-company differences that can really impede your progress, because you have people with different tolerances of risk working in devices, versus drugs, versus combinations."

Susan Neadle
Head of The Janssen Combination Products Centre of Excellence

What should a pharmaceutical company consider and understand before creating a combination product CoE?

I see three key considerations: business systems, cultural challenges, and product and process technology. From a product and process technology perspective, teams are composed of scientists and engineers accustomed to working through technical challenges. Technologies may fall outside of core capabilities, though, so those competencies need to be developed. It is likewise important for teams to effectively develop and characterize both constituent parts and the integrated product. These technical challenges may be magnified with business system and cultural challenges.

From a business systems perspective, consider the varied business cases. If you are a device company, the incentives, metrics, and strategies can be very different from those on the pharm side. Those management incentives, behind the business cases, may be very different.

From a quality systems perspective, you are dealing with multiple quality systems that have to be harmonized or potentially developed. There needs to be an understanding of the regulations that are uniquely interpreted under the Quality System Regulations (QSRs) compared to the Pharm GMPs. Much of the terminology used in the regulations is the same, but the interpretations may be different. If you are a pharma-centric organization, you need to ensure that these intricacies are incorporated into your quality systems.

With clinical and R&D systems, evaluate the governing project management. Do stage gate reviews include both device and drug subject matter experts? Was it designed for a pharma process, as is typical? Does it include the stages or the reviews that are required for the device at the right time? Treating these considerations as an afterthought could lead you to have to play catchup on the device, because the focus was on the drug.

Even with manufacturing systems, you have to implement the fundamental infrastructure and governance to make sure that your drug and device launches are synced. Do you have the systems built in to avoid manufacturability issues with your device? For example, devices require design validation. That design validation includes not just the device’s performance, but also the device’s interaction with the drug. More tests may equate to more time.

If developers focus primarily on how the drug is formed, that might impact your timeline. There are cross-company differences that can really impede your progress, because you have people with different tolerances of risk working in devices, versus drugs, versus combinations. “The drug matters; the device does not.” This is a cultural divide. Product developers must be aware of, and accept, the differences between pharma and device and then be willing to educate themselves to get past that barrier.

Those culture aspects … they are fun. How does each group perceive the other? If teams are collaborating on projects, is the cross-platform collaboration limited to, “I will consult with you when I need your opinion,” or is it truly collaborative? You need to realize there may be blind spots. It may not even occur to one group that there are questions they need to be asking/ consulting about, and vice versa. You need to develop the understanding that each group probably knows some things that the other does not and then ensure that they hold hands the whole way to get the best outcome.

Was there an overarching dynamic at Janssen that made you believe, “yes, we can make this happen”?

This entire process has been top-down. Senior management understood and fully supported what we needed to do. Then, it was just a matter of education, so the broader organizaton could get it.

What are the various segments and disciplines of the CoE team?

The CoE is a large cross-functional team. It includes a leadership team of mentor experts in design controls, combination product regulatory compliance, complaints management, Corrective Action Preventive Action (CAPA), market safety reporting, and risk management + criticality analysis. That last group is unique, because it merges risk management for the device and criticality analysis for the drug into one function. We also have the DtV/Quality Engineering group. That is the leadership team, and then we have other CoE people distributed across the businesses. We have specially trained people in customer complaint vigilance, because the way you ask questions for combination products is going to be different from the query process for stand-alone drugs or devices. Our CoE also includes combination products subject matter experts for supplier quality. Then, in our R&D group, we have experts in human factors and combination product analytics, and combination products regulatory affairs. Some of the other experts in the CoE include Quality Systems and IT professionals, Reliability Engineers, and Device Engineers.

"Much of the terminology used in the regulations is the same, but the interpretations may be different."

Susan Neadle, Head of The Janssen Combination Products Centre of Excellence

It has been set up so the CoE is integrated into all businesses and departments. We did not want it to be a separated governing group; we wanted it to evolve into, “This is just the way things are done,” and the combination products are just part of it. This is about bringing in the right skillsets and embedding and ingraining those skillsets across the company.

What role do you play on the CoE team?

I have oversight for all programs and the overall center of excellence. My leadership team does weekly reviews of all of our initiatives, making sure things are moving forward the way we want them to. We focus on products currently on the market, making sure that they meet the quality the company expects, as well as any new products in development.

Has the CoE changed the way the company approaches combination product design and development?

We have updated or upgraded all of our combination product design and development processes. We have embedded the deliverables required for devices into our pharma chemistry, manufacturing, and controls (CMC) stage gate system. The process and the teams are fully integrated now.

Device experts are getting more exposure to the drug aspects, and the drug experts are getting more exposure to the device aspects. More people are developing that mutual understanding. You do not get customer-centric design by working in silos. We are achieving it by working together, and it will only get better over time. It just becomes part of the normal way of doing product development.

How do you see the function of the CoE transforming over the next 10 years?

It is going to shift from a focus on making sure that all the quality systems are aligned and integrated to a focus on proactive quality. We will make sure that we are building those customer-centric designs and design controls in conjunction with our Combination Products Development Process (CPDP) quality by design (QbD) protocols. The whole thing will be integrated. That way, the products released to market are the best products they can be.