EXECUTIVE INTERVIEW - 3M Drug Delivery Systems Division: A Partner to Tackle Market Complexities

3M Drug Delivery Systems Division (DDSD) applies its 50-plus year history of global pharmaceutical development and manufacturing services to give customers proven expertise in inhalation, transdermal, oral, and topical solutions. In 2012, Drug Development & Delivery interviewed James D. Ingebrand, then Vice President and General Manager of 3M DDSD, who spoke about the challenges of globalization, technologies like the microstructured transdermal system and nasal MDI, and how 3M partners with pharmaceutical companies to help them control costs while bringing products successfully to market. Cindy R. Kent has recently succeeded Ingebrand as Vice President and General Manager of the division, transitioning from a role as Vice President of Strategy, Business Development and US Medical Key Accounts for 3M Health Care. Before she joined 3M, she spent time at both Medtronic and Eli Lilly, giving her broad expertise in both pharmaceuticals and medical devices. Drug Development & Delivery recently interviewed Ms. Kent to learn about her vision for the company and how developing trends are impacting the players in the pharmaceutical industry.

Q: Congratulations on your appointment. With a background in both pharmaceutical and medical device fields, how are you planning to utilize your experience and insight to help grow the division?

A: One of the things I’ll be the first to admit is that the healthcare marketplace today is radically different than the one I entered into 24 years ago. Part of what’s exciting to me, having transitioned through pharma, to devices and supplies, and now contract manufacturing and development, is that the marketplace in the past has changed significantly every 5 years on average, but of late, we are seeing significant changes every single year. However, what I believe is consistent – and the value that my background brings to this – is that I’m able to look at news and decipher what’s meaningful to us and what it suggests in terms of where the puck is going.

As a healthcare business within an industrial company, 3M Drug Delivery Systems has some unique advantages. For instance, 3M has its background in industrial adhesives and tapes, so our corporate scientists may be able to connect the dots when there’s a new polymer that impacts adhesive capabilities. In our case, this polymer change might impact our skin adhesive products, enabling changes like gentler adhesives for transdermal products. Given my background, I can look at a piece of news and be able to say, “This opens up an entire field of play for drug delivery.”

Q: What is your vision for the 3M Drug Delivery Systems Division and how do you plan to position the company to meet the needs of its partners?

A: One of the first things I did when I arrived here was to work with my team to come up with Drug Delivery Systems vision cards, outlining who we are, what we do, and where we drive value. I’m fortunate in that it’s not just me looking through old strategic plans and coming up with a new one; we recently conducted a customer survey that has given us data from approximately 150 of our customers. So we have their insights on what works well, and what are they looking for in an R&D and contract manufacturing partner. With that information, we are able to base our vision on aligning our core capabilities with what customers are asking for. This initial round of research was based on US customers; however, we have plans for the remainder of the year to do similar research in all of our major regions. Based on what we learned in the US, customers – not surprisingly – are saying they choose to partner with 3M Drug Delivery Systems based on our quality, our expertise with approval bodies and agencies around the world, and our technical expertise, both in manufacturing as well as in early stage development. Customers tell us that they recognize our technical expertise not only in drug delivery, but within the larger 3M, which gives us the backing of 3M’s innovation and rigorous scientific competence.

Given all of this, my hope and vision for our business is that we are the trusted developer and manufacturing partner of choice. There are reasons that partners come to us and want our help in bringing their products to market. Our core capabilities – product development, commercial manufacturing, global regulatory expertise, and our technological and innovation savvy – are resonating very strongly with customers.

Q: What general trends are you seeing in the healthcare industry, and how are these helping to shape the pharmaceutical market?

A: Among the big trends driving shifts in pharma is an increased focus on outcomes. It’s not a simple matter of being at parity anymore. When I was in pharma, we had some pretty defined development archetypes. A new product could be novel, second-and-better, or perhaps an additional entrant into a crowded market. We defined our value proposition within the boundaries of those archetypes. Frequently, in the case of a product that was a new entrant into a crowded market, we would design clinical studies to be non-inferiority studies, as opposed to superiority studies to dethrone the market leader. But I believe the bar has been raised, and the standard is now better outcomes at lower costs. It is a completely different game. I believe there will be fewer blockbuster drugs being developed, and the focus will shift to how to take cost out of the system – not just in terms of having a lower price point, but how one product might be able to eliminate the need for two to three others.

We are also in a time when pharmaceutical companies are facing a high number of patent cliffs, which is forcing consolidation. In this climate, it doesn’t seem applicable to label companies as friends or foes anymore; companies that are partnering together in one area may be competitors in other areas. It used to be that there were very clear lines of demarcation between branded pharma companies and generic pharma companies. But at this point, that’s no longer the case. Many companies are diversifying their own portfolios with a mix of branded and generic products, because if you’re only branded, you really leave no room for a situation like a government entity asking for volume discounts. In this situation, having a market laggard or a generic in the mix might give you the leverage you need. And thus a lot of companies are becoming their own generic providers, which is unheard of historically in the pharma universe.

Finally, the increased focus on emerging and developing markets means that we’re no longer only thinking about how we launch products in developed markets. We have to figure out quite quickly how to compete in international situations where a local company may receive preferred or accelerated approval status from the ministry of health and local regulatory agencies. When granting approvals for multinational companies, these ministries maintain the quality standards seen in developed markets, but they want price points for developing markets. We just don’t develop products that way, so this means that we must change our process to take costs out, or think about a pyramid of products and develop products at various tiers. This is simply a much different universe than we’ve ever been in as an industry.

Q: What main factors in the healthcare industry are influencing the innovations in drug delivery?

A: Some of the factors I see driving changes are the large and untapped opportunities as they relate to new therapeutic areas. For example, cancer continues to have devastating impacts on the health of people around the world. And yet, limited therapeutic solutions exist, depending on what type of cancer we’re talking about of course. So companies are considering what the therapeutic areas are that do not have a “gold standard,” and drug delivery can offer tremendous opportunity in these areas. Combining a marketplace need like that with our capabilities is an area that is very promising.

Furthermore, for therapeutic areas that we are already involved in, such as asthma or COPD, the trends toward minimizing waste and being patient-friendly are having important impacts. One of the factors currently driving increased demand for our products is that we have an innovative dose counter that helps assure patients of exactly how much drug has been dispensed, and also helps them stay on top of their remaining supply. We’re seeing increased requests for dose counters on actuators, so this is an innovation we are continually working to optimize.

Q: What advice do you have for pharmaceutical companies looking to become competitive in the generics marketplace?

A: The easy answer is to work with a reliable partner. That sounds self-serving, but it’s not as glib as it may seem. There’s evidence all around that the bar for generics is increasing. Companies in the past haven’t necessarily thought about generics as an “easy play,” but the point is that standards around generics are ever changing. At the end of the day, it’s becoming clearer that generic simply means, “yes, it’s off patent.” It’s a cheaper price point, but the regulatory pathway is as robust and rigorous as the initial branded innovator product.

Combine that insight with the reality of the market today. As companies become increasingly cognizant of cost at every point in the value chain, it becomes clear that not everyone can master every point in that value continuum. Given this, the best thing a company can do is to think about where its greatest area of expertise is and concentrate in that area. Then, when it comes to overall maximization of the value chain, companies should find a credible and competent partner that can handle other aspects. It’s in everyone’s best interest to maximize the value chain and help get high-quality products on the market faster. So I encourage companies, instead of trying to be all things to all people, to really consider working with a partner like 3M DDSD, with whom they can partner to navigate these new market realities.

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