Contract Manufacturing / Small Molecule / Large Molecule / Drug Delivery

Focusing Its Customer’s Customer Focus

West Pharmaceutical’s Graham Reynolds knows that better patient outcomes have everything to do with better drug delivery

By Steven E. Kuehn, Editor in Chief

By most measures West Pharmaceutical Services Inc. is one of Pharma’s most effective companies. Widely acknowledged for its leadership in parenteral drug administration systems and components, the company is a market leader and a well-known material-science innovator manufacturing everything from vial stoppers to sophisticated, electronics-enabled drug delivery systems.

West says it applies proprietary materials science, formulation research and manufacturing innovation to advance the quality, therapeutic value, development speed and rapid market availability of pharmaceuticals, biologics, vaccines and consumer healthcare products. As one of the predominant packaging suppliers for much of Pharma, West’s products are present across a broad swath of injectable therapies.

Seeking Alpha says West has a strong financial history, the company having grown its topline every year for the last 10 years. According to the transcript from its fourth quarter results analyst’s call, West achieved $1.4 billion in sales — its third consecutive year of record sales and earnings.

Seeking Alpha, explaining the company’s portfolio and its high potential for investor return, says the company operates with a “wide moat” and offers numerous sustainable competitive advantages including high customer switching costs (the price tag associated with moving to a new supplier) and regulatory protection to support its continued business success. Seeking Alpha’s glowing profile notes that “West Pharmaceutical’s clients conduct their drug testing process with its components for an extended period of time and subsequently [its] products are included as part of the filings for regulatory approval of drugs.” In fact, the company’s Drug Master File 1546 is the single most referenced document within the FDA’s archive. The results, says Seeking Alpha, speak for themselves. Understood as the market leader for most of its products, the company claims 60 percent market share in the U.S. and Europe and even higher for certain products in certain global markets.

West Pharmaceutical, globally headquartered in Exton, Pennsylvania, says it supports its partners and customers from 50 locations throughout North America, South America, Europe, Mexico, Japan, Australia, most recently India and now Ireland. West says its India facility expands its metal production capacity and is hosting 20 qualified customers already, and that permitting and site prep (at the time of announcement) was well underway for West’s proprietary insulin packaging facility it is erecting in Waterford, Ireland.
West Pharmaceutical goes to market structurally via two business segments: Packaging Systems and Delivery Systems and supports affiliated operations including West Analytical Services, The Tech Group and Medimop Medical Projects Ltd.

PATIENT-CENTERED STRATEGY
Success for West comes from many quarters, but underscoring it all is the attention the company pays to understanding the “buyer’s journey” it walks with its customers and regulators and addressing the pain points, perhaps literally, of patients that ultimately use the devices and technologies West creates. It also comes from its operational agility and its consistent ability to respond correctly to market and competitive forces. Graham Reynolds, vice president of marketing and communications, delivery systems, for West shared his insight at a recent encounter at DCAT week as to how West is navigating Pharma’s challenging seas: “There are a couple of major trends that I think are really driving West’s strategy. “First is the general growth in biologic drugs and in particular the newer molecules that are being developed [which] have their own challenges.”

Reynolds explains some of those therapies may need to be self-administered by patients and this creates challenges of how to make them effective, safe and as painless as possible for the patient. Reynolds notes that many newer injectable drugs tend to require higher dose volumes. “So what traditionally would be injected in a one mL syringe,” explains Reynolds, “now these newer molecules — because of the complexity — suddenly you have to deliver two mL or three mL or even more to make an effective dose.” That’s driving the development of newer delivery technologies, he says, “that will not only contain that volume of drug but deliver it in an appropriate time.” Reynolds says the evolution of plastic primary containers, syringes, etc., is certainly a driver adding that West understands some of the newer biologics are more sophisticated and that some molecules can interact with glass, thus prompting drug owners to explore the alternatives.

Viscosity of these newer biologic compounds is certainly a factor as well, and if it is an injectable, says Reynolds, the substance has to be injected through some device, and it obviously takes more force. “Glass is inherently a brittle material,” says Reynolds, “so the more injecting forces that challenge the device, the more risk there is to consider.” West’s response has been to expand its CZ plastics capabilities and capacity because of the materials’ suitability to pharma applications, especially injectable biologics.

SLOWER AND BETTER FOR IT
Among the exciting technologies West is developing is SmartDose, a wearable, electronic drug pump. West refers to it as an “electronic wearable.” According to Reynolds, the device is designed to administer the medicine packaged in a CZ cartridge. “All of the customers that we are working with — and we have about four of them in clinical studies at this point — are all using a CZ cartridge.” Reynolds explains the cartridge contains 2.5 or 3.5 mL of drug and feeds an electronic injector that basically sticks to the body, but delivers the proper dose slowly over a period of time. The reason for that, Reynolds says, is “if you used a traditional syringe and tried to inject 2.5 mL, first of all, you’d need a lot of force; it would also take a long time and that would be quite painful for the user. So to administer the drug slowly over a period of time makes it less painful and much more user friendly.”

TIME FOR YOUR MEDICINE
According to one scholarly review of the literature, “Compliance is not related to income, social class, occupation or educational background, and it cannot be accurately predicted by physicians. Unintentional errors in taking medication are made by 50 to 90 percent of patients.” That statistical range is startling and Reynolds, quoting an old phrase, points out the truism: “drugs don’t work in patients that don’t take them.” Increasingly, West’s customers are turning to the company to lead this area of development for them. “Our customers focus a huge amount on their drug molecule,” Reynolds says. “We help them to focus on the container aspect, to make sure it’s contained effectively.”

Reynolds says its customers are responding to market demands as well, declaring: “I need better injection devices and I need them to be more patient centric.” Reynolds explains its customers not only want to bring to market devices that people can manage to use physically, but designed in a way that actually promotes compliance because it functions perfectly and is easy to use.

Training people to administer meds with these devices is also another issue, and one that good design and well-engineered functionality come into play. “I think that it is becoming increasingly important, says Reynolds. “Within the reality of compliance, one could create the best drug molecule and the best container and the best delivery device, but if the patient doesn’t really want to go to the trouble today because ‘I don’t know how to do it, it’s too hard to do it, or I don’t see the benefit,’ they’re not going to take their medicine, says Reynolds, noting that ultimately that will make the drug, no matter how good, ineffective.

According to Reynolds, part of West’s B2B engagement strategy is to try to convince customers to start with the end in mind. In the beginning stages, he says, the focus rarely centers on the patient. Reynolds says they need to focus on the five Ws: Who is going to use it, Where are they going to use it, When are they using it and Why? “But if you’re thinking about the development of a pharmaceutical product, the first thing you should think about is who is going to use this? Is it going to be administered in a hospital or a home environment? Does it have to be portable? What competitive market space are we entering? Who’s doing what? What are our competitors doing?

When starting development with the end in mind, says Reynolds, the exercise of understanding the final requirements then feeding them back through a multifaceted organization to develop something to meet that set of requirements drives both packaging and device development. “I think the ultimate is when you can be part of a customer’s drug launch team, and be an integral part of that process. When you can work side-by-side with customers through the early stages and contribute to the success of the product, at the end of the day we all benefit.”

“We’ve always had focus on the container,” explains Reynolds, “but now we’re paying very close attention to device and even more to the patients, their behavior and how we can understand better and create devices that support better patient compliance.” It’s the confluence of the rise of biologics and meeting the special technical requirements these therapies’ formulations demand that are driving West’s strategic response.

“They’re knitted together in many ways because much of it relates to biologic and self-injection, says Reynolds. “In addition to all that, our customers are really focused on improving the quality of their drug product.” And West is focused on what it does best. The top 35 injectable biologics use West in some form because of its packaging expertise and focus. “So we’re in an enviable position of being able to help them,” says Reynolds, “and what we’re finding out is that [our customers] are really raising the bar in terms of quality.”

Pharma is always balancing risk against the reward of innovation, says Reynolds, agreeing that the industry is striving to improve, working to understand the challenges of patient compliance and it can better integrate supply chain partners into the drug development process. But without making an overly broad generalization, Big Pharma can be too risk averse and that can become a disadvantage.

“We certainly understand the need for risk aversion,” says Reynolds, “but sometimes that can be a challenge to innovation.” Reynoldsexplains that, although West may be doing things that really push the envelope and improve things, “sometimes it can take a little while because people have to feel comfortable that there’s no risk to their process.”

Free Subscriptions

Pharma Manufacturing Digital Edition

Access the entire print issue on-line and be notified each month via e-mail when your new issue is ready for you. Subscribe Today.

pharmamanufacturing.com E-Newsletters

A mix of feature articles and current new stories that are critical to staying up-to-date on the industry, delivered to your inbox. Choose from an assortment of different topics and frequencies. Subscribe Today.