Guiding customers through drug development challenges with intelligent collaboration

17 Oct 2019

Taking on the role as General Manager of Pfizer CentreOne, JoyL Silva leads Pfizer’s embedded contract development and manufacturing organization (CDMO). JoyL brings a wide range of commercial, strategy, and business leadership experience spanning her 20-year career at Pfizer.

Following is a recent discussion with JoyL around what it’s like to lead an embedded CDMO within one of the largest pharmaceutical companies and where the Pfizer CentreOne business is headed.

Guiding customers through drug development challenges with intelligent collaboration

You’ve held some exciting leadership roles in Pfizer and are now managing the company’s prominent CDMO business. What have you learned from the transition?

When transitioning to Pfizer CentreOne, I hit the road … a lot. I have spent time with our manufacturing sites, our scientists, quality, commercial / marketing teams and especially with our customers. This time spent has given me confidence in who we are, the intelligent collaborators we’ve become and why we are uniquely positioned in the market to offer a full range of services and products. That includes our APIs and intermediate products as well as strategic contract drug development and manufacturing service offerings to customers.

The transition to lead Pfizer CentreOne has really pushed me to think about the value of our collaborations. Internally, our strong relationships with Pfizer scientists, quality, regulatory, development services and manufacturing sites is what allows us to offer a level of expertise that carries the reputation of Pfizer with it.

Pfizer’s internal focus to ‘bring breakthroughs that change patients’ lives’ relative to our own pipeline demonstrates our commitment. As we evaluate potential customers, we often hear that it isn’t just about the manufacturing of the drug, it is about the trust they place in us from start to finish to bring their medicine along the drug development and manufacturing journey, collaborating with top-notch scientists and engineers to guide their drug product every step of the way.

How have Pfizer Centre One’s priorities evolved?

Our top priority is to become the CDMO partner of choice for our customers, whether that is providing contract manufacturing services or selling Pfizer owned APIs and intermediates. Solving customer challenges and guiding today’s drug strategies, we’re completely focused on making sure we deliver excellent customer service in terms of expertise, energy, listening skills and responsiveness. We call this intelligent collaboration.

This is Pfizer CentreOne’s unique value proposition and the reason many of our customers engage us for long-term, more strategic outsourcing relationships. In addition, as pharma’s leaders focus on consolidating suppliers -- in order to de-risk and simplify their supply chains -- we aim to attract these customers with our expertise and experience while retaining existing ones and truly become trusted as their supplier of choice.

As I mentioned earlier, we have a clear purpose across Pfizer to ‘deliver breakthroughs that change patients’ lives,’ and we want to support our customers to do the same.

From where you’re sitting, what’s the market demanding from strategic outsourcing suppliers?

One thing is for certain, CDMOs are doing more than ever to assure safe, reliable supply and support and improve the quality of the medications people take.

Demand for drugs and therapeutics of all kinds is growing with the globalization of pharmaceutical-based medicine. Manufacturing safe, effective and affordable medications and putting them into the hands of patients has always been the pharmaceutical industry’s main objective. That hasn’t changed; what has changed is how the industry is fulfilling its core mission.

The central question is ‘who is going to be the best guide to deliver on what the customer needs?’ Pharma and biotech are looking for outsourcing partners with the necessary expertise, technologies, facilities, insight and science to avoid common manufacturing pitfalls that may prevent the timely development and success of their drug.

Drug owners are looking to engage contract development and manufacturing partners that suit their drug strategies best. For some that has meant engaging CDMOs with comprehensive services and a complete end-to-end commercialization route. Others need a reliable, effective supplier, to fill out gaps in capacity or to mitigate API supply risks. More of a CMO relationship in the classic sense, with superior tech transfer and scale-up capabilities and a track-record with the API or drug substance to prove it. For others, executing drug strategy pivots on finding expertise specific to the development and manufacture of their compound at commercial scale. Many of today’s most exciting novel break-through therapies are coming from companies with 500 or less employees and they simply must engage partners to manage everything it takes to win their drug’s approval. There’s no disputing demand for a ‘one-stop-shop’ CDMO partner has driven a tremendous wave of consolidation in the industry. Now the trend is being shaped by companies acquiring technical expertise or niche capabilities that’s driving acquisitions and new alliances.

The top five end-to-end CDMOs only comprise 15 percent of the market. Beyond the top five or ten CDMOs, there are about 300 others vying for contract work. That’s a crowd and makes the process of finding the right partner more complex.

The point is, one size does not fit all, and with so many potential partners, drug developers are becoming even more challenged to select the best contract partners to suit their drug development strategies and business plans.

Drug developers are taking exciting new pathways to bring better medicines to market, is that placing new demands on their contract manufacturing and development relationships?

The marketplace is shifting from the days when a CDMO was just needed to stamp out millions of tablets on a press for the industry.

Now we are needed as technological leaders and strategic collaborators—that is, helping our customers think up the best ways to get their products to patients quickly and more economically than their competitors. We’re also tasked with making higher volumes of more complicated types of products and helping customers who need assistance with regulatory requirements—especially in light of rising product complexity.

We’re also seeing dose delivery transitioning to a more patient-centred space where convenience and compliance are key and dosage forms like extended release tablets are gaining ground.

As we move towards more complex treatments, dealing with affordability and patient access and all the challenges related to improving the therapeutic value of drugs to consumers and payers, the technical demands on contract service suppliers will continue to increase as pharma accelerates therapeutic innovation to meet global demand.

What would you say is Pfizer CentreOne’s unique selling proposition?

Without hesitation it’s the fact that we are embedded in Pfizer. Few organizations can provide the insight, as well as a thorough understanding of the challenges a given product faces as it makes its journey to market.

In terms of Pfizer CentreOne’s development, custom API and drug product contract services offering, we offer depth and regulatory experience that customers may not find with other CDMO providers and suppliers.

I also mentioned our collaborative approach to working with customers. We focus on listening, asking questions and combining our knowledge to overcome some of the toughest drug development challenges.

Working with Pfizer’s manufacturing organization, Pfizer CentreOne has been delivering successful drug projects and manufacturing the world’s most popular therapies at commercial scale for decades. We completely understand the hurdles, including efficient development pathways to reduce time to market.

Because we are embedded in Pfizer, Pfizer CentreOne can be one of the best strategic development partners. Our customers often come to us for a very valid reason – they have hit a juncture in the lifecycle of their product development where they need an experienced guide to move a product efficiently through the next phases of commercial development or they are missing something – like specific operational or technical experience and the flexibility and expertise needed for scale-up. We collaborate with our customers to help solve problems.

We also offer integrity. For example, we take confidentiality very seriously; we are 100 percent committed to protecting our customers’ IP and they can trust us with their most valuable assets.

In addition, focusing on our APIs and intermediates business, we are a key supplier to pharma. Pfizer CentreOne customers have direct, reliable access to high-quality APIs and intermediates based on Pfizer’s own IP. Customers come to us for a variety of reasons, including the fact that we are a robust and proven supplier – one that understands how to manage associated risks of API manufacture, especially with hard to make compounds. Our deep expertise in this area is second to none, as is our customer service related to APIs—which is considered best in class, evidenced by the number of customers we serve. In fact, we are one of the largest providers of APIs in the world.

Success can be measured in many ways, what in the coming months will spell success for Pfizer CentreOne and its customers?

Success for Pfizer CentreOne is to be considered the partner of choice for our customers. Currently, many drug owners are developing the innovative and novel therapeutics in their pipelines with strategic outsourced partners. These therapies require tremendous operational efficiency, tightly controlled chemistries and process engineering skill to manufacture correctly and economically. Many of these new drugs are hard to make and will require knowledgeable, intelligent collaborators like Pfizer CentreOne before these innovations can reach patients.

Pfizer CentreOne was founded on a central premise; providing our customers with access to great science and an established network of experts and global facilities. We’ve found that the key to successful partnerships is our ability to create and sustain high-performing collaborations. We also consider how well suited we are to each project in relation to Pfizer CentreOne’s operations and expertise. We’re not going to be right for everyone, and by the same token, not everyone’s going to be right for us.
It’s a great privilege to lead such an outstanding organization and an honor to work with such great people. Customers are relying on us more than ever and its extremely gratifying to know we’ve become their partner of choice.

Of all of Pfizer CentreOne’s offerings on exhibit at CPhI, what are you hoping to focus visitor’s attention on most? What are your plans for the show?

We’re excited to be introducing Intelligent Collaboration and Pfizer CentreOne’s new look to CPhI and the industry. We plan to discuss how the practical focused collaboration translates into better project outcomes and more effective drug strategies. Pfizer’s call-to-action is “Breakthroughs that change peoples’ lives.” For Pfizer CentreOne customers, intelligent collaboration delivers on that promise.

To serve our customer’s better we’ve restructured our leadership and account teams to be more responsive and accessible. They’ll be on hand to help you engage our experts and facilitate access to Pfizer’s deep technical and regulatory expertise – as well as share our experience successfully delivering a full range of contract manufacturing and development services including custom API synthesis, oral solids, and sterile injectables as well supplying our specialty APIs and intermediates.

We’re hoping to catch people’s attention with the fact that for the past 40 plus years, we’ve been guiding complex compounds securely and efficiently from development through commercial manufacture. Over the years we’ve found when we combine our knowledge with an open, direct dialogue with our partners we’re able to help solve their toughest challenges.

Ultimately, our customers’ therapeutic success is our success. Intelligent collaboration is what’s been the key to delivering it, project-after-project, year-after-year. We’re offering that and more at CPhI this year. Come see us and let’s collaborate.