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Guiding customers through drug development challenges with intelligent collaboration

By JoyL Silva September 2019, General CDMO

In my role as General Manager of Pfizer CentreOne, I am excited to now lead Pfizer’s embedded contract development and manufacturing organization (CDMO). Bringing a wide range of commercial, strategy and business leadership experience gained over a 20-year career at Pfizer, I understood quickly how well the organization is positioned to serve pharma’s current and emerging drug strategies.

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. It became clear to me our best, our most strategic contract relationships, our best tech-transfers – our smoothest scale-ups, our most successful projects, stemmed from an internal culture of collaboration developed over decades developing and manufacturing Pfizer’s legacy of therapeutic breakthrough’s and historic blockbusters.

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 products. That includes our custom APIs, drug substance and intermediates business 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 product along a journey, collaborating with top-notch scientists and engineers to guide their product every step of the way.

More than a change in leadership; a change in attitude

I am energized and passionate about our work as Pfizer CentreOne. The challenges we solve and the success we share with our customers as a product reaches an approval milestone, a launch, or ultimately a patient is unparalleled. The leadership I bring to Pfizer CentreOne, (i.e., key account management, business-to-business acumen and strategy) will help me set the tone for our organization and engage everyone to embrace our collaborative style and our collegial, professional approach to our customers.

However, it is the internal Pfizer partnership and our talented Pfizer CentreOne colleagues that truly drive our success. Our motto is that we “bring our best self to work each day because our work is personal” and that couldn’t be more true at Pfizer and Pfizer CentreOne.

Our priorities remain customer focused, project centered, and goal oriented

Our top priority is to become the CDMO partner of choice for our customers, whether that is providing custom API manufacturing services or reliably supplying commercial volumes of 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 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. 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 reliability and expertise.

We have a clear purpose across Pfizer to “deliver breakthroughs that change patients’ lives,” and as Pfizer CentreOne, we want to support our customers to do the same.

One thing is for certain, CDMOs are doing more than ever to assure safe, reliable supply to the market while also looking to simultaneously improve the quality of the medications people take.

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 offer process improvement steps and avoid common manufacturing pitfalls that may prevent the timely development and success of their drug.

Drug developers and intellectual property (IP) holders are looking to engage contract development and manufacturing partners that suit their drug strategies best. In some situations, that has meant engaging CDMOs with comprehensive services and a complete end-to-end commercialization route. In these scenarios the early development work is critical to ensure regulatory approval and scale up. Others need a reliable, secondary supplier, to fill out gaps in capacity or to mitigate risks around the API supply chain. 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 a CDMO who understand the specific processes to manufacture 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 may be offered to all, but often 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.

Pharma’s demanding more expertise and experience from their CDMO partners than ever before
The marketplace is shifting from the days when a CDMO was just needed to stamp out millions of pills on a tablet 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 complex types of products which come with rigorous regulatory and quality requirements.

We’re also seeing dose delivery transitioning from injectables for the masses to a more patient-centered space. We have advanced oral solid dose formulations replacing needles, and pre-filled combination devices delivering advanced therapies like monoclonal antibodies, gene therapies, and new classes of personalized medicines that weren’t an option just five years ago.

Pfizer CentreOne’s unique selling proposition has never been clearer

Without hesitation, Pfizer CentreOne’s unique value proposition is the fact that we are embedded in Pfizer. Few organizations can provide the insight, and thorough understanding of the challenges a product faces as it makes its journey to market. We don’t just understand it at Pfizer, we live it every day as evidenced by our own medicines on market and our pipeline.

In terms of Pfizer CentreOne’s development, custom API and drug product contract services offering, we offer depth and regulatory experience that customers tend to appreciate along with a more personalized touch. As a part of Pfizer’s manufacturing organization, we’ve 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, especially with the more complicated products reaching late-stage development and already in the market right now. 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 voice to listen, and 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 do our work with the utmost integrity and confidentiality is the very backbone of our business model. We are committed to protecting our customers’ IP so they can feel comfortable trusting us with their most valuable assets. Our internal firewall program provides the shield that separates our customers information from Pfizer and from other Pfizer CentreOne customers. We control tightly who has access to data and our colleagues across regulatory, development and manufacturing are trained, tested and tracked to ensure compliance.

Pfizer CentreOne offers access to high-quality APIs and intermediates based on Pfizer’s own IP. We are a robust and proven supplier over the years and one of the largest providers of API in the world. We’ve earned this distinction because of our ability to successfully manage the technical, regulatory, and manufacturing of highly potent API products while also innovating in this space to bring more environmentally sustainable offerings to customers.

We’re measuring success one customer, one project at a time

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.

Of course, collaborating with our customers from Phase II through commercial manufacture and helping their products reach patients successfully is our main focus—when that happens it’s truly a rewarding experience.

Ultimately, our customers’ is our success and I’ve found that from the very beginning of my tenure. Intelligent collaboration is what’s been the key to delivering on success, project-after-project, year-after-year. We offer our customers’ resources on a global scale with the expertise of Pfizer behind our name. We’ve recently organized our customer facing account teams where they can act quickly and be even more responsive, focused on engaging customers along the journey.

It’s a great privilege to lead such an outstanding organization of people. Our customers are relying on us more than ever and we look forward to becoming their partner of choice.