JoyL Silva is the General Manager of Pfizer CentreOne, the CDMO arm of Pfizer
1. What trends or market dynamics do you think are challenging contract services providers most these days?
The top five end-to-end CDMOs still only comprise 15 percent of the market.1 Beyond these, there are about 300 to 400 others vying for contract work.2 That’s a crowd and makes the process of finding the right contract manufacturer and best fit for your drug strategy more critical and more complex.
Today’s pharmaceuticals are being created by a diverse array of companies around the world. According to the FDA, more than half of the novel drugs approved over the last decade came from enterprises with less than 500 employees.3 Regardless of how large or small the company, more and more drug owners and developers are engaging external contract partners to take a greater and more strategic role in the development and commercial manufacture of their products.
To a certain degree that trend prompted the contract manufacturing industry to consolidate, creating an end-to-end CDMO model that’s been attractive to many developers and owners seeking partners able to deliver turnkey, ready-for-market drug product solutions. Currently pharma is outsourcing the development and manufacture of about 25 percent of all its products, according to a 2017 study.4
However, the demand for contract partners able to fulfil end-to-end drug strategies makes up only a portion of pharma’s demand for contract development and manufacturing services. Not all customers need or require end-to-end solutions and what shapes demand for contract services in general is as diverse as the global pharma industry is today.
That means that there is still plenty of demand for a wide range of CMO and CDMO manufacturing and development services, especially those offering particular experience and expertise.
Other important trends are shaping the CDMO landscape and influencing how pharma is engaging the industry.
For one, aseptic drug manufacturing and sterile fill-finish operations are proving to be extremely challenging for the industry. It’s a global issue and proving to be a tremendous ‘disruptor’ with sterility and quality excursions threatening critical supplies of certain therapeutics including vaccines, antibiotics and sterile liquids like saline.
Two other major drug development trends are impacting the contract outsourcing industry from our perspective.
The ascent of biopharmaceutical science and the increasing global consumption of biopharmaceuticals ranging from popular monoclonal antibody-based immunotherapeutics to their biosimilar generic cousins, is increasing demand for outsourcing partners capable of making these hard-to-make large-molecule drugs at scale—especially in volumes necessary to reach underserved patient groups around the world.
Similarly, biopharma’s drug innovators are also seeking highly competent partners to develop and commercialize their very small batches of novel, hard-to-make biopharmaceutical APIs and drug products.
The point is, large-volume or small, many of today’s therapeutics are hard-to-make and increasingly require partners with particular skills and experience to develop and manufacture them successfully. 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.
2. What can your CDMO peers expect from Pfizer CentreOne now that you are leading the business with your new leadership team?
Pfizer CentreOne has always offered world-class people and performance. This continues to be central to our value proposition. Potential customers aren’t contracting with just any CDMO, they’re collaborating with Pfizer’s CDMO. Our expertise and 150+ years of experience sets us apart. Few organizations offer the insight and understanding Pfizer has gained regarding the very real challenges facing successful drug development.
We’re also looking into extending our value to customers’ drug strategies by digging deeper into Pfizer’s expertise and offering access to our teams and people involved in early stage clinical development. We’re finding that the earlier we can influence formulation and synthesis routes the more successful our customers’ products will be. We have a great reputation for our work from Phase II through approval and we think it may be the right time to offer customers the benefit of our experience in Phase I and earlier in the development cycle.
We’re also equipped with a new leadership team, and a refreshed organization structure more closely linked to Pfizer than ever before to support what we call ‘intelligent collaboration.’ This is our way of working that we embrace internally and externally to help our customers’ drug strategies succeed and involves collaborating with our customers and colleagues, asking questions and combining knowledge to solve some of today’s toughest drug development challenges.
Although we offer a broad range of experience and related manufacturing services to our customers, we’ll not be the right choice for every product or every developer’s drug strategy. Pfizer CentreOne begins its intelligent collaboration with customers with a frank, open dialogue; it is so important to establish that product, partners and strategy alignment from the very beginning. I think we all understand the poor outcomes that can result if fit isn’t established without early, intentional due diligence by both parties.
3. Pfizer CentreOne is one of three or four embedded CDMOs. What do you think differentiates the embedded business model from other CDMO models?
Without hesitation it’s our affiliation with Pfizer and our long history of delivering drug products and drug substances as part of the Pfizer Global Supply (PGS) network and as a leading supplier of commercial APIs and intermediates to the industry.
Few pharma organizations involved in developing products for commercial manufacture, whether in-house or as contractors, can offer the quality and regulatory experience Pfizer CentreOne can. With just over 150 years in drug development and commercial manufacturing our expertise in tech-transfer and scale-up has few peers.
Pfizer’s legacy of bringing generic and innovator products to market is not just our history, it’s our future – and we’re clear about it: Launch 25 blockbusters by 2025. Pfizer’s investments in facilities and capabilities will continue as the company works towards creating a very competitive CDMO with a compelling business model; that is, one embedded within Pfizer.
Another differentiator for our business is our breadth of capabilities. Some CDMOs, for example, may position themselves as offering very particular skills or experience with oral solid dose compounds. Although we have some very niche fermentation and synthesis capabilities, our capabilities and focus is much broader – and something that makes us different. Our clients benefit from leveraging our entire network of sites.
4. With a view toward the pipeline and trends in development, what technologies and expertise do you think will be in higher demand in the near term?
Drug developers are taking exciting new pathways to bring effective, affordable and safe medicines to patients, and that is placing new demands on contract manufacturing and development relationships. We’re being tasked with making more complex types of products under increasingly rigorous regulatory, quality and patient 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.
Another trend impacting pharma’s business plans and its reliance on strategic outsourcing is the FDA’s accelerated 505(B)(2) development pathway. This accelerated approval pathway is now allowing drug developers to improve the therapeutic value of existing products more economically.
For one, the 505(B)(2) pathway provides drug developers a clear, more economic path to improve existing drugs, including new faster-acting dose form combinations, formulating two active ingredients in a new way or creating new administration routes to enhance therapeutic performance or dose adherence.
Other companies are using 505(B)(2)s to develop a new indication for an already-approved drug or an opportunity to develop modified release dose forms, extend patent life and other life cycle management strategies – drug strategies that many are relying on their contract manufacturing partners to execute successfully.
5. What’s going to be your main business focus for 2020?
Our top priority is to become the CDMO partner of choice for our customers and help them deliver their drug strategies successfully.
Whether our partners require custom API manufacturing services or need a reliable supplier of commercial volumes of Pfizer owned APIs and intermediates, we’re focused on fostering intelligent collaborations. We believe that many minds are better than one and are passionate about sharing our regulatory and scientific knowledge. Solving customer challenges and guiding today’s drug strategies through close collaborations with our customers and colleagues will enable us to continue to overcome some of today’s toughest drug development challenges.
It’s part of our inquisitive, curious culture to find the best solutions to any drug development challenge. It’s a fundamental part of Pfizer CentreOne’s unique value proposition and the reason many of our customers engage us for long-term, strategic outsourcing. As pharma’s leaders focus on consolidating suppliers — in order to de-risk and strategically align their supply chains — we aim to open up conversations with potential customers with a purposeful approach to finding the right opportunities where we can add the most value.
6. Why do you think it’s important to be a member of the PBOA?
I believe there is tremendous value in being a PBOA member for two reasons:
One, offering a wealth of industry data, competitive metrics and trend analysis, PBOA has become a one-stop-shop resource for information and support dealing with today’s toughest market challenges.
Two, PBOA also provides a professional space where peers can talk to peers 1-to-1. It’s become a great community where all of us in the CDMO industry can work together and the best forum to advocate for our interests, as well as voice our collective concerns to the industry, regulators, governments and the public.
JoyL Silva is the General Manager of Pfizer CentreOne, the CDMO arm of Pfizer
References
1. https://www.outsourcing-pharma.com/Article/2018/10/22/Top-5-CDMOs-hold-15-of-the-market-as-industry-consolidation-is-expected-to-continue#
2. http://www.kurmannpartners.com/fileadmin/user_upload/_temp_/KP_Pharma_M_A_Report_2018_-_medium.pdf
3. https://www.pharmacist.com/article/fda-helping-small-businesses-get-big-results
4. https://resultshealthcare.com/wp-content/uploads/2017/01/Results-Healthcare_Pharma-Biotech-2017-Review-of-outsourced-manufacturing_Whitepaper.pdf
