Focusing on customer relationships and ensuring access, transparency, and alignment are essential to success as a CDMO. Pharma’s Almanac Scientific Editor in Chief David Alvaro, Ph.D., sat down with TriRx Pharmaceutical Services’ Chief Client Services Officer Michael J. Kays and Vice President, Sales Jeremy Tatum to discuss how nimble CDMOs keep their eyes on the customer experience in the face of ever-changing customer needs and how to avoid common pitfalls on both sides of the table.
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David Alvaro (DA): When innovator companies are evaluating potential CDMO partners, some criteria are fundamental, like capabilities, capacity, and quality. But are there other critical qualities that may be overlooked or insufficiently emphasized early on but can have a significant impact on execution and the overall customer experience?
JEREMY TATUM (JT): When you talk about the typical priorities or criteria that innovator companies use to evaluate potential CDMOs, the most obvious are definitely the things you mentioned. In my opinion, one element that is incredibly important but often overlooked is access — and not just access broadly, but access to the right people. Who’s going to put me in touch with the right people? Who’s going to let me talk to the plant general manager or to the head of regulatory? Unfortunately, too many companies rely overwhelmingly on junior project managers to manage these projects. As a result, clients are simply not getting access to the top-notch partners, even at the site. It may be the right company, but it’s the wrong person managing the project. Even at the best CDMOs, that can have an enormous impact on the success of the project, how valued the customer feels, and, ultimately, how satisfied they will be and how inclined they will be to stick with the CDMO in the future.
MICHAEL KAYS (MK): Another error that many companies make is considering each service need in isolation, saying “Who can make this liquid? Who can make this tablet?” You can find a good partner at a good price for each product-specific need, but that doesn’t necessarily add up to a sensible outsourcing strategy. Innovator companies need to think more holistically to reduce their total number of suppliers by finding real partners who they can rely on for a broader range of needs and have the flexibility to adapt in sync with the customer as their needs change. Of course, this is complicated by the reality that many drug companies grow by acquisition and add multiple products through each deal, and they can end up with multiple products with the same dosage form produced by multiple legacy CDMOs. Even if they do recognize the benefits of streamlining their outsourcing to fewer partners, they don’t always have the time to run the analyses and determine how to move these acquired products to one strategic partner with one team that can manage all of their products. To me, a much better strategy is to approach a CDMO like TriRx and ask: “What can you do to support the full scope of my business? What is your strategic plan? Where can you invest to help me reduce the huge number of outsourcing relationships to a number that is a lot more manageable?”
DA: Clearly, there are a lot of less tangible but highly differentiating qualities that make the difference between a decent provider for a single transaction and a CDMO that is properly aligned in terms of culture and philosophy to be an effective long-term partner. But when it comes down to acquiring business, how can a CDMO outwardly project those more subjective qualities to potential customers?
MK: The best way for a CDMO to put their best face forward is to involve the senior management team from the start. For the customer, being able to sit down at a table with senior executives to have a real strategic discussion is an invaluable opportunity that really gives them insight into the true nature of a CDMO. Equally important is getting everybody around the table for an interactive discussion, so you have full access to the people with the appropriate expertise to understand your needs, whether it is quality, manufacturing, or site scheduling, and also your concerns, so that you can align at the top level from the very start.
JT: Other keys to success are projecting the same message throughout the organization and continually pushing the customer to talk a little more strategically. The best approach is to always bear in mind that every single person in the company that interacts with a customer is part of the sales process. Even at those initial technical calls, the director of technical operations can help present the CDMO’s full picture to potential customers and acquire an upfront understanding of what is in the customer’s pipeline and how the CDMO might be able to help with the customer’s current and future needs.
DA: How challenging is it for a CDMO to establish a culture that enables it to be an ideal partner for potential customers with such a range of sizes, needs, and processes?
MK: Honestly, that’s the fun part of this job, at least for us! First, you get to know people, develop a very personal relationship with them, and build that crucial trust factor. That requires the CDMO team to have the necessary depth of knowledge and the agility to forge those relationships, build that trust, and steward so many different types of projects for different companies. At TriRx, we really do feel like we can be an ideal partner to so many different types of customers. It’s all in how we approach them. We treat the smallest customers the exact same way we do the absolute largest customers, because every customer and every project is important. And to them, of course, every single product is important, no matter who they are, and they really want that emphasis reflected back to them from their partners.
JT: We focus on relationships. Everything that we do is focused on the relationship with the customer and on building that trust, because with that comes more open and transparent communication and more opportunities to collaborate on new projects and anticipate what’s on the horizon. Serving customers on these critical, life-changing and lifesaving products is ultimately about delivering on a very high level of expertise, communication, and transparency and taking care of the customer’s products as if they were our own. It also makes a huge difference to keep sight even beyond the customer to their ultimate customers, the patients who depend on these products.
DA: What can you tell me about some of the common pitfalls that CDMOs can fall into or mistakes you’ve seen other CDMOs make?
MK: For tech transfer projects, often either milestones aren’t accomplished on time or change orders have to occur because when the proposal was originally conceived, the CDMO didn’t really think every element through to completion or put everything into the right context. The CDMO team either didn’t ask the right questions or didn’t fully understand what they were putting into the proposal, so the pricing or the timeline was wrong and simply not achievable. For commercial projects, one of the worst things you can do is to launch a product and then have a stock-out. Often within the CDMO world, the person that’s delivering the information to the customer on when products will ship really does not have full knowledge of what’s happening inside the operation. These CDMOs typically don’t have regular, integrated sales and operations planning meetings at the site and at the global levels. Nor do they have customer-facing processes and open lines of communication in place.
JT: Everyone always wants to be the customer’s best friend, but you can’t give them everything all the time, at least not on a timeline that wasn’t comprehensively considered. Far too often, we have seen that CDMOs delay the inevitable. They wait until the very last minute to deliver bad news, which invariably puts the customer in an uncomfortable position.
DA: How is digitalization changing the relationship between CDMOs and their customers?
JT: The ability to have virtual customer visits — not pre-recorded tours, but truly interactive virtual tours — is having a real impact. Customers can traverse the entire facility and stop anywhere to ask for a close-up look at any piece of equipment or process that is underway. This technology helps facilitate quality audits and site visits and even makes it possible to exhibit batch manufacturing processes. In our experience at TriRx, this capability has helped us to win multiple projects. Obviously, this technology helps to make this huge world a little smaller and more manageable, enabling CDMOs to meet and speak with both new and existing customers around the world and allows them to really investigate their facilities and processes. Being able to unite large groups of people from around the world to hold strategic discussions facilitates building strong relationships and more effective alignment.
MK: For CDMOs that are invested in peerto-peer access and discussion across disciplines, virtual meeting platforms like Zoom and GoToMeeting enable spontaneous discussions with people from all over the world. This doesn’t mean that travel as it was conducted before the pandemic is a thing of the past; we will still all visit customers and have them visit us. But, if a customer is remotely located, we can very easily have conference calls with our site and our executive team, reducing the total number of excursions without impacting that critical, high-level access and transparent communication.
DA: An overall trend that has been widely discussed is an increased interest on the part of innovator companies in onshoring and working with domestic suppliers. What have you heard from customers about how much of a priority that is to them?
MK: Lately, what I often hear is a greater demand for regional manufacturing. I’m hearing it in Europe, and I’m hearing it in North America, and, in both cases, customers are definitely looking to simplify supply chains so that as much manufacturing as possible is done in that region. However, the problem is that not many CDMOs are offering those alternatives. I think we’re going to see more of that, and, for our part, it’s definitely something that we are trying to honor and accomplish.
JT: For CDMOs, building capabilities that mirror each other in different countries or regions is important, such as offering sterile and oral liquids capabilities in both Europe and the United States. We are fortunate to have both sides covered, should the customer have a very specific need or desire for a product to come from a certain region, and I think you will see more acquisition activity on the part of major CDMOs to do the same.
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DA: As a relatively young company, how did you build TriRx from the start to emphasize customer service and differentiate yourselves from your peers and competitors?
MK: Our leadership team brought decades of experience — not only from top CDMOs but from commercial innovator companies as well — and those experiences led us to design TriRx from day one to provide a different experience for customers. Our focus has always been on making customers feel that our sites are their sites and that our people are their people. They’re in charge, and they don’t have to worry about the execution of the product. We provide world-class performance, and providing exceptional customer service is always top of mind when we evaluate acquisitions and new hires. Every aspect of our operations network is ultimately designed around the customer relationship team. When a customer receives a proposal from TriRx, the technical team that prepared the proposal is already in place and ready to execute. They know where the supplies are coming from, what the costs are going to be, and how long it will take to make things happen. That full knowledge enables us to be fully transparent with the customer and set realistic expectations that we can guarantee we can fulfill.
JT: Once a project is signed, it is handed over to the site, which is responsible for managing the project and adhering as closely as possible to the timeline. The senior director of technical operations, the head of the labs, and the site GM are all heavily involved. If there are any disruptions or anything arises that could delay or impact a milestone, it gets escalated pretty quickly through all relevant stakeholders so that we can rapidly determine the best way to get the project back on track.
MK: At TriRx, customers know they can speak to the top-level team members about any issues they have. That level of communication takes a real commitment from the top down. That part of our strategy and the manner in which we go to market was designed into the company from the beginning. We feel that it is a true differentiator.
JT: As importantly, the customer relationship has helped to guide our acquisition strategy. On both the human and animal health sides, we have learned what our customers need and made acquisitions that will help us address those needs. The same is true for investments in facilities. Our customers help to guide our growth and how we reposition ourselves. In fact, we are in a tremendous growth curve at the moment, and it is a perfect time for companies that aren’t dealing with TriRx right now to call us, because they can help shape our acquisition strategy and grow with us as their needs grow or as they look to transfer projects and simplify their outsourcing activities.
Want to learn more about how TriRx differs from other CDMOs in the industry? Get in touch with the team today and let us show you our commitment to customer success.
The terrain between concept and clinic-ready formulations can be tricky to navigate, especially when working with New Chemical Entities (NCE). Partnering with a Contract Development and Manufacturing Organization (CDMO) can help alleviate the uncertainty of drug development but finding the right CDMO partner to suit your projects’ needs can be challenging- especially when those needs change throughout development. The optimal goal is to find a full-service CDMO (with a wide range of services) that can support your needs for the life of the program.
Technical capability is usually the first consideration when choosing a CDMO. What capabilities does your project require, and what services do they provide? Not all CDMOs have the infrastructure, technology, or service menu to meet your project’s demands through every phase of development. Using CDMOs with limited capabilities (or only a singular area of expertise) can result in a complex web of service providers, extensive project management coordination, and a high probability of delays in project timelines. A full-service CDMO -- a CDMO that offers formulation, manufacturing, and analytical testing services -- can provide a more effective approach while assuring quality and scientific robustness throughout development.
CDMOs that align formulation development with manufacturing, method development, and release testing services under one enterprise can speed development by smoothing technical transfers and minimizing logistical coordination. A full service CDMO offers clients research-based, cross-functional project oversight that maximizes quality when scaling up for clinical demands. Fewer logistical nightmares facilitate faster timelines to the clinic. Additionally, keeping your technical expertise under one roof also gives project teams more opportunities to learn the intricacies of your project. In CDMOs where formulation scientists can work directly with analytical chemists and manufacturing project managers, you’ll have a designated team of technical experts with your project from concept to clinic. This means manufacturing teams can learn directly from formulation development studies; collaborating to determine an approach that will work for your particular formulation needs.
Scale for Success
Aligning formulation studies with analytical method development and production expertise can guide decisions in the early stages of product development, but it can also help progress projects through critical milestones and ensures the scalability of your formulation to the production environment. No matter where your project begins in your partnership with a CDMO, working with a single organization rather than several locations for testing and manufacturing support will streamline your approach. Even small-scale manufacturing projects can save critical time and funding, eliminating unnecessary product transfers and duplicate process validations by using a single service provider.
While technical capabilities are essential, an agile CDMO with the ability to align their strategic approach to product development with the client’s clinical strategy will foster long-term program success. In early-stage development where API is limited and priceless, effective use of materials is an important consideration. Your CDMO should have an approach that will maximize experimental design to answer the most pressing questions while preserving API. Investing in development may seem like a sacrifice for speed, but a purpose-driven formulation and process developed by a CDMO with designated formulation and engineering teams may buy critical project flexibility, generate important scientific data, and ultimately save costs.
For some projects, a formulation, limited product, and an analytical characterization is all you need to enter the clinic to assess safety or proof of concept. Further development work could be continued in parallel to initial clinical trials (saving you time). Even simple formulations can present challenges when scaling up from the lab-bench but approaches that offer formulation development alongside GMP manufacturing increase the probability of project success in scaling to the clinic. Complex projects may demand a more thorough formulation development program due to the nature of the active, drug product challenges, or clinical trial design. Such projects will require more development work which will ultimately impact the cost and timeline of your project. Choosing a CDMO with experienced staff that can correctly and rapidly assess your project needs will be beneficial in constructing a phase appropriate strategy for product development leading to clinical supply manufacturing. Though project needs may vary, identifying a quality-focused partner with scientific integrity and whose strategic approach aligns with the project plan is the crucial foundation for project success.Can your CDMO grow to support advancing your program? In early stages of product development, the availability of Active Pharmaceutical Ingredient may limit batch sizes and clinical demand for First in Human (FIH) or Proof of Concept (POC) studies may be small. Finding a CDMO partner with the capability to manufacture small clinical supply batches and scale to meet Phase 2 and Phase 3 supply demands can reduce the number of technical transfers- saving teams both time and money- but also ensures quality by sharing process information amongst internal teams as the project progresses. These CDMOs can assure consistent quality practices throughout each stage of development while building the scientific database or foundation to support regulatory registrations. If need be, this scientific database or foundation will then serve as the foundation for t he technical transfer for larger scale manufacturing.
Prioritize development quality to maximize speed and minimize cost.
Quality, technical expertise, services provided and adherence to cGMPs will all ultimately affect the success of your project. A CDMO that has manufacturing, analytical testing, and formulation capabilities will speed your development process, but a partner that also has an experienced quality organization is critical to assuring cGMP compliance and product quality. Finding this strategic partner in a full-service, agile CDMO will ensure a scientific approach with a quality emphasis is taken in meeting all your project needs.
Continued partnerships with CDMOs that have cross-functional testing and manufacturing facilities, means technical teams can directly apply their scientific expertise to every phase and aspect of development, but it has the added benefit of allowing teams to improve their processes according to your project’s needs. UI Pharmaceuticals has the technical capability to support drug development at any program stage. For over 45-years, this FDA registered cGMP CDMO has partnered with bio-tech start-ups, government agencies, and University research groups to develop, manufacture, and test novel treatments in sterile and non-sterile formulations.
To learn more about UIP's formulation, testing, and manufacturing capabilities visit them in-person at AAPS PharmSci 360 in Orlando or anytime online.
In Fall , UI Pharmaceuticals will launch production for an innovative 16,000 square foot sterile processing facility. Two fill lines feature state of the art sterile manufacturing equipment, depyrogenation tunnels, and capping stations incased in an ISO 5 integrated isolator sterilized by Vapor Hydrogen Peroxide (VHP). Top industrial equipment for compounding and transfer minimize contamination in pre-production clean-room areas. Telastar Lyophilizers, integrated to load from either fill line, maximize lyophilized batch production potential for client partners. The new facility, equipped with two fully automated lines in ISO controlled areas and designed with SCADA control, will operate in tandem with UI Pharmaceutical’s existing small-scale facility. This new facility is designed to expand the CDMO’s capabilities into advanced stages of development, investigational, and commercial drug manufacturing.
To learn more about UIP's formulation, testing, and manufacturing capabilities visit them in-person at AAPS PharmSci 360 in Orlando or anytime online.
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