The M.O. Behind Choosing a CDMO: Three Considerations for New Drug Developers
For many who are new to drug development, the greatest challenge is not necessarily discovering a blockbuster molecule—it’s finding a team capable of carrying that molecule through the complexities that lie between the research lab and the patient’s bedside.
That’s especially true today, as the COVID-19 pandemic continues to disrupt our industry. To get a new drug to market, you must navigate a turbulent global supply chain, a complex regulatory landscape, and an intensely competitive and fast-moving commercial environment, all without losing sight of your reason for starting this journey in the first place: the patient whose life may depend on your product.
To get it right, and to manage it all cost-effectively and on an accelerated timeline, you need the right partner. But how will you know when you’ve found one?
1. THEY DEMONSTRATE FLEXIBILITY AND TRANSPARENCY FROM DAY ONE
With so many options in the marketplace, it isn’t difficult to draft a list of potential CDMO partners. Identifying the best partner on that list—the one most uniquely suited to your situation—is where the task may get harder. To really understand which CDMO is worthy of your trust and your investment, you’ll need to conduct initial qualifying audits designed to uncover facts about their history and operational approach. During those audits, you’ll inspect details such as delivery metrics, approach to data security and integrity, regulatory track record, and their sourcing strategy (for example, do they have a robust plan for sourcing alternate suppliers to ensure reliability and continuity?).
This information will help to paint a picture of your potential partner’s credibility, but the auditing step offers other, more qualitative insights as well, if you know to look for them. For example, have the appropriate global regulatory authorities (FDA, EMA, PMDA, KFDA, ANVISA, MHRA, etc.) inspected and approved your potential partner’s systems? Does this partner offer both remote and in-person opportunities to assess their capabilities? This indicates flexibility, and suggests that they are willing to work the way you do, accommodating whatever level of scrutiny you require to feel secure in your choice. At Curia, we invite remote auditors to take the driver’s seat during site tours, giving us verbal instructions to indicate what they would like to observe and for how long. We have all the equipment and conferencing technology necessary to support this interactive witnessing experience, including explosion-proof tablets that enable remote auditors to enter and inspect controlled GMP spaces.
Watch your potential partner for these and other indicators of a collaborative, “open book” attitude. If they get it right from the start, chances are they’ll maintain that attitude throughout your project, which lays the foundation for trust and transparency at every step.
2. THEY HAVE A “MULTI” MINDSET: MULTI-SITE, MULTI-SOURCING, MULTI-EXPERTISE
Drug developer startups may find themselves drawn to partners who are small like them, and—as the thinking goes—are faster and more agile because of it. But size does not necessarily translate to speed. In fact, a smaller-scale CDMO with a limited footprint may slow down your commercial scale-up process, particularly when the unexpected happens—a pandemic sweeps the globe; a natural disaster strikes; a regulatory change necessitates a new strategy. Any of these unpredictable events could disrupt your manufacturing operation or the supply chain that it relies on. Scrambling for backup will cost you valuable time, especially if that means finding another CDMO with capacity, conducting another qualifying audit, and then undertaking a complex transfer of technology and acquired knowledge between different systems and manufacturing teams.
You can avoid these disruptions by finding a partner with multiple sites in different geographies, all of which share a standardized global quality system and IT platform, making technology and knowledge transfers easy. An especially resilient CDMO will ensure that several of those sites comply with the same standards while plugging into different supply networks. Just as a diversified investment portfolio protects your bottom line from the fluctuating value of any given stock, a CDMO with diverse sourcing options can protect your supply of materials, intermediates, and APIs from the bumps and jolts of the global supply chains. In this way, a larger CDMO offers a level of speed and agility that many smaller entities—with their smaller footprint—simply can’t sustain.
Larger doesn’t have to mean less personalized, either. In fact, because a global CDMO has access to a much broader and more diverse pool of talent and resources, they’re able to tailor your project team to suit the specific needs of your business case and manufacturing goals, giving you the “white glove” experience that you and your project deserve. This is especially valuable when it comes to navigating current and emerging regulatory requirements, which can vary from region to region and can throttle your forward momentum if you aren’t prepared. The right experts understand the hot-button regulatory issues in different markets, and they can help you plan a proactive strategy—one that takes into consideration not only your short-term objectives, but also the possibility of expansion and growth over time. Get that strategy right from the start and you can avoid significant regulatory delays down the road—but that’s very hard to do without the right experts, representing the complexities of your journey at the right time.
3. THEY ARE FOCUSED ON YOUR FUTURE
They meet you here and now with flexibility and transparency, and they offer you the protection and resilience of a “multi” mindset. The last factor to consider when selecting a strong partner has to do with what happens after the here and now. What can this partner offer you in terms of planning for your future? As you evolve through the clinical research pipeline and towards validation, do they have what it takes to scale with you? Are they capable of meeting global regulatory and GMP requirements at commercial manufacturing volumes? If you experience a spike in demand next year, or three years from now, will they be able to accommodate your needs—or will you find yourself having to qualify an alternative manufacturer before the window of opportunity closes?
Many CDMOs speak of end-to-end capabilities, but meeting your needs when you arrive on their doorstep is only one aspect of partnership. Continuously and dynamically adapting those capabilities as your needs change is quite another. For that to work, you need a partner who has extensive experience navigating the concept-to-commercialization pipeline, and who can turn that experience into a proactive, pragmatic, and forward-looking strategy that’s customized for your project. What will you need next month? What will you need in a year? What will you need in five years, and can you make decisions about your processes, your analytical methods, your materials, and all other factors right now so that you’re prepared to meet those needs in the future? These are the questions that a strong CDMO will ask—and answer—alongside you, while continuously adapting and growing as your needs change.
THE BOTTOM LINE: PARTNERSHIP IS A PROCESS, NOT A CHECKLIST
These three considerations are not enough to guarantee a smooth journey as you take your molecule forward. They’re only a foundation; putting them into practice will help you begin that journey in the right way, with the right partner.
That foundation underlies everything we do at Curia. When you reach out to us for a possible partnership, we’ll support your decision-making process with open access to our history of regulatory approvals and ample opportunities to conduct in-depth site inspections, whether remotely or in-person. We’ll be transparent with you about the “fit” between your needs and our global capabilities, and if you decide to partner with us, we’ll tailor a flexible service agreement according to where you are right now—and where you want to take your molecule next. To start the journey from curiosity to cure, reach out to us.
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