Co-authored by Dr. David Smith, VP of Development, and Dr. Chathuranga De Silva, Sr. Director of Business Development
If you are a preclinical or early-stage biotechnology company with an eye towards clinical proof of concept, using a CDMO for your manufacturing makes sense. In a previous article, we identified the top 10 intangibles a CDMO must offer to help you select the right CDMO — and know how to look out for tell-tale signs to run the other way. But, say you found that CDMO, or maybe you even have two or three CDMO candidates to choose from (which is the best-case scenario). In this article, we’ll discuss things that a cell therapy CDMO will do to demonstrate that not only are they a strong and capable CDMO, but also a true partner in what will be the most important two to three years of your company’s journey to success. Before we talk about what a true partner looks like, let’s peek into the “must haves” for any CDMO to be worth your consideration.
Common Benefits Derived from a Cell Therapy Service Provider/CDMO
Your CDMO should do the following — at minimum:
- Help you avoid expensive capital investments in equipment and facilities
- Provide you with the depth of knowledge for clinical translation. This should be achieved through expert staffing in process development, manufacturing execution, and quality and supply chain personnel you’d otherwise have to hire yourself
- Understand the challenges associated with manufacturing cell therapies, and maybe even recommend mitigation strategies
- Advise you on future enhancements to your product’s lifecycle, customized to your company’s needs/desires; i.e., automating, closing, scale-up, secondary suppliers, storage options, etc.
- Be familiar with the latest manufacturing technology and have the expertise to transition your process to that equipment where needed
- Understand what you need or help you prepare the documentation required for your CMC filing
- Know how to write protocols and master batch records that are clear and easy for operators to follow
- Risk-assess your GMP-readiness and help you close the gaps appropriate for your company’s success, i.e., phase-appropriate regulation
These are just some of the common benefits typically attributed to working with a dependable cell therapy CDMO. Interestingly, when you talk about moving from a service provider to a true partner, you will find lots of articles written about CDMO partnership models that are financial in nature, such as examples of a CDMO investing in early-stage development and manufacturing projects with their clients in exchange for a guarantee that a sponsor will continue with them for larger scale manufacturing, or in exchange for equity as well. While this type of model seems really attractive in 2023 — when biotech funding comes at a premium — this indicates that moving from service provider to partner is a financial discussion. We argue that financials, though tremendously important, are only part of the story.
What we want to cover, which we don’t see discussed very often, is the more strategic and subtle benefits of working collaboratively with a CDMO in the kind of relationship where both of you consider each other to be true partners. When you elevate your relationship from buyer and service provider to true partners, even without any change in your financial arrangements, you will unlock the additional value that your cell therapy CDMO partner brings to the table.
Additional Value a Strategic and Collaborative Cell Therapy Partner Will Deliver
A strategic cell therapy CDMO partner who takes on a role above and beyond that of a mere service provider will do the following:
- 1. Serve as your advocate when managing internal and external stakeholders. Sometimes you just need a sounding board to figure out what is possible. A strategic CDMO will not shy away from putting in the time to generate that information for you so that you can make a well-informed decision.
- 2. Work alongside you to justify and rationalize timelines and budgets. A well-thought-out timeline and budget can make all the difference when it comes to reporting back to and gaining the support of your board of directors.
- 3. Conduct and communicate the risk-reward or cost-benefit analyses of any changes to your program. CDMO’s know that your success is tied to reaching milestones. However, sometimes it takes working collaboratively to figure out the path of least resistance and, by definition, the path with higher chances of success.
- 4. Continually identify improvement areas for your therapeutic, including providing an alternative production schedule that reduces costs, improves throughout, or gets your product to patients faster. The CDMO sees granular details of your process and should come to you with opportunities to achieve efficiency and reduce costs and turn-around times.
- 5. Introduce you to novel technologies, tools, reagents, and suppliers that can reduce your costs, improve your timelines, or increase your yield or potency. This applies especially to cell therapies where the technology landscape is improving so rapidly. A true partner will think of you when they learn about new technologies that may apply to your process.
- 6. Suggest process improvements that serve to increase throughout and/or streamline manufacturing or remove risk. Reducing risk is the key concept here; too many times cell therapy sponsors discover too late that they had an opportunity to make changes that would have minimized risks which are now creating costly delays in their program.
- 7. Identify situations where decisions or changes you are making may have a potential impact on product quality and alert you to those risks. Your partner should have enough experience to see potential impacts way before they happen. They should be paying enough attention to you to both see those potential impacts and communicate those risks early enough before you make a mistake.
- 8. Advocate for you with suppliers, third party vendors, and regulators. Your CDMO partner should always be in your corner to advocate for you. That may come in the form of joining calls, conducting site visits, performing vendor audits, etc.
As you can see, while the first list of benefits is impressive and underlies many of the business cases we’ve seen employed to hire a cell therapy CDMO, the second list describes a heightened degree of collaborative and strategic support.
How to Elevate Your Relationship From Service Provider to Partner
There are a few things that must be in place to elevate your relationship from service provider to partner and gain that kind of strategic support. Let’s look at a few.
First, you and your team must be transparent.
The team at your cell therapy CDMO can’t help you if they don’t know what you are trying to do and where you expect to face your greatest challenges and opportunities. You must enlighten them on your successes to date as well as your concerns. Taking the time to map out a strategic plan will ensure that all parties are aligned and rowing in the same direction.
Another area in which you must be transparent is in the commitments you’ve made to your investors, board of directors, and other stakeholders. Ideally, you can even involve your CDMO in proposing and agreeing on major milestones and funding gates before you commit to them. Your CDMO should be able to help you propose attractive and realistic milestones while avoiding anything overly aggressive or risky. If they are taking the lead or engaged in decision-making on your process development, it’s critical that you involve them and not commit on their behalf to timelines or improvements without their buy-in. A key advantage of CDMOs is the size and depth of their team; often, if timelines need adjusting, the best CDMOs can add resources where needed to ensure deliverables are met, but they need a certain amount of notice to make that happen — so engage them in that discussion early.
Second, you have to make sure the cell therapy CDMO you’re working with has assigned the kind of team to your program that’s capable of adding the value described above.
If you don’t have very senior and experienced program managers, process development, and MS&T professionals assigned to your project, you won’t be able to extract the kind of insights and work products described above. A more junior team will struggle to deliver, not from a lack of trying, but from a lack of experience and knowledge. Communication needs to occur at all levels — from the manufacturing operators to the senior leadership team — and valuable information needs to continually flow between both partners (the drug sponsor and CDMO) to support the success of the program.
Lastly, you need to partner with a CDMO whose entire team is passionate and educated about your program and motivated to see it succeed. You need to make sure the leadership and culture at the CDMO is designed to help the team see the forest through the trees and continuously look for opportunities to improve speed, costs, and at the end of the day, patient access to your therapeutic. The industry is not at the six-sigma stage, but some of the more rudimentary approaches of Lean principles can help accelerate your program and ensure success while sticking to timelines and budgets.
If this is happening at your CDMO, you will see evidence of it. You will know that personnel from the supply chain understand your program and are educated enough about your product to recognize potential alternative products and suppliers that they can present to the MS&T, PD, or manufacturing teams for consideration. The quality team will be well versed on what’s in the CMC section of your IND-filing or provide input into its creation. They will point out risks and opportunities related to efficient and successful release of your product. The facilities and engineering teams will demonstrate that they are up to speed on the requirements of your program and, from time to time, offer insights or recommendations for changes that might have a positive impact on your program. Like a well-oiled machine, all these cogs must work seamlessly together for the success of your program. As you look for a CDMO, make sure you are speaking to all these groups and understand their interest and desire in your program.
To summarize, all of the functional groups inside your cell therapy CDMO may have invaluable insights and recommendations for you, but if they aren’t aware of and personally invested in your program, they won’t be able to deliver them to you.
The Bottom Line
There are many different types of relationships between a cell therapy CDMO and a drug sponsor. By investing in your relationship — not just financially, but also by making sure you have a team of seasoned professionals assigned to your project — and by being as transparent as possible; involving your CDMO in discussions about KPIs, milestones, and funding gates; and helping your CDMO educate anyone who touches your program, you and your CDMO will elevate your relationship to partner status. By having your CDMO partner at your side, you’ll gain valuable benefits that will help usher you through each milestone.