David Caron, Senior Vice-President of CMC, AL102 at Immunome, shares why choosing the right CDMO partner can make or break a biotech’s development timeline: “For biotechs, the main business challenge is to do right the first time. To do this, we need to look at the risks related to each activity.”
David Caron brings over three decades of pharmaceutical industry experience across multiple biotechs, with expertise spanning from bench formulation to senior leadership roles. His background includes extensive work with various dosage forms and regulatory requirements across EU and US markets.
In this latest episode of the PharmaSource podcast David shares crucial insights on how emerging biotechs can optimize their CDMO partnerships, manage costs effectively, and align CMC strategy with business objectives.
David Caron will be sharing advice about how to overcome biotech CMC challenges at CDMO Live 2025. Book your ticket here
Strategic CDMO Selection: Think Long-term While Moving Fast
For biotechs, selecting the right CDMO partner requires careful consideration of both immediate needs and long-term potential. David emphasizes that while many companies focus on immediate development work, considering a CDMO’s ability to scale up to commercial manufacturing can be crucial.
“In the process of selection for making clinical batches, I would prefer to have a CDMO that can also take it to the next step, to the scale-up and to the commercial phases,” David explains. “Over the days and years that you’re working together, you learn a lot. It’s not only what is written – there are things that you get to understand better through practice, and the people working with you are learning together with you.”
However, he cautions against automatically choosing larger CDMOs: “The large CDMOs can be very slow and very expensive, and as a biotech, you will compete with other large companies working at those CDMOs. Even the quotation process can be very lengthy – till you ask for a quote, you get a quote, it’s been reviewed internally, you get it signed off, and you get a slot that can take two or three months easily.”
Risk Mitigation Through Parallel Development
One of the most critical strategies David advocates for is running multiple prototypes in parallel, particularly for stability testing and pharmacokinetics studies.
“If you’re developing a product and you have only one prototype, and you wait six months or 12 months to see something happening… you lost seven months of your life. How do you recover that?” he notes. “If you were having two prototypes in the stability chambers, maybe the second one would show better results because you’ve done something different.”
This parallel approach not only saves time but can also be more cost-effective: “Running three stability programs with time intervals at different dates is more expensive than running three prototypes with one HPLC testing at the same time.”
Budget Management and Cost Control
David emphasizes the importance of detailed budgeting based on concrete quotes rather than estimates. He suggests:
- Requiring detailed breakdowns of costs for each service
- Negotiating payment terms that work for biotech cash flow
- Considering strategic splitting of services between providers based on expertise
- Evaluating the total cost of ownership rather than just service prices
“Budget should be really very detailed and should be based not only on estimation but on real quotes,” he advises. “When you’re sending an RFP, I think it’s essential to detail what needs to be done.”
Becoming a Strategic Partner to Leadership
For CMC leaders looking to gain strategic influence within their organizations, David recommends focusing on risk mitigation and business impact rather than technical details alone.
“CMC has always been found as people who come to the CEO to ask for money and come back with issues,” he reflects. “You need to learn how to appeal to the CEO by presenting strategic plans with risk mitigation and to capture their confidence that you really understand what you’re doing, and you know how to reduce cost, how to reduce the timelines, to accelerate a program.”
David emphasizes the importance of sophisticated project management tools and communication strategies to maintain alignment between CMC and business objectives.
“It’s really about preparing very good deck presentations which are built on real timelines,” he explains. “I’m really talking about using program tooling management, not just an Excel spreadsheet where you plug in some bars, but using MS Project, Smart Sheet, whatever, and you present a real timeline where you can put more or less detail depending on the audience you are talking to.”
Navigating HPAPI Development Challenges
When it comes to highly potent active pharmaceutical ingredients (HPAPIs), the CDMO landscape becomes significantly more complex. David highlights how specific technical requirements can narrow the field of potential partners.
“Not all CDMOs have the highly potent drug capabilities – some of them have for a certain class of high potent drug and they don’t have for higher,” he explains. The challenges multiply when additional requirements come into play: “If you need on top of the highly potent drug that you need to use organic solvent, then you have another issue. Not all highly potent drug CDMOs have ex-proof rooms.”
Small batch sizes present another strategic consideration for HPAPI development. “Does a large CDMO want to deal with 400-gram drug substance batch? Maybe not,” David notes. “Thinking about that maybe you will need to commercialize three to ten batches per year – is it worth it for the CDMO? We need to remember that from a development perspective, it’s still the same amount of work whether it’s 400 grams or 400 kilos.”
Global Manufacturing Strategy: Beyond Cost Considerations
While lower manufacturing costs in regions like India and China can be attractive, David advocates for a more nuanced approach to geographical decisions. He emphasizes that CDMO selection should be based on a matrix of quality attributes rather than cost alone.
“In India, and I would say also in China, there are a lot of CDMOs who can do very good work at a much better price,” he acknowledges. “Now the question is always an integration of all what you want to achieve – quality, speed of development.”
He suggests considering a hybrid approach: “You can decide to do very quickly at a low cost, and then tech transfer the development to a larger CDMO located somewhere else because you have in mind that you don’t want to go commercial from India. That can be a strategic decision.”
Managing international partnerships requires attention to practical considerations:
– Cultural differences
– Time zone challenges
– Communication protocols
– Quality oversight
– Tech transfer implications
“From my past experience, working with Indian CDMOs has not been any more of a challenge than Europe or US,” David shares. “It’s a cultural difference, time zone difference, and all that needs to be managed. With some experience, there is a good way to manage those challenges.”
Don’t miss David Caron speaking at CDMO Live 2025. Book your ticket here
Stay ahead of trends and best practices 
Exclusive downloads and podcasts 
Get invites to special events and meetups 
