“In Big Pharma, innovation is often stifled because the bureaucracy and mindset completely kills creativity and intuition needed for discovery. That’s why they now prefer to allocate their early-phase resources to smaller biotechs,” explains Julien Laizé, sharing candid insights about the delicate balance between innovation and compliance in vaccine manufacturing
Julien Laizé serves as Director of External Manufacturing CTM at Valneva, a French-based specialty vaccine company developing and commercialising vaccines for infectious diseases. With previous roles at Novo Nordisk and Eli Lilly, Julien brings unique perspectives on managing external manufacturing across both big pharma and biotech environments, particularly in navigating the tension between innovation and regulatory compliance.
In the latest PharmaSource podcast episode, Julien shares his experiences in fostering innovation while maintaining rigorous quality standards, and explains why the industry’s greatest discoveries often come from embracing calculated risks.
The Innovation-Compliance Balance
One of the most fascinating aspects of biopharma, Julien explains, is the inherent tension between risk-taking innovation and stringent compliance requirements.
From Louis Pasteur to Alexander Fleming, “most of the innovation in human history came from random discoveries and people taking risks. In pharma, you’ll test 100 things, and 99 will fail, but one will be a blockbuster. That’s how innovation is driven,” he explains. “But this approach doesn’t fit well within big pharma’s structure, which is why they now allocate their early-phase research and development to smaller structures.”
He adds: “We implement rigorous frameworks that allow exploration of novel approaches while adhering to regulatory standards. You can ensure both safety and efficacy in your vaccine candidates while still maintaining space for innovation.”
Cultural Transformation: Big Pharma to Biotech
The transition from established pharmaceutical companies to smaller, more agile organisations requires a fundamental shift in approach. Julien shares a telling example from his early career:
“At Eli Lilly, when I was 27, I proposed an idea to change the workflow that could save the department $300,000. But first, I needed to submit forms, get manager approval, present to a board of 10-12 directors. Eventually, two directors blocked it saying, ‘You’re technical, you should never suggest such ideas.’ That’s how efficiency can be stifled by structure and rigid job descriptions.”
In contrast, he describes the biotech environment: “At Valneva, you have objectives and global goals – help yourself. The most important thing is achievement, not how you get there. This creates space for innovation while maintaining necessary quality standards.”
Building Global CDMO Partnerships
When it comes to selecting and managing CDMO partnerships, Julien emphasises the importance of relationship quality and cultural understanding:
“Customer relationships account for 50% of your success rate with a CDMO. You can have a technically excellent CDMO, but if the relationship isn’t there, it can be a disaster,” he explains.
On evaluating potential partners, he adds: “The pharma industry is extremely small – everybody knows everybody. We interview our network about partners’ behaviour in real projects. The site visit is crucial – what happens between corridors, observing operators, sensing the atmosphere – these indicators help form judgment.”
Navigating Cross-Cultural Partnerships
Working with partners across different regions presents unique challenges, particularly in emerging markets. Julien shares insights from Valneva’s experiences working with partners in Brazil and India:
“Understanding cultural context is crucial. If you understand Brazil’s history, you can understand why their structures are more bureaucratic and decision-making slower. It’s linked to their colonial past and feudal structures that persisted after independence.”
He emphasises the importance of adaptation: “In Austria, being on time is a matter of respect. In Brazil, it’s different – they might make you wait and smile about it. If you’re too rigid about timelines, they’ll close themselves off. But if you accept some flexibility, you often get better outcomes.”
US Market Strategy and Political Shifts
Valneva have a growing presence in North America, marked by a recent $32.8 million contract with the US Department of Defense for their encephalitis vaccine, Ixiaro. However, the changing political landscape presents both opportunities and challenges for external manufacturing strategy.
“The US drives everything in the pharmaceutical industry, not only in terms of business but in terms of regulatory direction because the FDA is the most advanced regulatory agency,” Julien explains. “When the US decides something, it impacts the whole pharma industry.”
He notes particularly significant changes coming with the BIOSECURE Act: “This act, raised by the Biden administration and likely to continue under any future administration, will essentially exclude all Chinese CDMOs and partners for products marketed in the United States.”
These changes are driving a broader shift in manufacturing strategy to massively repatriate capabilities to the United States, Julien explains. “We’re seeing the end of globalization where the world was a small village. Now we’re seeing more of a rise of empires – a block for the United States, a block for China, a block for India.”
For companies like Valneva these changes require careful strategic planning and will have a “major impact” on the selection of future partners.
Embrace adaptability
Julien concludes with advice for emerging leaders in biopharma manufacturing:
“Embrace adaptability and continuous learning. Stay aware of industry trends, regulatory changes, and technical advancements. Build ethical relationships – it’s a small world, and reputation matters enormously.”
He adds a final philosophical note: “Remember we’re not producing iPhones or AI – we’re improving global health. That’s something very noble to keep in mind. As General de Gaulle said, ‘General culture is the weapon of a leader.’ Understanding geopolitics, cultural gaps, and broader context is crucial for success in this field.”
Join Julien Laizé and other external manufacturing leaders at CDMO Live 2025, for discussions about the future of biologics manufacturing. Download the full agenda here
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