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Boston, April 30: U.S. leadership in biopharmaceutical manufacturing is being reshaped by rapid technological change, geopolitical uncertainty and the growing need for resilient global supply chains, pharma leaders said Thursday.

Executives from major drugmakers said the traditional model of large, centralised manufacturing networks is giving way to more flexible, diversified systems built around speed, advanced therapies and global partnerships.

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Sanat Chattopadhyay, President of Merck Manufacturing Division, said the industry is at a turning point. “The network of the future is not going to be looking like the network of the past,” he said, pointing to the rise of complex modalities such as antibody-drug conjugates and cell and gene therapies.

These therapies require precision and speed. “It has to be a hundred percent right every time for every patient,” Chattopadhyay said, adding that companies now have “to be ready within… 12 to 16 months” for product launches.

Dave Maraldo, Senior Vice President of Human Health Manufacturing at Merck & Co., said the growing complexity of therapies is forcing companies to rethink partnerships.

“The ability to tap into more and more partners is becoming very evident,” Maraldo said. He described a two-stage approach to partnerships, including a “courting phase” and a “performing phase,” where companies assess compliance, digital capabilities and organisational culture.

Maraldo said cultural alignment is critical. “If you go in and… the only people talking about quality… are the quality individuals… that’s a red flag,” he said.

Executives said the rise of contract development and manufacturing organisations (CDMOs) is accelerating change in the sector.

Rao Mantri, Chief Manufacturing Officer at Astellas, said manufacturing must now be integrated earlier in the drug development process. “Manufacturing… is not an afterthought, but… a strategic enabler,” he said.

He said the shift to advanced therapies requires new approaches. “The overall life cycle is getting… shorter, and we don’t have much opportunity… post launch,” Mantri said, emphasising the need for early design and supply integration.

Mike McDermott, Chief Global Supply and Quality Officer at Pfizer, said the supply chain is becoming more central to business strategy.

“We have to be leading the conversation,” McDermott said. “We can’t afford to be the people that fill the warehouse.”

He said leadership in manufacturing is evolving rapidly. “You have to be a transformative leader… embrace new technologies like AI,” McDermott said, adding that the pace of change is “urgent.”

Artificial intelligence is emerging as a key tool, though adoption remains uneven.

McDermott told the invitation-only participants that AI can improve productivity by unlocking data. “What if I told you that every investigation… ever wrote… was available in a second to you?” he said, highlighting the potential for faster decision-making.

Maraldo said AI is already being used on the factory floor. “It tells the operator what is the next best decision,” he said, citing examples such as predictive maintenance and process optimisation.

However, executives cautioned that regulatory constraints may slow adoption. “The regulators are just not moving at the speed that we need,” McDermott said.

Industry leaders said geopolitical risks and policy changes are also shaping manufacturing strategies.

Edgardo Hernandez, Executive Vice President and President of Manufacturing Operations at Eli Lilly, said supply chains must be built for resilience rather than short-term policy shifts.

“Your strategy has to be based on resilience, not so much on geopolitical,” Hernandez said, noting that pharmaceutical supply chains are “very inflexible” and take years to adjust.

He said companies are focusing on diversification. “We basically diversify geographically… and internal versus external,” Hernandez said.

Maraldo said companies are also designing systems to remain “policy agnostic” in an uncertain environment. “If we’re reacting to policy, we’ve already lost,” he said.

Executives said intellectual property protection is another critical issue as companies expand partnerships globally.

Hernandez said “there is a lot of intellectual property… in manufacturing processes,” particularly for complex biologics, requiring strong safeguards when working with external partners.

Mantri added that advanced therapies increase the risk of technology transfer. “The risk… is lot more than… small molecules,” he said.

Despite these challenges, executives said global partnerships will remain essential.

The industry increasingly relies on a network of internal facilities and external partners to meet demand, particularly as new therapies require specialised capabilities.

At the same time, leaders stressed the importance of data quality and standardisation.

Maraldo said “80% of the engineers… are actually data wranglers,” highlighting the challenge of managing large volumes of manufacturing data.

Executives said AI, digital twins and automation will play a growing role in improving efficiency, though adoption will depend on data quality and regulatory alignment.

The discussion highlighted a broader transformation in the pharmaceutical manufacturing sector, driven by innovation, globalisation and rising patient expectations.

In recent years, the COVID-19 pandemic exposed vulnerabilities in global supply chains, prompting companies and governments to prioritise resilience and domestic capacity.

At the same time, advances in biologics, gene therapies and personalised medicine are changing how drugs are produced, requiring more flexible and technologically advanced manufacturing systems.

 

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