Viewpoint: Innovation and access is the life science industry’s central mission

ORIGINAL SOURCE: Delaware Business Times

DBT readers will have noted with interest the unprecedented series of announcements by leading global biopharma companies on planned investments in their US manufacturing and R&D.

The sums are staggering – the latest being GSK’s $30 billion pledge towards US-based research and manufacturing operations. From the industry publication Fierce Pharma:

“The U.S. has enjoyed a surge of pharma investment in the wake of the Trump administration’s import tariff threats, with Roche pledging to spend $50 billion, Johnson & Johnson unveiling a $55 billion plan that includes bolstering its medtech business, and Sanofi and Novartis each committing to spend at least $20 billion in the U.S. by the end of the decade.

And Eli Lilly recently announced that Goochland County, Virginia, will be the site of its new $5 billion manufacturing plant—the first of four that the Indianapolis drugmaker has planned as part of its own $27 billion U.S. pledge.”

AstraZeneca also recently announced $50 billion in new US manufacturing investment and, of course, most noteworthy for Delaware, we have Merck’s recent groundbreaking on a $1billion biomanufacturing site at the CRISP campus just outside Wilmington, part of more than $70 billion in new R&D and manufacturing company by that company in the US.

All told, the investments in innovation and high-tech operations push well into the hundreds of billions.

This massive wave of investment will mean long-term opportunities for US communities and domestic industry innovation. That includes hundreds of thousands of construction and contracting jobs and thousands more great careers with industry leaders, many of which don’t require college degrees.

The revitalized industrial capacity will also spark new technologies, startups and spinoffs – a whole subsector of entrepreneurial activity around advanced manufacturing, efforts NIIMBL (the National Institute for Innovation in Manufacturing Biopharmaceuticals) right here in Delaware is already facilitating. And it is inspiring new workforce development efforts like our own BioConnect DE – forcing smarter and faster approaches in engaging, mobilizing, training and deploying STEM talent into these exciting new roles.

For its part, Delaware can and should continue to benefit from this manufacturing renaissance, but that requires understanding and meeting industry needs – being a place where companies are dying to invest and grow their operations because of talent, infrastructure and a great business climate.

Of course manufacturing is only one key area of industry investment and China has steadily eroded the US – and Delaware’s – global leadership perch in scientific innovation. We must continue to improve and expedite the process by which breakthrough therapies and technologies come to market. That demands a strategic, comprehensive approach that nurtures the life science ecosystem from the earliest stages, incentivizes and rewards investment in cutting edge science and catalyzes more productive university-industry collaboration.

It also means having regulatory bodies moving at the speed of business, and I was pleased to recently hear FDA Commissioner Marty Makary detail his efforts to transform the agency’s process for approving new therapeutics, including hastening the application of technologies like AI to get cutting-edge medicines to patients faster.

One significant example of that modernization plan is the newly announced Commissioner’s National Priority Voucher (CNPV) pilot program, which will dramatically shorten the new medicine review timeline by convening a multidisciplinary team of physicians and scientists for a team-based review, condensing the standard 10-12 month review timeline into 1-2 months.

We recently had the opportunity to discuss these issues with state legislators and other policymakers at AstraZeneca’s thriving Newark manufacturing facility, one of several site visits we’ve conducted with the Life Science Caucus over the last year with the purpose of giving state leaders direct exposure to everything happening in Delaware Bio member labs, manufacturing floors and incubation spaces.

The discussion was timely – the Newark site has grown considerably over the last several years, adding hundreds of new employees and serving an increasingly critical role in the company’s global supply chain. It also comes on the heels of the August graduation of the first BioConnect DE biomanufacturing training program class and AstraZeneca Newark’s hiring of several of the graduates.

These are all great wins for our state and country, and, most critically, meaningful progress in expanding access to the innovation our members devote their lives to delivering.

Michael Fleming is the president and CEO of the Delaware Bioscience Association.