This is recognized as a pivotal scientific event: A 1975 gathering at the Asilomar Conference Center in Pacific Grove, California, established a new safety framework for recombinant DNA, guaranteeing that scientists would exercise care when it came to gene splicing. These concepts have proved so beneficial that in the years following, whenever new issues regarding scientific safety emerge, there are still requests for Asilomar-style gatherings to develop sound regulations.
However, an essential component is absent from this story: It required more than just the Asilomar conference to establish the standards we have today. The Asilomar ideas were designed with academic research in focus — yet the biotechnology sector also develops products, and those guidelines were formed in the aftermath of Asilomar.
“The Asilomar gathering and the Asilomar principles did not resolve the question regarding the safety of genetic engineering,” states MIT researcher Robin Scheffler, author of a recently published academic article on the topic.
Rather, as Scheffler illustrates in the paper, Asilomar sparked further discussions, but those industry guidelines were codified later in the 1970s — first in Cambridge, Massachusetts, where local politicians and concerned residents wanted nearby biotech companies to act responsibly. In reaction, the city enacted safety regulations for the nascent industry. Rather than relocating to places with no regulations, local companies — including a budding Biogen — opted to remain. Over the years, the Boston region evolved into the global leader in biotechnology.
Why did they decide to stay? Essentially, regulations provided biotechnology firms with the assurance they required to expand — and construct. Lenders and property developers sought indications that long-term investments in laboratories and facilities were viable. Generally, as Scheffler points out, although “the notion that regulations can stabilize businesses doesn’t have much weight” in economic theory, in this particular scenario, regulations indeed played a significant role.
“The path of the industry in Cambridge, including biotechnology businesses choosing to adapt to regulations, is extraordinary,” comments Scheffler. “It is difficult to envision the American biotechnology landscape without this concentrated cluster in Boston and Cambridge. The events that took place on a very localized level had profound ramifications.”
Scheffler’s paper, “Asilomar Goes Underground: The Long Legacy of Recombinant DNA Hazard Debates for the Greater Boston Area Biotechnology Industry,” features in the latest edition of the Journal of the History of Biology. Scheffler serves as an associate professor in MIT’s Program in Science, Technology, and Society.
Commerce: Relying on stability
To be clear, the Asilomar conference of 1975 did yield tangible outcomes. Asilomar resulted in a framework that aided in assessing the potential risks of projects and determining suitable safety protocols. The U.S. federal government subsequently embraced Asilomar-like principles for research it financed.
However, in 1976, discussions regarding the subject resurfaced in Cambridge, particularly following a feature article in a local newspaper, the Boston Phoenix. Residents grew anxious that recombinant DNA projects could theoretically create new microorganisms that might threaten public health.
“Scientists had overlooked urban public health,” remarks Scheffler. “The Cambridge recombinant DNA discourse in the 1970s turned it into a matter of community perceptions.”
After several months of hearings, research, and public discourse (occasionally involving MIT faculty) extending into early 1977, Cambridge enacted a somewhat more rigorous framework than the federal government had suggested for the management of materials utilized in recombinant DNA activities.
“Asilomar found new life in local regulations,” according to Scheffler, whose research involved government archives, media reports, industry documentation, and more.
Yet an interesting development occurred after Cambridge approved its recombinant DNA regulations: The emerging biotech industry established itself, and other nearby municipalities enacted their interpretations of the Cambridge guidelines.
“Not only did cities implement additional safety regulations,” Scheffler notes, “but the advocates for these regulations shifted from being left-wing activists or populist mayors to the Massachusetts Biotechnology Council and real estate development interests.”
Indeed, he adds, “What’s fascinating is how quickly safety worries surrounding recombinant DNA faded. Many individuals opposing recombinant DNA altered their viewpoints.” While some local residents persisted in voicing concerns about the labs’ environmental effects, “those inquiries arise only when people no longer fret about the safety of the primary work itself.”
Unlike federal laws, these local regulations catered not only to lab research but also to products, thus informing firms that they could operate in a stable business environment with regulatory certitude. This had financial significance, and in a particular manner: It assisted companies in constructing the facilities required to produce the products they had developed.
“The venture capital cycle for biotech firms was heavily focused on research and thrilling intellectual concepts, but then came the need for physical infrastructure,” Scheffler states, referring to biotech production facilities. “The physical infrastructure poses a tougher challenge for many startup biotechnology companies.”
After all, he observes, “Venture capitalists are willing to fund major breakthroughs, but a banker approving a construction loan has very different concerns and is significantly more attentive to aspects such as factory permits and sewer access a decade down the line. This explains why numerous towns throughout Massachusetts enacted regulations in order to ensure that.”
To expand globally, act regionally
Naturally, another reason biotech companies opted to settle in the Boston area was the intellectual resources: With numerous local universities, there was an abundance of industry talent present. Local faculty members co-founded several of the prominent firms.
“The hallmark of the Cambridge-Boston biotechnology cluster is its density, situated around the universities,” Scheffler asserts. “This is a unique characteristic encouraged by local regulations.”
It is also true, Scheffler points out, that certain biotech firms initially attempted to dodge regulations through venue-shopping, although this was more prevalent in California, another state where the industry developed. Nonetheless, the regulations in the Boston region appeared to alleviate both industry and community anxieties on the matter.
The foundations of biotechnology regulation in Massachusetts contain some intriguing historical oddities, such as the period in the late 1970s when the city of Cambridge mistakenly left the recombinant DNA safety regulations out of its annually published bylaws, rendering the rules inactive. Officials at Biogen reminded them to reinstate the laws.
Half a century after Asilomar, its broad downstream impacts extend beyond a mere set of research principles — but also, reflected through the Cambridge situation, crucial ideas regarding public discourse and engagement; minimizing uncertainty for businesses, the unique financing requirements of industries; the influence of local and regional regulations; and the willingness of startups to identify what may assist them in flourishing.
“This represents an alternative approach to considering the legacy of Asilomar,” Scheffler remarks. “And it stands in stark contrast to what some might anticipate from solely following scientists.”