Lessons from BioNTech’s unorthodox path to breakthrough solutions

Building on Şahin’s initial work, by early February BioNTech’s scientists had proposed 20 vaccine candidates. Many of them were designed to configure proteins resembling a piece of the distinctive spike of the coronavirus to elicit an immune response. 

To press home this initial advantage, BioNTech reconfigured its processes. “We relentlessly pursued the principle of minimizing development times without skipping development steps or taking shortcuts,” Şahin told Business Insider. “The tasks that are normally approached sequentially in vaccine development were done in parallel.” 

Türeci and Şahin adopted an approach to experimentation that optimized two seemingly contradictory qualities. It combined high focus and high flexibility – keeping their options open for as long as possible. By mid-April, BioNTech scientists had eliminated 16 of the vaccine candidates, leaving the four most promising ones. 

The company had contacted the German regulators from the start to prepare them for the new type of vaccine and to try to ensure fast-track approval for Phase 1 and 2 clinical trials. A process that normally took the authorities three months was completed in just three days. 

BioNTech decided to test all four remaining vaccine candidates concurrently. The company also took the risk of organizing itself for success. In a New York Times podcast, Türeci explained: “We basically prepared the more advanced trials in parallel to conducting the Phase 1 trial, at risk of not having a candidate, which would then go into Phase 3.” 

By now BioNTech had expanded its production facilities, with assistance from the German government, but Şahin knew his company would need help not just to produce a vaccine, but also to conduct large-scale clinical trials and navigate international regulatory hurdles.  

He had taken the precaution of contacting Pfizer’s head of vaccine research, Kathrin Jansen, as early as February. By mid-March, the two companies had agreed to collaborate, meaning their joint venture was able to launch simultaneous clinical trials in Germany and the United States.

Switching scale 

A third barrier to breakthrough innovation is underestimating the gap between a working solution and a breakthrough solution. In innovation models, this final phase is often labeled execution, implementation, or launch; however, these labels don’t do justice to the agility and unorthodox thinking required to transform the ecosystem and adapt one’s message to the needs of different stakeholders. 

As dedicated researchers, Türeci and Şahin could easily have neglected the challenges of getting the product to market, preferring to focus on the science instead, but they were all too conscious of that risk. Asked whether logistical, purchasing, and supply chain concerns felt like an unwelcome distraction from the research, Türeci told Der Spiegel: “That’s just part of the deal when you are trying to bring something brand new from the laboratory to the patient. You have to be humble and take care of all those things that you always thought other people should handle. 

“You learn to see things like production, storage, cooling, and transportation as an extension of scientific innovation. Here, too, new solutions are required for problems that have never been encountered before.” 

Distribution was a case in point. While mRNA vaccines benefit from accelerated design, they have one critical disadvantage: they need to be stored at −70°C (−94°F). This posed a huge storage and transportation challenge. 

Again, Türeci and Şahin did not wait for the vaccines to be ready to line up an array of partners, this time with expertise in cold chain management. For example, within weeks of switching direction, BioNTech alerted the specialist glass manufacturer Schott that it would need to ramp up production of vials capable of resisting temperatures as low as −80°C (−112°F). 

By March 2020, BioNTech had contacted other key players in Germany: Binder, a manufacturer of “super freezers” to chill coronaviruses used in lab research; and Va-Q-Tec, a producer of shipping containers and boxes with an ultra-cool function. BioNTech also urged freight services at Frankfurt airport to invest in hi-tech refrigerated “dollies” to transport the vaccines from hangars to planes. 

Alongside clinical development, BioNTech had to mobilize a new network of collaborators. Ultimately, it was this smart alignment of multiple partners ahead of time that made the difference. 

On 18 November, 2020, less than10 months after first noticing the problem, BioNTech and its partner, Pfizer, were able to announce a successful result with a 95% efficacy against the virus. 

A double breakthrough 

Having achieved their coronavirus target, Türeci and Şahin now intend to resume their original goal of developing a new tool against cancer.  

But their COVID-19 breakthrough has been a game-changer. As the first mRNA vaccine to be approved, their achievement holds an even bigger promise. It opens the door to a new, disruptive technology that could revolutionize medical research. Şahin told the Financial Times: “Dozens of mRNA cancer therapies, immunizations for rare diseases, and treatments for HIV and tuberculosis could now be fast-tracked.” 

A scientific couple has probably not been so celebrated worldwide since Pierre and Marie Curie, who won the Nobel prize. Although Özlem Türeci and Uğur Şahin have not yet won theirs, their breakthroughs may yet be recognized when mRNA technology reveals its full impact.

• Cyril Bouquet, Jean-Louis Barsoux and Michael Wade are IMD faculty members and the co-authors of ALIEN Thinking: The Unconventional Path to Breakthrough Ideas, published in 2021 by Public Affairs and Penguin Business.