The biopharmaceutical ecosystem has long relied on a framework of partnerships among the government, academia and private sector to research and develop new medicines. In recent months, these partnerships, many among biopharmaceutical companies directly, have become crucial to the fight against COVID-19.
In early 2020, as details began to roll in about the severity of the novel coronavirus, scientists at Sanofi quickly realized the urgent need for action. By February, the biopharmaceutical company announced its intention to identify and develop a COVID-19 vaccine, building on previous experience with influenza and earlier work amid the 2002-03 SARS epidemic. As one of the top vaccine producers in the world, Sanofi has invested heavily in technology to improve its vaccine manufacturing capabilities, as well as its ability to advance clinical studies. Even so, leadership felt the public health need was too great for the company to tackle vaccine development on its own.
In addition to working internally to advance a vaccine candidate, Sanofi has joined forces with outside public and private organizations to accelerate the R&D process, including a partnership with the U.S. Biomedical Advanced Research and Development Authority (BARDA), and collaborative private sector partnerships with GlaxoSmithKline (GSK) and Translate Bio. The level of collaboration throughout the biopharmaceutical ecosystem in recent months is “unprecedented” according to Clem Lewin, associate vice president R&D strategy at Sanofi.
“Collaboration is nothing new to the industry, but amid COVID-19, the intensity of these partnerships has increased to a point we’ve never experienced before,” Lewin said. “Everyone recognizes the need to have a vaccine as quickly as possible, and we’re all operating from this sense of urgency to move things forward.”
Partnerships In Action
Vaccines work by imitating an infection to teach the immune system how to recognize, remember and target microbial invaders, like viruses and bacteria, without actually causing an infection. To develop a vaccine for the novel coronavirus, Sanofi is utilizing its recombinant technology to genetically engineer cells to produce a spike protein unique to the COVID-19 virus. The hope is that by introducing this spike protein to the human body, a person’s immune system will learn to recognize the protein and develop immunity in advance of any potential interaction with the real virus.
To boost the effectiveness of such a vaccine, Sanofi has partnered with GSK to provide an adjuvant, an ingredient added to enhance the immune response. If found successful, this step will be crucial in meeting global demand for a vaccine, because it could help reduce the amount of vaccine protein required per dose, speeding up the manufacturing process. According to Sanofi, the candidate is expected to enter clinical trials in the second half of 2020 and, if found successful, become available by the second half of 2021.
With this partnership, you’re seeing two of the largest vaccine companies, which are traditionally market competitors, putting aside individual company interests and coming together to address the pandemic,” Lewin said.
Sanofi is also working with Translate Bio to develop a potential vaccine that relies on messenger RNA (mRNA) to instruct a person’s cells to produce the spike protein within their own body—a cutting edge approach to vaccine technology that can be manufactured more quickly than traditional types of vaccines, if found successful. Additionally, Sanofi has utilized its longstanding partnership with BARDA to share key learnings with other members of the biopharmaceutical ecosystem.
‘We’re Working 24/7’
Scientists have learned a tremendous amount about the novel coronavirus since its discovery six months ago, but much remains uncertain about how to best develop an effective vaccine. The human body is incredibly complex, and scientists cannot predict how or if a vaccine will respond in an individual immune system. Researchers must go to great lengths to ensure a potential vaccine is not only effective but also safe by conducting extensive clinical trials, before a vaccine is ever made available to the public. Given the pressing need, a wide range of approaches to vaccine development are being tested by biopharmaceutical researchers throughout the world to greatly improve the odds that one or more of these approaches will be successful.
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The unprecedented progress in such a short time is due in part to active collaboration across the industry and with public partners, as well as the U.S. Food and Drug Administration (FDA) who conduct “a rigorous review of laboratory and clinical data to ensure the safety, efficacy, purity and potency of these products.” Importantly, the FDA also “has a stringent regulatory process for licensing vaccines that serves as a model for other countries.”
“We’re living in a challenging time, but watching the dedication of colleagues within the company, within the industry and within in the broader ecosystem inspires me,” Lewin said. “We’re operating with a collaborative spirit. We’re working 24/7. We’re working weekends—anything we can do to try and shave time off vaccine development. That keeps me encouraged."
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