Q&A with Cytiva: Enhancing biopharma resilience with government support

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EPM sat with Marivi Mendizabal, vice president Quality and Regulatory, Cytiva, as she explains how government policy and regulatory trends impact the biopharma industry, and how collaborating with the government can enhance biopharma resilience.

Key insights:

  • The accelerated approval process for the COVID-19 vaccines was about reducing unnecessary delays without compromising efficacy, safety and quality standards.
  • Collaborating with the government would ensure faster regulatory decisions and access to drugs are possible without compromising safety.
  • 63% of the respondents said that COVID-19 was a “wake-up call” for our governments to do more to support the industry.

In 2021, Cytiva launched the inaugural Biopharma Resilience Index, revealing how the biopharma industry is performing across in five key pillars: supply chain resilience, talent pool, R&D ecosystem, manufacturing agility, and government policy and regulation in 20 countries. This year, we dug deeper into one of those pillars—government policy and regulation. This survey of 500 senior biopharma executives worldwide reveals how greater government involvement in the industry during COVID-19 affected various areas of the industry.

How do government policy and regulatory trends impact the biopharma industry?

Changes in government policy and regulations impact the biopharma industry in a variety of ways. For example, changes in the approval process for new therapeutics influence new drug development and commercialisation plans for companies. The willingness of some governments to invest in expanding manufacturing capabilities regionally will contribute to the industry's long-term growth. It also helps address talent gaps and ultimately will help build strong R&D ecosystems. The COVID-19 pandemic showed what can be accomplished when governments, the biotech industry and academia work together to solve a global public health crisis.

During the COVID-19 pandemic, we saw that there has been a much closer collaboration between governments and the biopharma industry. What was the impact?

The collaboration between governments and the biopharma industry to develop, test, and distribute COVID-19 vaccines was unequalled in terms of scale-up, scope, budget, and results. While the accelerated pace was due to the global public health risk, the industry learned that we can accelerate the development and approval of therapeutics without compromising patient safety. Examining clinical data concurrently rather than sequentially allowed for faster approvals without compromising quality standards. The industry average was previously 10 years to bring a new therapeutic to the market. We must take these key learnings and apply them appropriately.

Do you think the industry is looking at the change during the pandemic in a positive way or are there other views as well?

The COVID-19 pandemic spurred positive change in the development, approval, and commercialisation of vaccines. In the Biopharma Resilience Index, 500 senior biopharma executives worldwide revealed how greater government involvement during COVID-19 pandemic affected the speed of drug approval, supply chain resilience and access to talent. 63% of the respondents said that COVID-19 was a “wake-up call” for our governments to do more to support the industry, with 52% responding they are ‘optimistic’ about future revenue growth as the government increases spending.

While widespread, the positive sentiments were not felt universally. The data indicated that the benefits of government intervention were felt unevenly across the industry and wider society, with some firms and populations benefitting more than others.

One of the respondents from our survey, Adrian van den Hoven, director-general of Medicines for Europe, says: “Everyone was working together because this was a huge public health crisis and governments did not know how to react. Then it died down. It is not clear that these governments see an interest in continuing, even though the cooperation was fruitful and constructive.”

The benefits of collaboration are clear, but both biopharma industry and governments must be committed to making future collaborations successful.

How do you think the changes we have seen in the drug approval process will continue from now on?

The accelerated approval process for the COVID-19 vaccines was about reducing unnecessary delays without compromising efficacy, safety and quality standards. There was also greater information sharing between regulatory authorities and clinical investigators which contributed to the accelerated approval process.

I believe that we must continue sharing information to accelerate the review cycles when appropriate. I also think we need greater industry and government collaborations based on a reasonable database system that can help reduce risk. We could, for example, see more innovative product launches being accelerated through temporary authorisation rules that had been only applied to circumscribed cases, such as orphan drugs in the past.

Do we expect this to continue in the industry overall and what are the lasting impacts of this?

In Cytiva’s Biopharma Resilience Index, 60 percent of respondents say they expect drug approval to become faster over the next two years, and 51 percent say that greater government involvement is already increasing the speed of bringing new drugs to market.

The lessons learned throughout the pandemic are very clear. First, faster regulatory decisions and access to drugs are possible without compromising safety. Second, the public wants clear rules for how and when this happens. 

In the post-COVID-19 world, we expect to see an enhanced level of interaction in countries and regions where governments and biopharma already had strong relationships; elsewhere, collaborations may need more encouragement. Governments must expand the ecosystems of companies they engage with to cover the full value chain of drug development and delivery. And given that a future pandemic is inevitable, they must work hand in hand with the industry to develop robust, long-term strategies for a better biopharmaceutical ecosystem.

Are there any other areas where governments can help biopharma sectors thrive?

One area where many governments are interested in forging closer relationships with industry is in addressing insufficient supply. Moving toward an in-region, for region manufacturing complemented by the larger global supply chain can help alleviate bottlenecks in the supply chain.

Accordingly, the majority of surveyed executives expect government investment in biopharma manufacturing to grow over the next two years, and more than half expect that governments will invest in regional manufacturing or onshoring the supply chain over the same period. In September this year, United States President Joe Biden announced the National Biotechnology and Biomanufacturing Initiative, a $2 billion initiative that includes strengthening the supply chains.

Investing in and fostering talent will contribute to the long-term growth of the industry. Only 49% of the respondents said the government’s involvement is having a positive impact on the ability to access talent. It is known that acquiring a workforce in the biopharma industry is not an easy task.

For this reason, Cytiva has been working in collaboration with global academic institutions to provide hands-on training and education programs to students, researchers, and manufacturing staff. At Cytiva’s Fast Trak Centers, which operate in nine locations worldwide, we train thousands of professionals each year, empowering them with the skills they need to drive this industry forward and the demand is constantly growing.

What do you think the general public learned about the drug development and approval process during the pandemic?

I think many people gained a significant appreciation for the biotechnology industry and how it has collaborated with governments, researchers, and large companies, to manufacture and distribute vaccines globally.