The research highlights five areas where countries are focusing their efforts to boost the resilience of their biopharma sectors.
The work of the pharma and biopharma sectors to produce Covid-19 vaccines in record times has been a bright spot in the response to the pandemic. It showed that the industry can step up to the plate when it has to.
But the Cytiva Biopharma Resilience Index shows that there is plenty more to do to ensure the resilience of drug development beyond Covid-19. Here are five ways for countries to boost the resilience of their biopharma sectors as they look to 2021 and beyond.
1. Re-evaluate the supply chain
The industry’s traditional model of drug development and manufacturing has, for the most part, made sure that countries can get by. But given some of the pain points revealed by the pandemic and our index results, getting by is not enough. One way to improve performance is to use emerging technologies to transform the supply chain.
Martin Meeson, chief executive of Fujifilm Diosynth Biotechnologies, explains how revamping the supply chain is a key area of focus for his company, given its specialty as a global contract development and manufacturing organization (CDMO). He gives the example of continuous manufacturing, which can offer “significantly increased output for reduced amount of usage of resources” compared with the more modular industry standard of batch processing.
Meeson also stresses that biopharma companies must continue to emphasise efficiency throughout this transformation. “We have to make sure that every time we do something, we are maximizing the output from the resources that we are using,” he says.
2. Invest judiciously in localized production
The pandemic has driven a step-change in how the biopharma industry approaches certain issues – from expediating drug approval processes through to localizing the production of certain pharmaceuticals. The experts we spoke to believe it’s critical that the industry doesn’t lose sight of these lessons as the world emerges from the crisis.
“The pandemic has really pushed governments to think differently,” says Mary Blenn, vice president of global supply chain at Cytiva. “They want localized production. They want more control. They've got an obligation to protect the people living in their countries. But it’s important to recognize that there's a balance between having everything done within your country, which can drive inefficiency, versus having certain things done locally.”
Blenn believes that executives’ desire to be self-reliant by becoming more localized, for example, necessitates a mindset that is willing to “pivot, innovate, accelerate”. Localizing the industry by bolstering talent pools, expanding manufacturing capacity and fostering a collaborative R&D ecosystem could make countries more versatile globally and locally.
Stanley Erck, president and chief executive of US pharma firm Novavax, also recognizes the drive towards localization: “We've all been surprised by the demands on supply chain and understanding how we can respond to that. Novavax started with zero manufacturing sites in January of last year, and now we have eight manufacturing sites in seven different countries. We use product like we never would have, as well as supplies of raw materials that we never would have forecast a year ago.”
3. Improve clarity and collaboration around industry-wide goals
There are few industries as competitive as pharma and biopharma, which has made working on projects together a rare occurrence. But to make sure countries are secure and have sufficient supplies of critical medicines in the coming years, governments need to foster a strong culture of collaboration across the biopharma ecosystem.
“Who would have thought that GSK and Sanofi would work hand in hand to develop a vaccine,” says Emmanuel Ligner, president and chief executive of Cytiva. “Or that Eli Lilly, needing some capacity, would tap into Roche.”
It’s unrealistic to expect that this type of corporate partnership will continue indefinitely. But governments can help to improve collaboration between biopharma firms, academia, and other industry bodies through providing transparency around industry-wide goals and what’s required at a regional level – whether this is related to improving supply chain resilience, strengthening manufacturing processes or transforming policy. “Let’s make sure that there is a very clear view of what is needed and where,” says Ligner. “Not only in terms of customers, but also in terms of geographical location.”
Collaboration will also help organizations with talent. The industry’s increasing digitization and use of data, for example, demands new skills from areas that may not be native to pharma and biopharma. The industry will need to look outside itself for partners.
“We are competing with the IT sector, but having said that, I think this is also about collaboration and partnerships with IT companies,” says Kiran Mazumdar-Shaw, executive chairperson of Indian pharma giant Biocon. “That is how we are solving the problem.”
4. Accelerate regulatory pathways where appropriate Out of the five pillars of the Cytiva Biopharma Resilience Index, government policy and regulation emerged as the strongest — a vote of confidence in how they responded to the Covid-19 pandemic.
Biocon’s Mazumdar-Shaw says that “warp speed” regulatory pathways allowed Covid-19 vaccines to be developed much more quickly than they otherwise would. But she says that with “common sense” — the simplification of regulatory requirements, for example — a streamlining of the lab-to-market process could be extended to other products.
“If we could make a vaccine in nine months, I do not see why we cannot make drugs and other important medicines in that kind of time,” she says. “Why are we denying patients access to new medicines just because we have such archaic regulatory systems and pathways? That is what I mean by common sense.”
5. Make flexible manufacturing a priority
Expediating drug approval processes isn’t the only area in which regulators can drive change. Stanley Erck believes they can also play a vital role in enabling more flexible manufacturing processes: “I think it's absolutely crucial for manufacturing to be both agile and flexible. Regulators don't always allow you to change manufacturing processes easily, but we really need the ability to do this.”
Mazumdar-Shaw agrees: “With data science, analytics, sensors and the kind of means that we have today to show compatibility, I'm sure we can simplify regulations and make manufacturing far more efficient. I think we need to revisit a lot of our manufacturing processes and really focus on how quickly we can pivot to move the process from one product to another. That is what is going enable us to improve the agility of biopharma manufacturing.”
Manufacturing agility and flexibility are also critical for biopharma R&D company Akesobio. “We have quite a few products in the development stage, but we cannot build a factory for just one compound,” explains Michelle Xia, Akesobio’s president and CEO. “So, manufacturing flexibility is very important for us,”
These five actions will help pharma and biopharma industries to continue taking giant steps towards securing the resilience of countries — beyond the achievements of 2020. As Emmanuel Ligner puts it: “We should never forget what we are learning right now.”