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Ludovic Brellier, President Biotechnology Integrated Solutions & Business Operations at Cytiva.
The biopharma industry has made minor strides toward improved resilience, but it’s not enough to meet future global demand for novel therapeutics. However, here are ways to get there.
The biopharma industry is not as resilient as it should be. We know that because we surveyed 1250 pharma and biopharma executives across 22 countries for our second Biopharma Resilience Index. Data from that survey allows us to better understand the progress, challenges, and opportunities currently confronting the industry. More importantly, the Biopharma Resilience Index can show us where to strengthen our collective efforts.
Measured across five key areas: supply chain resilience; talent pool; R&D ecosystem; manufacturing agility; and government policy and regulation, countries are scored on a scale of 0 to 10, where 0 reflects the worst performance and 10 denotes best practice. The overall 2023 Global Biopharma Resilience score is 6.08, which is lower than the 2021 score of 6.60.
This decrease could be a result of a broader data set used in 2023, including publicly available data on biopharma trends, and offers a more extensive overview of the industry. Regardless, the finding points to key areas of concern that the industry must address; specifically, the decline we see across the talent pool, R&D ecosystem, and government policy and regulation. In other words, areas where collaboration is needed. We do see an improvement in areas where the industry controls the progress, specifically manufacturing agility and supply chain resilience.
It’s surprising to see a decline, given the enormous investments and collaborative energy that went into finding a solution for the global COVID pandemic. On the other hand, it’s not a complete shock, since funding and focus on the industry have decreased in the post-COVID environment. To ensure a secure, affordable, and thriving future for human health, here are five actions the industry can take.
One: Developing a long-term roadmap that aligns government policy and biopharma regulations.
Biopharma companies and industry organisations must work in closer collaboration with both government policymakers and regulatory bodies. Regulatory processes must be adapted to suit emerging technologies and therapies. We saw this work well during the early stages of the pandemic when it was urgent to develop and distribute vaccines. However, other areas, such as digital health and gene therapy, continue to face challenges. Although there has been progress on facilitating faster drug approvals (while continuing to ensure safety and efficacy), new products must still overcome a large number of regulatory barriers before they reach the market. Fostering innovation should be prioritised in policy initiatives and be designed to translate into clear regulatory guidelines.
Switzerland, the highest performing country in the Global Biopharma Resilience Index, is particularly strong in this regard. Swissmedic, the Swiss Agency for Therapeutic Products, is known for being rigorous yet flexible in allowing expedited drug approvals and streamlining international data use in the local drug-approval process. The organisation works closely with international partners to accelerate market access for innovative therapies and is supporting “regulatory harmonisation” as a priority for the next three years. Further, programs like the US FDA’s Project Orbis aim to make concurrent international drug approvals a reality, although scope presently remains limited to high-priority oncology projects.
Two: Bridge the gap between emerging and developed economies.
The biopharma industries of developed economies can help strengthen the global R&D ecosystem. For example, the Global Gene Therapy Initiative, an international alliance of clinicians, scientists, engineers, advocates, and community members, is working to establish pathways to cell and gene therapies in Uganda and India, focusing on HIV and sickle cell anaemia. India’s efficient supply chain and China’s manufacturing agility should be studied by other developing countries for ways in which they could emulate these successes and thereby accelerate their own progress.
Another area key to bridging this gap is retaining their talent. China is attempting to reverse their “brain drain” of biopharma professionals seeking opportunities abroad using a series of talent-recruitment policies encouraging Chinese nationals to return to the country.
Three: Address the talent shortage through training, upskilling, and retention.
The global shortage of talent across the biopharma industry is no shock to anyone. The recently diminished talent pipeline is due to two major reasons. First, the rapid advances in biologics require a specialised skill set. These new sets of skills and advances have not been incorporated into traditional training programs, at least not yet. And secondly, for those that do have the technical skills and digital expertise, our industry is competing with the technology sector in Silicon Valley and elsewhere for talent.
Organisations struggling to keep their talent pools full have several ways to fill this gap. One way to do this is by investing in staff training and development, focusing on upskilling their existing workforce in digital technologies. Partnering with a specialist training facility, such as NIBRT in Ireland, can provide the hands-on experience that many universities cannot. Organisations like NIBRT can work directly with industry to design, develop, and deliver bespoke training programs for new and existing staff. These may help in the short term while the industry develops a longer-term talent pipeline.
Four: Strengthen digitalisation through targeted investment.
The difficulty in sourcing talent with expertise in digital solutions may be contributing to biopharma’s lack of momentum in adopting new technology. A focus on industry-specific applications — such as continuous manufacturing and Real Time Release Testing (RTRT), which uses data collected during the manufacturing process — could boost adoption rates. A move towards using robotics for all or part of the manufacturing process would significantly reduce costs and support scalability to meet demand. There is a clear need for greater investment in the platforms that enable continuous manufacturing for biologics. In the US, significant funding is coming from the government and contract manufacturing organisations, but companies based in countries without this support may need to seek private investment.
Five: Learn from leading countries’ investment models.
There are some small, high-performing ecosystems that have climbed the list thanks to their unique investments in the market. For example, Ireland, Switzerland, and Sweden are pairing government investment with R&D hubs for training and development, fostering a “small but mighty” approach to biopharma. There are also positive trends around mid-ranking countries in the index, in particular South Korea, where the government has promised an annual investment of $303 million to nurture the national biotech industry. This investment is combined with a raft of regulatory reforms intended to streamline innovation, decentralise clinical trials, and de-risk investment in new therapies. And in Japan, the Bioventure Support Program has announced that it will use a government investment of $420 million to strengthen the domestic ecosystem for drug and vaccine development. India and China provide a strong example of how robust government policy paired with a strong scientific culture can power growth in biopharma. Governments can make their investments go further by developing tax policies with an eye to the global market, ensuring competitiveness, attracting business from overseas, and encouraging established companies to remain in the country.
Focusing on these five areas, countries can build toward a streamlined system that prioritises alignment of internationally agreed standards and domestically applied regulations. Boosting resilience for individual countries and for the global biopharma ecosystem, will move us toward our ultimate goal of access and equity in healthcare.