Lifera was established in 2023 to address key priorities outlined in the National Biotech Strategy of Saudi Arabia, focusing on improving biopharma resilience and enabling the development of biologics, vaccines, cell and gene therapies, and other advanced medical therapeutics. The organisation's first chairman, Ibrahim Aljuffali, explains how Lifera aims to serve as a catalyst for advancing the biopharmaceutical sector in Saudi Arabia by not only manufacturing essential medications but also enabling R&D efforts. Aljuffali also outlines Lifera's strategic priorities, including expanding its manufacturing and therapeutic development ecosystem, embracing digital transformation, and leading innovation in personalized medicine and targeted therapies.

 

Why was Lifera launched in 2023 and what is your mandate as its first chairman?

Lifera was established to address two key KSA National priorities – (1) improving biopharma resilience and (2) enabling the National Biotech Strategy which was officially launch in early 2024. As part of this, Lifera is a contract development and manufacturing organization (CDMO) focused on building manufacturing and R&D capacity mostly for biologics, vaccines, cell and gene therapies and other advanced medical therapeutics. As part of this, Lifera aims to localize key priority molecules and develop the talent, infrastructure and commercial partnerships which address three out of four strategic themes of the National Biotech Strategy (NBS). This initiative gained momentum about a year ago, emphasizing the need to establish a robust infrastructure to address potential shortages and ensure the availability of specialized pharmaceuticals. As part of our mandate, we prioritize around 200 priority molecules essential for the national biopharma security agenda. This allows us to accommodate the manufacturing of various molecules and be responsive to specific product requirements within stipulated timelines, ensuring the timely availability of essential medications.

My appointment as chairman by the Public Investment Fund (PIF) signifies the challenging yet pivotal task of leading a startup company, backed by governmental resources, to fulfill the pharmaceutical needs of the Kingdom. Our mandate extends beyond mere production; we aim to be a catalyst for various healthcare initiatives, ensuring timely access to essential medications while navigating the complexities of the pharmaceutical landscape.

 

Could you elaborate on what sets Lifera apart as a new company and how it aims to serve as a catalyst for advancing the biopharmaceutical sector in the country?

Establishing a biopharmaceutical company like Lifera in a market such as Saudi Arabia demands patience and foresight from investors. It’s not merely about quickly entering the market; rather, it requires a technology transfer, intellectual property management, and collaboration with international manufacturers and biopharmaceutical companies. As a result, we need patient investors who are committed to the long-term success of the sector.

Lifera’s ambition lies in not only enabling the biopharmaceutical sector but also making a significant impact locally and beyond. We aim to expand our reach beyond the Saudi market to serve other adjacent markets, particularly within the Middle East. Our strategic vision encompasses a holistic approach to propelling the biopharmaceutical sector forward, ensuring sustainable growth and innovation while maintaining a focus on patient-centric healthcare solutions.

Lifera also aims to manufacture but also enable R&D in particular through developing at-scale genomics testing capacity to serve the needs of clinical, population health and pharmaceutical customers. The creation of Lifera Omics in Jan 2024 in partnership, and a partnership with Centogene, a global leader in rare disease genetic testing, is intended to enable precision health through omics, enabling a variety of innovative additions to the Saudi health ecosystem including clinical trials, cell and gene therapies, and R&D.

 

The vision for Saudi Arabia to become a regional biotech hub by 2030 and a global hub by 2040 is ambitious. Can you provide insights into the upcoming milestones and plans to achieve these goals?

The vision we have set forth is indeed ambitious, but it’s backed by tangible strategies and milestones. Over the past few years, we’ve made significant progress towards realizing this vision. One major milestone was our acquisition of Saudi Bio, positioning us as a major player in the biopharmaceutical landscape of the region. Additionally, we’ve announced plans to manufacture essential products like insulin in collaboration with international partners. Our focus on expanding our portfolio to cover multiple biopharma therapeutics, including vaccines and genetics, underscores our commitment to addressing diverse healthcare needs.

Partnerships, such as the one with Sanofi for localizing vaccines, further strengthen our capabilities. Moreover, our joint venture with Centogene for rare genetic disease testing not only enhances diagnostic capabilities but also lays the groundwork for future research and development endeavors. While these achievements are substantial, we recognize the need to scale up our efforts. Our focus extends beyond late-stage manufacturing; we aim to backward integrate our entire manufacturing line, starting with secondary packaging, to ensure quality and efficiency throughout the process. This approach will pave the way for further contributions to research and development in the biopharmaceutical sector.

 

You’ve highlighted the importance of healthcare resilience, particularly in light of the COVID-19 pandemic, and how it aligns with Lifera’s mission to contribute to national security. Could you elaborate on how this focus on resilience addresses the challenges of supply chain disruptions and product shortages, especially considering the global shift towards prioritizing local supply chains?

Healthcare resilience has become a paramount concern for governments worldwide, evident in the strategic shifts towards ensuring sovereignty across various industries, including healthcare. Lifera’s mission as a CDMO is intricately tied to this concept of resilience. By leveraging our capabilities to manufacture a diverse range of biomolecules within a single facility, we aim to contribute to the security of local supply chains, particularly during times of crisis such as the COVID-19 pandemic. The pandemic served as a stark reminder of the vulnerabilities inherent in global supply chains, leading governments to prioritize domestic production to address national and regional needs swiftly. Resilience, in this context, entails not only being responsive to government requirements but also ensuring timely access to essential medications and products when needed most. It’s a question of timing and readiness, factors that are central to our mission at Lifera.

 

In the context of Saudi Arabia, how would you define healthcare resilience and pharmaceutical resilience, and how do they intersect to ensure the population’s needs are met in a timely manner?

Healthcare resilience in Saudi Arabia is centered around addressing the population’s healthcare needs promptly and efficiently. Pharmaceutical resilience, as a subset of healthcare resilience, focuses on ensuring the availability of necessary medications when required, adhering to the principles of having the right medication at the right time, place, and price. Resilience, in this context, entails the ability to adapt our operational models to meet the evolving demands of the government and the healthcare sector.

This adaptability becomes crucial not only in responding to potential pandemics but also in addressing shifts in manufacturing priorities or changes in therapeutic focus. For instance, shortages of specific vaccines or medications can occur due to shifts in manufacturing focus, despite the presence of large pharmaceutical companies. In such cases, even countries representing a small percentage of the market may face significant shortages, highlighting the importance of pharmaceutical resilience in ensuring adequate supply to meet the specific needs of the population.

 

With the recent announcement of the National Biotech Strategy, which places significant emphasis on vaccine manufacturing and genomics, how does Lifera envision its strong contribution to these areas, aligning with the strategic direction outlined by the government?

The National Biotech Strategy unveiled by the government, with its focus on vaccine manufacturing and genomics, aligns seamlessly with Lifera’s strategic objectives. Positioned as a key player in the biopharmaceutical landscape, we foresee significant contributions to three out of the four pillars outlined in the strategy. Our role extends beyond mere enablement; it involves actively supporting and facilitating the realization of these pillars through strategic partnerships and initiatives. For instance, our collaboration with Sanofi to localize several vaccines crucial for the Kingdom’s vaccination requirements directly contributes to the first pillar of bio-manufacturing. Similarly, our efforts in insulin manufacturing, in partnership with Saudi Bio, align with the second pillar of bio-manufacturing localization. Furthermore, our joint venture with Centogene focusing on genomics underscores our commitment to advancing in this crucial area. These endeavors reflect our dedication to translating the government’s strategic vision into tangible outcomes, ensuring the availability of locally manufactured products to support the healthcare needs of the population.

 

Within less than a year, Lifera has secured three major deals spanning different models with diverse goals, but how does the company plan to address the need for skilled individuals in biomanufacturing and biotechnology to effectively execute its ambitious plans?

While our achievements in securing strategic partnerships are noteworthy, the cornerstone of our success lies in talent acquisition and development. Establishing a robust biomanufacturing and biotechnology ecosystem requires more than just infrastructure; it demands a skilled workforce. Recognizing this, Lifera has set out to train and nurture local talent, aiming to onboard 300 to 400 individuals in specialized areas such as biomanufacturing and genomics. Our partnerships with international entities in vaccine and insulin manufacturing will play a pivotal role in this talent development initiative. Additionally, our collaboration with Centogene to establish Lifera Omics underscores our commitment to building local capacity in genomics. While international expertise is valuable, we understand the importance of developing indigenous talent aligned with the government’s objective of fostering a skilled workforce in Saudi Arabia. Therefore, our efforts are geared towards striking a balance between leveraging international expertise and nurturing local talent, ensuring sustainable growth and innovation in the biopharmaceutical sector.

 

Establishing partnerships with international entities can indeed seem daunting given the vastness of the global landscape. Could you shed light on any specific approaches or strategies you employ to navigate this complexity and ensure effective collaboration?

We have a comprehensive plan to localize around 200 molecules, and this remains a key aspect of our strategy. Our ambition to collaborate with international partners will persist beyond the recent transaction we announced. We have a significant mandate to fulfill and a large number of products to localize. While we have already announced partnerships for certain products, our plan involves expanding our portfolio through continued collaboration with multiple international partners.

Navigating the global arena requires a strategic approach, especially when it comes to forming partnerships with international entities. One key aspect is ensuring that all parties involved have a vested interest, or as we say, “skin in the game.” At Lifera, we are deeply committed to realizing the objectives set forth by the government’s ambitious 2030 transformation plan. As part of this larger governmental movement, we understand that our actions are integral to contributing to the nation’s journey towards becoming a regional leader. Therefore, our approach to partnerships is not just about individual transactions but about aligning with the broader objectives and transformations underway within Saudi Arabia. By contextualizing our endeavors within the larger national agenda, we aim to foster meaningful collaborations that drive collective progress and impact. This approach ensures that Lifera remains a pivotal player in the global biopharmaceutical landscape while staying rooted in our commitment to Saudi Arabia’s vision for the future.

 

Given Lifera’s reliance on international partnerships, how does the company build trust with stakeholders and convince them to collaborate with a relatively new entity?

Establishing trust with international partners is pivotal for Lifera, especially as a new entity in the biopharmaceutical landscape. Central to this trust-building process is showcasing Saudi Arabia’s robust regulatory framework and stable oversight mechanisms. Our interactions with international manufacturers not only promote Lifera but also highlight the strength of the entire regulatory system in the country. With a stringent regulatory environment, clear processes, and government support, Saudi Arabia emerges as an attractive hub for investment and collaboration. Furthermore, the government’s emphasis on incentivizing localization and supporting both local and international entities instills confidence in stakeholders. Additionally, Saudi Arabia’s youthful population presents a unique opportunity, with a large pool of young talent available for training and development. With all the necessary infrastructure and resources in place, including tax incentives and supportive government policies, Lifera is poised to welcome international partners and embark on collaborative endeavors with confidence. It’s not merely about readiness but also about conveying this readiness to potential collaborators, inviting them to join us in shaping the future of biopharmaceuticals in Saudi Arabia.

 

Looking ahead to the next two to three years, what strategic priorities do you envision for Lifera?

My vision for the upcoming years is to propel the company upstream in manufacturing and therapeutic development. We aim to establish a comprehensive ecosystem that not only focuses on manufacturing but also encompasses research and development, pharmaceutical research, and localization of clinical trials. This entails forging partnerships that extend beyond commercial feasibility assessments to encompass opportunities both domestically and internationally. Our goal is to lay the groundwork for a platform that will drive innovation and agility in the pharmaceutical industry, leveraging the vast availability of data and transitioning towards a digitally enabled future. In line with the broader global shift towards the fifth Industrial Revolution, we recognize the need to embrace digital transformation and adapt our practices to meet the evolving needs of healthcare and pharmaceuticals. By capitalizing on the responsiveness of our regulatory framework and harnessing the potential of personalized medicine and targeted therapies, we are poised to lead the charge towards a more innovative and adaptive pharmaceutical landscape in Saudi Arabia and beyond.

 

Could you share some final thoughts or messages for our international audience regarding Lifera’s role in the future of healthcare and pharmaceuticals in Saudi Arabia?

As we draw to a close, it’s crucial to underscore the significance of fostering international collaboration and partnerships in shaping the landscape of healthcare and pharmaceuticals within Saudi Arabia. While Lifera stands as a significant player in this sector, we understand the profound impact that working alongside international manufacturers and innovators can have on propelling progress forward. Our vision transcends mere local service provision; we aspire to contribute meaningfully to the broader spectrum of humanity. Saudi Arabia’s ambitious Vision 2030 serves as a beacon of opportunity, providing an environment ripe for innovation and sustainable growth. In light of this, I extend a heartfelt invitation to the global community to join us in this transformative journey. Together, we can leverage the vast potential offered by Saudi Arabia’s vision to forge a brighter and more inclusive future for all.