How to drive innovation in times of uncertainty: An interview with Priya Nagarajan, Bayer, global cell and gene therapy intelligence lead
By: Mei Chee Lim, Ph.D. and Johannes Püllen — ZS Singapore
Throughout her career, Priya Nagarajan kept her focus on what mattered to her: Making a difference in patients’ lives. We talked to Priya about the role of emerging pharmaceutical companies in bringing treatment innovations, especially in the area of cell and gene therapies (CGT), the challenges that many of these companies face when developing CGTs, and what can be done to mitigate the concerning trend of these emerging companies discontinuing operations due to lack of investment.
Please note: The views expressed in this interview are solely those of Priya Nagarajan and don’t represent the opinions of Bayer.
ZS: Hello Priya, thank you for taking the time to speak to us. Could you please tell us more about your background and current role?
PN: After completing my studies in biochemistry and molecular biology, I began my career as a bench scientist at Amgen, in California. I spent the next 11 years taking on various roles in research and development (R&D), manufacturing operations, sales force effectiveness (SFE) and business intelligence. I moved to Singapore and joined the AbbVie marketing team in 2012, eventually becoming the biosimilar defense strategy lead for the Asia Pacific region. After three rewarding years, I was offered an opportunity to return to Amgen, this time in Hong Kong, as the regional lead of business intelligence and commercial excellence.
In 2017 I joined Bayer in Singapore, starting in a strategy role before transitioning to customer and business insights. For the past two years, I have been the CGT intelligence lead in the data science and customer insights function. In this role, I act as an internal consultant to the commercial team, providing strategic inputs for critical decision-making. I also oversee primary and secondary research and competitive intelligence related to CGT. My key objective is to provide our senior leadership with actionable market insights so that they can make informed business decisions with respect to our CGT pipeline and portfolio.
ZS: This is an impressive journey, spanning more than two decades. What keeps you motivated about the pharma sector?
PN: Patients! Developing effective therapies for patients in need is what motivates and drives me. I believe that it’s important to bring back the “human perspective” to the conversation about CGTs. We often tend to get lost in the science and strategy, thereby losing focus on what should be front and center — the patients and their needs.
ZS: You mentioned this point during your presentation in October 2023, when you were a speaker at the ZS cell & gene therapy and emerging pharma connect. As the title of your session, you chose “How to continue driving innovation in a time of uncertainty?” Why did you choose this title?
PN: I wanted to highlight significant hurdles in the CGT space, while also emphasizing the importance of driving innovation in this promising area, despite the challenges.
Given the number of CGTs in development and the impact we have seen that they can have, I sometimes wonder why more therapies don’t reach the patients. Sadly, many CGT startups seem to struggle, even those showing promising scientific progress. There’s been a spike in biotech bankruptcies in recent year, peaking in 2023 and coupled with large layoffs. This troubling trend is likely due to inadequate funding, exacerbated by economic challenges that have made investors more cautious. The high-risk, high-reward nature of CGTs requires significant upfront investment and long development timelines, which are difficult for early-stage startups to manage. Consequently, this funding hurdle has likely delayed the development of innovative therapies. Even though not all companies would have succeeded in bringing breakthrough treatments to the clinic, their efforts are crucial for advancing the field.
The folding up of CGT startups due to a lack of funding highlights the need for a more robust and sustainable financing ecosystem to support this rapidly evolving field. Increased collaboration between industry, investors and policymakers will be crucial in ensuring that the most promising CGT innovations can navigate the challenging path to commercialization and reach the patients who are in need.
ZS: Besides the funding-related challenges, what other challenges do you think are critical in the CGT field?
PN: The funding-related challenges are critical, but there are other challenges for CGT companies as well, given the complex scientific nature of many potential therapies. To name a few, emerging CGT companies have to navigate the fact that the time to market is often substantially longer or delayed due to factors out of their control — such as scientific innovations of their treatments requiring adjustments to trials to meet regulatory or access specifications — which eventually leads to a longer time for investors to see returns on their investments.
Additionally, the investment costs of CGTs are usually high throughout the entire development process, even for an industry such as ours, which is used to high investment costs. What doesn’t help is that financing costs have gone up overall, making it much more expensive for companies to operate. The high costs of therapies in turn result in complex and extensive value and access processes These high costs also make it challenging to scale up quickly and achieve broad market coverage.
Furthermore, patient populations available for CGT trials in rare diseases can be small and hard to identify.
Then there’s a concern around the durability of those expensive CGTs — how long will a treatment that comes with a high price tag last in terms of efficacy? Given the relatively short time that CGTs have been available, there’s a lack of long-term data to better understand durability and long-term safety.
Recently, there’s been an increasing trend of accelerated approvals of CGTs by the United States Food and Drugs Administration (FDA), provided there are promising results to date and strong patient unmet needs, demonstrating an opportunity to obtain approval even when primary endpoints are not met. An example is Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) gene therapy, Elevidys. Initially approved in 2023 for a restricted patient group, Elevidys later received expanded approval for all DMD patients over 4 years old, despite missing its primary endpoint in a pivotal study. This case highlights the FDA’s flexible approach to approving CGTs under priority review when there is a significant unmet medical need.
Additionally, there’s a strong need for increased harmonization in regulatory processes for CGTs globally. This will increase the feasibility for companies to bring their CGTs to patients.
ZS: You mentioned many substantial challenges, which leads to the question of what companies can do to overcome them.
PN: Not all challenges mentioned previously can be solved by CGT companies alone. Adopting pragmatic approaches that leverage strategic partnerships and innovative study designs could be ways to overcome the challenges. Other pathways could include collaborating with academic institutions and leveraging investigator-initiated studies for evidence generation. Companies need to closely collaborate with regulatory bodies, build strong data packages in close coordination with regulators and leverage expedited approval pathways wherever possible. It’s also important to note that traditional pharma models may not completely apply to CGTs. Therefore, companies need to consider innovative commercial models — for example outcome-based pricing, innovative patient support programs and innovative supply chain solutions where possible.
Additionally, it seems that there’s an opportunity to leverage digital technologies and AI for areas like patient recruitment, remote monitoring and data analytics to enhance efficiency and patient engagement, which can help reduce operational costs.
Importantly, it’s crucial for CGT companies to keep patients in mind — in the early stages of development, ensuring that their needs and perspectives are integrated into the development process. Close collaboration with patient groups will help companies better understand unmet needs, design more patient-centric trials from the start and improve access.
ZS: Switching gears: What’s your perspective about the current status of the Singaporean CGT community?
PN: There’s a lot of promising science happening in Singapore, which is great. However, awareness of the unique requirements for commercializing CGTs is still limited. CGTs have specific needs in terms of capabilities and infrastructure within the healthcare system, which can be challenging.
While recent global CGT conferences in Singapore have been dominated by presentations from academic labs that showcased excellent science, there’s been a lack of industry participation. This gap between the lab and the clinic is a concern, as those developing therapies need to keep the end goal of commercialization in mind. Startups should focus early on scalability and commercialization strategies to attract investors, given the declining funding appetite discussed earlier. Bridging this gap and ensuring the successful commercialization of innovative therapies calls for collaboration between academia, industry, and the healthcare system.
ZS: From your perspective, what do you see as critical trends impacting the local CGT community?
PN: The local CGT community is facing a dynamic environment, shaped by various global trends. We already discussed funding as a critical factor, Mergers and acquisitions (M&A) activities are shaping the ecosystem, as larger players seek to acquire innovative technologies and talent. Advancements in scientific and technological capabilities are enabling new frontiers in CGTs, pushing the boundaries of what is possible. These multifaceted trends are collectively influencing the local CGT community.
ZS: One last question: If you could make a wish to change one thing about the Singaporean CGT ecosystem, what would that be?
PN: I would like to see the great therapies currently being developed in the lab reach the patients who are eagerly waiting for them. We need more people with commercial expertise to support companies navigate the journey from the lab to the bedside while ensuring that the fruits of all the great scientific work done here in Singapore can benefit patients at home and beyond. By bridging the gap between the laboratory and the patient, we can maximize the impact of the great work being done by our researchers and unlock the full potential of these groundbreaking products. I’m optimistic about the huge impact these incredible scientific innovations will have on patients.
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Our ZS@SG_EmergingPharma team can support you with fundraising preparation, product target or asset identification and valuation and business strategy — including buy versus build, portfolio, pipeline and launch. Please feel free to reach out to learn more: johannes.puellen@zs.com or meichee.lim@zs.com.
This article reflects my personal views. They do not necessarily represent any official position of ZS.
