Tackling the production and manufacturing challenges faced by emerging pharmas in Singapore: an interview with David Loong (Merck Life Science Singapore)
By Mei Chee Lim [1], Ph.D.; Philippe Koch [2] and Johannes Püllen [1]
David Loong’s job title captures his important role well: “Head of Emerging Biotech for Southeast Asia, Taiwan, and Oceania for process solutions at Merck Life Science Singapore.” In this role, he spearheads efforts to support emerging pharmaceuticals (EPs) in Singapore and beyond, facilitating access to expertise and resources essential for overcoming manufacturing and production challenges.
David offers insights into how established pharmaceuticals can bolster Singapore-based EPs, emphasizing the mutual benefits of their success. He explores the typical production and manufacturing hurdles EPs face, along with strategies to surmount them effectively.
Please note: The views expressed in this interview are solely those of David Loong and do not necessarily represent the opinions of Merck Life Science Singapore.
ZS: David, thank you for taking the time to speak to us. Could you introduce yourself and tell us about your current role?
David: I started my career in organic chemistry back in the early 2000s obtaining my Ph.D. in synthetic organic chemistry in Australia. From there, I spent some time in good manufacturing practice (GMP) active pharmaceutical ingredients (API) manufacturing in the UK and Singapore, followed by a seven year-stint in small molecule drug discovery.
Since 2016 I have joined startups in biotech for monoclonal antibodies (mAbs) and cell and gene therapies (CGTs), one of which became what is today, Hummingbird Bioscience. In 2020, I joined Merck Life Science and was later appointed Head of Emerging Biotech for Southeast Asia, Taiwan and Oceania for the process solutions business in 2023.
ZS: You spent many years in EPs. What inspired you to work in earlier-stage pharmaceuticals for such a long time?
David: At my core, I am a scientist dedicated to translating groundbreaking science into societal benefits. Initially, I was involved in hands-on research, now I help early-stage companies access the resources they need to advance biotechnology. I also strive to simplify complex scientific concepts, enabling informed business decisions that drive scientific progress and improve patient outcomes.
ZS: What prompted your transition from a role within an EP to joining an established one?
David: Working in startups is rewarding due to their dynamic environment and the chance to engage in all business aspects, offering extensive learning opportunities. Everyone must chip in when launching a venture, allowing me to learn about both business and science, including molecular biology, immunology and CGTs. These experiences helped develop the diverse skills that I leverage today.
Transitioning to established pharma introduced me to distinct, yet equally valuable experiences, including enhanced access to resources — albeit accompanied by more intricate controls and less autonomy. Navigating through structured processes and collaborating within diverse teams underscored the importance of collaboration in advancing from laboratory breakthroughs to clinical application, ultimately making the fruits of innovative science accessible to patients.
ZS: What are your key goals in your current role?
David: I help EPs access critical resources and solutions. Specifically, I connect them with expertise and resources needed for growth, such as production experts within Merck Life Science or external consultants in clinical development, quality assurance and facility design. This vital support helps small biotech startups scale up and progress.
We recognized that for an EP to succeed, it must be part of a healthy ecosystem and well-connected to make informed decisions about research and development (R&D), clinical development and production.
ZS: But why focus on EPs as a solutions provider? Why not only focus on providing solutions to established pharmaceuticals that have more resources to spend?
David: Nowadays, EPs are a crucial source of new and innovative therapies. This isn’t only intuitively true, but we also see it in our analysis of the molecule pipeline. Of all the molecules — including biologics and novel modalities — over 60% are owned by EPs, which is a lot. This isn’t only a global trend but is also reflected in Asia Pacific and Southeast Asia. Supporting EPs is essential to ensure that innovative treatments continue to be developed for unmet patient needs.
In addition to Merck’s R&D and analysis offerings, we provide expertise for scaling up production. This includes upstream production, optimizing titers, transitioning from shake flasks to bioreactors or even purifying over ten liters of harvest. Early-stage companies often overlook production needs while focusing on fundraising and clinical development. This is especially challenging for those working on CGT, messenger ribonucleic acid (mRNA) or other less established modalities, as finding outsourcing partners can be difficult.
ZS: Merck Life Science has established an impressive workplace for your partners in Singapore — the M Lab™ Collaboration Center. How did that come about?
David: Merck founded the M Lab™ Collaboration Center for all our customers back in 2018 when the biopharma industry was establishing itself in Singapore. At the time, there were little to no training facilities available, so the facility was created to enable all our customers and partners to be trained in an environment with all the utilities of a GMP facility, but without the typical restrictions and environmental control.
Today, we use this facility to host our customers — including EPs — and their teams to train them on our technologies, conduct troubleshooting and process development.
ZS: Thank you, David. Switching gears slightly, what’s your perspective about the current status of the Singaporean EP community?
David: The Singapore EP ecosystem is small, tightly knit and increasingly well-supported by the government, in terms of facilitating infrastructure and stabilizing the community. We see a lot of great science coming out from the research institutes, excellent work by the folks at SMART-NUS to teach venture building and enabling investments by the government, such as ACTRIS.
The community is getting stronger and better connected to resources such as venture capitals (VCs), accelerators, clinical development and contract services for R&D and production. These are essential to enable biotech startups to scale quickly and efficiently.
ZS: In a recent interview, Guy Heathers and Ritika Khetawat shared similar thoughts. We also heard that despite the amazing benefits and impressive science being developed, the Singaporean biopharmaceutical community is somewhat “underachieving”. Mostly due to the lack of experienced biotech investors and expertise in product development. What’s your perspective?
David: I agree. Having experienced biotech investors onboard is crucial to guide EPs and ensures small startup teams aren’t overwhelmed from reassuring and educating inexperienced investors. In Singapore, we’re also missing a critical component, which is the presence of, or at least strong regional ties to, contract developers and manufacturers. These are still in their infancy.
ZS: Based on your interactions with EPs in Singapore, what other critical needs and gaps do you see?
David: Much of it depends on the stage of the company. For example, finding lab space and shared services is essential for a newly created startup. As it matures, building the right team can be challenging, especially given the size of Singapore. Ultimately, when the time comes for planning clinical trials, it’s chaotic as a small team must navigate both clinical development and production supply.
Knowing what questions to ask, and being able to interpret the answers you get to inform business decisions, is invaluable, especially when breaking it down for investors. Most people are eager to help but understanding their perspective and their lived experience and then matching that to your circumstances is an art.
As I deal mainly in the space of production and manufacturing, I regularly get questions about chemistry, manufacturing and controls (CMC) strategy. For example, who would be good contract development and manufacturing organization (CDMO) partners? Or how would you evaluate a production partner? There’s often a lack of expertise in this area, and especially any decision regarding in-house versus CDMO manufacturing involves a lot of complexity that should not be underestimated.
ZS: CMC strategy is a broad topic with many nuances. What are you typically suggesting when asked about CMC strategy?
David: It’s a topic that could be a lecture series, and I would quickly exhaust my expertise within the first 20 minutes [comment from ZS: David is being too humble here; he could easily give a lecture series on this topic!]. In terms of strategy, instead of giving “advice” on the perfect strategy, I try to help companies think about the critical questions they need to answer in their specific situation.
Just as an example, at an early stage of development — such as during in vitro and animal studies, prior to your first-in-human trial — it’s important to know what your therapeutic agent is and if it’s a cell, how would you characterize it to know when you have the right cell populations with therapeutic value. Is it surface markers? What probes would you use and how consistent is their performance? Are your antibody reagents from monoclonal sources? How do you consistently assess morphology, and viability?
If it’s a nucleic acid nanoparticle, your characterization might be size distribution, electron microscopy and internal structure of the nanoparticle. What techniques would you use for this? For process development, for lot release?
How do all these measurements ultimately predict the safety and efficacy of your product in vivo, and in humans? This then impacts how you manufacture and purify your product, how to assure the quality of your product and the consistency of your process.
Some of those questions seem basic, but to me, a robust strategy starts with having a clear answer to those types of questions.
ZS: What do you see as key challenges for EPs in terms of production and manufacturing, and what are the potential solutions?
David: We live in exciting times for scientific advancements, with many promising developments in production and manufacturing, each presenting unique challenges. New therapeutic modalities show promising in vitro and in vivo results but often struggle to achieve commercial success due to production difficulties. Investing in in-house production and manufacturing capabilities is sometimes the only way to ensure a reliable supply of experimental drugs, particularly in CGTs.
What’s critical is that EPs must create an investment roadmap that includes detailing where, when, and how much to invest for production and manufacturing.
Production challenges are often modality-specific. For instance, within the realm of gene therapy, certain adeno-associated virus (AAV) serotypes may present fewer hurdles in manufacturing compared to others. Similarly, when it comes to mAbs, immunoglobulin G (IgG) isotypes have a more established manufacturing process compared to other antibody isotypes. Understanding these nuances is crucial for EPs as they develop their products in tandem with their production strategies.
Another challenge for early-stage EPs is deciding between in-house manufacturing versus leveraging CDMOs. This decision involves selecting the right partner and considering how funding affects the choice. While outsourcing can be beneficial, it has its challenges, for example different company cultures and perceptions on quality. In my opinion, for exotic molecular constructs like nanoparticles or specific cell types, investing in in-house manufacturing may be the best option to secure clinical supply.
ZS: Thanks David, maybe one last question to end things on: if you could make a wish to change one thing about the Singaporean EP ecosystem, what would that be?
DL: I would strengthen regional networks to enable efficient development. Most EPs are aiming to have their first clinical trial in the United States simply because the runway to commercialization is established there. Countries with large patient populations make it easier to do all development within one regulatory framework, one VC funding environment, with locally-based production — Singapore doesn’t have this luxury but can leverage its hub status to connect regionally to countries like Taiwan, Australia, and the rest of Southeast Asia. Combined, this region would have a functionally complete ecosystem.
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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.
About the authors
Mei Chee Lim, Ph.D.: Based in Singapore, Mei Chee supports her clients with go-to-market strategies, market landscape assessments and launch planning. Before joining ZS, Mei Chee completed her Ph.D. in oncology at Duke-NUS Medical School.
Philippe Koch: Based in Berlin, Philippe supports his clients on multiple topics including strategy and transformation, and performance management. Before joining ZS, Philippe was actively involved in the startup ecosystem of the Netherlands.
Johannes Püllen: Based in Singapore, Johannes supports his clients in Asia Pacific and Europe, across many topics, in several therapeutic areas, including rare diseases, neurodegenerative diseases, oncology and vaccines.
[1] ZS Associates Singapore
[2] ZS Associates Berlin
