We brought together Anthony Davies (CEO and Founder), Katy Spink (COO & MP), Rob Allen (MP and GM of DHC Europe), and our newest ELT member, John Ng (GM of DHC Asia Pacific) to talk through DHC’s recent incorporation of the APAC office in Singapore, the experiences that led us here, the current APAC team, and how we plan to support clients in the region.
Q: Let’s kick things off with the most obvious question. DHC recently incorporated in Asia Pacific and opened an office in Singapore, headed up by John Ng. What is DHC’s rationale for setting up a footprint in Asia Pacific, and why now?
Anthony Davies: Back in June of 2018 I was invited on a UK trade mission to Japan and Korea, jointly organized by Phacilitate and the UK government. Our meetings—with both government and regulatory officials at PDMA (Japan’s regulatory agency) and MFDS (South Korea’s regulatory agency)—opened my eyes to something something I’d known but not considered quite so actively at the time, which is the range and pace of technical innovations in advanced therapies in the Asia Pacific region. I went back to the region again in 2019 and after an internal discussion and much research into growth patterns, we set an internal goal for DHC to have an office based in Asia Pacific in 2020.
We actually had an employee based in Singapore during that time period, but the pandemic upended everyone’s best laid plans and she returned home to the U.S. in 2020. We chose to table our internal goals of a new office until the timing seemed optimal again. We maintained a sense of urgency around effectively serving clients in the APAC region for obvious reasons: based on data published by the Alliance for Regenerative Medicine, the region is actually second only to North America in number of CGT development programs, and is growing at twice the rate of North America and Europe. Besides the two-year growth graph below, take a look at the first graph in this collection, Developers by Headquarter Region and Therapeutic Approach, or the second image in this grouping, Ongoing Clinical Trials by Phase and Region.)
We chose Singapore for our APAC headquarters in part due to its position as a large pharmaceutical manufacturing hub, with life sciences executives with prior experience working with companies in both the West and the East. It’s got a truly first-class healthcare system with cutting edge medicine; it’s simply one of the best healthcare systems in the world. Additionally, Singapore is a business-forward environment and is globally renowned for academic excellence and world class universities such as National University of Singapore (NUS) and Nanyang Technological University (NTU). It’s the right microcosm of innovation and business opportunity and allows us strategic access to supporting clients across the APAC region.
Q: Anthony and Katy...this question is for you: why did you choose John to lead this effort?
Katy Spink: We were searching for not just the right person with the right skill sets, but for the person who met our criteria to be naturally embedded in the APAC biotech ecosystem. This would ensure that our regional knowledge was as deep and accurate as possible and that we’d be positioned to take part actively and in person with clients in the East.
Anthony Davies: Right, we didn’t want to just send in an expat. We wanted someone who was Singaporean in the broadest sense of the word, and ideally bilingual, and John met all our criteria and more. He’s even worked extensively in the People’s Republic of China. He also had a significant tenure with Singapore-based Tessa Therapeutics, one of the most well-known CGT companies around. His candidacy was serendipitous, really.
Q: John, what made you choose to say yes to this opportunity?
John Ng: I have to say that this was one of the most rigorous interviews that I have gone through. In addition to Zoom interviews with the ELT and the board members, I had the opportunity to meet up face to face with the ELT and some other DHC employees during Phaciliate Europe in 2023. We spent several days together, getting to know each other better. My perception had always been that DHC was the best in the business and the go-to consultant firm for anyone working in CGT. My former company had used DHC services, and we were highly satisfied with their work and with the client-side interaction. Once I was able to spend a significant amount of time with the ELT, though, I came to understand precisely why the practice has been able to grow so rapidly. Beyond being very knowledgeable in CGT, the teamwork between the ELT was what impressed me the most. They treated each other as family and clearly had complete trust in each other. Based on my experience, I know that this is an uncommon working relationship to find but is much needed for the growth of a company.
Later I had an opportunity to join their DHC Principals’ training retreat, which allowed me to meet many of the principals and heads of departments here. If I can sum up my learnings from those two trips and multiple interviews I would say the takeaways are: great leadership, highly intellectual and driven employees, and a supportive board. This is the recipe for success in a company, which made it easy for me to say yes to joining DHC.
Q: John, you’ve brought with you two former colleagues from Tessa Therapeutics, Liying Guay and Deb Chen, both now DHC Senior Consultants. Tell us about them.
John Ng: Establishing the APAC office with the addition of Liying and Deb gives us the chance to build awareness of the DHC brand here in the APAC region as effectively as we’ve previously done elsewhere with DHC. Having three of us positioned locally allows us to focus on networking in the region and building our relationships face-to-face.
Liying has extensive CMC expertise spanning cell therapy as well as traditional biologics, from early stage through to commercial. She also has a lean Six Sigma certification. Deb has worked in both cell therapy and pure-play gene therapy and brings deep analytical experience for lot-release and biomarkers.
Both of them bring capabilities which would be helpful to many of the early biotechs looking to translate their research from academia to industry. When I was working with Deb at Tessa, she worked in the Analytical Science group. Similar to many biotechs, we needed to translate the manufacturing process and analytical methods from our academic partners. She developed and transferred many of our analytical methods to be used for our pivotal trial. After Tessa, she joined a gene therapy company where she led both process and analytical development. As for Liying, she headed up the PSAT (Process, Science and Technology) department, leading the CMC activities to translate our product from early-phase to the pivotal trial. She translated the open process from academia to a closed process for commercial manufacturing. She also developed the control strategies and batch records and completed the comparability and tech transfer to start the manufacturing for our in-house cGMP facility.
From my time working with them in Tessa I have experienced both of them as very collaborative, working closely to finalize the process and analytical methods. They thrive well in a start-up environment where we know that the field is actively growing: they are both able to find creative solutions for our challenges. The addition of both Liying and Deb brings very complementary capabilities to our APAC office, enabling us to best serve our clients.
Q: What are the most common client requests DHC has previously completed or anticipates being requested in the APAC region?
Katy Spink: Our most common client asks thus far (on behalf of APAC-domiciled companies) has been in supporting their expansion to the west. For example, we have authored and advised on preparation of U.S. regulatory packages (INTERACT, pre-IND, IND) for many clients looking to expand into the U.S., and even offer an option to be the U.S.-based agent for clients’ interactions with the FDA. Our unmatched understanding of how to put together a regulatory package for a CGT product for submission to FDA or EMA has been an easy fit for many clients. To give a sense of the degree to which our regulatory support makes a difference, more than half of the BLAs approved in 2023 were supported by DHC. Since 2021 we’ve supported more than 70 INTERACTs and pre-INDs, more than 65 INDs and CTSs, and more than 20 BLAs/MAAs. I would anticipate continued growth here.
Rob Allen: I would second that the intercontinental movement in regulatory remains a strong suit—we’ve supported clients in filings in all the jurisdictions you’d expect for CGT products, including, for example, Canada, Australia, and Japan in addition to the U.S., Europe, and the UK. Being the only global consultant practice focused on CGT requires a wide range of regulatory understanding, not just in understanding the workings of each agency but in how they interrelate. Our collective knowledge helps us recommend strategies to structure growth for maximizing potential opportunities internationally. There’s a high degree of nuance involved in understanding regulatory jurisdiction differences. And now, with boots on the ground in the East, we’ll be positioned to help that many more clients.
John Ng: The next steps I’ll be looking at are how to best support APAC-domiciled companies within APAC markets. The movement between markets can be intensely complicated but we already have so much collective experience in those areas that I’m able to harness that collective DHC knowledge as needed. There will be so many choices for clients: when to prioritize taking best advantage of one’s local market and jurisdiction and then when to take advantage of the opportunity to expand east to west or west to east.
Anthony Davies: Let’s not forget that so many challenges our clients face and requests that we support are not even geography-specific—they’re nearly universal. For example, what are the right analytic methods to characterize your product? How best does one address manufacturing and supply chain concerns? All of the same challenges we’ve helped our North American and European clients solve for are also applicable to our APAC clients. All twelve of our core capability areas (listed here) apply regardless of location. That said, this opportunity to be embedded in the APAC region and therefore more easily meet with regional clients face-to-face outside of the conference circuit is going to be a huge opportunity for us.
Q: Are there particular challenges you’ve seen western clients have in moving east or vice versa?
John Ng: For companies looking to move east or vice versa, it is daunting as there are different regulatory requirements that are specific to their country. As an example for China: there are restrictions on the export of genetic material which would be challenging for western biotechs who might be looking to utilize a Chinese CDMO for their U.S. Clinical trials. For companies that are in APAC looking to conduct clinical trials in the U.S. or EU, there are challenges in interactions with the regulatory bodies and determining where to manufacture the drug products. This is where we can be helpful in helping them to finalize their strategy and assist in the implementation. Furthermore, anytime manufacturing locations change there are a host of needs (CDMO selection, tech transfer, quality audits and assessments, etc.) that apply. Those needs might feel overwhelming to a client who hasn’t experienced them before, but that’s where DHC’s expertise comes in. We’re able to take a complicated set of variables and distill them down into the necessary steps and order of operations to maximize the possibilities of success.
Rob Allen: And specific manufacturing requirements change from jurisdiction to jurisdiction, not just in an east->west or west->east crossover. For example, EMA will want redundant/backup filtration for bulk production, but that isn’t currently a requirement elsewhere. The range of issues to consider (and jurisdictional nuances in regulatory requirements and expectation) can be daunting for anyone newer to CGT or who might be considering entering CGT from traditional biologics or small molecules, but that’s where it really matters to use a consultancy whose experience is deep and multi-faceted. We like to talk about our clients having access to the entire stable of talent because everyone at DHC works together to maximize success for the client. We’re prepared to interact effectively with companies who are branching out globally as well as those with an interest in remaining more local.
Q: What do you anticipate will be the greatest need in the APAC region in the short term?
Katy Spink: Well, first it’s important to note, as Anthony did earlier, that biology and engineering are not geography-specific and methods for establishing robust and reproducible manufacturing process don’t depend on where you’re domiciled. And since we’ve been a globally- and CGT-focused consulting company for ten years now, we’ve got an extraordinary depth of experience that goes beyond even the experience our staff brought with them when they joined. We’ve worked with over 375 clients on over 750 projects thus far. There just isn’t anyone else out there who can compete with us in terms of depth and breadth of experience or, I’d wager, with success rates in helping clients achieve their goals. So, beyond the regulatory support and CDMO selection offerings we discussed earlier, I think many of the more technical support services that we see a lot of demand for among our North American and European clients (for example, process development planning, analytical development, risk assessment, process trending and root cause analysis) will also prove highly valuable to APAC-based clients.
John Ng: I’d add that we’re likely to see a large proportion of APAC-based requests taking place in the earlier stages of development. That’s where many of our local companies are in the development process, and there are quite a few others being spun off from academia. Furthermore, the pace of innovation is not currently the same as that of the U.S. Many of our companies here are currently focused on cell therapies, with fewer developing gene-modified cell products or pure-play gene products just yet. In many ways, Asia Pacific is currently in a similar place along the development timeframe as North American/European clients were several years ago, so the step to take to bring products through those earlier development stages on towards commercialization is exactly what we’ve done for many clients elsewhere. There is one interestingly different challenge relative to North America or Europe, though, which is that we’re facing a relative talent shortage here in APAC for CGT. We simply have fewer experienced CGT executives because the previous bio-pharma experience was focused on biologics and small molecules. It’s yet another reason why we think there’s tremendous opportunity for DHC to support the development of CGT products in the region.
Rob Allen: Which is a good reminder of the way we scale our offerings up or down (and bring in specific expertise) depending on client need and who is available in-house for any given client.
Katy Spink: Yes, it’s common for us to be hired by start-ups or younger companies who are in the process of assembling their full team but need deep expertise in place to keep development moving forward before they can hire full-time for that same expertise. Or to be brought in during a leadership transition when a key employee has left a client and they are looking to backfill that function while they hire a replacement. We refer to that service offering as interim functional leadership. In contrast, for clients with fully established teams, we may be brought in more on a specific project basis when they have need for our greater breadth and depth of experience, or when specific projects like authoring regulatory filings or developing a QMS challenge their internal bandwidth.
Anthony Davies: When I founded DHC in 2014, CMC was our primary focus and we’ve remained a CMC powerhouse. We branched out very quickly and effectively, but CMC is the kernel of nearly everything we do because it’s the center of most client needs. Nearly everything ties back to CMC development and how important it is to get things right at an early stage: nonclinical is impacted by manufacturing and analytical strategy and of course it all comes together with regulatory strategy. It won’t surprise my colleagues that I’m thinking of that evergreen Scott Gottlieb quote from May of 2018. I was there when he was speaking to ARM’s annual board meeting at that time and he said something that has aged very well because it’s so accurate: He said: “In contrast to traditional drug review, where 80 percent of the review is focused on the clinical portion of that process, and maybe 20 percent is focused on the product issues, I’d say that this general principal is almost completely inverted when it comes to cell and gene therapy.” To simplify it further, I’d say: “Without a deep CMC focus, CGT doesn’t move forward.”
Rob Allen: I’d be remiss if I didn’t mention that we’re putting together a “top-ten” piece addressing the top-ten things that can trip up a CGT company early in the process. We’re planning to email out this list in the next month or two. If you’d like to receive those insights, join our email list here.
Q: Most of our conversation thus far has been about therapeutic developers, but they’re not the only types of clients DHC works with.
Katy Spink: Right, we typically consider our clientele to be divided into three main buckets: therapeutic development, tools/tech/services (which can include CDMO/CROs), and investors. As you would imagine, investor interest in the APAC region is growing with respect to the growth of development in the area, and anytime you have a therapeutic product development need, there are tools/tech/services to accompany those. A good way to see samples of our work in the other areas is to review the case study library and search by client-type. For example, this link will take you to case studies that touch on tools/tech/services and this link will pre-sort the library into case studies about investment clients.
Q: What action should potentially interested clients take in getting to know Dark Horse?
John Ng: Besides Rob’s suggestion to join our email list, I’d say that we have plans to travel widely throughout the region: reach out on email or come catch up with us in person. DHC is attending three APAC-based conferences this year: we just recently attended CGT Asia in Shanghai. We’re also attending IMAPAC in Singapore in September and BioJapan in October in Yokohama. I have a personal goal to meet as many current or potential clients face-to-face as I can during these first years of my tenure with DHC. Please feel free to reach out to me directly at jng@darkhorseconsultinggroup.com. You can also write to the business development team at any time (bdteam@darkhorseconsultinggroup.com) to ask any questions you may have or get help reaching out to the right people.
Rob Allen: I’d also recommend attending our Unbridled Excellence webinars. We began them last year in order to pass along lessons learned from ten years of client work in CGT, whether that be early workforce development, various regulatory frameworks, operational challenges, product development, investment cycles…you name it. These webinars are a chance for anyone interested to dig in a little deeper into a particular area. This page archives those we have completed to date and will also keep you current on forthcoming episodes. We have approximately eight more slated for this year and I’m sure there will be even more to cover with each passing year.
Q: Lastly, John, would you please speak to the location of the Singapore office?
John Ng: It’s in the Metropolis, strategically located within 5 minutes of A*STAR, the Agency for Science, Technology and Research for Singapore. Many Singapore biotechs are also located within 10 minutes of the Metropolis, enabling us to service them better. For overseas visitors, know that the Metropolis is just 40 minutes away from Changi Airport. We want to make it as easy as possible for us to get to speak face-to-face with potential or current clients.
