Ling Su: I’m Ling Su. I’m currently a venture partner in LAV (Lily Asia Ventures), where I support evaluation and post-investment management of our biotech portfolio companies. I’m also the Chief Development Officer in Skyline Therapeutics, a clinical-stage gene therapy biotech company.

DIA: How did you come into these roles?

LS: I’ve worked in regulatory agencies, followed by more than 16 years in multinational pharmaceutical companies. I started to have interest in broader work settings, including consulting, teaching, and advising, and then opportunities came up in venture investment and biotech companies. I’m doing jobs of a similar nature, just in different settings. I consider myself a drug developer.

DIA: Please tell us a little more: Which regulatory agencies, for how long, and in what roles?

LS: I started my career in the Chinese Ministry of Health, Bureau of Drugs, which was the predecessor of today’s NMPA, the National Medical Products Administration, in the late 1980s in China. I also had a brief experience in the US FDA in my early time in the US in the 1990s, as a visiting scientist in a few divisions in CDER.

DIA: What was it like to work in the Chinese agency, the predecessor of the NMPA, in the 1980s, compared to today?

LS: That was very different. At that time, the agency was a very small regulatory body within the Ministry of Health. And at that time, there were no innovative new drugs being developed or even brought into China by foreign companies, and there were many generic companies. By the mid-1980s, the first Drug Administration Law was introduced and started the modern era of drug regulation in China. I was there to witness that early beginning of this new era. When the regulatory reform started in 2015, I can relate it to the change started 40-some years ago, and it’s a fascinating journey to see the Chinese regulatory agency grow from a regulatory system that’s kind of outdated into today’s global regulatory and global drug development environment. It has changed so much. For example, the agency is a member of ICH and has moved rapidly into a more modern drug regulatory system.

DIA: What was the impetus for the Chinese agency to evolve into something very different today, compared to what it was 40 years ago?

LS: I think there are multiple reasons. One is that the way a drug is developed has changed fundamentally and dramatically, from 40 years ago to today. At that time, it was more region-specific and there was not much globalization in drug development. Today, globalization of drug development and clinical research is the norm, so the regulatory agency must adapt to this change. They must have the regulations, processes, paradigms, and the expertise or human resources available to embrace this change.

The second is that the economy in China has developed from the 1980s to today. It’s a totally different kind of country and economy, more closely integrated into the global economy and with new drug development technologies. The agency must adapt to this new environment and to a new global regulatory system as well.

DIA: What did you do when you worked in the pharmaceutical industry?

LS: I spent about 16 years in the pharmaceutical industry, with multinational companies. I started as an epidemiologist in Merck. Several years later, I worked in the medical department, responsible for drug regulation, regulatory affairs, and clinical research for MSD (Merck Sharp & Dohme) China. I then joined a couple of other companies in the clinical research and regulatory areas, including VP for clinical research for the Asia Pacific region in Wyeth and as SVP and head of drug development for Greater China Region in Novartis. So, mostly in regulatory and clinical development as part of a global team to develop drugs for the global market but with a particular focus on Asia and China.

DIA: How did you first become involved with, and what initially attracted you to, DIA?

LS: I got to know the name and organization of DIA in 1994, when I was a post-graduate PhD student, and I presented a poster at the DIA 1994 Annual Meeting. I was very impressed by the broad and rich content of the DIA meeting in its multidisciplinary way, and because I was very much into regulatory affairs and drug development, I thought that this is a very good organization for me to attach to and to meet more people in.

DIA: Were you a PhD student in China or in the US?

LS: I was attending the University of North Carolina at Chapel Hill.

DIA: Could you please describe your journey from presenting a student poster at the DIA Annual Meeting to becoming involved in DIA through various roles? It will be quite inspiring for other young professionals.

LS: I got my PhD in 1996 and joined MSD in the US. My boss was Dr. Harry Guess, who was also my PhD dissertation adviser, and one of the world’s most well-known pharmacoepidemiologists. Harry was DIA president in 1992 and had been very much involved in DIA.

In 1996, DIA was discussing a meeting in Asia. Harry knew my background and experience in China, so he recommended me to the DIA Executive Director. We met and found this to be a very interesting and valuable idea, so we started to explore the possibility of DIA meetings in China and then in the Asia region. I became a member of the DIA international steering committee and then started to work with my former colleagues in the Chinese regulatory agency. We organized the first DIA meeting in China, focused on clinical drug development and the application of biostatistics, in 1997. To my knowledge, this was one of the first if not the first international conference talking about biostatistics in drug development in China. There was no discussion of applying biostatistics in early drug development in China at that time.

We held another meeting in 1999—again, very much myself with colleagues in China from industry and the agency. We introduced the topic of GCP in 1999, and in 2002 we had another meeting in Shanghai on regional drug development in the Asia Pacific. In 2003, we had another meeting on drug CMC (Chemistry, Manufacturing, and Controls) testing and quality control. In 2004, we held a big conference on the theme of Multi-Regional Clinical Trials, MRCTs.

You can see that these were quite forward-looking topics, at least for a Chinese audience at that time. That’s always been my belief: If we are going to organize this type of conference in China, particularly from a well-known organization such as DIA, we must bring forward innovative new ideas, new content, and experienced insightful speakers into China. This supports industry, the regulators, and drug development in the region through this growth.

DIA: You were an early champion for DIA’s involvement in China. Was it a steep curve to persuade DIA to become more involved in China or to persuade people to go to DIA meetings in China?

LS: For the China-based audience, these are great opportunities. It’s like opening the door to the outside world because we brought in a lot of very experienced and insightful speakers and they presented what’s happening in the global drug development and regulatory world outside China. I think that’s very welcome. DIA at that time became sort of a brand name for this type of information. DIA provided a lot of support to these kinds of meetings. It’s not about generating revenue, it’s kind of providing the thought process, but DIA has been very supportive of this.

I also see the need for the audience outside China to become more familiar with what’s happening in China, to be aware of specific issues or circumstances they need to understand better about drug development and regulation in China. So, almost every year I help organize the China delegation (including regulators, industry people, academic clinicians, and clinical trial principal investigators and researchers) from China to the DIA Annual Meeting. That gradually became today’s DIA Annual Meeting NMPA Town Hall or China Town Hall. This is very important because we really need two-way communications.

DIA: The DIA China Annual Meeting, even with the pandemic interruption, has still become quite a large event?

LS: Yes, that’s true; several thousand attendees including exhibitors and speakers. It is one of the major events in China dedicated to drug development and drug regulation. That’s one of the things that I’m quite proud of: I organized a group of people to evaluate the possibility of this event, then, with DIA staff’s support, we set it up, and now look at the size and scale and depth of today’s event.

We started with a five-person organizing group. We did a feasibility assessment to see how quickly we could get this set up and grow. In 2008, I proposed a plan to the board and the board decided to act on it. Then I led the group of 20+ people who formed the Provisional Advisory Council of China, or pACC: I invited all the R&D heads from multinational companies and CROs in China and included the CCFDIE (China Center for Food and Drug International Exchange), which is the branch of the Chinese regulatory agency that deals with external collaboration. We had agencies, industry people, and a few people from academia.

This group of very enthusiastic and active people, working as volunteers, started to run the pACC across various fronts: What should we do immediately? What “quick wins” will help get things moving, up and running? How do we organize DIA to set foot and develop in China from a strategic perspective? How about membership? How about revenue?

You may be interested in knowing that it was all multinational companies. Back in 2008, local industry in China was mostly focused on generics. There was little new drug innovation or innovative drug research and development, so there was no interest from local industry to be part of this. We have seen this dramatic change: Local companies are almost as active as multinational companies in China today.

The first DIA meeting (workshop) on statistics was held in May 2009, the year after we started this activity, followed by the first DIA China Annual Meeting in November 2009, which started with about 400 people; now it’s over 4,000 people plus exhibitors or speakers, so that has been quite excellent progress. DIA has become a brand name in China as “the go-to resource” for drug development and regulation. The DIA office in China has wonderful staff organizing all these activities, and others. DIA Communities are also very active in China and have a very good track record in developing white papers and other community events beyond the Annual Meeting.

DIA: It took a leader of your vision, energy, and dedication to leverage the fertile ground that obviously existed in China with DIA’s capability to go to China and deliver offerings that were of interest to professionals in China. But that’s not all you did. Please continue to walk us through your journey.

LS: That’s been a joint effort by many people, many volunteers. The other thing is the DIA Asia region. In 2007, the year before all the DIA China activity, Dr. Hironobu Saito (of Daiichi Sankyo) and I began discussing a DIA Japan meeting on Drug Development in Asia, a meeting in Japan but focused on regional, Asian drug development. We co-chaired that first meeting. We brought people from China, Korea, Singapore, and all other countries or regions in Asia Pacific together to discuss regional and global drug development and regulation, biostatistics, and other issues. This evolved into today’s DIA Asia Annual Meeting, which is now held in different countries. It’s quite challenging to organize this kind of regional meeting because the discussion topics can easily overlap with topics at other meetings like the DIA China or DIA Japan Annual Meetings. You need to develop a conference agenda that draws enough interest from other countries but doesn’t overlap too much with what has been discussed in the host country. It’s quite challenging. It also requires committee members from different countries to collaborate in a way that will meet everyone’s needs. It has been a very interesting experience, and we do see this DIA Asia meeting continuing to grow. We have enthusiastic volunteers from different countries who have become a core of DIA members and volunteers, and that certainly helped with all these activities and with further expansion into other areas, if that time comes.

DIA: What other roles have you played at DIA?

LS: I had the honor to become a Board Member in 2008 and served two terms on the Board from 2008 to 2014, certainly a rich experience for me. It was valuable because that was my first time as a board member in an international organization. Before that, I was typically involved in a company’s business and organization. But the DIA Board required a different skill set of communication, interaction, and dealing with different kinds of cultural issues as well as business issues. And not business like the company P&L or managing a department budget, but as a nonprofit organization: a very different setting in different contexts.

I was elected as President (now called the Chair) of the Board in 2011, so I served one year as President-elect, then President, and then as immediate Past President. Working with other board members and the DIA staff gave me a very rich experience, and I learned a lot from this activity. You can really show responsibility and leadership in this organization. Then I became a Fellow of DIA, a new thing for DIA, as a member of the inaugural class in 2014. One thing I really enjoy is mentoring, and I signed up for the Fellows Mentoring Program. We went through the first round in one-to-one mentoring, and now the second round is Mentoring Circles through the Fellows. I really enjoyed it.

Last but hardly least, I’m also a member of the DIA Science and Policy Advisory Council that was started several years back. This is also a very important space where DIA needs to invest resources and advocacy. Change is constant and rapid in many ways—technology, regulation, etc.—so it’s very important for DIA to have a good grasp of not only short-term upcoming trends but also prepare for mid- to long-term changes or opportunities.

DIA: You have been involved with DIA for so long. Have you found any changes in DIA particularly noteworthy or even inspiring?

LS: The most obvious is that DIA used to be considered “just” a meeting organizer and convener. You could get content on a CD after the meeting, but it was sort of raw material, if you will, and DIA was just the meeting convener. Over the last several years, DIA has started to transform from this kind of event organizer to a content generator, a content developer. DIA works with other industry or nonprofit organizations to collaboratively develop position papers or consensus papers. The world is constantly changing in drug development and drug regulation. With new technologies and new paradigms, it is ever changing. Our mutual platform for discussion, to gather different people to share their thoughts and insight, is still very important. But we need to go beyond that, and I notice that change. People may not only go to a meeting once or twice a year; they want to hear from their peers and experts constantly. DIA meets this need through multiple publications like Therapeutic Innovation and Regulatory Science and Global Forum, for example, and in other ways.

DIA: Are there any specific areas that DIA could serve particularly well as a thought leader?

LS: DIA historically is very strong in clinical development, GCP, biostatistics, to name a few. We also have very strong insight into regulatory science that encompasses many subareas. It’s a balance between working on our strengths but with a forward-looking attitude to develop expertise in emerging areas. For example, AI is a very important area. But everybody may have a different definition of AI and how it may be applied in drug development and regulation. It could be at an operational level or at a strategic level. We need to keep an eye on those things.

DIA: Is there any specific aspect of DIA’s history in the last 60 years that you find to be particularly worthy of recognition or celebration in this anniversary year?

LS: One is globalization. DIA is truly a global organization with representation in different parts of the world, not just offices, but people as part of this organization, as members or active volunteers. DIA has grown into a global footprint. Second, DIA is now a partner with many important stakeholders in drug development. Bringing a drug to market to benefit patients is part of the DIA mission. DIA is also very good partners with patient organizations; for example, our last several DIA Annual Meetings have been designated as Patients Included events. This will become even more important moving forward.

DIA: Drug development ultimately must benefit patients and patients must have affordable access to medicines they need. Do you think DIA can or should play a role in bringing in the payer or insurer community into these conversations?

LS: Yes, I think we will see that health technology assessment (HTA), payers, regulators, and drug developers will be more integrated or entwined together. We see consideration of access issues in the course of drug development.

Listen to Ling’s closing message to DIA members for the next 60 years from his Q&A with Global Forum Editor-in-Chief Alberto Grignolo below.