Betty Li, managing director of PPC, a well-positioned leader in the APAC CRO landscape, speaks about the strategic significance of the group’s Taiwan affiliate and goes on to share her views on Taiwan’s increasingly attractive clinical trial landscape. Li concludes by explaining how Taiwan and PPC can be a top partner to biotechs both from the APAC region or those looking to enter Asia.
Please introduce yourself and your journey to PPC.
I entered into the field as a CRA [clinical research associate] for a company which at the time went by Quintiles. I believe I entered this industry at the right moment because at this time many clinical trials were moving to Asia. After seven years of experience and growth, I moved to a TaiGen Biotechnology where I gained an appreciation for the other side of development. Being a CRA in a CRO, you only see one side of the story and do not know where the drug came from and how it was created.
Afterwards, I moved back to the CRO sector with PPD where I started taking on more managerial roles. From then, I moved between different CROs – at one point having a brief career period in the biopharma side once again – where I took on many diverse challenges in organizations of different sizes, countries, and departments such as business development. This was a long journey took dedication, determination, and patience.
Now that you are at the steering wheel of PPC Taiwan, what have been your top priorities since taking on the role of managing director last May?
As a managing director, my first priority in PPC is of course to grow the business. I see PPC as being in a very unique position to serve our clients and help them bring products to the next level. This is not only through clinical research but through central laboratory and bioanalytic services from small to large molecules. Furthermore, with the increase in biologics and immunotherapies, we are focusing on enriching our capabilities to meet industry needs.
PPC also offers site management services focused on phase I and clinical pharmacology units. PPC has one clinical pharmacology unit here in Taiwan in collaboration with Mackay Memorial Hospital and an additional three sites in China. Additionally, PPC can perform bioavailability and bioequivalent studies, an area in which we specialized for over 20 years. Overall, PPC is able to offer our clients a total end-to-end solution.
As a midsized CRO, we have an added flexibility which allows us to work well with a range of clients from small biotechs to more mature biomedical players. PPC is made up of a dedicated team of experts who have the knowledge to navigate regulatory processes and design protocols for effective early phase trials and onwards. We are not just a CRO, but rather a dedicated partner who has the ability to cooperate in development step by step.
What is PPC’s primary client profile?
A majority of our clients are local pharma and biotech companies, particularly those focused on generic drugs. However, we also do work with global players particularly for conducting local phase I to IV trials in countries like Taiwan, Korea, and China. In the end, we understand that each client has a unique need so we are always willing to adapt for each project.
What is the strategic significance that the Taiwan affiliate has for PPC?
PPC was founded here in Taiwan, so many of the group’s procedures are developed within the affiliate. For example, when PPC was opening a lab in China many of the systems were modelled after the Taipei operations. Of course, each subsidiary is adapted to the local conditions of a market, but the general layout is crafted using Taiwan as a blueprint. Within the PPC Group, Taiwan acts as a think tank for the rest of the world.
Currently, we have over 150 employees in the Taiwan office. In Taiwan, we have many long-term relationships with clients, but the market is too small for them to only stay here. When it comes time for our clients to expand to markets like China or Korea they want to continue their partnership with PPC rather than find new CROs. Therefore, Taiwan also helps bring more business to our other locations as our biotech clients then venture into new markets. Although we are not the largest by size, we make an important contribution to PPC through our talent, know-how, and strategic location.
As an experienced clinical researcher who has spent time in markets across Asia like Singapore, China, and Korea, what is your assessment of Taiwan’s current clinical trial landscape?
Ten years ago, everyone in biotech wanted to get US R&D funding, however, we see today that the government has made an enormous effort in bolstering Taiwan’s biomedical sector. A lot of support is being given to the industry and the change is very evident within the previous ten years. More and more the infrastructure for biotech success is being built in Taiwan, but we are still not entirely mature yet. Taiwan has yet to deliver a groundbreaking new innovation, so this will have to change if the biotech companies here want to ever truly become a fully realized MNC.
However, I do believe Taiwan is embracing emerging technologies like cell therapies and precision medicine. Looking at the production of these therapies, it is very complicated and the cells must be kept alive for the entire process. For this reason, Taiwan could have an advantage in its small size. Transporting cell therapies across the island would be much simpler and manageable than other countries. Furthermore, if an ambitious company can plan the logistics well enough, perhaps they could even export their products to other markets in the region.
What are Taiwan’s unique strengths in attracting clinical trials?
Our talent in Taiwan is absolutely a major asset. Not only is the level of English very high in Taiwan, but all of the country’s health records are also in English as well. Taiwan’s regulations are also aligned with ICH guidelines as we are constantly striving to stay up to date to the highest international standards. Additionally, even though Taiwan may be small, we have a favourable population density compared to countries like Australia that have a very similar population size. It is easier to organize trials and bring in patients to study sites from all around the country.
Despite the ideologies and politics of Taiwan and China – do you see any opportunities which Taiwan can benefit from having China as a neighbour?
Yes, there is an opportunity that exists. For example, in 2016 the CFDA announced that clinical data from four Taiwanese hospitals can be used when applying for drug permits in China. This is an important change will give Taiwan a leg up in developing into an Asia-Pacific hub for pharmaceutical research and trials.
Today, biotechs need to think about their marketing strategy even before designing their clinical trial program. Historically, many biotech companies would go to the US or Europe for early-stage development and only come to Asia when they needed larger patient numbers for phase II and III trials. However, because of these changes in China which allow for the use of outside data, both the early stage and late stage development can be run from Taiwan. There is no need for Asian biotechs to go overseas for development where the cost is also significantly higher. Additionally, western countries can use Taiwan as a gateway to have easier access to the Chinese market, in addition to the rest of the world since here in Taiwan, we are certified by all of the highest regulatory bodies.
Even Japan is now accepting overseas data in the registration process. We have already entered into discussions with some Japanese companies regarding conducting clinical trials in Taiwan for the submission to the PMDA.
Overall, I would say that Taiwan’s clinical research environment is in the best moment it has ever been. In the operations sides, there are a large number of trials being conducted in Taiwan. Biotechs from APAC and also outside the region must begin to think more about their trial planning strategies. I believe that Taiwan and PPC are the key partners of choice to the industry.
What final message would you like to give about your further ambitions as managing director of PPC Taiwan?
My objective is to position PPC as the first-to-mind provider of phase I and II clinical trial services. From there I want to expand our reputation in the industry and someone who can also drive drug development through our strong bioequivalent offering.
On the personal side, PPC strong invests in its team. I want our employees to learn, grow, and gain experiences that will be with them through their career. I believe that PPC is a top CRO employer and anyone who is interested in the field or even wants to take their career to the next level can find a place with us.
