Asian Biotech: Experts Talk Regulation, Infrastructure, Funding & Talent Gaps

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Asia has experienced a biotech boom in the past five years. In 2020, almost 50 percent of the region’s clinical trials were led by biotechs and by 2025, biotech-led clinical trials will far exceed those led by Big Pharma, according to IQVIA. However, the region’s biotechs face a myriad of challenges along their development pathway, including navigating a challenging global regulatory landscape, building infrastructure, securing funding, and attracting and retaining talent.

 

To help fill these gaps and service this burgeoning industry, a network of CROs, CDMOs, and consultants with a specific focus on Asian biotech has sprung up. Here, some of its leading lights share their insights into what needs to be done to continue to propel the region’s biotech firms forward.

 

Today, the question of whether payers are willing to pay for a particular innovation needs to be taken into consideration at a much earlier stage.

Senthil Sockalingam, IQVIA Biotech

 

Senthil Sockalingam, head of CRO IQVIA Biotech’s operations in JAPAC, highlights navigating the evolving global regulatory landscape as the key challenge facing Asian biotechs today. “Most of these companies are single country-based organizations,” he points out. “Perhaps related to that point is the evolving medical landscape globally; an unmet need in Singapore may not necessarily be unmet in Europe, meaning that development plans need to be able to address a broad unmet need across geographies and populations which meet the criteria set by different regulatory bodies.”

 

Sockalingam continues, “Ten years ago, drug developers were not overly concerned with the fact that getting a product approved means nothing if no-one is paying for the drug. However, today, the question of whether payers are willing to pay for a particular innovation needs to be taken into consideration at a much earlier stage. Partnering with a global organisation [like IQVIA] helps Asian biotechs to navigate these challenges.”

 

For Francis Van Parys, VP Commercial Asia-Pacific at CDMO player Cytiva, which has a specific focus on servicing early-stage companies working in cell and gene therapy, infrastructure is a key concern. “Early-stage biotech is not always preoccupied with the infrastructure needed to ultimately manufacture a product at scale,” he explains. “When they do want to do so, time is of the essence and infrastructure is needed urgently, which is where Cytiva’s modular facilities can play a role. This model is not exclusive to cell and gene therapy, but we are increasingly focusing on the area due to its high level of promise.”

 

Even though the APAC investment community is more vibrant than before, partly thanks to the pandemic, it is necessary to allow time to come with the right solutions there

Francis Van Parys, Cytiva

 

Another challenge for Asian biotechs is securing the funding needed to take them to their next inflection point; which for smaller firms could be a matter of life or death. “There is room for a little more risk taking from a funding perspective in cell and gene therapy in APAC,” posits Van Parys. “A lot of activity is happening in this space, but not all of it will succeed and we should be more comfortable with that. Risk is inherent in the cell and gene therapy field. Even though the APAC investment community is more vibrant than before, partly thanks to the pandemic, it is necessary to allow time to come with the right solutions there.”

 

Abhay Bangi, partner and life sciences & healthcare lead for ASEAN at Big Four consultancy EY has seen an evolution in the funding landscape but feels that Asian biotechs still need to look towards the US and Europe for cash injections at a certain point in their development. “Historically, the region’s healthcare start-ups and biotechs have struggled as the VCs have not appreciated the regulatory challenges surrounding health technologies,” he opines.

 

“VCs today are better informed and appreciate the high risk/high return nature of the healthtech industry and the journey that healthcare start-ups must go through. While some of these focused VCs do exist here, there is still greater expertise and experience in European and US VCs that understand the gestation period for these products to be developed and launched.”

 

For its part, Cytiva has attempted to address this funding issue through a series of ‘BioChallenge,’ competitions. “Through these competitions, biotech companies submit proposals to Cytiva which are then evaluated by an independent committee of professionals. The winners get scale-up, consulting, and process development services at our Fast Trak centres,” notes Van Parys.

 

Tech start-ups need data scientists and, on the biotech side, Singapore needs to continuously churn out biochemistry PhDs, which can be a challenge for such a small population

Abhay Bangi, EY

 

A final piece of the puzzle for Asian biotechs is access to the right talent. As Van Parys points out, “this issue cuts across both economically advanced and developing markets. In Korea, China, and Japan, the cost of talent is increasing very rapidly and there is a shortage of talent pool. However, in countries like Indonesia, Thailand, and Vietnam there is also not enough available talent which is coupled with bottlenecks in academic and training institutions developing the next generation of industry professionals.”

 

Bangi adds that, in Singapore, “Tech start-ups need data scientists and, on the biotech side, Singapore needs to continuously churn out biochemistry PhDs, which can be a challenge for such a small population. Volumes are not enough currently, although the government is working to attract talent to study and work in Singapore, offering grants, and creating incubation centres in universities.”

 

Perhaps emblematic of the evolving role of service providers, Van Parys sees helping fill this talent gap as “an important part of Cytiva’s mission to support the industry.” He continues, “Not only do our Fast Trak centres offer consulting services, process development, and scale up, they also do a significant amount of training in collaboration with governments. As an example, in Guangzhou, China, we run a Bioprocessing Academy in collaboration with the local government and our Fast Trak centre in Korea holds a significant amount of training programs to upskill and train new talents.”


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