Getting clinical trials back on track in Taiwan

By Peter Tu, Bio Fund Analyst, Taiwania Capital

Peter Tu, Bio Fund Analyst, Taiwania Capital

Clinical trials are a critical part of biopharma and biotech company operations in the treatment-discovery process. The late 2019 outbreak of a novel coronavirus disease known as “coronavirus disease 2019” (Covid-19) has significantly undermined the ability of companies and healthcare systems to conduct these trials. From the perspective of biopharma and biotech companies, Taiwan can be the place to resume clinical trial operations to avoid further delays caused by Covid-19.

In just a few months, Covid-19 has caused more than 8 million confirmed cases and 450,000 deaths worldwide as of June 19th, 2020 (according to Johns Hopkins University’s GIS Coronavirus data).A recent Asian Development Bank report estimates that the impact on the global economy could be in the range of trillions of dollars. As nations race to contain the virus and save lives, the subsequent reprioritization of the healthcare system to treat Covid-19 patients has severely affected clinical trials.

According to a reported authored by researchers at Charité – Universitätsmedizin Berlin and the Berlin Health institute, 3172 clinical trials have been suspended, terminated, or withdrawn (“stopped”) from December 1st, 2019 to June 16th, 2020, compared to 1515 stoppages in an equivalent period in 2017-18. From these,1426 (45%) explicitly mention Covid-19, affecting more than 4 million anticipated patients enrolled in these trials. Almost all therapeutic areas are affected, and a majority of the affected trials have indications in severe areas such as oncology, cardiovascular diseases, and neurologic diseases. In addition, many newly planned clinical trials are being delayed as companies deal with issues such as patient recruitment and monitoring. These delays are setting back years of progress on disease treatments.

Taiwan’s exceptional performance at controlling the spread of Covid-19 and its competitive clinical environment makes it a top choice for biopharma companies to get back on track with clinical trials and drug development

With this also comes a heavy toll on investor confidence as markets slow, and fundraising becomes more difficult. As of May 22nd, US-based IPO research firm Renaissance Capital estimates there was a -42% change in US IPO pricings compared to the equivalent time in 2019. Extended timelines for drug development will also lead to earlier loss-of-exclusivity, placing additional financial pressure on companies. Larger companies may have longer runways, but smaller companies or startups with limited pipelines may not be able to weather this. As Covid-19 has seen resurgences in countries such as South Korea, China, and the U.S. after initial waves were controlled, long-term mitigation plans need to be in place.

Despite the sentiment of doom and gloom, Taiwan stands out as one of the few countries that have controlled Covid19well and have minimized economic losses, having never locked down, providing an attractive proposition for companies to resume clinical trials there. A standout case, Taiwan has recorded only447cases so far and no community transmission since April 12th. Despite the proximity to where the first outbreaks were observed, early, decisive, and comprehensive action means that aside from international travel, business and life are essentially normal in Taiwan with fewer than five active cases of Covid-19 remaining. Taiwan’s exceptional performance at controlling the spread of Covid-19 and its competitive clinical environment makes it a top choice for biopharma companies to get back on track with clinical trials and drug development.

This is not a new idea: Taiwan has steadily built its reputation as an excellent location for clinical trials. Its clinical trial system, first established in 1993, eventually became a role model for many of its neighbors. A 2019 report by the US-based life science consultancy Pugatch Consilium ranked Taiwan in the highest tier of emerging markets for biotechnology competitiveness and investment along with Singapore and Israel, and above South Korea. Taiwan is well-experienced with clinical trials: its clinical trial information platform reports more than 3,000 tests overall have been completed (more than 200 in 2018 alone), with 73% of them multi-regional.

The medical infrastructure is also very impressive – as of 2019, Taiwan has more than 146 GCP-certified clinical trial sites. The number of beds per capita (6.8+ per 1000 pop) is one of the highest in the world, and there is a huge talent pool of well-trained clinical practitioners fluent in English. The national health insurance program enrolls 99.9% of the population (according to Taiwan’s Ministry of Health and Welfare), and a centralized medical records database in English means easy and secure access to high-quality patient data.

Furthermore, Taiwan’s government has aggressively improved its regulatory environment in recent years. Taiwan’s Food and Drug Administration (TFDA) streamlined its review and approval process for clinical trials in August 2018, greatly accelerating the development and commercialization of new drugs. I.P. protection is also strong, with Taiwan ranked21st in the 2020Global I.P. environment survey run by the Global Innovation Policy Center (GIPC) of the U.S. Chamber of Commerce.

In the short-term, biopharma and biotech companies can be confident that Taiwan will be a safe, cost-effective location to resume clinical trials without compromising quality. It is the ideal environment to de-risk pre-clinical or early-stage clinical assets for the next 12-18 months, particularly for early-stage biopharma companies that cannot afford any delay in their developmental pipelines.

In the long-term, Taiwan will remain an attractive option as a secondary site or a dedicated R&D center based in Asia. The demographic makeup provides useful and generalizable preclinical and clinical relevance to major patient populations and markets such as China and Japan. Its useful strategic location and proximity to major markets can also serve as a stepping-stone for biopharma companies to enter Asian markets.

As the world continues to manage the Covid-19 pandemic, further delays to clinical trial operations are expected. Taiwan should be a top option for biopharma and biotech companies to best continue their dual mission of bringing treatments to patients and providing confidence in their investors.

Weekly Brief

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Getting clinical trials back on track in Taiwan

Getting clinical trials back on track in Taiwan

Peter Tu, Bio Fund Analyst, Taiwania Capital