生策要聞
年份:
談台灣醫療科技創新研發趨勢-Discovery訪談摘要
2020-07-21

生策會翁啟惠會長7月在台接受Discovery頻道訪問。對談除了分析台灣生技產業的機會、綜觀全球疫情下包括檢測與疫苗發展的挑戰,翁會長更向全球介紹台灣醫療X科技兩大優勢如何突破現況,帶來精準健康新樣態!

翁會長特別指出台灣醫療服務全世界第一,但台灣醫療支出只占GDP的6.6%,相較全球10.9%的平均水準有不小差距。而台灣ICT產業也是世界領先,平均一年投入的研發費用約占營收的2.85%,只要其中有1%研發投入生技或精準醫療產業,帶動跨領創新合作非常可觀!

Discovery節目將會介紹多項台灣生醫科技原創發明,預計於十月播出,以下為節目提問與完整回應:

Discovery Channel Interview Questions and Answers

Chi-Huey Wong, President of IBMI, July 8, 2020

1.When was the IBMI founded and what is the mission behind its founding? Why is it crucial for Taiwan to set up an organization like IBMI to assist and promote the biotechnology and medical industry?

IBMI was founded in 2002 by Mr. Jin-Pyng Wang, President of the Legislative Yuan, as a non-profit organization to promote the development of biomedical industry in Taiwan.

As you know, the discovery of recombinant DNA technology in the Bay Area of California during the 70s (by Paul Berg, Herbert Boyer and Stan Cohen) to produce human proteins from genetically modified bacteria is a game change in the pharmaceutical industry and has stimulated the birth of the biotech industry. In 1980, the first biotechnology patent was granted to produce human insulin from genetically modified E. coli, and the Bayh-Dole act was passed in the US congress to encourage the development of biotech industry. In 1982, the first biotech product human insulin was approved by the FDA.  

These exciting landmark developments marked the beginning of the biotech era. Since then, the biotech industry has been growing very fast in the US and globally, but Taiwan at that time was still very much focused on the electronic industry especially in the contract manufacturing business; and biotech was relatively new and far from having a global presence. However, the pharmaceutical industry and the healthcare sector in Taiwan had realized the importance of biotechnology and urged the government to pay attention to this emerging industry. So, through a lot of discussions, the government decided to develop the biotech industry, and IBMI was later established to help promote the industry.

2.Please tell us what the IBMI does.

As mentioned, IBMI was established to promote the development of biotech and healthcare industry. It serves as a platform to encourage interdisciplinary collaborations and to facilitate policy dialogues between the government and the biomedical industry. In addition, IBMI is responsible for the selection of national awards in biomedical innovations and is a virtual incubator for biotech startups. In the beginning, IBMI took the initiative to establish national quality standards and encourage the biotech industry to emphasize R&D and innovation. After this, the foundation then moved to the second phase aiming to help create a better and positive business environment for biomedical development and establish a healthy regulatory and policy-making system. Going forward, IBMI is now entering the third phase trying to help establish Taiwan as a regional hub for interdisciplinary collaboration and biomedical innovation. We would like to create a platform to encourage the cooperation and dialogue between the world-leading ICT industry and the world-class healthcare service in Taiwan. Hopefully, through the dialogue and cooperation, new opportunities will be generated for the development of a more competitive biomedical industry.

3.Biotechnology is an all-encompassing term that includes everything from agriculture to medicine. What are the sectors that Taiwan currently focuses on? 

The initial focus was on the development of high-end medical devices and new medicines, because these two areas are the most challenging and relatively weak areas for Taiwan. However, recent advances in science and technology and the increasing aging population have caused a paradigm shift in healthcare from disease treatment to early-stage detection and prevention, and from precision medicine to precision health. Precision health is all about using novel technologies to measure the level of health risk based on one’s gene, dietary, life style and other environmental factors, and to help develop prevention strategies or make informed decisions on treatment to minimize any risk of developing a life-threatening disease. Precision health requires the technologies from the ICT industry, and areas such as AI, IoT, 5G, 8K for high-resolution display, cloud computing, sensing technology, remote control, software and hardware designs are all important and will certainly give the sector a competitive edge.  

4.What role does Artificial Intelligence play in the overall development of Taiwan’s biotechnology industry?

I think AI will become more and more important in healthcare and biomedical development, and Taiwan has a good opportunity in the field. Taiwan has a big pool of talents in science and technology and a big database generated from the more than 25-year universal healthcare and the newly established biobanks; all are important resources for AI development. I should also point out that Taiwan is often ranked number 1 in the Global Open Data Index.

The areas considered to be promising for Taiwan include early diagnosis (such as imaging and genetic testing); AI-assisted decision making in healthcare and medical treatment (such as assessment of drug safety, combination therapy, cancer diagnosis and prognosis); health management (such as monitoring and pre-warning of health condition, disease risk assessment and prevention); drug discovery and development, identification of patients for clinical trials and for treatment.

In practice, the big data can be retrieved and run through machine learning and ultimately an algorithm is created to provide solutions or prediction models. There are several ICT giants working with local hospitals to come up with data-driven and AI-based solutions in precision healthcare. The personal computer sector has been playing a crucial role in AI development in Taiwan. Also, the ICT and manufacturing sectors have built a huge capacity for hardware and software engineering. So, I think AI will play an important role in Taiwan’s healthcare and biomedical development.

5.What are Taiwan’s strengths and challenges in developing biomedical industry? What does Taiwan need to do to overcome those challenges?

The biomedical industry in Taiwan remains high on the government’s agenda, and the sector has been supported both strategically and financially. Taiwan has several areas of strength, including

  • World-class quality of healthcare and medical professionals.
  • Leading ICT industry, including the supply chain, talent and manufacturing
  • Comprehensive big data from universal healthcare and biobanks
  • High quality clinical trials and R&D capacity
  • Well-established infrastructure for biomedical industry.
  • Compliance with international regulations
  • R&D in AI and 5G at the national level

The major challenge for Taiwan is that small and medium-size companies are the backbone of the economy. This situation often results in a shortage of talents at the managing level. In addition, the small domestic market and the lack of funds for early-stage startups and late-stage clinical development have affected its competitiveness. One way to overcome these shortcomings is to develop an international network to facilitate interdisciplinary cooperation and to explore new opportunities and markets outside of Taiwan. The Covid-19 pandemic has changed the way we live and the way we do business. Taiwan has successfully managed to contain the pandemic and enhanced its global presence. I hope the ICT industry and the healthcare sector in Taiwan will work together to come up with a new and sustainable business model for the development of biomedical industry.

Another point I want to make is that the ICT sector in Taiwan has spent about 2.85% of its annual revenue in R&D, so it could make a huge difference if the ICT sector spares just 1% of its annual revenue in healthcare innovation, as that will be equivalent to US$5bn investment.

6.What has the IBMI done, or what policies have been pushed forward, to foster a friendly environment for biotechnology to flourish in Taiwan?

Over the years, IBMI has been actively involved in the reforms of policy and regulation for the biomedical industry. In 2007, IBMI helped to enact the Development of Biotechnology and New Pharmaceutical Industry Act. The Act provides incentives for technology developers, investors and other professionals to work together to drive innovation in the development of new pharmaceuticals and high-end medical devices. More specifically, the act provides incentives for tax-reduction in the investment and R&D spending in these two areas, and tax deferral for professionals that hold technical shares. The Act was amended in 2017 to further expand the scope to include class II medical devices which require clinical trials and cell-based therapy. Up to now, there are over 150 companies and 360 R&D projects benefited by the Act. Of these, seven out of 18 late-stage new drugs have gained the market entry to the US, EU and Japan, and the others have entered different types of licensing agreements. The act will expire by the end of next year and the government has planned to extend and expand the bylaw to include some new items associated with precision health.

In addition, IBMI participated in the revision of the Fundamental Science and Technology Act to encourage technology transfer and cooperation between industry and academia, played a crucial role in the signing of the cross-strait medical and health agreement to accelerate the clinical trials and registration of new drugs under the International Conference Harmonization (ICH) guidelines, and is currently helping the legislation of the Regenerative Medicine Act to provide regulations for the development of heterologous gene- and cell-based therapies. IBMI also contributed to the legislation of other bylaws, including the Medical Care Act and the Pharmaceutical Affairs Act, et al.

7.What steps are IBMI taking to bring Taiwan’s biotechnology to the rest of the world?

IBMI comes all the way from scratch to the current stage having developed a huge contact network. A number of professionals from the biotech and healthcare sectors and research organizations are connected. Because of this, IBMI took a big step in 2017 to initiate the Healthcare+ Expo Taiwan which has become the largest event in Asia. The Expo brought together the healthcare and biotech sectors to showcase their strength and attracted new participants from other sectors, including the ICT, the electronic, and the manufacturing sectors interested in healthcare. The Expo is more than just a large-scale trade fair for product roadshows, it ties with international conferences joined by high-profile speakers, presentation of the national innovation awards, networking events and value-added services. The Expo has become a signature and reputable event in Taiwan and in the APAC market. It is also a medium used by IBMI to engage the rest of the world.

8.Where does Taiwan’s biotechnological development stand when compared to the rest of the world? Is Taiwan ahead in certain industries? Is Taiwan behind on certain developments?

According to the 2019 Emerging Markets Biotechnology Competitiveness and Investment (BCI) Survey, Taiwan ranks Second among the 17 emerging markets. (Singapore 1, Israel 3rd, South Korea 4th). Taiwan is relatively strong in business environment, mainly in the areas of policies and regulations, scientific and clinical research as well as IP protection. However, the output and business scale of the biomedical industry in Taiwan are relatively small. The sector has to look for exports and explore new opportunities and markets. This is why IBMI comes in to serve as a platform to encourage dialogue and cooperation among the ICT industry, the healthcare sector, the biomedical industry, the research organizations, the venture capital groups and overseas networks to identify new opportunities and develop innovative technologies, products and business models, and take them to the global stage and broaden the horizon of the biomedical industry in Taiwan.

9.What is your personal vision for the future of the biomedical industry in Taiwan.

Taiwan has been well recognized for its ICT industry and healthcare service. I think the healthcare sector knows about the unmet medical needs and the ICT industry knows how to design and manufacture the products to meet the demand; so the cooperation and dialogue between these two sectors will generate new opportunities for the biomedical industry. As mentioned, due to the increasing aging population and the advances in science and technology, we have seen a paradigm shift from disease treatment to prevention and early disease detection, and from precision medicine to precision health. The global healthcare spending in 2018 is about 10.6 trillion US dollars, almost 11% of the global GDP exceeding the growth of economy; and about one trillion of the spending was for prevention and early detection. The healthcare spending will continue to grow and reach 15 trillion in 2030, about 12% of the global GDP, and almost 4 trillion of which will be spent on disease prevention and early detection. Since the healthcare growth is faster than the economy growth, how to properly use the resources has become an important issue, and I believe more and more technologies from the ICT industry, such as the AI, IoT, 5G, and 8K will be used by the biomedical industry to improve the precision and efficiency of healthcare. The trend toward digital health and smart medicine to meet the goal of precision health is obvious.

10.SARS-CoV-2 and COVID-19.

How many testing methods have been developed in Taiwan, what difficulty was encountered, what is the direction of vaccine development?

The initial outbreak of the 2019 coronavirus (2019-nCoV or SARS-CoV-2) that caused severe acute respiratory syndrome (COVID-19) was first detected in Wuhan, China in December 2019, and in three months, the virus spread all over the world with more than 200,000 confirmed cases and 10,000 deaths. The WHO declared a global health emergency on January 30, 2020 and officially a global pandemic on March 11, 2020. Now the confirmed cases are over 13 million worldwide with more than 500,000 deaths. In addition, the virus continues to mutate, making it more challenging to contain the pandemic. Since currently there is no effective therapy for COVID-19, the pandemic has become a major threat to public health. So, tremendous worldwide efforts have been made to find ways to contain the pandemic, and in addition to contact tracing, distancing, masking and washing, development of effective and rapid diagnostics, therapeutic treatments and preventive vaccines as countermeasures against this devastating infectious disease has been the major efforts.

There are three methods of testing being developed in Taiwan, the most popular and also the most accurate one is the RT-PCR method which is based on the principle of genetic amplification with designed primers followed by fluorescence detection. After taking the sample from the nose or throat, it usually takes about 4-6 hours to get the result. With the aid of new technology such as AI-assisted automatic processing, genomic editing, lateral flow and enhanced fluorescence sensitivity, the analysis can be completed within an hour. The other two methods include the use of antibody to detect viral antigens such as nucleocapsid protein or the spike glycoprotein, and the use of viral antigens to detect the presence of antibody in potential patients.

Antigen or antibody testing is faster but may not be as accurate as RT-PCR, and requires clinical validation to ensure specificity and sensitivity. Since Taiwan has been managing the pandemic very well, the number of cases in Taiwan is relatively small, just a few hundreds, so the validation process is relatively more difficult and thus slowing down the development of testing kits. However, despite this hurdle, there have been several testing kits developed in Taiwan and approved for emergency use by the US- and EU-authorities.

With regard to vaccines, I think it is like other infectious diseases, vaccination will be the most effective mean to contain the pandemic, and there are several vaccines currently being developed, including the use of inactivated virus, viral mRNA or DNA, spike protein and viral-like particle with or without a carrier or adjuvant. Using inactivated virus as vaccine requires the scale-up of cell culture to produce the virus for vaccine development. Since the virus is very contagious, cell-culture is a dangerous process and there is also a concern of antibody-dependent enhancement.

I believe Taiwan is currently developing spike protein-based and gene-based vaccines, and is ready for human trial. In addition, glyco-engineered spike protein, pseudo-virus particle and nanoparticle-conjugated vaccines are also being developed. In any case, to develop a safe and effective vaccine is a challenge, because the virus continues to mutate and the spike protein is highly glycosylated to help the virus escape from the host immune surveillance. According to the database in GISAID, there have been more than 60,000 sequences of the viral spike protein deposited. This spike protein has approximately 1,300 amino acids and more than 800 of which have mutations, though the mutation rate is relatively slow, just less than 0.1%. So, identification of highly conserved consensus epitopes or antigens for the development of a broadly protective antibody or vaccine (also called universal vaccine) against various mutants including any upcoming ones would be the goal in this effort.

Information

會 址:115台北市南港區園區街3號16樓之1 電 話:(02)2655-8168 傳 真:(02)2655-7978
社團法人國家生技醫療產業策進會 版權所有
Copyright © 2012 Institute for Biotechnology and Medicine Industry (IBMI). All Rights Reserved