Several developments orchestrated by governments around the world over the past three years have been reshaping the landscape of the global health and medical industry.
In January 2015, U.S. President Barack Obama launched the Precision Medicine Initiative; the following year, Obama and U.S. Vice President Joe Biden jointly proposed the Cancer Moonshot project, which would raise US$1 billion to combat cancer.
At the end of 2016, the U.S. Congress enacted the 21st Century Cures Act in an effort to expedite the approval process of new drugs and devices by the U.S. Food and Drug Administration and promote medical research innovation.
The U.K. government began implementing the 100,000 Genomes Project in 2014, and unveiled in the following year the nearly US$10 billion Precision Medicine Catapult. Precision medicine is also a key plank in mainland China’s 13th Five-Year Plan for Economic and Social Development, with Beijing planning to invest 60 billion renminbi (US$9.03 billion) before 2030.
As a result of these policy measures by major economies, biotech businesses around the world are gearing up to seek a slice of the potential-laden pie.
According to projections by global consulting firm Frost and Sullivan, the global precision medicine sector is expected to grow to US$134 billion by 2025. But what exactly is precision medicine?
In the words of Yen Yun, former president of Taipei Medical University, precision medicine aims to provide tailored treatment through DNA sequencing and big data analysis of a patient’s genetic information.
As an example, the current president of Taiwan Oncology Society said breast cancer is triggered by mutations of different genes such as HER-2 or BRCA. It is important to perform screening to identify the cause and prescribe the right treatment.
Now that the world is making strides in precision medicine development, is Taiwan ready to jump on the bandwagon?
According to Johnsee Lee, chairman of Taiwan Bio Industry Organization, precision medicine comprises screening, diagnosis, treatment and monitoring, with each one of the areas a major sector boasting tremendous business potential.
“For example, screening involves full DNA sequencing so as to avoid diagnoses based on partial information,” Lee said. Genomics refers to the complete set of genetic material within an organism and comprises 3.3 billion base pairs. To process such tremendous data and conduct follow-up research, high-speed and accurate DNA sequencing technologies are necessary, as is a diverse biobank.
Based on the input of experts from Taiwan’s biotech sector as well as academics and officials, there are four challenges that need to be addressed if the country is to develop the local precision medicine industry.
First of all, the information contained in Taiwan Biobank needs to be open to the public. Launched in 2012, the initiative seeks to collect blood and urine samples, as well as other related health information, from 200,000 healthy individuals and 100,000 patients for research into the etiologic agents of diseases common to locals as well as their mechanisms.
Widely seen as the arsenal behind efforts to develop precision medicine in Taiwan, the databank contains diverse health information representative of the global ethnic Chinese community. Research based on such information will be highly applicable to hundreds of millions of people.
“Such information cannot sit idle in the databank. It must be shared for the greater good,” said Rick Wen, risk management partner of Deloitte Taiwan. After DNA sequencing, the next step is to examine the practices of other countries and propose regulations that encourage sharing of DNA information while balancing the need to safeguard privacy. Wen said such information must be made available to both medical institutions and businesses. For example, an insurance carrier may redesign policy products based on the health information obtained.
Taiwan Biobank ran into controversy over research ethics late last year, with Taipei City-based Academia Sinica alleging that the databank illegally obtained samples from the nation’s various medical institutions. The Ministry of Health and Welfare intervened and ordered Taiwan Biobank to stop collecting samples until the controversy is resolved.
The government keeps a biobank filled with information collected through the National Health Insurance program, but access is strictly limited for privacy protection. From the perspective of many of those attempting to bolster the precision medicine industry, this is unfortunate.
Secondly, Yen called for amendments to the Physicians Act to develop a medical examination industry in Taiwan. While the country is a global leader when it comes to clinical diagnosis and medical research, medical professionals find it very difficult to examine patients’ genetic profiles, or track their medical histories and make comparisons against related big data.
According to Lee, who also heads the Precision Medicine & Molecular Diagnostics Industry Association in Taiwan, given the fast-paced developments in the global precision medicine industry, it is important to allow businesses in Taiwan to set up medical laboratories.
As an example, Lee said U.S. health service company NantHealth Inc. uses sophisticated software to perform fast genomic data analysis and identify the most effective FDA-approved medication. It also helps physicians make the best treatment decisions with suggestions based on the benefits of different insurance plans and the effects of different combinations of medication.
As the result of a policy change by Beijing three years ago, there are more than 200 private businesses offering medical diagnostic and referral services in mainland China, helping spur development of precision medicine on the other side of the Taiwan Strait.
The third challenge is the need to promote laboratory developed tests (LDT) to accelerate medical innovation. According to Lawrence Gan, chief executive officer of Taipei City-based Development Center for Biotechnology, companion diagnostics is playing an increasingly important role in the development of new pharmaceuticals.
Gan said that, with precision medicine, patients carrying specific genes or biomarkers identified through genetic screening can be administered the appropriate targeted therapies at the right dosage, with their treatment constantly monitored and adjusted by physicians.
A veteran in the development of new medicine, Gan said the DCB will be working with firms providing genetic screening services to develop new medicine. He added that local R&D activities have to be geared toward demand.
However, as examples from abroad show, in order to develop companion diagnostics and corresponding medicine, Taiwan needs to introduce laboratory-developed tests (LDT), in addition to the existing in vitro diagnostics (IVD).
Johnsee Lee explained that clinical verification requires an extended period of time when using the IVD method. Given the fast-paced development of precision medicine, new discoveries need to be taken into account on a timely basis in new medicine development. Under the LDT system being used in the U.S., laboratories are allowed to perform certain specific experiments during the development process. This provides a decreased verification time and allows more room for innovation.
The government is drafting a bill on laboratory-developed services, and the private sector is calling for the bill to be renamed so that local regulations can be more in line with the global practices.
Lastly, Taiwan needs to position itself as the cancer research center of Asia. “The county needs to develop its own niche in precision medicine,” said Wu Tsung-tsong, minister without portfolio in charge of technological development.
Wu said Academia Sinica, National Taiwan University Hospital and Chang Gang Memorial Hospital are all participants in the U.S. Cancer Moonshot project, and the government has also launched a cancer precision medicine development project with a focus on lung and breast cancers.
According to Lee, Taiwan possesses superior advantages in treating and researching cancers, in addition to a rich DNA databank. “It is high time for Taiwan to establish itself as the Asian cancer research hub and capitalize on the business stemming from precision medicine,” he added.
Yen said the country’s ICT firms can also carve out a slice of the precision medicine pie. For example, they can develop wearable devices that collect genomic and health data, which can be analyzed in real time with artificial intelligence, or 3D printing technology to produce medical devices.
As a matter of fact, Taiwan’s ICT and medical sectors are already converging in various ways. Earlier this year, Foxconn founder Terry Gou announced a 10-year project to offer free genomic screenings for breast cancer and leukemia.
But it takes more than the efforts of the richest man in Taiwan to develop precision medicine and grow the local biotechnology sector. The key is to successfully develop an industry ecosystem to maximize sector output and expand its global footprint.
[By Lin Jang-chun / tr. by Meg Chang]