An interview with Dr Goh Choo Beng, Head of Medical Affairs, Takeda APAC on unmet disease areas and the treatments and trials in the pipeline at Takeda.
COVID-19 has highlighted how cross-sector collaboration and strong investments into science can accelerate the development of life-saving vaccines. However, in the Asia Pacific region, in addition to the pandemic, other health conditions, like cancer, also pose a threat to the region’s healthcare systems.
Takeda’s longstanding investment into innovative research and development in these unmet disease areas has culminated in an exciting pipeline of first-in-class and best-in-class new molecular entities that are poised to meet this need. This includes a dengue vaccine and a treatment for a particular mutation of non-small cell lung cancer that is especially prevalent in East Asian women who are non-smokers.
Here, we have with us Dr Goh Choo Beng, Head of APAC Medical Affairs at Takeda to elaborate more on the treatments and trials in the pipeline and how they would revolutionise healthcare in the region.
With COVID-19 dominating the headlines, many diseases have been pushed to the sidelines. Specifically to Asia-Pacific, what are some health conditions we should be focusing on even as we grapple with managing the pandemic?
Cancer, rare disease, and dengue are prevalent threats to the region’s healthcare system and care must be prioritised in these areas.
According to a whitepaper on cancer, Asia Pacific accounts for 50 per cent1 of the total global cancer incidence, and we can expect that cancer mortality will increase in the region by nearly 40 per cent by 2030.
Inconsistency and inequity in rare disease diagnosis and care is a challenge for many patients in the Asia Pacific. While those with more well-known conditions of a rare disease may be able to access some adequate care, patients with lesser-known conditions, or who live in rural areas and lack convenient access to clinical services and adequate diagnostic tools, may go undiagnosed for some time – years, in some instances. On average, it can take up to seven years for rare diseases to be diagnosed.2 The rarity of these complex diseases also means that there is limited knowledge of and exposure to rare diseases amongst healthcare professionals in the region.3
Dengue is both an economic and healthcare burden in the region. With 3.5 billion people living in dengue-endemic countries and over 1 billion of these residing in Southeast Asia, there is a greater potential for the situation to escalate, particularly with the effects of climate change and the spread of urbanisation.
We are a 240-year-old company that is deeply committed to patients, people, and the planet. We have a clear purpose to create Better Health for People and a Brighter Future for the World and recognise that there are significant areas of unmet medical need. As such, we take an Access First approach, partnering with local stakeholders to support the strengthening of healthcare systems, building local real-world evidence where we can help to fast-track the delivery of specialty, life-changing treatments to patients who need them most.
For the conditions you have mentioned, what are the current treatment options patients can expect and how effective are they?
Takeda has established a strong pipeline of innovative products across our core therapeutic areas of oncology, rare genetic diseases & haematology, neuroscience, and gastroenterology, and plasma-derived therapies. The total APAC portfolio will be driven by global brands, a dengue vaccine candidate that is set to address this global health priority, and an R&D pipeline of transformative best-in-class and/or first-in-class new molecular entities (NMEs) for sustainable innovation.
We understood that we had to continue taking steps to bridge the knowledge gaps of these rare and complex diseases among healthcare professionals, especially more pressing with the ongoing global pandemic and more patients facing increasingly limited options to travel for treatment. Hence, in many countries, we introduced regular virtual discussions with key experts who shared valuable clinical practice insights. This helped our doctors to learn from each other and share best practices. While there may be existing treatment options, they are limited particularly for rarer mutations of cancer and rare disease. Logistical challenges can also hinder treatment delivery especially as hospitals divert part of their resources to managing the pandemic. As a result, we are seeing a stronger preference for oral-based treatments from patients and clinicians, and several assets in our pipeline are meeting this demand.
For dengue, most countries are focused on preventive measures such as disposing of stagnant water and reducing mosquito breeding sites. There is an urgent need to address the burden of dengue, particularly as we continue battling the pandemic, as there is a potential for it to take a higher toll. Singapore saw a higher number of dengue-related deaths in 2020, compared to COVID-19.
What are some technology and/or knowledge gaps that are hindering progress in developing safe and effective treatments for the abovementioned health conditions?
In such a socio-economically diverse region as the Asia Pacific, the healthcare infrastructure varies from country to country.
There are sophisticated, highly developed mature countries like South Korea, Taiwan, and Australia. While other countries may have some structure in place, their healthcare systems may function largely out-of-pocket, or are quite generic in terms of what may be publicly reimbursed. While Takeda has established safe and effective treatments for patients, challenges exist in building awareness and capabilities of physicians and health care providers. There is no one-size-fits-all solution here, and in line with our purpose to create better health for people and a brighter future for the world, we work hard to address financial or logistical barriers to accessing the treatments they need.
Vaccine hesitancy is also on the rise due to the hyper-awareness around vaccines and their efficacy rates, and the spread of misinformation online has fuelled distrust and fear. It is a growing challenge globally that is plaguing the progress of COVID-19 national vaccination programmes and it can be challenging to convince at-risk groups to undergo vaccinations for threatening diseases.
The rise of telemedicine has been driven by the pandemic and can open up new channels and opportunities to create easy access to information and guidance for patients and doctors while overcoming barriers in infrastructure. However, it has potential challenges that could make it difficult for clinicians to properly identify and diagnose more complex conditions, such as rare diseases, or even a risk of misdiagnosis.4 This is where it’s vital for us to enhance our capabilities to deliver the right scientific support and foster greater information exchange that enables healthcare providers to better serve their patients. We are continuously working towards this, through internal capability-building initiatives to create an ecosystem partnership with our customers to support the delivery of higher-quality patient care within the region’s healthcare systems.
How has Takeda worked to address these gaps in technology and/or knowledge?
In countries where there are gaps in the healthcare infrastructure, we are enrolling more patients into our Patient Assistance Programs (PAPs), which are crucial in providing them access to highly innovative and transformative treatments that they cannot afford and these come at very low, or almost zero out-of-pocket cost. This year, we have enrolled around 300 patients in 12 programs across Malaysia, the Philippines, Indonesia, Singapore, Thailand and Vietnam.
We are aiming to have more than a thousand patients that can receive access to our PAPs and we also spend a considerable amount of effort to help shape the environment so that there may be sustainable reimbursement opportunities in the future.
We prioritise physician education to equip them with the knowledge of different diseases and treatment best practices. We recognise that in some parts of Asia Pacific, physicians are ready for digital engagement, so we are building their capabilities through the use of data and digital and providing them with tailored and agile educational content. In Thailand, this culminated in the launch of “DigiTAK”, a series of virtual engagements with physicians, including roundtable discussions, 3D launch booths to introduce brigatinib, a first-line treatment option for patients with a rare and severe form of lung cancer.
In addition, we want to improve the awareness of rare diseases, as when patients and doctors are more knowledgeable on these complex conditions, this can accelerate diagnosis, help healthcare professionals make better-informed decisions about treatment pathways and improve patient outcomes. In Taiwan, we launched “MediPASS”, a one-stop digital app for rare disease patients with Fabry and Gaucher disease and the physicians treating them. Through this app, patients and their physicians can easily access educational materials, patients can get matched to social welfare resources based on their conditions, and doctors can follow up on the patients’ treatment journey and case management.
We know we cannot do it alone, so we prioritise forging partnerships with local governments and external stakeholders to improve access to medicines in less established countries.
In Thailand, we have a five-year Rare Disease Memorandum of Understanding (MoU) with key stakeholders in the healthcare community in order to raise public awareness for rare diseases and drive collaboration with key stakeholders in rare disease policy development. We are aiming to extend the reach of this MoU to the larger Mekong countries such as Laos and Cambodia, where awareness and education are critical.
While in Taiwan last year, we signed a memorandum of cooperation with the National Health Research Institute (NHRI) to further the science around early detection of certain rare diseases, neurodevelopmental diseases, and cancers. In addition, we are also keen to establish an Asian ethnic disease gene database that will promote the development and capabilities of Taiwan’s biomedical industries and lead to greater innovation and research into diseases that are unique to the region.
In Vietnam, Takeda has recently kicked off the first meeting with the Japanese National Center for Global Health and Medicine to improve diagnostic and treatment capabilities for Hereditary Angioedema (HAE) patients.
This is how we live our deeply embedded values and I am proud to be part of a company that really places patients at the centre of all that we do.
To combat vaccine misinformation, we believe we need to educate our own staff members first. We are constantly educating them with information backed up by scientific research and data that supports the safety of vaccines and their benefits. Through this, our staff are empowered to act as vaccine ambassadors to their families and friends and amplify science-based truths. In addition, we work with industry associations to bring more transparency and education of the science behind the development of vaccines and treatments. As part of BIO’s Infectious Disease Prevention Network, we are supporting a new vaccine advocacy campaign launched this past summer by The Public Good Projects titled “Stronger,” which aims to stop the spread of harmful misinformation about science, medicine, and vaccines.
As a company invested in innovative research and development, what are some treatments and trials that are currently underway at Takeda? What can patients look forward to in time to come?
We started a very exciting transformational journey two years ago, where we shifted away from primary care or over-the-counter products such as ones for cardiovascular and diabetes and instead, streamlined our focus to highly innovative specialty care therapies. This has culminated in a very strong product pipeline of innovative specialty care therapies across five core R&D areas of focus – oncology, gastroenterology, rare genetics and haematology, neuroscience and strategic investments into plasma-derived therapies and vaccines, which are being defined into two Waves.
In Wave 1, we are placing a strong emphasis on precision medicine and targeted treatments, and a number of them are targeted at diseases that have a high prevalence in the Asia Pacific region, such as dengue and non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
In Wave 2, which is planned for five to ten years from now, our pipeline will support our sustainable growth across our core business areas. It will be the result of our continued investment into data sciences, and cell and gene therapies, and will include nearly 30 NMEs with a transformative or curative potential for different diseases that include liver deficiency disease or multiple cancers.
In Asia Pacific, we have several clinical trials that are running in South Korea, Taiwan, and Australia in the areas of neuroscience, oncology, and gastroenterology.
We are focused on delivering care in underserved disease areas, and this includes rare mutations of diseases such as non-small cell lung cancer. This is a specific rare lung cancer that is highly prevalent for people with second-hand or smoking history and is particularly difficult to treat. Our treatment candidate for this recently received approval by the FDA based on results from its Phase ½ trial. As a disease that has historically been underdiagnosed and lacking in treatment options, mobocertinib brings a tailored treatment that will adequately address the needs of patients.
Due to its prevalence in North Asian populations, we have ensured that patients from regions such as South Korea are represented at clinical trials – in order to have an adequate understanding of what are the unique challenges such patients face and to make sure we are addressing the needs of the populations who need this treatment most.
Our dengue candidate, TAK-003, is undergoing regulatory review in several dengue-endemic countries in the Asia Pacific region, and its Phase 3 TIDES trials showed that it prevented 83.6 per cent of hospitalisations and 62.0 per cent of dengue illness overall three years following vaccination, with no identified safety risks. Besides delivering transformative care for patients, we also want to make sure that our treatments are supporting the healthcare ecosystem in each country, such as reducing rates of hospitalisation and ensuring healthcare capacities are not overwhelmed in the event of an outbreak. Life-changing vaccines like TAK-003 will go a long way in ensuring we do this, especially with the ongoing global pandemic.
Since the rapid development of COVID-19 vaccines, some individuals may be concerned about the shortened duration of clinical trial phases. Can Takeda, as a pharmaceutical company, explain to us how clinical trials are run and how they are regulated?
It is important to understand that the accelerated development of COVID-19 vaccines was not achieved through ‘shortened’ clinical trial phases, or through regulatory shortcuts. It was a success because the world recognised the threat of the pandemic, and this led to the investment of unprecedented financial capital into vaccine innovation, allowing the rapid scaling and adaptation of pre-existing vaccine research and new technology. In addition, authorities sped up administrative hurdles because of the public health emergency, meaning ‘rolling reviews’ of data on an ongoing basis throughout the trials, instead of reviewing all of the data at once at the end of each trial phase. In December 2020, Singapore’s Health Sciences Authority (HSA) granted interim authorisation of the COVID-19 vaccines under the Pandemic Special Access Route (PSAR), aimed at facilitating access to these novel vaccines to combat the pandemic.
The pharmaceutical industry is highly regulated and has strict processes that determine how treatments or vaccines are brought to market. Takeda strictly adheres to these incredibly long procedures, with drawn-out steps involving preclinical work ‘in vitro’ inside the lab, before moving on to ‘in vivo’ testing, which is testing in animals. Only after this can regulators approve the testing of the product to begin in healthy human volunteers. These stages happen as a standard before trials begin in a patient population with that disease. Every stage of research is reviewed meticulously by regulators before being allowed to move on to the next stage of the study.
It is important to stress that the safety measures we put in place are standard practice due to the global, regional, and national regulatory bodies in the regions we operate in. Clinical trials are amongst some of the most heavily regulated activities that exist.
As a company, we are committed to being transparent about our clinical research as it forms the foundation of our business. Therefore, we make our clinical research visible and accessible on a dedicated website (https://clinicaltrials.takeda.com/), where clinical trial protocol information and summary results are accessible to stakeholders such as academic researchers. As the industry becomes digitalised, we are also taking the opportunity to leverage avenues such as virtual platforms and technology such as DocuSign to create new ways of working for clinical trials, making processes much more efficient.
Finally, with a strong presence in Asia-Pacific, how will Takeda revolutionise healthcare in the region?
As we mark our 240th anniversary this year and set the course for our future, we remain strongly rooted in our heritage and deeply committed to our patients, our people, and the planet. But what defines us for the future is that we are driven by purpose-led sustainability for these three groups.
Patients have been at the centre of our business for more than two centuries, but as we evolve, we recognise that health is more than treating medical conditions, it is viewing it in a more integrated way that accounts for healthcare systems and environmental sustainability. That is why in the next stage of our growth, we are evolving our ambitions to create more meaningful, long-lasting impact where we operate, while still being guided by our values and priorities in the order of: putting the Patient first, building Trust with society, reinforcing our Reputation, and developing a sustainable Business.
In recent years, it has become quite clear that in the healthcare industry, working to deliver new avenues of treatment and care is but one part of the business. We cannot overlook the impact of climate change any longer, and the detrimental impact that it has on our health. It is a challenge that concerns all industries – therefore at Takeda, we seek sustainable ways to deliver new avenues of care for patients across the world.
We achieved carbon neutrality since 2019, and we are working towards eliminating 100 per cent of our greenhouse gas emissions from our factories and internal operations by 2040 to truly become carbon zero. The steps we’re taking towards this milestone include the recent launch of our first zero energy building in Singapore, which manufactures life-saving medicines for patients with haemophilia A and B. It utilises 800 photovoltaic roof panels to fully cover its energy needs. It is also the first of its kind amongst global pharmaceutical companies in Singapore and is but one of the ways we are working to take a more sustainable approach to healthcare. [APBN]
About the Interviewee
Dr Goh Choo Beng has fourteen years of medical affairs experience with GSK and Takeda and was trained in oncology at the National Cancer Centre Singapore.
He has robust experience in Vaccines, with the launch of the HPV vaccine for GSK, and is excited for the anticipated launch of Takeda’s dengue vaccine candidate, to deliver excellence and access to life-saving medicines.