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The 10th APAC (Asia-Pacific Association of Pharmaceutical Manufacturers and Associations) Conference held
-Mission: Rapidly bring innovative medicines to the people of Asia-.
The theme is "Overcoming COVID-19 and Towards a Decade of New Innovation Challenges in Asia
The Asia Partnership Conference of Pharmaceutical Associations (APAC), which has been held since 2012, marked its 10th anniversary in 2021. Although the 9th APAC had to be cancelled due to the pandemic of the new coronavirus infection, preparations for the 10th APAC were made with a web-based event in mind, and it was held in an online format on April 13, 2021, with over 700 audience members participating. The conference was more timely than ever, with e-labeling featured in the Access To Innovative Medicines (ATIM) session for the first time and lively discussions in each session in light of the new coronavirus infection. Here is a summary of each session of the APAC conference.
Presenters
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Greetings and Congratulatory Addresses
Joji Nakayama, then chairman of the Pharmaceutical Manufacturers Association of Japan (PMAJ), and the audience
In his opening remarks at the beginning of the program, Joji Nakayama, then President of the Pharmaceutical Manufacturers Association of Japan (PMAJ), introduced the agreements and accomplishments made in the past and expressed his expectations for the discussions in line with the theme of the 10th APAC, "Overcoming COVID-19 and Toward a Decade of New Challenges for Innovation in Asia, He also thanked the regulators and academia for their cooperation. He was followed by a video congratulatory address from Thomas Kuenyi, President of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), who shared details of IFPMA's efforts against the novel coronavirus.
Mr. Thomas Kuenyi, President of PMDA
Keynote Speech
In his keynote speech, Yasuhiro Fujiwara, President of the Pharmaceuticals and Medical Devices Agency (PMDA), introduced PMDA's efforts and international cooperation against novel coronaviruses. First, he introduced three of the seven priority work areas defined by the Asia-Pacific Economic Cooperation (APEC) Regulatory Harmonization Steering Committee (RHSC): multinational clinical trials/GCP inspection, Good Registration Practices (GRM), and the Center of Excellence (CoE) for medical devices. of Excellence (CoE) were mentioned and explained that since the PMDA Asia Training Center started its education and training activities in 2016 to APEC member economies including Asia, it has contributed to regulatory harmonization in each area and has been set as a goal of the Grand Design of the National Healthcare Strategy developed in 2019. He explained that it is also set as a goal in the National Healthcare Strategy's Grand Design for 2019.
Regarding novel coronaviruses, the PMDA has given top priority to the practical application of novel coronavirus-related products, including the establishment in October 2020 of a new, free-of-charge "Vaccine Strategy Consultation for New Coronavirus Infections" and the use of rolling reviews (sequential reviews), He introduced his efforts, including the speedy review of Lemdecivir, which was approved for emergency use in the U.S. on May 1, 2020, using the special approval system, in one week and granted domestic approval on May 7, 2020. He also introduced his participation in the International Collaboration of Medicines Regulatory Authorities (ICMRA), which consists of members at the director level of each regulatory authority, in discussions on regulatory concerns in the development of new coronavirus-related products. The meeting reaffirmed PMDA's commitment to proactively work on regulatory harmonization in Asia as "Team Asia" by holding bilateral discussions and symposiums with Asian countries and economies in conjunction with the APAC event.
PMDA President Yasuhiro Fujiwara
RA (Regulations and Licensing) Session
After that, we moved on to the five sessions. Following Fujiwara's keynote speech on regulatory updates related to novel coronaviruses in Japan and around the world, the RA session kicked off with a presentation by John Lim, Professor at Duke-NUS Medical School from Singapore, on pre-pandemic regulatory trends and the coronavirus crisis. He reviewed the regulatory trends prior to the pandemic and the response during the coronary disaster, and then used digital health as an example to look at regulatory trends for the next 10 years and the new normal (digital health and the 7 T's as agile review requirements) after the new coronary outbreak is over.
A panel discussion was then held with invited Asian regulators on the theme of "COVID-19 Disaster and New Drug Review Initiatives". The first panelist from Taiwan's FDA reported that since establishing a cooperative framework with the PMDA in 2013, they have held annual meetings and working group activities, and in 2019, both parties issued a position paper to promote cooperation in the review and approval of new drug approvals, and as a result, there have been two cases of completed reviews based on the position paper. The PMDA introduced that there are two cases of completed review implementation and three cases of ongoing review based on the position paper.
PMDA explained that ICMRA, of which Dr. Fujiwara serves as vice-chair, played an important role in the recent outbreak of the new coronavirus, and that many workshops were held to exchange useful information among regulatory authorities in each country. It is hoped that by prioritizing efforts among authorities based on trust building, regulatory monitoring activities will proceed efficiently and effectively, and access to essential items will be expedited under a declared state of emergency.
The National Pharmaceuticals Regulatory Agency (NPRA) of Malaysia reported that the conditional expedited review system for medicines introduced at the end of 2020 will include novel coronavirus vaccines, that rolling applications can be submitted, and that priority review will be 120 working days. He also introduced the efforts of the ASEAN Joint Assessment Coordination Group (JACG), a platform for building trust through cooperation among the Association of Southeast Asian Nations (ASEAN) members, strengthening the technical capacity of each country, and establishing timely and efficient assessment operations. The JACG is a platform that aims to build trust through cooperation among allies, strengthen technical capabilities of each country, and establish timely and efficient assessment operations.
The Chinese member, the Research and Development Pharmaceutical Industry Association of China (RDPAC), reported on the results of the National Medicines Regulatory Administration of China (NMPA)'s response to COVID-19, including the application of the emergency approval system to the development of a novel coronavirus vaccine, the acceptance of e-CPP, remote inspections, and decentralized clinical trials. The report also noted that the emergency approval system had been applied to the development of a new coronavirus vaccine. He also explained how the Coronavirus Disaster is also promoting regulatory reform by issuing a number of related regulations, starting with the Drug Registration Law (DRR) in July 2020. He expressed hope that ICH regulatory harmonization and confidence building will be further promoted in the future.
At the end of the session, the participants strongly recognized the importance of the "New Normal of Regulatory Affairs" in which Asian regulators have demonstrated regulatory agility, and confirmed that APAC will do its utmost to support the continuation of this trend even after the new coronavirus has been contained.
A scene from the RA session
ATIM Session-1
E-labeling
The second session was ATIM Session-1 on the theme of "E-labeling," which was newly introduced this year.
In Japan, the Pharmaceuticals and Medical Devices Act (PMD ACT) has been revised, and from August 1, 2021, the attached document will basically be provided electronically, and the mandatory code (GS1 code) on the packaging will be printed and scanned to view the attached document. Five Benefits of Electronic Attachment", including Accessibility (ease of access to information), Efficiency (efficiency), Ecological (environmental protection), Searchability (ease of search), and Arrangeability (ease of change/arrangement). The presentation provided easy-to-understand explanations on Efficiency, Ecological, Searchability, and Arrangeability. In addition, while work is underway to translate Japanese package inserts into English, the introduction of e-labeling and other measures will enable worldwide access to the latest Japanese review reports, package inserts, patient guides, and other information on the PMDA website in the future, not only in Japanese but also in English, He suggested that the results of the approval review in Japan could be used in the approval review process in other countries, thereby simplifying the review process.
Based on the experience of the Drug license online search system, which has been in the works since 2006, Dr. Po-Wen Yang of the Taiwan FDA suggested that a user-friendly interface and an open data e-labeling structure will be developed in the future. Based on his experience with the drug license online search system, which he has been working on since 2006, Mr. Yang stated that he plans to set and release XML format standards to enable a user-friendly interface and open data e-labeling structure. Mark Wong of the Health Sciences Authority of Singapore (HSA) also introduced the opinions and advice from various stakeholders to date, and added, "As of March 2021, a total of 270 products are E-labeling, and most of them are 2D barcodes and can be accessed from company websites to labeling can be viewed. Most healthcare professionals welcome such initiatives." Draft guidance on E-labeling requirements is also expected to be completed by April 2021, and there is interest in future developments. Nguyen Thanh Lam of the Department of Drug Administration (DAV), Ministry of Health, Vietnam, explained the status of interest in the country, how it will proceed, and provided information on the future status of E-labeling.
In the discussion that followed with the speakers, the identification of issues in each country was helpful to the conference participants, including the audience, and the possibility of collaboration in the Asian region was also discussed. It was mentioned that a position paper is needed to share knowledge of the commonalities, advantages, and challenges in the Asian region with each economy and to practice e-labeling in the Asian region, as well as to present broader choices and better choices for the future.
Co-chair Junko Sato of PMDA suggested that a blueprint (roadmap) be developed after further research on the situation in other Asian countries not participating on the day and around the world.
E-labeling session
ATIM Session-2
Bioequivalence Study Exemption (BioWaiver)
At the start of the session, Mr. Tomonori Nakagawa, a member of the Quality Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ), explained that the position paper proposed at the 8th APAC had been revised to include the impact of the spread of the new coronavirus, summarized the history of activities of the ATIM Task Force to date, and explained the background and proposal on post-approval Background and proposal on biowaiver in change management was explained. After that, the moderator, Mr. Ryosuke Kuribayashi of PMDA, gave an overview of the Japanese "Bioequivalence Study Guidelines" revised in March 2020 and the status of biowaiver. Following this, Rizka Andalucia of the Food and Drug Administration (BPOM) and Chien-Liang Lin of the Taiwanese FDA provided an overview of the situation in Indonesia and Taiwan, respectively, followed by a panel discussion.
The panelists discussed the challenges in proceeding with study exemptions in accordance with ICH M9, the challenges of incorporating in vitro evaluation into membrane permeation assessment, and the challenges of advancing science-based assessment and risk-based biowaiver in humans, in order to bridge the minute differences in guidance between the various economies on biowaiver. The speakers expressed their opinions on these issues, and Indonesia, Taiwan, and Japan agreed to promote biowaiver based on the Biopharmaceutics Classification System (BCS) in ICH M9.
DA (Drug Discovery Collaboration) Session
The Expert Working Group on Drug Seeds Alliance (EWG) has been sharing information on drug seeds, building a platform for drug discovery collaboration, and educating young researchers since 2013. The 10th APAC meeting reported on the status of two initiatives: the Drug Seeds Alliance Network in Asia (DSANA) and the APAC Natural Product Drug Discovery Consortium (ANPDC).
The Drug Seeds Alliance Network Japan (DSANJ) is a program developed by the Osaka Chamber of Commerce and Industry (OCCI) to create R&D activities for innovative drug creation in Japan. The Drug Seeds Alliance Network Japan (DSANJ) is an Asian version of the Drug Seeds Alliance Network, which was launched in 2015 as a pilot initiative of the DSANA to match Taiwanese academia and bio-venture companies with Japanese pharmaceutical companies. The first of its kind in the online interview format, D-Bio was held over three days from January 27, 2021, and was attended by six companies from Taiwan and many from Japan. Although the number of proposals from Taiwan, the number of proposers, and the number of interviews increased dramatically, the content of the proposals seemed to be mixed. Dr. Chi Wei-Kuang, Director of the Development Center for Biotechnology (DCB), Taiwan, reported that the quality of the proposal was impressive and that it would be necessary to ensure the quality of the proposal content and make it more attractive to Japanese pharmaceutical companies.
In October 2018, ANPDC signed and launched a Memorandum of Understanding for collaboration among Thailand, Taiwan, and Japan, and in 2019, ANPDC started an internship program between Thailand's Expert Committee on Addictive Drugs (Excellent Center for Drug Discovery, ECDD) and Takeda Pharmaceutical Company Limited ECDD The internship program provided technology transfer of high-throughput screening (HTS) and iPS cell-based screening systems to Dr. Phongthon Kanjanasirirat, who was sent by ECDD to learn about the technology of testing methods for cell death testing of motor neurons and bring it back to Thailand. After setting up the screening system in Thailand and confirming its reproducibility for the development of a therapeutic agent for amyotrophic lateral sclerosis (ALS), we conducted screening and found one natural compound and two synthetic compounds with EC50 less than 0.1 μM. The target identification is expected to be completed in August/September 2021, after which Takeda plans to conduct pharmacological and safety evaluations.
From February to April 2020, Dr. Supawan Jamnongsong from Sirila Hospital, Mahidol University, Thailand, was sent to Takeda to learn the technique to differentiate iPS cells into neural progenitor cells to obtain cerebral cortex cells, as well as the Macropinocytosis assay method. After returning to Thailand, he set up a screening system at Sirila Hospital and screened 2588 compounds provided by Chulalongkorn University and the Thai Biotechnology Center for Genetic Engineering (BIOTEC) using ECDD's natural product library, and succeeded in identifying 8 hit compounds. The next step was to identify the 8 hit compounds. In the next step, a secondary screening will be conducted using a dose-response curve to confirm the absence of cytotoxicity.
Meanwhile, in the collaboration between BIOTEC and Eisai, an internship utilizing online meetings was conducted due to the impact of the new coronavirus, and the technology transfer of the screening system, construction of the clude extract library, and learning about medicinal chemistry have been completed and will be After studying the construction of the screening system and learning how to select hit compounds through technology transfer, we hope to conduct screening of microorganism-derived compounds at BIOTEC using the fungal-derived database and other resources at TBRC (BioResource Research Center in BIOTEC).
In addition to the above two projects that are showing steady progress, we plan to update our activity strategy as DA-EWG, taking into account future drug discovery trends in response to infectious diseases, precision medicine, aging society, digital medicine, etc.
VBH (Value-Based Healthcare) Session
Re-Creation of Healthcare by the power of digital technology
In the VBH session, the third of its kind at APAC, Mr. Gusayuki Otsuka, Director of APAC Operations, gave an overview of the current situation in which the new coronavirus infection has cast a shadow over sustainability, while the promotion of telemedicine has brought new benefits to those who have had difficulty accessing medical care in the past. Mr. Tsuyuki Otsuka, Director of APAC Operations, opened the session with the following opening remarks: "We would like to discuss how we can utilize the power of digital technology to realize VBH in Asia.
The session consisted of four presentations and a panel discussion.
First, Mr. Vikram Kapur of BAIN & COMPANY (Singapore) talked about the current situation in Asia, where digital health has been quickly activated by the pandemic disaster and digital health is becoming a point of triage to face-to-face services throughout the healthcare value chain, and how most medical consultations He pointed out that most medical consultations can be handled through digital health platforms, which could be a solution to curb the rising healthcare cost curve in the Asia-Pacific region.
Dr. Jiruth Sriratanaban, Professor of Chulalongkorn University, followed with a presentation on the four SAFE areas (Sustainability, Adequacy, Fairness, Efficiency) as an initiative to improve the system in Thailand, which achieved Universal Health Coverage (UHC) in 2002 and is facing increasing healthcare costs. He also explained how VBH is positioned as a means of addressing SAFE and is being incorporated into specific measures. One of these measures is strategic purchasing, which introduces various measures from the perspective of what to buy, how to buy, and how to pay. However, VBH is not only used for cost containment, but also as one of the strategies to promote the National Health Reform Plan, and its application in areas such as medical care for maternal and child health issues, palliative care, and personalized health data was also introduced.
Eduardo Banzon of the Asian Development Bank also gave a presentation from the perspective of value-based financing to achieve UHC, stating that the issues that need to be focused on as much of Asia is working to ensure access to healthcare for patients include strengthening government purchasing, ensuring that the population He mentioned the need to cover a large portion of the population with insurance, and to shift payment methods from volume-based to outcome-based value-based payments to healthcare providers (e.g., application of health technology assessment (HTA)), among others. This means that, as Asia's population ages, it will be necessary to focus on VBH (bundled payment). He also stated that digital health is the key to promote VBH.
Dr. Yasuhiro Suzuki, former Medical Superintendent of the Ministry of Health, Labour and Welfare (MHLW), in his overview of the current situation in Japan and the world after the pandemic disaster and discussion of challenges and countermeasures, stated the need for a data-driven healthcare system based on the utilization of big data and digital transformation. He pointed out that these modalities have a high affinity with lifestyle-related diseases that consume half of medical resources, that they are expected to contribute to improving productivity in the medical field, which is under heavy labor, and that they can help eliminate redundant parts of healthcare (duplication, gaps, etc.).
In closing, he quoted the words of then U.S. President John F. Kennedy during the Cuban Missile Crisis: "A crisis is both a risk and an opportunity.
A panel discussion moderated by Mr. Toshihiko Takeda, former Director-General of the Medical Policy Bureau of the Ministry of Health, Labour and Welfare and Senior Advisor to The Boston Consulting Group (BCG), followed, focusing on two topics: (1) Building a sustainable healthcare system and (2) New challenges to the healthcare system revealed by the novel coronavirus. The panelists were asked to comment on two themes: (1) building a sustainable health care system and (2) new challenges to the health care system revealed by the new coronavirus.
For theme (1), Mr. Eduardo Banzon commented that primary care is weak in many countries in the Asia-Pacific region, with many countries self-paying and dependent on private insurance, while in developed countries with well-organized healthcare systems, procurement is done by the government. It is important to effectively invest in primary care where there are economic benefits, and to this end, government purchasing needs to be strengthened and reimbursement and payment schemes need to be developed. If it is left to the private sector, incentives need to be put in place for the private sector and healthcare providers to provide primary care," he said.
Under theme (2), Vikram Kapur spoke on the importance of seamless integration of offline and online medical care in terms of treatment experience, while Yasushi Okada, then vice president of the Pharmaceutical Manufacturers Association of Japan (PMAJ), said, "We are requesting the government to standardize, integrate and structure medical big data such as electronic medical record data, but high-quality medical Mr. Suzuki pointed out the following lessons to be shared among Asian countries: (1) Do not start from the provider's perspective (the Big Data program started in the 1970s as a tax collection system, but it faced strong opposition and did not succeed due to unfavorable public opinion), (2) Excessive privacy protection is not a good way to obtain consensus, and (3) The government must not use Big Data to collect data on medical care. (2) Excessive privacy protection delays the process of obtaining consent, so a balance is needed from the viewpoint of promoting innovation, and (3) Regarding penalties for unreasonable disclosure of patient information, the line between legal and illegal disclosure needs to be clarified.
In closing the session, Vice Chairman Okada stated, "The pharmaceutical industry has a mission to contribute to the extension of healthy life expectancy and economic growth of the nation through innovation, and to create a virtuous cycle for the development of science. To realize VBH, the pharmaceutical industry will continue to strive for the creation of innovative new medicines and healthcare solutions that improve healthcare outcomes. We will also promote active collaboration across borders and work with governments and academia to unite APAC's 13 associations in working together to achieve a sustainable healthcare system," said Kenji Yasukawa of the Pharmaceutical Manufacturers Association of Japan.
VBH session speakers and task force members
Closing Remarks
Kenji Yasukawa, Vice President of the Pharmaceutical Manufacturers Association of Japan (PMAJ), summarized the day's sessions in closing.
In the past, pandemics have drastically changed lifestyles and accelerated global change. Again, in the development of a vaccine for the new coronavirus, he noted that it was a remarkable change that a compound that was pre-clinical a year ago was able to expand GMP-level manufacturing to commercial scale, complete large-scale clinical trials, and prepare for submission within a year, and that similar changes could very well occur in other therapeutic areas in the future. He pointed out that the same could very well happen in other therapeutic areas in the future. He concluded his remarks by saying, "In order to bring innovative drugs to patients in Asia faster, cheaper, and with greater anticipation, industry should accelerate R&D activities by utilizing all kinds of new technologies, including AI and gene modification technologies, etc. I hope that the regulatory side will be more open-minded and flexible. I would like to ask for a more open-minded and flexible approach in terms of regulations.
( Kazuharu Matsuoka, Director, International Cooperation Department)