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Held the 10th APAC (Asia-Pacific Association of Pharmaceutical Manufacturers and Associations) Conference
-Mission: Delivering Innovative Medicines to the People of Asia Quickly
The theme is "Overcoming COVID-19 and Toward 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 the participation of over 700 audience members. 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 JPMA, and the venue
In his opening remarks at the start of the program, Joji Nakayama, then Chairman of the JPMA, traced the organization’s history to highlight agreements and achievements. He expressed his expectations for discussions aligned with the theme of the 10th APAC—“Overcoming COVID-19 and Looking Toward a Decade of New Innovation in Asia”—and expressed his gratitude for the cooperation of regulatory authorities and the academic community. This was followed by a video message from Thomas Kueni, Chairman of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), who provided details on IFPMA’s efforts regarding the novel coronavirus.
Chairman Thomas Queni
Keynote Speech
In the keynote address, Mr. Yasuhiro Fujiwara, PMDA Chief Executive, presented on the PMDA’s efforts regarding the novel coronavirus and international cooperation.First, he mentioned the three Centers of Excellence (CoE) for Multinational Clinical Trials/GCP Inspections, Good Registration Practices (GRM), andand medical devices. He explained that since the PMDA Asia Training Center began its education and training activities in 2016 across APEC member economies, including those in Asia, it has contributed to regulatory harmonization in each of these areas, and that these efforts are also included as objectives in the Grand Design of the National Health Strategy formulated in 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 engage in regulatory harmonization in Asia as "Team Asia" by holding bilateral discussions and symposiums with Asian countries and economies in conjunction with the APAC meeting.
Mr. Thomas Kueni, PMDA Chief Executive Mr. Yasuhiro Fujiwara, PMDA Chief Executive
RA (Regulatory Affairs 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 assemblies 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 this new coronavirus outbreak, 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 Authority of Malaysia (NPRA) reported that the conditional expedited review system for medicines introduced at the end of 2020 will include novel coronavirus vaccines, that rolling applications are also possible, 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 that the National Medical Products Administration (NMPA) of China has applied the emergency approval system to the development of a novel coronavirus vaccine, and has also implemented e-CPP acceptance, remote inspections, and distributed clinical trials as a result of its response to COVID-19. 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 Attachments," including Accessibility (ease of access to information), Efficiency (efficiency), Ecological (environmental protection), Searchability (ease of search), and Arrangeability (ease of modification and arrangement). Explanation was given in an easy-to-understand manner. 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 with 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 open data e-labeling 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 the use of 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 situation in the country, where there is a lot of interest and how to proceed and provide 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 Test Exemption (BioWaiver)
At the start of the session, JPMA Quality & Technology Committee member Tomonori Nakagawa 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 the ATIM Task Force activities to date, and provided background on the post-approval Background and proposal on biowaiver in change management was explained. After that, the moderator, Ryosuke Kuribayashi of PMDA, gave an overview of the Japanese "Bioequivalence Study Guidelines," which were revised in March 2020, and explained 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 in incorporating in vitro assessment into membrane permeation assessment, and the challenges in 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 Alliance) 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 related to 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 the ECDD to learn 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 had previously had difficulty accessing medical care. 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. Explanation was given on 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 paying for their own care and relying 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.
In Theme (2), Vikram Kapur spoke on “The Importance of Seamlessly Integrating In-Person and Online Medical Care from the Perspective of the Patient Experience,”Yasufumi Okada, then Vice Chairman of the JPMA, stated, “While we are urging the government to standardize, integrate, and structure healthcare big data—such as electronic medical record data—a national consensus is also necessary to collect high-quality healthcare data,”Mr. Suzuki shared the following lessons that should be shared among Asian countries: “(1) Do not start from the provider’s perspective (a big data program was launched in the 1970s as a tax collection system, but it faced strong opposition, public opinion was unfavorable, and it ultimately failed);(2) Excessive privacy protection delays the consensus-building process, so a balance is needed from the perspective of promoting innovation; (3) Regarding penalties for the unreasonable disclosure of patient information, it is necessary to clarify the line between what is legal and what is illegal.”
At the end of the session, Vice Chairman Okada stated, “The pharmaceutical industry has a mission to contribute to extending the healthy life expectancy of the public and fostering economic growth through innovation, thereby creating a virtuous cycle for the advancement of science. To realize VBH, the pharmaceutical industry will continue to devote itself to creating innovative new drugs and healthcare solutions that improve healthcare outcomes.Furthermore, we will promote active cross-border collaboration and work together with governments and academia. United under the umbrella of 13 APAC organizations, we will cooperate to realize a sustainable healthcare system.”
VBH session speakers and task force members
Closing Remarks
Kenji Yasukawa, Vice Chairman of the JPMA, summarized the day’s sessions as the conference drew to a close.
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 you to be more open-minded and flexible in terms of regulations," he concluded the 10th APAC Conference.
( Kazuharu Matsuoka, Director, International Cooperation Department)