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- 2025-12-19 07:15:54
- InterView
- KRPIA “Narrowing the gap with gov. on appropriate pricing"
- by Eo, Yun-Ho Aug 31, 2020 05:57am
- CEO Lee Youngshin Surely, the number one value of the pharmaceutical industry is ‘new drug.’ And the multinational pharmaceutical companies’ interests are more focused on the ‘adequate value of new drug’ than ever. As the age of ‘high-cost drug’ has emerged, the government and the pharmaceutical industry’s discrepancy when viewing the drug pricing is increasingly widening. Korean Research-based Pharmaceutical Industry Association (KRPIA), an organization representing the multinational companies in South Korea, is raising its voice to narrow the discrepancy. The two parties also have had points they agree on. Last year, the South Korean health authority has expanded scope of risk sharing agreement (RSA) subjects and also announced a plan to further extend the RSA system on follow-on drugs and widen the pharmacoeconomic evaluation (PE) exemption system this year. Nevertheless, they have a mountain of tasks to work on as well. Recently, KRPIA had a conflict with National Health Insurance Service (NHIS) when it presented the revised drug pricing negotiation guideline. The government and the industry still have many issues to talk over, such as adding more drugs subject to negotiation and authorized pricing reduction, adding drugs approved with Phase III clinical evidence in development as subject for RSA, and amending detailed operational guideline for negotiating price-volume agreement (PVA). Daily Pharm met with KRPIA CEO Lee Youngshin, as she celebrates one year anniversary of her appointment, and got to listen to her opinions up close on what KRPIA sees in the age of high expectation and changes. -Based on the organization structure and member companies of KRPIA, its relationship with stakeholders tend to change time to time. For the past one year, which part did the organization concentration on? Each member company has different priority, but we are more focusing on common issues we all face instead of their respective interest. Currently, the organization has about 50 active groups, consisting of seven committees and various TF teams and working groups. With various agenda on the table, we are constantly discussing on solutions for the companies to mutually advance forward. A clear advantage is having conversations with committees formed with respective expertise. The collective expertise helps us find good solutions. The organization is trying to create a communicational platform taking in account not only for the industry, but also for other various stakeholders. -The common denominator that resonates with all stakeholders and priority, we assume, would be the ‘drug pricing.’ Let’s hear the organization’s wider perspective on the drug pricing and relevant issues. Besides KRPIA, many of stakeholders put the drug pricing first on the agenda. When the government creates regulation and environment that does not acknowledge the value of new drug by claiming the logic of drug pricing is keeping them low, the Korean pharmaceutical companies would also struggle to develop new drugs. For a single new drug to be developed, a company has to invest trillions of wons along with that many of human resources for over a decade of time. An appropriate drug pricing should be guaranteed to generate a positive cycle of constantly investing and seeking for innovative new drugs. South Korea’s national income per capita has exceeded USD 30,000, and also by growing out as a developing country, the country has consolidated its position as an advanced country. When Korea’s pharmaceutical and bio companies develop and export their new drugs, we would wish for them to be priced at an appropriate pricing in other advanced countries. There could be various opinions on what is an appropriate pricing for a drug, but for advanced countries like South Korea, using the OECD average pricing would be a reasonable answer. -It seems like the government and companies should narrow the gap between different notions of an ‘appropriate drug pricing.’ Now that the ultra expensive drugs are released to the market, the health authority’s concerns are deepening. Highly expensive drugs capable of shaking up the whole market are emerging. These expensive drugs would continue to make their ways to the market. The traditional drugs have bloomed from chemicals, but the cost of these drugs would grow further as they are branching out from new technologies in bio, cell and gene therapies. KRPIA also wishes to supply treatments with inexpensive pricing. Considering the innovativeness and social needs of a new drug, we need to have further discussion on flexibly applying ICER threshold value. In other words, RSA is the answer to mutually benefit everyone—the government, company and patients. KRPIA wants the RSA system to operate in more flexible manner, as an improved framework of RSA could have the government and companies meet eye to eye on highly expensive drugs. -As the ‘drug pricing’ has become the key agenda KRPIA deals with, the expertise in ‘government affairs’ with related government bodies are now ever so crucial. But concerned voices are growing as Vice-chairman Lee Sang Suk has left the organization, followed by Senior Director Sean Kim of Market Access and Healthcare Policy. The organization has been consistently working on government affairs. The time when KRPIA’s Senior Director Sean Kim of Market Access and Healthcare Policy Committee left the organization overlapped with the time when Health Insurance Review and Assessment Service’ (HIRA) major personnel transfer happened. And because the government has been on overdrive amid COVID-19, many of the work could not progress as we hoped to. Regardless, the organization is still engaging with the government bodies to provide them our perspectives and recommendations. Fortunately, we have recently decided on the successor of former Senior Director Sean Kim. The organization newly appointed Senior Director Kim Minyoung, a senior manager at Amgen Asia. The senior director is an excellent specialist with 25 years of expertise in market access and healthcare regulations. As she has impeccable network with the government officials, we have high hopes on her. -The headquarters of multinational companies have been lately involved with so many corporate M&A or split-up cases. And they have caused some problems in job security within the working environment. In some extreme cases, there were a couple of suicide cases within the member companies. Shouldn’t the organization step in and address the issue? The decisions on corporate M&As are made by the headquarters. Such cases have happened before, and they would stay the same in the future. Comparatively, the Korean companies tend not to go through that many M&A cases. The cultures in the headquarter countries and Korea have seem to differ from each other. In last year, the organization newly formed HR Committee. For the organization to handle the labor union issues, we have legal restrictions. However, for the relevant company management to have open conversations as much as possible, we would seek for opportunities to provide any sort of help possible. -When speaking of drug pricing and financial cost, many of the experts argue the drug pricing structure should be changed to enhance the patients’ access to new drugs. While promoting the use of generics, some say the unnecessary expenditure on pharmaceuticals, like on chronic diseases, should be reduced. But KRPIA seems to reserve its opinion on generic. That would be correct. The organization has never issued an official statement on it. It would be inappropriate for the organization to have a say in the sensitive topic affecting other stakeholders, as generics are a big part of Korean pharmaceutical companies. Generics have been the foundation of the Korean pharmaceutical industry, and it serves as a major income source of the Korean companies. One of the biggest strength the Korean pharmaceutical industry has is that every company has their own manufacturing facility. In a wider sense, we need to seek opportunities to export more Korean-made generics to the global market. -Recently, KRPIA had a dispute with NHIS. Sources say the organization submitted official statement regarding problems in NHIS meeting operation, lack of transparency in guideline revision, and illogic in pricing negation procedure. After having a meeting with NHIS, the participants were gravely disappointed in the government body. Despite our request, NHIS handed out the revised guideline at the meeting and collected them back immediately, only allowing the organization representatives to talk about limited opinions. As the guideline would work as a practical regulation to affect upper-level standards and statutes, NHIS should clearly disclose the guideline and finalize the legislation process after accepting all opinions. We welcome the government body’s decision to hold regular quarterly meetings, but we would advise NHIS to contemplate with the organization to draw up prospective improvements at the meeting. -We had sources reporting the organization having conversations on recommending different drug pricings for each indication. Setting different pricing for different indication in same substance drugs is essential to enhance patients’ treatment access. Australia and many other countries have adopted the system and we have submitted relevant recommendation to HIRA and NHIS. Although it would be challenging to implement the indication-basis drug pricing in Korea, where a single pricing is given to a single drug, the organization would continue to work with the government to introduce the system.
- InterView
- AlphaGo will lead the development of new drugs
- by Nho, Byung Chul Jul 14, 2020 06:12am
- The director, Hwa Jong Kim "The future vision of the Center for AI-based New Drug Development Facilitation is the development of a global first in class drug that combines artificial intelligence and medical data." For Hwa Jong Kim (62 years old, director), the direction of organizational management of the Center for AI-based New Drug Development Facilitation is to present a new technological innovation paradigm and create a success model in the pharmaceutical bio industry, the country's new future. New drug development is an area of cutting-edge convergence technology that requires harmonious fusion of biology, chemistry, medicine, pharmacy, computer science, and business administration. The director Kim was in charge of establishing the Electronic Medical Record (EMR) at Kangwon National University Hospital from 2007 to 2011, and is a leading figure who led the successful Ubiquitous business of the Gangwon Provincial Government during a similar period. He is currently a professor of computer science at Kangwon National University and an adjunct professor at the Korea Advanced Institute of Science and Technology (KAIST). He is a top leader in the domestic convergence big data field. The Center for AI-based New Drug Development Facilitation, launched in March of last year, has eight employees, including six developers and two administrative office workers. In the near future, it is expected that it will finish the work of the foundation and successfully attract large-scale investments, including government and pharmaceutical bio companies. He said, “The key to the future project is to explore first in class drug candidates based on government and institutional and open health care databases with the center as the focal point. Although it is still difficult to disclose, the MOHW, the Ministry of Science, ICT and Future Planning, and the Ministry of Economy and Finance are also showing great interest in the development of new AI drugs, and are expected to successfully attract national research funds.” The reason why the government is showing interest in new drug development projects using artificial intelligence is to achieve tangible and effective results. Launched in March 2019, the Center for AI-based New Drug Development Facilitation provided practical training that combines deep learning and new drug development, and trainees experienced the substance discovery process with a personal laptop by accessing the Google Colab cloud services. Recently, 29 public databases have been downloaded to successfully organize similarity metrics for genes, drugs, and diseases. Most notably, the Center conducted convergence research among AI program developers, pharmaceutical companies, Korea Research Institute of Chemical Technology, Social Security Information Service, the HIRA, the NHIS, Daegu Gyeongbuk Medical Innovation Foundation, Osong Medical Innovation Foundation, and research-oriented hospital. Currently, the Center for AI-based New Drug Development Facilitation has formed a 'Artificial Intelligence New Drug Development Experts Association' with 25 pharmaceutical bio companies such as Hanmi, Daewoong, and SK Biopharm, and is conducting various brainstorming. It is also noteworthy that some companies are showing rapid results that are entering the final stage of candidate selection. The era in which artificial intelligence predicted by IT experts goes beyond human intelligence and recognizes and learns for itself is about the next 30 years. Therefore, as A.I new drug development enters the stage of this transformation, the government, industry, and academia should prepare for future strategies. In particular, in the United States, fast track is being applied to new drugs for artificial intelligence development for rare diseases, so Korea is also in need of actively responding to these system improvements. He said, "We plan to do our best to develop organic and systematic AI drugs through network and communication by forming an industry-university alliance. In addition, we are sharing various innovations with leading global companies and artificial intelligence conferences as well as open innovation research and cases. We will do our best to provide the latest knowledge." Meanwhile, he has been consulting with the Ministry of Science and ICT, the Ministry of the Interior and Safety, and the Korea Communications Commission, and has published books on the introduction of data science and big data business. Recently, LG Electronics, Korea Electric Power Corporation, LS Group, Doosan, and KB Financial are leading the cultivation of 'data scientists' necessary for corporate AI introduction and digital transformation of existing businesses.
- InterView
- Post-corona KSC academic conference finds answer in hybrid
- by An, Kyung-Jin Jul 08, 2020 05:37am
- (From left) KSC Secretary General Kang Seokmin, Academic Director Gwon Hyeon Cheol and Head of Convention Service team at Gyeongju Hwabaek International Convention Center, Park Seo-Joon. The Korean medical academy scene also took a hit from the novel coronavirus (COVID-19). Still not contained COVID-19 pandemic had affected the spring academic conference and other events, which left the academic event coordinators in a tight spot. So what is it like to have an academic conference in the day and age of ‘Post-coronavirus?’ The executives of Korean Society of Cardiology (KSC) say they found the answer in ‘hybrid.’ They concluded both online and offline events have to be simultaneously conducted to continue exchange academic findings and network while joining the movement to stop the spread of COVID-19. KSC Secretary General Kang Seokmin (Cardiovascular Department at Severance Hospital) and Academic Director Gwon Hyeon Cheol (Cardiology Division at Samsung Medical Center) at ‘2020 Annual Spring Scientific Conference of KSC with Affiliated Cardiac Societies’ claimed, “Simultaneously convening offline and online events would become the standard style of academic conferences post-coronavirus.” The academic society intends to share the tips they have learned from organizing the spring conference with other societies and to overcome the tough time together. ◆From special guideline to simulation, a month in making Only a month ago, KSC had decided to convene the annual spring conference in the first week of July at Gyeongju Hwabaek International Convention Center. Considering a large number of frontline healthcare providers of COVID-19 response had to participate, the society had internal dispute over having a complete virtual event. But some argued back it would diminish the level of networking and academic exchange and result in long-term loss. The executives pondered on the subject and finally found the solution; a hybrid event with an offline event strictly following the disease control guideline combined with the real-time presentation streaming online. Professor Kang Seokmin elaborated, “The annual spring conference is a massive scale of an event, where seven academic societies, including KSC, Korean Heart Rhythm Society, Korean Pediatric Heart Society, Korean Society of Heart Failure, Korean Society of Interventional Cardiology, Korean Society of Cardiometabolic Syndrome, Korean Society of Echocardiography and Korean Society of Lipid and Atherosclerosis, come together. As the participation of world renowned scholars was canceled, the invited professors were disappointed in losing a chance to expand their network.” Event staffs usher in conference participants to a lecture hall after checking their body temperature The executive committees of KSC had to struggle for a month to make an exemplary event amid COVID-19 pandemic. Professor Kang personally drafted the COVID-19 Response Guideline and edited eight times. The final version of the guideline reviewed by Korean Society of Infectious Diseases (KSID) defined the infection of COVID-19 and specified the floor plan and entrance management of the conference venue, management of the venue surroundings, management of relevant staffs, enforcement of disease prevention rules in participating members and operating the conference, and management of the event planning agency staffs. A day before the conference, the professor convened the convention center service team to conduct a simulation on contacting the public health center in case of spotting a suspected case of COVID-19 and transferring the patient. Professor Kang said, “The number of pre-registered members exceeded 1,700, and 900 of them participated in the morning of the first day. Keeping the safe distances in the seating arrangement, many had to listen to the live-streamed lecture from the lounge area,” and “We are grateful for the event staffs and participants complying with the guideline and safely and successfully closing the event.” ◆Hybrid academic conference with advantages of online and offline events to become a norm While the executive directors were busy organizing a safe event, academic committees were also hectic as well. They collected presentation material and voice or video recording of the foreign speakers unable to participate, and set up an online streaming system for the academic society members to conveniently use. By analyzing the pros and cons of international and domestic conferences convened online recently, the committees were able put up the basic framework of the event. As the spring conference was postponed over two months, the committees also simultaneously worked on the fall conference to come in three months time. As a result, they developed a system to watch lectures streaming from seven conference halls by simply clicking on a Smartphone app. The voice and video recordings from the foreign speakers were played from respective conference halls in a set order. Professor Kang demonstrates the real-time streaming lecture video on a Smartphone appProfessor Gwon Hyeon Cheol explained, “According to respective hospital guideline, many of the members are not allowed to participate in the conference unless they are speaker, mediator, or a panel,” and “Insisting on convening a virtual event would bring a serious impact on academic activity and networking.” The professor says the hybrid style of academic conference that fully embraces the advantages of both online and offline events would get more prevalent in the future. Professor Gwon also stated ultimately the executives of those academic societies hosting an academic event and the government should contemplate together on further improving the hybrid academic conference on more intricate level. The professor plans to create a system that enables real-time two-way feedback for question and answer session with the foreign speakers for the next conference. Professor Gwon advised, “The government also seems to have a lot to think about on setting the sponsorship standard as the conferences are changing their forms. Hopefully, they would also talk of setting detailed standard for the hybrid style with both online and offline events,” and “They should seek the most idealistic platform together with the relevant stakeholders to reflect their opinions”.
- InterView
- EASY-ON opens up new opportunity to Xarelto amid COVID-19
- by Eo, Yun-Ho Jun 19, 2020 06:24am
- PM Jung Changho COVID-19 has brought dramatic changes to our lives. Witnessing these changes, scholars stress the importance of responding and planning for the prospective changes in the post-coronavirus era. And many pharmaceutical companies are also seeking for new changes in business model amid COVID-19 pandemic. For the pharmaceutical industry, the novel infectious disease has been increasingly limiting the conventional sales activity, which highlighted the importance of non-contact multi-channel marketing. Now the online-based marketing tools are emerging as an answer, and companies are taking the cue to expand various non-contact sales channels like one-on-one detailing service, web symposium and e-catalogue. In March, when COVID-19 was spreading fast in Korea, Bayer Korea launched non-contact detailing service ‘EASY-ON’ and swiftly tackled on the changes in the society’s trend. EASY-ON is an online video consulting solution that provides latest clinical findings and anti-coagulant prescription related medical information for primary healthcare institutes like private clinics to better manage chronic atrial fibrillation. The program has specialized nurse with clinical experience as a consultant to engage with the healthcare providers. .Daily Pharm interviewed Product Manager (PM) Jung Changho, who led the EASY-ON project launch, for the story of the present and future of non-contact sales .Bayer -Please give us a short introduction to yourself for the readers Started as a medical representative in the cardiovascular sector since 2009, I joined the Xarelto sales division in 2016 .Currently, I am in charge of planning and operating the EASY-ON project in the marketing team, and it has been over a year being the PM for Xarelto team .-Marketing and sales around the world are largely obstructed by the COVID-19 pandemic .What kind of changes have you experienced after the outbreak, and how is the Xarelto team responding to the situation ? The non-contact marketing and sales back in the day used to lack the drive .Of course, many pharmaceutical companies have been continuously working on remote multi-channel marketing before, but after the outbreak, the companies are more eager to diversify the communication channels and try them in real life .As the conventional sales are deeply rooted in face-to-face engagement, I was always skeptical of other channels and their effect .But, with the recent incident, I have learned the clients are more ready to accept the new system than how we expected, and that they are more open and positive to review a new communication channel .-Apparently, EASY-ON program launch was planned before the COVID-19 ? Actually, the plan for EASY-ON predates the COVID-19 outbreak—it was initially planned to improve the atrial fibrillation patient management .And the project took the momentum as the outbreak started in the time of the launch .The objective of the EASY-ON is to inform private clinic healthcare providers to adequately manage atrial fibrillation patients, and to fixed imbalanced information caused when using an anticoagulant .Unlike general hospitals, private clinics have contacted the company through various channels to query prescription related information, which shows the information asymmetry between the two .And this is how EASY-ON came about .The ultimate goal of the project is to educate the healthcare providers for patients to truly benefit from treatment options .-How is the program generally operated ? The first and the most important benefit of EASY-ON is having seasoned specialist nurse to give consultation via video conference call .The second benefit is that the program focuses on atrial fibrillation, which tends to require more intricate care and treatment compared to other chronic disease .The healthcare providers can access relevant in-depth information, because EASY-ON specializes in atrial fibrillation and relevant treatment information, .About three months since the launch in March, approximately 200 healthcare providers have joined the program so far .It constantly provides scheduled consulting service to the members .The EASY-ON platform offers overall ten basic learning materials based on basic information of the health condition, which is accessible on demand after the consulting session .-General hospital and private clinic healthcare providers are torn between the prescription options of non-Vitamin K antagonist oral anticoagulants (NOAC) like Xarelto and initial care .Between the two clientele, which does Bayer tries to put more focus on ? Most importantly, no patient should be left behind by any one of them .So both are very important channels we need to take care of .At the moment, general hospitals are encouraging patients to be diagnosed at general hospital and to manage the condition at clinics .And clinics anticipate contributing in the initial anticoagulant treatment in atrial fibrillation patients .Bayer’s biggest mission is to have the patients with atrial fibrillation to receive adequate treatment, regardless of general hospital or clinic, and to manage the condition properly .-Any memorable anecdote with the EASY-ON to share ? A private clinic in a hard to access remote region gave a quite memorable feedback .Despite the needs for the anticoagulant treatment information, the healthcare provider there did not have a good and efficient access to the information .But in the end they expressed gratitude for our EASY-ON program when basic information and key information needed for seeing a patient were provided through a video call platform .-What’s next for EASY-ON ? The project is aiming to secure 2,000 members within this year .Although the service has been reactively responding, the company is preparing a channel to academically engage with general hospital professors in real time for their unmet needs .For the EASY-ON clients, web symposium consisting of specialized consulting webinars would be organized to talk about differences in each clinical trial and solution in each case .And other informative materials like FAQ or newsletter would be disseminated to the EASY-ON members to answer their queries on NOAC .
- InterView
- Why is Metformin’s investigation expanded?
- by Lee, Tak-Sun Jun 12, 2020 06:11am
- Namsu Kim, the chief explains the progress of NDMA in Metformin investigation in a briefing with reporters held at the MFDS in Osong on the 9thThe "detection of NDMA in metformin preparations" published by the MFDS is different from the previous cases. In particular, the difference is that NDMA was not detected in the raw materials. ertain raw materials were a problem in the case of Valsartan or Nizatidine. And, NDMA was also detected in raw materials in the case of Ranitidine. However, in the case of Metformin, Nothing was found among 970 commercially available raw materials. Nevertheless, the MFDS prohibits the manufacture and sale of 31 drug products that have been detected in excess of NDMA by investigating the drugs. In response, a briefing with reporters held at the Osong headquarters on the 9th, Nam-soo Kim, the chief of the Food and Drug Administration, said, "We inevitably tested imported products that had no raw materials in the country and expanded our investigation to domestic finished products due to cases of substandard NDMA detection." He said, "In fact, in the case of finished drugs, it was difficult to investigate all because the number of lots reached almost 15,000," he added, "Once we screened (exactly inspected) about 970 raw materials on the market, there were no major problems with the raw materials." However, there were no raw materials for imported pharmaceuticals in Korea. Moreover, it was difficult to import raw materials from overseas. For this reason, it was inevitable to conduct a test inspection on imported finished products, not raw materials. "NDMA in imported finished products is within the standard, but it has been partially detected, and accordingly, domestic pharmaceutical products have been investigated," said Kim. "Singapore authorities and the United States FDA also investigated both raw materials and finished products." He said that the investigation had to be expanded. If the investigation was stopped on raw materials, NDMA would not have been detected in the finished drugs. However, this decision confirmed the detection in the finished product, which made it possible to estimate that Metformin was incorporated into NDMA in the manufacturing process of finished drugs. However, it was not a complete investigation of the entire lots of the drug product. According to Kim, the total number of finished pharmaceutical products in circulation was 15,000. The MFDS collected three lots of 228 items on the market and conducted an investigation. Some critics pointed out that the accuracy of the survey results is not as good as some. In response, Kim explained, "If three items of finished products were collected and investigated, NDMA was detected uniformly by lot for the same item. "There was a so-called border line, and I think it would be better if it was managed more." However, Metformin's NDMA detection is only an estimate that it will be incorporated in the drug product manufacturing process. No specific cause has been identified. "If you submit data about the parts that companies think would be the cause of their own, we will discuss with external experts and consider improving the process for reshipment," said Kim. "In the case of metformin preparation, we had to do a lot of screening, so the inspection agency had a lot of trouble testing it for 5 months," said Kim. "FDA also screened all distribution items as quickly as the results detected in the finished product, not raw materials."
- InterView
- Improvement is urgent for many generic drugs
- by Lee, Tak-Sun May 22, 2020 06:16am
- Chae Gyu-han, the section chief of the MFDSAfter the Regulatory Reform Committee recommended the withdrawal of the joint bioequivalence test restriction policy in April, the Ministry of Food and Drug Safety's first reaction was to respect the recommendation to withdraw, but said that there was still a problem with the issue of generic restructuring. In a briefing with reporters on the 19th, Chae Gyu-han, the section chief of the MFDS, commented on the recommendation to withdraw the joint bioequivalence test restriction policy that everyone will agree that there is a need to somehow solve many of the generic drugs in the market, and one of them was the joint bioequivalence test restriction policy. We respect the recommendation to withdraw from the Regulatory Reform Committee, but that doesn't mean we have given up on the problem itself. There is no change in the policy direction itself to prevent generic insufficiency. In addition, he added that domestic generic drugs should have international competitiveness and contribute to public health. The public-private council for the competitiveness of generic drugs is expected to operate for the first time at the end of April, and plan to improve for two months. Some improvements have already been made. Until the comprehensive review of the consigned generics by the evaluation agency, the consigned generics are so-called 'bundled permission management' without separate examination. Because this system is aimed at efficiency in generic screening, some people were interested in amendments to the contents of submitting three batches of production data when the entrusted generic license was announced in November last year. In terms of efficiency, it is from the perception that this system is not necessary. However, Chae Gyu-han, the section chief said, “We have opinions through legislative notices, and final regulatory review is required. But, there is no change at this time.” In addition, Mr. Chae said, "There are some agreements in the public-private council. For example, discussions to strengthen the labeling system to give more consumer information and to implement a licensing system centered on complete pharmaceuticals with a bundled licensing system. It's being negotiated well," he said. "However, it is difficult to find a way to secure export competitiveness." Reinforcing the labeling of generic drugs is discussed not only on the product packaging by borrowing ICT technology, but also on how to communicate information through a prescription preparation system or a drug safety country. "I think it is the responsibility of the Ministry of Food and Drug Safety to satisfy the information the general public needs to know," said Chae. Regarding the investigation of impurities such as NDMA of Metformin, a diabetes treatment that is currently in progress, he briefly responded that he would pursue policy decisions in the direction of minimizing public inconvenience. Meanwhile, this briefing was meaningful in that it was the first policy communication position with the reporters after the COVID-19 incident.
- InterView
- I tried to make the KOEDC 'Social butterfly '
- by Lee, Jeong-Hwan May 08, 2020 06:34am
- The KOEDC (President Young-mi Yoon)“The KOEDC (Korea Orphan & Essential Drug Center) is the place where the government and the public need attention more than any other institution. I wanted to increase the utilization of the public by spreading the awareness to the society that it is a place to supply medicines that are essential for the treatment of incurable patients and that the social supply of essential medicines does not stop. I hope that the government's support for the center's operating budget will increase significantly, and that the capacity to contribute to society will increase rapidly.” 'Inssa (Insider, Social butterfly)', which stands for social and organizational mainstream and friendly person, is a word that seems somewhat distant from the KOEDC. This is because the KOEDC is dedicated to rare and incurable disease drugs that have a relatively small number of patients or have relatively low social awareness and are less likely to receive social attention. In a way, the KOEDC seems to have no choice but to support the supply and treatment of remedies for incurable patients who are prone to alienation in society, taking on a task close to Assa (Outsider, not social). However, President Young-mi Yoon (51, Dongduk University of Pharmacy), who has led the KOECD for the past two years, made efforts to imprint rare disease and the existence of the center by making the center from outsider to insider and beyond to a social bufferfly. Director Yoon's term for the center ended on the 22nd of last month, but the appointment of the next president has not been completed, and the term has been temporarily extended without a new leader being decided. If the next president is decided, she will be officially retired. Specifically, Director Yoon is in many ways, including nurturing rare proceeds that have been solidified through 20 years of practice, advancing delivery of orphan drugs through regional centers and base pharmacy projects, and improvement of purchasing treatment hemp oil, led the improvement of the system by communicating with the National Assembly. This is the background of last year's national audit that raised the center's profits and improved the efficiency of budget support for the MFDS. Director Yoon suggested that the center's operation would be normalized based on the increase in the budget-to-government support rate for the newly appointed director's main job. The detailed work is the president's intrinsic competency and authority, but she believes that the lack of budget should not continue to do what the center has to do for the society and patients. "Unfortunately, in the past two years, we haven't completed the budget support problem for normal operation of the center, the expenditure of money, and the delivery of courier services," she said. In the end, it resulted in the issue of budget support from the MFDS and remained as the next president's homework. ” "In order to solve the safety issues of biological products that require temperature-controlled shipping and courier delivery with illegality, it is a consignment delivery pilot project, and at the same time, we have worked hard to establish a safe supply process for orphan drugs as a regional base center and base pharmacy. "The system is not complete, but I think this is the way the future center should go," she said. When asked what led the center to focus on, President Yoon responded, "I wanted to improve the utilization of the center by greatly increasing the interest of the people and society in the center." The intention is to make the KOEDC that is unfamiliar to the general public a social butterfly . "To inform the existence of the KOEDC, we needed to innovate in the center's hardware and software as a whole," said Yoon. "We moved the office to the city hall to build facilities such as pharmacies and drug warehouses in the center. This is why we created a process that minimizes supply and demand inconvenience. " Director Yun suggested that the center should plan to enhance the accessibility and safety of orphan drugs. In particular, it is said that it is the path for the country and patients to minimize the probability that the center will fall into the supply of orphan drugs even in extreme situations by closely analyzing the current situation in which the domestic supply of orphan drugs in the world is struggling due to the COVID-19 crisis. "There are more than 20,000 orphan drugs that the center supplies per year. The importance and social needs of orphan drugs are getting bigger every day," she said. Nevertheless, the center still needs to be improved in terms of facilities, management, accounting and operating systems. "It is the KOEDC that can reveal the willingness of the nation to somehow care for the underprivileged," she said. "We need to constantly monitor which pharmaceutical companies around the world are developing, producing and distributing what kind of pharmaceutical companies in the world and check the distribution line in real time so that we can have the bargaining power to supply domestic patients' drugs," said the Center. It is time to further advance the system to increase social utilization, "she suggested. “I took the job as a general manager and worked every day, at least once a week, hoping that the KOEDC would be known in the media,” said she. The center faces the challenge of formulating a budget for the MFDS for normal operation. We ask for your continued interest and support to ensure that the Center plays a role in the national health defense frontier.
- InterView
- Law firm's entry into the pharmaceuticals is just beginning
- by Kim, Jin-Gu Mar 30, 2020 06:18am
- The role of law firms has recently grown in the pharmaceutical bio industry. Some process was through law firms. Kim & Chang, Lee & Ko, Yulchon, HMP Law, and LK Partners are expanding their business areas in the healthcare field. The most prominent law firm is Lee & Ko. The overall evaluation is that, in terms of the health care team members, they compete for the first and second place in the industry with Kim & Chang, both quantitatively and qualitatively. Legal Counsel of Lee & Ko, Hyeong Gun LEE On the 24th, I met Hyeong Gun LEE, a representative lawyer (51), who leads the healthcare team at the office of the law firm in Jung-gu, Seoul. In the field of law, he is already considered one of the M & A experts. He was in charge of M&A, division, and sale of large corporations. Limited to the healthcare sector, Samsung Bioepis, joint venture of Samsung Biologics and Biogen's was established by him. When asked why the law firm is expanding so aggressively in the healthcare sector and how much more it will expand, he said that it's only now that the team is perfect and full-fledged activities are from now on. In fact, in 1994 (at that time, the US-Korea Law Firm) when he joined Lee & Ko, the law firm had a healthcare team. However, at that time, it dealt with traditional fields such as M & A, litigation, and patent issues. As the size of Lee & Ko grew, there were many healthcare tasks. In particular, the demand for customers was expected to surge in terms of insurance listing and application. Eventually, from 2017, the business in the field of reimbursement, drug price, and regulations began to expand. Lee & Ko has been recruiting talent very aggressively in recent years. Former executive director of AstraZeneca, Young-Sik Byun and former Novartis Director Sung-ju Kim, who were considered to be a master of the M&A field, newly settled in Lee & Ko. Kyung-soo Kang, former head of the HIRA, Wook Lee, former deputy head of the HIRA, and Young-sup Han, former head of the MFDS, joined Lee & Ko. Prior to that, Chae-min Lim and Gun-ik Son, former Deputy Minister of Health and Welfare were appointed as advisors. As a result, Lee & Ko’s health care team of about 50 people including lawyers and professional committees was established. Accordingly, other law firms are also competitively recruiting talent. In Kim & Chang, Kyung-Ho Lee, former Vice Minister of Welfare, Man-Bok Jeon, and Yong-Hyun Park, former Welfare Department Head, In-Beom Kim, and Jun-Ho Yang, former head of the Food and Drug Administration, and Byung-il Lee, former head of the HIRA, were recruited early. In Yulchon, Hee-jung Choi, former head of the Welfare Department, Yang-ji Ryu, former head of the Welfare Department, and Seong-jin Kim, former head of the Food and Drug Administration were recruited. “For a long time, it was planned to recruit experts with long practical experience. It may be the first in the industry. The effect of recruiting experts was more than expected. Customer satisfaction and awareness have increased considerably. We can get a good idea of what customers want. Now, it is the best in this field because the team has been built to some extent.” It is said that it is now complete as a team. As a result, Lee & Ko is able to cover virtually all healthcare sectors, from traditional tasks such as M&A, litigation, patent issues, and compliance to drug price and regulatory affairs. “Among the various tasks, the areas that I want to focus more on in the future are drug prices and regulations. It is also a matter of the individual companies we consult, but we want to put more focus on the institutional aspects. reimbursement and drug prices are directly related to national health. In fact, there are many parts of the drug price regulation that I can't understand even if I look at it as an attorney. It is said that regulation leads the industry, but the standards are too difficult and complicated. I want to be a little clearer and kinder.” It also suggested the goal of expanding its business area towards domestic pharmaceutical companies and bioventures. In fact, the main clients of Lee & Ko (especially in the pharmaceutical sector) were mainly foreign pharmaceutical companies. However, recently, a domestic company has a new drug lineup and is seeking global advancement. He also predicted that their demand would increase. “Recently, the size of domestic companies has grown. Previously, it was mainly focused on generics and sales, but recently it is developing new drugs and seeking global expansion. However, it is true that the experience of developing new drugs is insufficient. We expect it to help.In fact, inquiries from domestic companies have recently increased. I want to help with bioventure work. Many of these major contracts (M&A, investment, and funding) are thought to be unreasonable. I want to help you to solve this reasonably.” Unlike large-scale law firms, the long-term vision is different from what was expected to prioritize performance and ranking competition. In the field of healthcare, I want to be uniquely happy with the first place. We want our health care team to be happier than any other place, and we want our customers working with us to be happier. I think that unparalleled happiness is truly the number one value that cannot be counted by numbers. ”
- InterView
- CEO Cho Jeong Woo “Cenobamate U.S. release is all ready"
- by Lee, Tak-Sun Mar 13, 2020 06:30am
- CEO Cho Jeong Woo of SK Biopharmaceuticals A new anti-epileptic drug from SK Biopharmaceuticals, cenobamate (U.S. brand name Xcopri), has set a new milestone in the Korean history of pharmaceutical industry history as it independently won an approval by the U.S. Food and Drug Administration (FDA). To this date, a new drug developed in Korea has been licensed out to foreign pharmaceutical sales companies before receiving approval from the U.S. or EU health authorities. So the Korean drug developers had no experience in processing overseas approvals by themselves. Moreover, SK Biopharmaceuticals plans to independently market the drug in the U.S. market. During a recent interview with Daily Pharm, President and CEO of SK Biopharmaceuticals Cho Jeong Woo said, “In the second quarter, 120 specialists in sales would release the product in the U.S. market. We have already established a sales network that could cover all regions in the U.S. at the same time.” Cenobamate also completed the last administrative procedure for the launch as the U.S. Drug Enforcement Administration (DEA) has designated the drug as a Schedule V medicine. DEA reviews FDA-approved central nervous system (CNS) medicine based on medical indication, and risk of abuse and dependency to categorize them into five levels (from Schedule I to V). And cenobamate received Schedule V for lowest risk of abuse. Accordingly, the level of pharmaceutical management on the drug would not be as stringent. Solely owned by SK Holdings, SK Biopharmaceuticals has fully emerged as Korea’s top new drug developing company after FDA granted approvals on solriamfetol, a new drug for sleep disorder licensed out to Jazz Pharmaceutical, and new anti-epileptic drug cenobamate. Daily Pharm asked CEO Cho Jeong Woo of what has been SK Biopharmaceuticals’ driving force to win two FDA approvals in a year and to independently launch a drug in the U.S. market. Following is CEO Cho’s answer to Daily Pharm’s questions. Q. Cenobamate has received the FDA approval in last November, and was nominated for the 21st Korea New Drug Award. Please tell us about the development process of cenobamate. In 2001, the company explored candidate medicines with high potential for anti-epileptic drug and discovered cenobamate. Since then, the company took step-by-step process, including nonclinical study, Phase 1 to 3 clinical trials, preparation for new drug marketing approval application and post-review procedure. And last year, the U.S. FDA has approved the drug to treat partial-onset seizure for adults. The commitment to develop a new drug targeting the U.S. market was made from strategic call expecting that receiving the strict FDA approval and releasing it in the world’s largest pharmaceutical market would put us on an advantageous side. Now that we have the FDA approval, we plan to move forward to accommodate cenobamate to various countries’ approval regulation. Q. Please tell us in detail about the process of selecting candidate medicine, initiating clinical trial and applying for approval. Over 2,000 candidate medicines were explored from 2001, and cenobamate was selected as an investigational candidate. The drug’s clinical protocols for testing efficacy in anxiety and epilepsy were approved by FDA in 2005 and 2007, respectively. Studies were conducted to develop an innovative and new anti-epileptic drug. With over 1,900 patients, Phase 2, randomized, double-blinded, placebo-controlled trial (completed 2013 and 2015) and Phase 3, large-scale, multicenter, open-label trial (completed 2018) were conducted. On Nov. 21 of 2018, cenobamate submitted a New Drug Application (NDA) to FDA and acquired the agency’s approval on Nov. 21 of 2019 after a year-long review. In 2020, FDA also reviewed and cleared current good manufacturing practice (cGMP) on SK Biopharmaceuticals and SK Biotek that produces active pharmaceutical ingredient (API) of cenobamate. As a result, SK is now a full-fledged new drug developing company capable of researching, conducting clinical trial, manufacturing and sales. Q. The company is the first in Korea to independently handle candidate medicine exploration, clinical development, sales and regulatory approval process. What has driven the company to cruise on with the standalone development, despite the high-cost of global clinical trials and R&D? The biggest driving forces have been the ‘solid sense of purpose’ and ‘daring mind’ taking the road not taken. The R&D capacity was built on years of research, but also on the sense of purpose to develop a breakthrough anti-epileptic drug. And in the process, the company gained experience in developing global-scale new drug and confidence of new drug development by collaborating with global pharmaceutical companies on a different drug. To acquire global drug development capacity, SK also collaborated with multinational company on post-Phase1 development of Sunosi, which provided rich experience like the approval application procedure. From then on, we were confident enough to plan for a transnational clinical trial and took the ‘standalone development route,’ unprecedented at the time in Korea, by personally persuading Chairman Chey Tae-won. Q. Sources say the U.S. subsidiary SK Life Science is planning to release the drug in the second quarter. Could you elaborate on the commercialization plan in the U.S.? Cenobamate is aiming for the U.S market release in the second quarter. The company has finished planning for marketing strategies, hiring salespeople and setting direct sales network covering the whole U.S. market. Commercialization of the anti-epileptic drug would be executed through intricately designed marketing strategy as the existing options are mainly prescribed by neurologists. While there are approximately 13,000 working neurologists the U.S., some 120 neurology sales specialists, on par with the scale of sales force for other anti-epileptic drug, would promote the Korean-made drug everywhere in the U.S. Q. Is there any news about the drug in development for other parts of the world besides the U.S.? Is Korea one of them? To commercialize cenobamate in the European market, the company has signed USD 530 million worth license-out deal with Arvelle Therapeutics last year. We are planning to submit application for European market authorization approval by the end of June. Although we are solely taking care of commercialization in the world’s largest market in the U.S., we are marketing the drug in Europe based on strategic partnership with local companies to accommodate their diverse regulatory and marketing landscapes. As for Korean, Chinese and Japanese markets taking up over 90 percent of overall sales in Asian anti-epileptic market, the company is preparing clinical trial and other approval review procedure required for respective countries. Q. Aside from solriamfetol and cenobamate, is there any other highly potential candidate drug? SK Biopharmaceuticals have been focusing on CNS disease for last 27 years, and solidified distinctive pipeline in the industry. Another Phase 3 clinical trial is ongoing for cenobamate to expand indication to treat patients with generalized tonic-clonic seizure. Carisbamate, a Lennox-Gastaut syndrome (LGS) treatment, is currently in development but also received Orphan Drug Designation from FDA in 2017. A new candidate anti-epileptic medicine, SKL24741, is to start Phase I trial from this year as FDA cleared its IND in March last year.
- InterView
- On how Eisa’s intrapreneur ‘HeLpy’ is ‘happy’
- by Eo, Yun-Ho Feb 27, 2020 06:35am
- Lately, companies emphasize a notion of internal entrepreneurship, also known as ‘intrapreneurship.’ For companies, innovation is not an option anymore. And this is the time when intrapreneurship becomes the source of internal innovation. So these days, ‘internal venture’ is popular among companies. Without massive investment, an internal venture can be incorporated with existing business, and also it could leave an impression of innovative and young brand image. Pharmaceutical industry recently had an impressive case of intrapreneurship. It is Eisai Korea’s ‘HeLpy’ team. Based on the management philosophy of ‘Human Health Care (HHC),’ all employees of Eisai around the world spend 1 percent of their working time every year to engage with patients looking for their issues and find an adequate solution. And Eisai has formed ‘Innovation’ team from 2016 to support intrapreneurs, who could actualize the solution proposed by Eisai Korea’s employees trying to create meaningful value for the community and the company, Senior Manager Sung Jong-seok, Deputy Director Kim Ah-reum and Senior Manager Ahn Woo-seok Started as a part of the corporate culture, HeLpy started with Senior Manager Ahn Woo-seok and Senior Manager Sung Jong-seok from the Sales developing a health management app after completing the second Innovation Academy. And recently the team added a new member, Deputy Director Kim Ah-reum, who has experience in app management. From then on, the HeLpy team became a small but fully fledged intraprenuer. Senior Manager Ahn Woo-seok said, “As I work at a pharmaceutical company, my father asked me often about his medication. Soon I realized drug information is searchable on portal websites but it was inconvenient to save them. I liked the idea that maybe I could improve it, so I applied for the Innovation Academy.” A Smartphone app, HeLpy, helps individuals to easily manage their medications by taking a photo of their dispensed drug packaging and prescription. Besides the basic medication management, the app also provides various functions for infants and toddler care, such as vaccine notification and baby growth percentile chart. And the users can also check their bio-age and health risk based on their medical check-up records accessible with one-off personal authentification. Launching an app with only a few developers was probably not the simplest task. Before the company decided to officially select the team’s project, HeLpy team members had to use their spare time to work on it. Senior Manager Sung Jong-seok smiled and reminisced, “Everyone trying to schedule spare time to work on the project was quite challenging as we each had our own business to tend. Regardless of whose fault it was, we had to walk on eggshells at the work. Although we had some hiccups, Ahn held us together tight to push on with the project.” Senior Manager Ahn explained, “Rather than ‘content with conviction,’ I’m perceived more as ‘stubborn.’ Continuing with the story, intrapreneurship has its perks. Although scheduling is difficult, intrapreneurship has irresistible advantage of requesting for company’s support and having comparatively less risk in failure than generic ventures struggling to find investors.” Deputy Director Kim Ah-reum joining the team late in the game actually expedited HeLpy’s launch. Certified as nutritionist and experienced in health management in previous company and National Cancer Center, Kim was the missing link for the team to finally meet the unmet needs. Deputy Director Kim said, “During my first year at the company, I was still concerned of adapting into the company well. But with two senior managers’ help, I was able to settle down soon. I focused on areas I could assist, like medical check-up data follow-up. I’m exhilarated that I can be a part of HeLpy’s launch.” HeLpy is just taking a baby step, now. The team is already in process of inking a partnership deal with a large insurance company, and also it is setting up marketing strategy with a marketing agency. The app’s download count has surpassed 125,000 recently, and 48,000 members have subscribed. HeLpy team commented, “We are still learning and figuring things out. We are shooting for 190,000 download count and 70,000 memberships in March by focusing on marketing. We want to become the success case of Eisai’s Innovation Project. We are happy doing what we like with the company’s support.”
