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- 2025-12-18 20:22:09
- InterView
- I'm happy to introduce Spinraza to patients.
- by Eo, Yun-Ho Feb 21, 2020 06:36am
- Se-eun Hwang, Biogen Korea’s CEOBiogen, a bioventure company in the US and a smaller company in Korea. Last year, Biogen Korea, which has about 10 employees, registered and launched insurance benefits for its famous spinal muscular atrophy (SMA) treatment Spinraza (Nusinersen). Prior to listing, Biogen Korea's employees had only five employees. Spinraza, a high-priced new drug for rare diseases, did not go well due to its price. Hwang was the only representative of Biogen and introduced the only but necessary new drug, Spinraza. From the approval stage to the reimbursement adequacy evaluation by the HIRA and negotiations with the NHIS, the CEO of the corporation directly persuaded the government. .After approval from the MFDS in December 2017, the company went through two reimbursement-based subcommittees and was also presented twice to the pharmaceutical benefits advisory committee .After a long discussion, It was able to pass a deliberation by accepting the pre-approval system in the form of a refund/expenditure cap of risk sharing agreement (RSA) in last April .Dailypharm met with the CEO of Biogen, Se-eun Hwang who launched a new drug in Korea to hear about the company's future .-For the general public, Biogen is a unfamiliar company so far .Please introduce briefly Biogen is a global biotechnology company founded in 1978 by five scientists, including Nobel laureates Walter Gilbert and Philip Sharp .Although it is a young company with low recognition in Korea, it is widely known as a neuroscience specialist company with over 40 years of history in the United States .The mission of the company is 'At Biogen, our mission is clear, we are pioneers in neuroscience' .In particular, the aim is to provide solutions in areas where therapeutics have not yet been developed and where more effective therapeutics are still needed .Until now, we have been developing and supplying therapeutic drugs in a wide range of neuroscience fields such as rare diseases and multiple sclerosis, Lou Gehrig's disease, and Parkinson's disease, which are equivalent to the field of neuroscience .-What is Biogen's goal in Korea and its short-term and long-term goals ?The first purpose of the Korean subsidiary was to allow for the rapid introduction of SMA therapeutic Spinraza into Korea .A Korean subsidiary was established after FDA approval in the United States in 2016, and the goal was to focus on creating an environment in which spinal muscular atrophy patients could have treatment as soon as possible .The short term goal is to improve the environment so that patients can be diagnosed early and begin treatment .Although Spinraza was released in April last year, it is a rare disease treatment, so I think there are a lot of patients who are not aware of the disease .It is also important for medical staff to provide accurate information with more opportunities for Spinraza .The long-term goal is to build and promote a foundation for providing patients with new drugs that can be introduced into the country in the future .To provide Korean patients with as many clinical opportunities as possible and to expand their investment in domestic clinical research to create a win-win environment .-It has been 40 years since its establishment .It's not short, but the only drug introduced in Korea is Spinraza .Companies basically aim to bring together many talented people to achieve business goals and grow together .Biogen Korea is pursuing an efficient structure .The currently approved drug is Spinraza, which has an optimized staffing structure .In the future, the introduction of new drugs will expand the scope as well as human resources .-Even if there aren't many drugs yet, Isn't the size of the corporation quite small ?Biogen pursues a small but strong organization .Biogen Korea was established with the initial goal of supplying Spinraza to Korea .And Biogen is an organization where the best people are agile in many situations .This spirit of bioventure is what makes Biogen a success for 40 years .-What corporate culture do you want to build as a CEO, and how do you want to run it ?Biogen aims to be a 'Matrix Organization' as a way of collaborating organically with employees in different departments while maintaining existing departmental systems .The Korean subsidiary is also a horizontal organization, where employees work in a way that reports directly to their line manager, instead of going through a number of procedures for each area of expertise .Each employee is an expert in his field .Last week's employee workshops also highlighted the importance of collaborating with experts in each field .-Are there any preparations after Spinaza ?It is difficult to know exactly which drugs will be introduced first (including next year and the future) .Rare diseases are difficult to develop therapeutics and predict the clinical outcome .Biogen is currently in phase 1 to 3 clinical trials of more than 20 pipelines worldwide .Although it may not be decided immediately, Biogen Korea's role is to make it possible to provide domestic patients as soon as possible when new drugs are introduced .-Listing and launching Spinraza was not an easy process .Please give your impressions .There were various discussions before insurance coverage was applied .I think it's too early to say it's because I think it's on the reimbursed list but it's not over yet .However, compared to the first time I decided to join Biogen Korea and wondered whether I can introduce Spinraza to Korea, It is a pleasure to be able to apply the benefits quickly and to be able to receive treatment .-What was the hardest part of the listing process ?Personally, I think it was the hardest thing to solve one by one with everything uncertain .Spinraza, in particular, had to start reimbursement process right after I joined Biogen as the first employee, but it was the most difficult to predict because I had never had a big role in the reimbursement process before, so the prediction of the possibilities was the hardest .-I wonder what the process of coordination with the head office was like .I think it was the first branch of Korea and the process of coordinating with the head office was not easy .How much does Biogen headquarters consider the situation in Korea ?Until I joined Biogen, I was primarily responsible for commercial work, and I was not directly responsible for Market Access .However, in the light of industry stories and personal experiences, the support is clearly a big boost .Biogen understands the domestic situation at a high level .In particular, close negotiations between the government and the company are very important in drug price negotiations, and in the process, the head office supported a large portion of them, which led to a successful reimbursement listing .It is also a reason to feel proud as a member of the company and to thank the company .-You have marketing experience in 'Soliris' in Handok, and Spinraza in Biogen .The two types of pipelines that represent careers are rare diseases .Is there any reason to be particularly interested in the field of rare diseases ?I have been in the pharmaceutical industry for over 20 years, but until I worked in Handok, my major was chronic disease .At that time, I was proud of all my medications and worked with the conviction that patients taking medications were much more useful than their competitors .After joining Handok, I was responsible for treating rare diseases for the first time .Unlike in the chronic disease market, which was judged by market share, I was able to feel and think more closely about the changes in patients' lives than in the market for rare diseases.
- InterView
- 27 years in the HIRA, feeling worthwhile in public service
- by Lee, Hye-Kyung Feb 03, 2020 06:20am
- There is a problem that the HIRA and the NHIS, which have completed the relocation to Wonju Innovation City, are worried. It is about recruiting professional personnel such as doctors and pharmacists. In particular, The number of pharmacist recruitment is 72 of the HIRA and 35 people in the NHIS, but both institutions cannot failed to fill the recruitment capacity. On the contrary, with the relocation of Wonju, pharmacists left one by one, and there are limits to filling up the vacancy even if the pharmacists are filled through the recruitment process from time to time. In this situation, let's hear about the advantages of public pharmacist from the director of Drug Management Information Center, Mi-young Yoo(54 years old, Duksung University 86)who returned from the Sejong Institute for the past year. Yoo joined the Medical Insurance Association (The HIRA Former) in 1993 and took charge of the Pharmaceutical Reimbursement Accreditation Standards, and in 2006, she continued his expertise as a pharmacist at the HIRA by applying for an open position as a director of the drug re-evaluation department. "It's been 27 years since I joined the HIRA. I worked as a pharmacist for 23 years in the pharmacy management departement, I was the head of the DUR management office and returned to the information center after dispatching to the Sejong Institute". In the first half of 2014, Yoo was the head of the Drug Registration Division, which was in charge of the core tasks of new drug reimbursement deliberation, including economic evaluation. She was a pharmacist at the time and followed the title of 'economic evaluation expert'. In January 2015, she went to Korea National Defense University (KNDU) for 1 year while she was promoted to general manager. In 2016, she was head of the dept. of therapeutic materials, and in 2017 after director of reimbursement department, she was returned to the head of DUR management, which is highly related to drugs. Pharmacist, Mi-young Yoo, is a young director who has been promoted to a director in her 40s after being recognized for her professionalism. Nowadays, she has been to the Graduate School of Defense and the Sejong Institute. It is like getting blood from a stone. "Life on the HIRA was a personally rewarding, opportunity to get a lot." The director Yoo has played an important role in the overall responsibility of drug distribution, reimbursement and patient safety management in the HIRA, from the Drug Management Office and the DUR Management Office to the current Information Center. She said, “The HIRA's role is to monitor pharmaceutical companies and wholesalers, but also to help the public receive better services, and as a pharmacist, I pride myself on the work of the public as well as pharmaceutical work. Because of this, I think I've been able to stay on the HIRA for a long time”. According to the recent complete relocation of Wonju, she said, "If you think that it is rewarding, fun and for the people, you will find the charm of a public pharmacist". In particular, she noted that the role of the pharmacist in the HIRA is more characteristic than other institutions. "The place where all the information of the medicine is gathered is the HIRA, and whatever role you play as a pharmacist, you will be in charge of all the important tasks related to the medicine. Nowadays, "work & life balance" is very important, and I feel that it is" work & life balance" that I can be rewarded and have fun". The director Yoo also said that while she was in her twenties and thirties, she was told by her colleagues why she works in public institutions with little pay and no treatment. However, she is in her 'activity' compared to her peers who are living in their usual patterns after their late 40s and 50s. "When I look at my colleagues around the world, they worked at drug companies, hospitals, etc., but most of the time, they work at retail pharmacies as they are getting older. I'm proud to say that I've done well when I look back on the work related to the health insurance and medicines that I've dedicated to youth“. The director Yoo said that the idea that our family and our people can receive proper health guarantees acted as a support. She emphasized that, unlike other public institutions, the HIRA, where there are many women, is also good for female pharmacists to work".
- InterView
- “Changing the public’s view on psoriasis patients”
- by An, Kyung-Jin Jan 22, 2020 06:27am
- (From upper left in clockwise) Manager Hwang Chae-rin, Reward Manager Kim Ye-ji, Public Relations Manager Jeon Se-bin, President Park Hye-won) “Too many people had no or wrong idea about psoriasis. We opened the crowd funding to raise awareness of psoriasis and to improve the public’s perception on the disease.” A university student-centered crowd funding union, ‘Wishtree’ opened a new funding project this month. The project aims to help patients with psoriasis. Although the non-infectious disease can get better with constant care, many psoriasis patients struggle with public’s inaccurate knowledge of the disease. Their small wish is for the people to see psoriasis as normally as they see atopic dermatitis. Daily Pharm interviewed Wishtree administration members—Park Hye-won (23, Sookmyung Women’s University), Kim Ye-ji (21, Sookmyung Women’s University), Jeon Se-bin (22, Dongguk University), and Hwang Chae-rin (22, Hongik University)—actively campaigning for a better social view on psoriasis. Met through crowd funding related class, the union has been operating for two years Wishtree is a university student group union formed in 2018 to create and operate crowd funding projects. Initially, the students taking crowd funding class came together to make a crowd funding project for a social cause. The first year of Wishtree funded for firefighters, patients with retinal degeneration and raising awareness of the East Sea. And the second year followed with funding for various social class including patients with complex regional pain syndrome (CRPS). The crowd funding project for psoriasis patient consists of 15 students including four administration members (President Park Hye-won, Reward Manager Kim Ye-ji, Public Relations Manager Jeon Se-bin, and Story Manager Hwang Chae-rin). The rest of the eleven members are participating under the following three teams; Reward Team in charge of selecting, making and pricing rewards; Story Team in charge of planning and setting up projects; and Public Relations Team in charge of promoting the funding project to reach the target amount. Members of Wishtree Regularly meeting every Saturday, the members learn about crowd funding in class and discuss about project topics first. And when the next topic is decided, the members specify activities in back story planning, reward selection, and PR activity planning. Further discussion flows as they each designate role in respective teams and share feedbacks on the team’s activities. Jeon Se-bin, a Public Relations Manager, explained “Wishtree’s crowd funding projects are not for profit, but for public interest and social cause. When recruiting for the group members, we value not only the students’ interest in crowd funding, but also their interest in social issues.” People misunderstanding the condition as an infectious disease, “Heart breaks as the patients feel isolated from the society " So what motivated them to select psoriasis as their funding topic out of all candidate diseases? The students answered, “Compared to other diseases we’ve talked about, psoriasis needed the most attention from the public. Even many of us did not know much about the condition, and some heard about the disease for the first time.” Psoriasis is a non-infectious chronic skin disease causing raised, red, scaly patches on skin and repeatedly worsens and recovers. With continuous care, a patient with the disease can improve the condition, but many miss their treatment timing because most of the people are clueless that it requires constant treatment. And majority of the patients are having difficulties in their social life due to people’s misunderstanding of the disease being infectious. Typically, a crowd funding project selects more popular topics to raise the funding success rate, but Wishtree saw the grave issue in the public’s inaccurate view about the disease. Apparently, the students interviewed psoriasis patients and truly felt the need to correct the common misunderstandings, when they heard a patient answering ‘We wish psoriasis would be taken as normally as atopic dermatitis.’ Manager Jeon said, “It broke our hearts when we studied about psoriasis from news articles and statistic data, and found how a lot of patients feel isolated from the society because of the people’s fear of the disease being infectious by judging if from visible condition.” She added, “We have decided to fund the patients as we discovered poor public awareness is hurting the psoriasis patients the most.” Personally designed mug as a reward for funding The crowd funding project has started calling for funders from Jan. 2 through a social venture, ‘Oh My Company.’ The funding participants would be rewarded with a personally designed mug, cup coaster, and sticker sets with hopeful messages. The fund raised via the project would be entirely donated to Korea Psoriasis Association, and used for survey research and publishing news articles through ‘Oh My Company’. President Park Hye-won of Wishtree showed her ambition for the project saying “We hope the funding raising project would help change the people’s inaccurate views about psoriasis patients,” and “in the long run, we also hope that Wishtree’s good influence would expand on in the future.”
- InterView
- “Why it took 20 years for new flu drug Xofluza to be out”
- by Eo, Yun-Ho Jan 16, 2020 03:07pm
- Since the 2009 flu pandemic, Tamiflu became a prescription drug with household name like Viagra. Tamiflu (oseltamivir) is a good drug. It shifted the world’s paradigm on influenza management and became the symbol of neuraminidase inhibitor drug. However, the unmet medical needs still exist in the market. Antiviral agent can always develop resistance, but for influenza treatment, no other agent than neuraminidase inhibitor is recommended. In Korea, the influenza vaccination rate boasts a top world class level, but 2.26 million patients have been infected with influenza in 2018. After two decades since Tamiflu was commercialized, Roche has showcased Xofluza (baloxavir). The new drug has a novel mechanism of action that inhibits polymerase acidic endonuclease and treats influenza with only a single dose (Tamiflu requires a five-day treatment). Daily Pharm met with Roche’s Principal Global Medical Director, Aeron Hurt, and spoke with him about the meaning and possibility created by developing Xofluza. He used to serve as a senior research scientist at the World Health Organization (WHO) Collaborating Centre for Reference and Research on Influenza. -What was your role at WHO? And what motivated you to be interested in influenza out of all infectious disease to study? At WHO, I led a team of researchers to analyze and monitor antiviral agents and vaccine for patients with influenza. Analyzing antiviral agents and vaccines’ effect at a research center in Melbourne, Australia, I came to realize the necessity and urgency to mange influenza better and more effectively. And naturally, I got interested in and passionate about advocating the importance of antiviral agent and vaccine to effectively manage influenza. -When it comes down to ‘influenza management,’ it is divided into ‘prevention’ and ‘treatment’ blocking the viral transmission. What is your idealistic management plan incorporating the two factors? First, the National Immunization Program (NIP) has to generate the maximum effect with limited resource. Accordingly, the government could consider conducting or expanding NIP focusing on patient group with high risk of inducing complications or with possibility of optimal vaccination effect. As WHO recommends, patient groups of the highest priority for vaccination—the elderly, children, individuals at high risk of medical complications and pregnant women—should be provided with quadriavalent vaccine than trivalent vaccine for better coverage of influenza vaccination. As far as treatment goes, it is crucial to use an exceptional antiviral treatment as promptly and widely as possible when it is released. Same goes for Xofluza and other antiviral treatment to be released in the future. Instead of saving the new and effective antiviral treatment as a last resort for a pandemic, patients’ symptoms should be alleviated by treating the patient with effective antiviral from the beginning, while social and financial burden of influenza should be lowered. -It sounds like you have Xofluza in mind. Could you elaborate on the major clinical outcomes of the treatment for the readers to fathom its efficacy? Xofluza demonstrated its positive efficacy in CAPSTONE-1 study treating a healthy patient group aged 12 to 64 diagnosed with acute influenza symptoms and CAPSTONE-2 study treating patient group aged over 12 at high risk of serious flu complications. Top-line findings of CAPTSONE-1 study evaluating the flu treatment on healthy adult and adolescent, Xofluza reduced the median time to alleviation of symptoms by approximately 26.5 hours compared to the placebo group. And it also demonstrated comparatively faster cessation of infectious viral shedding than the placebo. Xofluza’s median time of viral shedding marking 24.0 hours (about a day) was meaningful, as the placebo group took 96.0 hours (about four days) and oseltamivir group took 72.0 hours (about three days). Meanwhile, the CAPSTONE-2 study evaluated the treatment’s effect on elderly patient and who are at a high risk for influenza-related complications. The study also found exceptional effect of Xofluza as its median time to alleviation of symptoms in high-risk patient group took 73.2 hours (about three days), cutting down around 29 hours from the placebo group (102.3 hours). Moreover, Xofluza reduced the time to cessation of viral shedding in 48.0 hours, which was about more than 50 percent improvement than the placebo (96.0 hours) and oseltamivir groups (96.0 hours). -In the CAPSTONE-1 study, pediatric patients aged 12 to 19 years did not receive Tamiflu. What was the reason? The study was conducted in the U.S. and Japan from December 2016 to March 2017. The reason why adolescent patients from 12 to 19 were not in the Tamiflu group was because Tamiflu was not recommended to adolescent patients in Japan when the study initiated. Currently, the limitation has been lifted. For your reference, CAPSTONE-1 study had to apply equivalent condition to all participants in the U.S. and Japan, so the U.S. participants from age 12 to 19 only received Xofluza and placebo. -The outcomes of CAPSTONE-1 does not seem to show significant difference between Xofluza and placebo arms’ time to alleviation of symptoms The time to alleviation of symptoms between two groups may not have shown exceptional difference as the evaluation of ‘symptom’ could be subjective. The severity of symptoms could differ from each individual. And a patient infected with influenza virus show cytokine response, which is induced regardless of decreased virus titer. Therefore, it would be quite difficult to reduce the time to alleviation of symptoms by 24 hours more than the available antiviral agents, despite the new antiviral agent considerably shortens time of viral shedding. The most important differences between Xofluza and existing antiviral treatment are reduced time of viral shedding and lessened risk of complications. -With Tamiflu, there was an issue with neuropsychiatric events. Was there any similar event reported from Xofluxa study? The company is closely monitoring patients who have taken Xofluza, and there has not been any report of adverse neuropsychiatric event so far. Influenza itself could affect patients in neuropsychiatric event. And also, the correlation between oseltamivir and neuropsychiatric event in treated patient has not been proven. So medical professionals should carefully consider treatment benefit and adverse reaction from antiviral treatment and prescribe Xofluza according to the patients’ individual conditions. The same applies to Tamiflu. Although there were reports of adverse reaction in Japan about a decade ago, but the Tamiflu prescription limitation has been lifted and the public’s perception has been changing as well. -The present indication for Xofluza is quite narrower than other available flu treatments. Are there any other ongoing clinical studies? A few studies have been completed, but the outcomes have not been officially announced, yet. They specifically were on post-exposure prophylaxis and pediatric patients. The prophylaxis study evaluated probability of a patient diagnosed with influenza transmitting the virus to their household members, who have been administered with Xofluza. The study result found the risk of influenza virus infection has gone down by 86 percent when administered with Xofluza. Another clinical study, MINISTONE evaluated virus titer and time to alleviation of symptoms in children aged one to less than 12. Also, there are three more clinical studies currently calling for participants. The first one is for infants younger than 12 months, whereas the second one named FLAGSTONE is evaluating the efficacy and safety of Xofluza in combination with the current standard of care, compared to the standard of care alone from hospitalised patients. The study would administer Xofluza not by single dose, but by total three times respectively on the first, fourth and seventh day of treatment. Lastly, the CENTERSTONE study is reviewing Xofluza’s effect on patient’s viral infectiousness. Unlike the previously mentioned post-exposure prophylaxis study, the treatment is administered not on the household members, but only on the patient. The study aims to not only confirm time to alleviation of symptoms, but also the infectiousness to household members. -Is there any other investigational drug in development at the moment? Xofluza blocks polymerase acidic endonuclease, an enzyme crucial for viral replication. Other candidate medicines inhibiting different enzymes are in R&D phase by other respective companies. If these investigational medicines have successful clinical trials, they would be commercialized as well. However, pharmaceutical companies, including Roche, have tried researching other mechanism of antivirus treatment like monoclonal antibody, but most of them have failed in clinical trial phase. Considering the challenges, release of Xofluza is particularly meaningful. The fact that Xofluza works in a novel mechanism of action, developed after twenty years, illustrates how the journey of developing an antiviral treatment is challenging and rough.
- InterView
- “Key to healthcare innovation is pharmaceutical industry"
- by Kim, Jung-Ju Jan 02, 2020 06:08am
- Korea’s Ministry of Health and Welfare (MOHW) has stated two core goals of the current administration are ‘creating an inclusive welfare state’ and ‘supporting innovative growth of emerging industry.’ The key is definitely the pharmaceutical industry. During a question and answer session with correspondents, Park Min-soo, a director of Health Insurance Policy Bureau under Office for Planning and Coordination at MOHW, said this year the ministry is committed to support all-around new drug development covering from basic science research to commercialization, and to strengthen industry competitiveness. Director Park, in charge of the ministry’s budget plan each year, allocated 12.9 trillion won on healthcare sector this year. The plan reflects the record-high National Health Insurance state funding of 1.86 trillion won, whereas 2.7 trillion won was allocated besides for healthcare. Director Park stressed the importance of pharmaceutical industry among the industries government is backing up. He elaborated, “Other than the goal of creating inclusive welfare state, the government is devoted to support innovative growth of emerging industry.” “The government is trying to find the hidden gem of the healthcare industry and create an environment to polish it. Among the emerging industries of IT, bio, pharmaceuticals, agriculture, and food the government is currently pushing on for innovation, the pharmaceutical industry is the most valuable key,” he continued. One of ongoing inter-ministerial programs supporting the key industry is the big data platform project. Director Park explained, “Big data utilization is expected to embody vast amount of data, but it needs the government to build a foundation to optimize utilization of the information, because it has a limitation of private information protection.” So apparently the director allocated budget to connect the dots between dispersed information. Government support for R&D is another highly expected project. He emphasized the investment value for R&D is high as Korea’s R&D investment rate against GDP is at worlds highest. “From basic science research to commercialization, we need to bridge the gaps to ultimately make a living out of the industry. To strengthen the industry competitiveness, the ministry would support new drug development in every step of the way and also train specialists to reinforce the industry strength,” Director Park said. He added, “Laying the groundwork for the R&D system would encourage more research activities and contribute on advancing technology further. The result may not be tangible immediately, but the government is committed to continue support it.” Moreover, Director Park explained about MOHW’s plan to open a tentatively named ‘Office for Health Policy’ that reinforces government’s preventive healthcare programs to reduce medical expense and solve the issue of increasing dependants in the aging society. Additionally, he emphasized the importance of preventive healthcare programs to get under way from this year. “The point of the policy in the end is to make people live their lives without dealing with serious health condition. Mobile Healthcare program providing high-risk chronic disease management would open 30 more centers this year, while the mental health sector would secure human resources and open Emergency Intervention Team with 39 percent increase in budget,” he said.
- InterView
- The key to drug development is not just safety and efficacy
- by Jung, Hye-Jin Dec 05, 2019 06:12am
- 박영준 대표“In short, it is an area that is easy to miss even though it is important enough to be the core of new drug development. Most of the domestic companies that have applied for a permit with the US FDA or the European EMA are asked to submit additional data. As more and more pharmaceutical companies are attempting to penetrate overseas, Korean companies are also beginning to recognize the importance of quality data”. The reporter met with Park Young-jun, Ph.D. (55, Seoul National University) who is a professor of Ajou University, to hear about CosmaxIMD, IMDpharm joins a venture founded by CosmaxPharma. However, Professor Park emphasized the importance of Chemistry, Manufacturing and Controls (CMC) in the new drug development process. Professor Park has been developing medicine at pharmaceutical companies since graduating from pharmacy. After 17 years as head of product development at Yuhan Research Institute, he worked as research director at Samil Pharmaceuticals and CJ Healthcare. Korea's No. 30 new drug 'K-Cap' is a product that he developed as a CJ research director.Professor Park then set up a new drug research institute. IMDfarm stands for 'Innovative Medicine & Drug Delivery'. ◆Overlooking the importance of CMC to ensure 'quality of material' IMDpharm is a company researching new innovative new drugs, ▲At the same time as developing new innovative medicine for intractable diseases, ▲Improving absorption of poorly soluble drug solubilization, a pharmaceutical formulation technology ▲Sustained Release Drugs ▲Persistent Injectable Technology ▲Disease Targeted Nanoparticle Technology ▲ It is a company that develops convergent new drugs by holding technologies in various formulations such as eye drops and external preparation technologies and applying them to new drugs. However, at present, IMDpharm's cash cow is quality management, or CMC, which is an essential element in the process of leading clinical trials. Venture companies that are engaged in new drug development are the main customers of IMD Pharm CMC service. According to Professor Park, there is no company in Korea that offers a full range of CMC services from nonclinical to clinical. Most of the nation's top pharmaceutical and venture companies, which spend ₩billions on new drug development, use CMC companies in China or India. This is the result of the CMC not receiving attention in the domestic pharmaceutical industry. But the mood has changed recently. This is because CMC, the quality control of the substance, is considered as important as the efficacy and safety of the drug. "The first thing to notice when developing a new drug is the effectiveness, because any substance has a 'pharmacological effect' to get started. The next thing to notice is safety. It is marketable as a drug, 'Quality Control' covers the whole process, from the beginning to the end, demonstrating that all experiments and tests are made of the same substance and keeping this process as records and data". A typical case is 'Rolontis' by Hanmi Pharmaceuticals, . In March, the US FDA requested additional data from Hanmi Pharmaceuticals for marketing approval, which is CMC data. Overseas, the quality control of substances has already been considered important, and more quality control data are required for companies attempting to obtain a marketing license. Professor Park said, "The reason we have to conduct CMC thoroughly from the beginning of new drug development is that we can't do the same clinical trial again." "Even if you already have finished the clinical trial and submitted the results, if you should prove that you have tested all the animals and humans with the same substances and without impurities, can companies that haven't left their data back in time?" "CMC is important for finished products as well as new drugs, increased impurity risk " "Controversial impurity management is also an important part of CMC. With the development of analytical techniques and tightening impurity regulations, this poses a greater risk for pharmaceutical companies. CMC will become even more important throughout the production and distribution of finished products, and Valsartan, Ranitidine, and Nizatidine are all about this. " In this atmosphere, IMDpharm has recently expanded its business. Established in 2016 and started full-fledged business from 2017, the company expanded non-clinical CMC to clinical CMC from August. In September, the company established a joint venture with CosmaxPharma. Cosmax Pharma, which has a finished mass production facility, produces the formulation developed by IMDpharm. “CosmaxPharma and IMDpharm have combined to provide full-service services for CMC, and this year, non-clinical and clinical CRO, Dt & CRO (DTI & CRO), will join us to ensure the safety of materials at all stages of drug development, from non-clinical and clinical. The ultimate goal is to increase the success rate of new drug development for domestic companies”. Professor Park would like to help create a new drug development foundation so that all the processes and technologies necessary for drug development can be solved in Korea".
- InterView
- “Number one in Asia is what we are shooting for”
- by Kim, Jin-Gu Nov 26, 2019 07:15am
- “As far as dermatological treatment business goes, I think we have a shot at becoming the number one in Asian market”, Cho Yong-joon, CEO at Dongkoo Bio & Pharma (“Dongkoo”) commented. The CEO said ‘entering global market’ is the next long-term goal for the company while it gets closer to its 50th anniversary next year. CEO Cho was confident that Dongkoo’s two most prominent business sectors, dermatological treatment and contract manufacturing, would both be competitive in the global market. He explained the recent aggressive investment and company expansion have been executed with the global market in mind. Visiting his office on Nov. 18 for an interview, it has not even been 24 hours since came back from his business trip to the U.S. Apparently, Cho was already making moves for the global market. -What business took you to the U.S.? “It was to dip our toes in the water of global contract manufacturing organization (CMO) market. I shared some positive talks with a U.S. company especially on our strength, the soft capsule manufacturing. When we ink the deal, we would fully disclose the story. Next year would be Dongkoo’s 50th anniversary. Accordingly we would put forth our global market vision”. - Would it be safe to assume the latest Hwaseong plant expansion was a part of the vision? “We have invested ten billion won. The plant started running from this month. Our production capacity would go up half as much again as before or even double. The company’s CMO sector made 21 percent more last year with 33.1 billion won, compared to 15.3 billion won in 2014. We are expecting to make about 40 billion won this year. To date, the manufacturing factory could not catch up with orders pouring in. “When the manufacturing facility stabilizes from next year, the overall sales and profit would rise. Not only did we enhance production capacity, but also we are focusing on developing new technology on soft capsule. We gained expertise in dermatological treatment through our experience”. -After the valsartan incident, many are concerned of CMO industry “Korean CMO industry is faced with crisis and opportunity all at the same time. As the regulator decided to abolish the joint bioequivalence test system, and revived the gradual drug pricing system, I expect the industry would get the blow soon or later. That is what Dongkoo is preparing for. Specialization and differentiation is the key. The government is also encouraging companies to focus on specialized manufacturing. So far, Dongkoo has been doing well with soft capsule and ointment items. “But the opportunity lies in the global market. Korean CMO industry would be competent enough in the global market. I confirmed that at the CPhI Worldwide 2019. From now on production cost would heat up the already competitive generic market. Now it’s a matter of who sources drug the best. Korean companies could also easily source drug from other countries. We all need to target the global market competition”. -What are your visions on Dongkoo’s specialized sector, dermatological and urological treatments? “Not too different from others, we’re aiming for the global market expansion. First, we would tackle the Asian market. The company is carefully preparing for the leap. To be specific, we are considering opening an office in China. In Korea, our dermatological treatment prescription is ranked at the top with, and urological treatment prescription is at eighth place. Why not then go for the top rank in Asia? This is our goal. We have constantly introduced dermatological treatment. Some are ready to be released next year. For the long-run, we are in process of developing new drug and incrementally modified new drug”. -You’ve shown some notable moves not only on facilities but also on venture investment. “We have signed deals with Novacell Technology, D&D Pharmatech and BioNote. D&D Pharmatech is a bio venture led by a group of professors from the Johns Hopkins University School of Medicine. They are developing treatments for Parkinson’s disease, Alzheimer’s disease and rare fibrosis conditions. Dr. Lee Seulki from Johns Hopkins University School of Medicine is leading the R&D and clinical trials. “We have invested 3.1 billion won on D&D Pharmatech. The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for the venture company’s rare fibrosis treatment. Recently, the company successfully attracted 140 billion won worth of series B funding. We expect the company to go public next year. “Novacell Technology obtained its U.S. patent on atopic dermatitis peptide this year. And BioNote was the first Korean company to develop African Swine Flu diagnosis kit”. -Investment expansion comes with business profit drop. Seems like Dongkoo’s revenue has been falling for last two years. “It was given that operating profit would go down. We have spent much of capital on facility expansion investment, recruitment, clinical investment and marketing. But the actual sales revenue has constantly gone up. It verifies that the business is growing steadily. The last two years of decreased revenue was about preparing for the future ‘quantum jump’. The return on the investment is expected to show even from next year and on". -Some other business expansion on other sectors like cosmetics and medical device has been noticeable as well. “We’ve jumped into cosmetic market. ‘Cell Bloom’ is a brand based on 3D stem cell media skin care products. We are expecting the brand to generate synergy effect with our expertise in dermatological treatment. And we are taking this for a long run. A few home shopping TV channels have offered us a slot, but we turned them down. We could’ve gotten some instant sales hike, but we are planning to build the brand image centering hospitals and duty free shops first. “Besides Cell Bloom, we also have an ongoing development of bio medical device called ‘Smart X’. We are challenging the chronic disease sector with bio technology. There are unmet needs that cannot be resolved with drugs. An example would be diabetic foot (chronic foot condition derived from diabetic mellitus). Not many drugs treat diabetic foot. “Smart X is a convenient stem cell extraction kit. We have observed meaningful effect from extracting stem cell and injecting back into the ulcer on a foot. Clinical trial is in process to receive approval on the new medical technology. It would get approval in first half of next year at earliest, and generate expected sales from the latter half of the year. The approval application reviews are well on their ways in the U.S., China and Russia as well. And it’s already on sale in Spain”. -Celebrating the last 50 years of the business, what’s next for Dongkoo? “Bio sector is where Dongkoo would be investing on for the next 50 years. Cell Bloom and Smart X are on the same track as well. We would not superficially imitate bio technology, but strive for sustainable business with genuine bio technology, as I would reiterate at the company foundation ceremony. "For the goal, Dongkoo aims to transform from pharmaceutical and bio company into a total healthcare company. Dongkoo would generate great synergy effect with dermatological and urological treatments, as well as stem cell-applied healthcare technology, and reborn as a total healthcare company to cover from head to toe with diagnostic, preventive, treatment and maintenance products”.
- InterView
- I know CRA grievances better than anyone else
- by Lee, Tak-Sun Nov 14, 2019 09:59am
- For CRA(Clinical Research Associate), it is very hard to communicate with many professional people. It's even harder if you don't have expertise. I wish my juniors would work with proud. I would like to have the pride of being an expert that communicates effectively with clinical expertise, monitors clinical practice, and leads clinical practice overall. Kyungsun Kong(52 years old), CEO of dreamCIS knows CRA grievances better than anyone else. The core of the CRO(Clinical Research Organization) is often called CRA. However, CRAs have a lot of work and are irregular, so they often move over. when working as a clinical monitoring agent, you may get hurt by professional experts, such as doctors and nurses. However, the power of the CRA may gaurantee clinical trial quality. It's no wonder that pharmaceutical companies are rushing to many CROs with competent CRAs. CEO Kong was also one of the most competent CRAs. In 1995, she began to work clinical trials as a clinical nurse (CRC) at SMC. The CRC is responsible for coordinating communication between subjects and researchers. In 2003, she conducted clinical trials for 25 years, including Wyeth, Parexel and YUHAN. She worked as a PM managing CRA at Parexel, and she took care of the clinical trial of Lasertinib, a lung cancer drug as a clinical development team leader at Yuhan. CEO Kong is probably the only one who started as a CRC and experienced various duties in the clinical field and became the head of the domestic CRO. This is because most domestic CROs maintain owner representative system. About the reason why she joined dreamCIS last April,“I wanted to try new experience and challenge, CEO Gong said. dreamCIS is an important global CRO since it was acquired by Tigermed in China in 2015. It was the first domestic CRO to undergo preliminary screening. By the end of this month, it will be decided. CEO Gong said, "The goal is to stably grow dreamCIS as a global CRO and It is very symbolic to have listed stocks as a leading company in the industry. It is expected in many ways.“ In recent years, dreamCIS has been gradually increasing global challenges in cooperation with Tigermed. 20-25% of current projects are global. Most of them carry out clinical tasks in China and Korea. CEO Gong said, “Chinese pharmaceutical companies are also growing so much that there is an increasing demand to conduct simultaneously clinical trials in Korea and Japan because the data is mutual recognition.” She said, "Since the merger of Taigermed, the progress of global tasks has been increasing considerably, and there are many opportunities for domestic companies to enter China." I want to contribute to the successful entry of Korean companies to China. ” CEO Gong plans to carry out his management philosophy with a focus on improving clinical quality. She said, “The important thing is clinical quality and I pay much attention to education and talent Recruitment.” Speaking as CRO, It is the key to have good talented CRA. Especially good CRAs control clinical quality. More than 50% of the 200 employees are CRAs in the company, and 80% of them are women. CEO Gong plans to devote herself to building a good company for women to work.“There are many benefits according to the number of women, and many of our employees are working from home and flexible, and I will continue to encourage them.” "I have experienced various companies as a female representative and also as a working mom, but I think that the diverse and flexible culture and system of dreamCIS provide more opportunities for competent working moms and young women focusing on their work creatively", she added. While working as a CRA, she had a lot of hard work, but much experience brought her here with pride. She advised, "To work with professionals such as nurses, pharmacists, doctors or nurses, you need expertise in the clinical field you are in charge of, and you need to communicate based on that knowledge. I wish our staff, as well as juniors working in the clinical industry, would be proud to work with them. ” “Global CROs are starting from the CRA and going up to the country head as they build up their careers, and I also have come to this position as I build up my career from the CRAs." I think it will be a good model for new emloyees and juniors to work” she said. CEO Gong concluded that she is planning a multi-faceted business after the IPO and plans to focus on a business based on the CRO.
- InterView
- 50-year-old Pfizer Korea “For both patients and innovation"
- by Eo, Yun-Ho Nov 06, 2019 08:59am
- CEO Oh Dong-wook Half a century in Korean pharmaceutical industry, Pfizer Korea seems to have mastered ‘how to win’ in the Korean market. Pfizer took its first step into the Korean market as a joint corporation with Joongang Pharmaceutical in 1962 and founded Pfizer Korea in 1969. Except for a couple of times, Pfizer Korea’s sales have been the top among global pharmaceutical companies in Korea. Last year, the company had the highest sales so far of 734.4 billion won, a level no global company has ever reached. The key to its driving force is in ‘evolution’. The company has sought after ‘cash cow drugs’ by acquiring numerous companies like Warner-Lambert Company, Wyeth, Pharmacia, and Hospira, and also undergone various organizational reform like the recent split-up with Upjohn. Through series of changes, Pfizer and Pfizer Korea have achieved successful ‘survival’ and ‘development’ every single time. But, not all good drugs can make a success. If it were not for Pfizer’s solid foundation, its profitable drugs would not have made it. Celebrating the 50th anniversary of Pfizer Korea, CEO Oh Dong-wook (50) of Pfizer Korea spoke of the company’s history and the future. - Half a century in Korea, what have been the most important milestones for Pfizer Korea? I can say about three major achievements to note. First, Pfizer contribution on making patients live happier lives by providing outstanding new drugs. Second, Pfizer’s continuous effort to become a responsible corporate citizen of the community and to conduct long-running corporate social responsibility (CSR) activities. Many of CSR activities Pfizer Korea provide are over a decade old. Last but not least, the fact that Pfizer Korea has consistently contributed in creating a healthy pharmaceutical and bio environment along with various stakeholders to advance new drug development, health and society in Korea. Numerous clinical trials have been conducted in Korea so far, which we expect the gained experience and tips on developing innovative new drug with global company would come through eventually and immensely contribute to the future of new drug in Korea. -‘Drug’ has a unique quality as a commodity, which is why the sense of ethics is always under the limelight. But as a business, profit would have to be the main objective. What is Pfizer doing to balance out two polarizing values? Pfizer seeks for an ‘innovation that changes patient’s quality of life’. Not only Pfizer, but many of pharmaceutical companies used to maximize profit centering customer (healthcare provider) in the past. However, this day and age requires immensely high level and standard of ethics. And it makes a sense for stakeholders to have higher level of expectation on the industry than any other industry. In such strict environment, Pfizer would never seize to make every decision prioritizing and centering patients. -Reflecting patients’ voice is not that easy. A pharmaceutical company directly engaging with patients has its limitation, and a lot of times patients cannot have their way regardless. Despite availability of a great new drug, limited access (health insurance coverage) puts a gap between patient and the treatment. That is why patient advocacy groups usually voice out on drug approval review and National Health Insurance (NHI) listing policy-making processes. Medical industry has a quite unusual ecosystem, where a patient is an ultimate consumer, but an experienced and knowledgeable healthcare provider is making decisions on prescription. While a company supplies drug, consumer and National Health Insurance Service (NHIS) are paying for the drug. Even the ultimate consumer raises an issue, changes can only be made when experts’ judgment and reasonable decision making coincide. The decision making process has improved significantly compared to the past, but it still has a room to grow. As a leading company in pharmaceutical and bio sector, Pfizer plans to engage in various activities with various stakeholders in community, such as industry organization, healthcare providers’ group and patient advocacy group, to reflect patients’ voices on government policies. -As you mentioned, patients’ voices in Korean society is skewed on ‘NHI reimbursement’ and now their interest is growing on drug pricing for the same reason. The administration plans to reduce their expense on drug with expired patent and reuse the saved finance on introducing new drug to Korean market. After separating the organization into two and ‘Pfizer Upjohn’ solely dealing with expired patent, the said government’s plan could be a bad news. As a whole company, what do you think of the direction government policy is taking? Pfizer Korea has a say in making the best choice for patients, regarding what Pfizer Upjohn Korea and Pfizer Biopharmaceuticals Korea do in respective treatment sectors. My role is to represent general operation of the company when discussing with government body and other stakeholders, and respective branches are to make a reasonable decision for their own businesses. -Going back to Pfizer’s principle of ‘centering patient’, would it be safe to say Pfizer Upjohn would not oppose against Korean government when it reduces pricing of drug with expired patent? That is correct. As I said before, Pfizer’s aim is to supply as many new drugs as possible to patients and to bring changes to their lives. Regardless of patent expiration, we believe changing the lives of patients has enough meaningful merit. -But as the age of high-cost drug approaches, the gap between the government and pharmaceutical industry’s views on drug pricing is getting wider. I assume Pfizer Korea would experience discrepancies when negotiating with Korean government and persuading the headquarter office. Some are concerned about global pharmaceutical companies giving up on Korean market as more countries are referencing drug prices in Korea. Many have contributed for patients to benefit from Pfizer’s innovative new drug, but our companies’ staffs had poured in vast amount of work into it as well. We do our best to promptly introduce new drug to Korean market. And in the process, the company tries to find the middle ground between negotiating with Korean government and convincing headquarter as soon as feasible. One could simply think, lowering drug price would be the answer for putting patients first. Or in an extreme sense, providing drugs for free would be the answer if we were to truly think of patients. But, in the end, we are a company, and a company has to be sustainable. We are always faced with discrepancy between insured drug pricing and headquarter-approved drug pricing. Obviously, we are working hard to make Korean patients to receive benefit as soon as possible, and that is that is the direction we taking. While Chinese market is growing rapidly, many markets around the globe, including Taiwan, Thailand, Saudi Arabia and China have started to reference drug price in Korea. The U.S. also announced it would reference price in Korea as well. As for the headquarter office, making deficit after investing astronomical amount in R&D for new drug and receiving inadequately low pricing would be a devastating result. It would ultimately hinder any company from investing in future pipeline. This is why we need an appropriate pricing. -Let us now focus more on Pfizer. Upjohn was split from the recent reorganization. What is it like to manage the company in the new state? To enhance efficiency of Global Pfizer’s organizational structure, Pfizer Korea separated itself into two; Pfizer Biopharmaceuticals Korea focusing on new drug development and innovative drug, and Pfizer Upjohn Korea providing drug with expired patent and generic. We expect the two corporate bodies to mutually strengthen potential growth in respective fields. Based on a variety of drug pipelines and treatments each business sector owns, Pfizer aims to improve patient’s quality of life by providing treatment timely to many more patients. The approaches we would take are still in talks, but staffs’ role and responsibilities would be unchanged. -When a drug owned by Pfizer Biopharmaceuticals has its patent expired, then is it transferred to Pfizer Upjohn? No, it wouldn’t be. Drugs are categorized by disease group. -It feels like in the future, Pfizer Biopharmaceuticals and Pfizer Upjohn would be completely split up and would become completely different two entities. For now, management direction or timing has not been specifically discussed, yet. Until everything is set, both bodies would be managed under the name of Pfizer Korea. -How is the current status of the consumer healthcare (OTC) sector joint venture with GSK? As far as Global Pfizer goes, it officially announced closing of joint venture with GSK, as of Aug. 1. And accordingly, Pfizer’s consumer health sector was transferred to the new joint venture. However, each region would have different timing as to when the joint venture would take over the management. In case of Korea, the closing is delayed as the company has to complete the necessary approval process and end some ongoing operations. When the deal is finally closed, Pfizer’s staffs would undergo some organizational changes and those would be notified after everything is set in stone. -How would you define the last 50 years and the next 50 years of Pfizer Korea? Looking back at past 50 years, the company went through absence of well-established healthcare and corporate environment when it was first founded in 1969. Back then, Separation of Prescription and Dispensing (SPD), or proper medical and pharmaceutical regulations were not stipulated. But now, we feel quite proud of how Pfizer Korea contributed in building the current healthcare environment alongside many stakeholders by placing a brick at a time. In the end, we think Pfizer contributed in bringing meaningful changes to local communities and patients suffering from disease. But it also means Pfizer Korea still has a long way to go, although it made proud achievements under the corporate objective and goal. As a responsible corporate citizen and leading pharmaceutical company, Pfizer Korea would continue to keep its leadership among patients and in local community.
- InterView
- [기자의 눈] ‘깜깜이’ 약가인하 혼란, 언제까지 반복할까(K)
- by Kim JiEun
- [데일리팜=김지은 기자] 4000여개 품목의 보험약가 상한 금액 인하 단행이 임박했다. 보건복지부는 최근 지자체, 관련 기관, 단체 등에 내달 1일 자 약가인하 시행에 따른 한시적 서류상 반품 인정 안내 공문을 발송했다. 이번 공문이 발송되고 제약, 유통업계는 물론이고 약국가에서는 오히려 혼란스럽다는 반응이다. 공문 내용에 ‘약 4천여개 품목의 보험약가 상한 금액 인하 예정’이라는 표현이 기재된 만큼, 영향이 적지 않을 것으로 예상되지만 당장 어떤 대비도 할 수 없기 때문이다. 실제 복지부가 예고한 내달 1일 시행까지 보름도 채 안남았지만 현장에서는 대상 품목이나, 정확한 품목수, 인하율 등 어떤 정보도 알 수 없는 상황이다. 이런 문제는 그간 현장에서 지속적으로 반복돼 왔다. 복지부는 특정 일자에 적게는 수백개에서 많게는 수천여개 품목의 약가인하 고시를 발표했으며, 통상 고시는 시행일에 임박해 진행돼 왔다. 고시가 나기 전까지 현장에서는 구체적인 대상 목록이나 인하율 등을 확인할 수 없는 상황이 반복되면서 ‘깜깜이’ 약가인하라는 용어까지 생겨났다. 이런 ‘깜깜이’ 식 약가인하 단행은 현장에 적지 않은 영향을 주고 있다. 제약사의 경우 생산 리드 타임과 재고 정책을 조정하기 힘든 경우가 발생하게 된다. 유통업계는 시행일이 임박해서야 대규모로 가격 수정이 확정되면 출고가나 반품 가격, 재고 평가 등 시스템 조정과 서류 작업이 일시에 급증하는 현상을 겪게 된다. 반품 기한이나 기준도 제약사 별로 제각각인 상황에서 업체 별로 처리 방식이 달라 혼선이 클 수 밖에 없다. 약국은 또 어떤가. 고시일과 시행일의 간극이 짧은 탓에 재고 파악이나 청구 대비에 어려움을 겪을 수 밖에 없으며 이 과정에서 청구 오류가 발생하거나 제때 반품 처리를 하지 못해 경제적 손실을 떠안아야 하는 상황까지 반복되는 현실이다. 현장의 혼란을 최소화하기 위해 정부는 단발성으로 대상 목록을 사전에 공개하거나 서류상 반품을 한시적으로 인정하고 있지만 이는 근시안적 대책에 그친다는 지적이 나온다. 정부는 대규모 인하 때마다 반복되는 혼란을 최소화하고 정책의 실효성을 높이기 위한 제도적 대안을 고민해 봐야 한다. 현장에 혼란이 예상되는 규모가 큰 약가 조정 시에는 인하 예정 품목과 인하율 등을 고시 전에 공개해 제약, 유통, 약국 모두 체계적으로 대비가 가능할 수 있도록 하는 것이 하나의 대안일 수 있다. 더불어 고시와 시행일 사이 간극을 넓힐 수 있는 방안에 대한 검토도 필요해 보인다. 현장에서 재고, 청구, 정산 시스템 등을 조정할 수 있는 최소한의 시간은 확보할 수 있는 현실적 제도 보완이 필요한 부분이다. 약가인하는 건강보험 재정과 산업 정책 간 균형을 맞춰가야 할 중요한 부분임은 틀림없다. 하지만 ‘깜깜이’ 제도 시행은 현장 혼란을 넘어 국민 불편으로 이어질 수 있는 문제다. 반복되는 혼선과 혼란을 방치하는 것은 정부의 정책 신뢰도와 현장의 불신을 심화시키는 원인이 될 수 있다는 점을 주지해야 할 것이다.
