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- 2026-03-10 00:44:54
- InterView
- “Novartis will lead the provision of innovative medicines”
- by Eo, Yun-Ho Jan 25, 2023 06:08am
- Byungjae Yoo, General Manager of Novartis Korea The Korean subsidiary of Novartis underwent a period of turmoil last year. The company integrated its Pharmaceuticals and Oncology business units in line with the reorganization policy set by its global headquarters. Before then, the company had been operating 2 separate business units independently under one name. The two units had separate support departments including marketing·sales departments as well as drug pricing·government relations·approval departments. Through the integration process, all of these departments were merged into single departments with one head. As a result, layoffs were made and the head of the integrated subsidiary was appointed for the first time since the company’s establishment. The fact that a Korean representative was appointed to head this first-ever integrated Novartis Korea was also a big change. Since its establishment in 1997 and the first president Frans Hompe, the company had mostly appointed foreign heads to lead the Korean subsidiary, including Jean-Luc Scalabre in 1998, Peter Maag in 2003, Andrin Oswald in 2006, Peter Jager in 2008, Brian Galdsden in 2014, and most recently, Joshi Venugopal. The only Korean national that had been appointed until now was Hak-sun Moon in 2015. Dailypharm met with Byungjae Yoo, General Manager of Novartis Korea, who first-handly lead the company through this momentous change. - You were appointed General Manager of Novartis Korea’s Pharmaceutical division in 2021, and then the General Manager of the integrated Novartis Korea last year. What have you been focusing on in the company amid the various changes that had been made last year? My prime focus was on finding the role and direction for Novartis Korea in the changing global pharmaceutical industry. For this, I reviewed much research and consulting reports on the global pharmaceutical industry over the past year. Also, I discussed Novartis’s strategic priorities and Korea's role with our global head office and region managers. Secondly, I tried to connect with our employees and find out what the employees wanted and how to satisfy such desires. After various discussions, I came to the conclusion that Novartis Korea as a company excelled in being ‘goal-oriented,’ but needed to make more effort in being ’purpose-driven.’ Ultimately, I want Novartis Korea to become a purpose-driven company rather than a goal-oriented company. -The Pharmaceuticals and Oncology business units were integrated last year. What was the purpose of the integration and what is your future direction? The biggest purpose of integrating the business units was to ‘do what we do best.’ As so many companies exist in the pharmaceutical industry, each company needs to find its areas of specialty, such as generic drugs or specialty drugs. Also, the needs of each society or patient are also different. Therefore, Novartis decided to integrate its business units to do what it does best – ‘ to overcome diseases’ – and focus on its 5 core therapeutic areas (cardiovascular, immunology, neuroscience, solid tumors, and hematology) to bring synergistic effects. -What is Novartis Korea’s business goal for this year? From 2018 to 2022, Novartis has had one of the most extensive and innovative pipelines among global pharmaceutical companies. Therefore, the company’s priority this year is to increase patient access to its innovative treatments. We plan to discuss how to increase patient access to such innovative treatments within the limited National Health Insurance budget with experts and reach a social consensus on the measures derived. Also, we plan to continue working with domestic companies and startups. We plan to actively support Korean companies that wish to enter the global market through discussions with our head office. -When setting the 1-year business plan, what products have you set as a priority? Among the newly launched products, therapies that are not yet sufficiently supplied to patients in need will likely be given priority. These include Entresto, Cosentyx, Kisqali, Scemblix, Zolgensma, and Kymriah. -The company received much attention, both good and bad, for successfully listing ultra-high-priced drugs such as Zolgensma, and Kymriah for reimbursement in Korea last year. I heard you have other formidable new drugs awaiting release in your pipeline. Could you share your plans for the future? Novartis is not afraid to take risks in developing new drugs for incurable diseases. This is why the company has a higher probability of developing new drugs as well as a high R&D cost. therefore, we will also need to make efforts to reduce such costs while developing new drugs. Patients talk of how a ray of hope shone through in their desperate situation with the introduction of a new drug. I think access to innovative treatments that address existing unmet needs has been strengthened in general in Korea. However, a lot of discussions are still needed on how to address the resulting increase in social cost. The issue cannot be resolved by just strengthening one part while sacrificing others. Therefore, I plan to continue discussions with relevant parties to devise measures that fit the situation. -Do you have plans in place to improve access to ultra-high-priced drugs in Korea? I think making dialogues will be the answer to finding ways to improve treatment access to such drugs. In the past, when Korea’s health expenditure amount of the total GDP had not been as high as other advanced countries and NHI finances were not in deficit, the patient's medical needs were a decisive factor in determining reimbursement. However, that time has passed, and much discussion is now required for any reimbursement. If experts provide opinions on how to finance the national health insurance and the pros and cons, including whether to finance the NHI through funds, private insurance, or bring in other sources of finances other than the NHI, we could provide opinions from the pharmaceutical company’s perspective and seek out solutions together.
- InterView
- Avodart, Real World Data
- by Dec 28, 2022 05:48am
- GSK's large-scale real-world clinical results of Avodart, a treatment for prostatic hypertrophy, which marks the 13th anniversary of its launch in Korea, have been released for the first time. Based on actual field data, the company expressed its ambition to further strengthen Avodart's position in early hair loss treatment.LEAD clinical trials are the first RealWorld study conducted to evaluate the long-term clinical usefulness of Avodart in Korean male hair loss patients. It was compared with Finasteride, the two major mountain ranges for oral hair loss treatment. 600 patients participated in five general hospitals in Korea, including Inha University Hospital and Gangdong Kyung Hee University Hospital, and the average analysis period reached 3.4 years. In particular, the Korean Hair Loss Type Classification Act (BASP) developed by the Hair Institute for data analysis with the domestic medical staff was applied. The accuracy of the evaluation was improved by using the Korean classification method, not the Western classification method, which is difficult to apply to Koreans. Dr. Gary Ong, general manager of GSK Global Dermatology Medical, who led the LEAD clinical trial, said, "This study confirmed that Avodart is more effective in treating male hair loss based on Korean classification," adding, "M-shaped hair loss is the part that patients care the most, and Avodart showed good results compared to Finasteride." LEAD clinical results showed that Avodart had a significantly higher cumulative number of patients with improved symptoms compared to Finasteride in most types of hair loss. In M-shaped hair loss, which is most common in Korean men, the proportion of patients with improved symptoms was 86.0% for Avodart and 45.5% for Finasteride, showing a difference of more than 40%p. The improvement rate of hair growth was also about twice as high in the Avodart group as in the Finasteride group. A common misconception about Avodart is that it has higher side effects than Finasteride, which inhibits only type 2 by inhibiting both type 1 and type 2 of 5-alpha reductase. As a result of the Real World study, Avodart showed only a similar level of adverse reactions to Finasteride. Dr. Gary Ong said, "As a result, Avodart was more effective, and safety was similar. "I think the results of this study not only help reduce misunderstandings and prejudices about Avodart but also help doctors make more appropriate decisions when prescribing it in real life," he explained. Based on the results of the first Real World, GSK set a goal of further enhancing Avodart's position as a primary treatment in the Korean hair loss market. This is because there is still a high perception that finasteride is used first in the early stages of hair loss and Avodart is used after further progress. Dr. Gary Ong said, "This study broadens the path to prescribing Avodart as a primary treatment. Male-type hair loss is a progressive disease, so you need to start treatment as soon as possible to get better results in the long term, he stressed. In order to achieve this goal, GSK Korea has recently increased its marketing staff. BM Kim Hwan-geun, who joined Avodart marketing two months ago, said, "Avodart has maintained the top prescription for oral male hair loss treatment from the fourth quarter of 2020 to the second quarter of 2022, and real-world data for 600 Koreans will have a positive impact on Avodart's prescription expansion." "Avodart started as a latecomer amid fierce competition and showed double-digit growth every year," said BM, in charge of Avodart. As it is expected to grow further in the future, two managers will join us in marketing, he said. "We will try to make Avodart the epitome of hair loss treatments next year."
- InterView
- IL-23 Continued research on inflammatory pathways
- by Dec 23, 2022 06:05am
- Efforts to develop treatments through various studies such as combination therapy and receptor targets. Interleukin (IL) inhibitors used in autoimmune diseases such as psoriasis are evolving as several companies continue to develop them. With the emergence of more effective treatments, psoriasis can expect "PASI 100," which means complete improvement. Interleukin inhibitors are classified according to the mechanism. Stelara, which appeared first, targets IL-12 and IL-23 simultaneously. Cosentyx and Taltz are mechanisms that inhibit IL-17. Recently, drugs that are attracting attention are Tremfya and Skyrizi, which are exclusively targeting IL-23. It is known to have the most powerful effect. As IL-23 pathway research becomes more active, evidence is accumulating that IL-23 inhibitors are inevitably more effective than interleukin inhibitors of other mechanisms. In a recent interview with Dailypharm, Daniel Cua Janssen, vice president of the immune business department, said, "IL-23 inhibitors act on immune cells themselves that activate inflammatory pathways, preventing the underlying cause in the early stages. Recently, it was found that IL-23 reprogrammed a group of T cells that produce IL-17 and found that a fairly strong inhibitor was needed among IL-23 inhibitors, he explained. Daniel Cua is a world-renowned scholar who first discovered the IL-23 pathway 22 years ago. The IL-23 route he discovered was the beginning of the development of IL-23 inhibitors such as Trempier and Skyrich. Studies on the mechanism of how IL-23 causes inflammation are still ongoing. "It is clear that IL-23 is the strongest interleukin associated with autoimmune diseases. Based on this, he added, "In the future, challenges to develop treatments through various studies such as combination therapy and receptor targets will continue." The following is a question-and-answer session with Vice President Cua. -After studying immunology for a long time, we discovered the IL-23 pathway that is the target of autoimmune disease treatment. We are curious about the history. =22 years ago, I was researching a small biotech in Silicon Valley, USA. At that time, research was in full swing to discover substances that control inflammation. The goal was to find an inflammatory control substance, but the IL-23 pathway was found at that time. At that time, not many people believed it because it was an unexpected discovery. It was only a year or two later that the substance that academia wanted to find was IL-23 which we discovered in 2000. It began to be recognized as a very important discovery. Animal models that inhibited IL-23 showed all resistance to several autoimmune diseases. This also affected future research and treatment development. The discovery of the IL-23 pathway is considered to be the starting point of several subsequent studies. - Various interleukin inhibitors such as IL-12/23, IL-17 and IL-23 have been developed as treatments for autoimmune diseases. What differences do differences in mechanisms make? =One of the most frequently asked questions is why blocking only IL-23 works better than blocking IL-12 and 23 together. To put it simply, IL-23 is the standard target we have to hit. Cytokines sometimes cross-regulate each other. Controlling one means that the other rises. IL-12 and IL-23 are. Blocking the two together in a cross-regulation relationship results in a "push and pull" conflict effect of each other's actions at the same time, which reduces the effect. Only IL-23 should be blocked to show the most precise inhibitory effect we want. IL-17 is an interleukin present in a lower stage than IL-23 on the reaction path. It has higher specificity in intestinal epithelial cells and skin epidermal cells. On the other hand, IL-23 acts on immune cells themselves that activate inflammatory pathways. For this reason, IL-23 must be suppressed to prevent the underlying cause of the inflammatory system in a more early stage. In psoriasis, IL-23 shows a clinical improvement effect of 80-90% in more than 90% of patients. - Like immuno-cancer drug combination therapy in cancer, can autoimmune diseases be more effective by combining upper and lower series that suppresses interleukin? = combination therapy is the approach that many researchers and companies in this field are most interested in. The concern is the accumulation of adverse reactions caused by combination therapy. Therefore, research on port therapy is being conducted on the most reasonable and scientific basis. A combination of specific route drugs based on biomarkers is being sought. Although it is still in its early stages, many efforts are being made to find a combination that increases the effectiveness but does not increase the response. So far, it is known that blocking complementary paths may be more effective than targeting only specific paths. For detailed research, the understanding of various paths is improved based on biomarker analysis. -How far has the research on IL-23 progressed? =The level we know is that IL-23 induces the production of receptors called IL-17, IL-22, and GM-CSF. However, it was not clear exactly how IL-23 causes inflammation. It has recently been revealed that IL-23 reprogrammed a group of T cells that produce IL-17. Reprogramming is a fairly powerful action and cannot go back because it is semi-permanent in itself. To prevent this, considerably strong inhibitors among IL-23 inhibitors should be used. In the end, I realized that inhibiting IL-23 has a much stronger effect than inhibiting elsewhere and that it is also effective in preventing lower-level diseases when applying a mechanism that prevents reprogramming at the epigenetic level to new drug development. - What are the targets or pipelines to pay attention to in the subsequent development of interleukin formulations? = First, the receptor. Ligands such as IL-23 bind to receptors, a new drug that blocks the receptor itself to prevent binding. The number of receptors is smaller than that of ligands, so it is easier to block and has precise access, making them a good candidate. The second is the study of RORgamma-t. Many researchers are targeting it, but no one has succeeded yet. Treatments that produce the most accurate and precise effects in this route are expected to be developed in the future.
- InterView
- From domestic sales to the global brand general
- by Dec 22, 2022 05:53am
- Considering healthcare systems around the world such as in Russia, the Middle East, Southeast Asia, and South America, the company will set up a strategy to launch a new anti-cancer drug. It is the main job of Kim Soo-yeon (48), executive director of the International Lung Cancer Brand, at AstraZeneca. Managing director Kim's role has also grown as the number of new anti-cancer drug pipelines from companies such as Tagrisso and Enhertu has increased. Having been working in Singapore for two years, he is neither a study abroad nor a pharmacist or doctor. Executive Director Kim is the only case in a multinational pharmaceutical company where a native Korean, not an expert or a study abroad, has stood as a global marketer. Kim, who met in Singapore, cited four things. "I think confidence, courage, responsibility, and people have grown me this much." It is also something that executive director Kim wants to emphasize the most to his juniors. In fact, she plucked up courage in certain areas. Kim, who set foot in the domestic pharmaceutical industry about 20 years ago with cardiovascular sales at Pfizer Korea, moved to Novartis with the aim of marketing anticancer drugs. At that time, multinational pharmaceutical companies were just starting to set up an anti-cancer drug division. "I had a clear goal. I thought the market for anticancer drugs, which is more grounded and directly affects patients' lives, would grow, and I thought I should be in charge of anticancer drugs. I went to Novartis and launched the first targeted anticancer drug, Glivec, and I did a lot of work to tell them what targeted anticancer drugs were. Another targeted anti-cancer drug, Tasigna, was launched." Based on the successful launch of anticancer drugs such as Glivec and Tasigna, AstraZeneca contributed to the rapid introduction of Tagrisso in Korea. Korea's approval of Tagrisso was the fifth in the world. Kim was not satisfied with her domestic success. It has jumped into unfamiliar markets such as the Middle East and South America. Executive Director Kim was in charge of Tagrisso marketing in all global markets except the United States, Europe, and Japan. The situation was not good because it was a time when COVID-19 was spreading. Even under difficult conditions, Executive Director Kim successfully launched Tagriso and was promoted to the general manager of lung cancer once again after a year and 10 months of promotion. "In fact, the domestic anticancer drug market knows the market to some extent, so I was able to work well. I think it's time to try something new. When I was in charge of global marketing, the Middle East and South America were really unfamiliar. She didn't know anything about culture, economic conditions, government policies, and healthcare systems. It is also greatly affected by the international situation such as COVID-19 and the Russia-Ukraine war. On the contrary, it was new and fun to understand the market. It was also fun to communicate with employees all over the world." She made it his first goal to be responsible and influential in a given role until the end. In countries where the early diagnosis of lung cancer is not well performed, cooperation continued to activate the early diagnosis system. It is not just about introducing products, but about increasing the size of the market. Executive Director Kim's marketing strategy is to lead early diagnosis as an important agenda and create an ecosystem where lung cancer treatments can be used for patients at an appropriate time. Executive Director Kim stressed that such success cannot be achieved alone. As a mother of two children, the support and support of the family became the driving force to focus on work. The good influence of the surrounding seniors and juniors became manure and grew Executive Director Kim. This is why executive director Kim values "people." "People are important in the family, in the company, and everywhere. I was able to come here because my family supported my children when they were young. The company should also help each other so that the seniors and juniors can grow together. I can't succeed alone just because I'm good. With confidence, courage, and responsibility, what matters is people."
- InterView
- The issue of SE of JAK inhibitors should be given authority
- by Kim, Jin-Gu Dec 02, 2022 06:08am
- Shim Seung-cheol, professor of rheumatology at Chungnam National University HospitalThe treatment results of rheumatoid arthritis have improved dramatically. This is because doctors can use it a lot. Following the advent of MTX in the late 1980s, TNF-alpha inhibitors changed the treatment paradigm of this disease. Recently, JAK inhibitors that improved the shortcomings of TNF-alpha inhibitors have emerged. JAK inhibitors, which have been attracting attention as next-generation treatments, have recently been at the center of controversy due to safety issues. This is because concerns have been raised that the drug may cause cardiovascular side effects. How do the prescription sites view the safety issue of JAK inhibitors? Shim Seung-chul, a professor of rheumatology at Chungnam National University Hospital, said, " We should give some authority to experts who treat patients in the field rather than restricting the use of drugs entirely at the government level." He said, "If clinical data are added to confirm which patients are more likely to have drug side effects, detailed treatment guidelines for JAK inhibitors will be prepared." ◆ One in 10 patients is difficult to treat with MTX or TNF-alpha inhibitors Rheumatoid arthritis is an autoimmune disease. Treatment is also carried out in a way that suppresses autoimmune phenomena. The most traditional treatment is MTX. It is a drug that suppresses lymphocytes and was initially more commonly used as a treatment for leukemia. Since it was approved for the purpose of treating rheumatoid arthritis in 1988, it has been used for more than 30 years. Since it was originally developed as an anticancer drug, there were many patients whose drug did not work. In time, a better treatment was developed. It is a TNF-alpha inhibitor. It not only inhibits one target that causes autoimmune diseases but also inhibits several parts at the same time. Since the advent of this drug, the treatment results of rheumatoid arthritis have improved dramatically. The limitations of TNF-alpha inhibitors were also pointed out. The number of patients who do not respond to this drug has gradually increased. The disadvantage of injection was also pointed out. Patients with mobility difficulties due to arthritis wanted to treat the disease more comfortably by reducing hospital visits. JAK inhibitors have emerged. The method of suppressing inflammation has also improved. If existing drugs were a method of blocking inflammatory substances outside the cell, JAK inhibitors are a method of accurately targeting and suppressing substances within the cell. Professor Shim said, "The use of MTX is effective in 70% of patients. If there is no reaction here, using TNF-alpha inhibitors improves 70% of them. He said, "10% of all patients were difficult to treat. Unlike TNF-alpha inhibitors, the development of JAK inhibitors that block inflammatory signals in cells has made it possible to treat such patients. ◆MTX also experienced side effects of TNF inhibitors…JAK inhibitors can also be overcome Safety issues have recently emerged in JAK inhibitors, which have emerged with high expectations. In 2021, the U.S. Food and Drug Administration (FDA) warned of risks such as heart disease and cancer against JAK inhibitors, and the MFDS in Korea also distributed safety letters. Eventually, the FDA decided to include risk information such as major cardiovascular events, thrombosis, and death in the box warning in the JAK inhibitor. Professor Shim Seung-chul said, "The existing drugs have undergone a similar process," adding, "What is important is how well you manage side effects and treat diseases." "I think we can overcome the problems that are currently being raised," he said. According to him, MTX has had side effects such as an increase in liver levels since its appearance. Accordingly, drugs were used at the prescription site while simultaneously performing a liver biopsy. As the experience of use accumulated, the drug has been set up to be prescribed in low doses when used for rheumatoid arthritis rather than anticancer drugs. The same is true of TNF-alpha inhibitors. Concerns have been raised that it causes tuberculosis in the early stages of its appearance. These concerns were addressed by the use of anti-tuberculosis drugs. In the case of JAK inhibitors, concerns about herpes zoster were raised at the beginning. Professor Shim explains that the newly emerged cardiovascular risk can also be seen as an extension of this. Professor Shim said, "We need to pay attention to the extent to which side effects occur frequently in certain patients, not in the side effects themselves," adding, "We expect that detailed treatment guidelines for JAK inhibitors will be prepared when more domestic clinical data are accumulated and drug side effects occur. JAK inhibitors are limitedly used only when other drugs do not work. If drugs are used sequentially, there will be no big problem. I think we should give some authority to experts who treat patients in the field rather than restricting the use of drugs entirely at the government level." There are three representative JAK inhibitors released in Korea. In the case of Xeljanz, it is a general-purpose JAK inhibitor that inhibits all three inflammatory substances. Olumiant inhibits two substances and Rinvoq SR inhibits one substance. Professor Shim said, "There are currently various JAK inhibitors released, and further research is needed to find out the difference between general-purpose JAK inhibitors that suppress all inflammatory substances in cells and selective JAK inhibitors that suppress only certain substances."
- InterView
- The key to treating stroke tx is preventing the recurrence
- by Kim, Jin-Gu Nov 23, 2022 06:04am
- Stroke is a battle against time. Whether the blood vessels in the brain are blocked (brain infarction) or burst (brain hemorrhage), blood should be supplied to the brain normally within a short period of time. The medical community explains that the golden time of stroke is 4.5 hours. This means that the problem can be solved only when the symptoms occur and arrive at the hospital within 4 hours and 30 minutes. The importance of preventive treatment has been increasing. As the results of stroke treatment have improved compared to the past, drug treatment to prevent the recurrence of patients with stroke once has become more important. Park Jong-kyu, a professor of neurology at Cheonan Hospital affiliated with Soonchunhyang University, said, "The key to treating stroke drugs is to prevent a recurrence," adding, "Various drugs are used differently depending on the cause. Since the brain is a drug used in special areas, it should be used carefully in consideration of the side effects of bleeding, he said. ◆ Antiplatelet agents for vascular stroke and anticoagulants for embolic stroke There have been changes in the treatment of stroke over the past decade. In the past, even if a stroke occurred, it often came late. Many patients fell down holding the back of their necks and visited the emergency room. As such, the treatment period has been delayed. Major surgery was needed and the prognosis was not so good. As public awareness of stroke has been aroused, treatment performance has improved significantly recently. Unlike in the past, more and more patients visit the hospital due to initial symptoms, such as poor speech, narrow vision, and poor finger grip. Treatment methods are also changing. The importance of drug treatment is increasing as a secondary preventive treatment to prevent recurrence after treating an initial stroke. Professor Park Jong-kyu said, "Depending on the cause of stroke, drugs are used differently," adding, "In the doctor's opinion, if it is a vascular stroke caused by blood clots accumulating in the cerebral blood vessels, an anticoagulant is used." Professor Park emphasized, "In the case of anticoagulants, it may look better to prevent the recurrence of stroke in that it prevents blood itself from coagulating, but it should be used carefully because there is a high risk of side effects of bleeding." ◆"Anticoagulants have a high risk of bleeding side effects, so they should be used carefully for stroke" According to Professor Park, anticoagulants are mainly used for patients suffering from arrhythmia or heart valve disease at the same time. The problem is when heart disease is not clearly diagnosed. In this case, the doctor's judgment is involved. Professor Park explains, "Clinically, it seems that an embolized blood clot came from under the heart and blocked the cerebral blood vessels, but if there is not enough evidence." It is right to use antiplatelet drugs, but he explains that he uses anticoagulants on a limited basis because there is often a high risk of stroke recurrence. Multiple cerebral infarctions, in which several blood vessels in the brain are blocked at the same time, are a typical example. If the left blood vessel of the brain is observed to be blocked when the blood vessel of the brain is photographed, the cerebral infarction area should also be on the left side of the brain. However, there are patients who often have cerebral infarction on the right side of the brain. At this time, the location where the blood clot occurred is presumed to be below the heart, not the brain. At this time, if the patient has no history of heart disease, the anticoagulant is used under the judgment of a doctor that the patient lacks the basis for anticoagulant treatment, but the risk of recurrence is high. If multiple cerebral infarctions are not the first time, or if cerebral infarction occurs during recurrence prevention treatment with antiplatelet drugs, anticoagulants are used. Professor Park said, "Most of the patient's risk factors and mechanisms for cerebral infarction are identified and drug treatment is carried out accordingly to prevent a recurrence." ◆ Stroke is the fourth leading cause of death in Korea, and the number of young patients is increasing recently Severe or acute stroke is still treated surgically. Patients with blocked large blood vessels in the brain or blocked heavy blood vessels and poor symptoms are the targets. The key is to treat it as soon as possible. Generally, patients should visit the hospital within 4.5 hours. Professor Park said, "Finding and operating blood vessels is only possible when large blood vessels are blocked. In the case of heavy blood vessels and small blood vessels, surgery is attempted only when the symptoms are severe. He said, "Because there is a risk to the treatment itself, we solve it with thrombolysis through veins instead of surgery." Professor Park explained, "It can be rather harmful to perform surgery after golden time." He added, "This is because the bleeding occurs in weak areas in the process of penetrating blood vessels and supplying blood again, which can be dangerous for patients." Stroke is the fourth most fatal disease in Korea. According to the HIRA, 590,000 patients were diagnosed with stroke as of 2020. The perception of stroke has changed and the number of patients is increasing faster as the population ages rapidly. This is due to the increase in patients with hypertension and hyperlipidemia, which are the underlying diseases of stroke. The medical community estimates that the incidence rate doubles every 10 years after the age of 55. Professor Park explained, "As you get older, the risk factors you have are more likely to cause problems, so it will affect the increase in stroke." He said, "Recently, the number of young stroke patients under the age of 45 is increasing rapidly increasing. "There are concerns as risk factors for stroke, such as sleep apnea, are diversifying," he said.
- InterView
- “Korea is fully capable of developing new microbiome drugs"
- by Nho, Byung Chul Nov 18, 2022 06:04am
- Eung-Bin Kim, Professor of Systems Biology at Yonsei University “The development of metagenomics technology that extracts DNA directly from samples without culturing in 1998 enabled the field of human microbiome research to make a giant leap forward. The success and failure of innovative new microbiome-based therapeutics depend on identifying, standardizing, and materializing the keystone species in the human gut microbiome.“ The development direction for new, innovative next-generation human microbiome-based therapeutics sought by Professor Eung-Bin Kim, Department of Systems Biology at Yonsei University, is focused on the understanding of the material cycle in the ecological structure. More than 10,000 microorganisms inhabit our body (mouth, gut, nose, genital, skin, etc) along with 37 trillion bacteria. Regarding this, Professor Kim said, “What’s important is not the microorganisms themselves but the microbial genes and proteins. For example, microorganisms that digest fat are always present in a healthy intestine. However, the task is not always performed by the same microorganism. Just like how players replace each other’s role in sports games.” Among Professor Kim’s microbial studies, one that caught the reporter’s attention was his identification of the existence of probiotics in jeotgal (Korean traditional pickled fish made with croaker or hairtail, etc). In the early stages of the salt-aging period, jeotgal contains a lot of bacteria, but 99% of the bacteria are killed after 2 years of aging. In the end, only 2 or 3 types of basophilic lactic acid bacteria such as Tetragenococcus remain. The study received much interest from the academia and media. Professor Kim, who is considered an authority in microbiology, has his eyes on the potential held by Akkermansia muciniphila and Faecalibacterium prausnitzii in gut microbiota that is considered next-generation probiotic candidates.” Kim said, “The key to probiotics is in the time of residence in the intestine, and ‘Akkermansia’ and ‘Faecalibacterium’ were found to have a long survival time in the intestinal mucosal barrier. Also, the fact that these species were successfully cultured with domestic technology is also rated highly. We are looking forward to the development of innovative new drugs based on these species, which are the keystone species in the human gut microbiome.” On how to confidently compete against strong R&D players in developing new and innovative microbiome-based therapeutics in the global market, Kim said that the focus should be on treating various disease groups rather than simply developing and releasing intestinal microbiota products. In particular, open collaboration between the industry-academica-research and policy and systemic support should also be promptly prepared. Meanwhile, Professor Kim had served as the Dean of Admissions, and Dean of the College of Systems Biotechnology at Yonsei University, and authored ‘Alcohol, Disease, War: A History of Microorganisms', 'The Whole World is Full of Microorganisms', 'Biotechnology gives wings to Life Sciences’ and 'I Live with Microorganisms'.
- InterView
- “Amgen addresses all unmet needs regardless of indication”
- by Eo, Yun-Ho Nov 17, 2022 05:54am
- Philip Tagari, VP of Research at Amgen Global Amgen owns a vast portfolio of treatments in many areas. Rather than focusing on a particular field, the company has been known to release new drugs in the right places at the right time In addition to actively developing drugs for chronic diseases such as the osteoporosis treatments 'Prolia (denosumab)’ and ‘Evenity (romosozumab),’ the osteoporosis complication prevention drug ‘Xgeva (denosumab),’ and the dyslipidemia treatment ‘Repatha (evolocumab),’ the company has also followed up with the recent trend and released oncology drugs such as the acute lymphoblastic leukemia drug ‘Blincyto (blinatumomab), multiple myeloma treatment 'Kyprolis (carfilzomib),' and the recent KRAS inhibitor ‘Lumakras (sotorasib).’ These achievements were of course made possible with the support of the company’s R&D department. Dailypharm met with Philip Tagari, Vice President of Research at Amgen Global, who recently visited Korea, to hear about the company’s R&D direction and open innovation strategy. -You served over 20 years in Amgen’s R&D department. Which treatment were you most deeply involved in developing? I would say Lumakras. Amgen won the 2022 Prix Galien Award for Best Pharmaceutical Agent with Lumakras. This was very meaningful for us as the Prix Galien Award is considered the industry’s equivalent of the Nobel prize and the highest accolade for pharmaceutical research and development. I have been involved in the research and development of Lumakras in Amgen's R&D department for more than a decade with many colleagues. In a way, the drug has been researched and developed in the shortest time not only in Amgen but throughout the whole industry. I still remember the joy I felt when our belief was confirmed in the clinical trial with groundbreaking data in non-small-cell lung cancer. Also, there is Repatha, our hypercholesterolemia treatment. We had great confidence in Repatha since the discovery of its candidate substance. I think Repatha will continue to have significance in the field and bring positive impact on public health for decades to come. -You said Repatha was commercialized in the shortest period yet. Is there a special know-how of Amgen's or any episode behind the rapid development of Lumakras you’d like to share? Amgen had long been thoroughly analyzing how to shorten the entire new drug development process, since several years before we discovered sotorasib, the active substance of Lumakras. After several years of analysis, we had gained some idea on how to conduct the R&D. It was around that time we discovered AMG 510, the candidate substance that later became Lumakras. So I would say our rapid development was a result of the company’s implementation of a delicate and carefully planned development plan rather than a special technology or ability. -Amgen is also known to be interested in open innovation. Were any of the products in your pipeline born through open innovation? Evenity is one representative result of our open innovation. The drug was developed through collaboration with a doctor in South Africa, a UK-based small biotechnology company British Biotech, and Amgen. At the time, a doctor in South Africa recognized how a specific disease continued to emerge in the local community and asked British Biotech to analyze the cause. Results showed that the disease was caused by a mutation of the sclerostin protein. So the company first needed sclerostin to develop a treatment, and Amgen was the only company that owned such technology. Amgen produced the protein, which led to the commercialization of Evenity. -Would you like to introduce any promising candidate substances that are in development? It is difficult to mention specifics before approvals, but one of the most promising items in our development pipeline is an obesity drug. Obesity is a serious global public health issue that is growing in importance. So you can expect various treatments for obesity and cardiovascular diseases from Amgen to come in the future.
- InterView
- “BMS makes the next leap with its solid pipeline”
- by Eo, Yun-Ho Oct 31, 2022 06:06am
- 이혜영 대표 Mergers have become one of the main survival strategies for global multinational pharmaceutical companies. In addition to buying new substances, companies are also making synergy, absorbing companies that own pipelines with high potential. BMS is one representative example of such successful mergers. When the power of its portfolio declining with the patent expiration of blockbuster drugs such as 'Baraclude Tab.', the company decided to acquired Celgene, the company that owns ‘Revlimid,’ the drug that recorded the highest sales among prescription drugs at the time. In addition to CAR-T therapy, Celgene owned various candidate substances in various areas including blood cancer. In addition, the company also signed an agreement to copromote ‘Opdivo’ with the Japanese pharmaceutical company ‘Opdivo,’ to build competitivity in the oncology sector. Its Korean subsidiary is also working to quickly conclude the merger process and make the next leap with the organizational restructuring. In this whirlwind of change, the company has newly welcomed a new leader. Hye-Young Lee, who has serves as the founding Country Manager of BMS, is dreaming of a new heyday at BMS with her appointment in July. Dailypharm met with the new Country Manager. -It hasn’t been long since you took office. Some might think it is too early to conduct an interview. Is there a reason why you decided to do the interview at this time? I wanted to publicize BMS as it is now. Since we have not conducted many external activities, including media activities, I thought that our business scale and the potential for growth has not been well known. Although there are still a lot of things that I would need to understand in terms of business, I thought it would be good to start by relaying the changed status of our company and its future direction. -You have been a Country Manager before, but this is a new company. What was your first impression about BMS?? As I had only known the company as a member in the same industry before, I was surprised in many aspects after joining the company. BMS's business scale, global presence, and pipelines were much stronger than I expected, and the company owns various industry-leading promising pipelines. -Could you introduce some of those strong pipelines? BMS’s main pipeline cover the 5 fields including Cardiology, Hematology, Oncology, Immunology, and Neuroscience. More than 50 new drug candidates for more than 40 diseases are being developed in these five areas. Based on those that received current domestic or FDA approval, we have Revlimid and Sprycel in Hematology, as well as Onurec, Inrevic, and Reblozyl that were additionally approved this year. In addition, two CAR-T treatments approved by the FDA are receiving much anticipation these days. Our cardiovascular pipeline has been further strengthened by acquiring a company called Myokardia, and there is a treatment for hypertrophic obstructive cardiomyopathy that was approved by the US FDA this year. This first-in-class treatment with a new mechanism of action has been receiving high expectations. We cannot disclose details as it has not been approved in Korea yet, but we are working hard to introduce it quickly to domestic patients. In terms of Immunology, there are treatments for plaque psoriasis and ulcerative colitis with a new mechanism of action that has been recently approved by the FDA. In addition, the treatments it acquired from Turning Point Therapeutics are also from a new class but is yet to be approved in Korea. -BMS two new CAR-T therapies, Breyanzi and Abecma. The two are also in the process of approval. When looking at existing cases, simply introducing CART-T therapies is not enough, and many other preparations are needed for their prescription. How are you preparing for this part? As CAR-T is an innovative therapy that is needed by many patients in Korea, we are continuously reviewing the preparations necessary for the patients in need of treatment in Korea. However, as mentioned, use of CAR-T therapies require various considerations and preparations, therefore, its introduction requires more time. One encouraging fact is that a clinical trial is planned for one of the CAR-T therapies in Korea. It is expected that the experience we are accumulating with clinical trials will be helpful when introducing CAR-T treatments in the future -If you look at BMs, the company is actively engaging in mergers, joint development, and promotion activities. Is there a possibility of expanding such partnerships with Korean companies? Open innovation is the DNA of BMS, to such an extent that 60% of the BMS pipeline has been secured through open innovation, and 40% of current sales were accrued from drugs developed through open innovation. We also plan to actively carry out open innovation in Korea, and a lot of clinical trials are already underway. There are 50 clinical trials in progress in about 20 pipelines in progress in Korea. Unlike the past, where many clinical trials for new drug development were traditionally conducted in the US and Europe, Korea is now in the spotlight in conducting early-phase clinical trials, and is also considered one of the most important countries in terms of expansion. One aspect I found impressive after joining the company was in the number of early clinical trials being conducted in Korea. 6 Phase I clinical trials are underway, and the company is also seeking ways to collaborate with one of the country's major hospitals for basic research related to oncology and hematology.
- InterView
- "Lilly rises in anticancer and autoimmune diseases"
- by Eo, Yun-Ho Oct 27, 2022 05:52am
- The pharmaceutical company Lilly is known for their strong diabetes treatment pipeline. As the world’s first developer of insulin, Lilly has solidified its position in the field, introducing DPP-4 inhibitors, SGLT-2 inhibitors, and GLP-1 analogues into its pipeline. However, Lilly has transformed. It did not give up diabetes, the company just added more ‘weapons to its arsenal.’ From some point, the company began to exert its influence in the fields of cancer and autoimmune diseases. In the lung cancer drug market, where the company had made no significant impact other than with ‘Alimta,’ Lilly released the VEGFR-inhibitor 'Cyramza,’ and also introduced the first-in-class RET-targeted therapy ‘Retevmo.’ Also, its ‘Verzenio’ CDK4/6 inhibitor latecomer for breast cancer has successfully landed in the market with a successful insurance reimbursement strategy. The company is also showing marked growth in the autoimmune disease market. Its second JAK inhibitor ‘Olumiant’ has been targeting atopic dermatitis, and secured the first indication for alopecia areata among same-class drugs. Also, Interleukin-17A inhibitor ‘Talz’ is continuing to expand indications to psoriatic arthritis, ankylosing spondylitis, etc. In addition, the company’s new migraine drug ‘Emgality’ was recently listed for reimbursement. Dailypharm met with Mira Kwon (44), Lilly Korea’s Specialty Care BU Lead who oversees all of the products above. Mira Kwon, Sr. Brand Manager of Specialty Care BU, Lilly Korea-Please give us a brief introduction of yourself. I entered Lilly/s marketing team in 2006. Lilly runs an open talent development program that allows employees to experience various departments, through which I was able to experience various departments including the sales department, external affairs department, and also the oncology department at a time when the insurance drug pricing system was changing rapidly. I became the marketing lead of the Oncology department after working in Market Access, and since the company restructured the departments into Business Units, I have been in charge of the Specialty Care BU, which is the Oncology and Immunology Departments. -Lilly has undergone dynamic changes. It seems that your BU is in charge of the new growth engine of the company. Since Lilly acquired the anticancer drug company, Loxo Oncology in 2019, the company had been able to establish a strong pipeline in oncology as well, including Retevmo. The company is also developing and preparing launches of other candidate substances. In the field of autoimmune diseases, our main products are Olumiant and Talz. New indications were added in major areas in the past 2 years, and with new indications also set to be added next year, the pipeline is expanding quickly. At a recent global meeting, clinical data on the atopic dermatitis treatment that is currently undergoing clinical trials were also reviewed. - Autoimmune disease is one area that Lilly lacked experience in. It is also an area that has a high entry barrier in Korea, so it was surprising that Lilly jumped into this market. Despite the many companies that have already built a reputation in the field for more than 15 years, we have been receiving much feedback on how good and diverse Lilly’s portfolio is. We own both psoriasis and atopic dermatitis treatments with clinical trials being actively conducted on new indications. -The marketing points for anticancer drugs and autoimmune disease treatments may be different. What areas do you focus on for each in the promotion process? The oncology department, like the diabetes department, is Lilly Korea’s key area of focus, therefore, its sales division has experts with more than 13-15 years of experience and expertise. Due to the nature of anticancer treatments, we conduct various activities with various departments including Medical to produce domestic research data to meet the needs of patients and HCPs in Korea. The immunotherapy market is very competitive. With so many options available within the same class, we ponder ways to differentiate Lily's portfolio from others. In the case of the new indications that had been introduced during the COVID-19 period, our team has focused on activities that allow two-way communication via digital channels rather than traditional marketing activities or channels. -What do you consider most important in running your marketing department? This is no longer an era where a newborn first-in-class blockbuster dominates the market. That's how dynamic the market is. In particular, due to uncertainties in patient access in Korea, it is important to adapt quickly and modify our strategies in line with the ever-changing environment. Although the Oncology and Immunology departments are in charge of different diseases, both are facing the same situation in the pharmaceutical industry, especially in the current situation where so many new products and indications are being released. I think it is the role of our marketing department to think about in-depth strategies and prepare various scenarios in advance. -Your promotion strategies will also need to be changed with the end of the COVID-19 situation. So we plan to strengthen offline activities that have been restricted due to the COVID-19 pandemic. However, HCPs have also become familiar with digital channels for over two years in the COVID-19 pandemic, and as it also has advantages such as convenience, we are focusing on how to combine these well. We also have a digital marketing department within the company, and I know that they are actively discussing with the headquarters measures to find contact points with customers based on analyzed data. In the future, our marketing activities will evolve in the direction of delivering messages through effective channels by identifying areas with the greatest needs for HCPs based on data. -In the Korean pharmaceutical market, reimbursement became a determining factor that makes or breaks the success of drugs. Currently, Retevmo is undergoing reimbursement review, and marketing will also be conducting activities for reimbursement in addition to MA. The reimbursement listing process is always uncertain and requires discussion with authorities. Therefore, as a multinational pharmaceutical company, it is on us to facilitate smooth discussions between headquarters and regulatory authorities. Although the MA is responsible for communication with HQ, the marketing department provides opinions on how the drugs can be used for patients in Korea and to which extent the drugs can provide therapeutic benefits. -So how well do you communicate with global headquarters? Korea is one country where reimbursement is difficult, but with the environment in other countries rapidly changing as well, it seems that our global headquarters now understand Korea's situation. The company already saw through this reimbursement process with oncology drugs like Cyramza and Verzenio. However, it is true that Korea’s drug price differs greatly from other countries, and there are difficulties due to various related systems in Korea.
