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- 2026-03-10 04:13:03
- InterView
- MSD "Will care for employees and new drug reimbursement"
- by Eo, Yun-Ho Jul 13, 2021 12:59am
- Keven Peters, Managing Director at MSD KoreaApart from its positives and negatives, MSD (known as Merck in the U.S.) is a company apt at ‘adaptation.’ MSD, which first cut its appearance in circulatory, respiratory drugs, and vaccines, became a leader in the field of diabetes in the 2000s with the introduction of its Januvia(sitagliptin), a DPP-4 inhibitor. In 2010, MSD became a sensation with the release of its PD-1 inhibitor ‘Keytruda(pembrolizumab),’ marking the start of the era of cancer immunotherapies. MSD’s forward-looking eye that allowed for the launch and success of various first-in-class drugs regardless of the disease area, is an undeniable strength of MSD. However, MSD had also been in the throes of change from the adaptation process. Last year, the company had officially announced the completion of its spin-off of Organon. In the process of the spinoff, MSD suffered considerable labor-management conflict. Also, MSD is in a 3-year back and forth with the authorities regarding the reimbursement expansion of its lead product Keytruda to first-line treatment in lung cancer. Amid such change, MSD Korea had welcomed a new head to its office in November last year. Keven Peters, the new Managing Director at MSD Korea, who has come to head the Korean subsidiary after serving in the Thailand subsidiary, had jumped in to resolve the pending issues, signing a collective agreement with the union and holding meetings with the government to allow for the reimbursement of Keytruda. Dailypharm met with the new Managing Director Kevin Peters to hear about his seven months in office. -You have been very busy since you took office. Let’s first discuss the labor-management conflict issue. What efforts have you made to resolve the conflict that arose in the spinoff process? As you know, we have signed the 1st collective agreement in January. I am proud that we were able to reach a mutual agreement after close discussions with the labor union. Also, I plan to visit our 4 local offices in Daegu, Gwangju, Daejeon, and Busan to communicate with the employees there starting early July. I will be sharing the company’s stories there and will hold an ear out to what our local employees have to say on each matter. Also, I plan to humbly take the advice that they may have to offer. My top priority is to have employees take an interest in our company and engage them in company activities. I am doing my best to listen to what all our stakeholders have to say. -You should be quite well-read on Korea’s drug pricing policy due to the situation with Keytruda. What do you think about Korea’s policy? From my 7 months of experience here, I felt that the HCPs and the government in Korea have a strong will to reimburse drugs. Of course, there’s the wish that reimbursements could be discussed more quickly. As you know, we are in the process of discussing increasing the accessibility of Keytruda. With lung cancer patients in 52 countries around the globe already using Keytruda as first-line therapy, I hope that our Korean patients can also have improved access to the drug as soon as possible. Increasing accessibility of Keytruda is an issue for consideration for all governments around the world. I think it is important for the key stakeholders including the government, companies, and HCPs to cooperate and collaborate to find a better way to increase the accessibility of the drug. -It seems that you have some regrets regarding the ‘quickness’ of the reimbursement approval process in Korea. In fact, reimbursement discussions for Keytruda first-line have been ongoing for over 3 years now. Efforts both ways, not only the government but the company’s efforts, are also required for a successful resolution of the issue. And as you know, there have been many arguments over the inadequacy of the cost-sharing plan that was proposed by the company. What I can promise now is that MSD will continue to cooperate with the government and healthcare officials to ensure that our patients can receive the optimal treatment. The company has submitted a financial sharing plan to the Review Committee for Cancer Diseases that proposes an unprecedented level of cost-sharing by the company, based on which we hope to see progress in Keytruda’s reimbursement expansion within a few weeks. -From what I know, the global investment in Keytruda is nearly 15 trillion won. Domestic investment (15 billion won) seems to be small in comparison to the global amount invested. MSD Korea is ranked no.1 in terms of R&D investment size in the MSD Asia-Pacific region. Our number of new clinical trials approved in Korea over the past four years was at a leading level among multinational companies, and the amount invested in R&D last year increased by 66% compared to the previous year. Quality data and infrastructure are key considerations used for making investment decisions in rclinical research. Korea owns excellent resources in this regard. We are continuously looking for institutions to collaborate with in Korea, and plan to further expand our collaboration in the future. In particular, an unprecedented number of clinical trials are underway in the field of oncology. There are 1,400 clinical trials in the world related to Keytruda, of which more than 900 are combination therapy studies. -What other products do MSD Korea plan to introduce in Korea? I cannot share specificities regarding releases of drugs before their approval, but we are preparing to introduce a chronic cough treatment, HIV treatment, antibiotic, and pneumococcal vaccine among others. Also, a Phase III trial is ongoing for our oral antiviral ‘molnupiravir’ that is expected to contribute to bringing an end to the COVID-19 pandemic. Also in the mid-to-long term, we own an extensive portfolio ranging from PARP inhibitors, VEGF TKIs, HER2 TKIs, antibody-drug conjugates (ADCs), to antibiotics.
- InterView
- Takeda, “Alunbrig improved both OS and QoL”
- by Jul 08, 2021 05:58am
- Medical Science Liaisons (MSLs) in Medical Affairs of pharmaceutical companies act as a ‘bridge’ between healthcare professionals and companies. They gather the unmet needs of HCPs and establish strategies for new drugs to address such needs. MSLs also deliver academic data and expertise based on clinical grounds in compliance with local regulations to HCPs, patients, and internal employees. Competition has been fierce in the non-small cell lung cancer treatment market, particularly the ALK targeted therapy market, with the introduction of various new drugs. The market is moving on from the one-and-only 1st generation treatment, Pfizer’s ‘Xalkori,’ to 2nd generation products. By order of entry, three 2nd gen products - Novartis’s ‘Zykadia (ceritinib),’ Roche’s ‘Alecensa (alectinib),’ and Takeda Pharmaceutical’s ‘Alunbrig (brigatinib)’ – have entered the market. Among these, Roche and Takeda’s products are in the fiercest competition. The role and responsibility of MSLs in charge of these products have also increased. Dailypharm met with Bokyung Kim, MSL at Takeda Pharmaceuticals Korea’s to hear about the ALK-positive NSCLC treatment market, its unmet needs, and the role and strategy of Alunbrig in this market. Bokyung Kim, MSL at Takeda Pharmaceuticals Korea -Could you give us a brief introduction about yourself and your role in Medical Affairs of Takeda Pharmaceuticals Korea? = SInce entering Takeda Pharmaceuticals Korea as an MSL in October last year, I have been in charge of Alunbrig for 9 months. I meet with healthcare professionals to identify the unmet needs in the field to establish strategies based on the demand. In the company, I discuss with various business divisions to set the direction for Alunbrig and prepare the necessary medical grounds so that our drug can contribute to resolving the unmet needs in the field. In the past, the Medical Affairs division mainly performed tasks to support other business divisions in the company, however, perception of the role of our department has started to change around 10 years ago. Medical Affairs now develops core strategies for new drugs, serving as a bridge between various business units as well as research and development. Also, the unit provides academic data and expertise to internal and external stakeholders in an objective and fair manner in compliance with the local code of medical ethics and regulations and provides academic advice. -At the time Alunbrig was introduced to Korea, other ALK-targeted therapies were already in the domestic market. Were there any difficulties due to this late entry? =Other treatments that were released before Alunbrig have brought treatment benefits to patients, however, unmet needs still existed in various areas, ranging from treatment effect, adverse events, quality of life, to convenience in administration. I believed that the introduction of Alunbrig could bring new treatment benefits that existing treatments were unable to provide. -What unmet need still remains due to characteristics of ALK-positive NSCLC in Korea? =ALK mutation occurs in around 4-5% of all NSCLC patients and occurs more commonly in women and Asian patients. Also, it is found more frequently in non-smokers compared to other NSCLCs and affects a relatively younger population in their 50s to 60s. Therefore, in addition to data on survival such as progression-free survival (PFS), other factors such as tolerance, medication adherence, and quality of life should also need to be considered collectively. The biggest unmet need in the treatment of ALK-positive NSCLC lies in brain metastasis and tolerance. This patient population has a higher risk of brain metastasis than other lung cancer patients. How long a drug can delay brain metastasis, and how effective the drug is in patients with brain metastasis must be considered. Also, people may have developed tolerance to TKI targeted drugs, therefore, how effective the drug is in such a population is also an important consideration. -With Alunbrig approved for insurance benefit in April as a 1st-line therapy, all ALK-targeted drugs introduced to Korea are now available with reimbursement from 1st line. What strengths does Alunbrig have over other ALK-targeted therapies with regards to its mechanism of action? How effective was the drug in patients with brain metastasis in clinical trials? =Unlike other existing treatments, Alunbrig was developed into a unique U-shaped platform. This structural design allows the drug to bind more strongly to the ATP attachment site that is used as an energy source when activating the ALK gene. In a preclinical trial, the drug selectively bound to ALK mutant variants to act stably in the body. Furthermore, Alunbrig demonstrated superior progression-free survival (PFS) and improved health-related quality of life (QoL) versus Xalkori, the existing first-line treatment option, in the Phase III ALTA-1L trial. In particular, in the second interim analysis, Alunbrig demonstrated superior clinical efficacy over Xalkori in the first-line setting regardless of brain metastasis in all ALK-positive NSCLC patients. Also, Alunbrig demonstrated a differentiated PFS improvement compared to Xalkori from early on in patients with brain metastasis that are difficult to treat. In addition, Alunbrig significantly reduced HR compared to Xalkori, to 0.25. So far, the data presented from the ALTA-1L trial only covers up to a two-year follow-up study by June 28th of 2019. We expect to see longer survival data when the final results are released soon. -Compared to other drugs that conducted investigator-assessed trials, the ALTA-1L trial was designed closer to the real world with BIRC-assessed endpoints. Why did the study choose to use BRIC-assessed results, which would have brought out more conservative results? =According to FDA guidelines, review from an independent evaluation committee can minimize bias. This is not essential in randomized, blinded clinical trials, however, as chemotherapy is often the standard treatment in cancer treatment, comparing this with oral anticancer drugs in a blinded trial is realistically not possible. This is why the trials are designed as open-label trials, in which case, BIRC assessment is required. We used BIRC-assessed primary endpoints according to the guideline recommended by the FDA to increase the objectivity and fairness of our trial. -How does Alunbrig affect patients with regards to their quality of life? = ALK-positive NSCLC occurs commonly in the socially active 50s. Therefore, studies on Alunbrig assessed the improvement in quality of life in addition to the drug’s efficacy. Assessed with the representative tool used for quality of life in cancer patients, EORTC QLQ-C30, the Alunbrig arm maintained the quality of life without worsening for 26.7 months vs. Xalkori. Also, convenience in administration is also an important factor to consider in long-term treatment. Many studies on long-term treatment experience from chronic diseases among others have shown that convenience in administration is very important for the quality of life and prognosis of patients. Alunbrig’s 1 tablet once daily administration is expected to contribute to the improvement of quality of life in these patients. *Dose and schedule of first-generation Xalkori is 1 tablet taken twice daily. Zykadia is taken in 3 capsules once daily, and Alecensa is taken in 4 capsules twice daily. -How was Alunbrig received in the field after being approved for reimbursement as first-line? Some have said that Alunbrig and Alecensa have similar efficacy in patients with brain metastasis. What is your view on this? =Alunbrig was positively reviewed by HCPs since being reimbursed as second-line treatment due to its good treatment effect in patients. With its reimbursement expanded in April, doctors have highly rated the drug as a new treatment opportunity for patients with an unmet need and for those who saw unsatisfactory effects from existing first-line therapies. Expectations were high as Alunbrig had shown high clinical effects in patients, but they were also highly satisfied in terms of convenience in administration. Also, the company’s efforts to promptly approve and reimburse Alunbrig in Korea as soon as it was approved as a first-line in the U.S. were positively received. Alunbrig and Alecensa have both shown better effects than Xalkori in clinical trials on patients with brain metastasis. We cannot directly compare the two drugs due to a lack of head-to-head study, however, patients should consider various aspects in addition to treatment effect, such as tolerance and convenience in administration when selecting their treatment. -Some patients hesitate using Alunbrig due to its pneumonia adverse reaction. =In the field, clinical practitioners have deemed that the symptoms after administering Alunbrig were similar to pneumonia, but is an EOPE (Early-Onset Pulmonary Events) that occurs temporarily. In some patients, symptoms similar to pneumonia may appear temporarily, but when the symptom is resolved early on, the symptom has the characteristic of not occurring again during the period of administration. Also, clinical experts in Korea have also said that EOPE symptoms are reversible adverse reactions that are fully manageable and can be quickly recovered.
- InterView
- Leclaza's ASCO data is like a global champion
- by An, Kyung-Jin May 28, 2021 06:08am
- Cho Byung-chul, a professor at Yonsei UniversityThe response rate for 'Lazertinib+Amivantamab' is the same as when ESMO was announced? It's ridiculous. The data is incomparably more complete than it was 7 months ago. " Professor Cho Byung-chul (oncology at Yonsei Cancer Hospital) commented on Leclaza (Lazertinib) combined data. A number of questions have been asked since the opening of the American Society of Clinical Oncology (ASCO 2021) and some misinterpretations need to be corrected. Professor Cho will introduce the latest clinical results related to combined therapy of Leclaza and Amivantamab at the ASCO 2021 online conference on the 5th of next month. This is the follow-up announcement of CHRYSALIS 1b, which drew much attention at the European Oncology Society (ESMO 2020) last year. The purpose is to evaluate the response rate of 'Lazertinib+Amivantamab' combined therapy in patients with resistant non-small cell lung cancer. The published objective response rate (ORR) is 36%. Fifteen out of 45 Tagrisso-resistant patients reached a partial reaction (PR) that reduced the tumor size by more than 30%, and one showed a complete reaction (CR) that completely disappeared. Because ORR figures are the same as when ESMO 2020 was announced, it can be accepted as the same data. "Even if the ORR values are the same, the maturity of clinical data has completely changed," Professor Cho added. The key is the difference in follow-up periods. Data released at the time of ESMO showed a follow-up period of only about four months after medication. On the other hand, the tracking period of ASCO's announcement increased to 11.8 months. In other words, the same response rate was maintained even though the tracking period has more than doubled.The duration of the reaction in patients who responded to the drug administration was more than 10 months. When the concept of biomarker is combined, the reaction rate increases further. Eight out of 17 patients with EGFR and MET mutations, known as Tagrisso's most common cause of resistance, showed treatment responses, achieving ORR 47%. However, the absence of biomarkers does not mean that the response rate is low. Of the remaining 28 people whose biomarkers were not identified, eight showed tumor responses to combined Lazertinib+Amivantamab administration. In terms of ORR, it is 29%. "There is a group of patients who are good at responding to Lazertinib+Amivantamab combined therapy," Professor Cho said. "However, the data alone when there is no biomarker is far more competitive than the existing treatment." Previously, there were no lung cancer treatments that demonstrated a 30% response rate and a duration of 10 months in patients who failed Tagrisso treatment. For example, the most prescribed combination of Tagrisso and MET inhibitor Savolitinib is 30% response rate and 7.9 months response duration when only MET patients are selected. Professor Cho compared this data to boxing. It's nothing short of winning Mike Tyson.Treatment of non-small cell lung cancer, which has developed new resistance after Tagrisso administration, is quite difficult due to tumor heterogenicity. This means that the data has increased over a long period of tracking for cancer patients with such malignant conditions. Professor Cho said that there is a good chance that Lazertinib+Amivantamab combined therapy will be designated as a U.S. FDA innovative therapy (BTD) within this year. If similar levels of data are reproduced in Janssen's ongoing CHRYSALIS-2 clinical trial, FDA approval will not be long.
- InterView
- IQVIA provides a total solution based on big data
- by Eo, Yun-Ho May 20, 2021 05:41pm
- CEO Jeong Su-Yong IQVIA(CRO Quintiles & IMS Healths) is much bigger than before. In addition to simply providing clinical referral and sales data, IQVIA includes development, release, and subsequent marketing and Rx management. IQVIA Korea, a so-called 'Human Data Science Company', recently acquired CoreZetta, a sample big data analysis company of the HIRA, and MMK Communications, a healthcare marketing company, to upgrade the reliability and service area of the data. The number of executives and employees of Korean subsidiaries has already surpassed 780. Dailypharm met with CEO Jeong Su-Yong (48 yrs old), who has been leading IQVIA Korea since 2017, and heard about IQVIA's vision and strategy. - About five years have passed since the merger of Quintiles and IMS. What has been the change? The most noticeable change is the diversity of IQVIA customers. In the past, if it was a global clinical trial and market data and analysis business with multinational pharmaceutical companies, domestic pharmaceutical companies, biotech, investment companies such as medical devices and venture capital, consumer companies, private insurers, governments, hospitals, and wholesalers. Last year alone, it has expanded its ties with more than 100 companies as customers and partners. Specifically, the role of helping Korean customers globalize (strategies for overseas expansion, providing overseas market data and insights, supporting overseas clinical, commercialization, and selecting overseas partners) is growing. Companies that enter overseas markets need people by connecting overseas workers with a high understanding of the regulatory environment in overseas markets, and it supports related consulting and advice services. - It is also notable that it has acquired two domestic companies. As far as I know, it was led by a Korean corporation. Yes, IQVIA's Korean subsidiary is continuing its efforts to specialize in the domestic market. First, CoreZetta is a company that analyzes data from the HIRA. The HIRA's data are assets of our country with the NHIS system, but it is important how they can be analyzed and shown well. The cycle is slow and limited, and if it is supplemented with the advantages of IQVIA data, it will be possible to create new insights. Last month, it acquired MMK Communications, which provides medical communication and marketing, digital detailing, and nurse counseling services. Due to the COVID-19 situation, the need for digital detailing has increased and the importance of medical information contents has increased. It is trying to develop the data that doctors need and provide major contents in accordance with the Korean regulatory situation. IQVIA is a total healthcare solution company. -Due to the nature of acquisition companies, services to attract domestic customers are drawing attention. Recently, interest in the domestic biopharmaceutical industry has been increasing, how is it viewed by global consulting firms? I think we should look at it from an overall infrastructure perspective rather than from a technical or scientific perspective. It is possible and necessary to grow a step in line with the capital market's interest in the pharmaceutical bio market and the size of investment. This requires the technological superiority of individual companies, the establishment of an ecosystem for feasible growth, or globalization as much as the performance of each project. Domestic biotech and venture companies grow through investment, and IPO is almost the only way to recover investment in Korea. That is why there is a limit to the recovery market. I think there is a limit to growth in the domestic market alone. It is also important to have a competitive pharmaceutical company that can lead large projects. This seems to require a large merger within the pharmaceutical bio industry. Cases of expansion in overseas markets such as Celltrion's acquisition of Takeda and SK's acquisition of global CMO will have positive results. - Are you trying to combine 'big data' with diversified services? The importance of big data is essential for the development of healthcare industries. Clinical trials are essential for the pharmaceutical industry, but they have to take huge amounts of capital and high risks. However, we expect Real World Data to be able to convert substantially efficiently. South Korea's pharmaceutical industry still lacks large capital capacity. I think data is the driving force behind the growth of these conditions. If it wisely uses it while dispeling concerns about personal information leakage, IQVIA can do this, thinking it could be a big opportunity for the development of the domestic pharmaceutical industry. In addition to managing the risk of data, it is necessary to balance and develop the benefits that real data can give.
- InterView
- "The reason why BI is the ‘Crown Jewel’ among all MNCs"
- by Eo, Yun-Ho May 10, 2021 06:22pm
- Bom-Mai Park, Head of HR/HRBP at Boehringer Ingelheim Korea Multinational pharmaceutical companies are a dream job for many workers in the industry. With its high salary, good welfare, and smart business system, many multinational pharmaceutical companies have all the requirements that office workers desire. Even among these multinational pharmaceutical companies, Boehringer Ingelheim is considered to be top tier. Headquartered in Ingelheim, Germany, the company has maintained its ‘family-operated system' for over 100 years. Since its establishment in 1976, its Korean subsidiary, Boehringer Ingelheim Korea, has also been known as an ‘employee-oriented company that you can work for until retirement.’ Like other companies, Boehringer Ingelheim Korea had also implemented the Early Retirement Program (ERP) in 2014 and 2018 and made reductions in its workforce. However, its downsizing scale and frequency were much smaller and less than other subsidiaries in Korea. The company also showed an encouraging response to the current situation where COVID-19 had swept the world, changing everyone’s daily lives. Boehringer Ingelheim Korea took 'Our FOCUS' and 'Future of Work' as their key message to drive change to fit the new era with their employees. DailyPharm met with Bom-Mui Park (52), VP of Boehringer Ingelheim Korea who heads Human Resources (HR), to hear about the company’s vision and strengths. -What are Boehringer Ingelheim Korea’s strengths in HR? There are official strengths, and those I personally consider as strengths. Officially, the company considers the employee-company relationship in the long term. The policies HQ took during the COVID-19 crisis that broke out last year are a good example. The company made policies to preserve the level of income for employees in sales, such as MRs, who had suffered economic damage due to reduced incentives, etc. from COVID-19. Also, the company provided paid leave for employees who went to do volunteer activities related to COVId-19. I was moved by the immediate response to crisis and rewards provided for employees by the company. Personally, I believe the strength of Boehringer Ingelheim Korea lies in the provision of an ‘environment that allows learning from mistakes.’ Our company has a forgiving nature that allows employees to grow with feedback rather than being punished for a single mistake. Also, as Boehringer Ingelheim is a limited liability company that pursues long-term performance and value creation, it is relatively more stable than the other companies that I have previously worked for. -On the other hand, the company’s ‘forgiving’ culture could be abused and be considered an ‘easy company’ to work for, allowing employees to become lax in their work. I disagree. Those who make mistakes are those who made attempts. Employees who do nothing are the bigger threat to a company. Boehringer Ingelheim has a well-established organizational culture that silently pressures those who do nothing. In other words, our organizational culture is established so that everyone must do their part. The roles and responsibilities of each employee are clearly set, and the evaluation standards for assessing each employee’s performance are also set quite high. In these aspects, Boehringer Ingelheim is not an easy company to work for. Also, our system is constantly evolving to fit the changes, and our employees grow in line with the changes. -What is the ‘Future of Work’ that the company has newly implemented? The Future of Work was implemented in our headquarters to establish a flexible work culture and create a good environment for employees to work for which actively embraces the internal and external changes seen in the current era of change. We worked hard to change the role of the office, which was just a mandatory space for work, into a space for cooperation and innovation. In line with the efforts, Boehringer Ingelheim Korea also opened a smart office on April 5th. The newly transformed office was designed to maximize collaboration, work efficiency, creativity, and employee’s health and well-being based on the company’s vision of ‘creating value through innovation.’ The office is no longer a mandatory workspace, but rather a place of collaboration and innovation which may be selected according to an employee’s nature of work and personal preferences. Our new space has various kinds of meeting rooms and an Innovation Zone, as well as a Quite Zone where employees could focus on their work. We also offer telecommuting, so employees may work at the office or from home. The new office was designed so that all employees and executives may work efficiently and creatively without spatial constraints. - What kind of talents do Boehringer Ingelheim Korea seek for its employees? We have a very specific type of talent we desire in our employees. We want responsible individuals that are alert to change and have entrepreneurship, and not fear innovation or taking risks. This is not limited to Boehringer Ingelheim Korea; it is what Boehringer Ingelheim wants for all its employees and is what we strive to become. With work these days being conducted non-face-to-face and a leaner culture being set within the organization, the work culture in Korea as well has well moved away from the apprenticeship method. In other words, employees nowadays need to lead their own work independently as soon as they enter the company. Of course, feedback is provided; however, the learning curve has also become shorter than in the past, and employees must become on-set quickly. So, we need people who do not feel burdened by learning. We need learners with positive minds that say, ‘I will learn if I don’t know,’ that can strictly manage themselves. -What kind of organization does Boehringer Ingelheim Korea wish to become in the future? Much has changed with COVID-19. The biggest change that occurred is the non-face-to-face work through digital. At first, I had my concerns. But in fact, the flow now is better than expected. We had experienced changes every year, but after COVID-19, we started to consider how to engage and immerse employees in the non-face-to-face environment. In the past, I believed team-building was only possible face-to-face. But I changed my mind after working non-face-to-face. I now believe it is more about the vision set by the company. The vision itself should make the employee's heart beat faster, and a goal needs to be set so the employees can bond over and take pride in its achievement.
- InterView
- "Embrace precision medicine and tumor-agnostic therapy"
- by Eo, Yun-Ho Apr 30, 2021 06:12am
- 박경화 교수 “It’s our turn to adjust to tumor-agnostic therapies." HER2, ALK, EGFR, ROS1. These are keywords that frequently catch our eye in news about anticancer drugs. Times have changed. Effective treatment for patients these days depends on the genetic mutation of each patient. With treatments that target personalized genes continue being introduced, the development of precision medicine has heralded the shift in the field of anticancer treatment from ‘disease-based' to ‘gene-based' treatment. For example, Roche’s Neurotrophic tyrosine receptor kinase (NTRK) ‘Rozlytrek (entrectinib)’ has already been approved as a tumor-agnostic anticancer drug in Korea. Also, MSD’s PD-1 inhibitor immunotherapy ‘Keytruda (pembrolizumab)’ has been adding various indications in patients with microsatellite instability-high (MSI-H) tumors. Dailypharm met with Dr. Kyong-Hwa Park, Professor of Oncology and Hematology at Korea University Anam Hospital, an authority in the field of precision medicine in Korea who also runs the K-Master program, to hear about the currently accessible yet unfamiliar world of personalized treatment, and the paradigm shifts that have occurred in anticancer treatment with the introduction of precision medicine. -Precision medicine has become an inevitable trend. Please tell us about the K-Master project, its progress, and outcome.. Initially, our 5-year goal was to file genome sequencing of 10,000 patients with solid cancer and to launch 20 clinical trials. Based on the data, we wanted to provide new treatment opportunities to patients and create grounds to expand treatment indications. We are in our fifth year, and our project will close on December 31st this year. Since we already have registered and secured genome sequencing data on 9,000 cases, I think we will be able to easily reach our goal. We are also currently conducting 20 trials. Due to the characteristics of precision medicine, the 20 clinical trials could not be initiated all at once, so we needed to sequentially proceed on with our research. In other research areas, we could have started all the trials in the first year. However, precision medicine differs from other areas because of its unmet needs, as well as its unique timeline of drug development that depends on the discovery of new genes. -What is the K-Master program’s strength in conducting clinical trials? Our role model was the NCI (National Cancer Institute)-Match trial. Based on the trial and its limitations, we complemented and improved our project from its initial stages. When 50 institutions under the Korean Cancer Study Group send sample tissues, Central conducts NGS sequencing; however, if the sample tissues do not pass QC, the process of recollecting the tissues take long, and in some cases result in the non-registration of those patients. For our project, we increased the registration success rate by profiling the samples via a liquid biopsy platform to allow the use of blood samples for genome sequencing of patients whose tissues are unavailable or do not pass QC. - Two drugs, including Rozlytrek, were approved in Korea. These tumor-agnostics targeted therapies seem like typical examples of how ‘personalized medicine’ and ‘precision medicine’ are entering our society. What changes do you expect to see in Korea with the introduction of such medicines? The method of how we classify cancer has changed with the introduction of precision medicine. If cancer was classified by location in the past, like lung cancer, colorectal cancer, breast cancer, etc., now it is divided by pathway. So we can now classify cancer as those with HER2 overexpression, HER2 mutation, NTRK mutation, etc. Patients with such cancers are very rare, but doctors now know what to prescribe when such cases arise because we have research and findings on such cases. We can therefore use various methods to find the NTRK-mutations such as DNA sequencing, RNA sequencing, at the protein level or by FISH, etc. As DNA NGS has low sensitivity, we would be lucky to find the mutation at that level. However, for suspected patients, doctors can also order FISH or IHC tests. -Reimbursement remains an obvious issue. Reimbursing tumor-agnostic treatments must be a burden from the government’s perspective. When treatment for rare cancer types that occur in specific genes are granted evidence-based approval in the market, reimbursement should also be considered. I believe the higher-priced drugs can be reimbursed as rare cancer patients have a shorter life expectancy. Less than 1% of all solid cancer patients in Korea fall into the rare cancer patient category that can benefit from such advanced treatments. Considering our diagnostic efficiency, this amounts up to less than 200 patients. We are talking about providing treatment benefits to these very rare patients. If reimbursement is possible, it should be provided. Rare cancer patients typically do not respond to standard treatments. For example, breast cancer patients that do not respond to standard of care therapies show NTRK mutations. As these patients benefit a very short time from standard treatment, reimbursement of NTRK inhibitors for this population should also be possible. Overall, we need to devise a separate reimbursement track for precision medicine. With the introduction of Keytruda in MSI-H and Rozlytrek, there is a pressing need to prepare a separate reimbursement review standard for tumor-agnostic treatments that suits our current situation. If precision medicine is available according to a patients' NGS screening result, they should not be left to feel the immense deprivation of not being able to use the drug due to accessibility issues.
- InterView
- KRPIA will introduce advanced new drugs and seek co-growth
- by Eo, Yun-Ho Apr 26, 2021 05:52am
- Dong-Wook Oh, Chairman of KRPIA The Korean Research-based Pharmaceutical Industry Association (KRPIA), which represents the multinational pharmaceutical companies that are considered the key source for the supply of new drugs, welcomed a new leader last February. KRPIA’s newly appointed Chairman Dong-Wook Oh (51) has been leading Pfizer Pharmaceuticals Korea since 2015. Oh's appointment has brought on various changes within the organization. For the first time in three years, KPRIA has appointed a Korean to head its organization. Demand for the appointment of a Korean leader had been rising as it would enable better communication with relevant ministries, as the access and supply of new drugs is the primary objective of multinational pharmaceutical companies Moreover, with the pipeline of multinational companies weighing towards high-priced drugs, the ability to communicate with the government and list such drugs is being emphasized. In fact, related ministries, such as the Ministry of Health and Welfare (MoHW ) also tend to prefer Korean leaders. Former chairman Avi BenShoshan (former CEO of MSD Korea) was the first foreigner to be elected in 7 years since 2011, after the appointment of the former CEO of Pfizer Dong-Soo Lee (58), former CEO of GSK Korea Jin-Ho Kim (70), and former CEO of Janssen Korea Ok-Yeon Kim. The rise of the dominance of Korean leaders cannot be welcomed without reservations. However, from KRPIA’s perspective, there is no doubt that now is more important than ever. With Oh’s appointment, a new board of directors (BOD) has launched, including a new Vice-Chair and Director. Also, Min-Young Kim (51) joined KRPIA as a policy executive, a position that was left vacant for 6 months after executive director Seong-Ho Kim (63) resigned from his post last April. Dailypharm Korea met with Chairman Dong-Wook Oh, who is leading the change at KRPIA, to hear about the assosication's future direction and challenges. -Regardless of rights and wrongs, a difference certainly exists between companies led by a Korean and a foreigner. As the new chairman, how are you planning to run KRPIA? The trend these days is to pursue a win-win model in which Korean society, Korean patients, and business companies can coexist. In special circumstances like the current COVID-19 outbreak, promptly introducing vaccines to Korea was an extremely difficult task as the whole world needed vaccines. However, KRPIA and branch offices of multinational pharmaceutical companies were dedicated to securing a stable supply of the vaccine, persuading their headquarters, and cooperating with the government. The COVID-19 vaccine case is a perfect example of the efforts made by pharmaceutical companies to support the local community by persuading their headquarters and cooperating with the government. The win-win model is also important in terms of economic contribution. In the age of the 4th industrial revolution, barriers to entering the biopharma industry are higher than in other industries because the know-how and technology transfer of leading global companies is very extremely important. KRPIA has been acting as the bridge connecting domestic companies to form partnerships with global pharmaceutical companies through open innovation so that these companies may grow to establish themselves as leaders in the field by developing their own know-how and capabilities based on partnerships with the global companies. - As you have mentioned, it is encouraging that multinational companies were able to persuade their headquarters to improve Korea’s treatment and prevention environment. However, advanced new drugs that ㅊcannot be properly handled under Korea’s current healthcare system are pouring in right now. Persuading company headquarters may get more and more difficult in this aspect. That is true. With the development of advanced technology, ‘cures’ are now emerging. In other words, ‘one-shot treatment’ technologies that can fundamentally treat diseases caused by genetic defects are currently being developed. The key issue is whether the insurance models established in the past may embrace these innovative treatments. Although the drugs are good news for the patients, as it is an unprecedented technological advance, new financing methods and insurance models need to be introduced to allow the innovative drugs to be included in Korea's systems and policies. The government has also made much effort to deal with this challenge, such as by implementing the ‘Safety and Support Act for Advanced Regenerative Medicine and Advanced Biopharmaceuticals.' From now on, it will be important to bring together the relevant organizations, government, and various stakeholders to create an appropriate model for the introduction of advanced treatments. At this stage, it is too early to decisively point to a certain model and follow its direction. With no precedents available, I believe much social discussion will be needed in the future. - More countries, including the U.S. and China, have been referencing Korea's drug prices for more than just advanced new drugs. It seems ironic that the transparency of our system, which has led to more companies referencing Korea's prices, may ultimately cause supply difficulties in Korea. The phenomenon may seem positive. in terms of sharing information and in verifying that Korea's position in the global market has risen to the level where other countries wish to refer to Korea's prices. However, considering that Korea's drug prices are referenced in large overseas markets such as the US and China, and the influence power of Korea's price will continue to increases gradually, the dreaded situation of drugs being not released at all in Korea may really become a reality. In other words, I am very concerned about the 'Korea passing phenomenon,' in which the introduction of new drugs to Korea becomes delayed due to Korea's reference pricing system. KRPIA feels grateful the government made the decision to implement systems like RSA (Risk Sharing Agreement) as a means to overcome such situations. Currently, drugs eligible for RSA are limited, therefore continuous support is required for the system to expand flexibly and to allow more drugs to overcome such difficulties by devising various models. -‘Clinical investment’ cannot be left out when discussing the contributions made by multinational pharmaceutical companies. However, research investment in Korea is undoubtedly concentrated on Phase 3 research. Does KRPIA have plans to expand its funding to basic research? The association has been actively promoting and taking interest in domestic clinical trials and investment, as well as in the investment trend in the high value-added Phase 1 and 2 research. According to an annual R&D investment status survey conducted by KRPIA, in addition to the overall size of the field, the field of basic research has also been growing continuously recently. Discussions have been held to attract more early-phase clinical trials, and we encourage our members to also do so. KRPIA expects to expand investment to basic clinical studies and will continue to make further efforts in the future. - WIth regards to the direction discussed for KRPIA in the future, What is KPRIA's top priority challenge? Tackling challenges in the drug pricing system to allow the smoother introduction of new drugs is a priority. Also, our key objective is to find ways to transparently and reasonably improve various systems to allow the approval, distribution, and introduction of new drugs. More specifically, we need to find reasonable methods to flexibly expand the application of beneficial systems like the RSA and to utilize the scope, methodology, and real-world data in the PE exemption system.
- InterView
- “Amgen knows how to do it right in Korea”
- by Eo, Yun-Ho Mar 25, 2021 05:59am
- Amgen knows the game in the industry. Besides the title of the ‘Number One Global Bio Company,’ Amgen Korea knows how to be versatile in South Korea. Since opening the South Korean office in 2015, Amgen listed all six products—antiarthritis Prolia (denosumab) and Evenity (romosozumab), skeletal-related events preventing drug Xgeva (denosumab), high cholesterol treatment Repatha (evolocumab), acute lymphoblastic leukemia (ALL) treatment Blincyto (blinatumomab) and multiple myeoloma treatment Kyprolis (carfilzomib)—for the National Health Insurance (NHI) reimbursement. Considering the NHI system, listing each product was not the easiest job. However, Amgen Korea’s determination and concentration drove the negotiation with the government to the conclusion. Currently, all six products are leading the respective markets. Surely their products are ‘good,’ but also Amgen Korea can play the game the right way. Daily Pharm interviewed General Manager Noh Sang-kyung, who has been overseeing the Korean office from the start to date, for his insight and know-how. -Seeking for coverage on every product could not have been easy. Each product developed by pharmaceutical companies has its own unique quality and strengths. And as listing a drug for coverage in South Korea requires to raise awareness of the unmet medical needs, it is crucial, for the reimbursement negotiation process, to provide data to prove how much of benefit the treatment can give to patients. The ‘Value Access’ division staffs in charge of drug pricing in the company analyze and compile a vast amount of data to survey the unmet medical needs in South Korean clinical scene, and support the company to convince the government to fully understand and relate with the said needs through the provided data. -Amgen’s global pipeline seems to be actively working on biosimilars. Do you plan to release the biosimilar products in South Korea as well? About two years ago, we had a relevant discussion, and Amgen Korea has decided to not launch any biosimilar for now. As a leading biotechnology company emphasizing the value of ‘science,’ Amgen’s has a goal to provide innovative treatment in the areas with unmet medical needs for patients. The further option could be considered in the future, but there is no immediate plan. -Amgen is expected to receive the U.S. Food and Drug Administration’s (FDA) approval on currently investigating KRAS treatment sotorasib. Do you think the approval process in South Korea would be swift? South Korea’s Ministry of Food and Drug Safety (MFDS) makes the decision according to their review, so I cannot give you detailed schedule. But as the health authority is well aware of the highly unmet medical needs in KRAS targeted therapy for patients with non-small cell lung cancer, the company aims to do its best to accelerate the process. -As mentioned above, all six products have been listed. Now seems to be the time to think of expanding the coverage. Chronic disease patients may not have immediate risk of urgent health issue, even if they do not get treated right now. But if they are left untreated, the condition could cause severe health issue. Unfortunately in South Korea, I personally think the introducing the new paradigm in managing osteoporosis, cardiovascular diseases and other chronic diseases is far over due. Only in this country, the patients with osteoporosis have to suspend treatment due to the one-year limit on the coverage. -While negotiating with the headquarters regarding the drug pricing, have you ever felt the chance of so-called ‘Korea Passing?’ I have not felt the threat, yet. But I do feel that the drug pricing discussion with the headquarters would get tougher in the future. Already China and Canada have officially stated they would include South Korea as one of pricing reference countries, and the U.S. also said it would refer to all OECD member countries including South Korea for the drug pricing. Calculating the drug pricing in South Korea against GDP, it is considered the lowest among the world. So if the pricing here eventually affects the pricing in the U.S., we may face some difficulties in the future. -In November last year, Amgen Korea also formed a labor union. How do you plan to handle negotiation with the labor union? When a labor union is created in a company, both parties need some time to build the relationship together. I think the union was formed due to the uncertainty in employment amid COVID-19, where the sales activities were restricted and the risk of infectious disease was wearing them down too long. Personally, the forming of the labor union ultimately means the employees want to talk to the management. The labor union mostly shares common objectives with the management. So the company is attentively listening to their opinions and frequently open conversations. -Recently, Amgen Global announced a downsizing plan. How is it affecting Amgen Korea? The U.S. headquarters announced a downsizing plan. But the company has only started the business in APAC region five to six years ago, and it still has strong determination to expand the investment in the region. Clearly, the current employees do not have to stress about the downsizing.
- InterView
- “High pressure and hopes in the policy affairs at KRPIA"
- by Eo, Yun-Ho Mar 11, 2021 06:07am
- Director Kim Minyoung Some say this is the era where policy comes first than an academy, and pricing is more important than an approval. The top priority for pharmaceutical companies in South Korea supplying new drug is the National Health Insurance (NHI) coverage. The era of highly expensive drug has emerged, while the government and pharmaceutical industry are struggling to see eye-to-eye on drug pricing. And now the reimbursement listing and its timing became the deciding factor for the success of a new drug. The Korean Research-based Pharmaceutical Industry Association (KRPIA), representing the multinational pharmaceutical companies in South Korea, has appointed Kim Minyoung as a new Market Access and Policy Director after the position was vacant for about six months since a former Senior Director Sean Kim left the organization last April. Kim was in charge of Market Access (MA) at Korean branch of Eli Lilly and Sanofi-Aventis, and until last year, he was leading the MA within JAPAC region at Amgen Asia. Now at KRPIA, the director is to oversee internal and external activities in regards to the ‘adequate value of new drug’ the industry tries to resolve for a long time. KRPIA’s MA committee and Policy Committee would be managed by Director Kim from now on. “Started off with marketing and sales job, I have worked in policy and drug pricing related work at pharmaceutical companies for 25 years. And I have finally joined KRPIA. When I was working at Amgen Korea, I vaguely thought of drawing up a bigger picture of it all when I go back to South Korea, regardless of my humble experience. And I feel now I have a grip on a good opportunity. It’s burdening, but I also have big hopes for it.” But the pressure on Director Kim is real. The pressure of increased drug price entails delay in listing. Although the government is also trying to versatile with risk sharing agreement (RSA) and pharmacoeconomic evaluation (PE) exemption, their effort can hardly catch up with the speed of new drug development. And it casts a dark shadow on multinational pharmaceutical companies. Especially, at the movement KRPIA is considered to be missing personnel with former government affiliation. “I am aware of the raised concerns. But because we do not have staffs with previous government affiliation, it does not necessary mean the organization is incapable of operating policy related work. The organization does not operate only with the office staff, but with incorporated participation by 44 member companies at respective committees. Particularly, the Policy Committee consists of experts with various backgrounds from the National Assembly, government and media. The committee can assert the variety of opinions by the stakeholders.” Besides the MA and Policy Committees, he noted the importance of the Government Affairs staffs. Technically, the MA and GA within the industry have been ambiguously categorized, and the government affairs were limited to directly relevant institutes like the Ministry of Health and Welfare (MOHW), the Health Insurance Review and Assessment Service (HIRA), and the National Health Insurance Service (NHIS). Many companies have their MA staffs to also cover GA tasks. Director Kim said, “As the public’s interest is heightening not only in patients but also in new drugs, we are suddenly faced with more stakeholders to engage with like the National Assembly, civic groups and patient groups. To reflect the needs, the Policy Committee must be invigorated. This is one of our key agenda for the year.” If vitalizing the Policy Committee is the last piece of puzzle to achieve the goal, the policy recommendation would be outcome. KRPIA has to be nimble to improve the industry’s access to pipeline currently concentrated to rare disease area. Multinational pharmaceutical companies are taking steps to market targeted therapy, immunotherapy and gene therapy like CAR-T. Director Kim carefully mentioned of HIRA and NHIS regarding the core process in reimbursement listing. “As for HIRA, we could talk about the reimbursement standard expansion procedure. Previously, the Expert Committee used to deliberate clinical adequacy of reimbursement anticancer treatments, but now the agency demands for financial impact evidences besides clinical efficacy report. Financial impact can be reviewed once the clinical adequacy deliberation is completed. It would be wonderful if they could streamline the committee operation and deliberation process.” “And for NHIS, the fundamental predicament the industry faces regarding the negotiation procedure is largely the asymmetry in financial impact related information. NHIS has said the revised system would demand the negotiating company to confirm the financial impact evidences. As an industry representative, we welcome the agency’s decision and hope the system works as expected.”
- InterView
- There is still an unmet demand for antiviral drugs
- by Eo, Yun-Ho Mar 03, 2021 06:26am
- CEO Seung-Woo LeeCurrently, vaccines developed by AstraZeneca, Pfizer and others are a hot issue, but in the first half of last year, Remdesivir was ranked first as a keyword related to COVID-19. Gilead, the developer of Veklury (Remdesivir), is a pharmaceutical company specializing in antiviral drugs. It is leading and has pipelines in a variety of fields, from hepatitis B and C to HIV. Last year, the company is expanding its anticancer treatment portfolio by acquiring Forty Seven, an anticancer drug company, and Immunomedics, an ADC development company. This is the story of Lee Seung-woo ( 64 years old), CEO of Gilead, who has both'the original good and the latest trend' like killing two birds with one stone, celebrating the 10th anniversary of the foundation of the Korean subsidiary. -You've been very busy in 2020 with Remdesivir? Last year, as an antivirus company, I felt a great sense of responsibility and mission from the beginning of COVID-19. Upon receiving the news of the 'Wuhan virus' in January of last year, a clinical trial of Remdesivir in the headquarters' Asset Library began. At the same time, we developed and expanded production in a short time, taking all risks. Researchers have participated in various clinical studies in Korea, and many researchers around the world have contributed to the derivation of meaningful research results. Based on these results, we have obtained approvals in various countries such as the United States and Korea, and in Korea, we are grateful that the MFDS, the KCDA, and other related ministries and medical staff have worked together to ensure smooth supply. -Are there any problems with supply of Remdesivir? It is still supplying through consultation with the KCDA. The situation has improved a lot since last October, but treatment is still important because the vaccine supply is not smooth yet. Although there are difficulties due to the continuing pandemic, we will do our best to cooperate with the KCDA to provide a smooth supply. -Remdesivir also had price issues In the early days, it was supplied free of charge to many countries, including Korea. In the process of commercialization, fast supply was more important than anything else. Accordingly, advanced countries, including Korea, are supplying them at the most reasonable price. During the period designated by the WHO as a pandemic, it has been supplied to developing countries such as India and 129 low-income countries according to two price policies, which are provided at a low price without a license fee. -Gilead is recognized as an antiviral company. It has powerful pipelines such as Viread, Sovaldi, Harvoni, and Truvada. However, diseases such as hepatitis B, hepatitis C, and HIV are now well managed The company believes that there is still unmet demand for the diseases mentioned. Viread improved the quality of life of hepatitis B patients and improved prognosis, but has not yet reached a cure. Gilead is not satisfied with the current treatment options, and is still undergoing clinical trials aiming to cure hepatitis B in many countries, including Korea. There are good treatments for HIV as well, but they are investing more in research and thinking more about ways to cure them like hepatitis C. It is also preparing to build a new pipeline. In addition, in the anticancer field, it is carrying out various R&D through mergers and acquisitions of several specialized companies. In addition, they are continuously working on research and development in areas such as inflammatory drugs and NASH. -Is there an anticancer drug pipeline that is imminent for commercialization? Yescarta, which was introduced through the acquisition of Kite Pharma, is showing excellent treatment results based on good data. This treatment is also under consideration for introduction to Korea. Trodelvy, a breast cancer treatment acquired through the acquisition of Immunomedics, is also a breakthrough treatment, and Magrolimab, obtained through Forty Seven last year, is still in the clinical stage, but has high potential in the field of blood cancer. -It seems that Gilead's drugs have not been postponed in registration of insurance benefits in Korea. When communicating with the global headquarters, are there any cases of crisis such as Korea Passing? Any company has a global pricing policy, and I think it is important to create a balance for accessibility. So far, drugs for hepatitis B, hepatitis C, and HIV have been well listed according to the domestic price policy. And we will try to coordinate the products that will come in the future so that there is no disruption in the supply. There are many good things about the domestic medical system, but there are also some difficulties in setting prices for new drugs. I think the industry and the government should work together.
