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- 2026-04-25 09:44:12
- InterView
- The key to drug development is not just safety and efficacy
- by Jung, Hye-Jin Dec 05, 2019 06:12am
- 박영준 대표“In short, it is an area that is easy to miss even though it is important enough to be the core of new drug development. Most of the domestic companies that have applied for a permit with the US FDA or the European EMA are asked to submit additional data. As more and more pharmaceutical companies are attempting to penetrate overseas, Korean companies are also beginning to recognize the importance of quality data”. The reporter met with Park Young-jun, Ph.D. (55, Seoul National University) who is a professor of Ajou University, to hear about CosmaxIMD, IMDpharm joins a venture founded by CosmaxPharma. However, Professor Park emphasized the importance of Chemistry, Manufacturing and Controls (CMC) in the new drug development process. Professor Park has been developing medicine at pharmaceutical companies since graduating from pharmacy. After 17 years as head of product development at Yuhan Research Institute, he worked as research director at Samil Pharmaceuticals and CJ Healthcare. Korea's No. 30 new drug 'K-Cap' is a product that he developed as a CJ research director.Professor Park then set up a new drug research institute. IMDfarm stands for 'Innovative Medicine & Drug Delivery'. ◆Overlooking the importance of CMC to ensure 'quality of material' IMDpharm is a company researching new innovative new drugs, ▲At the same time as developing new innovative medicine for intractable diseases, ▲Improving absorption of poorly soluble drug solubilization, a pharmaceutical formulation technology ▲Sustained Release Drugs ▲Persistent Injectable Technology ▲Disease Targeted Nanoparticle Technology ▲ It is a company that develops convergent new drugs by holding technologies in various formulations such as eye drops and external preparation technologies and applying them to new drugs. However, at present, IMDpharm's cash cow is quality management, or CMC, which is an essential element in the process of leading clinical trials. Venture companies that are engaged in new drug development are the main customers of IMD Pharm CMC service. According to Professor Park, there is no company in Korea that offers a full range of CMC services from nonclinical to clinical. Most of the nation's top pharmaceutical and venture companies, which spend ₩billions on new drug development, use CMC companies in China or India. This is the result of the CMC not receiving attention in the domestic pharmaceutical industry. But the mood has changed recently. This is because CMC, the quality control of the substance, is considered as important as the efficacy and safety of the drug. "The first thing to notice when developing a new drug is the effectiveness, because any substance has a 'pharmacological effect' to get started. The next thing to notice is safety. It is marketable as a drug, 'Quality Control' covers the whole process, from the beginning to the end, demonstrating that all experiments and tests are made of the same substance and keeping this process as records and data". A typical case is 'Rolontis' by Hanmi Pharmaceuticals, . In March, the US FDA requested additional data from Hanmi Pharmaceuticals for marketing approval, which is CMC data. Overseas, the quality control of substances has already been considered important, and more quality control data are required for companies attempting to obtain a marketing license. Professor Park said, "The reason we have to conduct CMC thoroughly from the beginning of new drug development is that we can't do the same clinical trial again." "Even if you already have finished the clinical trial and submitted the results, if you should prove that you have tested all the animals and humans with the same substances and without impurities, can companies that haven't left their data back in time?" "CMC is important for finished products as well as new drugs, increased impurity risk " "Controversial impurity management is also an important part of CMC. With the development of analytical techniques and tightening impurity regulations, this poses a greater risk for pharmaceutical companies. CMC will become even more important throughout the production and distribution of finished products, and Valsartan, Ranitidine, and Nizatidine are all about this. " In this atmosphere, IMDpharm has recently expanded its business. Established in 2016 and started full-fledged business from 2017, the company expanded non-clinical CMC to clinical CMC from August. In September, the company established a joint venture with CosmaxPharma. Cosmax Pharma, which has a finished mass production facility, produces the formulation developed by IMDpharm. “CosmaxPharma and IMDpharm have combined to provide full-service services for CMC, and this year, non-clinical and clinical CRO, Dt & CRO (DTI & CRO), will join us to ensure the safety of materials at all stages of drug development, from non-clinical and clinical. The ultimate goal is to increase the success rate of new drug development for domestic companies”. Professor Park would like to help create a new drug development foundation so that all the processes and technologies necessary for drug development can be solved in Korea".
- InterView
- “Number one in Asia is what we are shooting for”
- by Kim, Jin-Gu Nov 26, 2019 07:15am
- “As far as dermatological treatment business goes, I think we have a shot at becoming the number one in Asian market”, Cho Yong-joon, CEO at Dongkoo Bio & Pharma (“Dongkoo”) commented. The CEO said ‘entering global market’ is the next long-term goal for the company while it gets closer to its 50th anniversary next year. CEO Cho was confident that Dongkoo’s two most prominent business sectors, dermatological treatment and contract manufacturing, would both be competitive in the global market. He explained the recent aggressive investment and company expansion have been executed with the global market in mind. Visiting his office on Nov. 18 for an interview, it has not even been 24 hours since came back from his business trip to the U.S. Apparently, Cho was already making moves for the global market. -What business took you to the U.S.? “It was to dip our toes in the water of global contract manufacturing organization (CMO) market. I shared some positive talks with a U.S. company especially on our strength, the soft capsule manufacturing. When we ink the deal, we would fully disclose the story. Next year would be Dongkoo’s 50th anniversary. Accordingly we would put forth our global market vision”. - Would it be safe to assume the latest Hwaseong plant expansion was a part of the vision? “We have invested ten billion won. The plant started running from this month. Our production capacity would go up half as much again as before or even double. The company’s CMO sector made 21 percent more last year with 33.1 billion won, compared to 15.3 billion won in 2014. We are expecting to make about 40 billion won this year. To date, the manufacturing factory could not catch up with orders pouring in. “When the manufacturing facility stabilizes from next year, the overall sales and profit would rise. Not only did we enhance production capacity, but also we are focusing on developing new technology on soft capsule. We gained expertise in dermatological treatment through our experience”. -After the valsartan incident, many are concerned of CMO industry “Korean CMO industry is faced with crisis and opportunity all at the same time. As the regulator decided to abolish the joint bioequivalence test system, and revived the gradual drug pricing system, I expect the industry would get the blow soon or later. That is what Dongkoo is preparing for. Specialization and differentiation is the key. The government is also encouraging companies to focus on specialized manufacturing. So far, Dongkoo has been doing well with soft capsule and ointment items. “But the opportunity lies in the global market. Korean CMO industry would be competent enough in the global market. I confirmed that at the CPhI Worldwide 2019. From now on production cost would heat up the already competitive generic market. Now it’s a matter of who sources drug the best. Korean companies could also easily source drug from other countries. We all need to target the global market competition”. -What are your visions on Dongkoo’s specialized sector, dermatological and urological treatments? “Not too different from others, we’re aiming for the global market expansion. First, we would tackle the Asian market. The company is carefully preparing for the leap. To be specific, we are considering opening an office in China. In Korea, our dermatological treatment prescription is ranked at the top with, and urological treatment prescription is at eighth place. Why not then go for the top rank in Asia? This is our goal. We have constantly introduced dermatological treatment. Some are ready to be released next year. For the long-run, we are in process of developing new drug and incrementally modified new drug”. -You’ve shown some notable moves not only on facilities but also on venture investment. “We have signed deals with Novacell Technology, D&D Pharmatech and BioNote. D&D Pharmatech is a bio venture led by a group of professors from the Johns Hopkins University School of Medicine. They are developing treatments for Parkinson’s disease, Alzheimer’s disease and rare fibrosis conditions. Dr. Lee Seulki from Johns Hopkins University School of Medicine is leading the R&D and clinical trials. “We have invested 3.1 billion won on D&D Pharmatech. The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for the venture company’s rare fibrosis treatment. Recently, the company successfully attracted 140 billion won worth of series B funding. We expect the company to go public next year. “Novacell Technology obtained its U.S. patent on atopic dermatitis peptide this year. And BioNote was the first Korean company to develop African Swine Flu diagnosis kit”. -Investment expansion comes with business profit drop. Seems like Dongkoo’s revenue has been falling for last two years. “It was given that operating profit would go down. We have spent much of capital on facility expansion investment, recruitment, clinical investment and marketing. But the actual sales revenue has constantly gone up. It verifies that the business is growing steadily. The last two years of decreased revenue was about preparing for the future ‘quantum jump’. The return on the investment is expected to show even from next year and on". -Some other business expansion on other sectors like cosmetics and medical device has been noticeable as well. “We’ve jumped into cosmetic market. ‘Cell Bloom’ is a brand based on 3D stem cell media skin care products. We are expecting the brand to generate synergy effect with our expertise in dermatological treatment. And we are taking this for a long run. A few home shopping TV channels have offered us a slot, but we turned them down. We could’ve gotten some instant sales hike, but we are planning to build the brand image centering hospitals and duty free shops first. “Besides Cell Bloom, we also have an ongoing development of bio medical device called ‘Smart X’. We are challenging the chronic disease sector with bio technology. There are unmet needs that cannot be resolved with drugs. An example would be diabetic foot (chronic foot condition derived from diabetic mellitus). Not many drugs treat diabetic foot. “Smart X is a convenient stem cell extraction kit. We have observed meaningful effect from extracting stem cell and injecting back into the ulcer on a foot. Clinical trial is in process to receive approval on the new medical technology. It would get approval in first half of next year at earliest, and generate expected sales from the latter half of the year. The approval application reviews are well on their ways in the U.S., China and Russia as well. And it’s already on sale in Spain”. -Celebrating the last 50 years of the business, what’s next for Dongkoo? “Bio sector is where Dongkoo would be investing on for the next 50 years. Cell Bloom and Smart X are on the same track as well. We would not superficially imitate bio technology, but strive for sustainable business with genuine bio technology, as I would reiterate at the company foundation ceremony. "For the goal, Dongkoo aims to transform from pharmaceutical and bio company into a total healthcare company. Dongkoo would generate great synergy effect with dermatological and urological treatments, as well as stem cell-applied healthcare technology, and reborn as a total healthcare company to cover from head to toe with diagnostic, preventive, treatment and maintenance products”.
- InterView
- I know CRA grievances better than anyone else
- by Lee, Tak-Sun Nov 14, 2019 09:59am
- For CRA(Clinical Research Associate), it is very hard to communicate with many professional people. It's even harder if you don't have expertise. I wish my juniors would work with proud. I would like to have the pride of being an expert that communicates effectively with clinical expertise, monitors clinical practice, and leads clinical practice overall. Kyungsun Kong(52 years old), CEO of dreamCIS knows CRA grievances better than anyone else. The core of the CRO(Clinical Research Organization) is often called CRA. However, CRAs have a lot of work and are irregular, so they often move over. when working as a clinical monitoring agent, you may get hurt by professional experts, such as doctors and nurses. However, the power of the CRA may gaurantee clinical trial quality. It's no wonder that pharmaceutical companies are rushing to many CROs with competent CRAs. CEO Kong was also one of the most competent CRAs. In 1995, she began to work clinical trials as a clinical nurse (CRC) at SMC. The CRC is responsible for coordinating communication between subjects and researchers. In 2003, she conducted clinical trials for 25 years, including Wyeth, Parexel and YUHAN. She worked as a PM managing CRA at Parexel, and she took care of the clinical trial of Lasertinib, a lung cancer drug as a clinical development team leader at Yuhan. CEO Kong is probably the only one who started as a CRC and experienced various duties in the clinical field and became the head of the domestic CRO. This is because most domestic CROs maintain owner representative system. About the reason why she joined dreamCIS last April,“I wanted to try new experience and challenge, CEO Gong said. dreamCIS is an important global CRO since it was acquired by Tigermed in China in 2015. It was the first domestic CRO to undergo preliminary screening. By the end of this month, it will be decided. CEO Gong said, "The goal is to stably grow dreamCIS as a global CRO and It is very symbolic to have listed stocks as a leading company in the industry. It is expected in many ways.“ In recent years, dreamCIS has been gradually increasing global challenges in cooperation with Tigermed. 20-25% of current projects are global. Most of them carry out clinical tasks in China and Korea. CEO Gong said, “Chinese pharmaceutical companies are also growing so much that there is an increasing demand to conduct simultaneously clinical trials in Korea and Japan because the data is mutual recognition.” She said, "Since the merger of Taigermed, the progress of global tasks has been increasing considerably, and there are many opportunities for domestic companies to enter China." I want to contribute to the successful entry of Korean companies to China. ” CEO Gong plans to carry out his management philosophy with a focus on improving clinical quality. She said, “The important thing is clinical quality and I pay much attention to education and talent Recruitment.” Speaking as CRO, It is the key to have good talented CRA. Especially good CRAs control clinical quality. More than 50% of the 200 employees are CRAs in the company, and 80% of them are women. CEO Gong plans to devote herself to building a good company for women to work.“There are many benefits according to the number of women, and many of our employees are working from home and flexible, and I will continue to encourage them.” "I have experienced various companies as a female representative and also as a working mom, but I think that the diverse and flexible culture and system of dreamCIS provide more opportunities for competent working moms and young women focusing on their work creatively", she added. While working as a CRA, she had a lot of hard work, but much experience brought her here with pride. She advised, "To work with professionals such as nurses, pharmacists, doctors or nurses, you need expertise in the clinical field you are in charge of, and you need to communicate based on that knowledge. I wish our staff, as well as juniors working in the clinical industry, would be proud to work with them. ” “Global CROs are starting from the CRA and going up to the country head as they build up their careers, and I also have come to this position as I build up my career from the CRAs." I think it will be a good model for new emloyees and juniors to work” she said. CEO Gong concluded that she is planning a multi-faceted business after the IPO and plans to focus on a business based on the CRO.
- InterView
- 50-year-old Pfizer Korea “For both patients and innovation"
- by Eo, Yun-Ho Nov 06, 2019 08:59am
- CEO Oh Dong-wook Half a century in Korean pharmaceutical industry, Pfizer Korea seems to have mastered ‘how to win’ in the Korean market. Pfizer took its first step into the Korean market as a joint corporation with Joongang Pharmaceutical in 1962 and founded Pfizer Korea in 1969. Except for a couple of times, Pfizer Korea’s sales have been the top among global pharmaceutical companies in Korea. Last year, the company had the highest sales so far of 734.4 billion won, a level no global company has ever reached. The key to its driving force is in ‘evolution’. The company has sought after ‘cash cow drugs’ by acquiring numerous companies like Warner-Lambert Company, Wyeth, Pharmacia, and Hospira, and also undergone various organizational reform like the recent split-up with Upjohn. Through series of changes, Pfizer and Pfizer Korea have achieved successful ‘survival’ and ‘development’ every single time. But, not all good drugs can make a success. If it were not for Pfizer’s solid foundation, its profitable drugs would not have made it. Celebrating the 50th anniversary of Pfizer Korea, CEO Oh Dong-wook (50) of Pfizer Korea spoke of the company’s history and the future. - Half a century in Korea, what have been the most important milestones for Pfizer Korea? I can say about three major achievements to note. First, Pfizer contribution on making patients live happier lives by providing outstanding new drugs. Second, Pfizer’s continuous effort to become a responsible corporate citizen of the community and to conduct long-running corporate social responsibility (CSR) activities. Many of CSR activities Pfizer Korea provide are over a decade old. Last but not least, the fact that Pfizer Korea has consistently contributed in creating a healthy pharmaceutical and bio environment along with various stakeholders to advance new drug development, health and society in Korea. Numerous clinical trials have been conducted in Korea so far, which we expect the gained experience and tips on developing innovative new drug with global company would come through eventually and immensely contribute to the future of new drug in Korea. -‘Drug’ has a unique quality as a commodity, which is why the sense of ethics is always under the limelight. But as a business, profit would have to be the main objective. What is Pfizer doing to balance out two polarizing values? Pfizer seeks for an ‘innovation that changes patient’s quality of life’. Not only Pfizer, but many of pharmaceutical companies used to maximize profit centering customer (healthcare provider) in the past. However, this day and age requires immensely high level and standard of ethics. And it makes a sense for stakeholders to have higher level of expectation on the industry than any other industry. In such strict environment, Pfizer would never seize to make every decision prioritizing and centering patients. -Reflecting patients’ voice is not that easy. A pharmaceutical company directly engaging with patients has its limitation, and a lot of times patients cannot have their way regardless. Despite availability of a great new drug, limited access (health insurance coverage) puts a gap between patient and the treatment. That is why patient advocacy groups usually voice out on drug approval review and National Health Insurance (NHI) listing policy-making processes. Medical industry has a quite unusual ecosystem, where a patient is an ultimate consumer, but an experienced and knowledgeable healthcare provider is making decisions on prescription. While a company supplies drug, consumer and National Health Insurance Service (NHIS) are paying for the drug. Even the ultimate consumer raises an issue, changes can only be made when experts’ judgment and reasonable decision making coincide. The decision making process has improved significantly compared to the past, but it still has a room to grow. As a leading company in pharmaceutical and bio sector, Pfizer plans to engage in various activities with various stakeholders in community, such as industry organization, healthcare providers’ group and patient advocacy group, to reflect patients’ voices on government policies. -As you mentioned, patients’ voices in Korean society is skewed on ‘NHI reimbursement’ and now their interest is growing on drug pricing for the same reason. The administration plans to reduce their expense on drug with expired patent and reuse the saved finance on introducing new drug to Korean market. After separating the organization into two and ‘Pfizer Upjohn’ solely dealing with expired patent, the said government’s plan could be a bad news. As a whole company, what do you think of the direction government policy is taking? Pfizer Korea has a say in making the best choice for patients, regarding what Pfizer Upjohn Korea and Pfizer Biopharmaceuticals Korea do in respective treatment sectors. My role is to represent general operation of the company when discussing with government body and other stakeholders, and respective branches are to make a reasonable decision for their own businesses. -Going back to Pfizer’s principle of ‘centering patient’, would it be safe to say Pfizer Upjohn would not oppose against Korean government when it reduces pricing of drug with expired patent? That is correct. As I said before, Pfizer’s aim is to supply as many new drugs as possible to patients and to bring changes to their lives. Regardless of patent expiration, we believe changing the lives of patients has enough meaningful merit. -But as the age of high-cost drug approaches, the gap between the government and pharmaceutical industry’s views on drug pricing is getting wider. I assume Pfizer Korea would experience discrepancies when negotiating with Korean government and persuading the headquarter office. Some are concerned about global pharmaceutical companies giving up on Korean market as more countries are referencing drug prices in Korea. Many have contributed for patients to benefit from Pfizer’s innovative new drug, but our companies’ staffs had poured in vast amount of work into it as well. We do our best to promptly introduce new drug to Korean market. And in the process, the company tries to find the middle ground between negotiating with Korean government and convincing headquarter as soon as feasible. One could simply think, lowering drug price would be the answer for putting patients first. Or in an extreme sense, providing drugs for free would be the answer if we were to truly think of patients. But, in the end, we are a company, and a company has to be sustainable. We are always faced with discrepancy between insured drug pricing and headquarter-approved drug pricing. Obviously, we are working hard to make Korean patients to receive benefit as soon as possible, and that is that is the direction we taking. While Chinese market is growing rapidly, many markets around the globe, including Taiwan, Thailand, Saudi Arabia and China have started to reference drug price in Korea. The U.S. also announced it would reference price in Korea as well. As for the headquarter office, making deficit after investing astronomical amount in R&D for new drug and receiving inadequately low pricing would be a devastating result. It would ultimately hinder any company from investing in future pipeline. This is why we need an appropriate pricing. -Let us now focus more on Pfizer. Upjohn was split from the recent reorganization. What is it like to manage the company in the new state? To enhance efficiency of Global Pfizer’s organizational structure, Pfizer Korea separated itself into two; Pfizer Biopharmaceuticals Korea focusing on new drug development and innovative drug, and Pfizer Upjohn Korea providing drug with expired patent and generic. We expect the two corporate bodies to mutually strengthen potential growth in respective fields. Based on a variety of drug pipelines and treatments each business sector owns, Pfizer aims to improve patient’s quality of life by providing treatment timely to many more patients. The approaches we would take are still in talks, but staffs’ role and responsibilities would be unchanged. -When a drug owned by Pfizer Biopharmaceuticals has its patent expired, then is it transferred to Pfizer Upjohn? No, it wouldn’t be. Drugs are categorized by disease group. -It feels like in the future, Pfizer Biopharmaceuticals and Pfizer Upjohn would be completely split up and would become completely different two entities. For now, management direction or timing has not been specifically discussed, yet. Until everything is set, both bodies would be managed under the name of Pfizer Korea. -How is the current status of the consumer healthcare (OTC) sector joint venture with GSK? As far as Global Pfizer goes, it officially announced closing of joint venture with GSK, as of Aug. 1. And accordingly, Pfizer’s consumer health sector was transferred to the new joint venture. However, each region would have different timing as to when the joint venture would take over the management. In case of Korea, the closing is delayed as the company has to complete the necessary approval process and end some ongoing operations. When the deal is finally closed, Pfizer’s staffs would undergo some organizational changes and those would be notified after everything is set in stone. -How would you define the last 50 years and the next 50 years of Pfizer Korea? Looking back at past 50 years, the company went through absence of well-established healthcare and corporate environment when it was first founded in 1969. Back then, Separation of Prescription and Dispensing (SPD), or proper medical and pharmaceutical regulations were not stipulated. But now, we feel quite proud of how Pfizer Korea contributed in building the current healthcare environment alongside many stakeholders by placing a brick at a time. In the end, we think Pfizer contributed in bringing meaningful changes to local communities and patients suffering from disease. But it also means Pfizer Korea still has a long way to go, although it made proud achievements under the corporate objective and goal. As a responsible corporate citizen and leading pharmaceutical company, Pfizer Korea would continue to keep its leadership among patients and in local community.
- InterView
- [Reporter's View] What's fair for addressing unmet needs
- by Son, Hyung Min
- Now, cancer therapy has entered a stage where a single option cannot explain it all. Previously, when cytotoxic chemotherapy was the center of treatment, the type of cancer was the core criterion for determining a treatment strategy.However, the situation is different now. Even within the same cancer type, entirely different agents are selected based on biomarkers, and even the sequence of treatment and combination strategies varies. The structure has changed to the point where a single disease is effectively split into several different diseases.This change is not a phenomenon limited to specific areas. Non-small cell lung cancer (NSCLC) treatment has been subdivided based on various genetic mutations, and the approach to colorectal cancer also varies depending on biomarker characteristics such as BRAF. Targeted-based therapy is also expanding in rare cancers like biliary tract cancer.Even in diseases where options were limited in the past, the treatment strategy must be redesigned.The problem is that this variation does not stop at simply increasing options but leads to an expansion of the treatment scope.Treatments previously applied primarily to metastatic patients are gradually expanding to include patients with stages 1 to 3, the early-stage patient group. As neoadjuvant, adjuvant, maintenance, and combination therapies are discussed simultaneously, treatment is shifting toward a structure that starts earlier and lasts longer.Of course, from the patient's perspective, the ideal scenario is to receive reimbursement for all possible treatments. If newly emerging agents can be used for more patients at an earlier stage, the opportunity for treatment expands. However, the fact that these changes are occurring simultaneously across multiple cancer types rather than in a specific disease presents another dilemma.Each treatment expansion may be a valid choice. However, the story changes if the same trend is repeated across various cancer types. This is because it is realistically difficult to raise all areas at the same pace with limited resources. Ultimately, it becomes necessary to decide which area to invest more resources in first.In this process, there is one point to be cautious of. The needs of other cancer types must not be ignored simply because discussions are active and voices are loud in a specific cancer type.Unmet needs are not a concept confined to specific diseases. Unmet needs are presented in different forms across various cancer types. There is a possibility that while the necessity of one area is emphasized, the gaps in other areas may be relatively overshadowed.Ultimately, the question is clear: "To what extent and by what criteria will we apply the increased treatment options?" Applying all treatments to all patients may be ideal, but it is not a realistically possible option. Therefore, a discussion is needed on what criteria will be used to set priorities.More opportunities for patients are available due to advances in cancer treatment. However, consideration must also be given to how to distribute those opportunities and to striking a balance to prevent bias toward specific areas during that process. This is why we must reconsider the concept of unmet needs from a broader perspective.
