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- 2026-06-11 00:00:15
- InterView
- I know CRA grievances better than anyone else
- by Lee, Tak-Sun Nov 14, 2019 09:59am
- For CRA(Clinical Research Associate), it is very hard to communicate with many professional people. It's even harder if you don't have expertise. I wish my juniors would work with proud. I would like to have the pride of being an expert that communicates effectively with clinical expertise, monitors clinical practice, and leads clinical practice overall. Kyungsun Kong(52 years old), CEO of dreamCIS knows CRA grievances better than anyone else. The core of the CRO(Clinical Research Organization) is often called CRA. However, CRAs have a lot of work and are irregular, so they often move over. when working as a clinical monitoring agent, you may get hurt by professional experts, such as doctors and nurses. However, the power of the CRA may gaurantee clinical trial quality. It's no wonder that pharmaceutical companies are rushing to many CROs with competent CRAs. CEO Kong was also one of the most competent CRAs. In 1995, she began to work clinical trials as a clinical nurse (CRC) at SMC. The CRC is responsible for coordinating communication between subjects and researchers. In 2003, she conducted clinical trials for 25 years, including Wyeth, Parexel and YUHAN. She worked as a PM managing CRA at Parexel, and she took care of the clinical trial of Lasertinib, a lung cancer drug as a clinical development team leader at Yuhan. CEO Kong is probably the only one who started as a CRC and experienced various duties in the clinical field and became the head of the domestic CRO. This is because most domestic CROs maintain owner representative system. About the reason why she joined dreamCIS last April,“I wanted to try new experience and challenge, CEO Gong said. dreamCIS is an important global CRO since it was acquired by Tigermed in China in 2015. It was the first domestic CRO to undergo preliminary screening. By the end of this month, it will be decided. CEO Gong said, "The goal is to stably grow dreamCIS as a global CRO and It is very symbolic to have listed stocks as a leading company in the industry. It is expected in many ways.“ In recent years, dreamCIS has been gradually increasing global challenges in cooperation with Tigermed. 20-25% of current projects are global. Most of them carry out clinical tasks in China and Korea. CEO Gong said, “Chinese pharmaceutical companies are also growing so much that there is an increasing demand to conduct simultaneously clinical trials in Korea and Japan because the data is mutual recognition.” She said, "Since the merger of Taigermed, the progress of global tasks has been increasing considerably, and there are many opportunities for domestic companies to enter China." I want to contribute to the successful entry of Korean companies to China. ” CEO Gong plans to carry out his management philosophy with a focus on improving clinical quality. She said, “The important thing is clinical quality and I pay much attention to education and talent Recruitment.” Speaking as CRO, It is the key to have good talented CRA. Especially good CRAs control clinical quality. More than 50% of the 200 employees are CRAs in the company, and 80% of them are women. CEO Gong plans to devote herself to building a good company for women to work.“There are many benefits according to the number of women, and many of our employees are working from home and flexible, and I will continue to encourage them.” "I have experienced various companies as a female representative and also as a working mom, but I think that the diverse and flexible culture and system of dreamCIS provide more opportunities for competent working moms and young women focusing on their work creatively", she added. While working as a CRA, she had a lot of hard work, but much experience brought her here with pride. She advised, "To work with professionals such as nurses, pharmacists, doctors or nurses, you need expertise in the clinical field you are in charge of, and you need to communicate based on that knowledge. I wish our staff, as well as juniors working in the clinical industry, would be proud to work with them. ” “Global CROs are starting from the CRA and going up to the country head as they build up their careers, and I also have come to this position as I build up my career from the CRAs." I think it will be a good model for new emloyees and juniors to work” she said. CEO Gong concluded that she is planning a multi-faceted business after the IPO and plans to focus on a business based on the CRO.
- InterView
- 50-year-old Pfizer Korea “For both patients and innovation"
- by Eo, Yun-Ho Nov 06, 2019 08:59am
- CEO Oh Dong-wook Half a century in Korean pharmaceutical industry, Pfizer Korea seems to have mastered ‘how to win’ in the Korean market. Pfizer took its first step into the Korean market as a joint corporation with Joongang Pharmaceutical in 1962 and founded Pfizer Korea in 1969. Except for a couple of times, Pfizer Korea’s sales have been the top among global pharmaceutical companies in Korea. Last year, the company had the highest sales so far of 734.4 billion won, a level no global company has ever reached. The key to its driving force is in ‘evolution’. The company has sought after ‘cash cow drugs’ by acquiring numerous companies like Warner-Lambert Company, Wyeth, Pharmacia, and Hospira, and also undergone various organizational reform like the recent split-up with Upjohn. Through series of changes, Pfizer and Pfizer Korea have achieved successful ‘survival’ and ‘development’ every single time. But, not all good drugs can make a success. If it were not for Pfizer’s solid foundation, its profitable drugs would not have made it. Celebrating the 50th anniversary of Pfizer Korea, CEO Oh Dong-wook (50) of Pfizer Korea spoke of the company’s history and the future. - Half a century in Korea, what have been the most important milestones for Pfizer Korea? I can say about three major achievements to note. First, Pfizer contribution on making patients live happier lives by providing outstanding new drugs. Second, Pfizer’s continuous effort to become a responsible corporate citizen of the community and to conduct long-running corporate social responsibility (CSR) activities. Many of CSR activities Pfizer Korea provide are over a decade old. Last but not least, the fact that Pfizer Korea has consistently contributed in creating a healthy pharmaceutical and bio environment along with various stakeholders to advance new drug development, health and society in Korea. Numerous clinical trials have been conducted in Korea so far, which we expect the gained experience and tips on developing innovative new drug with global company would come through eventually and immensely contribute to the future of new drug in Korea. -‘Drug’ has a unique quality as a commodity, which is why the sense of ethics is always under the limelight. But as a business, profit would have to be the main objective. What is Pfizer doing to balance out two polarizing values? Pfizer seeks for an ‘innovation that changes patient’s quality of life’. Not only Pfizer, but many of pharmaceutical companies used to maximize profit centering customer (healthcare provider) in the past. However, this day and age requires immensely high level and standard of ethics. And it makes a sense for stakeholders to have higher level of expectation on the industry than any other industry. In such strict environment, Pfizer would never seize to make every decision prioritizing and centering patients. -Reflecting patients’ voice is not that easy. A pharmaceutical company directly engaging with patients has its limitation, and a lot of times patients cannot have their way regardless. Despite availability of a great new drug, limited access (health insurance coverage) puts a gap between patient and the treatment. That is why patient advocacy groups usually voice out on drug approval review and National Health Insurance (NHI) listing policy-making processes. Medical industry has a quite unusual ecosystem, where a patient is an ultimate consumer, but an experienced and knowledgeable healthcare provider is making decisions on prescription. While a company supplies drug, consumer and National Health Insurance Service (NHIS) are paying for the drug. Even the ultimate consumer raises an issue, changes can only be made when experts’ judgment and reasonable decision making coincide. The decision making process has improved significantly compared to the past, but it still has a room to grow. As a leading company in pharmaceutical and bio sector, Pfizer plans to engage in various activities with various stakeholders in community, such as industry organization, healthcare providers’ group and patient advocacy group, to reflect patients’ voices on government policies. -As you mentioned, patients’ voices in Korean society is skewed on ‘NHI reimbursement’ and now their interest is growing on drug pricing for the same reason. The administration plans to reduce their expense on drug with expired patent and reuse the saved finance on introducing new drug to Korean market. After separating the organization into two and ‘Pfizer Upjohn’ solely dealing with expired patent, the said government’s plan could be a bad news. As a whole company, what do you think of the direction government policy is taking? Pfizer Korea has a say in making the best choice for patients, regarding what Pfizer Upjohn Korea and Pfizer Biopharmaceuticals Korea do in respective treatment sectors. My role is to represent general operation of the company when discussing with government body and other stakeholders, and respective branches are to make a reasonable decision for their own businesses. -Going back to Pfizer’s principle of ‘centering patient’, would it be safe to say Pfizer Upjohn would not oppose against Korean government when it reduces pricing of drug with expired patent? That is correct. As I said before, Pfizer’s aim is to supply as many new drugs as possible to patients and to bring changes to their lives. Regardless of patent expiration, we believe changing the lives of patients has enough meaningful merit. -But as the age of high-cost drug approaches, the gap between the government and pharmaceutical industry’s views on drug pricing is getting wider. I assume Pfizer Korea would experience discrepancies when negotiating with Korean government and persuading the headquarter office. Some are concerned about global pharmaceutical companies giving up on Korean market as more countries are referencing drug prices in Korea. Many have contributed for patients to benefit from Pfizer’s innovative new drug, but our companies’ staffs had poured in vast amount of work into it as well. We do our best to promptly introduce new drug to Korean market. And in the process, the company tries to find the middle ground between negotiating with Korean government and convincing headquarter as soon as feasible. One could simply think, lowering drug price would be the answer for putting patients first. Or in an extreme sense, providing drugs for free would be the answer if we were to truly think of patients. But, in the end, we are a company, and a company has to be sustainable. We are always faced with discrepancy between insured drug pricing and headquarter-approved drug pricing. Obviously, we are working hard to make Korean patients to receive benefit as soon as possible, and that is that is the direction we taking. While Chinese market is growing rapidly, many markets around the globe, including Taiwan, Thailand, Saudi Arabia and China have started to reference drug price in Korea. The U.S. also announced it would reference price in Korea as well. As for the headquarter office, making deficit after investing astronomical amount in R&D for new drug and receiving inadequately low pricing would be a devastating result. It would ultimately hinder any company from investing in future pipeline. This is why we need an appropriate pricing. -Let us now focus more on Pfizer. Upjohn was split from the recent reorganization. What is it like to manage the company in the new state? To enhance efficiency of Global Pfizer’s organizational structure, Pfizer Korea separated itself into two; Pfizer Biopharmaceuticals Korea focusing on new drug development and innovative drug, and Pfizer Upjohn Korea providing drug with expired patent and generic. We expect the two corporate bodies to mutually strengthen potential growth in respective fields. Based on a variety of drug pipelines and treatments each business sector owns, Pfizer aims to improve patient’s quality of life by providing treatment timely to many more patients. The approaches we would take are still in talks, but staffs’ role and responsibilities would be unchanged. -When a drug owned by Pfizer Biopharmaceuticals has its patent expired, then is it transferred to Pfizer Upjohn? No, it wouldn’t be. Drugs are categorized by disease group. -It feels like in the future, Pfizer Biopharmaceuticals and Pfizer Upjohn would be completely split up and would become completely different two entities. For now, management direction or timing has not been specifically discussed, yet. Until everything is set, both bodies would be managed under the name of Pfizer Korea. -How is the current status of the consumer healthcare (OTC) sector joint venture with GSK? As far as Global Pfizer goes, it officially announced closing of joint venture with GSK, as of Aug. 1. And accordingly, Pfizer’s consumer health sector was transferred to the new joint venture. However, each region would have different timing as to when the joint venture would take over the management. In case of Korea, the closing is delayed as the company has to complete the necessary approval process and end some ongoing operations. When the deal is finally closed, Pfizer’s staffs would undergo some organizational changes and those would be notified after everything is set in stone. -How would you define the last 50 years and the next 50 years of Pfizer Korea? Looking back at past 50 years, the company went through absence of well-established healthcare and corporate environment when it was first founded in 1969. Back then, Separation of Prescription and Dispensing (SPD), or proper medical and pharmaceutical regulations were not stipulated. But now, we feel quite proud of how Pfizer Korea contributed in building the current healthcare environment alongside many stakeholders by placing a brick at a time. In the end, we think Pfizer contributed in bringing meaningful changes to local communities and patients suffering from disease. But it also means Pfizer Korea still has a long way to go, although it made proud achievements under the corporate objective and goal. As a responsible corporate citizen and leading pharmaceutical company, Pfizer Korea would continue to keep its leadership among patients and in local community.
- InterView
- [기자의 눈] 오픈 이노베이션 선순환의 열쇠(H)
- by Son, Hyung Min
- [데일리팜=손형민 기자] 최근 글로벌 제약사와 국내 바이오기업 간 협력은 단순 기술도입을 넘어 공동 연구개발과 플랫폼, 초기 자산 발굴 단계까지 확대되고 있다. 과거 어느 정도 검증이 끝난 후기 임상 자산 중심이었던 협력 방식이 점차 다양해지고 있는 점이 특징이다.일라이릴리는 최근 한미약품의 GLP-2 기반 신약 후보물질을 도입했다. 이 회사는 지난해에도 에이비엘바이오, 알지노믹스, 올릭스 등 국내 바이오기업과 신약후보물질 도입 계약을 체결했다. MSD, 로슈, 화이자, 노바티스, 바이엘, 아스트라제네카, 암젠 등 여러 글로벌 제약사들 역시 국내 유방 바이오텍 발굴 프로그램과 공동 연구를 확대하고 있다.이 같은 변화는 국내 바이오기업의 기술력이 일정 수준 인정받고 있다는 의미로도 해석할 수 있다.글로벌 제약사들은 매년 수많은 후보물질과 플랫폼 기술을 검토한다. 연구개발 성공 가능성과 임상적 경쟁력, 사업성 등을 종합적으로 평가한 뒤 투자 여부를 결정한다. 기술이전이나 공동개발 계약이 곧 신약 성공을 의미하는 것은 아니지만, 최소한 해당 기술이 글로벌 시장에서 경쟁력을 검증받을 기회를 얻었다는 의미는 있다.정부 역시 오픈 이노베이션을 바이오산업 성장 전략의 한 축으로 강조하고 있다. 국내 연구개발 역량과 글로벌 제약사의 개발·상업화 역량을 결합해 혁신 신약 개발 성공 가능성을 높이겠다는 취지다.국내 기업이 발굴한 기술이 글로벌 제약사와 협력을 통해 신약으로 개발되더라도, 국내 시장에 진입하는 순간에는 임상적 유용성과 비용효과성 중심의 평가가 이뤄진다.이는 당연한 원칙이다. 건강보험 재정은 한정돼 있으며 허가와 급여는 객관적 근거를 기반으로 판단해야 한다. 특정 기업이나 특정 국가에서 개발했다는 이유만으로 우대받을 수는 없다.다만 정부가 오픈 이노베이션과 바이오산업 육성을 국가 전략으로 추진하고 있는 만큼, 국내 연구개발 생태계가 창출한 혁신의 가치를 현재 제도 안에서 어떻게 평가할 것인지에 대한 논의는 필요해 보인다. 국내 기업이 발굴한 기술이 글로벌 제약사와의 협업을 통해 세계 시장에서 경쟁력을 입증한 경우 그 성과를 단순히 하나의 수입 신약과 동일한 관점에서만 바라보는 것이 적절한지에 대해서도 고민이 필요하다.실제 국내 기술이 글로벌 제약사와 협력을 통해 글로벌 표준 치료 영역에 진입하는 사례까지 등장했지만 국내 환자들이 그 혜택을 체감하기까지는 여전히 적지 않은 시간이 필요하다. 글로벌 시장에서 인정받은 혁신이 국내 의료현장에 안착하는 과정은 또 다른 관문을 거쳐야 하기 때문이다.물론 이는 허가나 급여 기준을 완화하자는 의미는 아니다. 비용 효과성과 임상적 가치라는 원칙은 유지돼야 한다. 다만 오픈 이노베이션 활성화와 바이오산업 육성을 정책적으로 장려하고 있다면, 그 과정에서 창출된 혁신의 가치를 어떻게 반영할 것인지에 대한 논의 역시 함께 이뤄질 필요가 있다.오픈 이노베이션의 성과를 기술수출 계약 규모나 계약금 액수만으로 평가하는 데에는 한계가 있다. 국내에서 발굴된 혁신이 글로벌 개발 과정을 거쳐 다시 국내 환자 치료에 기여할 수 있을 때 비로소 선순환이 완성된다.정부는 바이오를 미래 성장동력이라고 말한다. 글로벌 제약사들 역시 한국 기업의 기술을 찾기 위해 경쟁하고 있다. 이제는 기술을 수출하는 데서 한 걸음 더 나아가, 그 성과가 국내 시장과 환자에게도 이어질 수 있는 구조를 고민할 시점이다.
