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- 2026-05-20 05:10:46
- Policy
- The MFDS will enact a law covering special cases
- by Lee, Tak-Sun Jul 16, 2020 05:54am
- The MFDS decided to promote the establishment of a law covering special cases to support the approval of vaccines and treatments for new infectious diseases such as COVID-19. It also plans to establish the Central IRB to expedite clinical trials. The MFDS made the announcement through the 'Major Business Reports' submitted to the National Assembly on the 15th. The MFDS plans to focus on establishing an institutional foundation to support COVID-19 treatment and vaccine products. First, it plans to promote a law covering special cases of the development and provision of public health crisis response products for rapid screening and approval of infectious diseases and vaccines, and support for development. In addition, the establishment of the Central IRB for rapid and integrated deliberation of multi-center clinical trials is being promoted through amendments to the Pharmaceutical Affairs law. In this regard, Seon-woo Kang , a member of Democratic Party of Korea had proposed a partial amendment to the Pharmaceutical Affairs law. The Central IRB provides patient support, including consultation on the operation of the clinical trial committee for each institution and compensation for damages. The MFDS has been operating a high-speed program since April, and has been promptly reviewing COVID-19 treatment and vaccines. It provides research support for candidate substances, TF team, and overseas development status and review information. As of June 30, 41 products received support such as consultation. In addition, it is making efforts to rationalize the clinical trial review procedure for COVID-19 therapeutics and vaccines, and to expand the institutions conducting clinical trials. In the past, the subject listened to the face-to-face description and signed a handwritten signature in order to consent to the clinical trial, but in the clinical trial of the COVID-19 treatment, the subject listened to non face-to-face explanation and improved the consent to be recorded or photo files. The MFDS said, "We will stop the spread of COVID-19 and seek a quick solution to COVID-19 through the development of therapeutics and vaccines."
- Company
- Influenza vaccine inoculation rate doubled from last year
- by Jul 16, 2020 05:54am
- n the aftermath of COVID-19, the number of influenza vaccination in the National Essential Immunization Vaccine (NIP) increased significantly in the first half of this year. On the other hand, for the same reason, other essential vaccination rates are rather have declined. According to the KCDC on the 13th, the number of NIP inoculations from January to June 2020 was 5,305,373 cases. This is a 13% decrease from the same period last year. The prominent part is the flu (influenza) vaccination rate. The only number of inoculants increased. Adults and the elderly increased 234% from 4,035 cases in the first half of last year to 13,462 this year. During the same period, the number of vaccinations for children's flu also increased by 16% from 144,080 to 166,483 cases. It is analyzed that this change has a large impact on COVID-19. The industry believes that the spread of COVID-19 has increased the number of patients who are concerned about worsening respiratory immune function and are looking for a flu vaccine as a preventive measure. Data: The KCDC In particular, in the case of the flu in the 2019-2020 season, the number of inoculums increased slightly from last year due to the aftermath of COVID-19 in the second quarter, despite the release of the watch on March 27, three months earlier than last year. Another change is the NIP range of adult flu vaccination that has expanded since the third quarter of last year. The government has added a pregnant woman to the adult flu vaccine NIP since September of last year. However, the vaccination rate of the vaccines excluding the flu fell significantly. The vaccination rate of BCG (tuberculosis) vaccine fell 41% year-on-year, and the MMR (measles, mumps, rubella) vaccine also decreased by 35%. The number of MMR vaccines in the first half of last year was 553,875 cases, but this year only 359,022 cases. In the same period, the vaccination rate of the IPV (poliomyelitis) vaccine also decreased by 31% from 101,225 to 69,999 cases. The pneumococcal vaccination rate targeting people over 65 also decreased by 17%, raising concerns that vaccination is urgent. Pneumococcus is one of the leading causes of pneumonia, especially fatal in the elderly. The KCDC focused on emphasizing pneumococcal immunization by expanding the number of inoculation institutions to private hospitals and clinics (designated medical institutions), fearing that the utilization rate of the intensive care unit in COVID-19 outbreak will increase due to the occurrence of serious ill patients due to pneumococcal infections and complications. In addition to this, vaccination rates, such as Japanese encephalitis vaccines (inactivated vaccines·live attenuated vaccine), hepatitis A (HepA), hepatitis B, and pneumococcal (PCV), all decreased, except for the human papillomavirus (HPV) vaccine. The KCDC urged the mandatory immunization to be immunized, saying, "If the immunization is delayed or discontinued, it may be necessary to respond to the epidemic of infectious diseases targeted for immunization such as measles in addition to COVID-19 response by the end of 2020."
- Opinion
- [Reporter’s Note] Hasty move on anti-droplet masks
- by Jul 16, 2020 05:54am
- “Anti-droplet masks? They’ll be available from Monday. People with waiting number tickets given out from 9:30 in the morning can buy a box each.” This is the answer I got at a hypermarket in Seoul asking for an anti-droplet mask. The anti-droplet mask has been in the hypermarkets and convenient stores for a month now, but they are a rare find. I have visited a number of retail shops selling the masks in Seoul, but they were “not in stock.” These places said the masks are not stocked every day, and the limited supply lasts only a few hours after opening. The absence of anti-droplet masks is replaced by mass produced single-use masks. Most of them are made in China with a price tag ranging from 280 won to 1,600 won per mask. The prices and qualities of these masks are inconsistent and the consumers can hardly check if they are made in Korea or China. Unlike quasi-drugs, these mass produced masks are not certified by the Ministry of Food and Drug Safety (MFDS) for liquid blocking or anti-bacterial function. In other words, the quality is questionable. If not at a pharmacy, clerks at general retailers cannot tell which mask is which. Many of the retail shops I visited said the single-use masks are dental masks. Surprisingly, some of them were selling anti-droplet masks as general single-use masks. In such chaos, pharmacies and distributors who used to supply the public-distributed masks are now torn. They are seeking for ‘Korea Filter (KF)’ masks with assuring quality, but now that low-quality products are as highly sought after, they can barely find a manufacturer to produce high-quality masks. Even after finding a willing manufacturer, the high-quality masks would always be more expensive than the single-use masks. An insider from a distributor complained, “To be honest, many of those Chinese-made products (general mask) offer a price as low as 100 won. They are using cheap and questionable felt material that we definitely say no to,” although “we are looking for certified anti-droplet or dental masks, they are realistically very difficult to get our hands on. Even if we supply the rare masks, we get complaints on the high price as the people get confused with cheap and widely available mass produced products.” The chaotic mess in the market was caused, when the Korean government designated the anti-droplet mask as a quasi-drug without confirming the stable supply and hastily promoted it as a replacement for KF masks. The skewed demand on inaccessible anti-droplet and dental masks actually benefited single-use masks. The mask manufacturers apparently prefer mass producing uncertified single-use masks, instead of quasi-drug masks requiring a certification by the government. Even worse, the certified masks get restricted from overseas exportation. Some hints that importing extremely low-cost Chinese-made masks is more profitable. The government is now sluggishly saying they would enforce KC certification on general masks after observing the situation. As the summer is approaching, the high demand on thin-layered masks was predictable. And the government could have easily expected the industry growing resistant to switch production from KF mask to anti-droplet mask. The thin-layered masks are uniquely and highly demanded for the summer season only, but a manufacturer has to exhaustingly change up the parts of production line. The government’s hasty actions like designating and promoting anti-droplet mask as a quasi-drug or retrospectively reinforcing quality control on mass produced masks could have been prevented, if only they have surveyed the industrial environment better and faster. Hopefully, we can expect the government to take more proactive actions in the future than reacting to already-stirred up market.
- Policy
- Use patent of Xarelto 2.5mg listed late
- by Lee, Tak-Sun Jul 15, 2020 07:54am
- Xarelto 2.5mgAlthough Hanmi and SK Chemicals acquired market monopoly rights as a follow-up drug to the anticoagulant drug (NOAC), Xarelto 2.5mg (Rivaroxaban), it may not exercise its right. This is because the use patent for Xarelto 2.5mg has been listed in the MFDS after the acquisition of the rights of both companies. According to the MFDS, Hanmi and SK Chemicals obtained generic exclusivity right on July 5, 2016, with Riroxiban 2.5mg and Rivaroxaban 2.5mg, respectively. The generic exclusivity period is from October 4, 2021 to July 3, 2022, when the material patent ends. Both companies succeeded in evading the patent for Xarelto 2.5mg, and were granted the right to generic exclusivity through the first application for permission. At the time, only the composition patent and the material patent were registered in the MFDS. Accordingly, the two companies that avoided the composition patent exercised the right to generic exclusivity after the termination of the material patent. However, in September of last year, Bayer Korea registered a use patent of Xarelto 2.5mg. The application patent expires on June 7, 2022. There is only a way to invalidate the patent in order for Hanmi and SK Chemical to release the patent normally during the copyright period, avoiding patent infringement. It should be launched from June 8, 2022, when the patent ends. The fact that the right to terminate the copyright was July 3, 2022. This use patent contains the contents of the use as a drug for the prevention or treatment of thromboembolic disorders. Xarelto 2.5mg has recently changed its efficacy and effectiveness. At the time of the first item approval ▲Reduced risk of stroke and systemic embolism in patients with non-valve atrial fibrillation ▲Treatment of cardiac venous thrombosis and pulmonary embolism ▲Reduced risk of recurrence of cardiac venous thrombosis and pulmonary embolism ▲co-administered with acetylsalicylic acid (ASA) alone or with ASA plus Clopidogrel or Ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers. Recently, Xarelto, ▲ co-administered with acetylsalicylic acid (ASA) alone or with ASA plus Clopidogrel or Ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers, ▲co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.·Changed to effect. Hanmi and SK Chemicals' generic exclusivity items were replaced with the same indications. All of the altered indications are known to be related to the use patent. Recently, Xarelto 2.5mg has been shown to reduce the risk of death from stroke, myocardial infarction and cardiovascular disease in adult patients with coronary artery disease or symptomatic peripheral arterial disease when used in combination with ASA. Based on this, a recent overseas conference recommends a combination therapy of Xarelto 2.5mg-ASA for high-risk chronic coronary syndrome patients. It is expected to boost the market preemption effect if the generic exclusivity is released earlier than the competitor based on the monopoly. It is noteworthy how Hanmi and SK Chemicals will respond to lately registered patents.
- Company
- "Ezetimibe combination drug, now key option in dyslipidemia"
- by Eo, Yun-Ho Jul 15, 2020 06:33am
- Professor Heo Jung Ho Statin has been demonstrating outstanding efficacy in low-density lipoprotein cholesterol (LDL-C) level control, while showing an assuring benefit in risk of cardiovascular death. The medicine has surely shifted the paradigm of dyslipidemia management. Nevertheless, there is no perfect drug in this world. Statin also has concerning reports of risk of diabetes and musculoskeletal adverse reactions when using high-dose (high-intensity). Still, the ‘statin plus ezetimibe’ combination is well sought after in the market. Following the current trend in cardiovascular disease treatment—the lower the LDL-C, the better for the benefit in cardiovascular system—the combination drug has taken up a significant share of the pie in dyslipidemia treatment prescription. Even in Korea, many pharmaceutical companies have combined ezetimibe with atorvastatin or rosuvastatin to launch combination drugs. The released drugs have now settled in the market. Daily Pharm interviewed Professor Heo Jung Ho of cardiology division at Kosin University Gospel Hospital to hear about his opinion on the ezetimibe and its efficacy. -Generally, when is ezetimibe combination therapy used? Personally, I still follow the pattern of initiating the prescription from moderate to high-dose statin through high-dose statin. But in some cases, patients cannot reach the recommended LDL-C target level at 70 mg/ dL (Korean guideline), or 55 mg/ dL (U.S. guideline), even with high-dose statin. And this is when I use the ezetimibe combination drug. And for patients seeing musculoskeletal adverse reaction or having high risk in diabetes, the ezetimibe combination therapy could be a good option. -What is your opinion on using the ezetimibe combination therapy as a first-line treatment for dyslipidemia patients? A clinical study in Korea is in process to confirm clear evidences. Currently, Professor Jang Yangsoo at Yonsei University Severance Hospital is leading the head-to-head comparative trial of high-intensity statin and ezetimibe combination therapy in over 3,000 patients with cardiovascular disease in Korea. 200 of the participating patients are registered from Kosin University Hospital. The outcome of the study to be disclosed in three years would give us some clearer answers. Personally, I expect both of the groups would demonstrate clinically meaningful result and efficacy. -Between rosuvastatin and atorvasutatin, what are some circumstances to be considered when prescribing a combination therapy? There is no big difference between the two. But some patients prefer either ‘atorvastatin plus ezetimibe’ or ‘rosuvastatin plus ezetimibe.’ In such case, I base my decision on clinical evidences. The effects of 20 mg of rosuvastatin and 40 mg of atrovasutatin are on par, but the combination that noticeably lowers LDL-C level would be used. -Do you prefer to use a combination drug for ezetimibe combination therapy? First of all, the combination drug is obviously more convenient. The medication convenience along with adherence is high. Patients these days ask many questions and research more information online when the number of drugs goes up. A combination drug is easy to explain how the effect is better with the same amount of drugs, and the patients also comply with the medication well. Moreover, the price of combination drug in Korea is comparatively lower against in other countries. As chronic disease patients are sensitive to the cost, the healthcare system in Korea has also boosted the preference in combination drug. - The Korean dyslipidemia treatment guideline recommends ezetimibe therapy as a second-line therapy. Although the U.S. and Europe recommends LDL-C level in the said ultra high risk group to be lowered to 55 mg/ dL and 40 mg/ dL, respectively, Korea recommends the level to be lowered to 70 mg/ dL. The bottom line is that I agree with the slogan of ‘the lower LDL-C is the better.’ However, it is not the absolute rule to be followed. I personally treat patients targeting LDL-C level at 70 mg/ dL at the moment. But when the patients show risk factors like acute coronary syndrome (ACS), myocardial infarction (MI) or peripheral artery disease (PAD), the target level is lowered to 55 mg/ dL. These patients should be more aggressive in lowering the LDL-C level. And if their level does not respond with ezetimibe, Proprotein convertase subtilisin/ kexin type 9 (PCSK-9) inhibitor is prescribed to breakthrough. According to the healthcare reimbursement standard, ezetimibe has to be prescribed as prerequisite. And this is one of the factors raising the prescription rate of combination drug.
- Product
- Will electronic masks by LG be commercialized?
- by Kang, Shin-Kook Jul 15, 2020 06:33am
- Electronic masks made by famous domestic home appliance companies are attracting attention. LG Electronics announced on the 12th that it has donated 2000 electronic masks made of electronics and IT technology to Severance Hospital to express appreciation and support to medical staff who need to work while wearing masks to overcome COVID-19. The electronic mask contains the patented technology and know-how of LG Electronics' puricare air purifier. Two replaceable HEPA filters (grade H13) are attached to the front of the mask, and the user inhales the air that has passed through the HEPA filters. Electronic mask developed by LG Electronics The amount of air entering the mask is controlled by an ultra-small fan mounted under each HEPA filter. The mask applies a sensor that detects the pressure generated during breathing and a breath recognition algorithm to increase the fan speed when the user inhales, increasing the amount of air entering the mask and reducing the speed when exhaling. In order to design a mask that fits well with the shape of the face, LG Electronics analyzed the face type in collaboration with the Ergonomics Design Laboratory of the Department of Industrial Management Engineering, Korea University. The product also received certification mark for EMF, which certifies that electromagnetic waves generated from electrical products are released below a certain level from the KTC. However, the timing, method, and price of selling to the public have not yet been determined. LG Electronics is also considering donating electronic masks for workers in public institutions who need to always wear masks due to frequent contact with people following medical staff. Therefore, outpatient pharmacies predicted that if there is little maintenance cost and the product price is reasonable, there is a possibility that it will work in the market. "COVID-19 outbreak may be an opportunity for a company. It should be seen in product size, price, and convenience, but it is likely to be used in places where there is a high likelihood of exposure to COVID-19, such as pharmacies and medical institutions," said Pharmacist K, in gangnam, Seoul.
- Company
- Zepzelca by Boryung designated as an orphan Drug
- by An, Kyung-Jin Jul 15, 2020 06:33am
- ZepzelcaBoryung announced on the 13th that it is in the process of receiving a new drug called small-cell lung cancer (SCLC) 'Zepzelca' (Lurbinectedin) as an orphan drug. Zepzelca is an anticancer drug that Boryung has exclusive rights to domestic development and sales. In 2017, Boryung signed a technology introduction contract with PharmaMar in Spain. Since Lurbinectedin obtained a sales license from the FDA last month, it is adjusting the timing of its introduction in Korea. It is confirmed that the application of an orphan drug has been recently submitted to the MFDS and the supplementary documents have been submitted. The indication that Zepzelca has been approved for this time is for adult patients with metastatic small cell lung cancer whose disease has progressed since platinum chemotherapy. The FDA made a rapid approval decision based on data from phase II clinical trials that proved superiority in terms of safety and effectiveness through indirect comparison with the existing treatment, Topotecan. The condition is that additional phase III clinical trial data must be submitted to remain approved. Small cell lung cancer is one of the most aggressive types of lung cancer. It has been known to cause metastasis from the early stages and a high recurrence rate after treatment. Anti-cancer drugs currently approved in Korea for secondary treatment for small cell lung cancer include Novartis Korea's 'Hycamtin' (Topotecan) and Chong Kun Dang's 'Camtobell' (Belotecan). Boryung plans to apply for phase III conditional domestic permit application in the same way as the United States when the designation of an orphan drug of Zepzelca is completed. It is expected that the acquisition of a domestic license will be a new treatment option in the field of recurrent small cell lung cancer. Kim Yeong-seok, chief of anticancer drugs at Boryung said, "Small cell lung cancer is a disease with poor prognosis and limited treatment options, but if Lurbinectedin is quickly approved through the designation of an orphan drug, it is expected to provide new treatment options to domestic patients and medical staff."
- Policy
- Emergency use of KRW 5.13 mln Soliris covered for aHUS
- by Lee, Hye-Kyung Jul 15, 2020 06:32am
- Soliris (eculizumab) injection costing 5.13 million won per vial is to get coverage for an emergency administration. Korea’s Health Insurance Review and Assessment Service (HIRA) has recently made an additional checkbox on the preliminary approval application for Soliris. The government body issued a notice on July 10 stating an emergency administration of Soliris is newly available for patients with atypical Hemolytic Uremic Syndrome (aHUS). A patient with aHUS needing an emergency administration of Soliris can now tick off a box for ‘emergency administration’ on the preliminary approval application, as provided by the method and procedure of Soliris use (HIRA notice No. 2018-165, June 28, 2018). The existing reimbursement criteria and notice are applied the same on the emergency administration of the injection. Soliris was listed for reimbursement in 2012 for three years under the condition of differentiated pricing (refund type), and it became a subject to risk sharing agreement (RSA) since Oct. 1 2015, which a patient that paid the full expense can receive a partial refund on the drug from the pharmaceutical company. As stipulated by the National Health Insurance Act and Healthcare Reimbursement Criteria, the reimbursement on Soliris is granted to patients with paroxysmal nocturnal hemoglobinuria (PNH) and aHUS. But because a single vial costs 5.13 million (as of July 2020), the recipient has to get a preliminary reimbursement approval to cover the approximate yearly cost of 400 million won for three vials per two weeks. According to the HIRA’s notice on July 10, the preliminary review committee’s bimonthly meeting is scheduled on the last Thursday of every even-numbered month. But the chair of the committee may call for a meeting on other days, if need be. The preliminary approval application and relevant data for using Soliris should be submitted by the 10th of the month of review to be processed. The healthcare institute that received preliminary approval of Soliris is also required to submit a monitoring report every six month, in which the same criteria are applied.
- Company
- Xofluza efficacy confirmed in household transmission
- by Eo, Yun-Ho Jul 14, 2020 06:12am
- A next-generation flu drug Xofluxa’s effect of preventing flu virus transmission among the patient’s household member has been confirmed. The latest edition of New England Journal of Medicine (NEJM) published on July 8 reported the clinical findings of Xofluza (baloxavir marboxil) and its flu preventive effect. The study evaluated the flu drug’s positive post-exposure prophylaxis efficacy on household contacts by administrating Xofluza. The outcomes of post-exposure prophylactic efficacy of the drug were confirmed based on household contacts of confirmed flu patients during the 2018–2019 flu season. After identifying the index patients confirmed with influenza of their households from November 2018 through March 2019, the researchers conducted a positive rapid flu diagnostic test on the patients and administered either Xofluza or neuraminidase inhibitor as an antiviral treatment. Based on the clinical trial participants consisting of 545 influenza patients and 752 household contacts, the study screened them twice-daily for axillary temperature until day 10 since the initial influenza diagnostic test and had at least 12-year-old participants self-monitor their influenza symptoms. 95.6 percent of the participants were tested positive for influenza A, 73.6 percent were younger than 12, and 52.7 percent were administered Xofluza. Major adverse reactions in patients over age 12, such as cough and sore throat, headache, nasal discharge or congestion, feverishness or chills, muscle or joint pain, and fatigue were noted. In the age group under 12, different levels of severity was scored by identifying symptoms like cough and nasal discharge or congestion. Participants developing moderate to severe level of flu-like symptoms like fever were instructed to visit respective clinical institutes and provide their samples with nasopharyngeal swabs. The obtained sample was processed with reverse-transcriptase-polymerase-chain-reaction (RT-PCR) analysis to confirm influenza virus, virus type and subtype. The study’s primary efficacy endpoint was the laboratory-confirmed clinical flu, and the secondary endpoint were a ratio of RT-PCR-confirmed viral infection regardless of fever of flu-like symptoms against RT-PCR-confirmed patients with body temperature of at least 37 degrees Celsius or demonstrating at least one moderate or severe symptom. Analyzing Xofluza group of 374 participants and placebo group of 375 participants, the ratio of patients developing clinically-confirmed influenza was lower in Xofluza group against the placebo group. The outcome was noticeably contrasting between 1.9 percent in the Xofluza group and 13.6 percent in the placebo group. The efficacy was also apparent in subgroup analysis in unvaccinated, high-risk and pediatric groups. In the Xofluza group, regardless of symptoms, the influenza risk was measured 57 percent lower. Moreover, the risk of adverse reaction in both groups of Xofluza and placebo did not show significant difference at 22.2 percent and 20.5 percent, respectively. Xofluza is a next-generation influenza drug Roche released after commercializing Tamiflu two decades ago. The new endonuclease-inhibiting flu drug is highly anticipated by the market as it can treat influenza by one-dose oral administration (Tamiflu administered for five days).
- InterView
- AlphaGo will lead the development of new drugs
- by Nho, Byung Chul Jul 14, 2020 06:12am
- The director, Hwa Jong Kim "The future vision of the Center for AI-based New Drug Development Facilitation is the development of a global first in class drug that combines artificial intelligence and medical data." For Hwa Jong Kim (62 years old, director), the direction of organizational management of the Center for AI-based New Drug Development Facilitation is to present a new technological innovation paradigm and create a success model in the pharmaceutical bio industry, the country's new future. New drug development is an area of cutting-edge convergence technology that requires harmonious fusion of biology, chemistry, medicine, pharmacy, computer science, and business administration. The director Kim was in charge of establishing the Electronic Medical Record (EMR) at Kangwon National University Hospital from 2007 to 2011, and is a leading figure who led the successful Ubiquitous business of the Gangwon Provincial Government during a similar period. He is currently a professor of computer science at Kangwon National University and an adjunct professor at the Korea Advanced Institute of Science and Technology (KAIST). He is a top leader in the domestic convergence big data field. The Center for AI-based New Drug Development Facilitation, launched in March of last year, has eight employees, including six developers and two administrative office workers. In the near future, it is expected that it will finish the work of the foundation and successfully attract large-scale investments, including government and pharmaceutical bio companies. He said, “The key to the future project is to explore first in class drug candidates based on government and institutional and open health care databases with the center as the focal point. Although it is still difficult to disclose, the MOHW, the Ministry of Science, ICT and Future Planning, and the Ministry of Economy and Finance are also showing great interest in the development of new AI drugs, and are expected to successfully attract national research funds.” The reason why the government is showing interest in new drug development projects using artificial intelligence is to achieve tangible and effective results. Launched in March 2019, the Center for AI-based New Drug Development Facilitation provided practical training that combines deep learning and new drug development, and trainees experienced the substance discovery process with a personal laptop by accessing the Google Colab cloud services. Recently, 29 public databases have been downloaded to successfully organize similarity metrics for genes, drugs, and diseases. Most notably, the Center conducted convergence research among AI program developers, pharmaceutical companies, Korea Research Institute of Chemical Technology, Social Security Information Service, the HIRA, the NHIS, Daegu Gyeongbuk Medical Innovation Foundation, Osong Medical Innovation Foundation, and research-oriented hospital. Currently, the Center for AI-based New Drug Development Facilitation has formed a 'Artificial Intelligence New Drug Development Experts Association' with 25 pharmaceutical bio companies such as Hanmi, Daewoong, and SK Biopharm, and is conducting various brainstorming. It is also noteworthy that some companies are showing rapid results that are entering the final stage of candidate selection. The era in which artificial intelligence predicted by IT experts goes beyond human intelligence and recognizes and learns for itself is about the next 30 years. Therefore, as A.I new drug development enters the stage of this transformation, the government, industry, and academia should prepare for future strategies. In particular, in the United States, fast track is being applied to new drugs for artificial intelligence development for rare diseases, so Korea is also in need of actively responding to these system improvements. He said, "We plan to do our best to develop organic and systematic AI drugs through network and communication by forming an industry-university alliance. In addition, we are sharing various innovations with leading global companies and artificial intelligence conferences as well as open innovation research and cases. We will do our best to provide the latest knowledge." Meanwhile, he has been consulting with the Ministry of Science and ICT, the Ministry of the Interior and Safety, and the Korea Communications Commission, and has published books on the introduction of data science and big data business. Recently, LG Electronics, Korea Electric Power Corporation, LS Group, Doosan, and KB Financial are leading the cultivation of 'data scientists' necessary for corporate AI introduction and digital transformation of existing businesses.
