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- 2026-05-18 17:10:27
- Company
- Celltrion signed a contract with the U.S. for DiaTrust
- by Lee, Seok-Jun Sep 24, 2021 05:56am
- Celltrion will supply DiaTrustTM COVID-19 Rapid Test, co-developed with Humasis, an in vitro diagnostic company, to the United States through Celltrion USA. According to the company on the 23rd, Celltrion USA was finally selected as a supplier in a purchasing project conducted by DLA under the U.S. Department of Defense. As early as the 1st of next month, it will begin supplying DiaTrust to 25,000 designated procurement sites in the United States, including military facilities, nursing homes, regional inspection centers, and major facilities. The contract period is until September 16 next year. The contract amount can increase by up to 738.2 billion won depending on the situation, the largest among the selected suppliers. An official from Celltrion emphasized, "The fact that we participated as a supplier in the U.S. defense procurement project, which has strict standards, has been recognized for Celltrion's technology and supply capabilities." Unlike other rapid diagnostic kits, DiaTrust is a product that improves sensitivity and specificity by applying two antibodies that bind to the N protein and S protein of the COVID-19 virus, respectively, and can check for infection within 15 minutes. It is possible to check for infection immediately after examination without additional equipment, and it shows accuracy of 93.3% sensitivity and 99.0% specificity. DiaTrust is divided into POCT and OTC that can be used with the help of medical experts under permission to use. This contract is supplied as POCT.
- Policy
- Rekirona are expanded to 50 years of age or older
- by Lee, Tak-Sun Sep 24, 2021 05:56am
- The MFDS approved the official approval based on the results report of phase 3 clinical trials of Celltrion's COVID-19 antibody treatment Rekirona, which completed phase 3 global submitted by the company. It has expanded the subject of administration. However, mild patients were not included. The MFDS announced on the 17th that it had carefully reviewed the results of a global phase 3 clinical trial of Rekirona (Regdanvimab), a domestic COVID-19 antibody treatment submitted by Celltrion on the 10th of last month, and approved the change to delete the permit conditions and expand the range of patients who can be administered. As the efficacy and effect of Rekirona was allowed to be changed to "treatment of mild and all secondary adult patients at high risk of COVID-19", the number of patients who can be treated increased. The previous high-risk patients were over 60 years old or with underlying diseases (one or more of cardiovascular disease, chronic respiratory disease, diabetes, and high blood pressure), which lowered the target's age to over 50 years old and added obese people (BMI index 30 or more), chronic kidney disease (including dialysis), chronic liver disease, bone marrow transplantation. The administration method also shortened the administration time from intravenous administration for 90 minutes to 60 minutes. The MFDS explained that the overall safety of Rekirona was good. In phase 3 clinical trials, the incidence of abnormal cases of Rekirona was similar to that of the placebo group, and most of the symptoms were mild or moderate. The most frequently reported abnormal cases included elevated liver enzyme levels and hyperglycermia, and significant abnormal cases were "injection-related reactions" (one patient), recovering within a few days. It has been confirmed that the effectiveness of Rekirona significantly reduces the duration of severe exacerbation and clinical recovery due to COVID-19. Among mild and secondary patients administered Rekirona, the rate of severe transmission from 446 high-risk patients decreased by 72% compared to placebo (434 patients), and the clinical recovery period was also shortened by 4.12 days compared to placebo (12.3 days). The MFDS explained that it consulted experts on the 3rd and the Central Pharmaceutical Affairs Council on the 10th on whether the results of Rekirona's phase 3 clinical trial could therapeutically confirm the effectiveness of the drug in the patient group that Celltrion applied for change. As a result, experts agreed that it is reasonable to delete the permit conditions and switch to formal permission, and that it is desirable to expand the scope of high-risk groups and apply them to high-risk mild and all secondary adult patients. However, in the case of mild symptoms other than high risk, the frequency of severe morbidity was low, and there was insufficient confirmation of effectiveness, so it was not included in the scope of use. In addition, it was suggested that it is reasonable not to include children over the age of 12 in the scope of use because they are not included in the clinical trial. The MFDS reviewed the results of the review and advisory opinions and decided on the scope of the drug's use as "all secondary adult patients in mild to high-risk groups" identified in the clinical trial.
- Company
- Trelegy Ellipta can be prescribed at general hospitals
- by Eo, Yun-Ho Sep 23, 2021 05:44am
- The COPD treatment Trelegy Ellipta can be prescribed at general hospitals. According to related industries, GSK Korea's COPA treatment Trelegy Ellipta (Fluticasone Furoate, Umecridinium Br, Villanterol Trifenate) passed DC at 38 medical institutions including Big 5 General Hospitals such as Seoul National University Hospital and Asan Medical Center. Since the insurance benefits in June, prescriptions have become possible quickly. Trelegy Ellipta is the first COPD complex approved in Korea in May 2018. It is prescribed as a maintenance therapy for moderate and severe COPD that is not properly controlled by persistent β2 agonist and inhalation corticosteroid combination therapy or LABA and LAMA combination therapy in adults. As for the benefit criteria, despite ▲ persistent beta 2 agonist and LAMA combination therapy, if FEV1 value is less than 60% of the normal prediction or acute exacerbation occurs more than twice a year, ▲If symptoms such as dyspnea are not properly controlled despite persistent beta 2 agonist and inhalation corticosteroid combination therapy, ▲If a patient who is simultaneously administering Vilanterol trifenate/Fluticasone furoate and Umecridinium Br satisfies each individual examination, this is the case when pt wants to switch to Trelegy. The validity of Trelegy Ellipta has been reaffirmed through a recent INTREPID phase 4 study. The study was conducted at 147 centers in five European countries, including the UK and Germany, with a total of 3,092 COPD patients participating. Patients were assigned to the Trelegy Ellipta treatment group and the multiple inhalation type three-drug combination treatment group on a one-to-one basis. The primary efficacy evaluation variable was the COPD Assessment Test (CAT) score, which is the COPD evaluation test, to evaluate patients' health status. As a result of measuring the ratio of patients whose CAT score decreased by more than 2 units to baseline at the 24th week of treatment, the median CAT score in the patient group treated with Trelegy Ellipta was 18.0 (8.0), and the median CAT score in the multiple inhalation groups was 19.1 (7.9), significantly improving overall health. The secondary efficacy evaluation variable based on the sub-analysis was the change in FEV1 identified at week 24 of treatment and the proportion of patients who committed more than one serious error when using each inhaler. As a result of the analysis, FEV1 in the Trelegy Ellipta treatment group was 77 mL, which showed statistically superior lung function improvement compared to the multiple inhalation treatment group (28 mL).
- Policy
- Pfizer voluntarily recalls Champix 10 days after MFDS annc.
- by Lee, Tak-Sun Sep 23, 2021 05:44am
- Some lots of Pfizer’s leading smoking cessation treatment, Champix, will be voluntarily recalled. Although the drugs were not subject to recall under the MFDS announcement on the 7th, Pfizer opted to voluntarily recall its products as the drugs exceeded the MFDS's temporary release standards. The standards that the company applied for recall were stricter than the initial recall standards set by the Ministry of Food and Drug Safety that had raised controversy over how the initial standards were set. On the 17, the MFDS announced that 9 lots of Pfizer Korea's ‘Champix 1mg (varenicline tartrate)’ will be voluntarily recalled by its seller. The lot numbers of the recalled products are 00026756, 00025815, 00025121, 00024632, 00024054, 00022720, 00021762, 00021761, and 00022721. The above products were manufactured from May 2019 to December of last year. As for the reason for the recall, the company wrote that the move was a ‘voluntary recall for products exceeding the temporary lot release standards of NNV (N-nitroso-varenicline).’ The said products were not subject to recall under the NNV safety investigation results that were announced by MFDS on the 7th. At the time, the MFDS explained that drugs with NNV exceeding 733 ng/day were to be voluntarily recalled. Based on the standards, Pfizer’s Champix, with NNV 151~632ng/day detected, was not subject to recall. However, Pfizer belatedly started to recall its product based on the temporary release standard at 185 ng/day rather than the recall standard. MFDS investigation data regarding safety of NNV containing varenicline that was announced on the 7th Controversy had arose as the NNV level of 733ng/day that was set for voluntary recall by the MFDS was based on Pfizer’s standards. The minutes of the Central Pharmaceutical Affairs Council that was disclosed on the webpage on the 17th stated that Pfizer's standards were inevitably applied for the recall. The minutes showed that CPAC had decided to maintain the voluntary recall standard at NNV of 733ng/day as set by Pfizer. However, as the standards set by Pfizer exclude Pfizer’s Champix from recalls, controversy arose as to whether the measures were unfairly supporting a specific company. Pfizer's decision to recall its products based on the temporary release standards (185ng/day), settled the controversy over the fairness of CPAC’s standards. However still, the fact that the authorities had decided to manage NNV impurities with different standards set for lot release and recall is still expected to raise some eyebrows.
- Policy
- Varenicline recalls were based on Pfizer's standards
- by Lee, Tak-Sun Sep 23, 2021 05:43am
- On why the recall and lot release standards were set differently for the smoking cessation treatment ‘varenicline,’ which was found to have nitrosamine impurities, is gaining attention. This difference in standards had allowed Pfizer’s Champix from being recalled. While announcing the N-nitroso-varenicline (NNV) impurity test results on varenicline products on the 7th, the Ministry of Food and Drug Safety announced that products with less than 185ng/day of NNV may temporarily be approved for lot release. On the other hand, products with NNV of 733ng/day or more were to be voluntarily recalled by their manufacturers. Regarding the set standards, the MFDS had explained that it had referenced cases from other major countries including the U.S. The minutes from the ‘Deliberation on feasibly of the human impact assessment results on pharmaceuticals containing impurities’ at the Central Pharmaceutical Affairs Council that was disclosed on the webpage on the 17th, also showed that the decision reflects cases from the U.S. and other countries. The meeting had been held on the 31st of last month before the measures were announced on the 7th. However, controversy is expected as the minutes of the CPAC meeting indicate that the U.S case also adopted the voluntary recall standards of a specific company – Pfizer. The recall standards that were set above the lot release standards allowed Pfizer’s ‘Champix’ from being subject to recalls. In the minutes, the MFDS stated that the ‘FDA has acknowledged the voluntary recall standards set by Company A (presumed to be Pfizer, 733ng/day), which allowed the company to recall lot numbers that exceeded the set standards. The FDA announcement on its webpage also contains the phrase that 'products that exceed the company’s voluntary recall standards were recalled.' Company A reported to MFDS that there was no case in which the company recalled products that contain less NNV than its set standards (733 ng/day) worldwide." On this, committee members who attended the CPAC generally agreed that it was inevitable and reasonable to maintain the voluntary recall standards set by Company A. One member said, “The FDA also set a different level for temporary lot release and recall. The decision may have been made in consideration of the patient’s right of choice and the potential lack of supply.” The member also inquired about the potential supply status expected for Korea if the temporary lot release standard of ‘185ng/day’ is applied. The MFDS explained that “Based on the domestic market shares, 90% of the products currently on the market will be subject to recall, and a supply shortage is expected to occur.” Another member had said, “As cancer caused by smoking is also a serious concern, I believe the doctor should fully explain the situation to the patient and allow the patient to make the decision. Also, it would be more reasonable to maintain the recall standards at the level set by Company A (744ng/day) until more drugs that meet the temporary lot release standard (185ng/day) are supplied, as it is not desirable for patients to not have the right to choice due to supply shortage.” With more agreeing to the MFDS’s proposal, the chairperson said, “We submit the opinion that Company A’s voluntary recall standard (733ng/day) should be applied and products with NNV that exceeds 185ng/day but lower than 733ng/day should be temporary allowed for distribution in consideration of the supply shortage, patient treatment and other case references from overseas including the FDA,” to which most members agreed. As a result, the MFDS set the recall standards to NNV of ‘733ng/day,’ under which CTC Bio recalled 19 lot numbers of 3 products that exceeded the set standards. The recall standards indicated in the minutes are Pfizer’s standards, and the concern over supply shortage is expected to have been the biggest factor in the decision. The problem is that Pfizer’s standards have excluded Pfizer’s original product ‘Champix’ from recalls. Pfizer’s self-investigation showed that its varenicline product contained NNV between 151~632ng/day. If the recall standards were set at the same level as the lot release, as ‘185ng/day,’ Pfizer’s products would also have been subject to recall. In other words, using Pfizer’s recall standards had led to Pfizer’s products avoiding recalls. As the decision, despite being made with considerations for patient treatment and supply shortages, had led to benefit Pfizer, the criticism arose that the Ministry of Food and Drug Safety was more considerate of the company's position rather than concerns over safety of impurities.
- Company
- It surpassed ₩1 trillion in monthly drug imports
- by Kim, Jin-Gu Sep 23, 2021 05:43am
- In August, pharmaceutical imports surpassed ₩1 trillion for the first time. This is due to the fact that imports of Pfizer, Moderna vaccines were reflected in statistics following July. Drug exports rose 10% year-on-year to ₩700 billion last month. However, as imports increased sharply around the COVID-19 vaccine, the deficit in the drug trade balance hit the highest level since December 2019. ◆In August, vaccine imports amounted to ₩340 billion, the highest ever According to the Korea Customs Service on the 15th, imports of domestic medicines in August were $870.81 million. This is the first time that monthly drug imports have surpassed 1 trillion won. Compared to $50.32 million in August last year, it jumped 64%. It renewed its highest import amount ever for two consecutive months following July. In July, drug imports amounted to $819.58 million. As imports of COVID-19 vaccines began in earnest, the total amount of medicines imported increased significantly. Domestic vaccine imports were only $34.45 million by February this year, but as COVID-19 vaccine imports began in earnest, they surged to $49.82 million in March, $54.91 million in April, $58.88 million in May, $15.51 million in June, and $211.62 million in July. It recorded $291.53 million in August, once again breaking the record for the highest amount set in July. Considering that the domestic supply of Moderna vaccine has been disrupted in July and August, it is predicted that vaccine imports may increase further after September. Excluding vaccine imports, monthly drug imports remain around $600 million, similar to last year. ◆Pharmaceutical exports amounted to ₩690 billion, the largest trade deficit in 20 months Exports of medicines in August amounted up to 10% from$50.303 million a year earlier. As imports increased significantly compared to pharmaceutical exports, the domestic pharmaceutical trade deficit increased significantly. The drug trade balance recorded a deficit of $277.78 million in August. The deficit is the largest in 20 months after recording $317.24 million in December 2019. The domestic drug trade balance has steadily recorded a surplus from August last year to March this year, except for October last year, due to increased biosimilar exports. However, since the import of COVID-19 vaccines began in earnest, the deficit has gradually increased.
- Policy
- Price for Kymriah needs a new management method
- by Lee, Hye-Kyung Sep 23, 2021 05:43am
- The NHIS continues to discuss finding a new drug price management method for the rapid registration of ultra-high-priced "one-shot treatments." However, he said he would consider the introduction of "post-registration evaluation" required by patient organizations as one of several alternatives, not the correct answer. The Guidelines for Calculating Estimated Claims, which have been prepared since the beginning of this year, will be released around October, and negotiations will finally be concluded today (15th) for Choline alfoscerate. Lee Sangil, the senior director of the NHIS, held a briefing with the Korea Special Press Association on the 14th and announced issues in the second half of the year on overall issues related to benefit guarantees, projects, and drug prices. ▶It is argued that a one-shot treatment that is directly related to the life of ▶ patients should be registered first and evaluated afterwards, and what is the director's personal opinion about rapid registration? "Unlike in the past, Breakthrough Therapy such as Kymriah and Zolgensma, which patients can only administer once in their lifetime, has been released. Instead, costs range from hundreds of millions to billions of won. Accessibility should be guaranteed because the drug itself is essential to patients. However, I think a new approach is necessary because it is difficult to guarantee accessibility for patients with existing drug price management. The NHIS is discussing with the pharmaceutical companies on what method would be appropriate. Since this drug has already been registered in other countries, we will review foreign cases and find appropriate measures for Korea. I think the evaluation plan after the first registration is one of several alternatives. The introduction of this plan cannot be immediately answered." ▶ It was said that it would disclose the guidelines for calculating the estimated claim amount Since April, a consultative body has been formed with KPBMA, KRPIA, and KoBIA to prepare guidelines for calculating the expected amount of claims. Currently, The NHIS and associations are in the process of collecting opinions on guidelines created through consultative bodies. The guidelines will be completed by October." ▶Is there any countermeasure to prevent litigation similar to Choline alfoscerate? All applications for suspension of execution by pharmaceutical companies related to the Choline alfoscerate lawsuit have been dismissed, and the main lawsuit remains. We cannot guarantee the possibility of similar lawsuits, but we plan to come up with countermeasures through consultations with related agencies such as the MOHW and the HIRA in the future." ▶ What projects will you focus on as a policy task in the second half of the year? In order to improve the effectiveness of the conversion index calculation model raised in annual fee negotiations, we intend to promote system improvement centering on the institutional development council formed for communication between stakeholders. In addition, the government will continue to strengthen the medical safety net for the vulnerable by improving the disaster medical expenses support system on November 1, implementing pregnancy maternity medical expenses in January next year, and a three-stage pilot project for disabled people. In addition, we plan to come up with a reasonable payment plan for expensive drugs that take into account patients' access to treatment so that they can be introduced stably."
- Company
- The once-daily Xeljanz XR lands in general hospitals
- by Eo, Yun-Ho Sep 17, 2021 05:56am
- The new extended-release formulation of Xeljanz, Xeljanz XR, has started its landing process in general hospitals. According to industry sources, Pfizer Korea’s rheumatoid arthritis treatment ‘Xeljanz XR 11mg’ passed the Drug Committees (DCs) of the Big-5s general hospitals in Korea - Seoul National University Hospital (SNUH), Asan Medical Center (AMC), Seoul St. Mary’s Hospital, Samsung Medical Center (SMC), and Severance Hospital – as well as other major medical institutions in the nation. Xeljanz XR, which was listed for insurance benefit since April last year, can be used in adult rheumatoid arthritis patients that meet the ACR/EULAR criteria whose: ▲DAS28 is more than 5.1, or ▲DAS28 is between 3.2 to 5.1 with radiographic damage progression in the joints, that have been treated with over 2 types of DMARDS (including MTX) for 6 months (3months each) but had inadequate treatment effect or discontinued treatment due to side effects of the drugs. However, Xeljanz XR was approved only for the rheumatoid arthritis indication and was unable to add indications for psoriatic arthritis or ulcerative colitis. The new approval hold significance as the Xeljanz 5mg that was previously approved for the treatment of rheumatoid arthritis in Korea was administered twice daily, but the new 11mg dose that was approved allows for once-daily dosing. Meanwhile, Xeljanz XR 11mg demonstrated non-inferiority with Xeljanz+methotrexate (MTX) in the ORAL SHIFT study. The study was conducted on 533 patients with rheumatoid arthritis who achieved low disease activity (LDA) with a Clinical Disease Activity Index (CDAI) of 10 or less after 24 weeks of treatment with Xeljanz+MTX combination to assess the non-inferiority of Xeljanz monotherapy (11mg, once-daily) in comparison to Xeljanz+MTX. The primary endpoint of the study was least squares (LS) mean changes in DAS-28-4(ESR) from weeks 24 to 48, which was deemed non-inferior if the difference between the two arms was less than 0.6. Results showed that the mean change in DAS-28-ESR from weeks 24 to 48 was 0.33 for the Xeljanz monotherapy group and 0.03 in the Xeljanz+MTX groups, demonstrating Xeljanz XR’s non-inferiority with an LS mean difference of 0.30 (95% CI; 0.12~0.48).
- Policy
- Azelnidipine was approved in Korea
- by Lee, Tak-Sun Sep 17, 2021 05:56am
- Azelnidipine, which was approved in 2003 in Japan as a calcium channel blocker (CCB), was also approved in Korea. There was no previously approved finished product. The MFDS approved Azelnidipine 8mg of Introbiopharma on the 14th. Azelnidipine is a treatment for hypertension, a drug administered oral after breakfast once a day. Previously, Dongbang FTL's and Jeil's drug substances were approved for export, but there were no domestic drug products. Azelnidipine has been used for a long time, but it has not been introduced because other CCB such as Amlodipine are widely used in Korea. The original is Calblock of Daiichi Sankyo Korea. It was approved for Japan's Ministry of Health, Labor and Wellness in 2003. It has already been approved for 18 years. As such, it is an item that has been proven to be safe and effective overseas, and the MFDS approved Introbiopharma's product in accordance with laws and regulations. Daiichi Sankyo is a family of ARB in Korea. It is focusing on supplying Olmesartan. The approval of Introbiopharma's Azelnidipine is not expected to change the market much. This is because existing CCB-based hypertension treatments have steady sales in the domestic market. However, other domestic pharmaceutical companies are expected to show interest because new options have been released for product development.
- InterView
- "A tenure professor’s calling is in developing a new drug"
- by Sep 17, 2021 05:56am
- On August 24th, the Hemato-Oncology Department of the Eijeongbu Eulji Medical Center was busy preparing for its new occupant. Professor Dongwook Kim (60), who looked new to his office, was busy discussing matters with various visitors including the hospital employees. Although the center had opened less than 6 months ago, its Hematol-Oncology Department looked more vibrant than ever. Professor Dongwook Kim, one of the leading authorities in the field of Chronic Myelogenous Leukemia (CML), had joined Eijeongbu Eulji Medical Center of the Eulji University after serving 30 years at the Seoul St.Mary’s Hospital. During his term at Seoul St.Mary’s Hospital, Professor Kim had made many first-ever achievements. At St.Mary's Kim had led the research of the first targeted therapy, ‘Gleevec,’ and many other next-generation drugs, and had also led the study on ‘Supect,’ the only locally developed targeted therapy for CML. His focus on gene analysis, to identify the causes why patients show different treatment effects, had laid the grounds for Korea's treatment environment to advance into precision medicine. Kim's efforts paid off, and the Seoul St.Mary’s Hospital became the first hospital to establish a center specializing in blood disorders - the Catholic Hematology Hospital - at which Kim served as the founding director. Professor Dongwook Kim When asked about why he joined Eijeongbu Eulji Medical Center after achieving so much, Kim's answer was “to conduct more research for a longer period of time.” Kim talked about a professor he met at the International Society of Hematology conference. The professor, who was over 90, came to chair one of the discussion sessions with a cane in one hand. This had left a deep impression in Kim’s mind. Also, he said that there are professors over the age of 80 in the Leukemia Network, for which 35 experts around the globe meet every 5 years to establish the standard of care for CML. Unfortunately, the circumstances at St.Mary’s Hospital were unfit for a professor to continue researching for the rest of his life. In medical schools in Korea, professors generally retire from his/her university at age 65, and stays as a professor emeritus, then continues work at a different hospital for 5 years before retiring. “As a director, I’ve watched many of my seniors retire. These able professors perform surgeries until the last day of their retirement. After 55 years of age, most professors experience reduced consultation hours and a lack of research labs. I also experienced this. My lab also saw a decline in funding and was on the verge of reducing our staff. In Korea, the government does not give government projects to professors over the age of 60. On the contrary, many senior professors over the age of 80 and even 90 take on research projects in Europe and the U.S. It is that different." With only 5 years left to retirement, Kim was also concerned about his patients, as they require lifelong treatment. Many patients asked professor Kim about his retirement plans. Those that were recently diagnosed showed the most concern. That was why Professor Kim started to consider seeking an environment where he can continue on his research without worries about retirement or lab reductions. And Eijeongbu Eulji Medical Center was the perfect place for Kim. “The Eijeongbu Eulji Medical Center promised full support and a stable environment where I could conduct research with my researchers for a long period of time. Thanks to such support, we are currently setting our new lab in the new building behind. We plan to sign MOUs with KAIST, UNIST, and Kwangwoon University and conduct joint research after my lab officially opens.” Professor Kim said, “We have already been planning various research projects. One is ‘Investigation on the single-cell dynamics related to the occurrence/recurrence of CML,’ which was selected as a research project by the government last year. The project aims to investigate the cause of CML and why the treatment effect differs in each patient." In other words, Kim and his team will attempt to find the cause of different treatment effects by analyzing the patient’s genes and the tens of thousands of cells in their blood. If the team discovers a gene related to leukemia, this may enable personalized treatment for each patient. This is what Professor Kim is investing most efforts in. Also, Kim is actively participating in the development of new drugs like ‘Supect’ in collaboration with bio ventures. Also, he had joined in the development of AI that can recommend appropriate treatment for each patient since 2 years ago. Kim plans to complete the government project within 5 years. Kim believes that the research will enable HCPs to discern which treatment is required for each patient according to their genes. Two new candidates were already discovered for new drug development. Also, the AI that Kim had started developing 2 years ago is now being tested in practice. After inserting all the characteristics of a patient from his/her age, gender, favorite food to genetic disorders, the program selects the most appropriate treatment among the 5 targeted therapies for CML, then recommends further measures according to each patient’s treatment response and side effects such as dose adjustments or discontinuation and switching. The goal is to be able to completely replace experts in the field. One of the questions I encounter most often during lectures is on ‘What drug to select.’ We aim to build an AI that can provide a perfect answer to that question. We are formulating the increase in speed, degree, grade of cancer cells to predict which patients will experience recurrence and how fast. This will allow us to predict how likely a patient may discontinue treatment within 5 years.“
