On September 30, 2021, Prof. Howard Lee was invited to a live news show, COVID-19 Pandemic, by Arirang TV, an English-speaking broadcasting company in Korea. Prof. Lee introduced the current status of vaccine developments against COVID-19 in Korea, led and sponsored by local biopharmaceutical companies. According to Prof. Lee, there are 10 vaccine candidates in Korea currently under clinical development, phase 1 through 3. Fifty percent or five of those 10 candidates are still in phase I of clinical testing, with 4 and 1 in phase 2 and 3, respectively. Prof. Lee explained, "The vaccine platforms are as diverse as they can be." 

Toward the end of the show, Prof. Lee also discussed the issues pertaining to the vaccine development program by Korean biopharmaceutical companies as a follower. They include design issues, securing a full amount of comparative vaccines, multinational site management, and commitment of the government to purchase or pre-order the vaccine if successfully developed. More details of the news show can be watched by clicking the YouTube link below: 

Prof. Howard Lee was featured in the 'Medical School Library', a lecture series channel at YouTube by the Young Doctors, an online journalism company with a focus on the medical societies, medical issues and policies, and the biopharmaceutical industry. Prof. Lee introduced the audience to the concept of biopharmaceutical products as to how different they are from the traditional, chemically synthesized, small-molecule drugs. He also discussed advanced biotherapeutics using a couple of tragic failures by two Korean biopharmaceutical companies, i.e., Shillazen and Tissugen to emphasize the informed design of clinical trials and the quality manufacturing for biopharmaceutical products. Prof. Lee finally talked about biosimilars: what they are, how different they are from the reference biologic, and what clinicians should know before [s]he prescribes a biosimilar.

Prof. Lee's lectures can be watched by clicking the following links: 

Prof. Howard Lee and some CCADD members including Yoomin Jeon, Yoona Choi, and YeSol Hong visited AstraZeneca Korea (AZK) on December 3, 2020. AZ is a research-intensive pharmaceutical company based in the UK and has recently developed a vaccine against COVID-19. AZK invited Prof. Lee to a big data seminar series, and he talked about the role of medical big data including real world data and artificial intelligence (AI) in drug discovery and development. Prof. Lee also discussed how pharmaceutical companies could prepare themselves for the active and efficient adoption of big data and AI technologies for the day-to-day drug development activities. 

Yoona and YeSol are actually a former employee to AZK, in the departments of medical affairs and marketing, respectively. Thus, this visit was a kind of homecoming, and everyone welcomed them.The visit was also a great opportunity for CCADD to introduce its research fields and capabilities to pharmaceutical companies. This opportunity will enable CCADD for exploring many collaboration projects with those who are involved in actual drug development, which will certainly fill a gap for CCADD such that academic research is well aligned with the reality.     

The 2020 Population Approach Group Korea (PAGK) Annual Meeting was held on November 27 with presenters attending at the WesternLife Hotel, Iksan, Jeolla-do while other participants joining the meeting on-line. The PAGK is a research group affiliated with Korean Society for Clinical Pharmacology and Therapeutics, of which members (currently >180) join from various sectors such as academia (clinical pharmacology, clinical medicine, and pharmacy), hospitals, pharmaceutical companies, CROs, and government agencies.

The plenary speech was delivered by Prof. Yangjin Kim, Professor at the Department of Mathematics at Konkuck University, titled “Mathematical modelling of tumor growth and signaling network, and development of anti-cancer drugs and therapeutic strategies”. The topics in the Young Researchers’ Sessions included physiologically-based pharmacokinetic (PBPK) model for clozapine in Korean patients with schizophrenia, misuse of the Michaelis-Menten for prediction of in vivo clearance for drugs, and microphysiological systems for predicting human pharmacokinetics.

Two PhD students of CCADD, Siun Kim and Tae Kyu Chung, presented their population pharmacokinetic and pharmacokinetic-pharmacodynamic modeling studies in the trainee session. Prof. Howard Lee also attended the PAGK annual meeting on-site to support and encourage Siun and Tae Kyu to expand their networks. The whole presentations of the two students can be watched at the Youtube channel of CCADD.

Prof. Howard Lee demanded that generic approval in Korea be tightened by not allowing the so-called 'joint-bioequivalence' or 'consigned-bioequivalence' route at a Korea National Assembly Forum, co-sponsored by Rep. Yoon Il-Kyu of the ruling Democratic Party and the Korean Doctor's Weekly. The forum was held to go over various regulatory issues associated with the recent recall of valsartan-containing anti-hypertensive agents by the Ministry of Food and Drug Safety in a haphazard way, prompted by a similar regulatory action by the European Medicines Agency, which was caused by a concern that the active ingredient manufactured by a Chinese company contained NMDA, which could be carcinogenic in humans.

According to Prof. Lee, there were at least three regulatory practices that could have prompted the valsartan debacle in Korea: too low bar for generic entry into the market, lack of a consistent quality assurance system to ensure the quality of generics and their sources (active pharmaceutical ingredients), and too generous pricing for generics. "These unique regulatory systems for generics in Korea have favored the incompetent generic maker to enter the market rather unruly", Prof. Lee emphasized. Prof. Lee added, "Many pharmaceutical companies, most which were not unsure of their quality, got generics approved through the join- or consigned-bioequivalence testing, and this system needs to be abolished."

More detailed story about the Forum can be found in the following articles in Korean or English. 

Three CCADD members (Dr. Jeong An Gim, Yoomin Jeon, and Tae Kyu Chung) attended the Pharma AI & IoT 2018 conference, held in London, UK, from July 11 through 12, 2018. Many invited from pharmaceutical companies, software firms, and universities spoke at the conference. The conference provided a comprehensive outlook on the key issues about artificial intelligence (AI), which has been actively adopted at the pharma and healthcare industry. AI-augmented human decision-making was the central theme of the conference. Dr. Margaret McDonald from Pfizer told the audience machine learning or AI would increase efficiencies in regulatory decision-making. She added, "Unsupervised AI may integrate enormous amounts of data and those real world data support regulatory decision-making about drug safety." Likewise, many attendants emphasized the importance of AI in their field of specialization. During the conference, attendants discussed and shared best practices in furthering AI technology development specific to the pharma and healthcare industry through inspiring presentations and network opportunities.

After the conference, the CCADD attendants visited several landmarks in London such as the Greenwich Observatory, Tate Modern museum, and London Eye. Amazing weather and the scenic view of London was a big plus. Visiting London was a great refreshing and learning opportunity.

Hyun A Lee and Dr. Kyeong-Ryoon Lee were invited to speak at a seminar on February 6, 2018, held in a laboratory at the College of Pharmacy, Kyungpook National University (PI: Prof. Kwang-Hee Shin). Hyun A and Dr. Lee shared their real world drug development experience in physiologically-based pharmacokinetic (PBPK) modeling and simulation using the Simcyp Simulator (Certara USA, Inc.). They both had considerable hands-on experience in PBPK modeling and simulation since they worked as researchers at Daewoong Pharmaceuticals, Korea.  

PBPK modeling and simulation can play a significant role in drug development decision-making. Particularly, Cetara's Simcyp Simulator, used by most of the top 50 global pharmaceutical companies along with other key regulatory agencies such as FDA, EMA, and Japan's PMDA, is the most sophisticated solution and has become the standard in the pharmaceutical industry. The Simcyp Simulator can assists determination of a maximum recommended safe starting dose (MRSD) in the first-in-human clinical study, design of optimal clinical trials, evaluation of  new drug formulations, and prediction of drug-drug interactions (DDIs) and pharmacokinetic outcomes in clinical populations. 

For more details about Hyun A and Dr. Lee's presentations, please contact them by clicking one of the following links: Hyun A Lee or Dr. Kyeong-Ryoon Lee.