So Jin Lee (1), Sangil Jeon (2,3), Seounghoon Han (1,2), Dong-Seok Yim (1,2)
(1) Department of Clinical Pharmacology & Therapeutics, The Catholic University of Korea, South Korea, (2) Pharmacometrics Institute for Practical Education & Training (PIPET), College of Medicine, The Catholic University of Korea, South Korea, (3) Q-fitter, Inc., South Korea
Introduction: As Korean pharmaceutical industry is reaching the golden era of drug discovery due to increased investments in R&D and government funds over the past decade, the need for a more efficient tool for the quantitative analysis has emerged. The traditional academia-based platform was no longer feasible to provide pharmacometric consultancy services to domestic pharmaceutical companies with evolving demand for higher quality services. Accordingly, the first pharmacometric analysis company in South Korea was launched in 2016 from the previous academia-based research institution, Pharmacometrics Institute for Practical Education & Training (PIPET) through academia-industry collaboration. The pharmacometric analysis project experiences were gathered and evaluated to show the changing landscape of the use of pharmacokinetic/pharmacodynamic modeling and simulation in drug development in Korea.
Objectives:
- Assess the pharmacometric analysis experiences in Korea
- Evaluate the characteristics of the pharmacometric consultancy projects over time from the academia-based to the current platform
- Identify the current trends of pharmacometric consultancy in Korea and identify unique local needs
- Assess the impact of the application of modeling and simulation techniques in drug development in Korea
- Identify an area of development to trail future demands
Methods: PK/PD modeling and simulation project lists and its experiences (2014-2018) were gathered; academia-based platform, PIPET, experiences (2014-2016), and current new platform, Q-fitter, experiences (2016-2018). The data analysis and graphing were done using Microsoft Excel. The project experiences were classified by categories, such as purpose, drug development stages, therapeutic areas, types of outsourcing companies. Each category results were ranked from highest to lowest to identify the most sought-after characteristics by clients. Project characteristics were compared between academia-based and current company-based era. With a current platform, a yearly comparison was made to observe differences in pharmacometric project characteristics between 2017 and 2018.
Results: Based on the assessment, we observed a steep increase in the number of projects per year and the expansion of the scope of analysis services. The number of projects completed increased by 240% from the previous platform to current. Also, on a current platform, the demand for PK/PD analysis increased consistently over the years, as high as 275% per year. The pool of outsourcing client expanded including domestic CRO and US bioventure from domestic pharmaceutical companies and biotech companies, a major client still consisting of 80% of the total. The most important goal of PK/PD analysis in Korean pharmaceutical industry was the prediction of first-in-human dose followed by optimization of efficacious doses and dose regimens (specific scenario-based). Consistently, greater than 90% of the projects focus on the translational step from preclinical to clinical, and clinical phases. Previously, oncology (~27%) and immunology (~27%) were the top therapeutic areas to use PK/PD analysis. With the transition, we observed increased use in oncologic drugs (~31%), but also a broader application in other therapeutic areas was seen, such as rare diseases and vaccines. Continuous use of a model-based approach for the monoclonal antibodies for oncology and immunology drugs were observed. The PK/PD analysis results were mainly used to support internal decision-making, supplement the regulatory submission and aid the process of out-licensing deals. Additionally, more complex systems pharmacology models and drug-drug interaction predictions were on demand from the industry.
Conclusions: Current transition of the pharmacometic analysis-providing platform and its project experiences indicate that the pharmacometrics environment in Korea is rapidly evolving. The model-based drug development is becoming one of the essential tools for successful drug development in Korea, and awareness is increasing. Through the assessments, we were able to identify the most important goal of the analysis, therapeutic areas of focus, and key trends of PK/PD analysis in Korea, as well as areas of improvement. The continued increase in the use of pharmacometrics is expected in Korea pharmaceutical industry, thus it is necessary to establish further strategic development goals to take the analysis services to the next level.
References:
[1] Gobburu, Jogarao VS. “Pharmacometrics 2020.” The Journal of Clinical Pharmacology 50.S9 (2010).
[2] Schuck, Edgar, et al. “Preclinical pharmacokinetic/pharmacodynamic modeling and simulation in the pharmaceutical industry: an IQ consortium survey examining the current landscape.” The AAPS journal 17.2 (2015): 462-473.
[3] Chien, Jenny Y., et al. “Pharmacokinetics/pharmacodynamics and the stages of drug development: role of modeling and simulation.” The AAPS journal 7.3 (2005): E544-E559.
Reference: PAGE 28 (2019) Abstr 9177 [www.page-meeting.org/?abstract=9177]
Poster: Methodology - Other topics