국가임상시험지원재단

● ?ICH E19: Update and Expectation from Industry

?Seong Choon Choe(Boryung Pharmaceutical)

ICH E19, a new guideline is proposed to provide internationally harmonized guidance on when it would be appropriate to use a targeted approach to safety data collection in some late-stage pre-marketing or post- marketing studies, and how such an approach would be implemented.
The guideline is currently step 1 and there is the right time for input from pharmaceutical industry. So I would like to discuss what industry wants to get with this guideline.
By tailoring safety data collection in some circumstances, the burden to patients would be reduced, a larger number of informative clinical studies could be carried out with greater efficiency, studies could be conducted with greater global participation, and the public health would be better served.
But there is no widely adopted guidance on when the use of targeted safety data collection would be appropriate in late-stage pre-marketing or post-marketing studies, or on how to implement such an approach. Thus, this topic represents an ideal opportunity for international harmonization.
Recognizing that protection of patient welfare during drug development is critically important, unnecessary data collection may be burdensome to patients, and serve as a disincentive to participation in clinical research. Regulators and industry have a shared interest in reducing the burden to patients and facilitating the conduct of studies that could yield important new medical knowledge and advance public health.
The guideline is currently step 1 and there is the right time for input from pharmaceutical industry. So I would like to discuss what industry wants to get with this guideline.?

● ?Pharmacovigilance for Oncology Combination Studies with Checkpoint Inhibitors

Stewart Geary(Esai)

Immunotherapy using checkpoint inhibitors has led to significant improvements in patient outcomes across a variety of tumor types and stages of disease. Recently attention has turned to combination studies using chemotherapy or molecularly targeted agents with checkpoint inhibitors in order to broaden the range of patients who benefit from immune- oncology and further improve patient survival. Pharmacovigilance for such combination studies can be challenging both because of the differing toxicities associated with these individual therapies, the different timelines over which toxicity may be anticipated for small molecule as compared to antibody therapies and the theoretical potential for overlap or augmentation of important toxicities such as interstitial pneumonia and hepatotoxicity. This presentation will present considerations for pharmacovigilance during clinical studies of these combinations.

● ?Innovative Technology for Case Intake to Enable Process Improvements and Focus on Data Analysis

Jamie Portnoff (Foresight)

Case Intake presents a significant issue for industry. Multiple and increasing sources, poor quality of initial data, multiple formats and platforms all combine to make Intake an expensive and error prone process that compromises case quality, has been difficult to optimise and takes resources from data analysis to data input.
Innovations in case intake enable a greater investment in value-added data analysis, which in turn supports the broader goal of maintaining products on the market with accurate safety profiles.
Multiple case studies will be shared to highlight different approaches taken within industry, ranging from small biotechs to the largest pharma companies. The unique challenges faced by each company leading them to pursue solutions for case intake, as well as the benefits and high-level return-on-investment realized by each company will be described with the case studies. A brief demonstration of a technical solution will be provided.
Innovations in case intake enable a greater investment in value-added data analysis, which in turn supports the broader goal of maintaining products on the market with accurate safety profiles.?

Seong Choon Choe(Boryung Pharmaceutical)

Stewart Geary(Esai)

Jamie Portnoff (Foresight) 

상기 과정은 보수과정으로 직능별, 단계별 인정가능시간이 상이함으로 관련규정 '[별표1] 임상시험등 종사자별 교육과정 및 이수시간'을 꼭 확인하시기 바랍니다.

[별표 1]

임상시험등 종사자별 교육과정 및 이수시간

(제5조 관련)