Clinical usability evaluation of cancer specialists from the early stages of new drug development, clinical development strategies, and scientific interpretation by brokerage research experts to design strategies for
one-stop services from non-clinical trials to clinical trials.
Increase the value of strategic advice in cooperation with
the AMC Cancer Institute and Clinical Trial Center
- About 14% of Korean cancer patients treated at Asan Medical Center Cancer Institute
- Selected by Newsweek in the U.S., ranked 7th in the world in cancer in 2021, and ranked 1st in Korea
- Having high knowledge and abundant experience in global anticancer clinical trials
- Clinical Trial Center conducts approximately 120 clinical trials each year
Service
Clinician consulting by cancer species
- Establishment of strategies for accelerating commercialization reflecting unmet medical needs at clinical sites by participating in clinical consultants for each cancer species from the beginning of development
- Design of non-clinical efficacy evaluation and interpretation of clinical outcomes by specialists tailored to clinical entry strategies and drug development stages
- Create an optimal advisory committee on candidate materials and participate in the entire process to achieve credible Go/No-Go decisions
Efficacy evaluation consulting
- Establishment of non-clinical trial strategies by the Advisory Group of Basic Scientists specializing in cancer research
- Providing advice on developing a market-tailored high-level anti-cancer efficacy evaluation model
- Reduce clinical entry time as much as possible and provide a non-clinical trial strategy that reflects clinical usefulness for successful clinical trials
- Clinical-oriented patient sample utilization model-based trial design and clinical entry strategy establishment
- Providing advice on strategies for utilizing specialized animal models and establishing state-of-the-art technologies
- Based on accumulated know-how in image efficiency evaluation before new drug development, advice on strategies for verifying mechanisms and utilizing clinical trials
Consulting on Pre/early-clinical trial
- Establishment of strategies for preclinical GLP testing and early clinical trials by an advisory group on brokerage research centered on animal toxicity pathologists and clinical pharmacologists
- Interpreting toxicokinetic results, clinical pathology and histopathology test results
- Preliminary safety assessment prior to pre-clinical GLP toxicity assessment supports toxicity analysis services and design of GLP toxicity assessment that can be utilized for early Go/No-Go decisions
- Predict optimal dosage∙usage in pre-clinical trials by analyzing cell, animal experiment results with PK-PD modeling and simulation
- Prediction of pharmacokinetics and treatment effects in humans through Physiologically based Pharmacokinetics model analysis
- CMC and drug characteristics advisory
- Pre-IND meeting support
- Establishing initial clinical development strategies such as first-in-human, proof of concept study from pre-clinical data analysis
- Risk management for issues identified at pre-clinical stage
- Review of the fitness and compatibility of clinical trial plans with regulatory agencies
- Advice on optimal initial clinical entry strategies reflecting efficacy evaluation, non-clinical and preclinical outcomes by clinical imaging