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Organizing a Phase 1 Unit in Korea

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Presentation on theme: "Organizing a Phase 1 Unit in Korea"— Presentation transcript:

1 Organizing a Phase 1 Unit in Korea
Kyu-pyo Kim Asan Medical Center/Univ of Ulsan

2 Contents Introduction to cancer care in Korea and Asan
Challenges in operating a Phase 1 trial unit Approaches to international collaborations

3 Korea: Similar yet Different from the World
Costs Patient pool Health care infrastructure

4 11/30/2018

5 Clinical Trials approved by Korean Regulatory MFDS (2012-2013)
Sponsor-Initiated Investigator-Initiated

6 Relation between CYP2C9 genotype vs phenotype (losartan/E-3174) in East Asians and Caucasians
Myrand SP et al. Clin Pharmacol Ther 2008; 84 (3)

7 Australia-Korea Co-Trials
Cancer centers though out Australia, New Zealand, Korea and Canada Not only did it show suggestions for signals for regorafenib for gastric cancer, but differences in regional area that has implementations for further study designs.

8 Number of Newly Diagnosed Cancer Patients at Asan (2006-2011)
2007 2008 2009 2010 2011 Korean total in 2011 Stomach 2,206 2,221 2,315 3,920 3,790 3,704 31,637 Liver 1,889 1,844 2,010 2,818 2,895 2,621 16,463 Lung 1,054 862 1,130 1,688 1,813 1,808 21,753 Thyroid 1,206 1,341 1,658 3,235 2,992 3,123 40,568 Breast 1,346 1,465 1,560 2,346 2,691 2,534 16,015 Rectum 839 796 686 1,263 1,322 1,327 28,112 Colon 725 750 758 1,383 1,422 1,548 Cervix uteri 566 548 623 883 819 853 3,728 Pancreas 401 369 433 698 759 761 5,080 Biliary tract 338 331 416 730 728 868 NA Prostate 347 410 430 799 925 1,009 8,952 Kidney 288 267 356 493 533 457 3,989 Bladder 211 255 341 358 3,549 Hematology 303 260 262 535 524 567

9 Gastric cancer patients receiving chemoTx in Asan
1st line 2nd line 3rd line 200 100 Kang YK, Ryoo BY, Ryu MH et al.

10 Leveraging the cons Busy clinics: large number of uniformly treated patients and specimens Multidisciplinary care within one campus Critical mass to set up infrastructures for rare entities

11 BioResource Center & PDX(Patient-derived Xenograft)
Total of 36,046 vials for 18,024 patients Molecularly Profiled Primary Cell Lines & Xenolines Cancer Patients Vials Breast Tumor 207 290 Normal 186 251 Colon 813 1,346 812 1,340 Liver 235 633 234 690 Lung 302 463 260 346 Stomach 223 431 Kidney 155 385 137 332 Pancreas 276 144 394 Tumor Primary cell PDX Total 2014 Lung 98 49 11 2 Colon 56 28 16 5 Stomach 35 17 27 Kidney 6 3 1 Liver 33 Breast Ovary 234 115 60 13 Structural genomics consortium

12 Early phase trials: another layer of complexity
Science: omics, fresh tissue Costs: reimbursement Patient pool: assess to new drugs Health care infrastructure: diagnostics and therapeutics on board Clinical trial operation: admission, rebiopsy Regulatory: IND holder, single INDs

13 Complexity: burning out our staff
Which phase: Dose escalation vs Dose expansion Multiple criteria for multiple cohorts Informed consents Assessment for multiple disciplinaries (ENT, Ophthalmology etc) Genomic sequencing Central vs Local tests: ECG, imaging review Tissues: Archive vs Fresh Weekly telecons: Time zones

14 Increase in Trial Complexity and Associated Workload
Choi et al, under submission At Asan Medical Center, approved sponsor-initiated cancer trials across six indications (all comer, stomach, colon, breast, lung, liver) No. of procedures in comparable visits (Pre-screening visit, Screening visit, Treatment visit; cycle 1, Treatment visit 2; efficacy visit, End of treatment)

15 Increase in Trial Complexity and Associated Workload Choi et al, under submission
International early phase trials are quite valuable as they increased information across various indications according to region. International studies are challenging despite their values. Korea alone International Asan alone

16 Network of Centers of Excellence
Fewer sites but sustainable enrollment and quality Lessen complexity of setting up multiple sites Sharing data and tacit knowledge are key to accelerate drug development and operational efficiency International collaboration between cooperative groups with multiple sites may not be the best approach

17 Summary Our experience of setting up a phase 1 trial unit has been challenging; however, as the value outweighs these difficulties, we are finding ways to overcome this. We should learn from each other; so that patients may receive earlier access to investigational agents in more safe and scientific ways.

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