Gap Analysis for Drug Development Process

Transcription

1 Gap Analysis for Drug Process Dr. Jia Ming Chang AM4 Preclinical Animal Testing Center Institute for Drug Evaluation Platform Center for Biotechnology

2 Benefit of Gap Analysis Gap analysis service support the drug in the es of Lead to and IND enabling. It is beneficial to drug in facilitating the timeline and cost down the budget because critical data are evaluated and remove redundant for IND application.

3 Gap in Drug Process Target Discovery Target Lead Discovery Lead selection GAP Lead Optimization/ Preclinical IND enabling studies GAP trials I, II, NDA Assay In vitro pharmacol ADME Pre formulation Formulation In vivo DMPK Pilot toxicity PK/PD GLP toxicity Early clinical plan IND filing safety in HV in patients Full PK PK/PD correlation GAP

4 Preclinical studies in drug Target Discovery Preclinical In vitro Proof of concept in vivo Early PK in rats (Cmax, AUC, CL, t 1/2, Chemical Pilot Geno toxicity Formulation and for Phase I Safety protocol phase I/II

5 Preclinical studies in drug Target Discovery Preclinical In vitro Proof of concept in vivo Early PK in rats (Cmax, AUC, CL, t 1/2, 資源中心 基因及蛋白質結構分析 (GP1) Chemical 資源中心 藥物化學樣品庫與超高速篩選 (SB1) Pilot Geno toxicity Formulation and for Phase I Safety protocol phase I/II

6 Preclinical studies in drug Target Discovery Preclinical In vitro Proof of concept in vivo 資源中心 小試量產之化學合成 (CS) Early PK in rats (Cmax, AUC, CL, t 1/2, Chemical Pilot Geno toxicity Formulation and for Phase I Safety protocol phase I/II

7 Preclinical studies in drug Target Discovery Preclinical In vitro Proof of concept in vivo Early PK in rats (Cmax, AUC, CL, t 1/2, Chemical 資源中心 AM4 service Pilot Geno toxicity Formulation and for Phase I Safety protocol phase I/II

8 Preclinical studies in drug Target Discovery Preclinical In vitro Proof of concept in vivo Chemical Early PK in 資源中心 rats (Cmax, AUC, 人類疾病動物模式 CL, t 1/2, (AM) AM1 陳志成台灣小鼠診所 國家綜合小鼠表現型暨藥效分析中心 AM2 蘇銘嘉以人類疾病動物模式進行之藥效探索 AM3 林武智輻射應用及分子影像技術平台計畫 AM4 張嘉銘 疾病動物藥效分析服務平台計畫 Pilot Geno toxicity Formulation and for Phase I Safety protocol phase I/II

9 Preclinical studies in drug Target Discovery Preclinical In vitro Proof of concept in vivo Early PK in rats (Cmax, AUC, CL, t 1/2, Chemical 資源中心 臨床前藥物動力與藥物代謝測試服務 (PC) Pilot Geno toxicity Formulation and for Phase I Safety protocol phase I/II

10 Preclinical studies in drug Target Discovery Preclinical In vitro Proof of concept in vivo Early PK in rats (Cmax, AUC, CL, t 1/2, Chemical Pilot Geno toxicity Formulation and for Phase I 資源中心 臨床前毒理測試服務 (PC) Safety protocol phase I/II

11 Preclinical studies in drug Target Discovery Preclinical In vitro Proof of concept in vivo Early PK in rats (Cmax, AUC, CL, t 1/2, Chemical Pilot Geno toxicity Formulation and for Phase I 資源中心 轉譯醫學資源中心 (TR) Safety 資源中心 AM4 Gap analysis service protocol phase I/II

12 Promise for Gap Analysis Service Confidential (CDA) Report on time within 2 weeks for basic level gap analysis within 4 weeks for advanced level gap analysis Gap analysis current status future progress Confer on NRPB resource center & core facility Budget and timeline suggestion Portfolio management

13 How to apply this gap analysis service of AM4 Contact window 周芳如專案經理財團法人生物技術開發中心藥物平台技術研究所藥理組 TEL:(02) ext Consultation committee Margret Ann Miller (Vice director, Department of, FDA, USA) 洪昭竹 () 張俊彥 (, clinical protocol design) 謝清河 (, clinical protocol design) 鄭瑞棠 () 溫國蘭 (CMC) 李威著 (CMC)

14 THANK YOU FOR YOUR ATTENTION