生物新药开发与市场课件

生物新藥開發與市場,總經理 黃一旭 博士,永昕生物醫藥股份有限公司總經理 (現任) 美國 CR Rockville 科技部主任 美國 CR Rockville 資深主任 (製造部負責人) 行政院衛生署藥品查驗中心顧問 成都中醫藥大學新藥研究開發中心顧問 專長： 藥廠經營/管理，藥品開發， 業務推廣， 製藥法規及市場分析 學歷 台大獸醫學士,獸醫師 1977 美國路易西安那州西北大,碩士 1983 美國奧本大學,博士 1987,生物製劑的種類,Therapeutics Gene Therapy In Vivo Diagnostics Therapeutic Vaccine BioDevice Tissue Repair Xenotransplantation Natural Product,生物製劑的特性,複雜高分子物質 三度空間結構特性 生物有效性或活性 需特殊安全測試,Critical Parameters for Biologics,Safety (安全性） Potency（強度） Purity （純度） Consistency （持續性） Efficacy （有效性）,新藥開發、製造、測試及申請流程,Phases and Quality,Pre-Clinical - Close to cGMP Phase I - cGMP w/ some changes Phase II - cGMP w/ changes Phase III - cGMP w/ No Changes BLA - No More Product Development,Process Development - Mission,To develop production processes of appropriate scale - from pre-clinical exploration to commercialization,Process Validation,Cell Culture Filtration Chromatography Viral Clearance Aseptic Manipulation Validation Equipment Other - cleaning, storage,transferring, packaging, and shipping,Manufacturing Scheme,Host,Bank,Production,Purification,Modification/formulation,Packaging,Manufacturing - Outline,Master Cell Bank & Working Cell Bank Starting Material Production Purification Modification Formulation Aseptic Vialing Labeling,Clinical Trials,Pre-Clinical & IND Animal studies, safety, metabolic, pharmacological & process description Phase I: Human Safety Clinical pharmacology studies,Clinical Trials,Phase II: Efficacy Controlled studies in patients with disease or condition Blinded clinical evaluation,Clinical Trials,Phase III: Safety and Efficacy Both controlled and open trials Closely monitored by sponsor for adverse reactions and information to be used for setting dosage requirements and labeling.,Clinical Trials,Treatment: (Physicians IND; Compassion) Involves patients with a serious, life threatening, or terminal illness when alternative treatment is not available or not effective and proposed treatment use has some evidence of effectiveness.,Documentation Control,To reduce the risk of error due to oral or informal communication, to provide clear, written instructions, and to permit traceability.,Document,Training Record Specifications (supplies, chemicals, products) SOPs Production Batch Records Validation Records + Equipment IQ/OQ/PQ Equipment use log,CONTROL,A documented process by which validated procedures are consistently followed to eliminated unacceptable deviations from the established standards.,CONTROL,General Controls Design Control Facility Control Equipment Control Material/Component Control Operational Control Finished Product Control,生物新藥市場評估,需求評估 New Case / Year Total Case / Year 用藥量 市場占有率 市場治療費用年,生物新藥市場評估,製作評估 Patent /法律問題 製造