生物新药开发与市场.ppt

生物新藥開發與市場永昕生物醫藥1生物新药开发与市场總經理總經理 黃一旭黃一旭 博士博士vv永昕生物醫藥股份有限公司總經理永昕生物醫藥股份有限公司總經理 ( (現任現任) )vv美國美國 CR Rockville CR Rockville 科技部主任科技部主任 vv美國美國 CR Rockville CR Rockville 資深主任資深主任 ( (製造部負責人製造部負責人) ) vv行政院行政院衛生署藥品查驗中心衛生署藥品查驗中心顧問顧問 vv成都中醫藥大學成都中醫藥大學新藥研究開發中心新藥研究開發中心顧問顧問 vv專長：專長：v藥廠經營/管理，藥品開發， 業務推廣， 製藥法規及市場分析vv學歷學歷v台大獸醫學士,獸醫師 1977v美國路易西安那州西北大,碩士 1983v美國奧本大學,博士 1987永昕生物醫藥2生物新药开发与市场生物製劑的種類–Therapeutics –Gene Therapy–In Vivo Diagnostics–Therapeutic Vaccine–BioDevice–Tissue Repair–Xenotransplantation–Natural Product永昕生物醫藥3生物新药开发与市场生物製劑的特性•複雜高分子物質複雜高分子物質•三度空間結構特性三度空間結構特性•生物有效性或活性生物有效性或活性•需特殊需特殊安全測試安全測試永昕生物醫藥4生物新药开发与市场Critical Parameters for Biologics•Safety ( (安全性）安全性）•Potency（強度）（強度）•Purity （純度）（純度）•Consistency （持續性）（持續性）•Efficacy （有效性）（有效性）永昕生物醫藥5生物新药开发与市场新藥開發、製造、測試及申請流程流程新藥開發新藥開發Drug DevelopmentDrug Development臨床前動物試驗臨床前動物試驗Pre-clinicalPre-clinicalDevelopmentDevelopment申請審核新藥物申請審核新藥物Investigational New DrugInvestigational New DrugApplication (IND)Application (IND)三階段人體臨床試驗三階段人體臨床試驗Clinical DevelopmentClinical Development申請藥物許可申請藥物許可BLABLA上市上市Introduction/DistributionIntroduction/DistributionTo the MarketTo the Market永昕生物醫藥6生物新药开发与市场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永昕生物醫藥7生物新药开发与市场Process Development - MissionTo develop production processes of appropriate scale - from pre-clinical exploration to commercialization永昕生物醫藥8生物新药开发与市场Process Validation•Cell Culture•Filtration•Chromatography•Viral Clearance•Aseptic Manipulation Validation•Equipment•Other - cleaning, storage,transferring, packaging, and shipping永昕生物醫藥9生物新药开发与市场Manufacturing SchemeHostHostBankBankProductionProductionPurificationPurificationModification/formulationModification/formulationPackagingPackaging永昕生物醫藥10生物新药开发与市场Manufacturing - Outline•Master Cell Bank & Working Cell Bank•Starting Material Production•Purification•Modification•Formulation•Aseptic Vialing•Labeling永昕生物醫藥11生物新药开发与市场Clinical Trials•Pre-Clinical & INDAnimal studies, safety, metabolic, pharmacological & process description•Phase I: Human SafetyClinical pharmacology studies永昕生物醫藥12生物新药开发与市场Clinical Trials•Phase II: EfficacyControlled studies in patients with disease or conditionBlinded clinical evaluation永昕生物醫藥13生物新药开发与市场Clinical Trials•Phase III: Safety and EfficacyBoth controlled and open trialsClosely monitored by sponsor for adverse reactions and information to be used for setting dosage requirements and labeling.永昕生物醫藥14生物新药开发与市场Clinical Trials•Treatment: (Physician's 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.永昕生物醫藥15生物新药开发与市场Documentation ControlTo reduce the risk of error due to oral or informal communication, to provide clear, written instructions, and to permit traceability.永昕生物醫藥16生物新药开发与市场Document•Training Record•Specifications (supplies, chemicals, products)•SOPs•Production Batch Records•Validation Records + Equipment IQ/OQ/PQ•Equipment use log永昕生物醫藥17生物新药开发与市场CONTROLCONTROLA documented process by which validated procedures are consistently followed to eliminated unacceptable deviations from the established standards.永昕生物醫藥18生物新药开发与市场CONTROL•General Controls•Design Control•Facility Control•Equipment Control•Material/Component Control•Operational Control•Finished Product Control永昕生物醫藥19生物新药开发与市场生物新藥市場評估需求評估需求評估•New Case / Year•Total Case / Year•用藥量•市場占有率•市場治療費用／年永昕生物醫藥20生物新药开发与市场生物新藥市場評估 製作評估製作評估•Patent /法律問題•製造困難度（量產／保存）•體內／外活性•劑量（單一／重複）•藥品壽命永昕生物醫藥21生物新药开发与市场生物新藥市場評估•Patent 費用•製造費用•臨床實驗費用•臨床實驗結果取得時間永昕生物醫藥22生物新药开发与市场生物新藥市場評估•Cost of Goods•Price per dose•Cost per patient•健保／保險業給付健保／保險業給付•市場接受度市場接受度永昕生物醫藥23生物新药开发与市场生物新药开发与市场。