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生物新藥開發與市場

生物新藥開發與市場. 總經理 黃一旭 博士 Michael Hwang, D.V.M., Ph.D. 永昕生物醫藥公司. 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

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生物新藥開發與市場

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  1. 生物新藥開發與市場 總經理 黃一旭 博士 Michael Hwang, D.V.M., Ph.D. 永昕生物醫藥公司 生技產業導論

  2. 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 生技產業導論

  3. 生物製劑的種類 • Therapeutics • Gene Therapy • In Vivo Diagnostics • Therapeutic Vaccine • BioDevice • Tissue Repair • Xenotransplantation • Natural Product 生技產業導論

  4. 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 生技產業導論

  5. Critical Parameters for Biologics • Safety (安全性） • Potency（強度） • Purity （純度） • Consistency （持續性） • Efficacy （有效性） 生技產業導論

  6. 臨床前動物試驗 Pre-clinical Development 新藥開發 Drug Development 申請審核新藥物 Investigational New Drug Application (IND) 上市 Introduction/Distribution To the Market 申請藥物許可 BLA 三階段人體臨床試驗 Clinical Development 新藥開發、製造、測試及申請流程 生技產業導論

  7. 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 生技產業導論

  8. Process Development - Mission To develop production processes of appropriate scale - from pre-clinical exploration to commercialization 生技產業導論

  9. Process Validation • Cell Culture • Filtration • Chromatography • Viral Clearance • Aseptic Manipulation Validation • Equipment • Other - cleaning, storage,transferring, packaging, and shipping 生技產業導論

  10. Manufacturing Scheme Host Bank Production Purification Modification/formulation Packaging 生技產業導論

  11. Manufacturing - Outline • Master Cell Bank & Working Cell Bank • Starting Material Production • Purification • Modification • Formulation • Aseptic Vialing • Labeling 生技產業導論

  12. Clinical Trials • Pre-Clinical & IND Animal studies, safety, metabolic, pharmacological & process description • Phase I: Human Safety Clinical pharmacology studies 生技產業導論

  13. Clinical Trials • Phase II: Efficacy Controlled studies in patients with disease or condition Blinded clinical evaluation 生技產業導論

  14. 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. 生技產業導論

  15. 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. 生技產業導論

  16. Documentation Control To reduce the risk of error due to oral or informal communication, to provide clear, written instructions, and to permit traceability. 生技產業導論

  17. Document • Training Record • Specifications (supplies, chemicals, products) • SOPs • Production Batch Records • Validation Records + Equipment IQ/OQ/PQ • Equipment use log 生技產業導論

  18. CONTROL A documented process by which validated procedures are consistently followed to eliminated unacceptable deviations from the established standards.

  19. CONTROL • General Controls • Design Control • Facility Control • Equipment Control • Material/Component Control • Operational Control • Finished Product Control 生技產業導論

  20. 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 生技產業導論

  21. 生物新藥市場評估 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 生技產業導論

  22. 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 生技產業導論

  23. 生物新藥市場評估 • Cost of Goods • Price per dose • Cost per patient • 健保／保險業給付 • 市場接受度 生技產業導論

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