『具利基候選藥物之可開發性策略』研討會 - 生技

2012 『具利基候選藥物之可開發性策略』 國際研討會
2012 Developability of Pharmaceutical Profiling for Drug Candidates

新藥能夠成功上市，許多關鍵因素環環相扣，台灣具有新藥開發的實力，但尚無實質的成
果由臨床前跨過各期臨床研究進而成功上市。候選藥物如何透過結構修改及製劑調整，進
而提升身體利用率，各家藥廠有獨特技術及評估策略。本研討會特別邀請知名國際藥廠之
研究人員，針對藥物鹽類/晶型、預劑型、固型製劑、控釋劑型及相關製造考量的篩選開
發策略進行精闢解說，透過實務經驗及專利解析，探討具潛力候選藥物之可開發性策略，
以活絡我國生技醫藥產業發展及加速新藥開發時程。
竭誠敬邀產、官、學、研各界先進積極參與報名參加，並熱情贊助共襄盛舉，以促進國際
交流與知識分享。

指導單位：經濟部技術處
主辦單位：工研院生醫與醫材研究所
協辦單位：台灣製藥工業同業公會、中華民國製藥發展協會
時 間：2012年9月12~13日
地 點：國立台灣大學集思會議中心蘇格拉底廳
台北市羅斯福路四段85號(鄰近捷運公館站2號出口)
報名時間：即日起至額滿為止，座位有限欲報名從速。
報名方式：採網路報名。網址：http://tinyurl.com/2012-pre-formulation

報 名 費: 包含研討會論文集及9/12、9/13中午便當與coffee-break費用
◎個人/一般廠商NT$3,000/人，8/31前匯款並報名成功可享早鳥優惠價NT2,500
(屬於小分子聯盟會員者可享學費9折優惠，以3人為限)
◎學生NT$1,500，8/31前匯款並報名成功可享早鳥優惠價NT1,200


議程表

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Agenda Time Topics Speakers
───────────────────────────────────────
Sep 12 8:40-9:00 報到
───────────────────────────────────────
9:00-9:05 開幕致詞 陳威仁
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Pre-formulation characterization: Linking
API propertiesto product development
(1) Background: polymorphism/crystallinity,
bulk characterization, solubility/
9:05-10:20 dissolution/permeability, and stability/ Sherry Ku
compatibility.
(2) Selection of formulation platforms
(3) Pre-formulation methodology
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Break
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Polymorph and salt screening
(1) Strategies at different development stages
10:40-12:00 (2) Selection criteria and overall consideration
(3) Risk mitigation Mengwei Hu
(4) IP protection
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Lunch
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Toxicology Formulation Development
(1) Strategies for formulation screening
and selection
13:30-14:30 (2) Conventional formulations Mengwei Hu
(3) Enabled formulations
(4) Excipient considerations
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Break
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Powder flow and segregation: State of the Art
Tools & Principles:
(1) Material properties
14:45-15:45 (2) Overview of tools for assessing flowbility Qun Lu

(3) Tools for assessing segregation potential
(4) Case study
──────────────────────────────────
Break
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Compaction: State of the Art Tools & Principles
(1) Fundamentals of powder compaction
(2) Compression simulation to facilitate the
16:00-17:00 development of tablet formulation and Ping Tong
manufacturing process
(3) Advances on tablet press
(4) Case study
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───────────────────────────────────────
Agenda Time Topics Speakers
───────────────────────────────────────
Sep 13 8:40-9:00 報到
──────────────────────────────────
Enhancing oral bioavailability through
enabled formulation
(1) Oral drug absorption and limiting factors
9:00-10:20 (2) Biopharmaceutics classification system Qun Lu
(BCS) and landscape of marketed products
(3) Overview of solubilization technologies
──────────────────────────────────
Break
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Case studies I: Solid dispersion:
(1) Compound characteristics and formulation
challenges
10:40-12:00 (2) Approaches to improve solubility/dissolution Qun Lu
(3) Formulation design and development
(4) Human pharmacokinetics
──────────────────────────────────
Lunch
──────────────────────────────────
Case studies II: Lipids
(1) Overview of lipid-based formulation
(2) Formulation of lipid-based formulation
13:30-14:30 - considerations of stability, Ping Tong
manufacturability and safety
(3) Case study of using lipid formulation
for the delivery of a BCS class IV
──────────────────────────────────
Break
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Enhanced technologies: modified release.
(1) Linking API properties to MR technology
selection
14:45-15:45 (2) Formulation design for robust performance Rob Ju
(3) Predictive in vitro and in vivo tools
for drug release
(4) Platform MR
──────────────────────────────────
Break
──────────────────────────────────
Enhanced technologies: emergence of fixed
dose combination.
(1) Why FDC
(2) Linking multiple API properties to
16:00-17:00 technology selection Rob Ju
(3) Emerging technologies for FDC and challenges
(4) Product design for robust bioavailability,
manufacturability, and stability performance.
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