活動資訊

CRDMO美商BioDuro-Sundia公司與TRPMA合作，針對藥物Formulation創新技術與IND申請的關鍵策略，將於12月23日下午舉辦 「Accelerating Early Drug Development - IND Strategies and Formulation Innovations」演講會，共同探討如何加速早期藥物開發，提升效率與成功率。

BioDuro-Sundia製劑部門總監黃于倫 (Ivy Huang) 將演講「Innovating Drug Formulation: Bridging Early Development with ASD Technology」，深入解析如何運用無定型固體分散體技術 (Amorphous Solid Dispersion, ASD) 改善難溶性藥物的溶解度及生物利用率，並透過體外溶解率試驗與PK數據快速篩選最佳配方組合。

BioDuro-Sundia法規部門總監連偉 (William Lian) 將以實務案例，演講「Navigating IND Filing- Key Strategies for Early Drug Development Success」，探討如何在藥物開發初期，通過優化API與配方研發、生產批次規劃及雜質控管，平衡研發效率、法規要求與合規性，加速IND的推進。

本活動全程免費，交流時段由BioDuro-Sundia贊助茶點及咖啡，歡迎對藥物發現、藥物研發、法規事務及對藥物配方和開發策略感興趣的各界先進踴躍參加，共同討論！

主辦單位：BioDuro-Sundia、台灣研發型生技新藥發展協會 (TRPMA)
時間：113年12 月23 日 (星期一) 14:00-17:00
地點：TRPMA會所演講廳 (台北市南港區忠孝東路六段465-1號1樓)
議程：

BioDuro-Sundia https://www.bioduro.com/

BioDuro-Sundia 是Advent Internation旗下投資企業，擁有28年的歷史，是一家值得信賴的全球一流的CRDMO。公司總部位於加州Irvine，在中國與美國共設有7個據點，擁有超過2,000名科學家的專業團隊。BioDuro-Sundia專注於小分子和大分子的藥物發現、開發、放大和生產服務，為生物技術和制藥企業提供從早期靶點確證到商業化生產的整合服務，涵蓋化學、生物學、藥代動力學、原料藥和製劑開發生產等多個領域。BioDuro-Sundia專注CRDMO服務，在全球化質量標準體系下運營，提供先進、快速和靈活的定制服務，以滿足生物技術和制藥企業的專屬需求。目前為止，我們已成功協助超過500個IND項目提交至台灣、美國、歐盟、中國、韓國與日本，助力客戶加速藥物上市。

【Speaker Biography】

Ivy Huang
Director, Formulation Department, BioDuro-Sundia

Ivy Huang graduated from Chia Nan University of Pharmacy and Science in Taiwan with a master’s degree in pharmacy. She has over 15 years of experience in pharmaceutical research and has worked in the R&D centers of top-tier pharmaceutical companies. She has been responsible for the development of NCE and generic drugs, is well-versed in regulations such as FDA, EMA, ICH, and GMP, and is proficient in formulation research and dosage form development. She has led the development, registration, batch production, scale-up, and submission of numerous products.

Ivy is currently the Director of the Formulation Department at Bioduro-Sundia. She is responsible for feasibility assessments of product development, formulation design, process development, and scale-up. She has provided solubilization and formulation enhancement research services for poorly soluble compounds to various renowned global pharmaceutical companies.

William Lian
Director, Filing and Regulatory Affairs Office, BioDuro-Sundia

With 13 years of experience in drug discovery and development, William Lian has specialized expertise in Computer-Aided Drug Design (CADD), generic drug and new drug development, and investigational new drugs (IND) filing. William has managed 60+ projects for over 40 clients, advancing innovation in pharmaceutical development. He has over 9 years of regulatory affairs experience, with a focus on China, the US, the EU, Taiwan, ASEAN, Korea, and Japan.

William holds a B.S. in Chemistry from National Tsing Hua University (Taiwan) and is a PhD Candidate in Molecular Medicine at the same institution. After joining BioDuro-Sundia in 2018, he oversees regulatory compliance and project management. His previous experience includes leading the Quality Assurance Department at Tai-Yu Chemical and Pharmaceutical Co. Ltd., where he was the primary responder for PIC/S GMP, GDP, and medical device audits. As a certified Project Management Professional (PMP®) and Certified Quality Technician (CQT), William has demonstrated strong leadership, communication, and project management skills. His experience includes managing GMP processes, responding to audits, and focus on regulatory compliance and quality assurance.