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Program Overview
The Asia Pharma R&D Leaders Summit 2021 ( ‘ APRDL 2021 ‘ ) will bring in fresh perspectives and establish an efficient platform to discuss about the ATMP Development, CMC Development, Promoting China Innovation and Trends for Future Pharma R&D Revolution

Brainstorm with over 100+ high caliber speakers and estimation to bring over 500+ Industry Stakeholders, Entrepreneurs, Influencers and Pharma R&D professionals, With this in mind, The Themes of “ Asia Pharma R&D Leaders Summit 2021 “ will cover:

Gene & Cellular Immunotherapy Revolution
-- Advanced Therapy Medicinal Products ( ATMPs ) Development Challenges
-- The CAR-T Cell Revolution -- CAR T-Cell Therapy targeting Leukemia, Lymphoma, and Future Hopes for Solid Tumors
-- Cell Based Therapies: Key Considerations for Clinicians, Health Care Systems, International Societies and Regulatory Authorities
-- Regulations and Platforms for Ensuring the Quality, Safety and Efficacy of Cell & Gene Therapy Products
-- Analytical Characterization & Comparability, Process Validation, Method Validation, CMC and Quality Control
-- Cell and Gene Therapy Bioprocessing, Commercialization Manufacturing and Supply Chain Strategies
-- TIL Therapy Development; Manufacturing and Optimization in TIL Therapy
-- Automated Manufacturing of Chimeric Antigen Receptor T Cells
-- Revolution of CAR-T Cell Therapies: Regulatory and Commercialization Considerations
-- The State of the ART of Manufacturing CAR T Cells and The Latest Advancements
-- Development of Safe and Potent CAR-T Cell Therapy in China targeting Hematological Malignancies and Solid Tumor
-- CAR NK Cell Therapy Development; Manufacturing NK Cell Products for Clinical
-- Engineering TCR-based Cell Immunotherapy against Cancer and Viral Infection
-- TCR-T Cell Therapy: TCR Design, Engineering, Translation and Development Strategies for Solid Tumor Success
-- Oncolytic Virus-based Cancer Therapy
-- Developing AAV-based Gene Therapy Products in China
-- A Broad Technology Platform for Reprogramming, Expansion of Pluripotent Stem Cells and Differentiation to Cell & Gene Therapies
-- Precision Immunotherapy: Development BCMA-Targeted CAR T-Cell Therapy for R/R Multiple Myeloma
-- Solid Tumor CAR-T Barriers and Solutions
-- Challenges and Prospects of Allogeneic CAR-T Cell Therapy
-- Advancing Cancer Adoptive Immunotherapy with CRISPR/Cas9 Gene Edited T cells
-- CAR-T Cell Therapy Translational Insights: Correlates of Toxicity, Safety & Efficacy
-- Developing Allogeneic Cancer Immunotherapy with iPSC Technology
-- Building a Cell Therapy Platform Company to Develop Best in Class Products in China
-- Treating solid tumors with TCR-mimic antibody redirected ARTEMISTM T-cells Research
-- Flow Cytometry for CAR-T Cell Therapy

R&D Innovation in China
-- Open Innovation Model for University-Industrial Strategic Partnership
-- Development and Commercialization of Globally Innovative Medicines in China
-- Promoting China Innovation and Strategic Partnership;
-- In-licensing Collaboration; Due Diligence and IP Patent Considerations
-- Ophthalmic Drug Development in China: Innovation & Global Collaborations
-- Accelerating Drug Development in China: How best to address important unmet needs in China with an integrated local development strategy
-- New Modalities Research Opportunities and Innovative Collaboration Model in China
-- The aftermath of COVID-19: How will this affect Global and China Pharma R&D Industry
-- Computer-accelerate rational discovery (CARD)
-- Growth in Quality of Innovation – Innovative Drug Discovery in China
-- 小分子创新靶向药物开发与前沿技术
-- 冷冻电镜技术与药物研发
-- 基于PROTAC技术的新药开发
-- 突破性眼科创新疗法的开发与合作
-- 抗病毒药物,中枢神经系统新药,核酸干扰药物,自体免疫,合成致死抗肿瘤药物研发与创新合作
-- 非酒精性脂肪性肝病药物研发 ( NASH & NAFLD )

新药研发到商业化生产: 原料药工艺开发; CMC的挑战和策略; MAH实践
-- 从新药研发到商业化生产
-- 4+7集采后创新药发展趋势和研发模式
-- 创新药研发与药学开发
-- 创新药中美双报CMC策略分享
-- 早期临床用药生产及原料药及制剂药学研究
-- 商业化制剂设计, 研发与中试放大, 技术及法规要求
-- 原料药工业生产中的杂质控制与系统研究
-- 新药创新中的原料药工艺开发
-- CMC的挑战和策略, 处方工艺设计
-- 原料药质量标准与参比制剂
-- 原辅料物化特性对合理的产品设计, 开发与中试放大的影响
-- 原料药的开发, 质量控制及未来发展趋势
-- 原料药工艺合成及工艺路线优化
-- 临床药品的生产放大及技术转移
-- 全生命周期药学研究策略
-- 制药行业的连续化生产, 智能制造及工艺创新
-- 从新药研发到商业化生产-产业化项目以及MAH实践
-- MAH制度赋能新药研发
-- 促进源于中国的创新: 汇聚中国制药产业“源动力”-- 我国原料药产业发展现状与趋势
-- Considerations and Approaches to Speed up CMC Development to Match the New Clinical Paradigms for Oncology Studies

基因毒性和元素杂质控制
-- Application of multi-stage mass spectrometry (MSn) in solving challenging problems in pharmaceutical industry: from rapid structure elucidation, drug degradation mechanism studies, to detection of genotoxic impurities
-- 基因毒性杂质和元素杂质控制策略与分析方法
-- 原料药工艺的杂质研究
-- 质量研究的通盘考量 ( 杂质, 晶型, 粒径 )
-- 亚硝胺杂质的质量风险控制与思考
-- 基因毒性杂质分析方法和前处理技术
-- 药物研发晶型研究与结晶工艺开发设计
-- 分析方法的开发验证及问题解析

创新制剂设计与开发; 改良型新药505(b)(2)的机遇与挑战
-- 口服固体制剂开发思路与策略
-- 口服固体制剂溶出度试验技术探讨-溶出度试验技术, 溶出度和溶出曲线
-- 吸入制剂颗粒处理工艺及制剂特性相关颗粒性质评价
-- 吸入制剂产品的设计与研发思路
-- 长效和靶向微球制剂工业开发及质量控制
-- 注射剂一致性评价开发以及制剂处方工艺开发及临床评价关键技术以及焦点问题探讨
-- 注射剂一致性评价与焦点问题
-- 多肽制剂的开发与创新
-- 脂质体制剂的设计与开发
-- 满足IND/NDA中美双报的创新制剂研发
-- 改良型新药的研发策略
-- 高技术壁垒仿制药的研发
-- 质量源于设计(QbD)理念在仿制药工艺研究中及仿制药申报中的应用
-- 仿制药一致性评价与参比制剂遴选
Asia Pharma R&D Leaders Summit 2021  |  Telephone: +86 21 6157 7321  |  E-mail: kevin.tan@deliver-consulting.com
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