Event
Oncology Breakthroughs: Smart Study Designs, Global Expansion, and AI-Driven Biomarker Strategies
October 28, 2024 2:30 PM - 4:30 PM Korea Standard Time
Room B, 6F, KPX Building, 137, Mapo-daero, Mapo-gu, Seoul, Republic of Korea
Join us at an exclusive seminar where our distinguished speakers will share actionable insights into accelerating and optimizing oncology trials, in an increasingly complex and technology-driven landscape.
Agenda
Baljit Samra, Executive Vice President, Clinical Operations, Asia Pacific
Presenter: Sinan Sarac, Senior Vice President, Head, Regulatory Strategy
- Implementing effective study designs in early development
- Strategies for accelerated approvals – faster and smarter
- Leveraging new policies, e.g., Project Frontrunner
- Recognizing FDA and EMA policy/ precedents differences and their impact on your global drug development strategy
Presenter: Angela Qu, Senior Vice President of Translational Medicine, Global Head of Biomarkers and Genomic Medicine
- All comer or enriched? - Optimize study design with right biomarker strategy
- Assay choice and lab strategy for global oncology trial success
- Real world genomic data-driven approach to accelerate rare patient oncology trials
- AI-powered innovation in next generation of oncology biomarker development
Presenter: Minsun Jeon, Senior Director, Project Management
- Scaling early phase Oncology trials from regional to global
- Journey from Korea and US markets to global expansion
- Key challenges and solutions in global trial management
- Lessons learned from recent project
Vicky Hsu, Senior Vice President, Head of Project leadership and Biotech Operations Asia
Speakers
Angela Qu, M.D., Ph.D.
Senior Vice President, Translational Medicine, Global Head of Biomarkers & Genomic Medicine
Dr. Qu brings over 25 years of drug development experience to her role at Parexel, spanning therapeutic areas such as oncology, immunology, CNS, metabolic, and rare diseases. As a subject matter expert, she has led innovative genomics and biomarker projects across preclinical and clinical phases, and has contributed to more than 50 peer-reviewed scientific publications and book chapters. She has served on multiple oncology professional committees including AACR and FDA IWG. At Parexel, Angela serves as a global team leader in biomarker, genomics, and precision medicine innovation, focusing on trial strategy development and execution, provision of scientific and medical guidance, and consulting on partnerships across therapeutic areas. She is also a core member of Parexel's Oncology Center of Excellence, where she applies her extensive expertise to enhance the company's oncology research capabilities and drive innovation in clinical studies.
Sinan Sarac, M.D., Ph.D., M.Sc.
Senior Vice President, Head, Regulatory Strategy Europe
Dr. Sarac has worked in the EU regulatory system for more than a decade. At the EMA, he has served as a member of the Committee for Medicinal Products for Human Use (CMP), the Committee for Advanced Therapies (CAT), and the Scientific Advice Working Party (SAWP), and as a member and chair of CHMP’s Oncology Working Party (ONCWP). He also served as chief medical officer at the Danish Medicines Agency. He was responsible for the scientific evaluation of new cancer products, extension of indications, and national scientific advice. His experience covers oncology, hematology, rare diseases, advanced therapies, small molecules, monoclonal antibodies, and other protein-based products.
Minsun Jeon
Senior Director, Project Management
Minsun brings more than 22 years of progressive experience to the clinical research and pharmaceutical industry. Her expertise spans a broad range of therapeutic areas, including oncology and hematology, gynecology, respiratory, neurology, psychiatry, cardiology, virology, and vaccine development. With rich experience in full-service projects from Phase I to Phase IV clinical trials, Minsun is accountable for account and client management, ensuring the delivery of all project deliverables. She provides overall project strategy and actively seeks efficiencies in clinical research processes. Her comprehensive knowledge makes her invaluable in managing complex clinical research projects and client relationships in the pharmaceutical sector.