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Join us for a series virtual workshops - with the Korea National Enterprise for Clinical Trials (KoNECT) – addressing key challenges faced by Korea biopharmaceutical companies developing rare disease therapies. Each live 90-minute session will feature brief presentations on a variety of topics as well as Q&A.
DATES AND TIMES:
September 7, 8, 9, 2021 – 9:00 am – 10:30 am KST (Seoul)
September 6, 7, 8, 2021 – 8:00 pm – 9:30 pm EDT (US)
September 7, 8, 9, 2021 – 2:00 am – 3:30 am CEST (Europe)
Featured Sessions
Day 1
(1.5 hours)
Shortening the Distance from Lab to Life®
- Sora Lee, Vice President, General Manager Korea
An Overview of the Western Rare Disease Market
- Dr. Raymond Huml, Vice President and Head of the Rare Disease Consortium
An Overview of Rare Disease Patient Recruitment Strategies in Korea, and Beyond
- Helen Green, Director, Site and Patient Access
Q&A
- Presenters and Sunny Han, Director, Clinical Operations
Day 2
(1.5 hours)
Navigating the Regulatory Landscape for Rare Diseases and Orphan Drugs in the EU
- Allison Gillespie, Vice President, Regulatory Affairs
Global Impact of US FDA Initiatives to Support Orphan Drug Disease Development
- Zohra Lomri, Executive Director, Global Regulatory Consulting
Q&A
- Presenters and Jinhak Kim, Director, SSU and Regulatory
Day 3
(1.5 hours)
Rare Disease Case Studies in Cell and Gene Therapy: Oncology, CNS, Ophthalmology
- Pete Robinson, Vice President and Head of the Cell & Gene Therapy Consortium
How Competition Affects Market Access for Rare Disease Therapeutics
- Keith Kelly, Sr. Managing Director, Consulting
- Fang Xu, Sr. Consultant, Consulting
The Critical, Multidimensional Role of Patient Advocacy Groups in Rare Disease Drug Development
- Keri McDonough, Vice President and Head, Patient Voice Consortium
Q&A
- Presenters and Paul Park, Senior Director, Clinical Development
- Jung Ok Jang, Project Director