Join us on Thursday 24th September 2020, 15:00 BST | 16:00 CEST | 10:00 EDT, when Dr Frank Casty, Judith Plon and Professor Steffen Thirstrup will guide you through the expedited regulatory pathways available in the EU and US and discuss how to effectively leverage these to accelerate and optimize your drug development program.
A timely market introduction is a critical component of any drug development strategy – not only from a commercial standpoint, where an earlier market entry can lead to a competitive advantage, but also for patients awaiting better treatment options.
Regulators worldwide have developed specialized pathways to expedite review and approval of new drugs. Navigating these pathways can be a daunting task for sponsors.
Partnering with experienced regulators both in the US and EU is critical to achieving expedited reviews since getting the strategy right, developing effective documentation, and preparing for regulatory interactions can make the difference between a standard regulatory review and a successful expedited review
Our panel will discuss:
- Which pathways are available
- When to apply for specific designations
- What data are required and what to expect if the designation is granted
- Best practice to create a successful strategy
Click here to book your place today!
About the Panel
Dr Frank Casty: Senior Clinical Regulatory Advisor, NDA Group
Frank works with small and large companies across several therapeutic areas including cardiovascular, respiratory, inflammation, oncology and rare diseases. He has led numerous FDA interactions, IND and NDA filings as well as presented at successful FDA Advisory Committee Meetings.
Before joining NDA, Frank worked for more than 25 years in small and large pharmaceutical companies leading Global Clinical Research and Medical Affairs organizations as well as serving as technical consultant for Business Development activities.
Judith Plon: Principal Consultant, NDA Group
Judy works with small and large companies across multiple therapeutic areas. She serves as a US Agent for clients leading the submission of their INDs, NDAs, and special designation requests (i.e. Orphan Drug Designations).
Prior to joining NDA Judy spent over 25 years in the Biopharma Industry, primarily working in the discipline of regulatory affairs. She held positions of increasing responsibilities and last served as a Vice President of Global Regulatory Affairs.
Professor Steffen Thirstrup: Director NDA Advisory Board, NDA Group
Steffen excels at advising companies on their development strategies to meet expectations of regulatory agencies around the world. He applies his skills to a broad range of therapeutic areas and have successfully helped numerous clients interact with regulatory agencies throughout the stages of development and during regulatory review.
Prior to joining NDA in 2013, Steffen was employed as the head of Division for Medicines Assessment and Clinical Trials at the Danish Health and Medicines Authority where he also acted as Danish member of the Committee for Human Medicinal Products (CHMP) at the EMA.