From Concept to Commercialization: How to Take Your Asset to the Next Level
January 28, 2019
Monday, January 28, 2019 11:30 am - 1:00 pm
Registration starts at 11:00 a.m.
Lunch will be served
An increasingly large part of innovation is driven by emerging biotech companies who combine knowledge with resources and enthusiasm to embark on the long winding road of drug development.
In today’s hypercompetitive landscape, it takes more than scientific expertise and experience with ever-changing health authority expectations to achieve long-term success. The ability to successfully navigate regulatory, clinical and commercial complexities is vital to achieving your end goals.
This session will focus on best practices for emerging biotech companies when working towards phase I proof of concept, preparing for regulatory review, communicating effectively with health authorities and exploring funding in support of sustained growth.
Topics for discussion include:
- Clinical and commercial best practices for programs that are in the early phase of development
- Optimal use of US and EU Expedited Drug Development and Marketing Application Review programs
- Key considerations for maximizing success with regulatory agencies, especially for the development of drugs for rare diseases and orphan indications
- Constructive tools designed to equip biotech companies for partnering, demonstrated with real world examples
- Critical insights into venture capital and large pharma criteria for investment
- Sugato De, M.S., Vice President, Technical, PAREXEL Consulting
- Mwango Kashoki, M.D., Vice President, Technical, PAREXEL Consulting