Path to IND for Biologics: From DNA to First-in-Human in 9 Months

Path to IND for Biologics webinar title slide
Path to IND for Biologics: From DNA to First-in-Human in 9 Months
June 10, 2025

Join Thermo Fisher Scientific for an exclusive webinar introducing a transformative approach to biologics development and clinical scale-up. Their "Path to IND for Biologics" method accelerates the journey from DNA to IND/IMPD submission and first-in-human clinical trials in as few as 9 months. Dr. Elena Gontarz, a leading expert in the biologics industry, will guide you through this innovative process, leveraging AI/ML, transposase technology, and integrated solutions during the session: "Path to IND for Biologics: From DNA to First-in-Human in 9 Months." Following the presentation, Dr. Gontarz will answer audience questions and discuss how these novel strategies can streamline the development of complex biologics, such as Fc-fusion proteins and bispecific antibodies, driving them swiftly from development to commercialization.

Get a sneak peek on this novel platform 

Terms and Conditions: Titer levels provided are estimates based on third party results and may vary depending on molecule type or other factors. Timeline from DNA to drug product and start of clinical trials for all path to IND for biologics options may vary depending on molecule type or other factors and are estimates to be finalized after third party cell line development dates are available and confirmed. 9-month timeline will incur additional risk.

Learn more about Dr. Elena Gontarz's expertise and background:

https://www.patheon.com/us/en/insights-resources/blog/navigating-the-complexities-of-process-performance-qualification.html

https://www.patheon.com/us/en/insights-resources/blog/choosing-a-cdmo-who-is-a-true-bioproduction-expert.html

Moderators & Speakers
Bernard Fallon headshot_2024_reisized_v2.1
Bernard V. Fallon, Moderator
Vice President, Industry Programs
Biotechnology Innovation Organization (BIO)
Elena Gontarz headshot
Elena Gontarz, PhD
Head of Technical and Scientific Affairs
Thermo Fisher Scientific