The topics of this seminar are designed for biotech companies aiming to attract investment by enhancing the appeal of their Phase 1 clinical trials. By covering non-clinical strategies for enabling FIH, innovative clinical trial designs, and navigating the regulatory environment, the seminar provides a comprehensive understanding of how to generate robust and reliable data that will instil confidence in investors. Additionally, the session on making data packages compelling for investors offers practical insights into presenting data clearly and persuasively, highlighting key findings, market potential, and risk management. This holistic approach ensures that biotech companies can effectively communicate the value and potential of their projects, thereby increasing their chances of securing investment.

Agenda
14.30 Welcome and Introductions

14.40  Non-Clinical Strategies for Enabling First-in-Human Studies
          Marin Mladinic, Nonclinical Strategy Director
-    What data package do you need before your FIH study?
-    Comparing biologics and small molecule
-    EU vs US, what are the differences?
-    Animal model alternatives

15.25    Designing Your Clinical Trial for Maximal Impact
Emma Field, Project Management Director
-    Innovative clinical trial design
-    How to design the study to get the most out of it

16.10  15 minute comfort break

16.25  Navigating the Regulatory Environment for your FIH
          Helen Tait, Senior Director Project Management
-    Tips for navigating the regulatory framework (EU vs USA vs Australia)
-    Common pitfalls and how to avoid them

17.10  Q&A with the speakers

17.30 Close

Registration
This event is free to attend to and by invite only and open to qualifying attendees only, such qualification being at the sole discretion of trialmed. To request an invitation please email Tony Jones at tony@onenucleus.com.