Events

Getting to a First in Man Clinical Trial: Where, Why and How?

In a competitive  environment where corporate partners and venture firms increasingly want to see clinical data before investing, it becomes critically important for young start up companies to find innovative yet strategically sound ways to acquire the data they need to raise the necessary follow up financing. As an entrepreneur faced with the challenge of securing human data, one should know the right questions to ask to get to the right answers: What are the steps to get started? Where do we do the trial – in US or outside of the US? How many patients and sites? How long does it take to get started? How long to enroll? How does one plan an appropriate budget?

Keys to answer these questions and more will be addressed in the next GCIC Path to Commercialization seminar, leaving you with valuable lessons in clinical trial strategy and execution. Join four veterans as they share their experience, insights and critical perspectives on clinical strategy and planning for financial success.

PROGRAM

10:30 - 11:25 AM
Key Elements of US Clinical Trials — Elizabeth Schwendler (CRM)

• The Players
• The Basic Elements
• Regulatory Oversight
• Type of Study: Drug vs. Device

11:30 - 12:00 PM
Clinical Execution: The European Perspective — Dimitri Buytaert (genae Americas Inc.)

• Which Country?
• How to choose?
• European Pitfalls

12:00 - 12:30 PM
The importance of Clinical Strategy in Fundraising — Panel Discussion moderated by Vicki Tifft (CRM)

• Top 5 considerations in clinical strategy
• Understanding what the VC/Funding source needs to see from a first in man
• US vs. OUS: Where’s the right place to go?

SPEAKERS AND PANELISTS

Vicki Tifft
CEO, Clinical Research Management Inc.
Elizabeth Schwendler, RN, CRN
Clinical Research Management Inc.
Dimitri Buytaert
President, genae Americas Inc.
Suzette Dutch
Managing Partner, Triathlon Medical Ventures