Mastering Oncology Immunotherapy Clinical Trials: The Smaller Biopharmaceutical Perspective

Date	May 5, 2016
Time	10:00 AM EDT
Cost	Free
Online

This complimentary webinar explores challenges smaller companies should consider when embarking on immunotherapy studies.
The reality of leveraging a patient’s immune system to disrupt cancer through immunotherapy is compelling. Standards of care are shifting, and drug developers are eager to leverage new technologies. Small to mid-sized biopharma companies play significant roles in innovating and adapting drug designs to create new immunotherapies, and often require outsourcing support to manage clinical investigations.
In this webinar, we’ll explore five areas of focus for smaller companies to understand in order to fully leverage the potential of immunotherapy candidates – and get it right the first time.

• Protocol design and endpoint selection
• Retaining the right patients
• Dose-escalation strategies and measuring response
• Reactions
• Patient Education

Learning Objectives

• Learn what to include in a well-written protocol to ensure successful recruitment and data collection, as well as guidance for investigators and site staff new to immunotherapy trials.
• Understand how to select measurable endpoints and when to consider pharmacodynamic (PD) endpoints for bioequivalence studies.
• Gain an understanding of dosing and patient response challenges unique to immunotherapy trials, including dose-escalation, irRC versus RECIST, and pseudo disease progression.
• Recognize the distinct challenges smaller companies face when embarking on immunotherapy studies.