9th Annual Biomarkers Congress
First In Human Dosing: Highlighting the Similarities and Differences Between Small and Large Molecular Pharmaceuticals
Hilton Washington Embassy Row
2015 MASSACHUSETTS AVE NW
WASHINGTON, District of Columbia
http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=25182&eventType=Meeting
Interactive, Team-based Approach to Understanding Drug Development Strategies for Small and Large Molecular Entities.
Learn proven concepts behind First-in-Human (FIH) dose selection and strategic considerations around issues for a spectrum of drug development programs. You will:
• Participate in break-out sessions where teams will discuss nonclinical programs for large and small molecules to support FIH dosing
• Discuss the challenges associated with clinical dosing and the outcomes of additional nonclinical data that may affect continued clinical development
• Develop strategies for consideration of FIH dose and interactions with FDA
• Evaluate toxicological and pharmacological data to provide an estimate of the FIH dose and justify the clinical dose escalation paradigm




FEATURED TOPICS
• Drug Development Process in the Current Regulatory Environment
– General overview of the drug development process
– Regulatory guidance for the design of nonclinical programs
– Regulatory submissions and interactions in the IND phase
• Regulatory Guidances and Interaction with Regulatory Authorities
– CMC issues for small molecules and large molecules
– Principles of FIH dose selection
– Differences in pharmacology/toxicology expectations to support FIH dosing based upon product attributes

Schedule of Presentations:

Monday, April 4, 2011
07:00:00 First In Human Dosing: Highlighting the Similarities and Differences Between Small and Large Molecular Pharmaceuticals Royce Morrison, Kenneth Hastings,, Melanie Hartsough, Bert Haenen, Joy A. Cavagnaro, Lorrene A. Buckley, William J. Brock
Tuesday, April 5, 2011
Wednesday, April 6, 2011
4th Annual Pharma R&D Asia Congress
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