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Date(s) And Time(s):
Apr 4 2011 8:00AM - Apr 6 2011 4:00PM

Location:
Hilton Washington Embassy Row
2015 MASSACHUSETTS AVE NW,
WASHINGTON, DC 20036-1075

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

Learning Objectives:
At the conclusion of this meeting, participants should be able to:
Describe First in Human (FIH) enabling toxicology package for large and small molecules to include relevant
pharmacological and toxicological data and identification of the HED, PAD, NOAEL, MABEL
Identify issues that often arise during early drug development of small and large molecules and learn diff erent
approaches for managing those issues
Interpret nonclinical data supporting first-in-human (FIH) dose selection and clinical safety
Describe the role of the clinician in FIH dosing and bridging of nonclinical to clinical considerations in FIH dose
selection.
Integrate the regulatory context, eg, guidance, into strategies for addressing emerging nonclinical and clinical issues in early stage drug development.
Identify strategies to support FIH based on product attributes, therapeutic target, CMC, treatment duration,
patient populations, etc. as they relate to small and large molecule pharmaceuticals
Identify unique patient populations and how FIH dose selection is considered for these populations
Apply hands-on experience with selected nonclinical data interpretation, clinical dose selection, IND sections and components of FDA meeting requirements and requests

Target Audience:
Professionals, especially from small- and mid-sized companies and nonclinical and clinical
CROs, involved in:
• Regulatory affairs
• Clinical research
• Clinical pharmacology
• Project management
• Nonclinical
• Academia

Event Code:
11013

Contact Information:
Contact Carrie Dunn, Program Developer,
Phone +1.215.442.6181

Fax +1.215.442.6199,
email Carrie.Dunn@diahome.org