HORSHAM, PA, USA—FEBRUARY 24, 2011—DIA today announced that it will host Nonclinical and Clinical Strategies for First-in-Human Dosing of Large and Small Molecules from April 4-6, 2011 in Washington, DC. This three-day conference will explore the concepts behind First-in-Human (FIH) dose selection and strategic considerations around issues for a spectrum of drug development programs. Session topics include:
- 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
“Participates will attend break-out sessions where teams will discuss nonclinical programs for large and small molecules to support FIH dosing,” says Program Chair J. Brock, PhD, DABT, Fellow ATS, Principal, Brock Scientific Consulting. “There will also be ample opportunity to discuss the challenges associated with clinical dosing and the outcomes of additional nonclinical data that may affect continued clinical development”
ABOUT DIA
DIA is a neutral, global, professional, member-driven association of nearly 18,000 professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices, and related health care products, Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies, and services to improve health and well-being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China.
