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DIA Conference Explores Team-Based Approaches to Understanding Drug Development Strategies for Small and Large Molecular Entities

Horsham, PA, USA — February 25, 2011

DIA today announced that it will host Nonclinical and Clinical Strategies in 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 the global connector in the life sciences product development process. Our association of more than 18,000 members builds productive relationships by bringing together regulators, innovators and influencers to exchange knowledge and collaborate in an impartial setting. DIA’s network creates unparalleled opportunities for the exchange of knowledge and has the interdisciplinary experience to prepare for future developments. The dedicated efforts of DIA staff, members and speakers enable DIA to provide a comprehensive catalogue of conferences, workshops, training courses, scientific publications and educational materials. DIA is a global community representing thousands of stakeholders working together to bring safe and effective products to patients. DIA is an independent, nonprofit organization with its global center in Washington, D.C., USA; regional offices covering North and South America (Horsham, Penn., USA); Europe, North Africa and the Middle East (Basel, Switzerland); and Japan (Tokyo), India (Mumbai) and China (Beijing). For more information, visit www.diahome.org.