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#34: Fourteen Steps from Research to Development

Tutorial name:
#34: Fourteen Steps from Research to Development

Day & Time:
June 24, 1:00PM - 4:30PM

Room Number:
121C

Description:
Maximize your learning while attending the DIA 2012 Annual Meeting! Receive $100 off of your DIA 2012 meeting registration by registering for two half day tutorials (#20-34) or one full day tutorial (#40-48). Purchases must be made at the same time in order to receive the discount.

There are 14 steps from research to development (R to D) and initiation of phase 3 clinical studies; the majority of time committed to drug development occurs during this period. A discussion of the 14 critical steps from R to D will include identifying ways to streamline the process and interactions with FDA. With each of the 14 steps used to develop the optimal strategic plan, discussion will address the resources and various approaches to tailoring the plan to a sponsor’s specific product under development and obtaining FDA concurrence with the strategic plan. A smooth progression through the preclinical process into early clinical programs will be presented in this half-day tutorial targeted to familiarize pivotal staff in start-up companies with the required terminology and functions, pharmaceutical/biological companies that have yet to file INDs, and those who want to improve their early development approach.

Learning Objective(s):
At the conclusion of this tutorial, participants should be able to:

• Identify ways to tailor the development, streamline the process, and interact with FDA

• Explain the specialties and resources needed to develop a product

• Design processes to guide your company smoothly through the progression of research and development



Target Audience:
This tutorial is designed for pivotal staff in start-up companies, pharmaceutical/biological companies that have yet to file INDs, and all personnel who want to broaden their knowledge of product development.

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