Product Quality for Patient Benefit

Registration

Your registration options are as follows:

	Register Online. Instructions: Please choose the appropriate rate, registrations will be verified for accuracy and if incorrect you will be required to pay the full, late Pharma/CRO registration fee of ($1,250). Industrial and CRO representatives - $1,250 ($1,050 prior to June 2) FDA and non-profit representatives - $950 ($750 prior to June 2)
	Download the registration form, complete & mail to: August Pharmaceutical Analysis Conference Extension Services in Pharmacy 777 Highland Avenue Madison, WI 53705
	By phone at 608.262.3130 or toll-free at 877-947-4255 using a credit card for payment.
	Download the registration form, complete & fax to 608.262.2431 using a credit card for payment.

General Conference Information

Background: With rapid advances in implementation of the Quality by Design (QbD) paradigm, new approaches and considerations for in vitro methods of drug release and their specifications are emerging. In vitro methods have great potential to be predictive of in vivo drug performance especially when used in conjunction with other biopharmaceutical tools, such as pharmacokinetic simulation and statistical modeling. Current predictive methodology while has proven to be valuable has not consistently shown to be clinically relevant. New technologies coupled with our evolving understanding of product development and clinical assessments hold promise of advancing the development of in vitro and in vivo relationships (IVIVRs-including IVIVCs) needed to set specifications that are clinically meaningful.

Goals: This conference is intended to build on ongoing efforts to harness the potential of applied biopharmaceutics and QbD for drug development and manufacturing, as well as regulatory decision-making for patient/consumer benefit. Quality attributes such as product drug release/dissolution characteristics will be considered in a clinical context encompassing risk assessment related to product efficacy, safety and quality. Clinically relevant drug release/dissolution testing, and/or other relevant methodologies that can serve as reliable and robust biopharmaceutics tools, should streamline the development, manufacture and lifecycle management of high quality drug product. The conference will have practical and forward focus such that current information and novel methodology/approaches will be discussed and encouraged. Current tools will be evaluated to determine how they can be used as is or modified to obtain meaningful IVIVRs that support the specification setting process within the QbD paradigm. In addition to current approaches, novel in vitro, in vivo, in silico and statistical models will be explored and their potential to assist the development of meaningful IVIVRs will be discussed. The conference aims to facilitate continuation of dialogue on advancing novel approaches in setting clinically meaningful in vitro drug dissolution/release specification consistent with QbD expectations.

Conference objectives include:

To assess where we are with dissolution/drug release methods utilized during various stages of drug development (including candidate selection and ultimately, specification setting) and illustrate the value of applied biopharmaceutics and QbD principles for streamlining drug development from early development to commercial scale manufacturing and lifecycle management.
To identify approaches for transitioning to new tools consistent with the QbD paradigm, integrating biopharmaceutics to meet current and future needs
To develop ideas/vision leading to "common ground" (a road map) for predictive, clinically meaningful in vitro methods for dissolution/release specification setting.

Format: The program will consist of plenary sessions and breakout sessions. The breakout sessions will identify fundamental goals and critical steps needed for a road map that brings together biopharmaceutics tools and clinically relevant specification setting under the QbD paradigm. Attendees, who wish to have extended discussion on areas of interest, are encouraged to provide questions for the breakout sessions. The proposed questions for the breakout sessions may be included with the registration form or sent in separately up to one month prior to the workshop. Attendees are also encouraged to actively participate in discussions and breakout sessions and share their ideas on how they envision biopharmaceutic tools (in vitro/in vivo drug release, modeling, risk assessment and statistics) can be used for setting clinically meaningful in vitro drug dissolution/release specification. The recommendations from the meeting, including identified research areas, will be summarized in a white paper. The white paper is expected to generate further input from our rapidly evolving scientific, technical and regulatory global community and it will also serve as a guide for the subsequent efforts.

Who should attend: Scientists from industry, academia and regulatory agencies (including Europe and Japan) involved with pharmaceutical development, such as in the areas of CMC, biopharmaceutics, biostatistics, quality risk management and regulatory.

Conference Travel Information

Location & Travel

The Hilton is convenient located in Rockville, Maryland. The hotel is immediately across the street from the Washington Metro Red Line subway station (Twin Brook). The Metro comes directly form Washington Reagan Airport (Yellow Line to Galleria to Red Line). From Washington Dulles Airport there is a convenient bus service to the Metro (Orange Line to Metro Center to Red Line).

Conference Fees

Instructions: Please choose the appropriate rate, registrations will be verification for accuracy and if incorrect you will be required to pay the full, late Pharma/CRO registration fee of ($1,250).

Industrial and CRO representatives	$1,250 ($1,050 prior to June 2)
FDA and non-profit representatives	$950 ($750 prior to June 2)

Conference Planning Committee

Maria T. Cruanes, Ph.D., Merck & Co., Inc., Whitehouse Station, NJ
James E. De Muth, Ph.D., University of Wisconsin, Madison, WI
Jennifer B. Dressman, Ph.D., J.W. Goethe University, Frankfurt, Germany
Anette Müllertz, Ph.D., University of Copenhagen, Copenhagen, Denmark
Moheb Nasr, Ph.D., Food and Drug Administration, Silver Spring, MD
Arzu Selen, PhD., Food and Drug Administration, Silver Spring, MD

For More Information

James E De Muth
Extension Services in Pharmacy
777 Highland Avenue
Madison, WI 53705
(608) 262-3130
FAX (608) 262-2431
Send Email

2009 Program Outline

Wednesday, June 10, 2009

8:00AM

Welcome and Introduction to the Conference/workshop Program

Christine M. V. Moore, Ph.D.
Acting Office Deputy Director, Office of New Drug Quality Assessment
Center for Drug Evaluation and Research
Food and Drug Administration, Silver Spring, MD

James E. De Muth, Ph.D.
Professor, School of Pharmacy
University of Wisconsin, Madison, WI