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ITFG/IPAC COLLABORATION: CONCLUDING REMARKS Presented by: Cynthia Flynn, PhD 26 April 2000 Rockville, MD. COMMITMENT OF THE ITFG/IPAC COLLABORATION.

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ITFG/IPACCOLLABORATION: CONCLUDING REMARKSPresented by: Cynthia Flynn, PhD26 April 2000Rockville, MD


COMMITMENTOF THE ITFG/IPACCOLLABORATION

  • More than 85 pharmaceutical scientists from more than 20 companies have been working diligently and constructively to address key concerns in draft CMC and BA/BE Guidance documents

  • ITFG/IPAC is committed to collecting and assessing all relevant data available to the Collaboration, and sharing the findings in a timely fashion with the OINDP Subcommittee and the Agency

  • ITFG/IPAC anticipates that this information will be useful to OINDP Subcommittee in its deliberations and the Agency in its preparation of final CMC and BA/BE Guidances that will benefit patients and the pharmaceutical industry


TIMEFRAME FOR TECHNICAL TEAM DELIVERABLES

  • BA/BE Team: technical paper on BA/BE issues will be completed by June 30, 2000

  • Specifications Team: initial assessment of actual DCU & PSD capabilities of OINDP based on a statistical evaluation of the gathered database by July 31, 2000

  • Test and Methods Team: technical paper on key MDI tests will be completed in next 3-4 months

  • Leachables/Extractables Team: technical reports will be written and recommendations made in next 3-4 months

  • Supplier Quality Control Team:act as a co-leader in developing a cGMP guideline for component manufacturers with the Agency


NEED FOR A SCIENCE-BASED INTERACTIVE DIALOGUE

  • The ITFG/IPAC Collaboration requests that the Agency:

    • continue the OINDP Subcommittee process in order to resolve concerns about key CMC and BA/BE issues through a science-based interactive dialogue


ACKNOWLEDGEMENTS

We express our gratitude to the Agency for holding this meeting and allowing us to present the work of the ITFG/IPAC Collaboration

We thank the members of the OINDP Subcommittee for considering our comments and proposals

We acknowledge the hard work, commitment and constructive collaboration of the numerous experts involved in the ITFG/IPAC Collaboration


Participants
PARTICIPANTS

Lex Adjei

V.P., Research

Kos Pharmaceuticals

Melton Affrime

V.P. Clinical Research

Schering-Plough

David Alexander

Glaxo Wellcome

Lisa Antonino

Inhale Therapeutics

James Blanchard

Staff Scientist

Aradigm

Allan Boksar

Sr. Manager

Quality Lab. Operations

Dura Pharmaceuticals

Lars Borgström

Scientific Adviser

AstraZeneca

Guillaume Brouet

Laboratory Manager

Valois of America

Scott Brown

Mgr., Pharmaceutical Dev.

Schering-Plough

Jean Cao

Statistician

Schering-Plough

Yung Sung Cheng

Lovelace Respiratory Institute

Eric Couture

Director, Regulatory Liaison

AstraZeneca

Jacqueline Crew

Aventis

Harris Cummings

Exec. Director

Aerosol Product Development

Magellan Laboratories

Kaushik Dave

Manager

Schering-Plough

Sarvajna Dwivedi

Dura Pharmaceuticals

Mark Eaves

Marketing Director

Presspart

Charles Eck

Dir., Inhalation

Technologies

Primedica

Bruce Ekholm

Biostatics Section Leader

3M Pharmaceuticals

Michael Eldon

Director, Regulatory Affairs

Inhale Therapeutics

James Elvecrog

Mgr. Analytical R&D

3M Pharmaceuticals

Elizabeth Erdos

Director, Quality Assurance

Aradigm

Mark Eskes

Associate Scientist

Agouron

Richard Evans

Sr. Director,

Pharmaceutical Dev.

Inspire Pharmaceuticals

Carole Evans

Section Head

Magellan Laboratories

Barbara Falco

Dir., Quality Assurance

Kos Pharmaceuticals

Stephen Farr

V.P., Pharmaceutical

Sciences

Aradigm

Joseph Ferrara

Director, Government Policy

Boehringer Ingleheim

Kevin C. Fitzgerald

Sr. Assistant Dir.,

Technical Regulatory

Affairs Department

Glaxo Wellcome


Participants1
PARTICIPANTS

Cynthia Flynn

Dir., Worldwide Drug Product

Pharmaceutical Quality

Analysis

Aventis

Igor Gonda

V.P., R&D

Aradigm

William Gore

Dir., Analytical Sciences

Boehringer Ingleheim

Bernard Greenspan

Dir., Aerosol Technology

Dura Pharmaceuticals

Kristi Griffiths

Senior Statistician

Eli Lilly

Gordon Hansen

Associate Dir.

Analytical Sciences

Boehringer Ingleheim

Lester I. Harrison

Sr. Research Specialist

3M Pharmaceuticals

Stephen Horhota

Research & Development

Boehringer Ingleheim

Paul Kovach

Sr. Research Scientist

Eli Lilly

Robert L. Kunka

Group Leader,

Clinical Pharmacology

Glaxo Wellcome

Susan Lanham

Regulatory Manager

Eli Lilly

Nicholas J. Licato

Sr. Manager, QC

Dura Pharmaceuticals

Alice Loper

V.P., Pharmaceutical

Development

Schering-Plough

Andrea McPhillips

Section Head,

Product Development

BI Roxane

Fiona Millar

Head, Product Development

IVAX

Jolyon Mitchell

Scientific Director

Trudell Medical

Matthew Moran

Sr. Regulatory Affairs

Specialist

Agouron

John Morgan

Director, Regulatory Affairs

Glaxo Wellcome

Thomas E. Needham

Applied Pharmaceutical

Sciences

University of Rhode Island

Steven Nichols

Aventis

Daniel Norwood

Sr. Principal Scientist

Boehringer Ingleheim

Jay Occulto

Dir., Regulatory Affairs

Pfeiffer of America

Bo Olsson

Scientific Adviser

AstraZeneca

Kevin Ostrander

Mgr., Formulation

Development

NanoSystems

Terry Pait

Manager, Quality Control

Glaxo Wellcome

Rajni Patel

Assoc. Dir., Pulm. Analy. Dev.

Boehringer Ingleheim

Björn Persson

Dir., Analytical

Development

AstraZeneca

Judith R. Plon

Director, Regulatory Affairs

Aventis


Participants2
PARTICIPANTS

Susan Tiano Sultzbaugh

Pharmaceutical R&D

Schering-Plough

Yosyong Surakitbanharn,

Research Scientist

Pharmaceutical

Development

Agouron

Terrence Tougas

Assoc. Dir, Analytical

Sciences

Boehringer Ingleheim

Keith Truman

Mgr., Dry Powder

Development Group

Glaxo Wellcome

Steven Viti

Assoc. Dir.,

Regulatory Affairs

IVAX

Ed Warner

Dir., Statistical Support

Schering-Plough

Tomas P. Weber

Sr. Manager,

Product Development

Dura Pharmaceuticals

Tony West

Aventis

Steve White

Technical Leader

Inhale Therapeutics

David Whitman

Inhalation

Analytical Scientist

3M Pharmaceuticals

Ronald Wolff

Sr. Research Scientist

Eli Lilly

Bruce Wyka

Dir., Physical &

Analytical Chemistry

Schering-Plough

Harold Yeager

Eli Lilly

Eric Plummer

Dir., Advance Sciences

Bespak

John N. Pritchard

Glaxo Wellcome

Ann Purrington

3M Pharmaceuticals

Nats Rajagopalan

Biopharm. Project Dev.

Eli Lilly

Michael T. Reibe

Dir., Inhalation

Product Development

Glaxo Wellcome

Shashank Rohatagi

Drug Metobolism/

Pharmacokinetics

Aventis

Darlene Rosario

Assoc. Dir.,

Regulatory Affairs

Dura Pharmaceuticals

Colin Rowlings

Agouron

Dennis Sandell

Principal Research Scientist

AstraZeneca

Julie Satterwhite

Res. Scientist

Eli Lilly

David Schultz

Research Specialist

3M Pharmaceuticals

Jeff Schuster

Dir., Aerosol

Technology Dev.

Aradigm

Christopher J. Sciarra

Vice President

Sciarra Laboratories

Joel Sequeira

Sr. Associate Director

Schering-Plough

Sam Shum

Analytical R&D

Kos Pharmaceuticals

Ann Smith

Operations CMC

Strategy Manager

AstraZeneca

Edmundo Stahl

Dir., Pulmonary Dpt.

IVAX


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