# Presentation: 251769

## ITFG/IPAC COLLABORATION: CONCLUDING REMARKSPresented by: Cynthia Flynn, PhD26 April 2000Rockville, MD

## COMMITMENT OF THE ITFG/IPAC COLLABORATION

- COMMITMENT** **OF THE ITFG/IPAC** **COLLABORATION

- 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

**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 

- 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

- 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

## 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

## PARTICIPANTS

- 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

- 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