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

ITFG/IPAC Collaboration Conclusion 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

ITFG/IPAC Collaboration Conclusion 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

ITFG/IPAC Collaboration Conclusion 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

ITFG/IPAC Collaboration Conclusion 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

ITFG/IPAC Collaboration Conclusion 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

ITFG/IPAC Collaboration Conclusion 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

ITFG/IPAC Collaboration Conclusion 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