# Presentation: 213819

## Welcome to theFDA/DIA Scientific Workshop on Follow-on Protein Pharmaceuticals 

- February 14 – 16, 2005
- Arlington, Virginia

## PLANNING COMMITTEE

**Co-chairs:**
- Chi-wan Chen, Ph.D. – CDER/ONDC
- Chris Joneckis, Ph.D. – CBER/OD
- Keith Webber, Ph.D. – CDER/OBP

- Theresa Gerrard, Ph.D. – TLG Consulting, Inc.
- Gordon Johnston, R.Ph., M.S., GPhA
- Anthony S. Lubiniecki, Sc.D., Centocor
- Gene Murano, Ph.D., Genentech, Inc.
- Sara Radcliffe, MPH, BIO
- Marie A. Vodicka, Ph.D., PhRMA

**Members:**
- Janice Brown, M.S. – CDER/ONDC
- Barry Cherney, Ph.D. – CDER/OBP
- Kathleen Clouse, Ph.D. – CDER/OBP
- Blair Fraser, Ph.D. – CDER/ONDC
- Dena Hixon, M.D. – CDER/OGD

- Frank Holcombe, Ph.D. – CDER/OGD
- Steven Kozlowski, M.D. – CDER/OBP
- Stephen Moore, Ph.D. – CDER/ONDC
- Amy Rosenberg, M.D. – CDER/OBP
- Marilyn Welschenbach, Ph.D. – CDER/OPS

- DIA
- Jessica Kusma
- Jill McNair

## PLENARY & BREAKOUT SESSION SPEAKERS & ORGANIZERS

- Andrea Weir, PhD
- Hong Zhao, PhD
- Dave Parkinson, MD
- William Schwieterman, MD
- Huub Schellekens
- Jay P. Siegel, MD
- Carole Ben-Maimon, MD
- Alexandra Worobec, MD
- Jay Lozier, MD, PhD
- Kathryn Stein, PhD
- Wendy Shores, Ph.D.
- David Orloff, MD
- Marc Walton, MD
- Dorothy Scott, MD
- Dawn Viveash
- Ajaz Hussain, PhD

- Blair Fraser, PhD
- William Hancock, PhD
- Ram Sasisekharan, PhD
- Joerg Windisch, PhD
- Hae-Young Ahn, PhD
- Raja B. Velagapudi, PhD
- Mark Rogge, PhD
- Andrew Chang, PhD
- Charles Diliberti, PhD
- Reed Harris, PhD
- Robin Thorpe, PhD
- Inger Mollerup, PhD
- Jeri El-Hage, PhD
- Mercedes Serabian, MS
- Joy Cavagnaro, PhD
- James D. Green, PhD, DABT

## SCIENTIFIC WORKSHOPS

- SEPTEMBER 14 – 15, 2004
- 	FDA PUBLIC WORKSHOP: SCIENTIFIC CONSIDERATIONS RELATED TO DEVELOPING FOLLOW-ON PROTEIN PRODUCTS
- FEBRUARY 14 – 16, 2005
- 	FDA/DIA SCIENTIFIC WORKSHOP ON FOLLOW-ON PROTEIN PHARMACEUTICALS

## SEPTEMBER SUMMARY

- PRESENTATIONS FROM 23 “INTERESTED PARTIES”
- COMMENTS AND RECOMMENDATIONS ON:
- TERMINOLOGY
- PRODUCT COMPLEXITY
- ANALYTICAL METHODS
- CLINICAL TRIAL DESIGN
- IMMUNOGENICITY
- TRANSCRIPTS ARE AVAILABLE FROM THE FDA DOCKET # 2004N-0355

## FORMAT FOR THIS MEETING

- MORNING PLENARY SESSIONS
- FOCUSED BREAKOUT SESSIONS IN THE AFTERNOON
- SUMMARY PRESENTATIONS OF THE BREAKOUT SESSIONS

## PLENARY SESSIONS

- INVITED SPEAKERS
- SERVES AS BACKGROUND FOR BREAKOUT SESSION DISCUSSIONS
- ADDRESS PROTEIN PRODUCTS OF LOW, MODERATE, & HIGH COMPLEXITY
- PLEASE RESERVE QUESTIONS & DISCUSSION FOR THE BREAKOUTS

## BREAKOUT SESSIONS

- EACH TOPIC WILL BE REPEATED TWICE
- FDA LEAD & TWO INDUSTRY MODERATORS
- MODERATORS WILL SOLICIT DISCUSSION FROM THE AUDIENCE VIA FOCUS QUESTIONS

## BREAKOUT SESSIONS

- SPEAK FROM THE MICROPHONES
- PLEASE KEEP COMMENTS CONCISE (_<_ 2 MINUTES) AND RELEVANT TO THE TOPIC UNDER DISCUSSION
- IF POSSIBLE, HAVE A BUSINESS CARD AVAILABLE TO AID THE TRANSCRIBER

## TODAY’S AGENDA

- KEYNOTE SPEAKER – CHARLES COONEY, PH.D.
- BACKGROUND – STEVEN KOZLOWSKI, M.D.
- TWO PLENARY SESSIONS
- PHYSICAL, CHEMICAL, & BIOLOGICAL CHARACTERIZATION
- PHARMACOKINETICS & PHARMACODYNAMICS STUDIES
- FOUR CONCURRENT BREAKOUT SESSIONS
- PHYSICAL-CHEMICAL CHARACTERIZATION
- BIOLOGICAL CHARACTERIZATION
- PRE-CLINICAL PHARMACOLOGY-TOXICOLOGY STUDIES
- CLINICAL PHARMACOLOGY STUDIES

## TUESDAY’S AGENDA

- BREAKOUT SESSION SUMMARIES:
- CHEMICAL, BIOLOGICAL, & PRE-CLINICAL PHARM-TOX SESSIONS
- TWO PLENARY SESSIONS
- IMMUNOGENICITY STUDIES
- CLINICAL SAFETY & EFFICACY STUDIES
- TWO CONCURRENT BREAKOUT SESSIONS
- IMMUNOGENICITY STUDIES
- CLINICAL SAFETY & EFFICACY STUDIES

## WEDNESDAY’S AGENDA

- BREAKOUT SESSION SUMMARIES:
- CLINICAL PHARMACOLOGY
- IMMUNOGENICITY STUDIES
- CLINICAL SAFETY & EFFICACY STUDIES
- INDUSTRY SUMMARIES
- SUMMATION
- CLOSING REMARKS & NEXT STEPS

## ADDITIONAL INFORMATION

- ADDITIONAL INFORMATION OR DATA THAT YOU WISH TO INCLUDE IN THE RECORD CAN BE SUBMITTED TO DOCKET # 2004N-0355
- TRANSCRIPTS OF THE MEETING WILL BE AVAILABLE SOON AFTERWARD