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Moderator: Valerie Whelan – Amgen Inc.
Moderator: Valerie Whelan – Amgen Inc.
Moderator: Valerie Whelan – Amgen Inc.
Presenter: Sabrina Restrepo, PhD – Merck & Co., Inc.
Presenter: Sabrina Restrepo, PhD – Merck & Co., Inc.
Presenter: Cristiana Campa, PhD – GlaxoSmithKline
Presenter: Cristiana Campa, PhD – GlaxoSmithKline
Moderator: Valerie Whelan – Amgen Inc.
Panelist: Cristiana Campa, PhD – GlaxoSmithKline
Panelist: Amin Khan, PhD – GreenLight Biosciences, Inc.
Panelist: Sabrina Restrepo, PhD – Merck & Co., Inc.
Moderator: Valerie Whelan – Amgen Inc.
@@@ Cristiana Campa, PhD – GlaxoSmithKline ### 1052496###Panelist###Technical R&D Advisor and Fellow###GlaxoSmithKline###Panelist: Cristiana Campa, PhD – GlaxoSmithKline
@@@ Amin Khan, PhD – GreenLight Biosciences, Inc. ### 1384517###Panelist###Chief Science Officer, Human Health###GreenLight Biosciences, Inc.###Panelist: Amin Khan, PhD – GreenLight Biosciences, Inc.
@@@ Sabrina Restrepo, PhD – Merck & Co., Inc. ### 684296###Panelist###Director, Global Vaccines Technical Operations###Merck & Co., Inc.###Panelist: Sabrina Restrepo, PhD – Merck & Co., Inc.
Moderator: Rebecca E. Dombrowski, MS – U.S. FDA
Moderator: Rebecca E. Dombrowski, MS – U.S. FDA
Moderator: Rebecca E. Dombrowski, MS – U.S. FDA
Regulatory Presenter: Weida Tong, PhD – U.S. FDA
Regulatory Presenter: Weida Tong, PhD – U.S. FDA
Moderator: Rebecca E. Dombrowski, MS – U.S. FDA
Regulatory Panelist: Weida Tong, PhD – U.S. FDA
Moderator: Rebecca E. Dombrowski, MS – U.S. FDA
@@@ Weida Tong, PhD – U.S. FDA ### 1394667###Regulatory Panelist###Director, Division of Bioinformatics and Biostatistics, NCTR###U.S. FDA###Regulatory Panelist: Weida Tong, PhD – U.S. FDA
Moderator: Mai X. Huynh, MS – U.S. FDA
Moderator: Mai X. Huynh, MS – U.S. FDA
Moderator: Mai X. Huynh, MS – U.S. FDA
Regulatory Presenter: Patricia F. Hughes, PhD – U.S. FDA
Regulatory Presenter: Patricia F. Hughes, PhD – U.S. FDA
Presenter: Tiffany A. Baker, MBA – ValSource Inc.
Presenter: Tiffany A. Baker, MBA – ValSource Inc.
Moderator: Mai X. Huynh, MS – U.S. FDA
Panelist: Tiffany A. Baker, MBA – ValSource Inc.
Regulatory Panelist: Renée S. Blosser, MS – U.S. FDA
Regulatory Panelist: Patricia F. Hughes, PhD – U.S. FDA
Moderator: Mai X. Huynh, MS – U.S. FDA
@@@ Tiffany A. Baker, MBA – ValSource Inc. ### 1220639###Panelist###Consultant###ValSource Inc.###Panelist: Tiffany A. Baker, MBA – ValSource Inc.
@@@ Renée S. Blosser, MS – U.S. FDA ### 700082###Regulatory Panelist###Microbiologist, CVM###U.S. FDA###Regulatory Panelist: Renée S. Blosser, MS – U.S. FDA
@@@ Patricia F. Hughes, PhD – U.S. FDA ### 794273###Regulatory Panelist###Senior Scientific Advisor, CDER###U.S. FDA###Regulatory Panelist: Patricia F. Hughes, PhD – U.S. FDA
Moderator: Susan J. Schniepp – Regulatory Compliance Associates Inc.
Moderator: Susan J. Schniepp – Regulatory Compliance Associates Inc.
Moderator: Susan J. Schniepp – Regulatory Compliance Associates Inc.
###Regulatory Presenter: Peter W. Marks, MD, PhD – U.S. FDA
Regulatory Presenter: Peter W. Marks, MD, PhD – U.S. FDA
###Regulatory Presenter: Douglas R. Throckmorton, MD – U.S. FDA
Regulatory Presenter: Douglas R. Throckmorton, MD – U.S. FDA
###Regulatory Presenter: Steven M. Solomon, DVM, MPH – U.S. FDA
Regulatory Presenter: Steven M. Solomon, DVM, MPH – U.S. FDA
###Regulatory Presenter: Judith A. McMeekin, PharmD – U.S. FDA
Regulatory Presenter: Judith A. McMeekin, PharmD – U.S. FDA
###Moderator: Susan J. Schniepp – Regulatory Compliance Associates Inc.
Regulatory Panelist: Matthew A. Lucia, DVM – U.S. FDA
Regulatory Panelist: Peter W. Marks, MD, PhD – U.S. FDA
Regulatory Panelist: Judith A. McMeekin, PharmD – U.S. FDA
Regulatory Panelist: Douglas R. Throckmorton, MD – U.S. FDA
Moderator: Susan J. Schniepp – Regulatory Compliance Associates Inc.
### @@@ Matthew A. Lucia, DVM – U.S. FDA ### 1396815###Regulatory Panelist###Director, Office of New Animal Drug Evaluation, CVM###U.S. FDA###Regulatory Panelist: Matthew A. Lucia, DVM – U.S. FDA
### @@@ Peter W. Marks, MD, PhD – U.S. FDA ### 790281###Regulatory Panelist###Director, CBER###U.S. FDA###Regulatory Panelist: Peter W. Marks, MD, PhD – U.S. FDA
### @@@ Judith A. McMeekin, PharmD – U.S. FDA ### 1396816###Regulatory Panelist###Associate Commissioner for Regulatory Affairs, ORA###U.S. FDA###Regulatory Panelist: Judith A. McMeekin, PharmD – U.S. FDA
### @@@ Douglas R. Throckmorton, MD – U.S. FDA ### 790410###Regulatory Panelist###Deputy Director of Regulatory Programs, CDER###U.S. FDA###Regulatory Panelist: Douglas R. Throckmorton, MD – U.S. FDA
###Moderator: CDR Tara Gooen Bizjak, MBS – U.S. FDA
QUALITY ASSURANCE & QMS
Moderator: CDR Tara Gooen Bizjak, MBS – U.S. FDA
QUALITY ASSURANCE & QMS
Moderator: CDR Tara Gooen Bizjak, MBS – U.S. FDA
Presenter: Conor C. Collins, PhD, MBA, MSc – GlaxoSmithKline
Presenter: Conor C. Collins, PhD, MBA, MSc – GlaxoSmithKline
Regulatory Presenter: Milind Ganjawala, MS, MBA – U.S. FDA
Regulatory Presenter: Milind Ganjawala, MS, MBA – U.S. FDA
Moderator: CDR Tara Gooen Bizjak, MBS – U.S. FDA
Panelist: Conor C. Collins, PhD, MBA, MSc – GlaxoSmithKline
Regulatory Panelist: Milind Ganjawala, MS, MBA – U.S. FDA
Regulatory Panelist: Jeffrey D. Meng, MSE – U.S. FDA
Moderator: CDR Tara Gooen Bizjak, MBS – U.S. FDA
@@@ Conor C. Collins, PhD, MBA, MSc – GlaxoSmithKline ### 1405857###Panelist###Head of Validation/PLM for Pharma Supply Technical###GlaxoSmithKline###Panelist: Conor C. Collins, PhD, MBA, MSc – GlaxoSmithKline
@@@ Milind Ganjawala, MS, MBA – U.S. FDA ### 1405858###Regulatory Panelist###Division Director, CDER###U.S. FDA###Regulatory Panelist: Milind Ganjawala, MS, MBA – U.S. FDA
@@@ Jeffrey D. Meng, MSE – U.S. FDA ### 1072390###Regulatory Panelist###Director, Investigations Branch, OPQO, ORA###U.S. FDA###Regulatory Panelist: Jeffrey D. Meng, MSE – U.S. FDA
Moderator: Clarice H. Hutchens, PhD, MA, DM – Pfizer
SUPPLY CHAIN & MANUFACTURING CHALLENGES
Moderator: Clarice H. Hutchens, PhD, MA, DM – Pfizer
SUPPLY CHAIN & MANUFACTURING CHALLENGES
Moderator: Clarice H. Hutchens, PhD, MA, DM – Pfizer
Presenter: Kevin J. O'Donnell, PhD – Health Products Regulatory Authority
Presenter: Kevin J. O'Donnell, PhD – Health Products Regulatory Authority
Presenter: Frank Montgomery, PhD – AstraZeneca
Presenter: Frank Montgomery, PhD – AstraZeneca
Moderator: Clarice H. Hutchens, PhD, MA, DM – Pfizer
Panelist: Frank Montgomery, PhD – AstraZeneca
Regulatory Panelist: Kevin J. O'Donnell, PhD – Health Products Regulatory Authority
Regulatory Panelist: Mahesh R. Ramanadham, PharmD, MBA – U.S. FDA
Moderator: Clarice H. Hutchens, PhD, MA, DM – Pfizer
@@@ Frank Montgomery, PhD – AstraZeneca ### 1396991###Panelist###Global Head, Regulatory CMC###AstraZeneca###Panelist: Frank Montgomery, PhD – AstraZeneca
@@@ Kevin J. O'Donnell, PhD – Health Products Regulatory Authority ### 1397000###Regulatory Panelist###Market Compliance Manager###Health Products Regulatory Authority###Regulatory Panelist: Kevin J. O'Donnell, PhD – Health Products Regulatory Authority
@@@ Mahesh R. Ramanadham, PharmD, MBA – U.S. FDA ### 1077354###Regulatory Panelist###Associate Director Scientific Operations, CDER###U.S. FDA###Regulatory Panelist: Mahesh R. Ramanadham, PharmD, MBA – U.S. FDA
Moderator: Mike G. Labruto, MS – University of Pennsylvania/Gene Therapy Program
EMERGING TRENDS & INNOVATION
Moderator: Mike G. Labruto, MS – University of Pennsylvania/Gene Therapy Program
EMERGING TRENDS & INNOVATION
Moderator: Mike G. Labruto, MS – University of Pennsylvania/Gene Therapy Program
Presenter: Jeff J. Bedford – GlaxoSmithKline
Presenter: Jeff J. Bedford – GlaxoSmithKline
Presenter: Ravi Yalamanchili, MS, MBA – Merck & Co., Inc.
Presenter: Ravi Yalamanchili, MS, MBA – Merck & Co., Inc.
Moderator: Mike G. Labruto, MS – University of Pennsylvania/Gene Therapy Program
Panelist: Jeff J. Bedford – GlaxoSmithKline
Panelist: Ravi Yalamanchili, MS, MBA – Merck & Co., Inc.
Moderator: Mike G. Labruto, MS – University of Pennsylvania/Gene Therapy Program
@@@ Jeff J. Bedford – GlaxoSmithKline ### 1384515###Panelist###Director, R&D Quality Futures###GlaxoSmithKline###Panelist: Jeff J. Bedford – GlaxoSmithKline
@@@ Ravi Yalamanchili, MS, MBA – Merck & Co., Inc. ### 1384518###Panelist###Executive Director Global Quality###Merck & Co., Inc.###Panelist: Ravi Yalamanchili, MS, MBA – Merck & Co., Inc.
EMERGING TRENDS & INNOVATION
QUALITY ASSURANCE & QMS
SUPPLY CHAIN & MANUFACTURING CHALLENGES
Moderator: Patricia F. Hughes, PhD – U.S. FDA
QUALITY ASSURANCE & QMS
Moderator: Patricia F. Hughes, PhD – U.S. FDA
QUALITY ASSURANCE & QMS
Moderator: Patricia F. Hughes, PhD – U.S. FDA
Presenter: Susan J. Schniepp – Regulatory Compliance Associates Inc.
Presenter: Susan J. Schniepp – Regulatory Compliance Associates Inc.
Presenter: Maik W. Jornitz, MSEng – G-CON Manufacturing, Inc.
Presenter: Maik W. Jornitz, MSEng – G-CON Manufacturing, Inc.
Moderator: Patricia F. Hughes, PhD – U.S. FDA
Panelist: Maik W. Jornitz, MSEng – G-CON Manufacturing, Inc.
Panelist: Susan J. Schniepp – Regulatory Compliance Associates Inc.
Regulatory Panelist: Rick L. Friedman, MS – U.S. FDA
Moderator: Patricia F. Hughes, PhD – U.S. FDA
@@@ Maik W. Jornitz, MSEng – G-CON Manufacturing, Inc. ### 684264###Panelist###CEO###G-CON Manufacturing, Inc.###Panelist: Maik W. Jornitz, MSEng – G-CON Manufacturing, Inc.
@@@ Susan J. Schniepp – Regulatory Compliance Associates Inc. ### 802446###Panelist###Distinguished Fellow###Regulatory Compliance Associates Inc.###Panelist: Susan J. Schniepp – Regulatory Compliance Associates Inc.
@@@ Rick L. Friedman, MS – U.S. FDA ### 760525###Regulatory Panelist###Deputy Director, OMQ, CDER###U.S. FDA###Regulatory Panelist: Rick L. Friedman, MS – U.S. FDA
Moderator: Douglas A. Campbell – InterPro QRA
SUPPLY CHAIN & MANUFACTURING CHALLENGES
Moderator: Douglas A. Campbell – InterPro QRA
SUPPLY CHAIN & MANUFACTURING CHALLENGES
Moderator: Douglas A. Campbell – InterPro QRA
Presenter: Biswarup Dasgupta, MS – NA
Presenter: Biswarup Dasgupta, MS – NA
Regulatory Presenter: Brooke K. Higgins, MS – U.S. FDA
Regulatory Presenter: Brooke K. Higgins, MS – U.S. FDA
Regulatory Presenter: Simone E. Pitts, MS – U.S. FDA
Regulatory Presenter: Simone E. Pitts, MS – U.S. FDA
Moderator: Douglas A. Campbell – InterPro QRA
Panelist: Biswarup Dasgupta, MS – NA
Panelist: Glenn E. Wright, MA – PDA
Regulatory Panelist: Brooke K. Higgins, MS – U.S. FDA
Regulatory Panelist: Simone E. Pitts, MS – U.S. FDA
Moderator: Douglas A. Campbell – InterPro QRA
@@@ Biswarup Dasgupta, MS – NA ### 1384516###Panelist###Quality Professional###NA###Panelist: Biswarup Dasgupta, MS – NA
@@@ Glenn E. Wright, MA – PDA ### 824082###Panelist###Vice President, Scientific and Regulatory Affairs###PDA###Panelist: Glenn E. Wright, MA – PDA
@@@ Brooke K. Higgins, MS – U.S. FDA ### 760558###Regulatory Panelist###Senior Policy Advisor, CDER###U.S. FDA###Regulatory Panelist: Brooke K. Higgins, MS – U.S. FDA
@@@ Simone E. Pitts, MS – U.S. FDA ### 1082542###Regulatory Panelist###National Expert, Pharmaceutical, ORA###U.S. FDA###Regulatory Panelist: Simone E. Pitts, MS – U.S. FDA
Moderator: Sharyl D. Hartsock – Eli Lilly and Company
EMERGING TRENDS & INNOVATION
Moderator: Sharyl D. Hartsock – Eli Lilly and Company
EMERGING TRENDS & INNOVATION
Moderator: Sharyl D. Hartsock – Eli Lilly and Company
Presenter: Travis A. Frick, MSc – Istari Oncology
Co-Presenter: Kir F. Henrici – The Henrici Group
Presenter: Travis A. Frick, MSc – Istari Oncology
@@@ Kir F. Henrici – The Henrici Group ### 684719###Co-Presenter###CEO###The Henrici Group###Co-Presenter: Kir F. Henrici – The Henrici Group
Presenter: Bethany B. Rexing, MS – Eli Lilly and Company
Presenter: Bethany B. Rexing, MS – Eli Lilly and Company
Moderator: Sharyl D. Hartsock – Eli Lilly and Company
Panelist: Travis A. Frick, MSc – Istari Oncology
Panelist: Kir F. Henrici – The Henrici Group
Panelist: Bethany B. Rexing, MS – Eli Lilly and Company
Regulatory Panelist: Atul J. Agrawal, MS – U.S. FDA
Moderator: Sharyl D. Hartsock – Eli Lilly and Company
@@@ Travis A. Frick, MSc – Istari Oncology ### 1000375###Panelist###Senior Director, Manufacturing Operations###Istari Oncology###Panelist: Travis A. Frick, MSc – Istari Oncology
@@@ Kir F. Henrici – The Henrici Group ### 684719###Panelist###CEO###The Henrici Group###Panelist: Kir F. Henrici – The Henrici Group
@@@ Bethany B. Rexing, MS – Eli Lilly and Company ### 1401583###Panelist###M&Q Data Management Director###Eli Lilly and Company###Panelist: Bethany B. Rexing, MS – Eli Lilly and Company
@@@ Atul J. Agrawal, MS – U.S. FDA ### 1417494###Regulatory Panelist###Supervisory Consumer Safety Officer, ORA###U.S. FDA###Regulatory Panelist: Atul J. Agrawal, MS – U.S. FDA
Moderator: Mary E. Farbman, PhD – Merck & Co., Inc.
Moderator: Mary E. Farbman, PhD – Merck & Co., Inc.
Moderator: Mary E. Farbman, PhD – Merck & Co., Inc.
###Presenter: Peter J. Hotez, MD, PhD – Baylor College of Medicine
Presenter: Peter J. Hotez, MD, PhD – Baylor College of Medicine
###Regulatory Presenter: Peter W. Marks, MD, PhD – U.S. FDA
Regulatory Presenter: Peter W. Marks, MD, PhD – U.S. FDA
###Moderator: Mary E. Farbman, PhD – Merck & Co., Inc.
Panelist: Peter J. Hotez, MD, PhD – Baylor College of Medicine
Regulatory Panelist: Peter W. Marks, MD, PhD – U.S. FDA
Moderator: Mary E. Farbman, PhD – Merck & Co., Inc.
### @@@ Peter J. Hotez, MD, PhD – Baylor College of Medicine ### 1397745###Panelist###Dean National School of Tropical Medicine###Baylor College of Medicine###Panelist: Peter J. Hotez, MD, PhD – Baylor College of Medicine
### @@@ Peter W. Marks, MD, PhD – U.S. FDA ### 790281###Regulatory Panelist###Director, CBER###U.S. FDA###Regulatory Panelist: Peter W. Marks, MD, PhD – U.S. FDA
###Co-Chair: Francis RW Godwin, MBA – U.S. FDA
Co-Chair: Valerie Whelan – Thermo Fisher Scientific
Co-Chair: Francis RW Godwin, MBA – U.S. FDA
### @@@ Valerie Whelan – Thermo Fisher Scientific ### 760527###Co-Chair###Vice President, Quality###Thermo Fisher Scientific###Co-Chair: Valerie Whelan – Thermo Fisher Scientific
###