2nd FDA/PQRI Conference on Advancing Product Quality 5-7 October 2015 Attendee List Name Company Bertil Abrahamsson AstraZeneca Jenny Agila-Sefen Food & Drug Administration Mina Ahmadi Food & Drug Administration Behnam Alizadeh Food & Drug Administration Ilgaz Akseli Boehringer Ingelheim Allison Aldridge Food & Drug Administration Christina Alemu-Cruickshank Food & Drug Administration Barbara Allen Eli Lilly and Company Greg Amidon University of Michigan Celestina Arowosegbe Food & Drug Administration Ashraf Food & Drug Administration Upinder Atwal Food & Drug Administration Debbie Avant Food & Drug Administration Stefan Baier PepsiCo Denyse Baker Parenteral Drug Association (PDA) Jeffrey Baker Food & Drug Administration Patrick Ballmer Inna Ben-Anat Teva Pharmaceuticals Al Berchielli Pfizer Ecevit Bilgili New Jersey Institute of Technology Tara Gooen Bizjak Food & Drug Administration Ashley Boam Food & Drug Administration Gary Boerner McNeil Consumer Healthcare Division Nicholas Buhay CPIER of Peking University Cindy Buhse Food & Drug Administration Bryan Bulatao University of the Philippines Manila Gilbert Burckart Food & Drug Administration Kelley Burridge Food & Drug Administration Monica Cahilly Green Mountain Quality Assurance LLC Bing Cai Food & Drug Administration Yanxi Cain Novartis Doug Campbell InterPro QRA Jean Casauay University of the Philippines Manila, College of Pharmacy Dennis Casey PDR Pharma Consulting LLC Margaret Caulk Food & Drug Administration Sharmista Chatterjee Food & Drug Administration Mari Cheliah Food & Drug Administration Name Company Kang Chen Food & Drug Administration Mei-Ling Chen Food & Drug Administration Xiao Chen Food & Drug Administration Kejung Cheng Food & Drug Administration Nora Chew Gilead Sciences Inc. Joanne Chia Food & Drug Administration Dave Christopher Merck & Co., Inc. Pei-I Chu Food & Drug Administration Jon Clark U.S. Pharmacopeia (USP) Tanya Clayton Food & Drug Administration Stephen Conway Merck Tom Cosgrove Food & Drug Administration Bowman Cox The Gold Sheet Joyce Crich Food & Drug Administration Celia Cruz Food & Drug Administration Alberto Cuitino Rutgers University Junhao Dai CPIER of Peking University Megan Daly Johnson & Johnson Consumer Inc. McNeil Consumer Healthcare Division Karin Daniolowicz Johnson & Johnson Jennifer Del Valle Ortiz Food & Drug Administration Kushal Desai AbbVie Tony DeStefano PQRI Sheetal D'mello Food & Drug Administration Dave Doleski Food & Drug Administration Ke Dong CPIER of Peking University Angelica Dorantes Food & Drug Administration Karen D'Orazio Food & Drug Administration Jinhui Dou Food & Drug Administration Eric Dowdy Gilead Sciences Inc. Tom Dowling Celgene Jennifer Drake Merck & Co., Inc. James Drennen Duquesne University Abi D’Sa Food & Drug Administration Krupa Dubey Bristol-Myers Squibb Brett Duersch Merck & Co., Inc. Joanne Eglovitch The Gold Sheet Arwa Elhagrasy Food & Drug Administration Steve Falcone Amgen Christine Fallabela Food & Drug Administration 2 | Page Name Company Joseph Famulare Genentech, A member of the Roche Group Liam Feely AbbVie Adam Fisher Food & Drug Administration Kelly Forney-Stevens Food & Drug Administration Prof. Dr. Thomas Friedli University of St. Gallen Scott Furness Food & Drug Administration Dhaval Gaglani Food & Drug Administration Bob Gaines Food & Drug Administration Mamta Gautam-Basak Food & Drug Administration Zhengfe Ge Food & Drug Administration Mohamed Ghorab Food & Drug Administration Gerlie Gieser Food & Drug Administration Máiréad Goetz Novartis Fabiola Cervantes Gomez Food & Drug Administration Yanira Gonzalez-Berrios Food & Drug Administration Oriana Greene International Pharmaceutical Quality (IPQ) John Groskoph Pfizer Peter Guerrieri Food & Drug Administration Todd Halpern Pfizer Brian Hasselbalch Food & Drug Administration Henry Havel Havel BioPharma LLC/Nanomedicines Alliance Karen Hayes Johnson & Johnson Consumer Inc. Brooke Higgins Food & Drug Administration Steven Hoag University of Maryland Baltimore Frank Holcombe Food & Drug Administration Greg Huang Food & Drug Administration Glenn Hunt Genentech Inc. Ashok Illapakurthy Food & Drug Administration Bob Iser Food & Drug Administration Jennifer Ivey Evonik Orlando Jaquez Biogen Matthew John Food & Drug Administration Bruce D. Johnson Perrigo Company plc Rob Ju AbbVie Mamta Kapoor Food & Drug Administration Paula Katz Food & Drug Administration John Kauffman Food & Drug Administration David Keire Food & Drug Administration San Kiang Bristol-Myers Squibb Loice Kikwai Food & Drug Administration 3 | Page Name Company Chong-Ho Kim Food & Drug Administration Dory Koehler-King Bend Research, a division of Capsugel A.D. Kinghorn College of Pharmacy The Ohio State University LCDR Patric Klotzbuecher Food & Drug Administration Tim Kramer Eli Lilly and Company Kiran Krishnan Apotex Peter Krommenhoek Food & Drug Administration Emanuela Lacana Food & Drug Administration Melinda Lee Food & Drug Administration Sau Larry Lee Food & Drug Administration Su-Lin Lee Food & Drug Administration Rich Levy Parenteral Drug Association (PDA) Dawei Li CPIER of Peking University Jingning Li Novavax Yuexia Li Food & Drug Administration Yan Loo Food & Drug Administration Julie Lorenz Zoetis Rik Lostritto Food & Drug Administration Drew Love Food & Drug Administration Elise Luong Food & Drug Administration Lana Lyapustina PQRI Secretariat Rapti Madurawe Food & Drug Administration Jennifer Maguire Food & Drug Administration Frank Malinoski Liquidia Technologies Douglas Mans GlaxoSmithKline Ingrid Markovic Food & Drug Administration Lucas Marletta Fraile Roche Tania Mazza Food & Drug Administration Grace McNally Food & Drug Administration Mehul Mehta Food & Drug Administration Steve Mendivil Amgen Sarah Pope Miksinski Food & Drug Administration George Millili Genentech Tony Mire-Sluis Amgen Ganapathy Mohan Merck Carlos Monteagudo Amgen Vikas Moolchandani Amway, Inc. Christine Moore Food & Drug Administration Stephen Moore Food & Drug Administration Lee Nagao PQRI Secretariat 4 | Page Name Company Renuka Nair Food & Drug Administration Ajit Narang Bristol-Myers Squibb Co. Moheb Nasr GlaxoSmithKline Linda Nelson Daiichi Sankyo Inc. Kiet Nguyen Food & Drug Administration Roger Nosal Pfizer Mary Oates Pfizer Inc. E. Kwame Obeng Valeant Pharmaceuticals Thomas O'Connor Food & Drug Administration Geoffrey Okelo Food & Drug Administration Tim O'Leary International Pharmaceutical Quality (IPQ) Larry Ouderkirk Food & Drug Administration Horacio Pappa US Pharmacopeia Rebecca Parrilla Food & Drug Administration Don Parsons BIND Therapeutics Sachinkumar Patel Food & Drug Administration Rajib Paul Food & Drug Administration Bill Paulson International Pharmaceutical Quality (IPQ) Daniel Peng Food & Drug Administration Anna Pickering Perrigo Jim Polli University of Maryland John Punzi CHPA Yihong Qiu AbbVie Haibin Qu Zhejiang University G.K. Raju Light Pharma Mahesh Ramanadham Food & Drug Administration Giuseppe Randazzo Food & Drug Administration Bhagwant Rege Food & Drug Administration Barbara Rellahan Amgen Stephen Reta Hyland’s Susan Rosencrance Food & Drug Administration Mark Rosolowsky Bristol-Myers Squibb Hari Sachs Food & Drug Administration Mike Saleh Pfizer George Salem Food & Drug Administration Nashed Samaan Food & Drug Administration Tamra Sami FDAnews Jim Santilli Prestige Brands Vilayat Sayeed Food & Drug Administration John Schiel NIST 5 | Page Name Company Dave Schoneker Colorcon Inc. Paul Schwartz Food & Drug Administration Anna Schwendeman University of Michigan Arzu Selen Food & Drug Administration Paul Seo Food & Drug Administration Vinod Shah Pharmaceutical Consultant, PQRI Marjorie Shapiro Food & Drug Administration Bart Shrode Perrigo Company Ambarish Singh Bristol-Myers Squibb Janeen Skutnik Wilkinson BIOGEN Glen Smith Food & Drug Administration Harry Smith Food & Drug Administration Corinna Sonderegger Sandoz Ramesh Sood Food & Drug Administration David Sperry Eli Lilly and Company Olen Stephens Food & Drug Administration Selen Stromgren Food & Drug Administration Sandra Suarez Food & Drug Administration Zhigang Sun Food & Drug Administration Scott Suralik Bayer Healthcare Peg Szymczak Johnson & Johnson Simin Tabasi Food & Drug Administration Cassandra Taylor Food & Drug Administration Michael Thien Merck & Co., Inc. Hayden Thomas Vertex Karen Thompson Merck & Co., Inc. Michael (Geng) Tian Food & Drug Administration Tony Tong Teva Michael Trehy Food & Drug Administration Sonia Trivic Johnson & Johnson Consumer Inc. Bernhardt Trout Massachusetts Institute of Technology Yu Chung Tsang Apotex Inc. Steve Tyler AbbVie Katherine Tyner Food & Drug Administration David Tyree Perrigo Esther Urkin Perrigo Siva Vaithiyalingam Teva Martin VanTrieste Amgen Ubrani Venkataram Food & Drug Administration Alex Viehmman Food & Drug Administration 6 | Page Name Company Justin Vitale Gilead Sciences, Inc. Fionnuala Walsh Eli Lilly and Company Ke Wang Pfizer Inc Keith Webber Perrigo Paul Weninger Perrigo Russell Wesdyk Food & Drug Administration Bryan Winship Mylan Marc Wolfgang Cerulean Pharma Janet Woodcock Food & Drug Administration Bing Wu Food & Drug Administration Fang Wu Food & Drug Administration Geoffrey Wu Food & Drug Administration Huiquan Wu Food & Drug Administration Larisa Wu Food & Drug Administration Wini Wu Strategic Regulatory Partners LLC Xiaoming Xu Food & Drug Administration Naiqi Ya Food & Drug Administration Xiaochuan (Ben) Yang Food & Drug Administration Yueshing Ye Food & Drug Administration Krishnaiah Yellela Food & Drug Administration Lawrence Yu Food & Drug Administration Louis Yu Perrigo Company plc Zach Yvaire International Pharmaceutical Quality (IPQ) Diane Zezza Novartis Zheng Zhao CPIER of Peking University Qiang Zheng CPIER of Peking University Li Zhi Novavax Deliang Zhou AbbVie Andy Zych Food & Drug Administration 7 | Page .