Thomas Abrams, Director, Office of Prescription Drug Promotion, CDER, FDA
Rosemary Addy, Supervisory Consumer Safety Officer, Office of New Drugs, CDER, FDA
Celine Adessi, Senior Clinical Safety Scientist, F. Hoffmann - La Roche
Akhil Agrawal, Associate Director, Merck Research Laboratories
Sunita Ahir, Regulatory Affairs Manager, D-Target SA, A Premier Research Company
Julie Aker, President & CEO, Concentrics Research LLC
Jeff Allen, Executive Director, Friends of Cancer Research
Mitzi Allred, Assistant Director, R&D Technical Information, Mgmt Clinical Sciences, Sanofi
Igor Altman, Product Manager, Medidata Solutions Worldwide
David Amato, Vice President, Biometrics and Data Management, Vertex Pharmaceuticals
Sharon Ames, Director, Enterprise Program, NextDocs Corporation
Sarah Arbe-Barnes, Senior Vice President, Translational Sciences, Aptiv Solutions
Patrick Archdeacon, Medical Officer, Office of Medical Policy, CDER, FDA
Yasuko Asahina, Researcher, Office of Regulatory Science, Pharmaceuticals and Medical Devices Agency (PMDA)
Bhanu Bahl, Director, Clinical and Translational Science Center, Harvard University
Jaime Baldner, Manager, Clinical Data Management, Genentech, A Member of the Roche Group
Justin Balint, Post-Doctoral Fellow, Oncology Advocacy and Policy, Rutgers, The State University of New Jersey
Swapu Banerjee, Deputy Managing Director, Pope Woodhead & Associates Ltd
Kristina Barkhouser, President, Excelen Performance, Inc.
J. Lynn Bass, Director, Medical Scientists, Jazz Pharmaceuticals
David Bates, Senior Vice President for Quality and Safety, Chief Quality Officer, Brigham and Women's Hospital
Sonica Batra, Director, Medical and Scientific Affairs, Jubilant Clinsys Ltd.
Robert Baughman, Senior Vice President, Clinical Sciences, MannKind Corporation
Joel Beetsch, Vice President, Patient Advocacy Group, Celgene Corporation
Ulrike Behr, Director, Regulatory Affairs, PAREXEL International GmbH
Virginia Behr, Ombudsman, Office of Executive Programs, CDER, FDA
Mary Lou Bell, Head, Portfolio and Program Management, Nimbus Discovery
Stacie Bell, Director, Clinical and Translational Research, Questcor Pharmaceuticals
Danny Benau, Director, Biomedical Writing Programs, University of the Sciences in Philadelphia
Alan Bennett, Managing Partner, DC Office, Ropes & Gray
Cynthia Bens, VP, Public Policy, Accelerate Cure/Treatments for Alzheimer's Disease (ACT-AD), Alliance for Aging Research
Charles Benson, Medical Fellow, Eli Lilly and Company
Ori Ben-Yehuda, Vice President, Clinical Research, Gilead Sciences, Inc.
Barry Berger, Professor of Regulatory Affairs, Temple University
Conny Berlin, Global Head, Quantitative Safety Function, Novartis Pharma AG
Alejandro Bermudez-del-Villar, Project Coordinator, Latin America and Global Program Development, DIA
Amy Bertha, Regulatory Health Project Manager, OND, CDER, FDA
Louise Binder, Patient Advocate, International Community of Women Living With HIV/AIDS
Stella Blackburn, EMA Risk Management Development and Scientific Lead, European Medicines Agency, European Union
Christine Blazynski, Chief Science Officer and Senior Vice President, Citeline, Inc.
Nate Blevins, Director, Global Regulatory Affairs and Patient Safety, AstraZeneca Pharmaceuticals LP
Steven Blum, Director, Health Economics, Forest Research Institute
Kathryn Bohannon, Principal Strategist, Pediatrics, INC Research
Philip Bonasia, Executive Director and Head, Chemistry and Pharmaceutical Sciences, Sunovion Pharmaceuticals Inc.
Denise Booker, Associate Director and Relationship Manager, Merck & Co., Inc.
Reingart Bordel, Senior Pharmacovigilance Manager, Dr. Ebeling & Assoc. GmbH
Marcin Boruk, Senior Policy Analyst, Health Canada
Marc Boutin, Executive Vice President and Chief Operating Officer, National Health Council
Linda Bowen, Head of US Regulatory Policy and Intelligence, Sanofi
David Bowers, Director, Medical Communications, PPD
Russell Boyd, Executive Director, Head of Project Management (Americas), Covance Inc.
Darran Boyer, President, clinicalRSVP
Simone Braggio, Director, Drug Design and Discovery, Aptuit
Scott Brand, Principal Scientist, Global Data and Bioinformatics, QPS LLC
Kristina Brannstrom, Director and Regional Head, Global Medical Writing and Document Publishing, Quintiles Inc.
Vicki Breitbart, Director, Health Advocacy Program, Sarah Lawrence College
Michael Brennan, Director, Informatics, Johnson & Johnson Pharmaceutical Research & Development, LLC
Benjamin Brodey, CEO, TeleSage, Inc.
Richard Brook, Head, Retrospective Analysis, The Jestarx Group
Sabine Brosch, Business Lead, EudraVigilance and International Standardisation in PhV, European Medicines Agency, European Union
Mary Patrice Brown, Partner, White Collar Defense and Corporate Investigations Practice, O'Melveny & Myers LLP
Mark Browning, Consumer Safety Officer, OMPQ, Office of Compliance, CDER, FDA
Meredith Brown-Tuttle, Regulatory Affairs, Regulatorium
, President and CEO, IDEC Inc.
Christina Bucci Rechtweg, Head, Pediatric & Maternal Health Policy, Novartis Pharmaceuticals Corporation
Rebecca Budd, Managing Director, Navita Clinical Strategy Group
Gary Bufferd, Associate Director, Corporate Training and Employee Engagement, RPS, Inc.
Jonca Bull, Director, Office of Minority Health, Office of the Commissioner, FDA
Douglas Burgener, Product Manager, EDC and Virtual Clinical Adjudication System (VCAS), Perceptive Informatics
Rodney Butt, Director, Project Management & Quality Systems, Nutrasource
Denise Calaprice-Whitty, Consultant, The Avoca Group Inc.
Douglas Call, Consultant, Call & Warwick Project Partners, LLC
Laurie Callen, Senior Manager, Clinical Data Management, Tesaro Biosciences
Pamela Campbell, Senior Consultant, EMC Corporation
Peter Carberry, Senior Vice President, Global Development Operations, Astellas Pharma Global Development, Inc.
Brian Carey, Partner, Life Sciences and Health Care, Foley Hoag LLP
, Professor and Head of Biostatistics, University of Minnesota
Daniel Carnese, CEO, KDH Systems
, Senior Advisor, US Department of Commerce
Elisa Cascade, Vice President, Global Head of Operations, Quintiles Inc.
, Vice President, Trial Planning Solutions, Medidata Solutions Worldwide
Travis Caudill, Director, Feasibility & Site Identification, INC Research
, Senior Director, Medical Business Operations, Medical Strategy and Operations, Millennium: The Takeda Oncology Company
Nancie Celini, Chief Learning Consultant, CAB Inc.
Francesca Cerreta, Scientific Administrator, European Medicines Agency, European Union
, Chief Operating Officer, CenterWatch
Dannis Chang, Medical Communications Scientist, Genentech, A Member of the Roche Group
Owen Charles, Manager, Outsourcing Management, Bristol-Myers Squibb Company
Adam Chasse, Chief Operating Officer, RxTrials, Inc.
Deborah Chee, Medical Director, AbbVie Korea Ltd.
Charlie Chen, Vice President, GCP Clinplus
Chi-Wan Chen, Executive Director, Global CMC, Global Research & Development, Pfizer Inc
Zhen Chen, Deputy Office Director, Office of New Drug Pharmaceutical Science, Center for Drug Evaluation of CFDA
Stephen Chick, Vice President, Competitive Health Insights, A Humana Company
Karla Childers, Associate Director, Project Management, Merck Research Laboratories
Raffy Chilingerian, Senior Regulatory Manager, Novartis Pharmaceuticals Corporation
Surya Chitra, Director, Biostatistics, Endo Health Solutions
Leslie (Mi Ok) Chong, Senior Clinical Program Leader, Genentech, A Member of the Roche Group
Mary Christian, Executive Director, Mature Products and Geographic Optimization, Bristol-Myers Squibb Company
Anastasia Christianson, Senior Director, R&D Information, AstraZeneca
Diana Chung, Associate Director, Clinical Operations, Gilead Sciences, Inc.
Clifton Chunn, Sr. Director, Global Medical Writing, Allergan Inc.
Leslie Citrome, Clinical Professor of Psychiatry and Behavioral Sciences, New York Medical College
David Clemow, Senior Clinical Research Scientist, Eli Lilly and Company
James Cobbs, Associate Director, US Regulatory Affairs, Johnson & Johnson PRD LLC
Barton Cobert, President, BLCMD Associates, LLC
James Cohen, Partner, Head, FDA Practice, McDermott Will and Emery
Jacqueline Cole, Oncology Clinical Operations Portfolio Management, NA Clinical Operations, Eli Lilly and Company
Jean Cole, Associate Director, Drug Safety and Public Health, Gilead Sciences, Inc.
Anita Coleman, Dossier Technical Lead, Sanofi
Cal Collins, CEO, OpenClinica
Preciosa Coloma, Researcher, Erasmus University Medical Center
Helen Colquhoun, Senior Vice President, CROMSOURCE
Meryl Comer, President, Geoffrey Beene Foundation Alzheimer's Initiative
Larissa Comis-Tis, Director, Product Strategy, Clinical Solutions, Thomson Reuters
Emer Cooke, Head of International and European Cooperation, European Medicines Agency, European Union
Freda Cooner, Mathematical Statistician, Div. of Biometrics III, OB, OTS, CDER, FDA
Diane Cooney, Principal, Perceive Media Group LLC
Stephen Coons, Executive Director, PRO Consortium, Critical Path Institute
Julia Cooper, Senior Director, Worldwide Head of Medical Writing Services, PAREXEL International Ltd.
Gary Coward, Global Head, Patient Safety Services, PAREXEL International
Oliver Cox, Consultant, PAREXEL International
Anne Cropp, Executive Director, Pfizer Inc
Graeme Currie, Head, Clinical Project Management Office, Regeneron Pharmaceuticals
Chris Dagdigian, Co-Founder and Principal Consultant, BioTeam, Inc.
Ralph D'Agostino, Chair, Mathematics and Statistics Department, Boston University
Gerald Dal Pan, Director, Office of Surveillance and Epidemiology, CDER, FDA
Aaron Dane, Biometrics & Information Sciences Infection Head, AstraZeneca
Sean Darcy, Senior Director, Global Patient Safety and Global Medical Information, Vertex Pharmaceuticals
Mat Davis, Project Statistician, Theorem Clinical Research
Sonia Davis, Director of the Collaborative Studies Coordinating Center, Dept of Biostatistics, University of North Carolina
Yasmin de Faria Krim, Manager, Global CMC Regulatory Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson
Mitch Dekoven, Director - Health Economics and Outcomes Research, IMS Health
Susanna Del Signore, Associate Vice President, Global Regulatory Affairs, Sanofi
Cari DeLoa, Principal Data Manager, Genentech, A Member of the Roche Group
Janel Demeter, Manager, Regulatory Operations, Accenture LLP
Carl DeMoor, Vice President Epidemiology NA, REGISTRAT MAPI
Susan Dentzer, Former Editor-in-Chief, Health Affairs; Senior Policy Advisor, Robert Wood Johnson Foundation
Frank DePaoli, Director, Pharmaceutical/Life Sciences R&D, PricewaterhouseCoopers LLP
Louise Dery, Director, Policy, Planning and International Affairs Directorate, Health Canada
Elizabeth Desrosiers, Director, Global Trial Management, Merck Research Laboratories
Michael Diem, Director and Head of Business Development, GSK Rare Diseases, GlaxoSmithKline
Ulysses Diva, Principal Statistician, Bioinformatics and Information Sciences, AstraZeneca
Alex Dmitrienko, Executive Director, Center for Statistics in Drug Development, Quintiles Inc.
James Dodge, Executive Director, Diabetes Field Medical Affairs, Novo Nordisk
Jessica Dolfi, Senior Business Consultant II, Medidata Solutions Worldwide
Richard Dolinar, Chairman, Alliance For Safe Biologic Medicines
Erling Donnelly, Manager, Worldwide Regulatory Strategy, Pfizer Inc
Karen D'Orazio, Pre-Approval Manager, Office of Regulatory Affairs, FDA
Donna Dorozinsky, President, DWD & Associates, Inc.
Keith Dorricott, Director, Operations Management - Process Improvement and Metrics, INC Research
Nikki Dowlman, Product Director, Perceptive Informatics
Marie Dray, President, International Regulatory Affairs Group LLC
Nancy Dreyer, Senior Vice President, Global Chief of Scientific Affairs, Quintiles Outcome
Michael Drues, Founder and President, Vascular Sciences
Dinah Duarte, Head, Scientific Evaluation Unit, Directorate of Medicinal Products, INFARMED
Sue Dubman, Senior Director, Global Biomedical Informatics, Sanofi
Michael Duenas, Chief Public Health Officer, American Optometric Association
Susan Duke, Manager, Benefit/Risk Evaluation, Global Clinical Safety & Pharmacovigilance, GlaxoSmithKline
Anne Dupraz-Poiseau, Director, Voisin Consulting Life Sciences
Earl Dye, Director, Technical Regulatory Policy, Genentech, A Member of the Roche Group
Lauren Edelstein Henry, Principal Operational Specialist, Janssen Pharmaceutical Companies of Johnson & Johnson
Stanley Edlavitch, Professor, Epidemiology, School of Medicine; Center for Behavioral Medicine, University of Missouri Kansas City
Ann Edmunds, Principal Investigator, Omaha Ear, Nose and Throat Clinic, P.C.
Diane Edquist Dorman, Vice President, Public Policy, National Organization For Rare Disorders (NORD)
Lisa Egbuonu-Davis, Co-Founder, Director, ROI Squared LLC, ROI Squared LLC
Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency, European Union
Steffan Ekman, Senior Clinical Scientist, F. Hoffmann-La Roche AG
Julie Ely, Senior Medical Writer, Proscribe Medical Communications
Andrew Emmett, Managing Director, Science and Regulatory Affairs, The Biotechnology Industry Organization (BIO)
Tracy England, Vice President, Marketing, OpenQ
Julie Evans, Senior Director, Technical Services, CDISC
Scott Evans, Senior Research Scientist, Harvard University School of Public Health
Betsy Fallen, Lead, Global Essential Document and Supply Chain Management, Merck & Co., Inc.
Steve Farrand, Vice President and Head Bioprocess Development, Merck Research Laboratories
Valerii Fedorov, Vice President, Predictive Analytics, Innovation, Quintiles Inc.
Robert Feeney, Senior Director, Evidence-Based Reimbursement, Sanofi
Fred Feldstein, Senior Director, Head of GCP/GLP/PV QA, Primary Care and Consumer BUs, Pfizer Inc
Yi Feng, Office of Evaluation Management and Communication, Center for Drug Evaluation of CFDA
, Executive Vice President, Business Development, INC Research
Marta Fields, Senior Director, Compliance and Quality Systems, Seattle Genetics, Inc.
Anna Fine, Director, Health Professional Liaison Program, Office of the Commissioner, FDA
Suzanne Fink, Senior Project Lead, Clinical Data Management, RPS, Inc.
Carl Fischer, Chief, General Hospital Devices Branch, OC, CDRH, FDA
Ron Fitzmartin, Senior Advisor, Office of Planning and Informatics, CDER, FDA
J. Michael Fitzmaurice, Senior Science Advisor for Information Technology, Office of the Director, Agency for Healthcare Research and Quality (AHRQ)
Mary Flack, Vice President, Clinical Research, NanoBio Corporation
Kelleen Flaherty, Assistant Professor, University of the Sciences In Philadelphia
Rachael Fleurence, Acting Director, PCOR Methods, Patient Centered Outcomes Research Institute (PCORI)
Robin Foldesy, Vice President, Strategic Drug Development, Quintiles Transnational Corp.
Michael Folkendt, Associate Director for Regulatory Affairs, ONDQA, OPS, CDER, FDA
Christy Foreman, Director, Office of Device Evaluation, CDRH, FDA
David Forster, Vice President, Office of Compliance, Western Institutional Review Board
Erin Fox, Director, Drug Information Service, University of Utah Hospitals and Clinics
Jeffrey Francer, Assistant General Counsel, PhRMA
Robert Franco, Principal, PricewaterhouseCoopers LLP
Lori Frank, Senior Research Scientist; Deputy Director, Center for Health Outcomes Research, United BioSource Corporation
Juergen Froehlich, Vice President, Global Regulatory Affairs, Vertex Pharmaceuticals
Pete Fronte, President, Altura
David Fryrear, Head, GCP Operations & Pharmacovigilance Compliance, R&D Quality Assurance, AbbVie, Inc.
Shayesteh Fuerst-Ladani, Director, SFL Regulatory Affairs & Scientific Communication
Stacey Fung, Associate Director, Medical Communications, Genentech, A Member of the Roche Group
Valentin Fuster, Physician-in-Chief, Mount Sinai Medical Center
Jessie Galson, Director, Regulatory Writing, Amgen Inc.
Shelley Gandhi, Director, NDA Group
Adolfo Garcia, Partner, K&L Gates LLP
Tim Garnett, Chief Medical Director and Senior Vice President, Eli Lilly and Company
Elizabeth Garrard, Specialist Leader, Deloitte Consulting L.L.P.
Bink Garrison, President, Bink, Inc.
Almenia Garvey, Senior Clinical Feasibility Leader, PAREXEL International
David Gaugh, Senior Vice President for Sciences and Regulatory Affairs, Generic Pharmaceutical Association (GPhA)
Helle Gawrylewski, Senior Director, Regulatory Medical Writing, Janssen Research & Development, LLC
Mark Gaydos, Vice President, US Regulatory Affairs Marketed Products, Sanofi
Urte Gayko, Senior Vice President, Global Regulatory Affairs, Pharmacyclics
Stewart Geary, Vice President, Chief Medical Officer, Director, Corporate Medical Affairs HQ, Eisai Co., Ltd.
Mary Jane Geiger, Vice President, Clinical Development, Relypsa, Inc
Kerstin Geldmeyer-Hilt, Quality Manager, Dr. Ebeling & Assoc. Gmbh
Art Gertel, Vice President, Strategic Regulatory Consulting and Medical Affairs, TFS International
Thomas Gesell, Development Director, Medical Affairs, Envision Pharma, Inc.
Kenneth Getz, Director of Sponsored Research, Tufts CSDD; Chairman, CISCRP, Tufts University
Jeffrey Gibbs, Director, Hyman Phelps & McNamara, PC
Ryan Gifford, Senior Manager, Business Development, CTI Clinical Trial and Consulting Services
Cortney Gilbert, Associate Director, Global Regulatory Operations, Merck & Co., Inc.
Dalvir Gill, CEO, TransCelerate Biopharma Inc
David Gillogly, Senior Director, Clinical Outsourcing, Otsuka Pharmaceutical Development & Commercialization, Inc.
Francesca Gino, Associate Professor, Negotiation, Organization, and Markets Unit, Harvard University Business School
Kyle Given, Senior Vice President, Embedded Programs, Training and Quality Control, RPS, Inc.
Coleen Glessner, Vice President, Clinical Trial Processes and Quality, Pfizer Inc
Paul Glover, Assistant Deputy Minister of the Health Products and Food Branch, Health Canada
Jogarao Gobburu, Professor, School of Pharmacy and School of Medicine, University of Maryland
Barbara Godlew, President, The FAIRE Company, LLC
Kathleen Goin, Associate Director, Clinical and Data Operations, Endo Pharmaceuticals Inc.
Gretchen Goller, Senior Director, Patient Access and Retention Services, PRA
Federico Goodsaid, Vice President, Strategic Regulatory Intelligence, Vertex Pharmaceuticals
Laurie Graham, Biologist, Division of Monoclonal Antibodies, OBP, OPS, CDER, FDA
Amy Grant, Director, Global Regulatory Strategy & Science, ViroPharma Incorporated
Mark Gray, Director, Div of Data Management Services and Solutions, OBI, CDER, FDA
Melvyn Greberman, President, Public Health Resources
Andrea Greiter-Wilke, Head, Safety Pharmacology, F. Hoffmann-La Roche AG
Kenneth Grice, Associate Director, ePRO Operations, Global Electronic Data Capture, Bayer Healthcare Pharmaceuticals
Andrew Grieve, Senior Vice President Clinical Trial Methodology, Aptiv Solutions
John Groskoph, Senior Director, Global CMC, Pfizer Inc
Matt Gross, Director, Health Care and Life Sciences Global Practice, SAS Institute Inc.
Vikas Gulati, Director, Clinical Data Management, Vertex Pharmaceuticals
Ted Guo, Mathematical Statistician, Office of Biostatistics, OTS, CDER, FDA
Andrey Gurachevsky, Senior Technical Logistics Coordinator, PAREXEL International
Margaret Gurian, Director of Quality Assurance, CompleWare Corporation
Alberto Gutierrez, Director, Office of In Vitro Diagnostic Device Eval and Safety, CDRH, FDA
Paula Guy, Chief Executive Officer, Georgia Partnership for TeleHealth, Inc.
William Gwinn, Vice President, Clinical Informatics Solutions, OptumInsight
Karleen Habin, Nursing Supervisor, Clinical Research Program Breast Oncology, Massachusetts General Hospital
Cindy Hahn, President and CEO, Alagille Syndrome Alliance
Laurie Halloran, President and Chief Executive Officer, Halloran Consulting Group
Margaret Hamburg, Commissioner, FDA
Michael Hamrell, President, MORIAH Consultants
Jeffrey Handen, Vice President, Clinical Solutions, Medidata Solutions Worldwide
Ralph Harkins, Senior Statistical Consultant and Project Manager, RDH Statistical Consulting Service
James Harnett, Senior Director, Real World Data and Analytics, Pfizer Inc
Peter Harpum, Managing Director, Harpum Consulting Ltd.
Chuck Harris, Director, Product Development, Endpoint Clinical, Inc.
Melissa Harris, Executive Director, US Medical Information and Field Medical Operations, Bristol-Myers Squibb Company
Judy Harrison, Senior Medical Officer, MedDRA MSSO
Brian Harvey, Vice President, US Regulatory Strategy, Pfizer Inc
Martin Harvey-Allchurch, Head of Communications, European Medicines Agency, European Union
Eric Haseltine, Research Scientist, Vertex Pharmaceuticals
Colin Hayward, Vice President, Medical Affairs, Premier Research Group
Sandra Hecker, US Agent; Regulatory Consultant, Hecker & Associates, LLC
Kate Heffernan, Founder, KGH Advisors LLC
Mark Hegarty, Partner/Attorney, Shook, Hardy & Bacon L.L.P.
Jeffrey Heilbraun, Director Strategic Development, Bioclinica Inc
Jonathan Helfgott, Operations Research Analyst, OSI, OC, CDER, FDA
Michael Henning, Director, Project Management, PPD
Jack Henningfield, Vice President, Research, Health Policy, and Abuse Liabiliy, Pinney Associates
Jennifer Henry-Smith, Director, Business Development and Account Management, Quintiles Central Laboratory
Robert Hilke, CEO, Hilke Communications Corporation
Stacy Hitchman, Associate Director, Global Clinical Operations, Biogen Idec
Kenneth Hitchner, Vice President, Development Sciences Project Management, BioMarin Pharmaceutical Inc.
Vicky Hogan, Director, Office of Risk Management and Science, Marketed Health Products Direct, Health Canada
Donna Holder, Senior Director, Global MSL Excellence, AstraZeneca Pharmaceuticals
Alison Holland, Executive Director, Alliance Leader, Covance Inc.
Sam Holliday, Greenway Medical Technologies
Drew Holzapfel, Managing Director, High Lantern Group
Mark Hope, Global Head of Neuroscience and Cardiovascular-Metabolism, Regulatory Affairs, F. Hoffmann-La Roche Ltd.
Lynette Hopkinson, Senior Director, Commercial Regulatory Afairs, Eisai Inc.
Florence Houn, FDA Alumni Association; Celgene
Christopher Hoyle, Executive Director, Elite Research Network
Lan Huang, Mathematical Statistician, Office of Biostatistics, OTS, CDER, FDA
Sherri Hubby, Director, US Quality Assurance, Premier Research Group
Diana Hughes, Vice President, Worldwide Safety, Pfizer Inc
Thomas Hughes, President and CEO, Zafgen, Inc.
Mohammad Huque, Director, Division of Biometrics IV, Office of Biostatistics, OTS, CDER, FDA
Patricia Hurter, Senior Vice President, Product Development, Vertex Pharmaceuticals
Carrie Hurwitz, Director, Corporate Strategy and Business Development, McKesson
Michael Ibara, Head of Business Development Coordination & Innovation, WW Safety Reg Operations, Pfizer Inc
David Iberson-Hurst, CEO, Assero
Ekopimo Ibia, Director and US Regulatory Policy Lead, Global Reg Strategy, Policy, and Safety, FDA Alumni Association International Network; Merck & Co., Inc.
Nita Ichhpurani, Director, Drug Development, Celerion
Nathan Ihle, Executive Director, Process Chemistry and Analytical Biochemistry, Seattle Genetics, Inc.
William Irish, Vice President, Outcomes Research and Biostatistics, CTI Clinical Trial and Consulting Services
John Isidor, CEO, Human Subject Protection Consulting, LLC
Erin Iturriaga, Clinical Trials Specialist, National Heart, Lung, and Blood Institute (NHLBI)
Paul Ivsin, Vice President, Consulting Director, CAHG
Teiki Iwaoka, Executive Consultant, Director of Drug Safety Outsourcing Planning, CAC EXICARE Corporation
Rima Izem, Mathematical Statistician, Office of Translational Science, CDER, FDA
David Jackson, Chief Scientific Officer, Molecular Health GmbH
Tom Jacobs, Principal Statistician, Janssen R&D
Sherri Jacobsen, Associate Director, Global Clinical Training, Compliance and Initiatives, AbbVie
Fred Jacobson, Principal Scientist and T-DM1 Technical Team Leader, Genentech, A Member of the Roche Group
Karen Jaffe, Regulatory Research, Alfred Mann Institute
Nirdosh Jagota, Vice President and Global Head - Small Molecules, Genentech, A Member of the Roche Group
Brenda Jamerson, Associate Professor, Clinical Research, Campbell University College of Pharmacy and Health Sciences
John Jenkins, Director, Office of New Drugs, CDER, FDA
Robin Jenkins, Head, Strategic Planning North America Medical Affairs, Sanofi
Janet Jenkins-Showalter, Senior Regulatory Group Director, Regulatory Policy and Intelligence, Genentech, A Member of the Roche Group
Gregg Jewett, Global Procurement Leader, AstraZeneca
Haiyan Jiang, Senior Director, Preclinical and Clinical Research (Hemophilia), Biogen Idec
Shun Jin, Associate Director, Regulatory Affairs, Asia, Takeda Development Center
Kimberly Jochman, Manager, Global Medical Writing, PPD
Kevin Johnson, Global Head, Regulatory Affairs, Novella Clinical
Steve Jolley, Principal, SJ Pharma Consulting
Ryan Jones, Senior Director, Business Development, Pubget
Ursula Jorch, President, Jorch Consulting, Inc.
David Jordan, Leader, Data Standards Project, TransCelerate Biopharma Inc.
Jeewon Joung, Deputy Director, Korean Ministry of Food and Drug Safety (MFDS)
Ethel Kagan, President, Innovations Clinical Research, LLC
Kenneth Kaitin, Professor and Director, Center for the Study of Drug Development, Tufts University School of Medicine
Charles Kalfaian, Director, Global Services Health Sciences, EMC Corporation
Aginus Kalis, Executive Director, Medicines Evaluation Board
Suresh Kannan, Vice President, Product Development, Clinical Trial Optimization Solutions, IMS Health
Jeffrey Kasher, Vice President, Clinical Trial: Materials, Implementation and Transformation, Eli Lilly and Company
Eliezer Katz, Senior Director, Transplantation, Medicines Development Group, Pfizer Specialty Care
Mitchell Katz, Executive Director, Medical Research Operations, Purdue Pharma LP
Nancy Katz, President and Principal Medical Writing Consultant, Illyria Consulting Group, Inc.
Cassandra Kennedy, Senior Vice President, Global Quality Assurance, Quintiles Inc.
Ciara Kennedy, Vice President, Operations, Lumena Pharmaceuticals
Sukhwant Khanuja, President and CEO, Carematix / Blipcare Inc
Suzanne Kiani, Associate Director, CMC Regulatory, MedImmune
Kostas Kidos, Vice President, Product Strategy, Pharmacovigilance and Risk Management, Oracle Corporation
Peter Kilford, Senior Project Manager, Covance Inc.
Lisa Kim, Global Trial Optimization Specialist, Inventiv Health Clinical
Paul Kim, Partner, Foley Hoag LLP
Lynn King, Assistant Vice President, Clinical Operations, Rho, Inc.
Bron Kisler, Vice President, Strategic Initiatives, CDISC
Agnes Klein, Director, Evaluation of Radiopharmaceuticals and Biotherapeutic Products, Health Canada
Cynthia Kleppinger, Senior Medical Officer, Office of Scientific Investigations, CDER, FDA
Craig Klinger, Consultant, Medical Liaison Operations - Trainer, Eli Lilly and Company
Kristin Koehler, Partner, Sidley Austin LLP
Chin Koerner, Executive Director, Regulatory Policy, Novartis Pharmaceuticals Corporation
Andreas Koester, Vice President, Clinical Trial Innovation, External Alliances, Janssen Pharmaceutical Companies of Johnson & Johnson
Rebecca Komas, Director, CMC Advocacy, GlaxoSmithKline
Tatsuya Kondo, Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA)
Evdokia Korakianiti, Head of Chemicals Section, Quality of Medicines, European Medicines Agency, European Union
Krystyna Kowalczyk, Executive Vice President, Clinical Operations, Novella Clinical
Nicholas Kozauer, Medical Officer, Office of New Drugs, CDER, FDA
Daniel Kraft, Executive Director, FutureMed
Judith Kramer, Professor of Medicine, Duke University Medical Center, Duke Translational Medicine Institute
James Kremidas, Consultant
Sriram Krishnaswami, Director, Clinical Pharmacology, Specialty Care Business Unit, Pfizer Inc
Stephanie Krogmeier, Director, Global CMC Regulatory Affairs Strategy, Vertex Pharmaceuticals
Lynne Krummen, Vice President, Technical Regulatory, Biologics, Genentech, A Member of the Roche Group
Mark Kryah, Advisor, Pharmaceutical Project Management, Eli Lilly and Company
Rebecca Kush, President and CEO, CDISC
Monica Kwarcinski, Executive Director, Medical Services, Purdue Pharma LP
Denise Lacey, Principal Consultant, Halloran Consulting Group
Mary Jo Lamberti, Senior Project Manager, Tufts Center for the Study of Drug Development, Tufts University
Martin Landray, Reader in Epidemiology, Clinical Trial Service Unit, University of Oxford
Charles Lankford, CEO, PharmaSys, Inc.
Larissa Lapteva, Medical Officer, Rare Diseases Program, Office of New Drugs, CDER, FDA
Sheryl Lard Whiteford, Associate Director for Quality Assurance, Ombudsman, CBER, FDA
Sarah Doyle Larson, Associate Director, Clinical Operations, Biogen Idec
Peter Lassoff, Vice President and Head of Global Regulatory Affairs, Quintiles Inc.
Courtland LaVallee, Director, Project Management, Theravance, Inc.
Lisa LaVange, Director, Office of Biostatistics, Office of Translational Science, CDER, FDA
Jonathan (Yoni) Lebowitsch, Product Manager, Medidata Solutions Worldwide
Andy Lee, Senior Vice President, Global Clinical Operations, Genzyme Corporation, A Sanofi Company
Chia Wen Lee, Head, Emerging Markets Access, Biogen Idec
Fred Lee, Director of Business Development, IPS Research Company
Howard Lee, Professor, Department of Clinical Pharmacology and Therapeutics, Seoul National University Hospital
Hsin-Jung Lee, Reviewer, Division of New Drugs, Center for Drug Evaluation
Yil-Seob Lee, Executive Member, Korea National Enterprise for Clinical Trials (KoNECT)
Barbara Leishman, External Business Alliance Leader, F. Hoffmann-La Roche Ltd.
James Leong, Regulatory Specialist, Health Sciences Authority
Bill Leslie, Executive Director, Global Regulatory Submissions, Covance Inc.
Ning Li, Vice President, GRA Head, Medical Policy, Asia, Sanofi
Rebecca Li, Executive Director, Multi-Regional Clinical Trial (MRCT) Center at Harvard
Larry Liberti, Director, Centre For Innovation In Regulatory Science (CIRS)
Michael Liebman, Managing Director, IPQ Analytics
Jay Liebowitz, Orkand Endowed Chair in Management and Technology, University of Maryland University College
Angela Lightfoot, Director, OnDemand Health and Life Sciences Consulting, SAS Institute Inc.
David Lilley, Non Executive Board Director, SFJ Pharmaceuticals Inc.
Robyn Lim, Senior Science Advisor, Office of Legislative and Regulatory Modernization, HPFB, Health Canada
Cheng-Ho Lin, CEO, Rare Genomics Institute
Chih-Hwa Wallace Lin, Director, Division of Resource Development, Center for Drug Evaluation
Ralph Lin, Global Strategy and Corporate Development Officer, SNBL Ltd.
Elizabeth Lincoln, Worldwide Director, Human Resources, DIA
Pamela Lindroos, Senior Director, Medical Writing, WebbWrites, LLC
Craig Lipset, Head of Clinical Innovation, Worldwide Research and Development, Pfizer Inc
Patrick Loerch, Director, Health Informatics, Merck & Co., Inc.
Brian Loew, CEO, Inspire
Jim Long, Co-Founder and Principal, BioSolutia
Pamela Loughner, President, Loughner and Associates Inc.
Patricia Love, Deputy Director, Office of Combination Products, OC, FDA
Sarah Luijpers, Director, Study Feasibility and Patient Recruitment, Forest Research Institute
Michael Luker, Eli Lilly and Company
Murray Lumpkin, Commissioner's Senior Advisor and Representative for Global Issues, OC, FDA
J. Jason Lundy, Assistant Director, Patient-Reported Outcome Consortium, Critical Path Institute
Johan Luthman, Vice President, Neuroscience and Opthalmology R&D for Franchise Integrator, Merck & Co., Inc.
Daniel MacArthur, Group Leader, Analytic and Translational Genetics Unit, Massachusetts General Hospital
Alistair MacDonald, Chief Operating Officer, INC Research
Jamie Macdonald, Chief Executive Officer, INC Research
Rajnikanth Madabushi, Team Leader, Division of Clinical Pharmacology I, OCP, OTS, CDER, FDA
Kent Mahoney, Director, Soltex Consulting LLP
Penelope Manasco, CEO, MANA Consulting
Barry Mangum, Director, Clinical Pharmacology, Duke University Medical Center
Carla Mann Woods, CEO and Founder, Fight to Live
Heather Manna, Senior Manager, Regulatory Affairs, Idis Pharma
Shyam Manoj Karunakaran, Senior HIT Consultant, CitiusTech Inc.
Libbie Mansell, President, White Oak Biopharma Solutions
Heidi Marchand, Assistant Commissioner for Special Health Issues, OC, FDA
Lisa Marks, Director, Business Development, PharmaSeek
Christopher Marrone, Outcomes Liaison, Eli Lilly and Company
Jennifer Marsh, Senior Director, Global Medical Quality, Eli Lilly and Company
Linda Martin, Principal and Founder, KMR Group Inc.
Mona Martin, Executive Director, Research Scientist, Health Research Associates Inc.
Roan Martin, Senior Director and Head of Research Regulatory Compliance (RRC), PAREXEL International
Scott Martin, Principal, KMR Group Inc.
Jay Mason, Professor of Medicine; Chief Medical Officer, Spaulding Clinical Research, University of Utah
Joao Massud, CEO, Trials Consulting
Michelle Masterson, Project Manager, Diabetes Trials Unit, Oxford University
Jonathan McConathy, Assistant Professor of Radiology, Department of Radiology, Washington University
Yvonne McCracken, President and CEO, Carolinas Research Associates
Robert McCray, President and Chief Executive Officer, Wireless-Life Sciences Alliance
John McKew, Acting Director, Division of Preclinical Innovation, National Center for Advancing Translational Sciences
Karen McNamara, Senior Manager, Clinical Supply, Infinity Pharmaceuticals, Inc.
Robert Medve, Chief Medical Officer, Nektar Therapeutics
Ann Meeker-O'Connell, Director, Division of GCP Compliance (Acting), OSI, Office of Compliance, CDER, FDA
Alan Menius, Senior Director, Medical Analytics, GlaxoSmithKline
Robert Metcalf, Vice President, Global Regulatory Affairs - US, Eli Lilly and Company
Joan Meyer, Executive Director, Operational Strategy and Planning, Covance Inc.
Nancy Meyerson-Hess, Compound Development and Branding, Gruenenthal
Damon Michaels, Director, Clinical Trials Research, Vanderbilt University Medical Center
Karen Midthun, Director, Center for Biologics Evaluation and Research, FDA
Aaron Miller, Alliance Manager, Labeling & Submissions Management, Janssen Research & Development, LLC
Mitch Miller, Director, Publications and Medical Writing, Drug Safety Alliance, Inc.
Sandra Milligan, VP, Regulatory Affairs, Immunology, Infectious Disease & Ophthalmology, Genentech Inc., A Member of the Roche Group
Juliane Mills, Senior Project Manager, United BioSource Corporation
Jules Mitchel, President, Target Health Inc.
C. Latham Mitchell, Managing Principal, Erudita Biotechnical LLC
Lesa Mitchell, CEO, Marion Kauffman Foundation
Justina Molzon, Associate Center Director for International Programs, CDER, FDA
Gareth Monteath, Program Director, Link Global Solution Inc.
Debra Montgomery, eCRF Librarian, CDS III, Duke Clinical Research Institute
Christine Moore, Acting Director, Office of New Drug Quality Assessment, OPS, CDER, FDA
Tristen Moors, Associate Director, Clinical Operations, Hyperion Therapeutics
Elaine Morefield, Deputy Office Director, Office of New Drug Quality Assessment, OPS, CDER, FDA
Kazuhiko Mori, Chief Safety Officer, Pharmaceuticals and Medical Devices Agency (PMDA)
Don Morris, Vice President, Scientific Products and Technology, Archimedes Inc.
Sandra Morris, Vice President, Strategy Realization, Johnson & Johnson World Headquaters
Susan Morris, Director, Merit Systems
Briggs Morrison, Head, Global Medicines Department, AstraZeneca
Jeffrey Morrison, Director, Global Regulatory Operations, GlaxoSmithKline
Royce Morrison, Executive Vice-Chair, Quorum Review, Inc.
Eduardo Motti, Owner, Trials & Training Consult
Willie Muehlhausen, Vice President, eCOA and Innovation, ICON Late Phase and Outcomes Research
Bernard Munos, Founder, InnoThink
Noriaki Murao, Representative, NM Consulting
Dianne Murphy, Director, Office of Pediatric Therapeutics, Office of the Commissioner, FDA
Ciaran Murray, Chief Executive Officer, ICON Plc
Mike Myers, Senior Director, Eli Lilly and Company
Nancy Myers, President, Catalyst Healthcare Consulting, Inc
Jane Myles, Global Head, Recruitment Strategy, Genentech, A Member of the Roche Group
Amy Nadel, Executive Director, Professional Relationships, Medscape
Nobumasa Nakashima, Director, Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA)
Sunitha Nalla, Associate Director, Regulatory Operations, Aveo Pharmaceuticals, Inc.
Tae Kyun Nam, Deputy Director, Korean Ministry of Food and Drug Safety (MFDS)
Moheb Nasr, Vice President, Regulatory CMC Strategy, GlaxoSmithKline
Victor Navarro, Chair, Hepatology, Einstein Medical Center
Peter Neumann, Prof of Medicine; Director, Center for Evaluation of Value and Risk in Health, Tufts Medical Center
Cecil Nick, FTOPRA, Vice President (Technical), PAREXEL Consulting
Cortney Nicolato, Vice President for Healthcare Strategies, Get Real Health
Maryanne Nicosia, Director, Clinical Data Management, Neurocrine Biosciences Inc.
Junichi Nishino, Group Head, Novartis Pharma K.K.
Frances Nolan, Vice President, Quality and Regulatory Affairs, Medidata Solutions Worldwide
Cynthia Nolte, Director, Medical Device Regulatory Services, Aptiv Solutions
Niklas Noren, Chief Science Officer, Uppsala Monitoring Centre (UMC)
Nicki Norris, CEO, Symphony Clinical Research
Jonathan Norton, Mathematical Statistician, Division of Biometrics V, OB, OTS, CDER, FDA
Dennis Nosco, Senior Director, Global Labeling, Regulatory Affairs, Mallinckrodt, The Pharmaceuticals Business of Covidien
Brian Nugent, Associate Director, Clinical Operations, Gilead Sciences, Inc.
Susan Nunchuck, Senior Clinical Research Associate, Actelion Clinical Research
Mary Oates, Vice President, Global Quality Operations and EHS, Pfizer Inc
Patrick O'Brien, Vice President, Chief Legal Officer, Shire Regenerative Medicine, Inc.
Toby Odenheim, Director, IT Services, SynteractHCR
Walter Ogier, Chief Executive Officer, Acetylon Pharmaceuticals, Inc.
David Ohlssen, Senior Expert Methodologist, Novartis Pharmaceuticals Corporation
James O'Keefe, Director, Clinical & Regulatory Optimization, Paragon Solutions, Inc.
Carolyn O'Leary, Associate Director, Global Project Management, Merck & Co., Inc.
Dan Ollendorf, Chief Review Officer, Institute for Clinical and Economic Review
Robert O'Neill, Senior Statistical Advisor, Office of Translational Sciences, CDER, FDA
Yoshihiko Ono, Executive Director, Head of Regulatory Affairs, Japan Development, MSD K.K.
Mick O'Quigley, Program Group Leader, Genentech, A Member of the Roche Group
Daniel Orfe, Assoc. Director, Global Regulatory Operations-Technology, Standards, Vendor Mgmt, Teva Pharmaceuticals USA, Inc
Suzanne O'Shea, Counsel, Faegre Baker Daniels
Leeza Osipenko, Senior Scientific Advisor, Centre for Health Technology Evaluation, National Institute for Health and Care Excellence (NICE)
George Pajovich, Head of Safety Risk Research, Pfizer Inc
Antoinette Paone, Senior Director, Global CMC Regulatory Affairs Strategy, Vertex Pharmaceuticals
Elektra Papadopoulos, Medical Officer, Office of New Drugs, CDER, FDA
Samantha Parker, Director of External Affairs and Rare Disease Partnerships, Orphan Europe
Julie Parmelee, Director, Patient Recruitment, Quintiles Transnational Corp.
Marianne Parnell, Manager, Medical Affairs, Sigma Tau Pharmaceuticals Inc
David Passov, Senior Vice President, Eastern Europe, ClinStar, A PRA Company
Darshna Patel, Director, Global Regulatory Affairs and Safety: Pipeline Product Labeling, Amgen Inc.
Hitesh Patel, Product Manager, Pharma Technical Regulatory, Hoffmann-La Roche Inc.
Nitin Patel, Founder, Chairman and Chief Technology Officer, Cytel Inc.
, Director of Stakeholder Engagement, Clinical Trials Transformation Initiative (CTTI)
Pradip Paul, Consultant, Strategic Pharmacovigilance and Risk Management
Kirsten Paulson, Senior Officer, Medical Device Initiative, The Pew Charitable Trusts
Douglas Peddicord, Executive Director, Association of Clinical Research Organizations
Kenneth Pennline, Vice President and Global Head, Cytometry Services, LabCorp Clinical Trials
Annick Peremans, General Manager, Phase 1 Unit, Research Centre Aalst
Frank Pétavy, Biostatistician, Human Medicines Development and Evaluation, European Medicines Agency, European Union
Todd Peterson, Director, Nuclear Imaging; Associate Prof., Radiology and Radiological Sciences, Vanderbilt University
Maryrose Petrizzo, Manager, Clinical Services- Vendor Management, Allergan Inc.
Stephen Pew, Professor, Bethel University
Edmund Pezalla, National Medical Director, Pharmacy Policy and Strategy, Aetna
Lawrence Phillips, Emeritus Professor of Decision Sciences, Department of Management, London School of Economics
Christine Pierre, President, Society for Clinical Research Sites
Wayne Pines, President, Regulatory Services and Healthcare, APCO Worldwide Inc.
Moisha Platto, Vice President, Global Proposals and Finance, PRA International
Jonathan Plehn, Vice President, Global Therapeutic Lead, Cardiovascular/Metabolic Unit, Covance Inc.
Jalene Poh, Director (Ag), Therapeutic Products Branch, Health Sciences Authority
John Poland, Senior Director, Regulatory Policy and Compliance, Covance Clinical Development Services
Sarah Pope Miksinski, Acting Director, Div.1, Office of New Drug Quality Assessment, OPS, CDER, FDA
Karen Price, Research Advisor, Eli Lilly and Company
Sheila Przybysz, Safety Manager, Allergan Pharmaceuticals Ltd
Nicole Pushlar, Clinical Scientist, Clinical Trial Management, Boehringer Ingelheim Pharmaceuticals, Inc.
Brian Quinn, Team Director and Senior Program Officer, Robert Wood Johnson Foundation
Nandini Raghavan, Associate Director, Biostatistics & Programming, Global Development Organization, Janssen Research & Development, LLC
Lembit Rago, Coordinator for Quality Assurance and Safety for Medicines, World Health Organization (WHO)
Krithika Rajagopalan, Vice President, Health Economics & Outcomes Research, Sunovion Pharmaceuticals Inc.
Anil Rajpal, Medical Team Leader, Div. Gastroenterology and Inborn Errors Products, OND, CDER, FDA
Kanchna Ramchandran, Postdoctoral Fellow, Department of Psychiatry, University of Iowa Hospitals and Clinics
Anupama Ramkumar, Director, Arkus Clinical Trial Support Solutions
Andrew Rankin, Vice President, Biopharmaceuticals, Prescient Life Sciences
Anu Rao, Medical Officer, Division of Cardiovascular Services, National Heart, Lung, and Blood Institute (NHLBI)
Guido Rasi, Executive Director, European Medicines Agency, European Union
David Reasner, President and Founder, Albemarle Scientific Consulting LLC
Jayanthi Reddy, Director and Biologics Pipeline Leader,Global Project Management, Merck & Co., Inc.
John Reites, Director, Operations , Quintiles Inc.
Badri Rengarajan, Medical Director, Archimedes Inc.
Jesus Rivera, Senior Learning Manager, Bristol-Myers Squibb Company
Evonne Roberts, Director, Business Development, assisTek
Mitra Rocca, Senior Medical Informatician, Office of Translational Science, CDER, FDA
Frank Rodino, President and Founder, Churchill Outcomes Research, LLC
Janet L. "Lucy" Rose, President, Lucy Rose and Associates, LLC
Michael Rosenblatt, Executive Vice President and Chief Medical Officer, Merck & Co., Inc.
Helen Rosenbluth, Head, Licensing Department, Instituto de Salud Publica de Chile, Agencia Nacional de Medicamentos (ANAMED)
Susan Rosencrance, Supervisory Chemist, Office of Generic Drugs, OPS, CDER, FDA
Lorenzo Rossaro, Chief, Division of Gastroenterology and Hepatology, University of California Davis School of Medicine
Kenneth Rothman, Distinguished Fellow, RTI Health Solutions
Matthew Rousculp, Director, Comparative Effectiveness Research, US Health Outcomes, GlaxoSmithKline
Bill Row, Director, Clinical Operations, REGISTRAT-MAPI
Amit Roy, Group Director, Clinical Pharmacology and Pharmacometrics R&D, Bristol-Myers Squibb Company
Daniel Rubin, Statistician, Office of Translational Science, CDER, FDA
Tomasz Sablinski, Founder and CEO, Transparency Life Sciences
Leonard Sacks, Associate Director for Clinical Methodology, Office of Medical Policy, CDER, FDA
Rob Saiter, Managing Director, Life Sciences Practice, Accenture LLP
Allison Salke, COO, Tombolo, Inc.
Peter Saltonstall, President and CEO, National Organization For Rare Disorders (NORD)
Leslie Sam, Director, Global Quality Systems, Eli Lilly and Company
Marc Samuels, Managing Partner, HillCo HEALTH
Nicholas Sarlis, Vice President and Head, Medical Affairs, Experimental Station, Incyte Corporation
Andrew Satlin, Senior Vice President, Eisai Inc.
James Sawyer, CEO, Prism Ideas Ltd
Amanda Sax, Senior Director, Integrated Processes and Technologies, Quintiles Transnational Corp.
Rick Sax, Vice President, Integrated Clinical Services, Quintiles Transnational Corp.
Nidhi Saxena, Founder and CEO, Karmic Lifesciences, Inc.
Megan Schaeffer, Director, Oncology R&D Quality Management, GlaxoSmithKline
Richard Schilsky, Chief Medical Officer, American Society of Clinical Oncology
Sven Schirp, Head of Global Pharmacovigilance Writing, Boehringer Ingelheim Pharma Gmbh & Co. KG
Gregg Schneider, Director, R&D Financial Management, Otsuka Pharmaceutical Development & Commercialization, Inc.
Heike Schoen, Managing Director, LUMIS International
Hermann Schulz, CEO, INTERLAB Central Lab Services - Worldwide GmbH
Marion Schwartz, Director of Advocacy, Cholangiocarcinoma Foundation
Jim Schweitzer, Director, Commercial Technology Services, Vision Point Systems
Leonard Seeff, Consultant in Hepatology, The Hill Group
Dorry Segev, Associate Professor of Surgery, Div. of Transplantation, Dept of Surgery, Johns Hopkins University School of Medicine
Edward Seguine, CEO, Clinical Ink
Rick Seibert, Vice President, Project Management and New Business Development and Engineering, Sharp Corporation
Mary Ann Sellers, Senior Project Leader, Duke Clinical Research Institute
Jonathan Seltzer, President and CEO, Applied Clinical Intelligence, LLC
Mary Sendi, Director and Team Lead, Medical Information, Pfizer Inc
Aamir Shahzad, President, European Society For Translational Medicine (EUSTM)
Michele Sharp, Senior Director, Global Regulatory Affairs - US, Eli Lilly and Company
Paul Sheives, Director for Diagnostics and Personalized Medicine Policy, Biotechnology Industry Organization (BIO)
David Shen, Vice President, Global Head of Biologics Development, Global R&D, Teva Pharmaceuticals
Guei-Jen Shieh, Director, Clinical Group, National Research Program For Biopharmaceuticals
Vladimir Shnaydman, President, ORBee Consulting
Stephen Shrewsbury, Shrewd Consulting LLC
Leigh Shultz, Executive Director, Global Project Management, Merck & Co., Inc.
Jeffrey Shuren, Director, CDRH, FDA
Donald Sickler, Group Account Supervisor, CAHG
Debra Silberg, Senior Director, Clinical Medicine, Shire Specialty Pharmaceuticals
Ronit Simantov, Senior Director, US Medical Affairs, Oncology, Pfizer Inc
C. Grant Simmons, Director, Clinical Systems Innovation, Novartis Pharmaceuticals Corporation
Arpad Simon, Site Head, Drug Safety, Global Development Safety Evaluation Center, Mitsubishi Tanabe Pharma Development America
Joseph Singer, Vice President, Clinical Affairs, HealthCore Inc., a subsidiary of WellPoint Inc.
Mary Ann Slack, Deputy Director, Office of Planning and Informatics, CDER, FDA
Jennifer Sliwa, Director, CNS Medical Information, Janssen Scientific Affairs, LLC
David Small, Research Advisor, Global Pharmacokinetics/Pharmacodynamics, Eli Lilly and Company
Nancy Smerkanich, Program Specialist/Doctoral Candidate, University of Southern California
Julie Smiley, Director, Product Management, SOA Software
Nancy Smith, Adjunct Professor at Temple University, FDA Alumni Association
William Smith, President & Principle Investigator, New Orleans Center For Clinical Research
Kristen Snipes, Senior Project Manager, Rho, Inc.
Mike Sobczyk, Senior Director, Regulatory Compliance, Gilead Sciences, Inc.
Dana Soloff, Senior Director, Standards and Architecture, Genzyme Corporation, A Sanofi Company
Stephen Sonstein, Director, Clinical Research Administration Program, Eastern Michigan University
Bryan Souder, Associate Director, Project Management, Merck & Co., Inc.
Stuart Sowder, Vice President, External Medical Communications, Pfizer Inc
Reisa Sperling, Director; Professor, Neurology, Harvard Medical School, Brigham and Women's Hospital and Massachusetts General Hospital
Kenneth Sprenger, Executive Director, Medicine Team Leader, Pfizer Inc
Jane Springer, Principal Specialist, Medical Relations and Information, Amylin Pharmaceuticals, LLC
Eric Staib, Senior Director, IT Quality Systems, RPS, Inc.
Raymond Starrett, Senior Director, Project Management Operations, Ikaria, Inc.
Komathi Stem, Senior Director, Product Development, Innovation Lead, Genentech, A Member of the Roche Group
Stella Stergiopoulos, Project Manager, Tufts Center for the Study of Drug Development
Tim Steven, Global Alliance Leader, Scientific Sourcing, Roche Products Ltd.
Charles Stevens, Vice President and General Manager, PAREXEL Consulting
Lise Stevens, Project Manager, Bioinformatics Support Staff, CBER, FDA
Fraser Stodart, Senior Director, Global Regulatory Affairs, Emerging Markets, Eisai Limited
Teri Stokes, Director, GXP International
Andrew Storey, Head, Regulatory Affairs Area and Affiliate Strategy, US/Canada, AbbVie
David Strauss, Medical Officer, Office of Science and Engineering Laboratories, CDRH, FDA
Jeffrey Stuart, Director, Regulatory Affairs, Novartis Pharmaceuticals Corporation
Ling Su, Strategic Advisor, Life Sciences, Sidley Austin LLP
Linda Sullivan, Vice President of Operations, Metrics Champion Consortium
Marshall Summar, Chief, Genetics and Metabolism, Children's National Medical Center
John Sun, Novartis Pharmaceuticals Corporation
Stacy Surensky, Principal, Sustained Cultural Integration
Douglas Swain, Senior Functional Manager, Northeast Region, Genentech, A Member of the Roche Group
Fergus Sweeney, Head of Sector, Compliance and Inspection, European Medicines Agency, European Union
, Special Counsel, Duane Morris, LLP
David Tainsh, Chief Product Quality Officer, Governance, Ethics and Assurance, GlaxoSmithKline
Rudolph Tanzi, Head, Genetics and Aging Research Unit; Prof, Neurology, Harvard Medical School, Massachusetts General Hospital
Mathew Taylor, Senior ICT Strategist and Architect, Intel, Inc.
Russell Teagarden, Senior Vice President, Medical and Scientific Affairs, National Organization For Rare Disorders (NORD)
Judith Teall, Exco InTouch
Jan Teller, Science Officer, Dystonia Medical Research Foundation
Robert Temple, Deputy Center Director for Clinical Science, CDER, FDA
Pamela Tenaerts, Executive Director, Clinical Trials Transformation Initiative (CTTI), Duke Translational Medicine Institute
Marcia Testa, Senior Lecturer, Harvard School Public Health
Michael Thien, Senior Vice President, Global Science, Technology and Commercialization, Merck & Co., Inc.
Ram Tiwari, Associate Director, Office of Biostatistics, OTS, CDER, FDA
Paolo Tomasi, Head of Paediatric Medicines, European Medicines Agency, European Union
François Torche, CEO, Cluepoints
Maria Torres, Clinical Research Manager, RPS Colombia LTDA
Alan Touch, Consultant
Karen Towns, Senior Director and Global Head, Publishing and Product License Support, Pfizer Inc
Walter Townsend, Director, Quality Assurance, DATATRAK International, Inc.
Andrew Townshend, Vice President, Alliance Development, INC Research
William Trepicchio, Senior Director, Molecular Medicine, Division of Translational Medicine, The Takeda Oncology Company
Gianluca Trifiro, Assistant Professor, Dept of Clinical and Experimental Medicine and Pharmacology, University of Messina
Mark Trusheim, Executive in Residence and Visiting Scientist, Massachusetts Institute of Technology, Sloan School of Management
Troy Trygstad, Vice President, Pharmacy Programs, Community Care of North Carolina
Tracy Tsuetaki, Group President, Life Sciences, OptumInsight
Atsushi Tsukamoto, Director, Global Project Management, Daiichi Sankyo Co., Ltd.
Sara Tullberg, Senior Project Leader, PAREXEL International
Nicole Turner, Associate Director, Global Feasibility, Quintiles Inc.
Daniel Ulrey, President and CEO, Midwest Clinical Support, Inc.
Laszlo Urban, Head, Preclinical Safety Profiling, Novartis Institutes for Biomedical Research
James Valentine, Program Analyst, Office of Health and Constituent Affairs, OC, FDA
Spiros Vamvakas, Head of Scientific Advice, Human Medicines Special Areas, European Medicines Agency, European Union
Jim Vandergriff, Pharmaceutical Project Management, Eli Lilly and Company
Shyla VanReenen, Senior Manager, Clinical Operations, Synteract, Inc.
Jose Vega, Vice President, Global Safety, Amgen Inc.
Jurgen Venitz, Professor, Pharmaceutics, Virginia Commonwealth University
Thirunellai Venkateshwaran, Director Pharma Technical Regulatory, Genentech, A Member of the Roche Group
Guy Villax, Chief Executive Officer, Hovione
Marianne Vogt, Manager, Regulatory Operations (EUCOC), Abbott GmbH & Co. KG
Inessa Volonueva, Associate Director, Medical Information, Janssen Scientific Affairs, LLC
George Vradenburg, Co-Founder/President, USAgainstAlzheimer's
Tad Waddington, CEO, Lasting Contribution ? LLC
Steven Walker, Co-founder, Abigail Alliance
Stuart Walker, Founder, Centre For Innovation In Regulatory Science (CIRS)
Ivan Walrath, Process Owner, Trial Master File, Pfizer Inc
Mey Wang, Reviewer, Division of New Drugs, Center for Drug Evaluation
Sue-Jane Wang, Assoc. Dir., Adaptive Design & Pharmacogenomics, OB, OTS, CDER, FDA
Kimberly Washburn, Director, Quality Assurance, Quintiles Transnational Corp.
J. Kyle Wathen, Director, Janssen Research & Development, LLC
Lynn Webster, Medical Director, CRI Lifetree
Neil Weisman, Executive Vice President and General Manager, Blue Chip Patient Recruitment
Joel Weissman, Associate Professor, Health Policy, Harvard Medical School
Keith Wenzel, Senior Director, Global Alliances, Perceptive Informatics
Kimberly Westrich, Director, Health Services Research, National Pharmaceutical Council
Mary Westrick, Vice President, US Phase I, Quintiles Inc.
James Wetzel, Principal Consultant, Pharmica Consulting
Robin Whitsell, President, Whitsell Innovations, Inc.
Nancy Widener, Executive Director, Clinical Science and Operations, Bristol-Myers Squibb Company
Beat Widler, Managing Partner, Widler & Schiemann AG
Sandra Wiejowski, Senior Director, Global Medical Review, Abbott Laboratories
Marc Wilenzick, Consultant, Core Risks, Ltd
Linda Wilhelm, Consumer Advisory Council, Canadian Arthritis Network
Kelly Willenberg, Consultant, Kelly Willenberg, LLC
Leslie Williams, Director, Founder, President and Chief Executive Officer, ImmusanT
Rebecca Williams, Assistant Director, ClinicalTrials.gov, National Library of Medicine, National Institutes of Health (NIH)
Pamela Williamson, Senior Vice President, Global Head, Regulatory Affairs and Compliance, Genzyme Corporation, A Sanofi Company
Kevin Wilson, Root Cause Analysis and CAPA Quality Consultant, ASQ Certified SixSigma, Eli Lilly and Company (via Rockwell Automation)
Paul Wilson, Vice President, Catalina Health
Stephen Wilson, Director, Division of Biometrics III, Office of Translational Science, CDER, FDA
Susan Winkler, Assistant US Attorney, US Attorney's Office, District of Massachusetts
Barbara Winrich, Senior Clinical Research Program Manager, Massachusetts General Hospital
Robin Winter-Sperry, President and CEO, Scientific Advantage LLC
Christa Wirthumer-Hoche, Deputy Head, Austrian Medicinal and Medical Device Agency (AGES)
Janet Wittes, President, Statistics Collaborative Inc.
Douglas Wixted, Informatics Project Leader, Duke Translational Medicine Institute
Diane Wold, Director, Data Standards, GlaxoSmithKline
Vera Wolowodiuk, Vice President, Product Development, Nora Therapeutics
Linda Wood, President, MedWrite, Inc.
Tam Woodrum, Executive, Software, GE Healthcare
Liz Wool, President and Chief Executive Officer, QD-Quality and Training Solutions Inc.
Marta Wosinska, Director for Economics Staff, Office of Planning and Analysis, CDER, FDA
Craig Wozniak, Head, Americas Clinical Operations, GlaxoSmithKline
Jack Xu, Senior Vice President, Shanghai Clinical Research Center (SCRC)
Takao Yamori, Director of Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency (PMDA)
Peiling Yang, Team Lead, Division of Biometrics I, Office of Biostatistics, OTS, CDER, FDA
Jeffrey Yap, Senior Diagnostic Physicist, Dana-Farber Cancer Institute
Tamar Yarkoni, Manager, Medical Information, Sanofi
Naoyuki Yasuda, International Planning Director, Pharmaceutical Affairs, Minister's Secretariat, Ministry of Health, Labour and Welfare (MHLW)
Robert Yetter, Associate Director for Review Management, Office of the Director, CBER, FDA
Kyung-Sang Yu, Associate Professor, Clinical Pharmacology, Seoul National University College of Medicine
Lianng Yuh, Vice President, Quantitative Sciences, Endo Health Solutions
Ivan Zhai, CEO, GCP CMIC ClinPlus Co., Ltd.
Julia Zhang, Associate Director, Sanofi
Jinglin Zhong, Mathematical Statistician, Office of Biostatistics, OTS, CDER, FDA
John Ziegler, Medical Director, Premier Research Group
Anne Zielinski, Global Lead, Patient Cloud, Medidata Solutions Worldwide
Joe Zimmerman, Senior Director, R&D Business Operations, Amylin Pharmaceuticals, Inc.
Martine Zimmermann, Executive Director, Global Regulatory Affairs, Alexion Pharma International Sàrl
James Zuazo, Senior Biostatistician, MMS Holdings Inc.
Jonathan Zung, Vice President, Head of Global Development Operations, Bristol-Myers Squibb Company