Current List of Speakers

DIA 2013 49th Annual Meeting 

As of May 21, 2013

Search Program

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

Chris Bruenger, 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

Bradley Carlin, Professor and Head of Biostatistics, University of Minnesota

Daniel Carnese, CEO, KDH Systems

Nancy Carter-Foster, Senior Advisor, US Department of Commerce

Elisa Cascade, Vice President, Global Head of Operations, Quintiles Inc.

Frank Cattie, Vice President, Trial Planning Solutions, Medidata Solutions Worldwide

Travis Caudill, Director, Feasibility & Site Identification, INC Research

Catherine Celingant, 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

Joan Chambers, 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

Neil Ferguson, 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.

Bray Patrick-Lake, 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

Michael Swit, 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,, 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

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