Faculty List

Lynne Becker, MSPH, National Project Manager, Weight Management Center Department of Psychiatry and Behavioral Sciences, Medical University of South CarolinaCarol Breland, MPH, Research Recruitment Director, NC TraCS Institute, UNC Chapel Hill

Rebecca Carew, Sr. Manager – Process Management, Purdue Pharma L.P.

Diarmuid De Faoite, Communication & Education Manager, AO Documentation and Publishing Foundation, AO Foundation

M. Peggy Fay, Ph.D., RN, CCRC, CRA, Director, Global Clinical Monitoring, Medtronic Clinical Operations, Medtronic, Inc.

Stuart Halasz, Associate Director, Clinical Quality Management, Merck Research Laboratories

Megan Jung, Regional CRA Manager, Clinical Studies, BIOTRONIK

Eddy Lyons, CCRP, Senior Clinical Research Associate, Clinical Studies Department, Biotronik, Inc.

Jessica Masarek, Quality Assurance Consultant, Muse Clinical

Angie Maurer, BSN, MBA, CCRA – Clinical Operations Consultant, Gilead Sciences, Inc.Brian Nugent, BSN, DC – Associate Director, Clinical Operations, Gilead Sciences, Inc.

Rosanne Petros, PMP, Associate Director, Clinical Research, Clinical Research Manager US Global Clinical Trial Operations, The Americas, Merck Research Laboratories

Erika Stevens, MA, Senior Manager, Healthcare Advisory Practice, Ernst & Young, LLP

Linda B. Sullivan, Co-Founder & President, Metrics Champion Consortium (MCC)

Linda Tedder, Director, US Clinical Project Management, Clinical Operations, DePuy Synthes

> Vendor Management in Clinical Trials

Beverly Brown, Manager, Global Regulatory Quality (GCP and PV), Allergan

Donelle Bussom, RN, MSN, Senior Director, Medical and Safety Services, ICON Clinical Research

Jennifer Gaskin, CCRP, Operations Director, Clinical Operations, Alliance for Clinical Trials in Oncology (Alliance Foundation Trials, LLC)

Michael Howley PA-C, PhD, Physician Assistant – Certified Faculty Coordinator, MBA Healthcare Concentration, Associate Clinical Professor, Department of Marketing, LeBow College of Business, Drexel University

Vinita Leslie, M.A., Director, Trial Master File Process Owner, Knowledge, Records & Information Strategies, Biogen Idec

Erik Olson, MPH, Clinical Trials Oversight Manager (CTOM), Amgen Inc.

Joe Pollarine, Director Quality Monitoring & Compliance - Bioresearch Q&C, Janssen R&D – Springhouse US

Valerie Rosemond, Quality Assurance, Johnson & Johnson Vision Care

Peter Schiemann, Ph.D., Managing Partner, Widler & Schiemann Ltd.

Linda B. Sullivan, Co-Founder & President, Metrics Champion Consortium (MCC)

Erika Vento, MBA, Clinical Trials Oversight Manager (CTOM), Amgen Inc.

Liz Wool, RN, BSN, CCRA, CMT, President and CEO, QD-Quality and Training Solutions, Inc.

Nicole Yingst, MBA, CCRP, Patient Recruitment Specialist II, PAREXEL International

> Clinical Auditing Forum

Beverly Brown, Manager, Global Regulatory Quality (GCP and PV), Allergan

Rita Farrell, Compliance Specialist, Global Quality & Regulatory Compliance – Clinical Trials & Safety (GQRC-CT&S), Bristol-Myers Squibb

Federico Feldstein, J.D., Vice President, Medical Regulatory Compliance, Pfizer, Inc.

Bob Figarotta, Sr. Manager, Clinical, Allergan

Dirk Gille, Vice President, Head Bioresearch QA, Janssen R&D, Belgium

Dr. Barbara Heumann, Managing Director, GXP-Engaged Auditing Services GmbH

Janis A. Little, MS, Vice President, Global Regulatory Quality, Janis A. Little, MS, Vice President, Global Regulatory Quality, Allergan

Jeanne M. Mattern, Ph.D., Director, QHS Regulatory Compliance Office, Section Head QHS Clinical Research Informatics, Business Intelligence/OHCD Compliance, Cleveland Clinic

Jerri B. Perkins, M.D., Former Medical Officer, FDA

Debra Ploss, Quality Manager, GXP-Engaged Auditing Services GmbH

Robert Romanchuk, Principal, Clinical Research Advisors, LLC

Denise Shelly, NIHJohanna L. Stamates, RN, MA, CCRC, CHRC, Executive Director, RCQA (Research Compliance and Quality Assurance), University of Miami

Linda B. Sullivan, Co-Founder & President, Metrics Champion Consortium (MCC)

> Clinical Project Management Forum

Moe Alsumidaie, MBA, MSF, Chief Data Scientist, Annex Clinical

Betsy Fallen, Global Head of Program and Business Development, SAFE-BioPharma Association

Jennifer Gaskin, CCRP, Operations Director, Clinical Operations, Alliance for Clinical Trials in Oncology (Alliance Foundation Trials, LLC)

Dirk Gille, Vice President, Head Bioresearch QA, Janssen R&D, Belgium

Donna Holloway, Director, Clinical Project Management, Quintiles

Michael Howley PA-C, PhD, Physician Assistant – Certified Faculty Coordinator, MBA Healthcare Concentration, Associate Clinical Professor, Department of Marketing, LeBow College of Business, Drexel University

Greg Koski, Ph.D., M.D., Co-Founder & President, ACRES; former Director, Office for Human Research Protections, U.S. Department of Health and Human Services

Patricia Nowowieski, Head, Global Clinical Operations, Cambridge, Global Clinical Operations, Alexion Pharmaceuticals

Rosanne Petros, PMP, Associate Director, Clinical Research, Clinical Research Manager US Global Clinical Trial Operations, The Americas, Merck Research Laboratories

Roland Rich, Quality & Compliance Excellence, Operations Expert, DevQA, Novartis

Peter Schiemann, Ph.D., Managing Partner, Widler & Schiemann Ltd.

Mollie Shields-Uehling, President and CEO, SAFE-BioPharma Association

Lynnette Wright, Global Contracts & Outsourcing Lead (GCOL), Astellas Pharma Global Development, Inc.