Clinical Trial Risk Management Using Decision Analytics

Coleen Glessner, Vice President, Clinical Trials Process & Quality Pfizer Inc.

As Vice President, Head of Clinical Trial Process and Quality (CTPQ), Coleen Glessner leads Pfizer’s GCP quality management system to ensure that the portfolio of clinical trials meets the highest standards of quality, compliance, and process excellence. CTPQ is also accountable for processes and controls that include SOPs, training, metrics and quality assessments. Most recently, she has been focused on building quality into Pfizer’s partnerships and driving a culture of quality.

Brian W. Hagen, Ph.D., Managing Director, Decision Empowerment Institute

Brian Hagen is a founder and Managing Director of the Decision Empowerment Institute. He is an internationally acknowledged authority and advisor in the field of decision and risk analysis as well as an author, educator, and frequent speaker. He is the winner of the 2011 Risk Innovator of the Year for the PRO Enterprise Management Methodology awarded by Risk & Insurance Magazine. Dr. Hagen has been a practicing decision and risk consultant for over 25 years providing consulting, coaching, and training to more than 30 corporations in the Fortune 200 and numerous mid-size corporations for the automotive, biotech, defense, energy, enterprise applications, high-tech, information and media, oil, pulp and paper, and Pharmaceuticals industries.

Dr. Hagen holds a Ph.D. in decision and risk analysis from Stanford University.

Ann Meeker O'Connell, Senior Director, Clinical Strategy Strategic Development QA, Janssen Research & Development LLC

Ann Meeker-O’Connell is the Senior Director for Clinical Strategy in Janssen’s R&D Quality & Compliance organization. Prior to joining Janssen, she served as the Acting Division Director for Good Clinical Practice Compliance in the Office of Scientific Investigations (OSI), Office of Compliance (OC), Center for Drug Evaluation and Research (CDER) at FDA. In this role, Ms. O’Connell led CDER’s compliance and enforcement program for clinical trials, developed regulatory policy related to risk-based clinical trial oversight and quality, and was closely engaged in initiatives to facilitate innovation in clinical development. Ann served as the FDA lead for a Clinical Trials Transformation Initiative (CTTI) Quality by Design project seeking to developing efficient models for building quality into the scientific and operational design of trials.

Previously, Ms. O’Connell served as OSI’s Acting Associate Director for Risk Science, Intelligence, and Prioritization, leading a team developing risk-based analytic tools for pre- and post-marketing compliance activities and Sr. Policy Advisor, CDER, OC, Division of Scientific Investigations. Before joining FDA, she worked in clinical and compliance roles in industry and academia, where she was responsible for designing and implementing NIH-funded trials, designing and implementing a risk-based global clinical systems audit program, working on enterprise risk management framework, and developing and evaluating clinical trial and healthcare compliance policies and procedures. Ms. O’Connell is a certified ISO31000 Risk Management Professional.

Steve Whitaker, Executive Director, The Avoca Quality Consortium The Avoca Group

Steven Whittaker is Executive Director, for The Avoca Quality Consortium and Senior Consultant for the Avoca Group, where he conducts Quality Workshops, Executive Level Consulting for Pharmaceutical Quality, Clinical Development, Project Management, Sourcing, Alliance and Relationship Management. His wealth of experience through years of drug development leadership roles and his established network with professionals across these industries provide a unique and valuable combination of insights for organizational leaders.

Mr. Whittaker has served for 12 consecutive years on the Advisory Board for the annual Partnerships in Clinical Trial program, chairing the board for 2 years. In addition, he has moderated numerous quarterly Clinical Research Consortium forums, developing strategic agendas and facilitating the exchange of leadership concepts between clinical development executives across several top-tier Pharmaceutical and biotech organizations. Mr. Whittaker retired from Eli Lilly and Company in December 2009 where he served as Chief Operating Officer/Sr. Director of Operations and Project Management for the Cardiovascular/Acute Care Platform. As the leader of the Global Clinical Research Sourcing Office, Mr. Whittaker established Lilly’s first corporate strategy and operational design for outsourcing global clinical development to CRO preferred partners. This included the selection and initial implementation of the preferred partner approach for global, full-service CRO capabilities. Mr. Whittaker also led Lilly’s Project Management Center of Excellence, establishing standards for leaders of project development.