ICH E6 R2 – Guidance and road map of tools for navigating the regulatory landscape

Steven Whittaker, Executive Director, Avoca Quality Consortium, Senior Consultant, The Avoca Group

Steven Whittaker has significant expertise in pharmaceutical development, clinical development, project management, outsourcing strategies and execution plans. He currently serves as Executive Director for the Avoca Quality Consortium. Whittaker has moderated numerous Clinical Research forums, developing strategic agendas and facilitating the exchange of leadership concepts between clinical development executives across several top-tier pharmaceutical and biotech organizations.

Whittaker retired from Eli Lilly and Company in December 2009, where he served as COO/Sr. Director of Operations and Project Management for the Cardiovascular/Acute Care Platform.  He was accountable for leadership and delivery of all global Phase III and IV Cardiovascular/Acute Care development portfolio projects. In addition to other managerial roles with Lilly, Whittaker also led Lilly’s Project Management Center of Excellence, establishing standards for leaders of project development.

Ellen Kelso, Senior Consultant, The Avoca Group

Ellen Kelso is a business executive and advisor in developing strategic and operational frameworks for regulatory affairs, applied ethics (aka Good Clinical Practices(“GCP”)) and knowledge management.  She has more than 35 years of experience in the pharmaceutical industry serving clinical operations, domestic and international regulatory affairs, and human subject protections. Her experience includes managing worldwide regulatory strategies; providing GCP education and training; and establishing electronic performance, quality, submission, and knowledge management systems.

Ms. Kelso began her career at Eli Lilly and Company in clinical operations, followed by facilitating worldwide product registration strategies and global labeling development.  She established Lilly’s initial simultaneous worldwide marketing authorization submissions strategy and served as the worldwide regulatory point person for Humulin products.  Subsequently she served a global CRO, Kendle International, leading regulatory affairs. Following Kendle, she founded and led Goodwyn IRB, within which she established an extensive GCP education program for sponsors and investigators.

Kristin Mauri, Global Head – Risk Based Monitoring, Bioclinica

Kristin Mauri, MBA, PMP, heads Bioclinica’s global risk-based monitoring (RBM) practice and maintains responsibility for the technology and services practices. Ms. Mauri brings to Bioclinica more than 20 years of clinical operations experience and eClinical technology implementation for pharma, biotech and CRO organizations. Prior to joining Bioclinica, Ms. Mauri was Director, Product Strategy at Oracle Health Sciences where she was responsible for growing both the technology partnership program, as well as leading the risk-based monitoring strategy. A recognized thought leader and industry speaker, Ms. Mauri has presented broadly on clinical operations topics within the realm of emerging eClinical technology. Ms. Mauri’s educational credentials include an MBA from Lake Forrest Graduate School of Management, MGH Boston master’s program coursework in Clinical Investigations, and a bachelor’s degree from Pennsylvania State University.