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Tuesday, June 28 • 10:30am - 11:30am
#218: Lessons Learned from Eight Years of Drug Development Tool/Novel Methodology Qualification

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Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-548-L04-P; CME 1.00; IACET 1.00; RN 1.00

Innovative tools/methods acceptable to drug developers and regulators require focused development strategies for necessary evidence. This session presents case studies illustrating what has been learned to achieve success based on real examples.

Learning Objectives

Discuss the importance of consortia in advancing biomarkers, modeling, and simulation tools that inform drug development; Describe through a lessons learned approach on reaching consensus on the science (e.g. data sharing, governance procedures); Identify and help scientists understand the competencies and expectations involved in development of novel tools and methodologies.


Martha Ann Brumfield, PhD


FDA Perspective
ShaAvhree Y. Buckman-Garner, MD, PhD

avatar for Martha Brumfield

Martha Brumfield

President and Chief Executive Officer, Critical Path Institute
Martha A. Brumfield, PhD, heads the Arizona-based non-profit in its mission to catalyze the development of new tools to advance medical product innovation and regulatory science. She has 20 years’ experience at Pfizer most recently as senior vice president of worldwide regulatory... Read More →

avatar for ShaAvhree Buckman-Garner

ShaAvhree Buckman-Garner

Director, Office of Translational Sciences, CDER, FDA
ShaAvhrée Buckman-Garner, MD, PhD, FAAP is the Director of the Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), at the FDA. Prior to serving as Director of OTS, Dr. Buckman-Garner served as Deputy Director for OTS and as medical team leader in the... Read More →
avatar for Emer Cooke

Emer Cooke

Head of International Affairs, European Medicines Agency, European Union
Ms. Cooke holds a MSc in Pharmaceutical Chemistry and an MBA from Trinity College, Dublin. Emer joined EMA as Head of Inspections in Jul. 2002. In Jan. 2009, Emer was appointed first International Liaison Officer for EMA. In July 2012 becomes the Head of Int. and European Cooperation... Read More →

Tuesday June 28, 2016 10:30am - 11:30am EDT
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Forum