Trk 11: Quality in CT/GCP [
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8:30am EDT
#114: Bringing the Trial to the Patient: Making the Patient Voice Central from Trial Design Onward
Chair
Assistant Commissioner for Minority Health, Office of the Commissioner, FDA
Dr. Bull worked at the FDA from 1994 to 2006. She served as Director of Clinical Regulatory Policy at Genentech and as Vice President for US Regulatory Policy at Novartis, returning to FDA in 2012 to serve in the Office of the Commissioner as Assistant Commissioner for Minority H...
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Speakers
Senior Advisor, Clinical Innovation, Eli Lilly and Company
Joseph Kim serves as a Senior Advisor in Clinical Innovation at Lilly, focusing on innovative patient engagement solutions. He has spent over 17 years in the Pharma industry, recognized as one of “Top 100 individuals on the 2015 MedicineMakers Power List, and “20 Innovators Changing...
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Associate Director, Clinical Outcome Assessments Staff, OND, CDER, FDA
Dr. Papadopoulos serves as the Associate Director of the Clinical Outcome Assessments Staff in the Office of New Drugs in the Center for Drug Evaluation and Research (CDER). The staff provides consultation to CDER’s Review Divisions as well as other FDA Centers on clinical outcome...
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Founder and President, Patient Advocate
Jane Perlmutter is long-term cancer survivor, involved in a wide-range of advocacy which is rooted in her own experiences, but also informed by her formal training and professional experience. She focuses on clinical trials--ensuring the patient voice is considered in selection of...
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Monday June 27, 2016 8:30am - 9:45am EDT
204A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
10:45am EDT
#137: Using Technology to Make Trials Accessible to More Clinical Trial Participants
Chair LC
Director, Human Research Protection Program, Yale University
Ms. Coleman is the Director of the Human Research Protection Program at Yale University. Prior to joining Yale, she was the Vice President of Regulatory and Legal Affairs at Quorum Review and an attorney at Bennett Bigelow & Leedom. Ms. Coleman has experience in research ethics, regulatory...
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Speakers
Principal, Global Compliance and Strategy, Medidata Solutions
Phil Coran is a Principal of Global Compliance & Strategy at Medidata. Prior to joining Medidata, Phil was at Pfizer for 12 years in the Medical Quality Assurance and Internal Audit groups. From 1999-2001, Phil was an IT Risk Consultant at Deloitte & Touche & Arthur Andersen accounting...
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Consultant, Innovation Lead, Eli Lilly and Company
Kevin works in the Clinical Innovation group at Lilly as an Innovation Lead focused on implementing eConsent and other technologies across the Lilly portfolio. Kevin participated in the CTTI Informed Consent project and is currently a member of the TransCelerate eConsent project...
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Monday June 27, 2016 10:45am - 12:00pm EDT
204A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA