Institute for International Research

Chair's Welcoming Remarks

Paul A. Frohna,MD, PhD, PharmD, Senior Director, Clinical Development, Head, Clinical Pharmacology and Drug Safety
FIBROGEN, INC.

Pushing the Innovation Envelope: Increasing Speed-To-Decision

Kenneth I Kaitin, PhD, Director
TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT,
Associate Professor of Medicine,
TUFTS UNIVERSITY SCHOOL OF MEDICINE

Part I: A Paradigm Shift in the Works – Translational Medicine and Pharmacogenomix in Phase I Clinical Trials

Giora Feuerstein MD, Head, Discovery Translational Medicine
WYETH RESEARCH

Part II: How can Working with Patients Earlier in Phase I will get you to Proof of Concept Faster?

Paul A. Frohna,MD, PhD, PharmD, Senior Director, Clinical Development, Head, Clinical Pharmacology and Drug Safety
FIBROGEN, INC.

Lawrence Brownstein, Chief Administrative Officer
CRI WORLDWIDE

Part III: How to Choose the Most Viable Candidate to Invest In? Optimizing Economics

Sam Holtzman, PhD, CEO
ROSA PHARMACEUTICALS, INC.

Track A:
Preclinical Data and
Using it to Maximize Phase I Studies

Track Chair:
Bruce H. Morimoto, PhD, ALLON
THERAPEUTICS INC.

Track B:
Innovative Trial Design and Management

Track Chair:
B. Nebiyou Bekele, PhD,
UNIVERSITY OF TEXAS M.D.
ANDERSON CANCER CENTER

Track C:
QT Studies – Is This the Only Effective Method to Measure Cardiac Safety?

Track Chair:
Philip Sager
ASTRAZENECA

What is Needed to Bring a Product to Phase I?

Stephen Freestone, MD, Medical Director
CHARLES RIVER CLINICAL SERVICES

Innovative Trial Design for Phase I Oncology Trials

B. Nebiyou Bekele, PhD, Associate Professor,
Research Statistician Coordinating Supervisor,
UNIVERSITY OF TEXAS M.D. ANDERSON CANCER CENTER

Overview of ICG E14, the Thorough QT Study

Philip Sager, Executive Director of Cardiovascular Research, ASTRAZENECA

Do's And Don'ts In Early Drug Development

Stéphane Lamouche, PhD, Project Manager, Drug
Development, Scientific and Regulatory Affairs,
ANAPHARM, A PHARMANET COMPANY

Case Study: Incorporation of Translational Medicine into Phase I

Judy Fox
Senior Director
SUNESIS PHARMACEUTICALS 

Regulatory, Procedural, and Statistical Considerations in the Thorough QT Study:The Complexity of the Design of a Thorough QT Study

Charles M. Beasley, Jr., MD, FFPM, Distinguished Lilly Scholar, Chief Scientific Officer, Global Product Safety
ELI LILLY AND COMPANY

Networking Break

Bridging Preclinical to Phase I: A Case Study for an Intranasal Delivered CNS Drug

Bruce H. Morimoto, PhD, Vice President, Drug Development
ALLON THERAPEUTICS INC.

Does the Use of Biomarkers Change the Utility of Intensive Medical Monitoring in Early Clinical Development?

Jonathan Sackner-Bernstein
Chief Medical Officer
CLINILABS

Implications of Cardiac Safety Testing in Phase I Clinical Trials

Christopher H. Cabell, MD MHS FACC, Director ECG / Echocardiography Core Laboratory
DUKE CLINICAL RESEARCH INSTITUTE