The scientific program includes keynotes by leading researchers in the field and selected presentations of contest dataset analyses. The two-day meeting will also feature a social dinner with and opportunities for informal discussions.

Program (tentative)

Saturday, 7 July 2018

08:15 ISMB Welcome
08:30 ISMB keynote
09:30 Coffee break
10:00 CAMDA Welcome
10:05 CAMDA Keynote
11:00 The CAMDA Challenges
19:30 CAMDA Dinner

Sunday, 8 July 2018

08:15 ISMB Welcome
08:30 ISCB 2017 Overton Prize Award Keynote
09:30 Coffee break
10:00 CAMDA Welcome
17:00 Panel discussion: key insights & future challenges
17:40 Award of the Camda Trophy
17:50 Closing remarks, invitation to contribute to special proceedings issue

Keynotes

Lawrence J. Lesko, PhD

Emeritus Professor and Founding Director of the Center for Pharmacometrics and Systems Pharmacology at the University of Florida, U.S.A.
Presentation Title: TWhy You Should Care (A Lot) About Real World Evidence?

Abstract: Healthcare problems need technology solutions. Clinicians expect to understand how a new therapeutic intervention will perform in the real world – the actual medical practice setting outside the controlled environment of randomized controlled clinical trials. Real world data (RWD) comes from many sources, for example: electronic health records and patient chart reviews, off-label use of medications, adverse event databases, health monitoring devices, patient registries, pragmatic clinical trials and payer claims databases. Many researchers, corporations and government institutions, including the Food and Drug Administration, are eager to tap into these RWD streams in order to provide answers to questions about the efficacy and safety of medicines. RWD, in and off itself, is meaningless until critical context is added which transforms RWD into useful information. Technology, in turn, can analyze this information to yield real world evidence (RWE) that can be used to answer carefully framed scientific and clinical questions. This presentation will show how technology and RWE can be used to support decision-making with an emphasis on opportunities in drug development and regulatory science.

Short Bio: Dr. Lawrence J. Lesko is currently Emeritus Professor and Founding Director of the Center for Pharmacometrics and Systems Pharmacology at the University of Florida College of Pharmacy at Lake Nona (Orlando). He started the Center in 2011 and served as its full-time Director for 5 years. He continues part-time in the Center and officially retired in February 2018. He now serves as a consultant to pharmaceutical companies and healthcare organizations. Dr. Lesko, starting in 1995, became the first director of the Office of Clinical Pharmacology (OCP) in the Center for Drug Evaluation and Research at the Food and Drug Administration. His tenure as Office Director was for 16 years until his retirement in 2011. At the FDA, Dr. Lesko formed a pharmacological mechanism-based drug safety assessment team to analyze the root cause of adverse drug events. This program used mechanistic approaches to understand off-target drug effects using bioinformatics strategies. He also led the advancement of precision medicine through the update of labels of previously approved drugs with new genetic information on safety, dosing and efficacy. Dr. Lesko coauthored numerous Guidance for Industry including “Clinical Pharmacogenomics: Premarketing Evaluation in Early Clinical Trials” and “Pharmacogenomics Data Submissions”. He also started a Division of Pharmacometrics (i.e., Biosimulation) that is responsible for quantitative analysis of dose response and PK-PD (biomarkers) relationships to support optimal dosing in FDA approved drug labels, and the development of drug-disease models to support clinical trial simulations in drug development. Dr. Lesko has published more than 200 peer-reviewed manuscripts and is a frequent invited national and international speaker. In 2018, Dr. Lesko received the first FDA OCP Distinguished Alumni Lectureship Award for his contributions to clinical pharmacology. He was the recipient of the 2015 Leadership Award from the International Society of Pharmacometrics, the 2015 Agilent Technologies Thought Leader Award in Integrated Systems Toxicology and the 2014 AAPS Distinction in Biomarker Research Award. In 2011, he received the Gary Neil Prize for Innovation in Drug Development from the American Society of Clinical Pharmacology and Therapeutics (ASCPT). Dr. Lesko also was honored with the Rawls Palmer Progress in Medicine award from ASCPT, the Coriell Scientific Leadership Award for Personalized Medicine, the University of North Carolina Institute for Pharmacogenomics and Individualized Therapy Award for Clinical Service, and the Nathanial B. Kwit Distinguished Service Award for Clinical Pharmacology from the American College of Clinical Pharmacology.


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PAST KEYNOTE SPEAKERS

Atul Butte, MD, PhD
Atul Butte, MD, PhD
Stanford University School of Medicine

Nikolaus Rajewsky, PhD
Nikolaus Rajewsky, PhD
Max-Delbrück-Center for Molecular Medicine

Terry Speed, PhD
Terry Speed, PhD
The Walter and Eliza Hall Institute of Medical Research

Sandrine Dupoit, PhD
Sandrine Dudoit, PhD
University of California, Berkeley

John Quackenbush, PhD
John Quackenbush, PhD
Harvard School of Public Health

Eran Segal, PhD
Eran Segal, PhD
Weizmann Institute of Science

John Storey, PhD
John Storey, PhD
Princeton University

Chris Sander, PhD
Chris Sander, PhD
Memorial Sloan Kettering Cancer Center

Temple F. Smith, PhD
Temple F. Smith, PhD
Boston University

Curtis Huttenhower, PhD
Curtis Huttenhower, PhD
Harvard School of Public Health

Christopher E. Mason, PhD
Christopher E. Mason, PhD
Weill Cornell Medicine

Mick Watson, PhD
Mick Watson, PhD
The Roslin Institute

Lodewyk Wessels, PhD
Lodewyk Wessels, PhD
Netherlands Cancer Institute

Cesare Furlanello, PhD
Cesare Furlanello, PhD
Fondazione Bruno Kessler

IMPORTANT DATES
Intention to Submit due5 April 2018
FDA meta-analysis opt in due15 April 2018
Extended Abstract Proposals due13 May 2018
Notification of Accepted Contributions20 May 2018
Early Registration Closes7 Jun 2018
CAMDA2018 Conference7-8 Jul 2018
ISMB 2018 Conference6–10 Jul 2018
Full Paper Submission 24 Sep 2018
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