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Program Information

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  • Thursday, March 14, 2019, 2:30 PM - 4:30 PM: Physiologically Based Pharmacokinetic Modeling in Vulnerable Populations: Pregnant Women, Breastfeeding Infants, Neonates, and Young Children
  • Friday, March 15, 2019, 3:45 PM - 5:15 PM: The Future of Clinical Pharmacology: An Engaging Conversation with ASCPT Presidents
    


WEDNESDAY, MARCH 13, 2019 | 8:00 AM – 5:00 PM

Co-Sponsors: ASCPT, IQ Consortium, and the International Society of Pharmacometrics (ISoP)
Chairs: Cynthia J. Musante, PhD, Jane Bai, PhD, and Suzana Petanceska, PhD

Overview: 
Quantitative Systems Pharmacology (QSP) is an emerging field with increasing utilization in recent years. This full-day Pre-Conference will focus on applications of QSP in drug discovery, development, and regulatory reviews. Through presentations and panel discussions, this session aims to raise awareness amongst scientists and decision-makers in academia, the pharmaceutical and biotech industries, and regulatory/funding agencies on: 

  • The potential value of QSP in drug discovery, development, and review, as illustrated by recent case study examples; 
  • Real and perceived technical and operational challenges to implementing a QSP approach; and
  • Roadblocks and opportunities for greater adoption and acceptance. 
This session is aimed for a broad audience; if you are a clinician, executive, scientist, or part of a drug discovery or development team, please join us to find out how QSP can improve decision-making from targets to treatments.

Click here for agenda.
WEDNESDAY, MARCH 13, 2019 | 8:00 AM – 5:00 PM
Chairs: Liang Zhao, PhD, and Ping Zhao, PhD

Background:
The FDA and ASCPT have expressed a willingness to leverage their combined strengths for the joint development of the substantive actions of this pre -conference to raise awareness amongst scientists and decision-makers in academia, the pharmaceutical/biotech industry, and federal regulatory/funding agencies.

Goals and Objectives:
  • To provide a forum for open discussion on the challenges and critical role of PBPK for locally acting drug products in regulatory decisions. 
  • Recognize challenges and opportunities for PBPK with inhalation drug products, dermal drug delivery and ophthalmic drug products.   
  • Discuss challenges and opportunities for the community in enhancing PBPK models. 
Who Should Attend:
This ASCPT 2019 PBPK Modeling for the Development and Approval of Locally Acting Drug Products is intended for a diverse group of scientists from academia, industry, consulting, and regulatory agencies committed to improving drug discovery, development, and review who can benefit from an understanding of PBPK modeling for locally acting drug products. .
Click here for agenda.
Penny Heaton, MD
BILL & MELINDA GATES MEDICAL RESEARCH INSTITUTE, CAMBRIDGE, MA
From Molecule to Patient: A Global Health Perspective
THURSDAY, MARCH 14, 2019
9:00 AM – 10:00 AM

ASCPT welcomes Penny Heaton, MD as a State of the Art speaker. She has been a tireless advocate for combating inequities in health for over twenty years, with a passion for finding new and effective interventions against diseases affecting the world’s poorest people. Dr. Heaton’s career journey as a pediatric infectious disease physician spans from the Centers for Disease Control and Prevention to the pharmaceutical industry before joining the Bill & Melinda Gates Foundation in 2013 to lead the vaccine development team. Dr. Heaton recognized the need to disrupt global health by applying cutting-edge science and technology to combat age-old diseases in the world’s poorest populations. Now, she is charged with leading the Bill & Melinda Gates Medical Research Institute (Gates MRI)—a nonprofit biotech organization focused on thinking big, exploring novel ideas, collaborating across disciplines, and being fearless in its approach to scientific inquiry in ways that aren’t always possible in the private sector or in academic research labs. The institute’s focus is translational medicine, with the ambitious goals of eradicating malaria, accelerating the end of the tuberculosis epidemic, and ending diarrheal deaths in children.


James (Jay) Bradner, MD
NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH, CAMBRIDGE, MA
A New Science of Therapeutics for Undruggable Targets
FRIDAY, MARCH 15, 2019
9:00 AM – 10:00 AM

James (Jay) Bradner, MD President of the Novartis Institutes for BioMedical Research (NIBR), is welcomed as a State of the Art speaker. He is a member of the Executive Committee of Novartis.
Prior to joining Novartis, Dr. Bradner was on the faculty of Harvard Medical School in the Department of Medical Oncology at the Dana-Farber Cancer Institute in the United States. Dr. Bradner is a co-founder of five biotechnology companies and has authored more than 200 scientific publications and 30 US patent applications. Dr. Bradner is a graduate of Harvard University and the University of Chicago Medical School. He completed his residency in medicine at Brigham and Women's Hospital and his fellowship in medical oncology and hematology at the Dana-Farber Cancer Institute. He has been honored with many awards and was elected into the American Society for Clinical Investigation in 2011 and the Alpha Omega Alpha Honor Medical Society in 2013.


Robert S. Langer, Jr., ScD
MASSACHUSETTS INSTITUTE OF TECHNOLOGY, CAMBRIDGE, MA
From Molecule to Patient: A Biotech Perspective
FRIDAY, MARCH 15, 2019
1:00 PM – 2:00 PM

ASCPT welcomes Robert S. Langer, Jr., ScD, as a State of Art speaker. He is one of 13 Institute Professors at MIT (an Institute Professor is the highest honor awarded to a faculty member). His h-index of 259 is the highest of any engineer in history. He has over 1,300 issued and pending patents which have been licensed or sublicensed to over 350 companies. He served as Chairman of the US Food and Drug Administration’s SCIENCE BOARD (highest advisory board) from 1999-2002. Dr. Langer is one of a very few individuals elected to the National Academy of Medicine, the National Academy of Engineering, the National Academy of Sciences and the National Academy of Inventors. He is one of four living individuals to receive both the US National Medal of Science and the US National Medal of Technology and Innovation. In 2015, Dr. Langer received the Queen Elizabeth Prize for Engineering. He has also received the Draper Prize (considered the engineering Nobel Prize), Albany Medical Center Prize, Wolf Prize for Chemistry, Millennium Technology Prize, Priestley Medal (highest award of the American Chemical Society), Gairdner Prize, Kyoto Prize, Breakthrough Prize and the Lemelson-MIT prize, for being “one of history’s most prolific inventors in medicine.” He holds 33 honorary doctorates, including honorary degrees from Harvard and Yale.

Nancy J. Brown, MD
VANDERBILT UNIVERSITY, NASHVILLE, TN
ACE, DPP4 and NEP Inhibitors: Understanding Mechanism to Optimize Cardiovascular Benefit
THURSDAY, MARCH 14, 2019
10:30 AM – 11:30 AM

Dr. Brown serves as chair of the Vanderbilt Department of Medicine and physician-in-chief of Vanderbilt University Hospital. A graduate of Yale College and Harvard Medical School, Dr. Brown also leads a translational research program that focuses on developing new pharmacological strategies to prevent vascular disease in patients with high blood pressure and diabetes. Dr. Brown has worked to promote the career development of physician-scientists. She established the Vanderbilt Master of Science in Clinical Investigation in 2000. From 2006-2010, Dr. Brown served as the Associate Dean for Clinical and Translational Scientist Development and established infrastructure to promote the development of physician-scientists. Dr. Brown has served as a member of the NIH National Advisory Research Resources Council and currently serves National Heart, Lung, and Blood Advisory Council. Her research has been recognized by the American Heart Association (Harriet Dustan Award), the E.K. Frey-E. Werle Foundation, the American Society of Hypertension and the American Federation for Clinical Research. In 2018, she was named the Robert H. Williams, MD, Distinguished Chair of Medicine by the Association of Professors of Medicine. Dr. Brown is a fellow in the American Association for the Advancement of Science and a member of the American Society for Clinical Investigation, the American Association of Physicians, and the National Academy of Medicine.


Neal L. Benowitz, MD
UNIVERSITY OF CALIFORNIA SAN FRANCISCO, SAN FRANCISCO, CA
Electronic Cigarettes and the Debate on Tobacco Harm Reduction
FRIDAY, MARCH 15, 2019
2:15 PM – 3:15 PM

Neal L. Benowitz, MD, is Professor of Medicine and Bioengineering & Therapeutic Sciences, and Chief of the Division of Clinical Pharmacology and Experimental Therapeutics, University of California, San Francisco (UCSF). He received his medical degree from the University of Rochester School of Medicine in 1969, following which he served as a resident in internal medicine at the Bronx Municipal Hospital Center from 1969 to 1971. He then completed a postdoctoral fellowship in clinical pharmacology at UCSF and joined the faculty in 1974. His research interests have focused primarily on the human pharmacology and toxicology of nicotine. He has published more than 700 research papers. Dr Benowitz maintains an active clinical practice in cardiovascular medicine and medical toxicology. Dr Benowitz was a scientific editor of the 1988 United States Surgeon General’s Report on Smoking and Health: Nicotine Addiction; a scientific editor of the 2001 NCI Monograph 13 Report on Risks Associated with Smoking Cigarettes with Low Machine-Measured Yields of Tar and Nicotine; and served as section editor for the 2010 Surgeon General’s Report on How Tobacco Smoke Causes Disease. He, has served as a member of the National Institutes of Health Pharmacology Study Section and the FDA Nonprescription Drug and Tobacco Products Science Advisory Committees. He has served as President of the American Society for Clinical Pharmacology and Therapeutics and as President of the Society for Research on Nicotine and Tobacco. Dr Benowitz has received the Ove Ferno, Alton Ochsner, and Rawls-Palmer Progress in Medicine awards, and the Oscar B. Hunter Memorial Award in Therapeutics for his research on nicotine, tobacco, and health, and was the 2002 UCSF Annual Distinguished Clinical Research Lecturer.

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