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Friday, March 15, 2019 Presentations

SCIENCE AT SUNRISE: Opportunities in Evaluating Abuse Deterrence of Opioid Drug Products
Chairs
Myong-Jin Kim, PharmD, US Food and Drug Administration, Silver Spring, MD
Kristin Bigos, PhD, Johns Hopkins University, Baltimore, MD
Speakers
Evaluation of ADF Opioid Drug Products
Lynn R. Webster, MD, PRA Health Sciences, Salt Lake City, UT
Quantitative Analysis of Opioid ADF PK/PD
Liang Zhao, PhD, US Food and Drug Administration, Silver Spring, MD
Nasal PK Study of Abuse-Deterrent Opioid Products Following Insufflation of Physically Manipulated Products
Bradley Vince, DO, Altasciences Clinical Research / Vince & Associates, Overland Park, KS

SPECIAL SESSION: Career Exploration and Transition Beyond Traditional Roles
Chairs
Sharvari Bhagwat, PhD, Amgen, South San Francisco, CA
Christina Drenberg, PhD, The Ohio State University, Columbus, OH
Speakers
Transitioning from Big Pharma to a Start-Up: Challenges and Opportunities
Mark Dresser, PhD, Denali Therapeutics, South San Francisco, CA
Hyper-Accelerating Career Transitions into Management Consulting and Venture Capital
Rosemarie Truman, BA, Gazelle Futures, Bethesda, MD
Transitioning into Patent Law as a Scientist
Erin Heenan, PhD, JD, Sterne, Kessler, Goldstein and Fox, Washington, DC
 
STATE OF THE ART LECTURE
Chair: Peter H. O’Donnell, MD, University of Chicago
Speaker: A New Science of Therapeutics for Undruggable Targets
James (Jay) Bradner, MD, Novartis Institutes for BioMedical Research, Cambridge, MA
 
WORKSHOP: Geriatric Clinical Pharmacology: State of the Art in a Neglected Majority
Chairs
Robin O'Connor-Semmes, PhD, PAREXEL International, Research Triangle Park, NC
Donald L. Heald, PhD, Janssen - Johnson and Johnson, Spring House, PA
Speakers
Applying Clinical Pharmacology Principles to Improve Care for the Older Adult
Patricia Slattum, PhD, PharmD, Virginia Commonwealth University, Richmond, VA
Regulatory Perspectives in Developing Drug Products for Older Adults in the United States
S.W. Johnny Lau, PhD, US Food and Drug Administration, Silver Spring, MD
Pharmacometric Approaches to Streamline Pharmacotherapy in Older Adults
Jan Schlender, MSc, Bayer AG, Leverkusen, Germany
 
NOVEL FORMAT: All of Us and More!
Chairs
Kathleen M. Giacomini, PhD, University of California, San Francisco, San Francisco, CA
Minoli Perera, PharmD, PhD, Northwestern University, Chicago, IL
Speakers
All of Us Research Program
Holly Garriock, PhD, National Institutes of Health, Bethesda, MD
 
SPECIAL SESSION: Innovation Forum
Chair
Piet H. van der Graaf, PhD, PharmD, Certara, Canterbury, United Kingdom 
Speakers
Navigating the AI Tsunami in Pharma: Where Actionable Biology Separates Fact From Fiction
Niven Narain, PhD, BERG, Framingham, MA
Digital Health Technologies in Systems Pharmacology
Lara Mangravite, PhD, Sage Bionetworks, Seattle, WA
Machine Learning and Computational Medicine for Clinical Development, Patients, and Regulators
Pratik Shah, PhD
RNA Splicing as a Target for a New Generation of Precision Medicines
Adrian Krainer, PhD, Cold Spring Harbor Laboratory, Cold Spring Harbor, NY

STATE OF THE ART LECTURE
Chair:  Dan Hartman, MD
Speaker: From Molecule to Patient: A Biotech Perspective
Robert S. Langer, Jr., ScD, Massachusetts Institute of Technology, Cambridge, MA

AWARD LECTURE: Leon I. Goldberg Early Investigator Award Lecture
Award Presenter: Laura Ramsey, PhD, Cincinnati Children's Hospital Medical Center, Cincinnati, OH
Speaker: Using Big Clinical Data for Small (Pediatric) Patients
Sara Van Driest, MD, PhD, Vanderbilt University Medical Center, Nashville, TN

AWARD LECTURE: Sheiner-Beal Pharmacometrics Award Lecture
Award Presenter: Jill Fiedler-Kelly, MS, Cognigen Corporation, Williamsville, NY
Speakers: Pharmacometrics 3.0: The Next Big Thing
Jogarao Gobburu, PhD, University of Maryland, University of Maryland, Baltimore, MD

FEATURED SPEAKER
Chair: Deanna L. Kroetz
Speaker: Electronic Cigarettes and the Debate on Tobacco Harm Reduction
Neal L. Benowitz, MD, University of California San Francisco, San Francisco, CA

EDUCATION SESSION: Primer on Immunology and Cancer Immunotherapy
Chairs
Sree Kasichayanula, PhD, AbbVie Biotherapeutics, Redwood City, CA
Sandhya Girish, PhD, Genentech, South San Francisco, CA
Speakers
Basic Immunology for Clinical Pharmacologists
Timothy Bullock, PhD, University of Virginia, Charlottesville, VA
Translational and Clinical Pharmacology Perspectives in Cancer Immunotherapy
Amit Roy, PhD, Bristol-Myers Squibb, Princeton, NJ

WORKSHOP: Evolution of Next Generation Therapeutics: Past, Present, and Future of Precision Medicines
Chairs
Anuradha Ramamoorthy, PhD, US Food and Drug Administration, Silver Spring, MD
Rebecca Blanchard, PhD, CRISPR Therapeutics, West Point, PA 
Speakers
Evolution of Precision Medicines from a Regulatory Perspective
Michael Pacanowski, PharmD, MPH, US Food and Drug Administration, Silver Spring, MD

SYMPOSIUM: Connecting Cell Biology to Patient Populations: Clinical Applications of Multi-Scale Systems Pharmacology
Chairs
Daniel Kirouac, PhD, Applied BioMath, Oakland, CA
Michael Block, PhD, Bayer, Leverkusen, Germany 
Speakers
Bridging Mechanistic Models and Patient Data in Virtual Clinical Trials
Feilim Mac Gabhann, PhD, Johns Hopkins University, Baltimore, MD
Strategies to effectively deploy quantitative systems pharmacology approaches in clinical development
Paolo Vicini, PhD, MBA, Kymab Ltd., Cambridge, United Kingdom


 

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