Friday, March 11, 2016 Presentations

SYMPOSIUM Benefit/Risk Optimization in the Confirmatory Space and Beyond: Myths, Reality and Possibilities
Rajanikanth Madabushi, PhD, US Food and Drug Administration, Silver Spring, MD
Pankaj Gupta, PhD, Pfizer Inc., Groton, CT

Scientific, Strategic and Organizational Challenges and Opportunities: An Industry Perspective
Sriram Krishnaswami, PhD, Pfizer Inc., Groton, CT

Registration Trials: Are They Meant to be Confirmatory or is Learning Allowed?
Joga Gobburu, PhD, FCP, MBA, University of Maryland, Baltimore, MD

Does Pharmacometric Modeling Reliably Predict Efficacy and Safety Outcomes in Registration Trials and Can it be Utilized to Optimize Benefit-Risk?
Sanjay Kaul, MD, MPH, FACC, FAHA, Cedars-Sinai Medical Center, Los Angeles, CA

Integration of Knowledge from Late Phase Trials to Support Regulatory Decisions
Yaning Wang, PhD, US Food and Drug Administration, Silver Spring, MD

SYMPOSIUM Don’t Do Different Things…Do Things Differently! Drug Development in Rare Diseases
Joan Korth-Bradley, PharmD, PhD, Pfizer Inc., Collegeville, PA
Michelle A. Rudek, PharmD, PhD, The SKCCC at Johns Hopkins, Baltimore, MD

Challenges and Hurdles to Business as Usual in Drug Development for Treatment of Rare Diseases
David Swinney, PhD, Institute for Rare and Neglected Diseases Drug Discovery, Mountain View, CA

Regulatory Perspectives on the Approval of Rare Diseases
Edward Dennis Bashaw, PharmD, US Food and Drug Administration, Silver Spring, MD

The Patient's Perspecitve
Lorna Speid, PhD, Putting Rare Diseases First!, San Diego, CA

ROUNDTABLE Food for Thought: Need, Timing and Labeling Implications for Clinical Food Effect Studies
Neeraj Gupta, PhD, Takeda Pharmaceuticals, Cambridge, MA

Design, Need and Timing of Food Effect Studies, an Industry Experience
Joan Korth-Bradley, PharmD, PhD, Pfizer Inc., Collegeville, PA

Regulatory Perspective on the Need and Timing of Food Effect Studies
Mehul Mehta, PhD, US Food and Drug Administration, Silver Spring, MD

Inflammation as a Source of Variability in Drug Disposition and Response
Micheline Piquette-Miller, PhD, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada


African American Pharmacogenomics: Challenge Accepted
Minoli A. Perera, PharmD, PhD, University of Chicago, Chicago, IL

Pharmacogenomics: Science and Promise
Liewei Wang, MD, PhD, Mayo Clinic, Rochester, MN

What are Our Drugs Truly Doing to Our Patients?: Lessons from Pharmacoepidemiology
Brian L. Strom, MD, MPH, Rutgers the State University of New Jersey, Newark, NJ

WORKSHOP Quantitative Systems Pharmacology: A Case for Disease Models

Mechanistic Modeling of the Cancer-Immunity Cycle: A Platform Approach in I-O
Brian Schmidt, PhD, Bristol-Myers Squibb, Princeton, NJ

A Mechanistic Model of Lipoprotein Metabolism and Kinetics for Cardiovascular Disease Targets
James Lu, PhD, AstraZeneca, Cambridge, United Kingdom;

WORKSHOP Rationale Development of Combination Cancer Immunotherapy through Collaborations
Paul Statkevich, PhD, Bristol-Myers Squibb, Lawrenceville, NJ
Eric Masson, AstraZeneca, Waltham MA

Role of Biomarkers in Immuno-Oncology Combination Development
John Kurland, PhD, MedImmune, Gaithersburg, MD

Quantitative Clinical Pharmacology for Early Decision Making during Combination Immunotherapy Development
Shruti Agrawal, PhD, Bristol-Myers Squibb, Lawrenceville, NJ

Regulatory Considerations for Immuno-Oncology Combination Drug Development
Atiqur Rahman, PhD, US Food and Drug Administration, Silver Spring, MD

Advances in Targeted Therapies for Lung Cancer
Alice T. Shaw, MD, PhD, Massachusetts General Hospital, Boston, MA

SYMPOSIUM The Path to Effective Treatments for Alzheimer's Disease:  From the Bench to the Clinic

Clinical Candidates for the Treatment of Alzheimer’s Disease
William Potter, MD, PhD, NIMH, National Institutes of Health, Bethesda, MD

Building Whole Brain Models of Alzheimer’s Disease to Advance Our Understanding of Disease Pathophysiology, Aid Target Identification, and Improve Translational Research
Julie Harris, PhD, Allen Institute for Brain Science, Seattle, WA

Identifying and Overcoming Clinical Pharmacology Challenges during Development of Alzheimer’s Disease Interventions: From Discovery to the Clinic
Mark Forman, MD, PhD, Merck & Co., Inc., Whitehouse Station, NJ

Increasing the Probability of Success for Alzheimer’s Disease Interventions through Modeling and Simulation
Stephen P. Arneric, PhD, Coalition Against Major Diseases, Critical Path Institute, Tucson, AZ

SCIENCE AT SUNRISE Use of Medications during Pregnancy and Breastfeeding: Maternal, Fetal, and Neonatal Impact
Anne Zajicek, MD, PharmD, National Institutes of Health, Bethesda, MD
Catherine M. T. T. Sherwin, BSc(Hons), PhD, University of Utah School of Medicine, Salt Lake City, UT

Clinical Pharmacology during Pregnancy: Efforts of the MFM and OPRU to Expand Understanding
Maged Costantine, MD, University of Texas Medical Branch, Galverston, TX

Application of Pharmacometrics in Pregnancy
Kevin Krudys, PhD, US Food and Drug Administration, Silver Spring, MD

Generating Meaningful Information for Use in Pregnant Women during Program Development
Christina Bucci-Rechtweg, MD, Novartis Pharmaceuticals, East Hanover, NJ

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