Monday, November 4

9:00 AM–12:00 Noon

Antibody-Drug Conjugates: The Next Evolution in the Cure for Cancer
Chair: Kenneth J. Olivier, Jr., Merrimack Pharmaceuticals
Co-Chair: Beth Hinkle, Amgen

Translating Nonclinical Cardiovascular Toxicity Findings into Clinical Trial Design
Chair: Janice Lansita, US FDA/CDER
Co-Chair: David L. Hutto, Eisai, Inc

Dermal Toxicology: Current Requirements, Methods, Model, and Regulatory Perspectives
Chair: Dave Hobson, LoneStar Pharm Tox, LLC
Co-Chair: William J. Brock, Brock Scientific Consulting

2:00 PM–5:00 PM

4 M’s: Mistakes, Misuse, Mismanagement, Misunderstanding…Looking at Things That Have Gone Wrong in the Past: What to Learn to Plan for the Future
Chair: David Woolley, ForthTox Ltd.
Co-Chair: Glenn Myatt, Leadscope Inc.

Clinical, Regulatory, and Nonclinical Study Design Issues Associated with Testing
and Approval of Medical Devices

Chair: Kathleen A. Funk, Experimental Pathology Laboratories, Inc
Co-Chair: Maralee McVean, Pre-Clinical Research Services, Inc.

Tumorigenicity Assessment in Preclinical Development of Pluripotent Stem Cell-Based Therapies
Chair: Justine Cunningham, Allergan
Co-Chair: Joy Cavagnaro, Access BIO

Tuesday, November 5

9:00 AM–12:00 Noon

The Art of Dose Selection: From the Bench to the Clinic
Chair: Herve Lebrec, Amgen Inc., Toxicology Sciences
Co-Chair: Kenneth J. Olivier, Jr., Merrimack Pharmaceuticals

Endocrine Disruption Screening—Status of the US EPA and EU Programs: State of the Science and Slate for the Future
Chair: Elliot Gordon, Elliot Gordon Consulting, LLC
Co-Chair: Susan Borghoff, ToxStrategies, Inc.

Secondary Pharmacology: Assay, Uses and Evaluation
Chair: Vincent Murphy, Array BioPharma, Inc.
Co-Chair: Donna M. Dambach, Genentech

2:00 PM–5:00 PM

The Drug Development Paradigm for a Small Molecule: Case Study of the Janus Kinase (JAK) Inhibitor Tofacitinib for the Treatment of Rheumatoid Arthritis
Chair: Douglas J. Ball
Co-Chair: W. Mark Vogel, Pfizer Inc

Impact of Combination Toxicology Studies on Pharmaceutical Development: Careful Consideration of Study Objectives, Timing, and Design
Chair: Christopher Ellis, US FDA/CDER
Co-Chair: Leigh Ann Burns Naas, Gilead Sciences, Inc.

Phospholipidosis: Evaluation and Management of its Risk
Chair: Kok Wah Hew, Takeda Global R & D Center, Inc.
Co-Chair: Kenneth Hastings, Sanofi

Wednesday, November 6

9:00 AM–12:00 Noon

Prospective Approaches to Characterize Potential Neurotoxicity
Chair: Robert Sills, NIEHS
Susan Borghoff, ToxStrategies, Inc.

Consumer Healthcare Ingredient Issues and Potential Impact on Product Safety and Risk Communication
Chair: Tracey L. Spriggs, GlaxoSmithKline Consumer Health
Co-Chair: William J. Brock, Brock Scientific Consulting

Managing the Regulatory Impact of Rodent Tumor Findings
Chair: Jeri El Hage, Aclairo Pharmaceutical Development Group
Co-Chair: Frank D. Sistare, PhD, Merck and Co.

2:00 PM–5:00 PM

Hot Topics
Chair: Mary Ellen Cosenza, Amgen Inc.
Co-Chair: Timothy J. McGovern
, SciLucent, LLC