May 15, 2018 Discovery Toxicology
May 16, 2018 Discovery and Development Toxicology
May 17, 2018 Development Toxicology
Session Topic Speaker Company Time
Registration and Breakfast   8:00-9:00
Conference Opening and Plenary Lecture Introduction  Dolo Diaz Denali Therapeutics 9:00-9:10
Plenary Speaker - "Leveraging Toxicology Experience to Solve Problems in the Developing World" Ken Frazier GlaxoSmithKline 9:10-9:55

Session I:  When Knowledge is Power: Impactful Investigative Toxicology / Case Studies

Christine Karbowski, Amgen
Ken Frazier, GSK

Session Topic Speaker Company Time
 Session Introduction     9:55-10:00
“A Zebrafish Testing Laboratory: Impacting the Pipeline Through Enhanced Toxicity and Efficacy Endpoints” Steven Cassar AbbVie 10:00-10:30
"Time (and Resource) Well Spent: Case Studies of High-Impact Cardiovascular Investigative Toxicology" Kevin French GlaxoSmithKline 10:30-11:00
Break     11:00-11:20
"Dose-Limiting Thrombocytopenia in the Clinic: Strategies in the Discovery Space for Assessing Risk" Jonathan Maher Genentech 11:20-11:50
"Integrating Alternative Developmental Toxicity Assays for Pharmaceutical Risk Assessment" Maia Green Merck 11:50-12:20
Lunch     12:20-1:50

Session II: "Falling Off the Needle": Acute Anaphylactoid Reactions in the Nonclinical Space

Zoe Zhong, Genentech

Session Topic Speaker Company Time
 Session Introduction     1:50-1:55
"Concurrent Mast Cell and Complement Activation in the Cynomolgus Monkey" Darcey Clark La Jolla Pharmaceutical Company 1:55-2:25

"Mitigation Strategy to Enable Dosing through an Anaphylactoid Reaction in Rodent Species to Identify Target Organ Toxicity"

Dong Lee Revolution Medicines 2:25-2:55
"MrgX2 the "Other" Mast Cell Receptor: Involvement/Prediction of Anaphylactoid Reactions in Nonclinical Toxicology Species" Deidre Dalmas Wilk GlaxoSmithKline 2:55-3:25
Panel Discussion     3:25-3:55
Poster Session and Reception     3:55-5:25
Session Topic Speaker Company Time
Registration and Breakfast 7:30-8:30

Session III: Hot Topics in Discovery Toxicology

Michael Santostefano, Merck

Session Topic Speaker Company Time
 Session Introduction     8:30-8:35
"Utility of Animal Models for the Assessment of CAR T Efficacy and Safety" Jenny Marlowe bluebird bio 8:35-8:55
"Preclinical Assessment of Immunomodulatory Antibody Combinations" Claudette Fuller Merck 8:55-9:15
“ADA or Non-ADA: That is the Immune Complex Question” Curtis Maier GSK 9:15-9:35
"CLL-1 T-cell Dependent Bispecific: A Tale of Two Affinities." Steven Laing Genentech 9:35-9:55
Break     9:55-10:15
DEVELOPMENT WORKSHOP (Wednesday May 16th, 2018)
Intro to Development Workshop 10:15-10:25

Session IV: Impurities and Occupational Exposure Limits / Health Hazard Categorization

Heather Dowty, Pfizer and Lauren Mihalcik, Amgen

Session Topic Speaker Company Time
 Session Introduction     10:25-10:30
"Genotoxic Potential of Drug Substance/Product Impurities and Guidance" John Nicolette AbbVie 10:30-10:50
"Risk Assessment of Two Mutagenic Diboron Reagents" Krista Dobo Pfizer 10:50-11:10
"Extractables & Leachables in Intravitreal (IVT) Drugs" Barry Astroff  Novartis 11:10-11:30
"Ocular Impurities: Understanding the Impact of Potential Endotoxin Contamination for Intravitreally Administered Formulations" Vladimir Bantseev Genentech 11:30-11:50
"Occupational Exposure Limit and Permitted Daily Exposure Applied to Ophthalmic Drugs" James Chastain Novartis 11:50-12:10
Lunch       12:10-1:35

Session V: Regulatory Guidance Development and Updates

Lise Loberg, AbbVie
Stephanie Powlin, Takeda

Session Topic Speaker Company Time
Session Intro and Plenary Speaker Introduction     1:35-1:40

Plenary Speaker -

"Recent Regulatory Updates from ICH and FDA: Implications for Oncology Drugs"

John Leighton FDA 1:40-2:25
"Nonclinical Development and Human Dose Selection for CD3 Bispecifics" Haleh Saber FDA 2:25-2:55
"Comparison of Developmental Toxicity Signals Between Alternative Assays and in vivo Studies: An Oncology Case Study" Sarah Campion Pfizer 2:55-3:25
Break     3:25-3:45
"Proposal for the Evaluation of Therapeutics for the Treatment of Severely Debilitating or Life-Threatening Diseases” Judith Prescott Merck 3:45-4:15
Panel Discussion     4:15-5:00
Poster Session and Reception     5:00-6:30
Session Topic Speaker Company Time
Registration and Breakfast 8:00-9:00

Session VI: Key Learning from Recent Clinical Trials Experience

Paul Cornwell, Eli Lilly
Eunice Musvasva, Boehringer Ingelheim 

Session Topic Speaker Company Time
Session Introduction     9:00-9:05
“Rates and Reasons for IND Clinical Holds” Larissa Lapteva CBER, FDA 9:05-9:35
"Resolving a Clinical Dilemma using a Preclinical Model: Insights from the Genentech Lucentis Sustained Delivery Program"  Giulio Barteselli Genentech 9:35-10:05
Break     10:05-10:35
"Addressing Differences in Opinion on NOAEL: A Case Study" Paul Cornwell Eli Lilly 10:35-11:05
“A Tough Nut to Crack - Overcoming Risks of Testicular Toxicity in the Clinic” Jeff Moffit Bioverativ 11:05-11:35
Closing Remarks        11:35- 11:40 





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