May 10, 2021 Discovery Toxicology
May 11, 2021 Discovery Toxicology
May 18, 2021 Development Toxicology
May 19, 2021 Development Toxicology

Session Topic Speaker Company Time
Conference Opening Jonathan Heyen  Pfizer 11:00-11:10

Session I:  IO in Discovery Toxicology Space

Chairs:  Rama Pai, Merck and Jonathan Heyen, Pfizer

Session Topic Speaker Company Time
Keynote Lecture: Navigating Through Uncharted Territory at the Frontlines of Immuno-Oncology Innovation as a Nonclinical Safety Scientist Jacintha Shenton Janssen 11:10 - 11:40
Q&A     11:40 - 11:45
CAR T Neurotoxicity: Translational Insights Juliane Gust Seattle Children's Hospital 11:45-12:05
Q&A     12:05-12:10
Experience with Nonhuman Primate Models in CAR-T Therapy Nonclinical Safety Assessment Kavita Raman Amgen 12:10-12:30
Q&A      12:30-12:35
Break     12:35 - 1:20
Nonclinical Evaluation of CD3 Bispecific Antibodies Changhua Ji Pfizer 1:20-1:40
Q&A      1:40-1:45
 Preclinical Safety for a Small Molecule Sting Agonist Immunotherapy Christopher Brynczka Merck 1:45-2:05
Q&A      2:05-2:10





Session II: Microphysiological Systems (MPS)

Chairs:  Jodi Goodwin, Takeda & Zoe Zhong, Genetech

 Session Introduction      2:30-2:35

Vendor Presentation - The Human Duodenum Intestine-Chip for Applications in Safety, Absorption, Transport, and Metabolism

 Sushma Jadalannagari 2:35 - 2:55


    2:55 - 3:00

Surviving the Technology Hype Cycle/Where MPS are Having an Impact Today, and Where They're Needed Next

Matt Wagoner Takeda 3:00-3:20
Q&A      3:20-3:25
3D Renal Proximal Tubule-on-a-Chip for Assessing Drug-Induced Nephrotoxicity Tomomi Kiyota Genentech 3:25-3:45
Q&A      3:45-3:50
Session Topic Speaker Company Time

Session III: Novel Approaches to Identify Off-target Drivers of Toxicity

Chair:  Christine Karbowski, Amgen & Bruce Leroy, AbbVie

Session Topic Speaker Company Time
 Session Introduction     11:00-11:05
Integrating a Big Toxicity Data Framework to Better Evaluate Drug Safety Andy Vo AbbVie 11:05-11:25
Q&A     11:25-11:30
CiPA: Practical Applications in Discovery Scott Mittelstadt Abbvie 11:30-11:50
Q&A     11:50-11:55
The Impact of Toxicokinetics on the Design and Interpretation of Toxicology Studies Suman Mukherjee Merck 11:55-12:15
Q&A     12:15-12:20

Plenary Speaker 

Reimagining Druggability using Chemoproteomic Platforms

Daniel Nomura UC Berkeley 12:20-12:50
Q&A      12:50-12:55
Break      12:55-1:40
Vendor Presentation - Utility of Human Pluripotent Stem-Cell Derived Cardiomyocytes in Cardiotoxicity Assays Using the Maestro MEA System and STEMdiff Cardiomyocytes Products  Nathan Moerke   1:40-1:50
Q&A     1:50 - 1:55

Session IV: Case Studies in Investigative Toxicology

Chairs:  Yoav Timsit, Blueprint Medicines and Jon Maher, Theravance Biopharma

Session Topic Speaker Company Time
 Session Introduction     1:55-2:00
Early Assessment of Bone Marrow Toxicity in Immunodeficient Mice Kim Maratea AstraZeneca 2:00-2:20
Q&A      2:20-2:25
Role of Drug Exposure Quantification for Safety and Efficacy Evaluation in Non Clinical and Clinical Trials Jonathan Stauber IMA Biotech 2:25-2:45
Q&A      2:45-2:50
Spectral Imaging/Multispectral Imaging Approaches to Understand Mechanism of Toxicity Chandra Saravanan Novartis 2:50-3:10
Q&A      3:10-3:15


Session Topic Speaker Company Time
Conference Opening  Rebecca Erickson Denali Therapeutics 11:00-11:10

Session I:  COVID19: Development of Vaccines and Therapeutics

Chairs:  Joe Cichocki, Vertex & Michel Santostefano, Merck

Session Topic Speaker Company Time
Rapid Development of REGN-COV2, an Anti-Spike Antibody Cocktail for Treatment and Prevention of COVID-19 Matt Liu Regeneron 11:10-11:30
Nonclinical Safety Assessment Strategies for COVID19 Mabs: Expediting Clinical Trials and Emergency Use Authorization John Vahle Eli Lilly 11:30-11:50
COVID19 Vaccine AstraZeneca: Mission Impossible  Richard Stebbings AstraZeneca 11:50-12:10
Panel Discussion All Speakers Session I     12:10-12:25
Break      12:25:1:10
Keynote Speaker Introduction  Michael Santostefano  Merck 1:10-1:15

Plenary Speaker 

Discovery and Development of Vaccines and Worldwide Regulatory Experience

Lisa Plitnick Merck 1:15-1:45
Q&A      1:45-1:50
Vendor Presentation - Transforming DILI Prediction using Transcriptomics and AI Christopher Strock 1:50-2:10
Q&A     2:10- 2:15

Session II: Developing Products for Rare Diseases and Conditions

Chairs: Rebecca Erickson, Denali Therapeutics & Jairo Nunes, Takeda

Session Topic Speaker Company Time
Introduction 2:15-2:20
Regulatory Challenges and Considerations in Rare Disease Drug Development Kerry Jo Lee FDA 2:20-2:40
Safety Considerations in the Development of Pharmacologically Active Proteins for Rare Diseases  John McNulty Takeda 2:40-3:00
Risdiplam - Fast Development to Turn the First Small Molecule mRNA Splice Modifier into an Approved Medicine Lutz Mueller F. Hoffman-La Roche Ltd. 3:00-3:20
The Nonclinical Safety Profile of ONPATTRO® (patisiran), a First-in Class RNAi Therapeutic for the Treatment of Polyneuropathy of Hereditary Transthyretin-mediated Amyloidosis (hATTR amyloidosis)  Jessica Sutherland Alnylam 3:20-3:40
Panel Discussion - all speakers  session II      3:40-4:00
Session Topic Speaker Company Time

Session III:  Gene Therapy: Non-clinical to Clinical Translation

Chairs:  Lise Loberg, AbbVie & Eunice Musvasva, Roche

Session Topic Speaker Company Time
Introduction     11:00-11:05
Adapting Traditional Tox Strategy to Patients with High Risk, Genetic Disorders: Do Regulations Speak to the Heart of the Issue? Lauren Black Charles River Laboratories 11:05-11:25
Q&A      11:25-11:30
Things to Consider When Translating Gene Therapy Nonclinical Data to Support Clinical Trials Laurence Whiteley Pfizer 11:30-11:50
Q&A       11:50-11:55
MicroRNA-mediated Inhibition of Transgene Expression Juliette Hordeaux UPenn 11:55-12:15
Q&A     12:15 - 12:20


    12:20 - 12:45
Break      12:45:1:30
Keynote Speaker Introduction  Lauren Mihalcik Alcairo 1:30-1:35

Plenary Speaker 

Engaging CBER on Preclinical Gene Therapy Projects - A Consultant's Perspective

Laura Dill Morton Aclairo Pharmaceutical Development Group 1:35-2:05
Q&A      2:05-2:10



Session IV: Peripheral Neuropathy

Chairs: Heather Dowty, Pfizer, Paul Cornwell, Eli Lilly, and Ed Dere, Genentech

Session Topic Speaker Company Time
Introduction: Heather Dowty, Pfizer; Ed Dere, Genentech; Paul Cornwell, Eli Lilly 2:30-2:35
Toxic Peripheral Neuropathies: Clinical Perspective Ahmet Hoke Johns Hopkins School of Medicine 2:35-2:55
Intra-epidermal Nerve Fiber Analysis: a Sensitive, Clinically-Relevant Tool for Assessing Sensory Nerve Damage in Animal Models Lisa Magnus Johns Hopkins School of Medicine 2:55-3:15
Toxicologic Evaluation of the Peripheral Nervous System to Support a First-in-human Study for a New Molecular Entity Chris Aluise Eli Lilly and Company 3:15-3:35
Improving Preclinical to Clinical Translation of Drug-induced Peripheral Neuropathy: A Case Example with MMAE Containing Antibody Drug Conjugates Nicola Stagg Genentech 3:35-3:55
Panel Discussion - Session Speakers        3:55-4:10
Webinar Closing Remarks     4:10 - 4:15





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