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

DISCOVERY TOXICOLOGY WORKSHOP-Monday MAY 10, 2021
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

POSTER SESSION

 

 

  2:10-2:30

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

Q&A

    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
       
 
DISCOVERY TOXICOLOGY WORKSHOP- Tuesday MAY 11, 2021
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

POSTER SESSION

    3:15-3:35
 
DEVELOPMENT TOXICOLOGY WORKSHOP-Tuesday MAY 18, 2021
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
DEVELOPMENT TOXICOLOGY WORKSHOP-WEDNESDAY MAY 19, 2021
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

POSTER SESSION

    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

POSTER SESSION

    2:10-2:30

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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