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ON DEMAND
Prologue: A Physiologically Based Pharmacokinetic Framework to Develop Predictive Endogenous Biomarkers
Location: On Demand
Prologue Speaker: Sibylle Neuhoff, PhD – Certara UK Limited, Simcyp Division
Preclinical and Translational Sciences
ON DEMAND
Prologue: An End-to-End Biomarker Strategy to Accelerate Drug Development: Current Landscape and Future Prospects
Location: On Demand
Prologue Speaker: Kelly A. Fader, PhD (she/her/hers) – Pfizer Inc.
Preclinical and Translational Sciences
ON DEMAND
Prologue: Role of Biomarkers in Rare Disease Drug Development and Regulatory Approval
Location: On Demand
Prologue Speaker: Lakshmi Amaravadi, PhD – Kojin Therapeutics
Preclinical and Translational Sciences
Monday, Oct 23rd
9:00 AM – 10:30 AM ET
Symposium: Advances in Predictive Biomarkers For Drug Development
Location: 311 CD West
Moderator: Manthena V. Varma, PhD – Pfizer Inc
Preclinical and Translational Sciences
Monday, Oct 23rd
9:00 AM – 9:30 AM ET
Pharmacodynamic Biomarkers Evidentiary Considerations for Biosimilar Development and Approval
Location: 311 CD West
Speaker: Lakshmi Manasa S. Chekka, PharmD, PhD – U.S. FDA
Preclinical and Translational Sciences
Monday, Oct 23rd
9:30 AM – 10:00 AM ET
Leveraging Biomarkers in Establishing PK/PD Models
Location: 311 CD West
Speaker: Donald E. Mager, PharmD, PhD – University at Buffalo, SUNY/Enhanced Pharmacodynamics, LLC
Preclinical and Translational Sciences
Monday, Oct 23rd
10:00 AM – 10:30 AM ET
Metabolomics: a Powerful and Efficient Tool for Drug Discovery and Development
Location: 311 CD West
Speaker: Thomas P. Roddy, PhD (he/him/his) – Atavistik Bio
Preclinical and Translational Sciences
Monday, Oct 23rd
9:00 AM – 11:00 AM ET
Symposium: PD Biomarkers As Evidence in Rare Disease
Location: 311 AB West
Moderator: Lakshmi Amaravadi, PhD – Kojin Therapeutics
Preclinical and Translational Sciences
Monday, Oct 23rd
9:00 AM – 9:30 AM ET
Supporting Rare Disease Drug Development and Use of Biomarkers: Ravulizumab Case Study
Location: 311 AB West
Speaker: Mark Ma, MD (he/him/his) – Biotech
Preclinical and Translational Sciences
Monday, Oct 23rd
9:30 AM – 10:00 AM ET
Critical Path for Rare Neurodegenerative Diseases Initiative for Drug Development
Location: 311 AB West
Speaker: Colin Hovinga – C-Path Institute
Preclinical and Translational Sciences
Monday, Oct 23rd
10:00 AM – 10:30 AM ET
Neurodegenerative Rare Diseases: Biomarkers in Drug Development and Regulatory Decisions
Location: 311 AB West
Speaker: Bilal AbuAsal, PhD – US FDA
Preclinical and Translational Sciences
Monday, Oct 23rd
10:30 AM – 11:00 AM ET
Pharmacodynamic Biomarkers as Confirmatory Evidence in Rare Disease Drug Development
Location: 311 AB West
Speaker: Nayeem Hossain, PhD – US FDA
Preclinical and Translational Sciences
Monday, Oct 23rd
11:00 AM – 12:00 PM ET
Inhalation Pharmacokinetics and Toxicity of CBD and other Cannabinoids
Location: 360 Stage #4 Exhibit Hall West A4-B3
Partner Presentation Speaker: Philip J. Kuehl, PhD – Lovelace Biomedical Research Institute
Preclinical and Translational Sciences
Presented By
Monday, Oct 23rd
11:15 AM – 12:00 PM ET
Accelerating Immunogenicity Analysis: From IgG- to AAV-based Therapies
Location: Spotlight Stage B Exhibit Hall West A4-B3
Chalk Talk Presenter: Eric Feeley, Ph.D. – Gyros Protein Technologies
Preclinical and Translational Sciences
Presented By
Monday, Oct 23rd
12:00 PM – 2:00 PM ET
User Group Meeting: The Power of Phoenix Tools Analyzing PK Data
Location: 360 Stage #1 Exhibit Hall West A4-B3
Tech Spotlight Speaker: Ana Henry, M.S., Biomathematics – Certara
Tech Spotlight Speaker: Chris Mehl, M.S – Certara
Tech Spotlight Speaker: Fred Mahakian (he/him/his) – Certara
Tech Spotlight Speaker: Michael Clifton, BS – Certara
Preclinical and Translational Sciences
Presented By
Monday, Oct 23rd
1:30 PM – 2:30 PM ET
Keynote: Apply Endogenous Biomarkers to Detect DDIs
Location: 311 AB West
Keynote Speaker: Hiroyuki Kusuhara, PhD (he/him/his) – Graduate School of Pharmaceutical Sciences, the University of Tokyo
Moderator: Yurong Lai, PhD (he/him/his) – Gilead Sciences, Inc.
Preclinical and Translational Sciences
Monday, Oct 23rd
1:30 PM – 2:30 PM ET
Keynote: Biomarker Selection and Utility in Clinical Drug Development Today: Workhorses and Unicorns
Location: 311 CD West
Keynote Speaker: Lindsay Ewan King, Ph.D. (he/him/his) – Pfizer Inc
Moderator: Jaya Vaidyanathan, PhD – Division of Cardiometabolic and Endocrine Pharmacology, OCP/OTS/CDER/US Food and Drug Administration
Preclinical and Translational Sciences
Monday, Oct 23rd
2:30 PM – 3:30 PM ET
Speaker Spotlight: Advances in Predictive Biomarkers for DDIs
Location: Spotlight Stage B Exhibit Hall West A4-B3
Spotlight Speaker: Manthena V. Varma, PhD – Pfizer Inc
Moderator: Fei Hua, PhD – Applied BioMath
Preclinical and Translational Sciences
Monday, Oct 23rd
3:00 PM – 4:00 PM ET
Rapid Fires: Predictive Biomarker Strategies to De-Risk Drug Development 1
Location: 311 AB West
Rapid Fire Moderator: Mahmoud Salama Ahmed, PhD (he/him/his) – Texas Tech University Health Sciences Center
Preclinical and Translational Sciences
Monday, Oct 23rd
3:00 PM – 4:00 PM ET
Rapid Fires: Predictive Biomarker Strategies to De-Risk Drug Developments 2
Location: 311 CD West
Rapid Fire Moderator: F. Yushra Thanzeel, PhD – Merck & Co., Inc.
Preclinical and Translational Sciences
Monday, Oct 23rd
3:00 PM – 3:15 PM ET
Spatial Biomarker to Inform Biological Context Drug Response
Location: 311 CD West
Rapid Fire Speaker: Corinne Ramos (she/her/hers) – Aliri
Preclinical and Translational Sciences
Monday, Oct 23rd
3:15 PM – 3:30 PM ET
Stability & Compatibility of Peptides for Oral Drug Delivery
Location: 311 CD West
Rapid Fire Speaker: F. Yushra Thanzeel, PhD – Merck & Co., Inc.
Preclinical and Translational Sciences
Monday, Oct 23rd
3:30 PM – 3:45 PM ET
Comprehensive LC-MS/MS Analysis of VSV-GP Lipidome
Location: 311 CD West
Rapid Fire Speaker: Yuecheng Xi, PhD (she/her/hers) – Boehringer Ingelheim
Preclinical and Translational Sciences
Monday, Oct 23rd
3:45 PM – 4:00 PM ET
Development of Immunoactive Polymeric Nanocomplex to Activate Innate Immune Response for Cancer Immunotherapy
Location: 311 AB West
Rapid Fire Speaker: Fanfei Meng, PhD (he/him/his) – University of Mass-Lowell
Preclinical and Translational Sciences
Monday, Oct 23rd
3:45 PM – 4:00 PM ET
Strategy for Assessing Stability in Multiplexed Cytokine Panels
Location: 311 CD West
Rapid Fire Speaker: Christian Braithwaite, M.S. – BioAgilytix
Preclinical and Translational Sciences
Tuesday, Oct 24th
9:00 AM – 11:00 AM ET
Symposium: Evolving Clinical Pharmacology and Translational PK/PD Approaches For New Modalities
Location: 309 AB West
Moderator: Hardik Mody, PhD – Genetech
Preclinical and Translational Sciences
Tuesday, Oct 24th
9:00 AM – 11:00 AM ET
Symposium: Harnessing The Power of AI/ML in Drug Development
Location: 311 CD West
Moderator: Raja B. Velagapudi, PhD (he/him/his) – Tolmar Inc
Preclinical and Translational Sciences
Tuesday, Oct 24th
9:00 AM – 9:30 AM ET
Application of Mechanistic Physiologically Based Pharmacokinetic Models to Oligonucleotides
Location: 309 AB West
Speaker: Felix Stader, PhD (he/him/his) – Certara UK Limited
Preclinical and Translational Sciences
Tuesday, Oct 24th
9:00 AM – 9:30 AM ET
Understand the Regulatory Environment for AI and Machine Learning
Location: 311 CD West
Speaker: Kim Huynh-Ba, MS, PMP, FAAPS – Pharmalytik Consulting & Training
Preclinical and Translational Sciences
Tuesday, Oct 24th
9:30 AM – 10:00 AM ET
PK/PD Modeling of Bispecific T Cell Engagers for Clinical Translation
Location: 309 AB West
Speaker: Yanguang (Carter) Cao, PH.D – University of North Carolina at Chapel Hill
Preclinical and Translational Sciences
Tuesday, Oct 24th
9:30 AM – 10:00 AM ET
The Use of Machine Learning in the Development of Scoring Rule for the Identification of Adult Patients Under the Emergency Use Authorization for Anakinra for Treatment of COVID-19 in the United States
Location: 311 CD West
Speaker: Ruihao Huang, PhD (he/him/his) – U.S. Food and Drug Administration
Preclinical and Translational Sciences
Tuesday, Oct 24th
10:00 AM – 10:30 AM ET
Clinical Pharmacology Considerations for Allogeneic Cell Therapies
Location: 309 AB West
Speaker: Dhruvitkumar Sutaria, PhD (he/him/his) – Genentech
Preclinical and Translational Sciences
Tuesday, Oct 24th
10:00 AM – 10:30 AM ET
Integrating Machine Learning and Systems Pharmacology to Predict Clinical Outcomes to CAR-T Therapies
Location: 311 CD West
Speaker: Avisek Deyati, PhD (he/him/his) – Notch Therapeutics
Preclinical and Translational Sciences
Tuesday, Oct 24th
10:30 AM – 11:00 AM ET
A Quantitative Systems Pharmacology Model to Characterize the PKPD Relationship Following Treatment with IL-15R Agonists
Location: 309 AB West
Speaker: Louis Joslyn, PhD – Genentech
Preclinical and Translational Sciences
Tuesday, Oct 24th
10:30 AM – 11:00 AM ET
When Modeling & Simulation Meets GPT
Location: 311 CD West
Speaker: Liang Zhao, PhD – US Food and Drug Administration
Preclinical and Translational Sciences
Tuesday, Oct 24th
9:30 AM – 10:30 AM ET
Speaker Spotlight: Evolving Clinical Pharmacology and Translational PK/PD Approaches for New Modalities
Location: Spotlight Stage B Exhibit Hall West A4-B3
Spotlight Speaker: Joshua F. Apgar, PhD (he/him/his) – Applied BioMath, LLC
Moderator: Fei Hua, PhD – Applied BioMath
Preclinical and Translational Sciences
Tuesday, Oct 24th
12:30 PM – 1:30 PM ET
Impurity/Degradation Products: Time to Move Beyond Standard ICHQ3 Qualification Studies?
Location: 360 Stage #2 Exhibit Hall West A4-B3
Partner Presentation Speaker: Jim Herman, PhD, DABT (1992-2022) – Certara
Preclinical and Translational Sciences
Presented By
Tuesday, Oct 24th
1:30 PM – 2:30 PM ET
Keynote: Navigating Project Optimus: Use of Modeling and Simulation to Inform Dosing Strategies in Oncology
Location: 311 CD West
Moderator: Fei Hua, PhD – Applied BioMath
Keynote Speaker: Dean Bottino, PhD (he/him/his) – Takeda Pharmaceuticals
Preclinical and Translational Sciences
Tuesday, Oct 24th
1:30 PM – 2:30 PM ET
Keynote: Towards Development of Translational PBPK Models for Biologics
Location: 309 AB West
Keynote Speaker: Dhaval K. Shah, PhD (he/him/his) – University at Buffalo
Moderator: Jaya Vaidyanathan, PhD – Division of Cardiometabolic and Endocrine Pharmacology, OCP/OTS/CDER/US Food and Drug Administration
Preclinical and Translational Sciences
Tuesday, Oct 24th
2:30 PM – 3:30 PM ET
Hot Topic: Engineering Human Organoids and Organs-on-Chips for Disease Modeling, Drug Development and Personalized Medicine
Location: 308 AB West
Hot Topic Moderator: Yurong Lai, PhD (he/him/his) – Gilead Sciences, Inc.
Hot Topic Speaker: Rodrigo Cristofoletti, Ph.D. (he/him/his) – University of Florida
Preclinical and Translational Sciences
Tuesday, Oct 24th
3:00 PM – 4:00 PM ET
Rapid Fires: Advancing Innovation in In Silico Translational Approaches 1
Location: 309 AB West
Rapid Fire Moderator: Sean Ekins, PhD, DSc – Collaborations Pharmaceuticals, Inc.
Preclinical and Translational Sciences
Tuesday, Oct 24th
3:00 PM – 4:00 PM ET
Rapid Fires: Advancing Innovation in In Silico Translational Approaches 2
Location: 311 CD West
Rapid Fire Moderator: Cheng Chang, PhD – Pfizer Inc.
Preclinical and Translational Sciences
Tuesday, Oct 24th
3:30 PM – 4:30 PM ET
A Formulators Guide to Crossing the Valley of Death
Location: 360 Stage #2 Exhibit Hall West A4-B3
Partner Presentation Speaker: Darren Matthews, PhD – Charles River
Partner Presentation Speaker: Dolly Jacob, PhD – Quotient Sciences
Preclinical and Translational Sciences
Presented By
Tuesday, Oct 24th
3:30 PM – 4:30 PM ET
Immunogenicity Assessment and Functional Testing of Candidate Therapeutics
Location: 360 Stage #4 Exhibit Hall West A4-B3
Partner Presentation Speaker: Chloe Ackaert, PhD (she/her/hers) – ImmunXperts, a Q2 Solutions Company
Preclinical and Translational Sciences
Presented By
Wednesday, Oct 25th
9:00 AM – 10:30 AM ET
Symposium: Alternative Approach to Animal Studies
Location: 309 AB West
Moderator: Ketan D. Patel, PhD (he/him/his) – St. John's University
Preclinical and Translational Sciences
Wednesday, Oct 25th
9:00 AM – 9:30 AM ET
Application of (Q)SAR Modeling to the Safety Assessment of Pharmaceuticals
Location: 309 AB West
Speaker: Naomi Kruhlak, PhD (she/her/hers) – US Food and Drug Administration
Preclinical and Translational Sciences
Wednesday, Oct 25th
9:30 AM – 10:00 AM ET
A Novel in vitro Hepatocyte Culture System (icHep) for Biliary Drug Excretion Analysis Using Permeation Assay
Location: 309 AB West
Speaker: Ikumi Tamai, Ph.D (he/him/his) – Kanazawa University
Preclinical and Translational Sciences
Wednesday, Oct 25th
10:00 AM – 10:30 AM ET
SafetAI Initiative: AI Based Prediction Initiative For Predicting Toxicity End-Points
Location: 309 AB West
Speaker: Shraddha Thakkar, MSc, M.S., PhD – US FDA/CDER/OTS/OCS
Preclinical and Translational Sciences
Wednesday, Oct 25th
9:00 AM – 11:00 AM ET
Symposium: Methodologies to Expedite Drug Development
Location: 311 CD West
Moderator: Aniruddha S. Karve, PhD – University of Cincinnati
Preclinical and Translational Sciences
Wednesday, Oct 25th
9:30 AM – 10:00 AM ET
Promises and Pitfalls of Phase 0/1 Clinical Trials
Location: 311 CD West
Speaker: David M. Peereboom, MD – Cleveland Clinic Burkhardt Brain Tumor and Neuro-oncology Center
Preclinical and Translational Sciences
Wednesday, Oct 25th
10:00 AM – 10:30 AM ET
Bridging the Gap: Preclinical Modeling for Effective PK/PD-Driven Clinical Trials
Location: 311 CD West
Speaker: Shwetal Mehta, PhD – Ivy Brain Tumor Center / Barrow Neurological Institute
Preclinical and Translational Sciences
Wednesday, Oct 25th
10:30 AM – 11:00 AM ET
Marker Molecules to Measure BBB Permeability in and Around Brain Tumors
Location: 311 CD West
Speaker: William F. elmquist, PhD (he/him/his) – University of Minnesota
Preclinical and Translational Sciences
Wednesday, Oct 25th
11:00 AM – 12:00 PM ET
U.S. Government Contracts & Grants: Non-Dilutive Funding for Life Sciences
Location: 360 Stage #4 Exhibit Hall West A4-B3
Partner Presentation Speaker: Laura Powell, PhD – EverGlade Consulting
Partner Presentation Speaker: Steve Morris, PhD – EverGlade Consulting
Preclinical and Translational Sciences
Presented By
Wednesday, Oct 25th
11:30 AM – 12:30 PM ET
Speaker Spotlight: Innovative PK-PD is Helping Informed-Decision in Neuro-Oncology
Location: Spotlight Stage B Exhibit Hall West A4-B3
Moderator: Pankaj B. Desai, PhD (he/him/his) – University of Cincinnati
Spotlight Speaker: Nader Sanai, MD (he/him/his) – Ivy Brain Tumor Center at Barrow Neurological Institute
Preclinical and Translational Sciences
Wednesday, Oct 25th
1:30 PM – 2:30 PM ET
Keynote: Novel Tools and Insights into Predicting Systemic and Tissue Drug Concentrations in Humans Including Special Populations
Location: 309 AB West
Keynote Speaker: Jashvant D. Unadkat, PhD – University of Washington
Moderator: Yurong Lai, PhD (he/him/his) – Gilead Sciences, Inc.
Preclinical and Translational Sciences
Wednesday, Oct 25th
1:30 PM – 2:30 PM ET
Keynote: Predictive Drug Discovery Platforms
Location: 311 CD West
Keynote Speaker: James R. Gosset (he/him/his) – Pfizer Inc
Moderator: Fei Hua, PhD – Applied BioMath
Preclinical and Translational Sciences
Wednesday, Oct 25th
3:00 PM – 4:00 PM ET
Hot Topic: Understanding Data Needs for AI/ML Approaches During Preclinical Development
Location: 308 CD West
Hot Topic Speaker: Vibha Jawa, PhD, FAAPS – Bristol Myers Squibb
Hot Topic Moderator: Fei Hua, PhD – Applied BioMath
Hot Topic Speaker: Anant Madabhushi, PhD (he/him/his) – Emory University
Hot Topic Speaker: Michelle Graham, PhD (she/her/hers) – AbbVie
Hot Topic Speaker: Narendra Chirmule, Dr. (he/him/his) – SymphonyTech Biologucs
Preclinical and Translational Sciences
Wednesday, Oct 25th
3:00 PM – 4:00 PM ET
Rapid Fires: Novel Predictive Preclinical Models for Efficacy and Toxicology 1
Location: 309 AB West
Rapid Fire Moderator: Claudio M. Marzo, PhD (he/him/his) – Evotec SE
Preclinical and Translational Sciences
Wednesday, Oct 25th
3:00 PM – 4:00 PM ET
Rapid Fires: Novel Predictive Preclinical Models for Efficacy and Toxicology 2
Location: 311 CD West
Rapid Fire Moderator: Bill R. Thelin, PhD (he/him/his) – Altis Biosystems
Preclinical and Translational Sciences