Career Development

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Monday, Nov 10th
9:00 AM - 11:00 AM CT
Symposium: New Frontiers of Drug Development Through the Use of Non-Animal Models and Imaging
Location: 225 AB
Moderator: Karin Allenspach, DVM PhD DECVIM-CA (she/her/hers) – University of Georgia
Preclinical, Clinical, and Translational Sciences
Monday, Nov 10th
9:00 AM - 11:00 AM CT
Symposium: Advances and Case Examples of In Silico Modeling for Drug Development
Location: 225 CD
Moderator: Agostinho Rocha – Smithers - Pharmaceutical Development Services
Preclinical, Clinical, and Translational Sciences
Monday, Nov 10th
9:00 AM - 9:30 AM CT
Leveraging Mechanistic Static Models for DDI Waivers and Regulatory Approval
Location: 225 CD
Speaker: Sheila Annie Peters, MSc PhD (she/her/hers) – Boehringer Ingelheim Pharma GmbH & Co
Preclinical, Clinical, and Translational Sciences
Monday, Nov 10th
9:00 AM - 9:30 AM CT
Organoids Unleashed: Engineering Mini-Organs in a Dish to Accelerate Veterinary and Comparative Pharmaceutical Research
Location: 225 AB
Speaker: Jonathan Mochel, DVM, PhD, DECVPT – College of Veterinary Medicine/University of Georgia
Preclinical, Clinical, and Translational Sciences
Monday, Nov 10th
9:30 AM - 10:00 AM CT
Advancing Drug Development and Regulatory Toxicology with AI-Supported PBPK, IVIVE, and Computational Modeling
Location: 225 AB
Speaker: Shagun Krishna, PhD (she/her/hers) – Physicians Committee for Responsible Medicine
Preclinical, Clinical, and Translational Sciences
Monday, Nov 10th
9:30 AM - 10:00 AM CT
Where Are We for Successful Modeling for Oral Macrocyclic Peptide?
Location: 225 CD
Speaker: Armin Sepp, PhD – Certara Plc
Preclinical, Clinical, and Translational Sciences
Monday, Nov 10th
10:00 AM - 10:30 AM CT
Mechanistic PBPK Modelling for the Locally Acting GIT Drug: Mesalamine
Location: 225 CD
Speaker: David B. Turner, PhD – Certara Predictive Technologies, Certara UK Limited
Preclinical, Clinical, and Translational Sciences
Monday, Nov 10th
10:00 AM - 10:30 AM CT
Testing and Qualification of the Microphysiological Systems Through an Academia-Industry-Government Collaboration
Location: 225 AB
Speaker: Ivan Rusyn, MD, PhD – College of Veterinary Medicine and Biomedical Sciences/Texas A&M
Preclinical, Clinical, and Translational Sciences
Monday, Nov 10th
10:30 AM - 11:00 AM CT
Perspectives on PCR-Based Cellular Kinetics and Biodistribution in Cell Therapy
Location: 225 CD
Speaker: Nanda Balasubramanian, PhD (he/him/his) – BMS
Preclinical, Clinical, and Translational Sciences
Monday, Nov 10th
10:30 AM - 11:00 AM CT
Pursuing the Holy Grail of Predicting Human Tissue Drug Concentrations
Location: 225 AB
Speaker: Jashvant D. Unadkat, PhD (he/him/his) – University of Washington
Preclinical, Clinical, and Translational Sciences
Monday, Nov 10th
9:30 AM - 10:15 AM CT
Advancing Physiologically Based Pharmacokinetic (PBPK) Modeling for Dermal and Ocular Drug Development
Location: Spotlight Stage C, Aisle 3800, Exhibit Hall
Chalk Talk Presenter: Bryan W. Holland, PhD – Certara
Chalk Talk Presenter: Daniel Paterson, PhD (he/him/his) – Certara
Preclinical, Clinical, and Translational Sciences
Sponsored By
Monday, Nov 10th
11:00 AM - 12:00 PM CT
Driving Drug Development Efficiency with Single Cell & Spatial Omics
Location: 360 Stage #2, Exhibit Hall
Partner Presentation Speaker: Joshua S. Talboom, MA, PhD (he/him/his) – 10x Genomics
Preclinical, Clinical, and Translational Sciences
Sponsored By
Monday, Nov 10th
11:15 AM - 12:00 PM CT
Integrated Preclinical CRO Strategies: From Target Engagement to IND
Location: Spotlight Stage B, Aisle 2500, Exhibit Hall
Chalk Talk Presenter: Lilly Xu, PhD (she/her/hers) – Medicilon
Preclinical, Clinical, and Translational Sciences
Sponsored By
Monday, Nov 10th
12:00 PM - 1:00 PM CT
PK/TK Strategy in Drug Development: Optimizing Design, Execution, and Data Integrity
Location: 360 Stage #3, Exhibit Hall
Partner Presentation Speaker: Sara Underwood – Alturas Analytics, Inc.
Preclinical, Clinical, and Translational Sciences
Sponsored By
Monday, Nov 10th
1:30 PM - 2:30 PM CT
Keynote: Human Organ Chips as Tools for Clinical Mimicry
Location: 225 AB
Keynote Speaker: Girija Goyal, PhD (she/her/hers) – Wyss Institute at Harvard University
Moderator: Krishna Veerubhotla, PhD (he/him/his) – Pfizer Inc
Preclinical, Clinical, and Translational Sciences
Monday, Nov 10th
1:30 PM - 2:30 PM CT
Keynote: The Evolution of PK/PD Models for Clinical Practice and Drug Development
Location: 225 CD
Keynote Speaker: Murray P. Ducharme, DPH, PharmD, FCCP, FCP – Learn & Confirm, Inc.
Moderator: Pankajini Mallick, PhD (she/her/hers) – Neurocrine
Preclinical, Clinical, and Translational Sciences
Monday, Nov 10th
3:00 PM - 4:00 PM CT
Rapid Fires: Novel In Silico and In Vitro Approaches in Drug Development 1
Location: 225 AB
Rapid Fire Moderator: Janey Ronxhi, MS, ALM (she/her/hers) – Takeda Development Center Americas, Inc.
Preclinical, Clinical, and Translational Sciences
Monday, Nov 10th
3:00 PM - 4:00 PM CT
Rapid Fires: Novel In Silico and In Vitro Approaches in Drug Development 2
Location: 225 CD
Rapid Fire Moderator: Ishwor Poudel, PhD (he/him/his) – University of Washington
Preclinical, Clinical, and Translational Sciences
Monday, Nov 10th
3:00 PM - 3:15 PM CT
Bridging In Vitro to In Vivo: Preclinical In Vitro Models for Characterizing Oligonucleotide Metabolism
Location: 225 CD
Rapid Fire Speaker: Hong Zhang, PhD (he/him/his) – WuXi AppTec
Preclinical, Clinical, and Translational Sciences
Monday, Nov 10th
3:00 PM - 3:15 PM CT
Virtual Cells in Drug Discovery: A Physics-to-Intelligence Journey
Location: 225 AB
Rapid Fire Speaker: Christopher Korban – Revilico Inc
Preclinical, Clinical, and Translational Sciences
Monday, Nov 10th
3:15 PM - 3:30 PM CT
Cellular Mechanisms Underlying Species-Related Differences in LNP-mRNA Delivery
Location: 225 AB
Rapid Fire Speaker: Kari Martyniak, Ph.D. (she/her/hers) – Pfizer, Inc.
Preclinical, Clinical, and Translational Sciences
Monday, Nov 10th
3:15 PM - 3:30 PM CT
ddPCR-Based Assessment of Dendritic Cell Activation for Immunogenicity Evaluation
Location: 225 CD
Rapid Fire Speaker: Jean-Pierre Minembe – Takeda Pharmaceutical Company Limited
Preclinical, Clinical, and Translational Sciences
Monday, Nov 10th
3:30 PM - 3:45 PM CT
Enhancing Biorelevance: Unveiling Enzymatic Impact on Simulated GI Dissolution
Location: 225 AB
Rapid Fire Speaker: Catarina I.D Chendo, MS (she/her/hers) – Hovione
Preclinical, Clinical, and Translational Sciences
Monday, Nov 10th
3:30 PM - 3:45 PM CT
Poloxamer-Coated Camel Milk Exosomes for Oral Cannabidiol Delivery: A Triad of In-Silico, In-Vitro, and In-Vivo Insights
Location: 225 CD
Rapid Fire Speaker: SANDEEP Chary PADAKANTI, PhD – FLORIDA A&M UNIVERSITY
Preclinical, Clinical, and Translational Sciences
Monday, Nov 10th
3:45 PM - 4:00 PM CT
Advancing In Vitro Methods for Nose to Brain Delivery - Current Prospects and Future Possibilities
Location: 225 CD
Rapid Fire Speaker: Debanjan Das, MS (he/him/his) – Bayer Healthcare LLC
Preclinical, Clinical, and Translational Sciences
Monday, Nov 10th
3:45 PM - 4:00 PM CT
In vitro + In Silico: Advanced Tools for Absorption Prediction
Location: 225 AB
Rapid Fire Speaker: Balint Sinko, PhD – Pion Inc.
Preclinical, Clinical, and Translational Sciences
Tuesday, Nov 11th
9:00 AM - 11:00 AM CT
Symposium: Clinical Trials for Pediatric Populations
Location: 225 CD
Moderator: Sesha Rajeswari Talluri, M Pharm – Ernest Mario School of Pharmacy
Preclinical, Clinical, and Translational Sciences
Tuesday, Nov 11th
9:00 AM - 11:00 AM CT
Symposium: Special Considerations for Patient Populations in Clinical Trials
Location: 225 AB
Moderator: Viera Lukacova, PhD – Simulations Plus, Inc.
Preclinical, Clinical, and Translational Sciences
Tuesday, Nov 11th
9:00 AM - 9:30 AM CT
Hepatic Impairment and the Differential Effects on Drug Clearance Mechanisms
Location: 225 AB
Speaker: Manthena V. Varma, PhD – Pfizer Inc
Preclinical, Clinical, and Translational Sciences
Tuesday, Nov 11th
9:00 AM - 9:30 AM CT
Model-Informed Drug-Drug Interaction Assessment in Pediatric Populations
Location: 225 CD
Speaker: Valvanera Vozmediano, PhD – CTI Laboratories
Preclinical, Clinical, and Translational Sciences
Tuesday, Nov 11th
9:30 AM - 10:00 AM CT
AI in Designing and Delivering Clinical Trials for Specific Populations
Location: 225 AB
Speaker: Raja B. Velagapudi, PhD (he/him/his) – Tolmar Inc
Preclinical, Clinical, and Translational Sciences
Tuesday, Nov 11th
9:30 AM - 10:00 AM CT
Clinical Study Design and Effective Study in Pediatric Population
Location: 225 CD
Speaker: Daniel A. Morgenstern, MBBChir PhD (he/him/his) – Hospital for Sick Children
Preclinical, Clinical, and Translational Sciences
Tuesday, Nov 11th
10:00 AM - 10:30 AM CT
Trial Design for Obese: Right Compound, Right Dose, Right Patient
Location: 225 AB
Speaker: Maxime Le Merdy, Ph.D. – Simulations Plus, Inc.
Preclinical, Clinical, and Translational Sciences
Tuesday, Nov 11th
10:30 AM - 11:00 AM CT
Model-Informed Design of Clinical Trial in Patients with Renal Impairment
Location: 225 AB
Speaker: Viera Lukacova, PhD – Simulations Plus, Inc.
Preclinical, Clinical, and Translational Sciences
Tuesday, Nov 11th
10:30 AM - 11:00 AM CT
The Effect of Formulation Excipients for Oral Absorption in Pediatrics
Location: 225 CD
Speaker: Kazuki Matsui, PhD (he/him/his) – Ono Pharmaceutical
Preclinical, Clinical, and Translational Sciences
Tuesday, Nov 11th
9:30 AM - 10:30 AM CT
RNA Sequencing in Drug Discovery: Strategic Design, Evolving Technologies, and Translational Impact
Location: 360 Stage #4, Exhibit Hall
Partner Presentation Speaker: Kirthi Kumar Kutumbaka, MS, PhD (he/him/his) – Eurofins Clinical Trial Solutions
Preclinical, Clinical, and Translational Sciences
Sponsored By
Tuesday, Nov 11th
1:30 PM - 2:30 PM CT
Keynote: Creating Community Connections to Enhance Clinical Research
Location: 225 CD
Keynote Speaker: J. Nikki McKoy, MPH, MBA (she/her/hers) – RTI International
Moderator: Nirali Dholaria, MS (she/her/hers) – Ernest Mario School of Pharmacy
Preclinical, Clinical, and Translational Sciences
Tuesday, Nov 11th
1:30 PM - 2:30 PM CT
Keynote: Evolving Decentralized Clinical Research: Lessons from Five Years of Progress
Location: 225 AB
Keynote Speaker: Jean Branttie, PhD (she/her/hers) – Eli Lilly and Company
Moderator: Amita Datta-Mannan, PhD – Eli Lilly and Company
Preclinical, Clinical, and Translational Sciences
Tuesday, Nov 11th
2:30 PM - 3:30 PM CT
Hot Topic: New Technologies and Approaches for Translation to Clinical Practice
Location: 220
Hot Topic Moderator: Seeprarani P. Rath, Ph.D. – Rutgers - The State University of New Jersey
Hot Topic Speaker: Colin W. Castleberry, PhD (he/him/his) – Amgen
Hot Topic Speaker: Rodrigo Cristofoletti, PhD (he/him/his) – University of Florida
Hot Topic Speaker: Eshita Khera, PhD (she/her/hers) – Novartis
Preclinical, Clinical, and Translational Sciences
Tuesday, Nov 11th
3:00 PM - 4:00 PM CT
Rapid Fires: Designing and Delivering Effective Clinical Trials for Specific Populations 1
Location: 225 AB
Rapid Fire Moderator: Shoshana Oberstein (she/her/hers) – Takeda
Preclinical, Clinical, and Translational Sciences
Tuesday, Nov 11th
3:00 PM - 4:00 PM CT
Rapid Fires: Designing and Delivering Effective Clinical Trials for Specific Populations 2
Location: 225 CD
Rapid Fire Moderator: Hiroshi Sugimoto, PhD – Takeda
Preclinical, Clinical, and Translational Sciences
Tuesday, Nov 11th
3:00 PM - 3:15 PM CT
Emerging Trends for FIH Studies Over the Last 4 Years
Location: 225 AB
Rapid Fire Speaker: Andrew Lewis, PhD – Quotient Sciences
Preclinical, Clinical, and Translational Sciences
Tuesday, Nov 11th
3:00 PM - 3:15 PM CT
Multiplexed Targeted Proteomics for Translating Research Discoveries into Clinical Utility
Location: 225 CD
Rapid Fire Speaker: Sudhir Putty Reddy, PhD (he/him/his) – Bristol Myers Squibb
Preclinical, Clinical, and Translational Sciences
Tuesday, Nov 11th
3:15 PM - 3:30 PM CT
Iberdomide Biopharmaceutical Risk Assessment Using Model Informed Drug Development Approach
Location: 225 CD
Rapid Fire Speaker: Ajay Saxena, PhD – Bristol Myers Squibb
Preclinical, Clinical, and Translational Sciences
Tuesday, Nov 11th
3:15 PM - 3:30 PM CT
Translational Pharmaceutics to Support Clinical Trials for Orphan/ Rare Diseases
Location: 225 AB
Rapid Fire Speaker: Robert Cornog (he/him/his) – Quotient Sciences
Preclinical, Clinical, and Translational Sciences
Tuesday, Nov 11th
3:30 PM - 3:45 PM CT
Advancing Inclusive Research: Thinking End-to-End and Starting Early in Development
Location: 225 AB
Rapid Fire Speaker: Ken Wang
Preclinical, Clinical, and Translational Sciences
Tuesday, Nov 11th
3:30 PM - 3:45 PM CT
Novel Oral Molecules: Preclinical to Clinical Translation of Absorption-Disposition
Location: 225 CD
Rapid Fire Speaker: Sandhya V. Mandlekar, PhD (she/her/hers) – Genentech, Inc.
Preclinical, Clinical, and Translational Sciences
Tuesday, Nov 11th
3:45 PM - 4:00 PM CT
AAV-Based Gene Therapy Shedding Study Design in Clinical Trials
Location: 225 CD
Rapid Fire Speaker: Yi Feng, Phd (she/her/hers) – Lilly
Preclinical, Clinical, and Translational Sciences
Tuesday, Nov 11th
3:45 PM - 4:00 PM CT
Nemolizumab: Pediatric Extrapolation to Waive Placebo-Controlled Studies in Atopic Dermatitis
Location: 225 AB
Rapid Fire Speaker: Nathalie Wagner, MSc (she/her/hers) – Galderma R&D
Preclinical, Clinical, and Translational Sciences
Wednesday, Nov 12th
9:00 AM - 11:00 AM CT
Symposium: Translational Development of Cell and Gene Therapies
Location: 225 CD
Moderator: Rodrigo Cristofoletti, PhD (he/him/his) – University of Florida
Preclinical, Clinical, and Translational Sciences
Wednesday, Nov 12th
9:00 AM - 11:00 AM CT
Symposium: Translational Development of Diverse Drug Formulations
Location: 225 AB
Moderator: Shanghao Li, PhD – WuXi AppTec
Preclinical, Clinical, and Translational Sciences
Wednesday, Nov 12th
9:00 AM - 9:30 AM CT
Harnessing In Vitro Models for NAMs-Based Inhalable Substance Safety Assessments
Location: 225 AB
Speaker: Erin A. Huber, PhD (she/her/hers) – RTI International
Preclinical, Clinical, and Translational Sciences
Wednesday, Nov 12th
9:00 AM - 9:30 AM CT
Shedding Study in AAV-Gene Therapy Trials: What We Have Learned?
Location: 225 CD
Speaker: Yan G. Ni, PhD – Passage Bio
Preclinical, Clinical, and Translational Sciences
Wednesday, Nov 12th
9:30 AM - 10:00 AM CT
Oral Peptide Drug Development: Addressing Preclinical Bioavailability and PK Challenges
Location: 225 AB
Speaker: Jianping Sun (he/him/his) – WuXi AppTec
Preclinical, Clinical, and Translational Sciences
Wednesday, Nov 12th
9:30 AM - 10:00 AM CT
Physiologically Based Pharmacokientics Modeling of RNA-LNP to Characterize Clinical Consequence
Location: 225 CD
Speaker: Patrick Glassman, PhD (he/him/his) – Temple University
Preclinical, Clinical, and Translational Sciences
Wednesday, Nov 12th
10:00 AM - 10:30 AM CT
CAR-T Cell Therapy in Autoimmune Diseases: Clinical Pharmacology and Dosing Considerations
Location: 225 CD
Speaker: Fei Tang, PharmD, PhD (she/her/hers) – Genentech, Inc.
Preclinical, Clinical, and Translational Sciences
Wednesday, Nov 12th
10:00 AM - 10:30 AM CT
In-Vitro Tools to Streamline Subcutaneous Drug Development
Location: 225 AB
Speaker: Mikhail Murashov, PhD (he/him/his) – Merck & Co., Inc.
Preclinical, Clinical, and Translational Sciences
Wednesday, Nov 12th
10:30 AM - 11:00 AM CT
Predicting Human Subcutaneous Bioavailability of Monoclonal Antibodies Using an Integrated In-Vitro/In-Silico Approach
Location: 225 AB
Speaker: Jenna Caldwell, PhD – AstraZeneca
Preclinical, Clinical, and Translational Sciences
Wednesday, Nov 12th
10:30 AM - 11:00 AM CT
Quantitative Pharmacology of anti-CD19 Cell Therapies in Autoimmune conditions
Location: 225 CD
Speaker: Aman P. Singh, M.S., PhD – Johnson and Johnson Innovative Medicine
Preclinical, Clinical, and Translational Sciences
Wednesday, Nov 12th
1:30 PM - 2:30 PM CT
Hot Topic: Identifying Gaps and Pushing Boundaries in Mechanistic Dissolution Modeling
Location: 220
Hot Topic Moderator: Deanna M. Mudie, PhD (she/her/hers) – Simulations Plus, Inc.
Hot Topic Speaker: Deanna M. Mudie, PhD (she/her/hers) – Simulations Plus, Inc.
Hot Topic Speaker: Yanxing Wang, PhD (he/him/his) – New Mexico State University
Hot Topic Speaker: Jozef Al-Gousous, PhD – Johannes Gutenberg University Mainz and University of Michigan
Preclinical, Clinical, and Translational Sciences
Wednesday, Nov 12th
1:30 PM - 2:30 PM CT
Keynote: Current Status and Future Perspective of Pre-Clinical in vivo Studies vs in vitro/in silico Predictive Biopharmaceutics Tools
Location: 225 CD
Moderator: Yasuhiro Tsume, PhD (he/him/his) – Merck & Co.
Keynote Speaker: David C. Sperry, PhD – Eli Lilly and Company
Preclinical, Clinical, and Translational Sciences
Wednesday, Nov 12th
1:30 PM - 2:30 PM CT
Keynote: Development of Non-Invasive Wearable Physiological Sensors for Quantifying Treatment Outcomes
Location: 225 AB
Keynote Speaker: Conor Evans, PhD – Massachusetts General Hospital / Harvard Medical School
Moderator: Balint Sinko, Ph.D. – Pion Inc.
Preclinical, Clinical, and Translational Sciences
Wednesday, Nov 12th
3:00 PM - 4:00 PM CT
Rapid Fires: Translating Animal PK, Toxicology, and Biomarkers to Clinical Success
Location: 225 CD
Rapid Fire Moderator: Ananth Kumar Kammala, PhD (he/him/his) – The University of Texas Medical Branch
Preclinical, Clinical, and Translational Sciences
Wednesday, Nov 12th
3:00 PM - 3:15 PM CT
Harnessing a Cutting-Edge Single-Cell Flow Cytometry Platform for Enhanced Immunogenicity Assessment
Location: 225 CD
Rapid Fire Speaker: Janey Ronxhi, MS, ALM (she/her/hers) – Takeda Development Center Americas, Inc.
Preclinical, Clinical, and Translational Sciences
Wednesday, Nov 12th
3:15 PM - 3:30 PM CT
Exposure Response Assessment of a Novel, Directly Acting Antiviral, BDGR-251
Location: 225 CD
Rapid Fire Speaker: Ashish Srivastava, PhD (he/him/his) – University of Tennessee Health Science Center
Preclinical, Clinical, and Translational Sciences
Wednesday, Nov 12th
3:30 PM - 3:45 PM CT
Mechanistic Data to Support Iron-Carbohydrate Nanoparticle PBPK Models
Location: 225 CD
Rapid Fire Speaker: Amy Alston, PharmD, MS (she/her/hers) – CSL Vifor
Preclinical, Clinical, and Translational Sciences
Wednesday, Nov 12th
3:45 PM - 4:00 PM CT
Pre-Clinical Model for Simultaneous PK-PD Studies of CNS Active Compounds
Location: 225 CD
Rapid Fire Speaker: Abhisheak Sharma, Ph.D. (he/him/his) – University of Florida
Preclinical, Clinical, and Translational Sciences