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Tuesday, October 27, 2026
7:00 AM - 8:30 AM
CT
Mentor Breakfast
7:00 AM - 8:30 AM
CT
Mentor Breakfast
Location: The Great Hall B
Career Development
Sponsored By
7:00 AM - 9:00 AM
CT
Quotient Sciences Breakfast Seminar: Integrated Formulation Development: Solubility Enhancement, Modified Release and AI-Informed Drug Development
7:00 AM - 9:00 AM
CT
Quotient Sciences Breakfast Seminar: Integrated Formulation Development: Solubility Enhancement, Modified Release and AI-Informed Drug Development
Location: Fulton (Hilton New Orleans Riverside)
7:30 AM - 9:00 AM
CT
Dissolution Discussion Group Sponsored by Agilent
7:30 AM - 9:00 AM
CT
Dissolution Discussion Group Sponsored by Agilent
Location: R04
7:30 AM - 5:00 PM
CT
Speaker Ready Room
7:30 AM - 5:00 PM
CT
Speaker Ready Room
Location: 215-216
8:00 AM - 5:00 PM
CT
Registration Hours
8:00 AM - 5:00 PM
CT
Registration Hours
Location: B1 Lobby
8:30 AM - 5:00 PM
CT
Solution Center Hours & Poster Presentations
8:30 AM - 5:00 PM
CT
Solution Center Hours & Poster Presentations
Location: Exhibit Hall BC
9:00 AM - 10:00 AM
CT
Hot Topic: Immunogenicity Expectations: Are They Fact or Fear?
Hot Topic Speaker:
Susan Kirshner
– Former FDA OPQ
Hot Topic Speaker:
Yow-Ming C. Wang, PhD
– FDA OCP
Hot Topic Speaker:
Mita Mookherjee
Bioanalytics
9:00 AM - 10:00 AM
CT
Hot Topic: Immunogenicity Expectations: Are They Fact or Fear?
Location: 210
Hot Topic Speaker:
Susan Kirshner
– Former FDA OPQ
Hot Topic Speaker:
Yow-Ming C. Wang, PhD
– FDA OCP
Hot Topic Speaker:
Mita Mookherjee
Bioanalytics
9:00 AM - 9:15 AM
CT
Immunogenicity Expectations: Myth-Busting and Evidence Review
Location: 210
Hot Topic Speaker:
Susan Kirshner
– Former FDA OPQ
Bioanalytics
9:15 AM - 9:30 AM
CT
FDA Perspective on Immunogenicity Risk Assessment and Tiered Assays
Location: 210
Hot Topic Speaker:
Yow-Ming C. Wang, PhD
– FDA OCP
Bioanalytics
9:30 AM - 10:00 AM
CT
Panel Discussion: Industry Perspectives
Location: 210
Hot Topic Moderator:
Susan Kirshner
– Former FDA OPQ
Hot Topic Speaker:
Yow-Ming C. Wang, PhD
– FDA OCP
Hot Topic Speaker:
Mita Mookherjee
Hot Topic Speaker:
Helen Kang
Bioanalytics
9:00 AM - 11:00 AM
CT
Symposium: Advanced Structural and Biophysical Characterization of Lipid Nanoparticle Systems and Biosimilars
Moderator:
Phillip Ramsey, M.S., M.B.A., R.A.C. (he/him/his)
– Sangamo Therapeutics
Manufacturing and Analytical Characterization
9:00 AM - 11:00 AM
CT
Symposium: Advanced Structural and Biophysical Characterization of Lipid Nanoparticle Systems and Biosimilars
Location: 224
Moderator:
Phillip Ramsey, M.S., M.B.A., R.A.C. (he/him/his)
– Sangamo Therapeutics
Manufacturing and Analytical Characterization
9:00 AM - 9:30 AM
CT
Structural Insights into mRNA/LNPs: Cryo-EM for Advanced Vaccine Platforms
Location: 224
Speaker:
Pushkar A. Saralkar, PhD
– Pfizer
Manufacturing and Analytical Characterization
9:30 AM - 10:00 AM
CT
Thermodynamic Insights into Molecular Packing Governing mRNA Lipid Nanoparticles
Location: 224
Speaker:
Sutapa Barua, PhD (she/her/hers)
– Pfizer
Manufacturing and Analytical Characterization
10:00 AM - 10:30 AM
CT
Orthogonal SVP Analytics: Counts, Classification, and Decisions
Location: 224
Speaker:
Tyler Carter, PhD
– Yokogawa Fluid Imaging Technologies
Manufacturing and Analytical Characterization
10:30 AM - 11:00 AM
CT
Next‑Generation Characterization of Targeted Lipid Nanoparticles for mRNA Delivery
Location: 224
Speaker:
Liping Zhou, PhD
– AstraZeneca
Manufacturing and Analytical Characterization
9:00 AM - 11:00 AM
CT
Symposium: Enabling High Drug Load and High‑Viscosity Drug Products: From ASDs to Delivery Systems
Moderator:
Jayachandra Ramapuram, Ph.D.
– Auburn University
Formulation and Delivery
9:00 AM - 11:00 AM
CT
Symposium: Enabling High Drug Load and High‑Viscosity Drug Products: From ASDs to Delivery Systems
Location: 217-219
Moderator:
Jayachandra Ramapuram, Ph.D.
– Auburn University
Formulation and Delivery
9:00 AM - 9:30 AM
CT
High‑Drug Load ASDs: Linking Microstructure to Dissolution
Location: 217-219
Speaker:
Nitin K. Swarnakar, Ph.D. (he/him/his)
– BASF Corporation
Formulation and Delivery
9:30 AM - 10:00 AM
CT
Evaluating Kinetisol Technology as an alternative to spray drying to develop ASDs
Location: 217-219
Speaker:
Paroma Chakravarty, MS, PhD
– Genentech, Inc.
Formulation and Delivery
10:00 AM - 10:30 AM
CT
Impact of Polymeric Excipients on Physical Stability and Injectability of High-Concentration Protein Suspensions
Location: 217-219
Speaker:
Qi (Tony) Tony Zhou, Ph.D., FAAPS (he/him/his)
– Purdue University
Formulation and Delivery
10:30 AM - 11:00 AM
CT
Drug–Device Co‑Design for High‑Viscosity and Large‑Volume Delivery
Location: 217-219
Speaker:
Advait V. Badkar, PhD (he/him/his)
– Pfizer Inc
Formulation and Delivery
9:00 AM - 11:00 AM
CT
Symposium: Innovating Cancer Therapy: Translational Approaches Across New Modalities
Moderator:
Otilia M. Koo, PhD, FAAPS (she/her/hers)
– Novo Nordisk
Preclinical, Clinical, and Translational Sciences
9:00 AM - 11:00 AM
CT
Symposium: Innovating Cancer Therapy: Translational Approaches Across New Modalities
Location: 206
Moderator:
Otilia M. Koo, PhD, FAAPS (she/her/hers)
– Novo Nordisk
Preclinical, Clinical, and Translational Sciences
9:00 AM - 9:30 AM
CT
In situ Immunization of Tumors
Location: 206
Speaker:
Aliasger Karimjee Salem, PhD
– University of Iowa
Preclinical, Clinical, and Translational Sciences
10:00 AM - 10:30 AM
CT
Targeting RNA-Binding Proteins as a Novel Therapeutic Modality in Cancer
Location: 206
Speaker:
Shannon M. Lauberth, PhD
– Northwestern University Feinberg School of Medicine
Preclinical, Clinical, and Translational Sciences
10:30 AM - 11:00 AM
CT
Strategic Preclinical and Clinical PK/PD Modeling of Novel Antibody-Based Constructs
Location: 206
Speaker:
Donald E. Mager, PharmD, PhD (he/him/his)
– University at Buffalo, SUNY/Enhanced Pharmacodynamics, LLC
Preclinical, Clinical, and Translational Sciences
9:00 AM - 11:00 AM
CT
Symposium: Measuring the Unmeasurable: Bioanalytical Innovation for Emerging Modalities
Moderator:
Jennifer Grant, PhD
– Beam Therapeutics
Bioanalytics
9:00 AM - 11:00 AM
CT
Symposium: Measuring the Unmeasurable: Bioanalytical Innovation for Emerging Modalities
Location: 203-205
Moderator:
Jennifer Grant, PhD
– Beam Therapeutics
Bioanalytics
9:00 AM - 9:30 AM
CT
Bioanalytical Strategies for Antibody Oligonucleotide Conjugates
Location: 203-205
Speaker:
Padmanabhan Eangoor, PhD
– Sanofi
Bioanalytics
9:30 AM - 10:00 AM
CT
Data Integrity Through Orthogonal Confirmation: Strategies for Emerging Modalities
Location: 203-205
Speaker:
Jinhui Zhang, PhD (he/him/his)
– US Food and Drug Administration
Bioanalytics
10:00 AM - 10:30 AM
CT
Unlocking Efficiency with In-Vitro Expression Multiplexing and Smart Automation
Location: 203-205
Speaker:
Haiyan Sun, PhD
– Pfizer Inc.
Bioanalytics
10:30 AM - 11:00 AM
CT
Reagent Preparation and PK Method Development for Immuno-PCR Bioanalysis
Location: 203-205
Speaker:
Yang Chao, PhD
– GlaxoSmithKline
Bioanalytics
9:00 AM - 11:00 AM
CT
Symposium: Model-Informed Innovation: Integrating NAMs Across Translational Workflows
Moderator:
Kent Grindstaff, PhD
– BioIVT
Preclinical, Clinical, and Translational Sciences
9:00 AM - 11:00 AM
CT
Symposium: Model-Informed Innovation: Integrating NAMs Across Translational Workflows
Location: 207
Moderator:
Kent Grindstaff, PhD
– BioIVT
Preclinical, Clinical, and Translational Sciences
9:00 AM - 9:30 AM
CT
Advancing NAMs with Quantitative Systems Toxicology and Microphysiological Systems
Location: 207
Speaker:
Jeffrey Woodhead, PhD (he/him/his)
– Simulations Plus Inc.
Preclinical, Clinical, and Translational Sciences
9:30 AM - 10:00 AM
CT
Multi-Parametric Assessment of AAV Efficacy and Toxicity with Liver MPS
Location: 207
Speaker:
Murat Cirit, PhD
– Javelin Biotech
Preclinical, Clinical, and Translational Sciences
10:00 AM - 10:30 AM
CT
Integrating New Approach Methodologies to Advance Preclinical-Testing and Product Development
Location: 207
Speaker:
Vivek Agrahari, PhD (he/him/his)
– CONRAD, Macon & Joan Brock Virginia Health Sciences At Old Dominion University
Preclinical, Clinical, and Translational Sciences
10:30 AM - 11:00 AM
CT
Whole Blood NAMs for Replacing Key Animal Immunotoxicology Studies
Location: 207
Speaker:
Jason LaPorte, MS
– EpiVax, Inc.
Preclinical, Clinical, and Translational Sciences
9:00 AM - 11:00 AM
CT
Symposium: Modern Analytical Strategies for Impurity Characterization and Lifecycle Management
Moderator:
Wenshan W. Zhuang, PhD
– AbbVie, Inc.
Manufacturing and Analytical Characterization
9:00 AM - 11:00 AM
CT
Symposium: Modern Analytical Strategies for Impurity Characterization and Lifecycle Management
Location: 225-227
Moderator:
Wenshan W. Zhuang, PhD
– AbbVie, Inc.
Manufacturing and Analytical Characterization
9:00 AM - 9:30 AM
CT
Rapid Implementation of Spectroscopic Methods for Pharmaceutical Manufacturing
Location: 225-227
Speaker:
Carl Anderson, Ph.D.
– Duquesne University
Manufacturing and Analytical Characterization
9:30 AM - 10:00 AM
CT
Rethinking Impurity and Trace-Level Analyses for Ultra‑Low-Dose Pharmaceuticals
Location: 225-227
Speaker:
Wenshan W. Zhuang, PhD
– AbbVie, Inc.
Manufacturing and Analytical Characterization
10:00 AM - 10:30 AM
CT
Impurity Characterization Across Drug Development: Phase-Appropriate Analytical and Regulatory Strategies
Location: 225-227
Speaker:
Subathra Ramamoorthy, MS, RPh
– Veranova
Manufacturing and Analytical Characterization
10:30 AM - 11:00 AM
CT
Analytical Procedure Lifecycle Management
Location: 225-227
Speaker:
Jinhui Zhang, PhD (he/him/his)
– US Food and Drug Administration
Manufacturing and Analytical Characterization
9:00 AM - 11:00 AM
CT
Symposium: Oligonucleotide Bioanalysis: Ring Trial and Emerging Conjugate Modalities
Moderator:
Karan Agrawal, PhD (he/him/his)
– Johnson & Johnson Innovative Medicine
Bioanalytics
9:00 AM - 11:00 AM
CT
Symposium: Oligonucleotide Bioanalysis: Ring Trial and Emerging Conjugate Modalities
Location: 211-213
Moderator:
Karan Agrawal, PhD (he/him/his)
– Johnson & Johnson Innovative Medicine
Bioanalytics
9:00 AM - 9:30 AM
CT
A One-Year Update from the Oligonucleotide Ring Trial
Location: 211-213
Speaker:
Troy Voelker, PhD (he/him/his)
– Aliri Bioanalysis
Bioanalytics
9:30 AM - 10:00 AM
CT
Comparison of Three PCR Platforms for Oligonucleotide Therapeutic Quantification
Location: 211-213
Speaker:
Alex Washburn, MS
– Labcorp
Bioanalytics
10:00 AM - 10:30 AM
CT
Bioanalytical Strategies for Antibody Oligonucleotide Conjugates: Preclinical PK Toolkit
Location: 211-213
Speaker:
Sharmin Sultana (she/her/hers)
– LabCorp
Bioanalytics
10:30 AM - 11:00 AM
CT
Fit-for-Purpose or Box-Checking? Metabolite Assessment Strategy for Oligonucleotides
Location: 211-213
Speaker:
Kamalika Mukherjee, PhD (she/her/hers)
– Regeneron Pharmaceuticals
Bioanalytics
9:00 AM - 11:00 AM
CT
Symposium: Precision Delivery Frontiers: Redefining RNA and Advanced Therapeutics
Moderator:
Annette Bak, PhD, MBA, FAAPS
– AstraZeneca
Formulation and Delivery
9:00 AM - 11:00 AM
CT
Symposium: Precision Delivery Frontiers: Redefining RNA and Advanced Therapeutics
Location: 220-222
Moderator:
Annette Bak, PhD, MBA, FAAPS
– AstraZeneca
Formulation and Delivery
9:00 AM - 9:30 AM
CT
Future RNA Delivery Shaped by Next‑Generation LNP Mechanistic Insights 1
Location: 220-222
Speaker:
Mansor M. Amiji, PhD
– Northeastern University
Formulation and Delivery
9:30 AM - 10:00 AM
CT
Design, Structure-Activity Relations, and Unique Applications of the Ionizable Lipids: From Infectious Disease Vaccines to Intravenous Muscle Restoration in DMD
Location: 220-222
Speaker:
Arnab Rudra, PhD
– Boston Children's Hospital
Formulation and Delivery
10:00 AM - 10:30 AM
CT
Next-Generation Ethanol-Free mRNA-Lipid Nanoparticle Formulation for Enhanced Transfection Efficiency
Location: 220-222
Speaker:
Abhishek Shettar
– Sanofi
Formulation and Delivery
10:30 AM - 11:00 AM
CT
Antibody‑Conjugated Targeted LNPs for Extrahepatic Nucleic Acid Delivery
Location: 220-222
Speaker:
Sanjib Saha
– AstraZeneca Pharmaceuticals LP
Formulation and Delivery
9:00 AM - 11:30 AM
CT
Career Series 2: From Application to Offer: A Choose-Your-Own-Adventure Job Search
Career Center Speaker:
Stacey J. Tannenbaum, PhD
– SJTPharm LLC
Career Center Speaker:
Carina Clingman, Ph.D.
– Collaboratory Career Hub
Career Development
9:00 AM - 11:30 AM
CT
Career Series 2: From Application to Offer: A Choose-Your-Own-Adventure Job Search
Location: Careers 360, Exhibit Hall BC
Career Center Speaker:
Stacey J. Tannenbaum, PhD
– SJTPharm LLC
Career Center Speaker:
Carina Clingman, Ph.D.
– Collaboratory Career Hub
Career Development
9:30 AM - 10:00 AM
CT
Coffee Break in the Solution Center
9:30 AM - 10:00 AM
CT
Coffee Break in the Solution Center
Location: Exhibit Hall BC
10:00 AM - 11:00 AM
CT
Hot Topic: Hot Melt Extrusion 2.0-From Enabling Solubility to Smart Continuous Platforms
Hot Topic Moderator:
Gavin P. Andrews, PhD (he/him/his)
– Queen's University Belfast
Hot Topic Speaker:
Chengzhe Gao
Hot Topic Speaker:
Dana E. Moseson-Tarrh, PhD (she/her/hers)
– Eli Lilly and Company
Hot Topic Speaker:
Michael Repka, DDS PhD
– University of Missippi
Hot Topic Speaker:
Thomas De Beer, PhD
– Ghent University
Manufacturing and Analytical Characterization
10:00 AM - 11:00 AM
CT
Hot Topic: Hot Melt Extrusion 2.0-From Enabling Solubility to Smart Continuous Platforms
Location: 208-209
Hot Topic Moderator:
Gavin P. Andrews, PhD (he/him/his)
– Queen's University Belfast
Hot Topic Speaker:
Chengzhe Gao
Hot Topic Speaker:
Dana E. Moseson-Tarrh, PhD (she/her/hers)
– Eli Lilly and Company
Hot Topic Speaker:
Michael Repka, DDS PhD
– University of Missippi
Hot Topic Speaker:
Thomas De Beer, PhD
– Ghent University
Manufacturing and Analytical Characterization
11:00 AM - 1:30 PM
CT
Dedicated Solution Center Hours
11:00 AM - 1:30 PM
CT
Dedicated Solution Center Hours
Location: Exhibit Hall BC
12:00 PM - 1:00 PM
CT
The A.R.T. of Connecting: A New Paradigm for Technical Presentations
Career Center Speaker:
David P. Otey, MA, MBA (he/him/his)
– Speaking of Solutions, LLC
Career Development
12:00 PM - 1:00 PM
CT
The A.R.T. of Connecting: A New Paradigm for Technical Presentations
Location: Careers 360, Exhibit Hall BC
Career Center Speaker:
David P. Otey, MA, MBA (he/him/his)
– Speaking of Solutions, LLC
Career Development
1:30 PM - 2:30 PM
CT
Keynote: A Journey Navigating Drug-Drug Interaction in Discovery and Development
Keynote Speaker:
Xinning Yang, PhD (he/him/his)
– Food and Drug Administration
Moderator:
Fenglei Huang, Ph.D. (he/him/his)
– Boehringer Ingelheim
Preclinical, Clinical, and Translational Sciences
1:30 PM - 2:30 PM
CT
Keynote: A Journey Navigating Drug-Drug Interaction in Discovery and Development
Location: 206
Keynote Speaker:
Xinning Yang, PhD (he/him/his)
– Food and Drug Administration
Moderator:
Fenglei Huang, Ph.D. (he/him/his)
– Boehringer Ingelheim
Preclinical, Clinical, and Translational Sciences
1:30 PM - 2:30 PM
CT
Keynote: Converging Platforms and Expanding Biological Insight
Keynote Speaker:
Karan Agrawal, PhD (he/him/his)
– Johnson & Johnson Innovative Medicine
Bioanalytics
1:30 PM - 2:30 PM
CT
Keynote: Converging Platforms and Expanding Biological Insight
Location: 203-205
Keynote Speaker:
Karan Agrawal, PhD (he/him/his)
– Johnson & Johnson Innovative Medicine
Bioanalytics
1:30 PM - 2:30 PM
CT
Keynote: Enabling Oral Delivery of Next-Generation Drugs: Expanding the Role of Amorphous Solid Dispersions
Keynote Speaker:
Lynne S. Taylor, PhD
– Purdue University
Moderator:
Sandip Tiwari, PhD (he/him/his)
– BASF Corporation
Formulation and Delivery
1:30 PM - 2:30 PM
CT
Keynote: Enabling Oral Delivery of Next-Generation Drugs: Expanding the Role of Amorphous Solid Dispersions
Location: 217-219
Keynote Speaker:
Lynne S. Taylor, PhD
– Purdue University
Moderator:
Sandip Tiwari, PhD (he/him/his)
– BASF Corporation
Formulation and Delivery
1:30 PM - 2:30 PM
CT
Keynote: From Mechanism to Market: Transforming Biotherapeutic Delivery — Insights from Two Case Studies
Keynote Speaker:
Mayank Patel, Ph.D.
– AstraZeneca
Moderator:
Manmohan Singh, PhD
– Beam Tx
Formulation and Delivery
1:30 PM - 2:30 PM
CT
Keynote: From Mechanism to Market: Transforming Biotherapeutic Delivery — Insights from Two Case Studies
Location: 220-222
Keynote Speaker:
Mayank Patel, Ph.D.
– AstraZeneca
Moderator:
Manmohan Singh, PhD
– Beam Tx
Formulation and Delivery
1:30 PM - 2:30 PM
CT
Keynote: Leveraging Advances in Analytical Technologies for Supporting Biosimilar Development/Characterization
Keynote Speaker:
Maria Guiterrez Lugo, PhD
– U.S. Food & Drug Administration
Moderator:
Tian Li, Ph.D.
– US Food and Drug Administration
Manufacturing and Analytical Characterization
1:30 PM - 2:30 PM
CT
Keynote: Leveraging Advances in Analytical Technologies for Supporting Biosimilar Development/Characterization
Location: 224
Keynote Speaker:
Maria Guiterrez Lugo, PhD
– U.S. Food & Drug Administration
Moderator:
Tian Li, Ph.D.
– US Food and Drug Administration
Manufacturing and Analytical Characterization
1:30 PM - 2:30 PM
CT
Keynote: Measuring the Unmeasurable
Keynote Speaker:
Jim X. Shen, Ph.D. (he/him/his)
– Bristol-Myers Squibb Company
Moderator:
Jennifer Grant, PhD
– Beam Therapeutics
Bioanalytics
1:30 PM - 2:30 PM
CT
Keynote: Measuring the Unmeasurable
Location: 211-213
Keynote Speaker:
Jim X. Shen, Ph.D. (he/him/his)
– Bristol-Myers Squibb Company
Moderator:
Jennifer Grant, PhD
– Beam Therapeutics
Bioanalytics
1:30 PM - 2:30 PM
CT
Keynote: Nanomedicine in Translation: From Design to Therapeutic Outcome
Keynote Speaker:
Annette Bak, PhD, MBA, FAAPS
– AstraZeneca
Moderator:
Seeprarani Rath, PhD (she/her/hers)
– Rutgers, The State University of New Jersey
Preclinical, Clinical, and Translational Sciences
1:30 PM - 2:30 PM
CT
Keynote: Nanomedicine in Translation: From Design to Therapeutic Outcome
Location: 207
Keynote Speaker:
Annette Bak, PhD, MBA, FAAPS
– AstraZeneca
Moderator:
Seeprarani Rath, PhD (she/her/hers)
– Rutgers, The State University of New Jersey
Preclinical, Clinical, and Translational Sciences
1:30 PM - 2:30 PM
CT
Keynote: Seeing is Believing: Importance of Detailed Characterization in Understanding Complex Parenteral Drug Products
Keynote Speaker:
Diane J. Burgess, Ph.D. (she/her/hers)
– University of Connecticut
Moderator:
Tian Li, Ph.D.
– US Food and Drug Administration
Manufacturing and Analytical Characterization
1:30 PM - 2:30 PM
CT
Keynote: Seeing is Believing: Importance of Detailed Characterization in Understanding Complex Parenteral Drug Products
Location: 225-227
Keynote Speaker:
Diane J. Burgess, Ph.D. (she/her/hers)
– University of Connecticut
Moderator:
Tian Li, Ph.D.
– US Food and Drug Administration
Manufacturing and Analytical Characterization
1:30 PM - 2:30 PM
CT
Owning Your Science — Intellectual Property, Contracts, and Career Leverage
Career Center Moderator:
Vivek Gupta, PhD, FAAPS
– St. John's University
Career Center Speaker:
Aliasger Karimjee Salem, PhD
– University of Iowa
Career Center Speaker:
Matyas Kolsofszki, RTTP, CPVA
– St. John's University
Career Center Speaker:
Michelle Lavrichenko, PharmD, JD
– Venable LLP
Career Development
1:30 PM - 2:30 PM
CT
Owning Your Science — Intellectual Property, Contracts, and Career Leverage
Location: Careers 360, Exhibit Hall BC
Career Center Moderator:
Vivek Gupta, PhD, FAAPS
– St. John's University
Career Center Speaker:
Aliasger Karimjee Salem, PhD
– University of Iowa
Career Center Speaker:
Matyas Kolsofszki, RTTP, CPVA
– St. John's University
Career Center Speaker:
Michelle Lavrichenko, PharmD, JD
– Venable LLP
Career Development
2:30 PM - 3:00 PM
CT
Coffee Break in the Solution Center
2:30 PM - 3:00 PM
CT
Coffee Break in the Solution Center
Location: Exhibit Hall BC
2:30 PM - 3:30 PM
CT
Hot Topic: GLP-1 Agonists and Drug Absorption: Gastric Emptying DDI Risks
Hot Topic Speaker:
Niloufar Salehi, PhD
– Eli Lilly and Company
Hot Topic Moderator:
Niloufar Salehi, PhD
– Eli Lilly and Company
Hot Topic Speaker:
Jessica Atieh, MD (she/her/hers)
– Mayo Clinic
Hot Topic Speaker:
Jessica Rehmel, MS
– Eli Lilly and Company
Preclinical, Clinical, and Translational Sciences
2:30 PM - 3:30 PM
CT
Hot Topic: GLP-1 Agonists and Drug Absorption: Gastric Emptying DDI Risks
Location: 208-209
Hot Topic Speaker:
Niloufar Salehi, PhD
– Eli Lilly and Company
Hot Topic Moderator:
Niloufar Salehi, PhD
– Eli Lilly and Company
Hot Topic Speaker:
Jessica Atieh, MD (she/her/hers)
– Mayo Clinic
Hot Topic Speaker:
Jessica Rehmel, MS
– Eli Lilly and Company
Preclinical, Clinical, and Translational Sciences
2:30 PM - 2:50 PM
CT
Clinical Consequences of GLP-1-Induced Gastric Emptying Delay
Location: 208-209
Hot Topic Speaker:
Jessica Atieh, MD (she/her/hers)
– Mayo Clinic
Preclinical, Clinical, and Translational Sciences
2:50 PM - 3:10 PM
CT
GLP‑1–Induced Drug–Drug Interactions: Clinical Impact and Mechanistic Understanding
Location: 208-209
Hot Topic Speaker:
Niloufar Salehi, PhD
– Eli Lilly and Company
Preclinical, Clinical, and Translational Sciences
3:10 PM - 3:30 PM
CT
PBPK Modeling of GLP-1 Agonist DDIs: An Industry Approach
Location: 208-209
Hot Topic Speaker:
Jessica Rehmel, MS
– Eli Lilly and Company
Preclinical, Clinical, and Translational Sciences
3:00 PM - 4:00 PM
CT
Rapid Fire: Advanced NAMs, Ex Vivo and Tissue Models
Rapid Fire Moderator:
Pankaj Dwivedi
Preclinical, Clinical, and Translational Sciences
3:00 PM - 4:00 PM
CT
Rapid Fire: Advanced NAMs, Ex Vivo and Tissue Models
Rapid Fire Moderator:
Pankaj Dwivedi
Preclinical, Clinical, and Translational Sciences
3:00 PM - 4:00 PM
CT
Rapid Fire: Artificial Intelligence, Predictive Modeling & Digital Pharmaceutical Development
Rapid Fire Moderator:
Manish Baviskar, MS, DBM (he/him/his)
– Hubot CDMO, South Bend, IN, USA
Manufacturing and Analytical Characterization
3:00 PM - 4:00 PM
CT
Rapid Fire: Artificial Intelligence, Predictive Modeling & Digital Pharmaceutical Development
Rapid Fire Moderator:
Manish Baviskar, MS, DBM (he/him/his)
– Hubot CDMO, South Bend, IN, USA
Manufacturing and Analytical Characterization
3:00 PM - 3:15 PM
CT
Bridging Biopharmaceutics Gap: A Multimodal Approach Transforming Long-Acting Injectable Development
Rapid Fire Speaker:
Siddharth S. Kesharwani, M.S., Ph.D.
– AbbVie Inc
Manufacturing and Analytical Characterization
3:00 PM - 4:00 PM
CT
Rapid Fire: Breakthrough Technologies for Drug Product Development and Evaluation
Rapid Fire Moderator:
Li Li, PHD (she/her/hers)
– Merck
Formulation and Delivery
3:00 PM - 4:00 PM
CT
Rapid Fire: Breakthrough Technologies for Drug Product Development and Evaluation
Rapid Fire Moderator:
Li Li, PHD (she/her/hers)
– Merck
Formulation and Delivery
3:00 PM - 4:00 PM
CT
Rapid Fire: Emerging Drug Product and Delivery Technologies
Rapid Fire Moderator:
Sharan Bobbala, PhD (he/him/his)
– West Virginia University
Formulation and Delivery
3:00 PM - 4:00 PM
CT
Rapid Fire: Emerging Drug Product and Delivery Technologies
Rapid Fire Moderator:
Sharan Bobbala, PhD (he/him/his)
– West Virginia University
Formulation and Delivery
3:00 PM - 4:00 PM
CT
Rapid Fire: Navigating Bioanalytical Complexity: Assay Performance, Biomarker Platforms, and Microsampling
Bioanalytics
3:00 PM - 4:00 PM
CT
Rapid Fire: Navigating Bioanalytical Complexity: Assay Performance, Biomarker Platforms, and Microsampling
Bioanalytics
3:00 PM - 4:00 PM
CT
Rapid Fire: Nitrosamine Risk Assessment & Advanced Analytical Characterization
Rapid Fire Moderator:
Heather Neu, PhD
Manufacturing and Analytical Characterization
3:00 PM - 4:00 PM
CT
Rapid Fire: Nitrosamine Risk Assessment & Advanced Analytical Characterization
Rapid Fire Moderator:
Heather Neu, PhD
Manufacturing and Analytical Characterization
3:45 PM - 4:00 PM
CT
Strategies for De-Risking Nitrosamine Formation in Pharmaceutical Formulations
Rapid Fire Speaker:
Ziyaur Rahman, Ph.D.
– Irma Lerma Rangel School of Pharmacy
Manufacturing and Analytical Characterization
3:00 PM - 4:00 PM
CT
Rapid Fire: Pre-Clinical and Clinical Models for Safety Assessment
Rapid Fire Moderator:
Sumanta Goswami
Preclinical, Clinical, and Translational Sciences
3:00 PM - 4:00 PM
CT
Rapid Fire: Pre-Clinical and Clinical Models for Safety Assessment
Rapid Fire Moderator:
Sumanta Goswami
Preclinical, Clinical, and Translational Sciences
3:00 PM - 4:00 PM
CT
Rapid Fire: When Biology Gets in the Way: Tackling Interference and Immunogenicity Challenges
Bioanalytics
3:00 PM - 4:00 PM
CT
Rapid Fire: When Biology Gets in the Way: Tackling Interference and Immunogenicity Challenges
Bioanalytics
5:30 PM - 7:00 PM
CT
Fellows Networking Reception (by invitation only)
5:30 PM - 7:00 PM
CT
Fellows Networking Reception (by invitation only)
Location: Compass (Hilton New Orleans Riverside)
5:30 PM - 7:00 PM
CT
Sustaining Sponsor Reception (by invitation only)
5:30 PM - 7:00 PM
CT
Sustaining Sponsor Reception (by invitation only)
Location: River / Port / Starboard (Hilton New Orleans Riverside)
5:30 PM - 7:30 PM
CT
National Institute for Pharmaceutical Technology & Education (NIPTE)
5:30 PM - 7:30 PM
CT
National Institute for Pharmaceutical Technology & Education (NIPTE)
Location: Rivergate Room
5:30 PM - 10:00 PM
CT
American Association of Indian Pharmaceutical Scientists (AAiPS) Annual Dinner Meeting
5:30 PM - 10:00 PM
CT
American Association of Indian Pharmaceutical Scientists (AAiPS) Annual Dinner Meeting
Location: Nirvana Restaurant (4308 Magazine Street)
6:00 PM - 9:00 PM
CT
Simulations Plus After Hours Event "Rx to Rock" (by invitation only)
6:00 PM - 9:00 PM
CT
Simulations Plus After Hours Event "Rx to Rock" (by invitation only)
Location: St. Charles (Hilton New Orleans Riverside)
6:00 PM - 10:00 PM
CT
IPEC Foundation Awards Ceremony (by invitation only)
6:00 PM - 10:00 PM
CT
IPEC Foundation Awards Ceremony (by invitation only)
Location: Kabacoff (Hilton New Orleans Riverside)