- Tuesday, October 18, 2022
7:00 AM – 8:30 AM ET
Mentoring Breakfast
7:00 AM – 8:30 AM ET
Mentoring BreakfastLocation:Harbor 1&2, Westin Boston Seaport District Hotel
7:30 AM – 5:00 PM ET
Registration Hours
7:30 AM – 5:00 PM ET
Registration Hours
Location:North Lobby
7:30 AM – 5:00 PM ET
Speaker Ready Room
7:30 AM – 5:00 PM ET
Speaker Ready Room
Location:252 AB
8:30 AM – 9:00 AM ET
Prologue: Advancements in Translational PK/PD Approaches Towards Novel Biologic ModalitiesPrologue Speaker: – Johnson and Johnson
Preclinical Development – Biomolecular
8:30 AM – 9:00 AM ET
Prologue: Advancements in Translational PK/PD Approaches Towards Novel Biologic ModalitiesLocation:254 APrologue Speaker: – Johnson and Johnson
Preclinical Development – Biomolecular
Prathap Nagaraja Shastri, PhD – Johnson and Johnson ### 567445###Prologue Speaker###Scientific Director###Johnson and Johnson ###Prologue Speaker: – Johnson and Johnson
### 8:30 AM – 9:00 AM ET
Prologue: Application of PBPK Modeling to Support Dose Selection in Underrepresented PopulationsPrologue Speaker: – University of Florida
Clinical Pharmacology – Biomolecular
8:30 AM – 9:00 AM ET
Prologue: Application of PBPK Modeling to Support Dose Selection in Underrepresented PopulationsLocation:152Prologue Speaker: – University of Florida
Clinical Pharmacology – Biomolecular
Rodrigo Cristofoletti, PhD – University of Florida ### 1650917###Prologue Speaker###Assistant Professor ###University of Florida###Prologue Speaker: – University of Florida
### 8:30 AM – 9:00 AM ET
Prologue: Current Status and Gaps in Predicting the Food EffectPrologue Speaker: – Daiichi Sankyo, Inc.
Preclinical Development – Chemical
8:30 AM – 9:00 AM ET
Prologue: Current Status and Gaps in Predicting the Food EffectLocation:253 CPrologue Speaker: – Daiichi Sankyo, Inc.
Preclinical Development – Chemical
Xinyuan Zhang, PhD – Daiichi Sankyo, Inc. ### 567518###Prologue Speaker###Director###Daiichi Sankyo, Inc.###Prologue Speaker: – Daiichi Sankyo, Inc.
### 8:30 AM – 9:00 AM ET
Prologue: Developmental Challenges with Antibody-Drug Conjugates Prologue Speaker: – Merck
Manufacturing & Analytical Characterization – Biomolecular
8:30 AM – 9:00 AM ET
Prologue: Developmental Challenges with Antibody-Drug Conjugates Location:205 CPrologue Speaker: – Merck
Manufacturing & Analytical Characterization – Biomolecular
Manoj Charati, PhD – Merck ### 1666037###Prologue Speaker###Principal Scientist###Merck###Prologue Speaker: – Merck
### 8:30 AM – 9:00 AM ET
Prologue: Patient Centric Bioanalysis: Where We’ve Been and Where We’re GoingPrologue Speaker: – Bill & Melinda Gates Medical Research Institute
Bioanalytics – Chemical
8:30 AM – 9:00 AM ET
Prologue: Patient Centric Bioanalysis: Where We’ve Been and Where We’re GoingLocation:253 APrologue Speaker: – Bill & Melinda Gates Medical Research Institute
Bioanalytics – Chemical
Joleen T. White, PhD – Bill & Melinda Gates Medical Research Institute ### 627094###Prologue Speaker###Head of Bioassay Development and Operations###Bill & Melinda Gates Medical Research Institute###Prologue Speaker: – Bill & Melinda Gates Medical Research Institute
### 8:30 AM – 9:00 AM ET
Prologue: PBPK/PBBM to Inform the Bioequivalence Safe Space, Food Effects, and pH-Mediated DDIsPrologue Speaker: – Pharmaceutical Sciences, Merck & Co., Inc., Rahway, NJ USA
Clinical Pharmacology – Chemical
8:30 AM – 9:00 AM ET
Prologue: PBPK/PBBM to Inform the Bioequivalence Safe Space, Food Effects, and pH-Mediated DDIsLocation:151 ABPrologue Speaker: – Pharmaceutical Sciences, Merck & Co., Inc., Rahway, NJ USA
Clinical Pharmacology – Chemical
Tycho Heimbach, PhD – Pharmaceutical Sciences, Merck & Co., Inc., Rahway, NJ USA ### 1329525###Prologue Speaker###Senior Principal Scientist/Director###Pharmaceutical Sciences, Merck & Co., Inc., Rahway, NJ USA###Prologue Speaker: – Pharmaceutical Sciences, Merck & Co., Inc., Rahway, NJ USA
### 8:30 AM – 9:00 AM ET
Prologue: Practical Considerations for Implementing Biomarkers in Clinical Trials, Challenges and OpportunitiesPrologue Speaker: – Dewpoint Therapeutics
Bioanalytics – Biomolecular
8:30 AM – 9:00 AM ET
Prologue: Practical Considerations for Implementing Biomarkers in Clinical Trials, Challenges and OpportunitiesLocation:253 BPrologue Speaker: – Dewpoint Therapeutics
Bioanalytics – Biomolecular
Lakshmi Amaravadi, PhD – Dewpoint Therapeutics ### 567500###Prologue Speaker###SVP, Head of Preclinical Development & Translational Medicine###Dewpoint Therapeutics###Prologue Speaker: – Dewpoint Therapeutics
### 8:30 AM – 9:00 AM ET
Prologue: Regulation of Cannabinoids for Histone Modification in Resistant Breast CancerPrologue Speaker: – Florida A&M University
Discovery and Basic Research
8:30 AM – 9:00 AM ET
Prologue: Regulation of Cannabinoids for Histone Modification in Resistant Breast CancerLocation:255Prologue Speaker: – Florida A&M University
Discovery and Basic Research
Mandip S. Sachdeva, PhD – Florida A&M University ### 848734###Prologue Speaker###Professor###Florida A&M University###Prologue Speaker: – Florida A&M University
### 8:30 AM – 9:00 AM ET
Prologue: Rethinking ASD Particle Architecture and Performance Utilizing Advances in Engineering Technologies Prologue Speaker: – Merck & Co., Inc.
Formulation and Delivery – Chemical
8:30 AM – 9:00 AM ET
Prologue: Rethinking ASD Particle Architecture and Performance Utilizing Advances in Engineering Technologies Location:205 ABPrologue Speaker: – Merck & Co., Inc.
Formulation and Delivery – Chemical
Luke Schenck – Merck & Co., Inc. ### 604981###Prologue Speaker###Principal Scientist###Merck & Co., Inc.###Prologue Speaker: – Merck & Co., Inc.
### 8:30 AM – 9:00 AM ET
Prologue: Science-Based Formulation and Process Development of Biologicals: Physical Chemical and Analytical AspectsPrologue Speaker: – Abbvie
Formulation and Delivery – Biomolecular
8:30 AM – 9:00 AM ET
Prologue: Science-Based Formulation and Process Development of Biologicals: Physical Chemical and Analytical AspectsLocation:204 ABPrologue Speaker: – Abbvie
Formulation and Delivery – Biomolecular
Evgenyi Shalaev, PhD – Abbvie ### 624499###Prologue Speaker###Distinguished Research Fellow###Abbvie###Prologue Speaker: – Abbvie
### 8:30 AM – 9:00 AM ET
Prologue: The Microbiome in Pharmaceutical Development and DiseasePrologue Speaker: – University of Illinois Chicago
Discovery and Basic Research
8:30 AM – 9:00 AM ET
Prologue: The Microbiome in Pharmaceutical Development and DiseaseLocation:254 BPrologue Speaker: – University of Illinois Chicago
Discovery and Basic Research
Matthew Henke, PhD – University of Illinois Chicago ### 1695109###Prologue Speaker###Assistant Professor###University of Illinois Chicago###Prologue Speaker: – University of Illinois Chicago
### 8:30 AM – 4:30 PM ET
Coffee Station
8:30 AM – 4:30 PM ET
Coffee StationLocation:Booth #1344, Exhibit Hall A&B
8:30 AM – 4:30 PM ET
Free Professional Headshots
8:30 AM – 4:30 PM ET
Free Professional HeadshotsLocation:Career Development Center, Exhibit Hall A&B
8:30 AM – 4:30 PM ET
LinkedIn Profile Critiques & Resume Reviews
8:30 AM – 4:30 PM ET
LinkedIn Profile Critiques & Resume ReviewsLocation:Career Development Center, Exhibit Hall A&B
8:30 AM – 5:00 PM ET
Solution Center Hours & Poster Presentations
8:30 AM – 5:00 PM ET
Solution Center Hours & Poster Presentations
Location:Exhibit Hall A&B
9:00 AM – 10:00 AM ET
Hot Topic: Phase Appropriate Design Controls for Combination Products during Clinical DevelopmentHot Topic Speaker: – Pharmalytik
Hot Topic Speaker: – Merck & Co., Inc.
Hot Topic Speaker: – Takeda
Hot Topic Moderator: – Takeda Pharmaceutical Company Limited
Manufacturing & Analytical Characterization – Chemical
9:00 AM – 10:00 AM ET
Hot Topic: Phase Appropriate Design Controls for Combination Products during Clinical DevelopmentLocation:153 AHot Topic Speaker: – Pharmalytik
Hot Topic Speaker: – Merck & Co., Inc.
Hot Topic Speaker: – Takeda
Hot Topic Moderator: – Takeda Pharmaceutical Company Limited
Manufacturing & Analytical Characterization – Chemical
Kim Huynh-Ba, MS, PMP, FAAPS – Pharmalytik ### 636579###Hot Topic Speaker###Managing Director###Pharmalytik###Hot Topic Speaker: – Pharmalytik
### @@@ Jiaying Shen, PhD – Merck & Co., Inc. ### 980258###Hot Topic Speaker###Distinguished Scientist, Research Sciences, Device Development###Merck & Co., Inc.###Hot Topic Speaker: – Merck & Co., Inc.
### @@@ Gretchen Vandal, MS, MBA – Takeda ### 1650360###Hot Topic Speaker###Executive Director, Global Regulatory Affairs – Head of Devices, Digital and Combination Products###Takeda###Hot Topic Speaker: – Takeda
### @@@ Shrinivas (Cheenu) Murti, PhD, MBA – Takeda Pharmaceutical Company Limited ### 720714###Hot Topic Moderator###Head, CMC Business Process Excellence & Systems###Takeda Pharmaceutical Company Limited###Hot Topic Moderator: – Takeda Pharmaceutical Company Limited
### 9:00 AM – 10:00 AM ET
Overcoming Today's Pharmaceutical Formulation Challenges with Aprecia's In-Blister ManufacturingFormulation and Delivery
9:00 AM – 10:00 AM ET
Overcoming Today's Pharmaceutical Formulation Challenges with In-Blister ManufacturingLocation:360 Stage #1, Exhibit Hall A&BFormulation and Delivery
Michael Gosselin, PhD – Aprecia ### 1743108###Tech Spotlight Speaker###Vice President of Pharmaceutical Development###Aprecia###Tech Spotlight Speaker: – Aprecia
### 9:00 AM – 10:00 AM ET
Promoting Yourself and Increasing Your Visibility in the WorkplaceCareer Center Moderator: – Duquesne University
Career Center Moderator: – AAPS
Career Center Speaker: – Bristol-Myers Squibb
Career Center Speaker: – Immunologix Laboratories
Career Development
9:00 AM – 10:00 AM ET
Promoting Yourself and Increasing Your Visibility in the WorkplaceLocation:360 Stage #3, Exhibit Hall A&BCareer Center Moderator: – Duquesne University
Career Center Moderator: – AAPS
Career Center Speaker: – Bristol-Myers Squibb
Career Center Speaker: – Immunologix Laboratories
Career Development
Mustafa Bookwala, M.S. – Duquesne University ### 1377263###Career Center Moderator###Ph.D. Candidate###Duquesne University###Career Center Moderator: – Duquesne University
### @@@ Stacey Axler – AAPS ### 1535109###Career Center Moderator###Community Manager###AAPS###Career Center Moderator: – AAPS
### @@@ Binodh S. DeSilva, PhD – Bristol-Myers Squibb ### 527148###Career Center Speaker###Vice President###Bristol-Myers Squibb###Career Center Speaker: – Bristol-Myers Squibb
### @@@ Lauren Stevenson, PhD – Immunologix Laboratories ### 802379###Career Center Speaker###Chief Scientific Officer###Immunologix Laboratories###Career Center Speaker: – Immunologix Laboratories
### 9:00 AM – 10:30 AM ET
Symposium: Epigenetic Drug Targets and Epigenetic ModifiersModerator: – Florida A&M University
Discovery and Basic Research
9:00 AM – 10:30 AM ET
Symposium: Epigenetic Drug Targets and Epigenetic ModifiersLocation:255Moderator: – Florida A&M University
Discovery and Basic Research
Mandip S. Sachdeva, PhD – Florida A&M University ### 848734###Moderator###Professor###Florida A&M University###Moderator: – Florida A&M University
### 9:00 AM – 9:30 AM ET
Non-Enzymatic Post-Translational Modifications and Their Effects on ChromatinLocation:255Speaker: – University of Arizona
Discovery and Basic Research
James Galligan, PhD – University of Arizona ### 1676332###Speaker###Assistant Professor###University of Arizona###Speaker: – University of Arizona
### 9:30 AM – 10:00 AM ET
Epigenetic Reprogramming in Carcinogenesis by Dietary Phytochemicals in Cancer PreventionLocation:255Speaker: – Rutgers University
Discovery and Basic Research
Ah-Ng Tony Kong, PhD – Rutgers University ### 604777###Speaker###Distinguished Professor, Glaxo Endowed Chair in Pharmaceutics; Graduate Director###Rutgers University ###Speaker: – Rutgers University
### 10:00 AM – 10:30 AM ET
Reciprocal MicroRNA-mRNA Pairings as Precision Biomarkers and Novel Drug Targets in Aggressive Prostate CancersLocation:255Speaker: – University of Maryland Eastern Shore School of Pharmacy
Discovery and Basic Research
Bi-Dar (Peter) Wang – University of Maryland Eastern Shore School of Pharmacy ### 1695111###Speaker###Associate Professor###University of Maryland Eastern Shore School of Pharmacy###Speaker: – University of Maryland Eastern Shore School of Pharmacy
### 9:00 AM – 10:30 AM ET
Symposium: Microbiome: Impact in Pharmaceutical Development and DiseaseModerator: – University of Illinois Chicago
Discovery and Basic Research
9:00 AM – 10:30 AM ET
Symposium: Microbiome: Impact in Pharmaceutical Development and DiseaseLocation:254 BModerator: – University of Illinois Chicago
Discovery and Basic Research
Matthew Henke, PhD – University of Illinois Chicago ### 1695109###Moderator###Assistant Professor###University of Illinois Chicago###Moderator: – University of Illinois Chicago
### 9:00 AM – 9:30 AM ET
Therapeutic Potential of the Gut Microbiota in Neurologic DiseaseLocation:254 BSpeaker: – Harvard Medical School/ Brigham & Women's Hospital
Discovery and Basic Research
Laura M. Cox, PhD – Harvard Medical School/ Brigham & Women's Hospital ### 1680384###Speaker###Assistant Professor###Harvard Medical School/ Brigham & Women's Hospital###Speaker: – Harvard Medical School/ Brigham & Women's Hospital
### 9:30 AM – 10:00 AM ET
Microbial Diversity as a Tool for Metabolism ResearchLocation:254 BSpeaker: – Pennsylvania State University
Discovery and Basic Research
Jordan Bisanz, PhD – Pennsylvania State University ### 1699109###Speaker###Assistant Professor###Pennsylvania State University###Speaker: – Pennsylvania State University
### 10:00 AM – 10:30 AM ET
Bugs, Drugs, and Autoimmunity: The Impact of the Gut Microbiome on the Treatment of Rheumatic DiseaseLocation:254 BSpeaker: – University of California, San Francisco
Discovery and Basic Research
Renuka Nayak, MD, PhD – University of California, San Francisco ### 1688946###Speaker###Assistant Professor###University of California, San Francisco###Speaker: – University of California, San Francisco
### 9:00 AM – 10:30 AM ET
Symposium: Novel Manufacturing Approaches in Pharmaceuticals and Biopharmaceuticals (BM)Manufacturing & Analytical Characterization – Biomolecular
9:00 AM – 10:30 AM ET
Symposium: Novel Manufacturing Approaches in Pharmaceuticals and Biopharmaceuticals (BM)Location:205 CManufacturing & Analytical Characterization – Biomolecular
Manoj Charati, PhD – Merck ### 1666037###Moderator###Principal Scientist###Merck###Moderator: – Merck
### 9:00 AM – 9:30 AM ET
Evaluation of New Drying Technologies for a mAb FormulationLocation:205 CManufacturing & Analytical Characterization – Biomolecular
Yuan Chen, PhD – AstraZeneca ### 1346614###Speaker###Senior Scientist###AstraZeneca###Speaker: – AstraZeneca
### 9:30 AM – 10:00 AM ET
Understanding Phase Behavior and Adsorption of Monoclonal Antibodies and Surfactants During Formulation Processing Location:205 CSpeaker: – Bristol Myers Squibb
Manufacturing & Analytical Characterization – Biomolecular
Ankit D. Kanthe, PhD – Bristol Myers Squibb ### 1446462###Speaker###Scientist###Bristol Myers Squibb###Speaker: – Bristol Myers Squibb
### 10:00 AM – 10:30 AM ET
Evolving Manufacturing Controls for Cell Therapy ProductsLocation:205 CSpeaker: – Philadelphia College of Pharmacy and Science
Manufacturing & Analytical Characterization – Biomolecular
Allison E. Radwick, Ph.D. – Philadelphia College of Pharmacy and Science ### 1650343###Speaker###Adjunct Faculty###Philadelphia College of Pharmacy and Science###Speaker: – Philadelphia College of Pharmacy and Science
### 9:00 AM – 10:30 AM ET
Symposium: Novel Manufacturing Approaches in Pharmaceuticals and Biopharmaceuticals (CE)Manufacturing & Analytical Characterization – Chemical
9:00 AM – 10:30 AM ET
Symposium: Novel Manufacturing Approaches in Pharmaceuticals and Biopharmaceuticals (CE)Location:206 ABManufacturing & Analytical Characterization – Chemical
Maria Cruanes, PhD Chemistry (she/her/hers) – Organon ### 1680406###Moderator###Director Analytical Chemistry ###Organon###Moderator: – Organon
### she/her/hers9:00 AM – 9:30 AM ET
Oral Granules as Pediatric Formulations?Location:206 ABSpeaker: – Vertex Pharmaceuticals Inc.
Manufacturing & Analytical Characterization – Chemical
Eleni Dokou, PhD (she/her/hers) – Vertex Pharmaceuticals Inc. ### 1680408###Speaker###Vice President###Vertex Pharmaceuticals Inc.###Speaker: – Vertex Pharmaceuticals Inc.
### she/her/hers9:30 AM – 10:00 AM ET
Machine Learning Assisted Optimization of Chemical ReactionsLocation:206 ABManufacturing & Analytical Characterization – Chemical
Kehua Yin – GSK ### 1650321###Speaker###Investigator###GSK###Speaker: – GSK
### 10:00 AM – 10:30 AM ET
Understanding the Sources of Error in PAT Methods That Monitor Continuous ProcessesLocation:206 ABSpeaker: – University of Puerto Rico Mayaguez
Manufacturing & Analytical Characterization – Chemical
Rodolfo J. Romanach, PhD – University of Puerto Rico Mayaguez ### 825188###Speaker###Professor of Chemistry###University of Puerto Rico Mayaguez###Speaker: – University of Puerto Rico Mayaguez
### 9:00 AM – 11:00 AM ET
Symposium: Advances in Engineering Technologies for Drug Substance and Enabling Drug Product (BM)Formulation and Delivery – Biomolecular
9:00 AM – 11:00 AM ET
Symposium: Advances in Engineering Technologies for Drug Substance and Enabling Drug Product (BM)Location:204 ABFormulation and Delivery – Biomolecular
Evgenyi Shalaev, PhD – Abbvie ### 624499###Moderator###Distinguished Research Fellow###Abbvie###Moderator: – Abbvie
### 9:00 AM – 9:30 AM ET
Understanding Mechanisms When Considering Alternative Surfactants in Biologic FormulationLocation:204 ABSpeaker: – IFF Pharma Solutions
Formulation and Delivery – Biomolecular
Susan Jordan, PhD – IFF Pharma Solutions ### 1302240###Speaker###Technical Fellow###IFF Pharma Solutions###Speaker: – IFF Pharma Solutions
### 9:30 AM – 10:00 AM ET
Enabling Solid-State Biological Products Through Advanced Engineering and CharacterizationLocation:204 ABSpeaker: – Merck & Co., Inc.
Formulation and Delivery – Biomolecular
Jing Ling, PhD – Merck & Co., Inc. ### 1650352###Speaker###Associate Principal Scientist###Merck & Co., Inc.###Speaker: – Merck & Co., Inc.
### 10:00 AM – 10:30 AM ET
Enabling Solid-State Biological Products Through Advanced Engineering and CharacterizationLocation:204 ABSpeaker: – College of Pharmacy, University of Minnesota
Formulation and Delivery – Biomolecular
Raj Suryanarayanan, PhD, MPharm, MSc – College of Pharmacy, University of Minnesota ### 466096###Speaker###Professor & Endowed Chair###College of Pharmacy, University of Minnesota###Speaker: – College of Pharmacy, University of Minnesota
### 10:30 AM – 11:00 AM ET
Enabling Solid-State Biological Products Through Advanced Engineering and CharacterizationLocation:204 ABSpeaker: – Purdue University
Formulation and Delivery – Biomolecular
Eric J. Munson, PhD, FAAPS – Purdue University ### 856795###Speaker###Professor###Purdue University###Speaker: – Purdue University
### 9:00 AM – 11:00 AM ET
Symposium: Advances in Engineering Technologies for Drug Substance and Enabling Drug Product (CE)Moderator: – Merck & Co., Inc.
Formulation and Delivery – Chemical
9:00 AM – 11:00 AM ET
Symposium: Advances in Engineering Technologies for Drug Substance and Enabling Drug Product (CE)Location:205 ABModerator: – Merck & Co., Inc.
Formulation and Delivery – Chemical
Luke Schenck – Merck & Co., Inc. ### 604981###Moderator###Principal Scientist###Merck & Co., Inc.###Moderator: – Merck & Co., Inc.
### 9:00 AM – 9:30 AM ET
Combining Crystal Structure Prediction with Formulation Technologies to De-Risk Solid Dosage DevelopmentLocation:205 ABSpeaker: – MilliporeSigma
Formulation and Delivery – Chemical
Gudrun Birk, PhD (she/her/hers) – MilliporeSigma ### 604429###Speaker###Head of Controlled Release, Senior Manager###MilliporeSigma###Speaker: – MilliporeSigma
### she/her/hers9:30 AM – 10:00 AM ET
In vitro and in Silico Modeling for Amorphous Solid DispersionsLocation:205 ABFormulation and Delivery – Chemical
Bart Hens, PharmD, PhD – Pfizer UK ### 1791678###Speaker###Biopharmaceutics Scientist/ Drug Product Design Biomodeler###Pfizer UK###Speaker: – Pfizer UK
### 10:00 AM – 10:30 AM ET
The Impact of Liquid-Liquid Phase Separation on Amorphous Solid Dispersions PerformanceLocation:205 ABSpeaker: – Purdue University
Formulation and Delivery – Chemical
Lynne S. Taylor, PhD – Purdue University ### 465958###Speaker###Professor###Purdue University###Speaker: – Purdue University
### 10:30 AM – 11:00 AM ET
3D PrintingLocation:205 ABFormulation and Delivery – Chemical
Alvaro Goyanes, PhD – FabRx ### 605229###Speaker###CEO and Co-founder###FabRx###Speaker: – FabRx
### 9:00 AM – 11:00 AM ET
Symposium: Breaking Through Barriers in Preclinical Development To Improve Clinical Translation (BM)Preclinical Development – Biomolecular
9:00 AM – 11:00 AM ET
Symposium: Breaking Through Barriers in Preclinical Development To Improve Clinical Translation (BM)Location:254 APreclinical Development – Biomolecular
Nagendra V. Chemuturi, GDMPK – Takeda ### 1010805###Moderator###Scientific Director Research###Takeda###Moderator: – Takeda
### 9:00 AM – 9:30 AM ET
QSP Model of AAV Based Gene Therapy for Clinical ApplicationsLocation:254 APreclinical Development – Biomolecular
Jatin Narula, PhD – Pfizer ### 857254###Speaker###Senior Principal Scientist###Pfizer###Speaker: – Pfizer
### 9:30 AM – 10:00 AM ET
Gene Efficiency Factor and its Application in the Development of Viral-Mediated in vivo Gene TherapyLocation:254 ASpeaker: – NewGround Pharmaceutical Consulting
Preclinical Development – Biomolecular
Chee Meng Ng, PharmD, PhD, FCP – NewGround Pharmaceutical Consulting ### 1650379###Speaker###Managing Director###NewGround Pharmaceutical Consulting###Speaker: – NewGround Pharmaceutical Consulting
### 10:00 AM – 10:30 AM ET
Challenges and Opportunities of Oncology CAR Cell Therapy FIH Dose SelectionLocation:254 APreclinical Development – Biomolecular
Haiqing Wang, PhD – Takeda ### 1650380###Speaker###Director###Takeda###Speaker: – Takeda
### 10:30 AM – 11:00 AM ET
Retrospective Look at Translational Considerations for T-cell RedirectorsLocation:254 ASpeaker: – Janssen Research and Development, LLC
Preclinical Development – Biomolecular
Nirav Shah, PhD – Janssen Research and Development, LLC ### 1650377###Speaker###Senior Scientist###Janssen Research and Development, LLC###Speaker: – Janssen Research and Development, LLC
### 9:00 AM – 11:00 AM ET
Symposium: Breaking Through Barriers in Preclinical Development To Improve Clinical Translation (CE)Moderator: – Merck & Co., Inc.
Preclinical Development – Chemical
9:00 AM – 11:00 AM ET
Symposium: Breaking Through Barriers in Preclinical Development To Improve Clinical Translation (CE)Location:253 CModerator: – Merck & Co., Inc.
Preclinical Development – Chemical
Yasuhiro Tsume, PhD – Merck & Co., Inc. ### 583852###Moderator###Scientist###Merck & Co., Inc.###Moderator: – Merck & Co., Inc.
### 9:00 AM – 9:30 AM ET
Physiological Considerations Around Food Effects On Oral Drug BioavailabilityLocation:253 CSpeaker: – AbbVie Deutschland GmbH & Co. KG
Preclinical Development – Chemical
Mirko Koziolek, PhD – AbbVie Deutschland GmbH & Co. KG ### 1664098###Speaker###Principal Research Scientist I###AbbVie Deutschland GmbH & Co. KG###Speaker: – AbbVie Deutschland GmbH & Co. KG
### 9:30 AM – 10:00 AM ET
Applications of Physiologically Based Biopharmaceutics Modeling and Simulation in Oral Drug DevelopmentLocation:253 CPreclinical Development – Chemical
Aishwarya R – Pfizer ### 1650325###Speaker###Biopharmaceutics Scientist###Pfizer###Speaker: – Pfizer
### 10:00 AM – 10:30 AM ET
In vitro Methodologies for Evaluating Food Effects on Intraluminal Drug Disposition: Possibilities and GapsLocation:253 CSpeaker: – Department of Pharmacy
National and Kapodistrian University of Athens
Preclinical Development – Chemical
Christos Reppas, PhD – Department of Pharmacy
National and Kapodistrian University of Athens ### 571995###Speaker###Professor in Pharmaceutics###Department of Pharmacy
National and Kapodistrian University of Athens###Speaker: – Department of Pharmacy
National and Kapodistrian University of Athens
### 10:30 AM – 11:00 AM ET
Got Hungry? Can Predict Food Effects in Preclinical and Clinical?Location:253 CPreclinical Development – Chemical
Brian Booth, PhD – FDA ### 576429###Speaker###Director, DCP I###FDA###Speaker: – FDA
### 9:00 AM – 11:00 AM ET
Symposium: Model Informed Drug Development (MIDD): Role in Dose Selection, Vulnerable Populations, and Biowaivers (BM)Clinical Pharmacology – Biomolecular
9:00 AM – 11:00 AM ET
Symposium: Model Informed Drug Development (MIDD): Role in Dose Selection, Vulnerable Populations, and BiowaiversLocation:152Clinical Pharmacology – Biomolecular
Rodrigo Cristofoletti, PhD – University of Florida ### 1650917###Moderator###Assistant Professor ###University of Florida###Moderator: – University of Florida
### 9:00 AM – 9:30 AM ET
WAPPS-Hemo Modelling on a Global Scale to Dose Optimize Clotting Factor (Biomolecule) Prophylaxis in Hemophilia PatientsLocation:152Speaker: – University of Waterloo, School of Pharmacy
Clinical Pharmacology – Biomolecular
Andrea Edginton, PhD – University of Waterloo, School of Pharmacy ### 603955###Speaker###Professor, Hallman Director###University of Waterloo, School of Pharmacy###Speaker: – University of Waterloo, School of Pharmacy
### 9:30 AM – 10:00 AM ET
MIDD Using PK/PD Modeling with Discrete Outcomes in Dose Selection for Biomolecules - General ConsiderationsLocation:152Clinical Pharmacology – Biomolecular
Serge Guzy, PhD – UF ### 1663981###Speaker###Courtesy Professor###UF###Speaker: – UF
### 10:00 AM – 10:30 AM ET
Modeling Informed Pre-Clinical to Clinical PK/PD Translation for siRNA TherapeuticsLocation:152Speaker: – Janssen Research & Development, LLC
Clinical Pharmacology – Biomolecular
Vivaswath S. Ayyar, PhD – Janssen Research & Development, LLC ### 1650347###Speaker###Senior Scientist###Janssen Research & Development, LLC###Speaker: – Janssen Research & Development, LLC
### 10:30 AM – 11:00 AM ET
Modeling and Simulation to Fill the Knowledge Gap in Pregnancy and LactationLocation:152Speaker: – University of Pittsburgh
Clinical Pharmacology – Biomolecular
Nupur Chaphekar, MS – University of Pittsburgh ### 1446978###Speaker###Graduate Student###University of Pittsburgh###Speaker: – University of Pittsburgh
### 9:00 AM – 11:00 AM ET
Symposium: Model Informed Drug Development (MIDD): Role in Dose Selection, Vulnerable Populations, and Biowaivers (CE)Clinical Pharmacology – Chemical
9:00 AM – 11:00 AM ET
Symposium: Model Informed Drug Development (MIDD): Role in Dose Selection, Vulnerable Populations, and BiowaiversLocation:151 ABClinical Pharmacology – Chemical
Tycho Heimbach, PhD – Pharmaceutical Sciences, Merck & Co., Inc., Rahway, NJ USA ### 1329525###Moderator###Senior Principal Scientist/Director###Pharmaceutical Sciences, Merck & Co., Inc., Rahway, NJ USA###Moderator: – Pharmaceutical Sciences, Merck & Co., Inc., Rahway, NJ USA
### 9:00 AM – 9:30 AM ET
Prospective Prediction of Food Effect Using PBPK Modeling: Is the Science On Par with Expectations?Location:151 ABSpeaker: – Pfizer Worldwide R&D
Clinical Pharmacology – Chemical
Ravi Shanker, PhD – Pfizer Worldwide R&D ### 1792082###Speaker###Senior Research Fellow###Pfizer Worldwide R&D###Speaker: – Pfizer Worldwide R&D
### 9:30 AM – 10:00 AM ET
Applying MIDD Paradigm to Inform Clinical Relevance of Dissolution SpecificationsLocation:151 ABClinical Pharmacology – Chemical
Mohamed-Eslam F. Mohamed, PhD, FCP – AbbVie ### 602556###Speaker###Director, Clinical Pharmacology and Pharmacometrics###AbbVie###Speaker: – AbbVie
### 10:00 AM – 10:30 AM ET
Applications of PBPK for Virtual BE Assessment of Dermal ProductsLocation:151 ABClinical Pharmacology – Chemical
Sebastian Polak, PhD – Certara UK ### 602670###Speaker###Senior Scientific Advisor###Certara UK###Speaker: – Certara UK
### 10:30 AM – 11:00 AM ET
Physiologically-Based Pharmacokinetic Modeling to Support BE and Products ApprovalLocation:151 ABGovernment Speaker: – US Food and Drug Adminstration
Clinical Pharmacology – Chemical
Eleftheria Tsakalozou, PhD – US Food and Drug Adminstration ### 1044996###Government Speaker###Staff Fellow###US Food and Drug Adminstration###Government Speaker: – US Food and Drug Adminstration
### 9:00 AM – 11:00 AM ET
Symposium: Sample Challenges, Yet Opportunities (BM)Bioanalytics – Biomolecular
9:00 AM – 11:00 AM ET
Symposium: Sample Challenges, Yet Opportunities (BM)Location:253 BBioanalytics – Biomolecular
Christian Braithwaite, M.S. – BioAgilytix ### 607032###Moderator###Manager II###BioAgilytix###Moderator: – BioAgilytix
### 9:00 AM – 9:30 AM ET
Overcoming Challenges to Profile ctDNA for Monitoring Tumor EvolutionLocation:253 BBioanalytics – Biomolecular
Anup Madan, PhD – PPD ### 1663785###Speaker###Director, Lab###PPD###Speaker: – PPD
### 9:30 AM – 10:00 AM ET
Considerations for Obtaining High-Quality PBMCs in Global Rare Disease Clinical TrialsLocation:253 BSpeaker: – Passage Bio, Inc
Bioanalytics – Biomolecular
Karen J. Quadrini, PhD – Passage Bio, Inc ### 604596###Speaker###Associate Director, Biomarkers and Precision Medicine###Passage Bio, Inc###Speaker: – Passage Bio, Inc
### 10:00 AM – 10:30 AM ET
Use of Tissue Biopsies to Improve Clinical TrialsLocation:253 BBioanalytics – Biomolecular
Keith Wharton, Jr., MD PhD FCAP – Ultivue, Inc. ### 1691762###Speaker###Vice President Medical Director###Ultivue, Inc.###Speaker: – Ultivue, Inc.
### 10:30 AM – 11:00 AM ET
Exosomes-Based Biomarkers: Challenges and the Promise of Cell Specificity and Multi Marker Approach Location:253 BBioanalytics – Biomolecular
Erez Eitan, PhD – NeuroDex Inc ### 1699107###Speaker###Chief scientific officer ###NeuroDex Inc###Speaker: – NeuroDex Inc
### 9:00 AM – 11:00 AM ET
Symposium: Sample Challenges, Yet Opportunities (CE)Moderator: – Virginia Commonwealth University
Bioanalytics – Chemical
9:00 AM – 11:00 AM ET
Symposium: Sample Challenges, Yet Opportunities (CE)Location:253 AModerator: – Virginia Commonwealth University
Bioanalytics – Chemical
Matthew S. Halquist, PhD – Virginia Commonwealth University ### 1447055###Moderator###Associate Professor and Laboratory Director###Virginia Commonwealth University###Moderator: – Virginia Commonwealth University
### 9:00 AM – 9:30 AM ET
XpressCollect: Enabling Home Collection for High-Throughput Diagnostics and SurveillanceLocation:253 ASpeaker: – Quantigen BioSciences
Bioanalytics – Chemical
Doug Rains (he/him/his) – Quantigen BioSciences ### 1755947###Speaker###Chief Scientific Officer###Quantigen BioSciences###Speaker: – Quantigen BioSciences
### he/him/his9:30 AM – 10:00 AM ET
Use of Volumetric Absorptive Microsampling in Remote / Hybrid Clinical TrialsLocation:253 ASpeaker: – Neoteryx, Part of the Trajan Family
Bioanalytics – Chemical
James Rudge, PhD – Neoteryx, Part of the Trajan Family ### 1663790###Speaker###Technical Director###Neoteryx, Part of the Trajan Family###Speaker: – Neoteryx, Part of the Trajan Family
### 10:00 AM – 10:30 AM ET
Microsampling and its Integration into Modeling in Long-Acting HIV ProgramsLocation:253 ASpeaker: – Merck & Co., Inc.
Bioanalytics – Chemical
Ryan Vargo, Ph.D – Merck & Co., Inc. ### 1651141###Speaker###Sr. Director###Merck & Co., Inc.###Speaker: – Merck & Co., Inc.
### 10:30 AM – 11:00 AM ET
Adopting Patient Centric Sampling for Routine Clinical Tests Location:253 ASpeaker: – Eli Lilly and Company
Bioanalytics – Chemical
Enaksha Wickremsinhe, PhD – Eli Lilly and Company ### 627103###Speaker###Senior Director###Eli Lilly and Company###Speaker: – Eli Lilly and Company
### 9:00 AM – 4:00 PM ET
Career Fair
9:00 AM – 4:00 PM ET
Career FairLocation:Career Development Center, Exhibit Hall A&B
9:30 AM – 10:00 AM ET
Coffee Break in the Solution Center
9:30 AM – 10:00 AM ET
Coffee Break in the Solution CenterLocation:Exhibit Hall A&B
9:30 AM – 10:30 AM ET
Platform Usage to Support Advanced Drug ModalitiesPartner Presentation Speaker: – BioAgilytix
Bioanalytics
9:30 AM – 10:30 AM ET
Platform Usage to Support Advanced Drug ModalitiesLocation:360 Stage #2, Exhibit Hall A&BPartner Presentation Speaker: – BioAgilytix
Bioanalytics
Jim McNally, PhD – BioAgilytix ### 1137442###Partner Presentation Speaker###Chief Scientific Officer###BioAgilytix###Partner Presentation Speaker: – BioAgilytix
### 9:30 AM – 10:30 AM ET
Speaker Spotlight: Gene Therapy Delivery Using Recombinant Adeno-Associated VirusSpotlight Speaker: – UMass Chan Medical School
Moderator: – Husson University
Formulation and Delivery
9:30 AM – 10:30 AM ET
Speaker Spotlight: Gene Therapy Delivery Using Recombinant Adeno-Associated VirusLocation:Spotlight Stage 3, Exhibit Hall A&BSpotlight Speaker: – UMass Chan Medical School
Moderator: – Husson University
Formulation and Delivery
Dan Wang, PhD – UMass Chan Medical School ### 1730309###Spotlight Speaker###Assistant Professor###UMass Chan Medical School###Spotlight Speaker: – UMass Chan Medical School
### @@@ Tianzhi Yang, PhD – Husson University ### 606403###Moderator###Professor of Pharmaceutical Sciences###Husson University###Moderator: – Husson University
### 9:30 AM – 10:30 AM ET
Speaker Spotlight: New Tools for Pharmaceutical Research Based on Tetrazine LigationModerator: – Adesis Inc.
Spotlight Speaker: – University of Delaware
Discovery and Basic Research
9:30 AM – 10:30 AM ET
Speaker Spotlight: New Tools for Pharmaceutical Research Based on Tetrazine LigationLocation:Spotlight Stage 1, Exhibit Hall A&BModerator: – Adesis Inc.
Spotlight Speaker: – University of Delaware
Discovery and Basic Research
Zhenzhen Dong, PhD (she/her/hers) – Adesis Inc. ### 1773700###Moderator###Associate Director###Adesis Inc.###Moderator: – Adesis Inc.
### she/her/hers @@@ Joseph Fox, PhD – University of Delaware ### 1773701###Spotlight Speaker###Professor###University of Delaware###Spotlight Speaker: – University of Delaware
### 9:30 AM – 10:30 AM ET
Speaker Spotlight: Post-Pandemic Configurations for Regulated BioanalysisModerator: – Bristol Myers Squibb
Bioanalytics
9:30 AM – 10:30 AM ET
Speaker Spotlight: Post-Pandemic Configurations for Regulated BioanalysisLocation:Spotlight Stage 2, Exhibit Hall A&BModerator: – Bristol Myers Squibb
Bioanalytics
HsinPin Ho, PhD – Bristol Myers Squibb ### 1466231###Moderator###Principal Scientist###Bristol Myers Squibb###Moderator: – Bristol Myers Squibb
### 9:30 AM – 10:00 AM ET
Regulated Bioanalysis in a Post-Pandemic WorldLocation:Spotlight Stage 2, Exhibit Hall A&BSpotlight Speaker: – Bristol-Myers Squibb Company
Bioanalytics
Jim Shen, PhD – Bristol-Myers Squibb Company ### 754507###Spotlight Speaker###Senior Director, Head of Regulated Bioanalysis & Operations###Bristol-Myers Squibb Company###Spotlight Speaker: – Bristol-Myers Squibb Company
### 10:00 AM – 10:30 AM ET
How the Pandemic Changed Lab-Based Bioanalytics to a New Normal: New (and Ongoing) ConsiderationsLocation:Spotlight Stage 2, Exhibit Hall A&BSpotlight Speaker: – Novartis Institutes for BioMedical Research, Inc.
Bioanalytics
Ann Brown, BS – Novartis Institutes for BioMedical Research, Inc. ### 1741077###Spotlight Speaker###Principle Scientist###Novartis Institutes for BioMedical Research, Inc.###Spotlight Speaker: – Novartis Institutes for BioMedical Research, Inc.
### 9:30 AM – 10:30 AM ET
The Evolution of Separations and Sample Preparation Technologies for BiopharmaPartner Presentation Speaker: – Phenomenex
Bioanalytics
9:30 AM – 10:30 AM ET
The Evolution of Separations and Sample Preparation Technologies for BiopharmaLocation:360 Stage #4, Exhibit Hall A&BPartner Presentation Speaker: – Phenomenex
Bioanalytics
John C. Gebler, PhD – Phenomenex ### 1778367###Partner Presentation Speaker###Director, Strategic Biopharma Business Dev###Phenomenex###Partner Presentation Speaker: – Phenomenex
### 10:30 AM – 11:30 AM ET
Design Your Career Board of DirectorsCareer Center Speaker: – Susan Morris Coaching
Career Development
10:30 AM – 11:30 AM ET
Design Your Career Board of DirectorsLocation:360 Stage #3, Exhibit Hall A&BCareer Center Speaker: – Susan Morris Coaching
Career Development
Susan Morris, M.Ed., CPCC, ACC – Susan Morris Coaching ### 1023071###Career Center Speaker###President###Susan Morris Coaching###Career Center Speaker: – Susan Morris Coaching
### 10:30 AM – 11:30 AM ET
Exploring Protein Degrader Drug Delivery ChallengesPartner Presentation Speaker: – Catalent
Preclinical Development
10:30 AM – 11:30 AM ET
Exploring Protein Degrader Drug Delivery ChallengesLocation:360 Stage #1, Exhibit Hall A&BPartner Presentation Speaker: – Catalent
Preclinical Development
Nathan Bennette, M.S. – Catalent ### 1743101###Partner Presentation Speaker###Director, Scientific Advisory###Catalent###Partner Presentation Speaker: – Catalent
### 10:30 AM – 11:30 AM ET
Special Poster Collection
10:30 AM – 11:30 AM ET
Special Poster CollectionLocation:Poster Forum #2, Exhibit Hall A&BPoster Collection Host: – Attralus, Inc.
Poster Collection Host: – Mercer University
Andrew Vick, Ph.D. – Attralus, Inc. ### 1140814###Poster Collection Host###Head of Toxicology, Drug Disposition, and PKPD###Attralus, Inc.###Poster Collection Host: – Attralus, Inc.
### @@@ Amruta A. Dandekar, B.Tech (she/her/hers) – Mercer University ### 1689916###Poster Collection Host###Ph.D. Candidate###Mercer University###Poster Collection Host: – Mercer University
### she/her/hers11:00 AM – 12:00 PM ET
New functional polyvinyl alcohol grade for optimized amorphous solid dispersionsPartner Presentation Speaker: – MilliporeSigma
Formulation and Delivery
11:00 AM – 12:00 PM ET
New functional polyvinyl alcohol grade for optimized amorphous solid dispersionsLocation:360 Stage #4, Exhibit Hall A&BPartner Presentation Speaker: – MilliporeSigma
Formulation and Delivery
Thomas Kipping, PhD – MilliporeSigma ### 604723###Partner Presentation Speaker###Head of Drug Carriers###MilliporeSigma###Partner Presentation Speaker: – MilliporeSigma
### 11:00 AM – 12:00 PM ET
Working with a CDMO to accelerate Lead to FIH journeyPartner Presentation Speaker: – Syngene International Limited
Formulation and Delivery
11:00 AM – 12:00 PM ET
Working with a CDMO to accelerate Lead to FIH journeyLocation:360 Stage #2, Exhibit Hall A&BPartner Presentation Speaker: – Syngene International Limited
Formulation and Delivery
Purushottam Singnurkar, PhD (he/him/his) – Syngene International Limited ### 635968###Partner Presentation Speaker###Associate Vice President & Head, Formulations###Syngene International Limited###Partner Presentation Speaker: – Syngene International Limited
### he/him/his11:00 AM – 1:30 PM ET
Dedicated Solution Center Hours
11:00 AM – 1:30 PM ET
Dedicated Solution Center HoursLocation:Exhibit Hall A&B
11:15 AM – 12:00 PM ET
AAPS Excipients Community Membership MeetingCommunity Leader: – Symbiotix
11:15 AM – 12:00 PM ET
AAPS Excipients Community Membership MeetingLocation:Spotlight Stage 1, Exhibit Hall A&BCommunity Leader: – Symbiotix
Allison E. Radwick, PhD – Symbiotix ### 1650343###Community Leader###Associate Medical Director###Symbiotix###Community Leader: – Symbiotix
### 11:15 AM – 12:00 PM ET
Combined In-Silico & Experimental Approach for Solid Form Crystallization DevelopmentChalk Talk Presenter: – J-Star Research Inc.
Chalk Talk Presenter: – J-Star Research Inc.
Formulation and Delivery
11:15 AM – 12:00 PM ET
Combined In-Silico & Experimental Approach for Solid Form Crystallization DevelopmentLocation:Spotlight Stage 3, Exhibit Hall A&BChalk Talk Presenter: – J-Star Research Inc.
Chalk Talk Presenter: – J-Star Research Inc.
Formulation and Delivery
Presented By J-Star Research
Yuriy Abramov, PhD – J-Star Research Inc. ### 1778370###Chalk Talk Presenter###Executive Director of Computational Chemistry and Data Science###J-Star Research Inc.###Chalk Talk Presenter: – J-Star Research Inc.
### @@@ Harsh Shah, PhD – J-Star Research Inc. ### 1446577###Chalk Talk Presenter###Senior Scientist###J-Star Research Inc.###Chalk Talk Presenter: – J-Star Research Inc.
### 11:15 AM – 12:00 PM ET
Improving oral absorption to rapidly advance early phase compoundsChalk Talk Presenter: – Lonza Small Molecules
Formulation and Delivery
11:15 AM – 12:00 PM ET
Improving oral absorption to rapidly advance early phase compoundsLocation:Spotlight Stage 2, Exhibit Hall A&BChalk Talk Presenter: – Lonza Small Molecules
Formulation and Delivery
Deanna M. Mudie, PhD – Lonza Small Molecules ### 602666###Chalk Talk Presenter###Sr. Principal Engineer R&D###Lonza Small Molecules###Chalk Talk Presenter: – Lonza Small Molecules
### 12:00 PM – 1:00 PM ET
Exploring Ways to Maintain your Network and Keep It AliveCareer Center Speaker: – Pharmalytik
Career Center Speaker: – Sanofi
Career Center Moderator: – Pharmalytik
Career Development
12:00 PM – 1:00 PM ET
Exploring Ways to Maintain Your Network and Keep It AliveLocation:360 Stage #3, Exhibit Hall A&BCareer Center Speaker: – Pharmalytik
Career Center Speaker: – Sanofi
Career Center Moderator: – Pharmalytik
Career Development
Kim Huynh-Ba, MS, PMP, FAAPS – Pharmalytik ### 636579###Career Center Speaker###Managing Director###Pharmalytik###Career Center Speaker: – Pharmalytik
### @@@ Jianmei D. Kochling, PhD, MBA – Sanofi ### 465971###Career Center Speaker###Senior Director###Sanofi###Career Center Speaker: – Sanofi
### @@@ Kim Huynh-Ba, MS, PMP, FAAPS – Pharmalytik ### 636579###Career Center Moderator###Managing Director###Pharmalytik###Career Center Moderator: – Pharmalytik
### 12:00 PM – 1:00 PM ET
Online Amino Acid Analysis for Spend Media ControlPartner Presentation Speaker: – Agilent Technologies
Manufacturing & Analytical Characterization
12:00 PM – 1:00 PM ET
Online Amino Acid Analysis for Spend Media ControlLocation:360 Stage #1, Exhibit Hall A&BPartner Presentation Speaker: – Agilent Technologies
Manufacturing & Analytical Characterization
Lorena Lopez, BSc / MBA – Agilent Technologies ### 1767416###Partner Presentation Speaker###LC Applications Scientist###Agilent Technologies###Partner Presentation Speaker: – Agilent Technologies
### 12:30 PM – 1:15 PM ET
AAPS Topical and Transdermal Community Membership MeetingCommunity Leader: – Solaris Pharma Corporation
12:30 PM – 1:15 PM ET
AAPS Topical and Transdermal Community Membership MeetingLocation:Spotlight Stage 1, Exhibit Hall A&BCommunity Leader: – Solaris Pharma Corporation
Lakshmi Raghavan, PhD – Solaris Pharma Corporation ### 1718883###Community Leader###Founder & President###Solaris Pharma Corporation###Community Leader: – Solaris Pharma Corporation
### 12:30 PM – 1:15 PM ET
Liposome formulation in cancer immunotherapy and challenges on early-stage developmentChalk Talk Presenter: – FUJIFILM Pharmaceuticals U.S.A., Inc.
Formulation and Delivery
12:30 PM – 1:15 PM ET
Liposome formulation in cancer immunotherapy and challenges on early-stage developmentLocation:Spotlight Stage 3, Exhibit Hall A&BChalk Talk Presenter: – FUJIFILM Pharmaceuticals U.S.A., Inc.
Formulation and Delivery
Presented By FUJIFILM Pharm.
Naoki Yamada, MS – FUJIFILM Pharmaceuticals U.S.A., Inc. ### 1377184###Chalk Talk Presenter###Director Strategy and Operation###FUJIFILM Pharmaceuticals U.S.A., Inc.###Chalk Talk Presenter: – FUJIFILM Pharmaceuticals U.S.A., Inc.
### 12:30 PM – 1:15 PM ET
Speaker Spotlight: Ask A RegulatorBioanalytics
12:30 PM – 1:15 PM ET
Speaker Spotlight: Ask A RegulatorLocation:Spotlight Stage 2, Exhibit Hall A&BBioanalytics
Brian Booth, PhD – FDA ### 576429###Spotlight Speaker###Director, DCP I###FDA###Spotlight Speaker: – FDA
### 12:30 PM – 1:30 PM ET
Oligonucleotide Analysis: How You Can Go Faster and Further?Partner Presentation Speaker: – Waters Corp.
Manufacturing & Analytical Characterization
12:30 PM – 1:30 PM ET
Oligonucleotide Analysis: How You Can Go Faster and Further?Location:360 Stage #4, Exhibit Hall A&BPartner Presentation Speaker: – Waters Corp.
Manufacturing & Analytical Characterization
Andrew Argo, MSc (he/him/his) – Waters Corp. ### 1777504###Partner Presentation Speaker###Sr. Global Marketing Manager###Waters Corp.###Partner Presentation Speaker: – Waters Corp.
### he/him/his12:30 PM – 1:30 PM ET
Solubility Enhancement Technology to Develop Particle-Engineered Free-Flowing Amorphous Solid DispersionPartner Presentation Speaker: – Evonik Corporation
Formulation and Delivery
12:30 PM – 1:30 PM ET
Solubility Enhancement Technology to Develop Particle-Engineered Free-Flowing Amorphous Solid DispersionLocation:360 Stage #2, Exhibit Hall A&BPartner Presentation Speaker: – Evonik Corporation
Formulation and Delivery
Mohammed Irfan Syed, M.S. – Evonik Corporation ### 1446733###Partner Presentation Speaker###Associate Director FAS Lab###Evonik Corporation###Partner Presentation Speaker: – Evonik Corporation
### 12:30 PM – 1:30 PM ET
Special Poster Collection
12:30 PM – 1:30 PM ET
Special Poster CollectionLocation:Poster Forum #2, Exhibit Hall A&BPoster Collection Host: – OnKure Therapeutics
Kevin Litwiler, PhD (he/him/his) – OnKure Therapeutics ### 803611###Poster Collection Host###Senior Vice President###OnKure Therapeutics###Poster Collection Host: – OnKure Therapeutics
### he/him/his1:30 PM – 2:30 PM ET
Keynote: Applications of MIDD for Dose Selection, Specific Populations, and Beyond: The Advantages of BracketingKeynote Speaker: – Certara
Moderator: – Pfizer Inc.
Clinical Pharmacology
1:30 PM – 2:30 PM ET
Keynote: Applications of MIDD for Dose Selection, Specific Populations, and Beyond: The Advantages of BracketingLocation:151 ABKeynote Speaker: – Certara
Moderator: – Pfizer Inc.
Clinical Pharmacology
Julie Bullock, PharmD – Certara ### 1595389###Keynote Speaker###Global Head of Clinical Pharmacology & Translational Medicine###Certara###Keynote Speaker: – Certara
### @@@ Vaishali Sahasrabudhe, PhD (she/her/hers) – Pfizer Inc. ### 1045004###Moderator###Clinical Pharmacology Therapeutic Area Head for Internal Medicine###Pfizer Inc.###Moderator: – Pfizer Inc.
### she/her/hers1:30 PM – 2:30 PM ET
Keynote: Challenges and Opportunities in the ADC Manufacturing Keynote Speaker: – Genentech, Inc.
Moderator: – Merck
Manufacturing & Analytical Characterization – Biomolecular
1:30 PM – 2:30 PM ET
Keynote: Challenges and Opportunities in the ADC Manufacturing Location:205 CKeynote Speaker: – Genentech, Inc.
Moderator: – Merck
Manufacturing & Analytical Characterization – Biomolecular
Sreedhara Alavattam, PhD (he/him/his) – Genentech, Inc. ### 803605###Keynote Speaker###Distinguished Scientist###Genentech, Inc.###Keynote Speaker: – Genentech, Inc.
### he/him/his @@@ Manoj Charati, PhD – Merck ### 1666037###Moderator###Principal Scientist###Merck###Moderator: – Merck
### 1:30 PM – 2:30 PM ET
Keynote: Fluidic Processes for Bottom-Up Engineering of Particles to Enable Drug Product PerformanceKeynote Speaker: – MIT
Moderator: – Pfizer Worldwide Research and Development
Formulation and Delivery – Chemical
1:30 PM – 2:30 PM ET
Keynote: Fluidic Processes for Bottom-Up Engineering of Particles to Enable Drug Product PerformanceLocation:205 ABKeynote Speaker: – MIT
Moderator: – Pfizer Worldwide Research and Development
Formulation and Delivery – Chemical
Patrick Doyle, PhD – MIT ### 1602135###Keynote Speaker###Professor###MIT###Keynote Speaker: – MIT
### @@@ Jaymin C. Shah, PhD – Pfizer Worldwide Research and Development ### 1554431###Moderator###Research Fellow and Head of Topical and Advanced Drug Delivery###Pfizer Worldwide Research and Development###Moderator: – Pfizer Worldwide Research and Development
### 1:30 PM – 2:30 PM ET
Keynote: From preclinical to clinical drug product development- a path for smooth transitionKeynote Speaker: – Simulations Plus, Inc.
Moderator: – Genentech
Preclinical Development – Biomolecular
1:30 PM – 2:30 PM ET
Keynote: From Preclinical to Clinical Drug Product Development- A Path for Smooth TransitionLocation:254 AKeynote Speaker: – Simulations Plus, Inc.
Moderator: – Genentech
Preclinical Development – Biomolecular
Sandra Suarez-Sharp, PhD – Simulations Plus, Inc. ### 1447017###Keynote Speaker###Vice President, Regulatory Affairs###Simulations Plus, Inc.###Keynote Speaker: – Simulations Plus, Inc.
### @@@ Christine Bowman, PhD – Genentech ### 1372299###Moderator###Senior Scientist###Genentech###Moderator: – Genentech
### 1:30 PM – 2:30 PM ET
Keynote: Gut Bugs and Fecal Transplants: Experience Over a Decade of Clinical Microbiome ResearchKeynote Speaker: – Lifespan Physician Group
Moderator: – University of Illinois Chicago
Discovery and Basic Research
1:30 PM – 2:30 PM ET
Keynote: Gut Bugs and Fecal Transplants: Experience Over a Decade of Clinical Microbiome ResearchLocation:254 BKeynote Speaker: – Lifespan Physician Group
Moderator: – University of Illinois Chicago
Discovery and Basic Research
Colleen R. Kelly, MD – Lifespan Physician Group ### 1602081###Keynote Speaker###Gastroenterologist###Lifespan Physician Group###Keynote Speaker: – Lifespan Physician Group
### @@@ Richard A. Gemeinhart, PhD (he/him/his) – University of Illinois Chicago ### 1378471###Moderator###Professor and Associate Vice Chancellor for Research###University of Illinois Chicago###Moderator: – University of Illinois Chicago
### he/him/his1:30 PM – 2:30 PM ET
Keynote: How Lyndra Is Working to 'Reinvent Medicine for a Healthier WorldModerator: – Organon
Keynote Speaker: – Lyndra Therapeutics Inc.
Manufacturing & Analytical Characterization – Chemical
1:30 PM – 2:30 PM ET
Keynote: How Lyndra Is Working to 'Reinvent Medicine for a Healthier WorldLocation:206 ABModerator: – Organon
Keynote Speaker: – Lyndra Therapeutics Inc.
Manufacturing & Analytical Characterization – Chemical
Maria Cruanes, PhD Chemistry (she/her/hers) – Organon ### 1680406###Moderator###Director Analytical Chemistry ###Organon###Moderator: – Organon
### she/her/hers @@@ Patricia Hurter, PhD (she/her/hers) – Lyndra Therapeutics Inc. ### 1595392###Keynote Speaker###CEO###Lyndra Therapeutics Inc.###Keynote Speaker: – Lyndra Therapeutics Inc.
### she/her/hers1:30 PM – 2:30 PM ET
Keynote: Keys to Improving Clinical Predictability via Preclinical DevelopmentKeynote Speaker: – UCSF School of Pharmacy
Moderator: – Exelixis
Preclinical Development – Chemical
1:30 PM – 2:30 PM ET
Keynote: Keys to Improving Clinical Predictability via Preclinical DevelopmentLocation:253 CKeynote Speaker: – UCSF School of Pharmacy
Moderator: – Exelixis
Preclinical Development – Chemical
Leslie Z. Benet, PhD – UCSF School of Pharmacy ### 466000###Keynote Speaker###Professor###UCSF School of Pharmacy###Keynote Speaker: – UCSF School of Pharmacy
### @@@ Jae H. Chang, PhD – Exelixis ### 1010871###Moderator###Head of Drug Discovery Sciences###Exelixis###Moderator: – Exelixis
### 1:30 PM – 2:30 PM ET
Keynote: Preparing for the Renaissance of the Dried Microsample: Lessons Learned in Newborn Screening
Bioanalytics – Chemical
1:30 PM – 2:30 PM ET
Keynote: Preparing for the Renaissance of the Dried Microsample: Lessons Learned in Newborn ScreeningLocation:253 ABioanalytics – Chemical
Donald Chace, MSFS PhD FAACC – Capitainer AB ### 1602080###Keynote Speaker###Senior Application and Product Specialist###Capitainer AB###Keynote Speaker: – Capitainer AB
### @@@ Matthew S. Halquist, PhD – Virginia Commonwealth University ### 1447055###Moderator###Associate Professor and Laboratory Director###Virginia Commonwealth University###Moderator: – Virginia Commonwealth University
### 1:30 PM – 2:30 PM ET
Keynote: Surrogate Matrices – A Creative Solution to Scarcity, or Simply Sound Science?Keynote Speaker: – Immunologix Laboratories
Moderator: – BioAgilytix
Bioanalytics – Biomolecular
1:30 PM – 2:30 PM ET
Keynote: Surrogate Matrices – A Creative Solution to Scarcity, or Simply Sound Science?Location:253 BKeynote Speaker: – Immunologix Laboratories
Moderator: – BioAgilytix
Bioanalytics – Biomolecular
Lauren Stevenson, PhD – Immunologix Laboratories ### 802379###Keynote Speaker###Chief Scientific Officer###Immunologix Laboratories###Keynote Speaker: – Immunologix Laboratories
### @@@ Amanda Hays, Ph.D. – BioAgilytix ### 1529523###Moderator###Scientific Officer###BioAgilytix###Moderator: – BioAgilytix
### 1:30 PM – 2:30 PM ET
Keynote: Targeting Epigenetic Regulator Mutations in CancerKeynote Speaker: – Mayo Clinic
Moderator: – University of Charleston
Discovery and Basic Research
1:30 PM – 2:30 PM ET
Keynote: Targeting Epigenetic Regulator Mutations in CancerLocation:255Keynote Speaker: – Mayo Clinic
Moderator: – University of Charleston
Discovery and Basic Research
Keith D. Robertson, PhD – Mayo Clinic ### 1602082###Keynote Speaker###Professor, Molecular Pharmacology and Experimental Therapeutics###Mayo Clinic###Keynote Speaker: – Mayo Clinic
### @@@ Tamer E. Fandy, PhD, BCGP, FCP – University of Charleston ### 1378497###Moderator###Professor & Chair, Department of Pharmaceutical & Adminstrative Sciences###University of Charleston###Moderator: – University of Charleston
### 1:30 PM – 2:30 PM ET
Quality attributes and characterization of gene vectors using light scatteringPartner Presentation Speaker: – Wyatt Technology
Bioanalytics
1:30 PM – 2:30 PM ET
Quality attributes and characterization of gene vectors using light scatteringLocation:360 Stage #1, Exhibit Hall A&BPartner Presentation Speaker: – Wyatt Technology
Bioanalytics
John Champagne, PhD – Wyatt Technology ### 1743098###Partner Presentation Speaker###Senior Application Scientist & Northeast Regional Manager###Wyatt Technology###Partner Presentation Speaker: – Wyatt Technology
### 1:30 PM – 2:30 PM ET
Strategies for a Successful Job InterviewCareer Center Moderator: – Nimbus Therapeutics
Career Center Speaker: – Hughes and Associates
Career Center Speaker: – AbbVie, Inc.
Career Development
1:30 PM – 2:30 PM ET
Strategies for a Successful Job InterviewLocation:360 Stage #3, Exhibit Hall A&BCareer Center Moderator: – Nimbus Therapeutics
Career Center Speaker: – Hughes and Associates
Career Center Speaker: – AbbVie, Inc.
Career Development
Nimita Dave, PhD – Nimbus Therapeutics ### 1650370###Career Center Moderator###Director, Clinical Pharmacology###Nimbus Therapeutics###Career Center Moderator: – Nimbus Therapeutics
### @@@ Jay Chapman, BS – Hughes and Associates ### 1650371###Career Center Speaker###Executive Director###Hughes and Associates###Career Center Speaker: – Hughes and Associates
### @@@ Patrick J. Marroum, PhD – AbbVie, Inc. ### 602558###Career Center Speaker###Distinguished Research Fellow###AbbVie, Inc.###Career Center Speaker: – AbbVie, Inc.
### 2:00 PM – 3:00 PM ET
Design and Manufacturing of Polymeric Long-Acting Injectable ProductsPartner Presentation Speaker: – Evonik
Formulation and Delivery
2:00 PM – 3:00 PM ET
Design and Manufacturing of Polymeric Long-Acting Injectable ProductsLocation:360 Stage #2, Exhibit Hall A&BPartner Presentation Speaker: – Evonik
Formulation and Delivery
Tom Tice, PhD – Evonik ### 1072987###Partner Presentation Speaker###Senior Director###Evonik###Partner Presentation Speaker: – Evonik
### 2:00 PM – 3:00 PM ET
Exponentially Expanding Science: Regulatory Acceptance and Use Cases for PBPKPreclinical Development
2:00 PM – 3:00 PM ET
Lost in translation? Predict first-in-human PK with Simcyp DiscoveryLocation:360 Stage #4, Exhibit Hall A&BPreclinical Development
Hannah Jones, PhD – Certara ### 1764091###Partner Presentation Speaker###Senior Vice President, Head of PBPK Consulting Services###Certara###Partner Presentation Speaker: – Certara
### 2:30 PM – 3:00 PM ET
Coffee Break in the Solution Center
2:30 PM – 3:00 PM ET
Coffee Break in the Solution CenterLocation:Exhibit Hall A&B
2:30 PM – 3:30 PM ET
Hot Topic: The Potential Dark Side of AI for Drug DiscoveryHot Topic Speaker: – Collaborations Pharmaceuticals, Inc.
Hot Topic Moderator: – University of Charleston
Discovery and Basic Research
2:30 PM – 3:30 PM ET
Hot Topic: The Potential Dark Side of AI for Drug DiscoveryLocation:153 AHot Topic Speaker: – Collaborations Pharmaceuticals, Inc.
Hot Topic Moderator: – University of Charleston
Discovery and Basic Research
Sean Ekins, PhD, DSc – Collaborations Pharmaceuticals, Inc. ### 1650348###Hot Topic Speaker###CEO###Collaborations Pharmaceuticals, Inc.###Hot Topic Speaker: – Collaborations Pharmaceuticals, Inc.
### @@@ Tamer E. Fandy, PhD, BCGP, FCP – University of Charleston ### 1378497###Hot Topic Moderator###Professor & Chair, Department of Pharmaceutical & Adminstrative Sciences###University of Charleston###Hot Topic Moderator: – University of Charleston
### 2:30 PM – 3:30 PM ET
Speaker Spotlight: Addressing the Gaps in Human PK and DDI PredictionSpotlight Speaker: – Pfizer Inc
Moderator: – Schrodinger, Inc. USA
Preclinical Development
2:30 PM – 3:30 PM ET
Speaker Spotlight: Addressing the Gaps in Human PK and DDI PredictionLocation:Spotlight Stage 1, Exhibit Hall A&BSpotlight Speaker: – Pfizer Inc
Moderator: – Schrodinger, Inc. USA
Preclinical Development
Li Di, PhD – Pfizer Inc ### 653545###Spotlight Speaker###Research Fellow###Pfizer Inc###Spotlight Speaker: – Pfizer Inc
### @@@ Naveen Thakral, PhD – Schrodinger, Inc. USA ### 1664123###Moderator###Director, Pharmaceutical Sciences###Schrodinger, Inc. USA###Moderator: – Schrodinger, Inc. USA
### 2:30 PM – 3:30 PM ET
Speaker Spotlight: Extrapolating Efficacy from Adults to PediatricsSpotlight Speaker: – University of Maryland
Moderator: – Tolmar, Inc.
Clinical Pharmacology – Chemical
2:30 PM – 3:30 PM ET
Speaker Spotlight: Extrapolating Efficacy from Adults to PediatricsLocation:Spotlight Stage 2, Exhibit Hall A&BSpotlight Speaker: – University of Maryland
Moderator: – Tolmar, Inc.
Clinical Pharmacology – Chemical
Joga Gobburu, PhD, MBA – University of Maryland ### 1075542###Spotlight Speaker###Professor###University of Maryland###Spotlight Speaker: – University of Maryland
### @@@ Raja B. Velagapudi, PhD – Tolmar, Inc. ### 567542###Moderator###Sr. Dir., Clinical Development###Tolmar, Inc.###Moderator: – Tolmar, Inc.
### 2:30 PM – 3:30 PM ET
Speaker Spotlight: Phase Appropriate Design Controls for Combination Products During Clinical DevelopmentSpotlight Speaker: – Takeda Pharmaceutical Company Limited
Moderator: – Pharmalytik
Manufacturing & Analytical Characterization – Chemical
2:30 PM – 3:30 PM ET
Speaker Spotlight: Phase Appropriate Design Controls for Combination Products During Clinical DevelopmentLocation:Spotlight Stage 3, Exhibit Hall A&BSpotlight Speaker: – Takeda Pharmaceutical Company Limited
Moderator: – Pharmalytik
Manufacturing & Analytical Characterization – Chemical
Shrinivas (Cheenu) Murti, PhD, MBA – Takeda Pharmaceutical Company Limited ### 720714###Spotlight Speaker###Head, CMC Business Process Excellence & Systems###Takeda Pharmaceutical Company Limited###Spotlight Speaker: – Takeda Pharmaceutical Company Limited
### @@@ Kim Huynh-Ba, MS, PMP, FAAPS – Pharmalytik ### 636579###Moderator###Managing Director###Pharmalytik###Moderator: – Pharmalytik
### 2:30 PM – 3:30 PM ET
Taste of Boston: Food Tour
2:30 PM – 3:30 PM ET
Taste of Boston: Food TourLocation:Exhibit Hall A&B
3:00 PM – 3:45 PM ET
Rapid Fire: Advances in Engineering Technologies For Drug Substance and Enabling Drug Product (BM)Rapid Fire Moderator: – Merck & Co., Inc.
Formulation and Delivery – Biomolecular
3:00 PM – 3:45 PM ET
Rapid Fire: Advances in Engineering Technologies For Drug Substance and Enabling Drug Product (BM)Location:204 ABRapid Fire Moderator: – Merck & Co., Inc.
Formulation and Delivery – Biomolecular
Suman A. Luthra, PhD – Merck & Co., Inc. ### 1689830###Rapid Fire Moderator###Director###Merck & Co., Inc.###Rapid Fire Moderator: – Merck & Co., Inc.
### 3:00 PM – 3:15 PM ET
CARTs: A New Vehicle for Nucleic Acid DeliveryLocation:204 ABRapid Fire Speaker: – Evonik North America, Vancouver
Formulation and Delivery – Biomolecular
Zahra Merchant, PhD – Evonik North America, Vancouver ### 1792340###Rapid Fire Speaker###Senior Scientist: Research, Development and Innovation###Evonik North America, Vancouver###Rapid Fire Speaker: – Evonik North America, Vancouver
### 3:15 PM – 3:30 PM ET
Antimicrobial Peptide, Nisin ZP, as an Inhaled Therapeutic for NSCLCLocation:204 ABRapid Fire Speaker: – St. John's University
Formulation and Delivery – Biomolecular
Suyash M. Patil – St. John's University ### 1755691###Rapid Fire Speaker###Doctoral Candidate###St. John's University###Rapid Fire Speaker: – St. John's University
### 3:00 PM – 3:45 PM ET
Rapid Fire: Microbiome: Impact in Pharmaceutical Development and DiseaseRapid Fire Moderator: – AbbVie
Discovery and Basic Research
3:00 PM – 3:45 PM ET
Rapid Fire: Microbiome: Impact in Pharmaceutical Development and DiseaseLocation:254 BRapid Fire Moderator: – AbbVie
Discovery and Basic Research
Maya Lipert, PhD – AbbVie ### 1611945###Rapid Fire Moderator###Principal Scientist I###AbbVie###Rapid Fire Moderator: – AbbVie
### 3:00 PM – 3:15 PM ET
Macropinocytosis Route for Drug Delivery: An Unexplored Avenue with Prospects and ChallengesLocation:254 BRapid Fire Speaker: – University of Toledo
Discovery and Basic Research
Rabin Neupane, MS – University of Toledo ### 1689551###Rapid Fire Speaker###Graduate Assistant###University of Toledo###Rapid Fire Speaker: – University of Toledo
### 3:15 PM – 3:30 PM ET
Developing a Dual Prodrug for Triggered Antibiotic ActivationLocation:254 BRapid Fire Speaker: – University of Otago
Discovery and Basic Research
Catherine L. Ross, BPharm – University of Otago ### 1690019###Rapid Fire Speaker###PhD Student ###University of Otago###Rapid Fire Speaker: – University of Otago
### 3:30 PM – 3:45 PM ET
Utilizing Tiny-TIM to Assess the Food Effect on the Absorption of Orally Administered DrugsLocation:254 BRapid Fire Speaker: – Genentech, Inc.
Discovery and Basic Research
Jia Liu, BS – Genentech, Inc. ### 1689653###Rapid Fire Speaker######Genentech, Inc.###Rapid Fire Speaker: – Genentech, Inc.
### 3:00 PM – 3:45 PM ET
Rapid Fire: Novel Manufacturing Approaches in Pharmaceuticals and Biopharmaceuticals (BM)Rapid Fire Moderator: – Pfizer
Manufacturing & Analytical Characterization – Biomolecular
3:00 PM – 3:45 PM ET
Rapid Fire: Novel Manufacturing Approaches in Pharmaceuticals and Biopharmaceuticals (BM)Location:205 CRapid Fire Moderator: – Pfizer
Manufacturing & Analytical Characterization – Biomolecular
Jay Jukyung Kang, PhD – Pfizer ### 1755672###Rapid Fire Moderator###Senior Scientist###Pfizer###Rapid Fire Moderator: – Pfizer
### 3:00 PM – 3:15 PM ET
Development Challenges and Lessons Learned During Development of Bispecific MoleculesLocation:205 CRapid Fire Speaker: – Pfizer
Manufacturing & Analytical Characterization – Biomolecular
Jay Jukyung Kang, PhD – Pfizer ### 1755672###Rapid Fire Speaker###Senior Scientist###Pfizer###Rapid Fire Speaker: – Pfizer
### 3:15 PM – 3:30 PM ET
Evaluation of a Commercial Alpha Kit for Detecting and Quantitating RVLP in In-Process and DS SamplesLocation:205 CRapid Fire Speaker: – Merck & Co., Inc.
Manufacturing & Analytical Characterization – Biomolecular
Rosalind Ang, PhD – Merck & Co., Inc. ### 1762952###Rapid Fire Speaker###Associate Principal Scientist###Merck & Co., Inc.###Rapid Fire Speaker: – Merck & Co., Inc.
### 3:30 PM – 3:45 PM ET
Fractionation of LNP-Nucleic Acid Drug Products Using Solid-Phase ExtractionLocation:205 CRapid Fire Speaker: – Waters Corporation
Manufacturing & Analytical Characterization – Biomolecular
Bonnie A. Alden – Waters Corporation ### 1755688###Rapid Fire Speaker###Principal Scientist###Waters Corporation###Rapid Fire Speaker: – Waters Corporation
### 3:00 PM – 4:00 PM ET
Early CMC Development Strategies to Support Late-Stage SuccessPartner Presentation Speaker: – Societal CDMO
Partner Presentation Speaker: – Societal CDMO
Manufacturing & Analytical Characterization
3:00 PM – 4:00 PM ET
Early CMC Development Strategies to Support Late-Stage SuccessLocation:360 Stage #1, Exhibit Hall A&BPartner Presentation Speaker: – Societal CDMO
Partner Presentation Speaker: – Societal CDMO
Manufacturing & Analytical Characterization
Neha Shah, Ph.D. – Societal CDMO ### 1743105###Partner Presentation Speaker###Director, Product Development###Societal CDMO###Partner Presentation Speaker: – Societal CDMO
### @@@ Kiran Pedada, Ph.D. – Societal CDMO ### 1743106###Partner Presentation Speaker###Associate Director, Analytical Development###Societal CDMO###Partner Presentation Speaker: – Societal CDMO
### 3:00 PM – 4:00 PM ET
Happy Hour Sponsored by Flow Sciences, Inc.
3:00 PM – 4:00 PM ET
Happy Hour Sponsored by Flow Sciences, Inc.Location:Booth #1310, Exhibit Halls A&BSponsored By Flow Sciences
3:00 PM – 4:00 PM ET
Happy Hour Sponsored by Prolytix
3:00 PM – 4:00 PM ET
Happy Hour Sponsored by ProlytixLocation:Booth #1246, Exhibit Hall A&B
3:00 PM – 4:00 PM ET
Rapid Fire: Advances in Engineering Technologies For Drug Substance and Enabling Drug Product (CE)Rapid Fire Moderator: – Merck & Co., Inc.
Formulation and Delivery – Chemical
3:00 PM – 4:00 PM ET
Rapid Fire: Advances in Engineering Technologies For Drug Substance and Enabling Drug Product (CE)Location:205 ABRapid Fire Moderator: – Merck & Co., Inc.
Formulation and Delivery – Chemical
Ashish Punia, PhD – Merck & Co., Inc. ### 1378020###Rapid Fire Moderator###Associate Principal Scientist###Merck & Co., Inc.###Rapid Fire Moderator: – Merck & Co., Inc.
### 3:00 PM – 3:15 PM ET
Aqueous Eye Drop Microsuspension Delivers Therapeutic Drug Concentrations to RetinaLocation:205 ABRapid Fire Speaker: – University of Iceland
Formulation and Delivery – Chemical
Thorsteinn Loftsson, PhD, FAAPS – University of Iceland ### 602997###Rapid Fire Speaker###Professor###University of Iceland###Rapid Fire Speaker: – University of Iceland
### 3:15 PM – 3:30 PM ET
Development of Reentry Vehicles and Payloads for In-Orbit Drug DevelopmentLocation:205 ABRapid Fire Speaker: – Varda Space Industries
Formulation and Delivery – Chemical
Jordan Croom, M.S. – Varda Space Industries ### 1755702###Rapid Fire Speaker###Head of Mechanisms###Varda Space Industries###Rapid Fire Speaker: – Varda Space Industries
### 3:30 PM – 3:45 PM ET
Unified Physical Property Estimation Relationships (UPPER)Location:205 ABRapid Fire Speaker: – University of Arizona, College of Pharmacy
Formulation and Delivery – Chemical
Samuel H. Yalkowsky, Ph.D., FAAPS – University of Arizona, College of Pharmacy ### 623865###Rapid Fire Speaker###Professor of Pharmaceutics###University of Arizona, College of Pharmacy###Rapid Fire Speaker: – University of Arizona, College of Pharmacy
### 3:45 PM – 4:00 PM ET
Leveraging Co-Precipitated Amorphous Dispersions as Alternatives to Spray Drying ChallengesLocation:205 ABRapid Fire Speaker: – Merck & Co., Inc.
Formulation and Delivery – Chemical
Marina Solomos, PhD – Merck & Co., Inc. ### 1755668###Rapid Fire Speaker###Senior Scientist###Merck & Co., Inc.###Rapid Fire Speaker: – Merck & Co., Inc.
### 3:00 PM – 4:00 PM ET
Rapid Fire: Breaking Through Barriers in Preclinical Development To Improve Clinical Translation (BM)Rapid Fire Moderator: – Janssen Research and Development, LLC
Preclinical Development – Biomolecular
3:00 PM – 4:00 PM ET
Rapid Fire: Breaking Through Barriers in Preclinical Development To Improve Clinical Translation (BM)Location:254 ARapid Fire Moderator: – Janssen Research and Development, LLC
Preclinical Development – Biomolecular
Nirav Shah, PhD – Janssen Research and Development, LLC ### 1650377###Rapid Fire Moderator###Senior Scientist###Janssen Research and Development, LLC###Rapid Fire Moderator: – Janssen Research and Development, LLC
### 3:00 PM – 3:15 PM ET
Pharmacokinetics/Pharmacodynamics Model to Predict the Therapeutic Index of Bispecific AntibodyLocation:254 ARapid Fire Speaker: – Genentech, Inc.
Preclinical Development – Biomolecular
Ran Li, PhD – Genentech, Inc. ### 1755671###Rapid Fire Speaker###Principal Scientist###Genentech, Inc.###Rapid Fire Speaker: – Genentech, Inc.
### 3:15 PM – 3:30 PM ET
Assays for Assessment of Anti-Drug Antibody Against STK-001 in SerumLocation:254 ARapid Fire Speaker: – Stoke Therapeutics
Preclinical Development – Biomolecular
Yanyan Cui, PhD – Stoke Therapeutics ### 1755692###Rapid Fire Speaker###Principal Scientist###Stoke Therapeutics###Rapid Fire Speaker: – Stoke Therapeutics
### 3:30 PM – 3:45 PM ET
A Mechanistic Ocular PK/PD Model with Systemic Target-Mediated Drug Disposition to Predict Human PK for Intravitreally Administered Anti-Tie2 AgonistLocation:254 ARapid Fire Speaker: – Genentech, Inc.
Preclinical Development – Biomolecular
Paulina Jakubiak, PhD – Genentech, Inc. ### 1690752###Rapid Fire Speaker###Scientist###Genentech, Inc.###Rapid Fire Speaker: – Genentech, Inc.
### 3:45 PM – 4:00 PM ET
Modeling Gastrointestinal Motility: The Multiple Moving Plug ModelLocation:254 ARapid Fire Speaker: – Intellipharm, LLC
Preclinical Development – Biomolecular
Kevin C. Johnson, PhD – Intellipharm, LLC ### 1755685###Rapid Fire Speaker###Pres.###Intellipharm, LLC###Rapid Fire Speaker: – Intellipharm, LLC
### 3:00 PM – 4:00 PM ET
Rapid Fire: Breaking Through Barriers in Preclinical Development To Improve Clinical Translation (CE)Rapid Fire Moderator: – Novartis
Preclinical Development – Chemical
3:00 PM – 4:00 PM ET
Rapid Fire: Breaking Through Barriers in Preclinical Development To Improve Clinical Translation (CE)Location:253 CRapid Fire Moderator: – Novartis
Preclinical Development – Chemical
Steven W. Louie, M.S. – Novartis ### 1328552###Rapid Fire Moderator###Senior Principal Scientist###Novartis###Rapid Fire Moderator: – Novartis
### 3:00 PM – 3:15 PM ET
Differential Effects of Metformin-Mediated BSEP Repression on Pharmacokinetics in HumansLocation:253 CRapid Fire Speaker: – University of Maryland School of Pharmacy
Preclinical Development – Chemical
James E. Polli, Ph.D., FAAPS – University of Maryland School of Pharmacy ### 605881###Rapid Fire Speaker###Professor###University of Maryland School of Pharmacy###Rapid Fire Speaker: – University of Maryland School of Pharmacy
### 3:15 PM – 3:30 PM ET
SRS-Microscopy and Deep-Learning: Novel Approach for Evaluation of Topical BioequivalenceLocation:253 CRapid Fire Speaker: – Harvard Medical School / Massachusetts General Hospital
Preclinical Development – Chemical
Fotis Iliopoulos, MPharm, PhD – Harvard Medical School / Massachusetts General Hospital ### 1689946###Rapid Fire Speaker###Research Fellow###Harvard Medical School / Massachusetts General Hospital###Rapid Fire Speaker: – Harvard Medical School / Massachusetts General Hospital
### 3:30 PM – 3:45 PM ET
Modeling Concentration-Dependent RBC-Partitioning for Human PK Prediction of SubasumstatLocation:253 CRapid Fire Speaker: – Takeda Development Corporation Americas
Preclinical Development – Chemical
Priyanka R. Kulkarni, PhD – Takeda Development Corporation Americas ### 1755699###Rapid Fire Speaker###Research Scientist II###Takeda Development Corporation Americas###Rapid Fire Speaker: – Takeda Development Corporation Americas
### 3:45 PM – 4:00 PM ET
Improving Brain Penetration Prediction via PBPK ModelingLocation:253 CRapid Fire Speaker: – Genentech
Preclinical Development – Chemical
Christine Bowman, PhD – Genentech ### 1372299###Rapid Fire Speaker###Senior Scientist###Genentech###Rapid Fire Speaker: – Genentech
### 3:00 PM – 4:00 PM ET
Rapid Fire: Epigenetic Drug Targets and Epigenetic ModifiersRapid Fire Moderator: – OnKure Therapeutics
Discovery and Basic Research
3:00 PM – 4:00 PM ET
Rapid Fire: Epigenetic Drug Targets and Epigenetic ModifiersLocation:255Rapid Fire Moderator: – OnKure Therapeutics
Discovery and Basic Research
Kevin Litwiler, PhD (he/him/his) – OnKure Therapeutics ### 803611###Rapid Fire Moderator###Senior Vice President###OnKure Therapeutics###Rapid Fire Moderator: – OnKure Therapeutics
### he/him/his3:00 PM – 3:15 PM ET
Piperlongumine Reverses EGFR Resistance as Adjuvant Treatment in NSCLC CellsLocation:255Rapid Fire Speaker: – MCPHS
Discovery and Basic Research
Shail Rakesh Modi, PhD – MCPHS ### 1378365###Rapid Fire Speaker###PhD Student###MCPHS###Rapid Fire Speaker: – MCPHS
### 3:15 PM – 3:30 PM ET
Prenatal E-Cigarette Use Disrupts Postnatal Blood-Brain Barrier (BBB) Integrity and Worsens Ischemic Stroke Outcomes- Implications on Brain Drug DeliveryLocation:255Rapid Fire Speaker: – Texas Tech University Health Sciences Center
Discovery and Basic Research
Sabrina Rahman Archie, MS – Texas Tech University Health Sciences Center ### 1377642###Rapid Fire Speaker###PhD Candidate###Texas Tech University Health Sciences Center###Rapid Fire Speaker: – Texas Tech University Health Sciences Center
### 3:30 PM – 3:45 PM ET
Vocacapsaicin (formerly CA-008): A Water-Soluble Prodrug for Rapid Release of Capsaicin for the Treatment of Post-Surgical PainLocation:255Rapid Fire Speaker: – Concentric Analgesics, Inc.
Discovery and Basic Research
Tarra Knotts, PhD (she/her/hers) – Concentric Analgesics, Inc. ### 1689703###Rapid Fire Speaker###Director of Nonclinical and Clinical Pharmacology###Concentric Analgesics, Inc.###Rapid Fire Speaker: – Concentric Analgesics, Inc.
### she/her/hers3:45 PM – 4:00 PM ET
Pharmacokinetic-Pharmacodynamic Modeling of the Antinociceptive Effect of Mitragynine, the Most Abundant Kratom Alkaloid in MiceLocation:255Rapid Fire Speaker: – University of Florida
Discovery and Basic Research
Abhisheak Sharma, MPharm, PhD (he/him/his) – University of Florida ### 603332###Rapid Fire Speaker###Research Assistant Professor and Assistant Director
###University of Florida###Rapid Fire Speaker: – University of Florida
### he/him/his3:00 PM – 4:00 PM ET
Rapid Fire: Model Informed Drug Development (MIDD): Role in Dose Selection, Vulnerable Populations, and Biowaivers (BM)Rapid Fire Moderator: – Kura Oncology
Clinical Pharmacology – Biomolecular
3:00 PM – 4:00 PM ET
Rapid Fire: Model Informed Drug Development (MIDD): Role in Dose Selection, Vulnerable Populations, and Biowaivers (BM)Location:152Rapid Fire Moderator: – Kura Oncology
Clinical Pharmacology – Biomolecular
Amitava Mitra, PhD – Kura Oncology ### 465957###Rapid Fire Moderator###Clinical Pharmacology###Kura Oncology###Rapid Fire Moderator: – Kura Oncology
### 3:00 PM – 3:15 PM ET
Assessing Food Impact on Bioequivalence Using Physiologically-Based Pharmacokinetic ModelingLocation:152Rapid Fire Speaker: – U.S. Food & Drug Administration
Clinical Pharmacology – Biomolecular
Fang Wu, PhD – U.S. Food & Drug Administration ### 604099###Rapid Fire Speaker###Senior Pharmacologist###U.S. Food & Drug Administration###Rapid Fire Speaker: – U.S. Food & Drug Administration
### 3:15 PM – 3:30 PM ET
First-in-Patient Dose Prediction for Adeno-Associated Virus-Mediated Hemophilia Gene TherapyLocation:152Rapid Fire Speaker: – Daiichi Sankyo Inc.
Clinical Pharmacology – Biomolecular
Peng Zou, PhD – Daiichi Sankyo Inc. ### 844096###Rapid Fire Speaker###Clinical Pharmacologist###Daiichi Sankyo Inc.###Rapid Fire Speaker: – Daiichi Sankyo Inc.
### 3:30 PM – 3:45 PM ET
Streamlined Pathways to Clinical Success through Integrated ModellingLocation:152Rapid Fire Speaker: – SEDA Pharmaceutical Development Services
Clinical Pharmacology – Biomolecular
Jake Dickinson, BSc (Hons) – SEDA Pharmaceutical Development Services ### 1378051###Rapid Fire Speaker###Senior Modeller###SEDA Pharmaceutical Development Services###Rapid Fire Speaker: – SEDA Pharmaceutical Development Services
### 3:45 PM – 4:00 PM ET
PK/PD and First-In Human Dosing Considerations for Cellular TherapiesLocation:152Rapid Fire Speaker: – Johnson and Johnson
Clinical Pharmacology – Biomolecular
Hardik Mody, PhD – Johnson and Johnson ### 1010836###Rapid Fire Speaker###Principal Scientist###Johnson and Johnson###Rapid Fire Speaker: – Johnson and Johnson
### 3:00 PM – 4:00 PM ET
Rapid Fire: Model Informed Drug Development (MIDD): Role in Dose Selection, Vulnerable Populations, and Biowaivers (CE)Rapid Fire Moderator: – Agios Pharmaceuticals
Clinical Pharmacology – Chemical
3:00 PM – 4:00 PM ET
Rapid Fire: Model Informed Drug Development (MIDD): Role in Dose Selection, Vulnerable Populations, and Biowaivers (CE)Location:151 ABRapid Fire Moderator: – Agios Pharmaceuticals
Clinical Pharmacology – Chemical
Punit Marathe, PhD – Agios Pharmaceuticals ### 1010799###Rapid Fire Moderator###Vice President DMPK-TOX###Agios Pharmaceuticals###Rapid Fire Moderator: – Agios Pharmaceuticals
### 3:00 PM – 3:15 PM ET
A Novel Mechanistic Model for Drug Release from PLGA ImplantsLocation:151 ABRapid Fire Speaker: – Certara UK (Simcyp Division)
Clinical Pharmacology – Chemical
Santosh Kumar Puttrevu, PhD – Certara UK (Simcyp Division) ### 844155###Rapid Fire Speaker###Research Scientist II###Certara UK (Simcyp Division)###Rapid Fire Speaker: – Certara UK (Simcyp Division)
### 3:15 PM – 3:30 PM ET
Application of Modeling and Simulation in Long Acting Injectable Product DevelopmentLocation:151 ABRapid Fire Speaker: – Simulations Plus, Inc.
Clinical Pharmacology – Chemical
Viera Lukacova, PhD – Simulations Plus, Inc. ### 1689910###Rapid Fire Speaker###Chief Scientist###Simulations Plus, Inc.###Rapid Fire Speaker: – Simulations Plus, Inc.
### 3:30 PM – 3:45 PM ET
Supporting Biowaivers with PBPK Virtual Bioequivalence: Importance of Within-Subject VariabilityLocation:151 ABRapid Fire Speaker: – Certara / University of Manchester
Clinical Pharmacology – Chemical
Amin Rostami-Hodjegan, PharmD, PhD – Certara / University of Manchester ### 465985###Rapid Fire Speaker###Director of CAPKR and Chief Scientific Officer###Certara / University of Manchester ###Rapid Fire Speaker: – Certara / University of Manchester
### 3:45 PM – 4:00 PM ET
No Polysorbate 80 Effect on Human Intestinal Drug PermeabilityLocation:151 ABRapid Fire Speaker: – University of Maryland School of Pharmacy
Clinical Pharmacology – Chemical
James E. Polli, Ph.D., FAAPS – University of Maryland School of Pharmacy ### 605881###Rapid Fire Speaker###Professor###University of Maryland School of Pharmacy###Rapid Fire Speaker: – University of Maryland School of Pharmacy
### 3:00 PM – 4:00 PM ET
Rapid Fire: Novel Manufacturing Approaches in Pharmaceuticals and Biopharmaceuticals (CE)Rapid Fire Moderator: – Karuna Therapeutics Inc.
Manufacturing & Analytical Characterization – Chemical
3:00 PM – 4:00 PM ET
Rapid Fire: Novel Manufacturing Approaches in Pharmaceuticals and Biopharmaceuticals (CE)Location:206 ABRapid Fire Moderator: – Karuna Therapeutics Inc.
Manufacturing & Analytical Characterization – Chemical
Praveen Kandi, PhD – Karuna Therapeutics Inc. ### 1765981###Rapid Fire Moderator###Director, Formulation Development, CMC & Preclinical###Karuna Therapeutics Inc.###Rapid Fire Moderator: – Karuna Therapeutics Inc.
### 3:00 PM – 3:15 PM ET
A QbD Approach for Continuous Crystallization and Filtration DevelopmentLocation:206 ABRapid Fire Speaker: – CONTINUUS Pharm
Manufacturing & Analytical Characterization – Chemical
Qinglin Su, PhD – CONTINUUS Pharm ### 1755673###Rapid Fire Speaker###Assoc. Director, MS&T###CONTINUUS Pharm###Rapid Fire Speaker: – CONTINUUS Pharm
### 3:15 PM – 3:30 PM ET
Investigating Excipient Induced Recrystallization of Spray Dried Intermediates in TabletsLocation:206 ABRapid Fire Speaker: – Merck & Co.
Manufacturing & Analytical Characterization – Chemical
Haichen Nie, PhD – Merck & Co. ### 1690377###Rapid Fire Speaker###Associate Principal Scientist###Merck & Co.###Rapid Fire Speaker: – Merck & Co.
### 3:30 PM – 3:45 PM ET
Transformational Conical Mill Screens Improve Efficiencies Without Affecting Validated ProcessesLocation:206 ABRapid Fire Speaker: – Quadro Engineering
Manufacturing & Analytical Characterization – Chemical
Wilf Sanguesa, P.Eng. – Quadro Engineering ### 605369###Rapid Fire Speaker###Pharma Research & Technology Manager###Quadro Engineering###Rapid Fire Speaker: – Quadro Engineering
### 3:45 PM – 4:00 PM ET
Manufacture of Mini-Tablets with High Drug Loading ContentLocation:206 ABSpeaker: – University of Chemistry and Technology Prague
Manufacturing & Analytical Characterization – Chemical
Frantisek Stepanek, PhD (he/him/his) – University of Chemistry and Technology Prague ### 1377223###Speaker###Professor###University of Chemistry and Technology Prague###Speaker: – University of Chemistry and Technology Prague
### he/him/his3:00 PM – 4:00 PM ET
Rapid Fire: Sample Challenges, Yet Opportunities (BM)Rapid Fire Moderator: – Biotech
Bioanalytics – Biomolecular
3:00 PM – 4:00 PM ET
Rapid Fire: Sample Challenges, Yet Opportunities (BM)Location:253 BRapid Fire Moderator: – Biotech
Bioanalytics – Biomolecular
Mark Ma, MD (he/him/his) – Biotech ### 1792079###Rapid Fire Moderator###VP, Head of Translational Clinical Sciences###Biotech###Rapid Fire Moderator: – Biotech
### he/him/his3:00 PM – 3:15 PM ET
Does Covid Infection Change our Immune Robustness Baseline ?Location:253 BRapid Fire Speaker: – SymphonyTech Biologucs
Bioanalytics – Biomolecular
Narendra Chirmule, Dr. – SymphonyTech Biologucs ### 516216###Rapid Fire Speaker###CEO###SymphonyTech Biologucs###Rapid Fire Speaker: – SymphonyTech Biologucs
### 3:15 PM – 3:30 PM ET
Novel Pharmacokinetic and Hematological Monitoring Methods Validated for Gene/Cell TherapiesLocation:253 BRapid Fire Speaker: – Frontage Laboratories, Inc.
Bioanalytics – Biomolecular
Bin Xu, PhD – Frontage Laboratories, Inc. ### 1653890###Rapid Fire Speaker###Director###Frontage Laboratories, Inc.###Rapid Fire Speaker: – Frontage Laboratories, Inc.
### 3:30 PM – 3:45 PM ET
A Total ADA Assay and Pre-Existing Antibodies to AAV9Location:253 BRapid Fire Speaker: – Eli Lilly and Company
Bioanalytics – Biomolecular
Yi Wen, PhD – Eli Lilly and Company ### 1011767###Rapid Fire Speaker###Director###Eli Lilly and Company###Rapid Fire Speaker: – Eli Lilly and Company
### 3:45 PM – 4:00 PM ET
Overcoming Challenges of Quantifying Protein Expression for Gene TherapyLocation:253 BRapid Fire Speaker: – Sangamo Therapeutics
Bioanalytics – Biomolecular
Jing Hu, PhD – Sangamo Therapeutics ### 1010831###Rapid Fire Speaker###Scientist###Sangamo Therapeutics###Rapid Fire Speaker: – Sangamo Therapeutics
### 3:00 PM – 4:00 PM ET
Rapid Fire: Sample Challenges, Yet Opportunities (CE)Rapid Fire Moderator: – Novartis
Bioanalytics – Chemical
3:00 PM – 4:00 PM ET
Rapid Fire: Sample Challenges, Yet Opportunities (CE)Location:253 ARapid Fire Moderator: – Novartis
Bioanalytics – Chemical
Wenkui Li, Ph.D – Novartis ### 602507###Rapid Fire Moderator###Director###Novartis###Rapid Fire Moderator: – Novartis
### 3:00 PM – 3:15 PM ET
Evaluation of Tasso-M20 Microsampling in Support of Clinical PK StudiesLocation:253 ARapid Fire Speaker: – Merck & Co Inc
Bioanalytics – Chemical
Huizhi Xie – Merck & Co Inc ### 1755674###Rapid Fire Speaker###Principle Scientist###Merck & Co Inc###Rapid Fire Speaker: – Merck & Co Inc
### 3:15 PM – 3:30 PM ET
Applying a Novel Patient-Centric Sampling Approach in Islatravir Clinical TrialsLocation:253 ARapid Fire Speaker: – Merck & Co Inc
Bioanalytics – Chemical
Li Sun, PhD – Merck & Co Inc ### 1302253###Rapid Fire Speaker###Principal Scientist###Merck & Co Inc###Rapid Fire Speaker: – Merck & Co Inc
### 3:30 PM – 3:45 PM ET
System Optimization to Mitigate Signal Suppression While Autonomously Running Multiple LC/MS/MS Methods in for SiRNAs, Peptides and Small Molecules in SequenceLocation:253 ARapid Fire Speaker: – Q2 Solutions
Bioanalytics – Chemical
Todd Lusk – Q2 Solutions ### 1689809###Rapid Fire Speaker###Senior Scientist###Q2 Solutions###Rapid Fire Speaker: – Q2 Solutions
### 3:45 PM – 4:00 PM ET
The ICH Process and the M10 JourneyLocation:253 ARapid Fire Speaker: – Merck & Co. Inc.
Bioanalytics – Biomolecular
Faye Vazvaei, M.S. – Merck & Co. Inc. ### 1529547###Rapid Fire Speaker###Executive Director###Merck & Co. Inc.###Rapid Fire Speaker: – Merck & Co. Inc.
### 3:00 PM – 4:00 PM ET
Scientist to Executive - Transition beyond PhD and 1st job,Career Center Moderator: – Sandoz, Inc.
Career Center Speaker: – Tergus Pharma, LLC
Career Center Speaker: – Longview Leader Corp
Career Development
3:00 PM – 4:00 PM ET
Scientist to Executive - Transition beyond PhD and 1st job,Location:360 Stage #3, Exhibit Hall A&BCareer Center Moderator: – Sandoz, Inc.
Career Center Speaker: – Tergus Pharma, LLC
Career Center Speaker: – Longview Leader Corp
Career Development
Prasad N. Tata – Sandoz, Inc. ### 1000523###Career Center Moderator###Clinical Development###Sandoz, Inc.###Career Center Moderator: – Sandoz, Inc.
### @@@ Vijendra Nalamothu, PhD – Tergus Pharma, LLC ### 604096###Career Center Speaker###Chairman & CEO###Tergus Pharma, LLC###Career Center Speaker: – Tergus Pharma, LLC
### @@@ Kurt Nielsen, PhD (he/him/his) – Longview Leader Corp ### 1804447###Career Center Speaker###Senior Advisor and Co-Founder###Longview Leader Corp###Career Center Speaker: – Longview Leader Corp
### he/him/his3:30 PM – 4:30 PM ET
Elimination of Titanium Dioxide from Film Coating-Challenges and OpportunitiesPartner Presentation Speaker: – ColorCon
Partner Presentation Speaker: – Colorcon
Manufacturing & Analytical Characterization
3:30 PM – 4:30 PM ET
Elimination of Titanium Dioxide from Film Coating-Challenges and OpportunitiesLocation:360 Stage #4, Exhibit Hall A&BPartner Presentation Speaker: – ColorCon
Partner Presentation Speaker: – Colorcon
Manufacturing & Analytical Characterization
Manish Ghimire, PhD – ColorCon ### 848929###Partner Presentation Speaker###Product Development Manager###ColorCon###Partner Presentation Speaker: – ColorCon
### @@@ Laura Scattergood (she/her/hers) – Colorcon ### 848338###Partner Presentation Speaker###Technical Manager###Colorcon###Partner Presentation Speaker: – Colorcon
### she/her/hers3:30 PM – 4:30 PM ET
Happy Hour Sponsored by Luminex
3:30 PM – 4:30 PM ET
Happy Hour Sponsored by Luminex a Diasorin CompanyLocation:Booth #1457, Exhibit Halls A&B
3:30 PM – 4:30 PM ET
Hot Topic: Novel-Approaches to Accelerate Access of Complex Locally-Acting Products to PatientsGovernment Speaker: – US Food and Drug Adminstration
Preclinical Development – Chemical
3:30 PM – 4:30 PM ET
Hot Topic: Novel-Approaches to Accelerate Access of Complex Locally-Acting Products to PatientsLocation:153 BCGovernment Speaker: – US Food and Drug Adminstration
Preclinical Development – Chemical
Priyanka Ghosh, PhD – US Food and Drug Adminstration ### 584219###Government Speaker###Pharmacologist###US Food and Drug Adminstration###Government Speaker: – US Food and Drug Adminstration
### 3:30 PM – 3:50 PM ET
Advancements in the in vitro Characterization Methodologies for Alternative BE Approaches of Locally Acting Complex Drug ProductsLocation:153 BCGovernment Speaker: – US Food and Drug Administration
Preclinical Development – Chemical
Ahmed Zidan, PhD – US Food and Drug Administration ### 1446962###Government Speaker###Senior Staff Fellow (Pharmacologist)###US Food and Drug Administration###Government Speaker: – US Food and Drug Administration
### 3:50 PM – 4:10 PM ET
Mechanistic Modeling and Simulation Approaches for Performance Prediction of Locally Acting Complex Drug ProductsLocation:153 BCGovernment Speaker: – US Food and Drug Adminstration
Preclinical Development – Chemical
Eleftheria Tsakalozou, PhD – US Food and Drug Adminstration ### 1044996###Government Speaker###Staff Fellow###US Food and Drug Adminstration###Government Speaker: – US Food and Drug Adminstration
### 4:10 PM – 4:30 PM ET
Panel DiscussionLocation:153 BCGovernment Speaker: – US Food and Drug Adminstration
Government Speaker: – US Food and Drug Administration
Hot Topic Speaker: – Merck & Co., Inc.
Hot Topic Speaker: – Schrodinger, Inc. USA
Preclinical Development – Chemical
Sam Raney, PhD – US Food and Drug Adminstration ### 604299###Government Speaker###Associate Director for Science###US Food and Drug Adminstration###Government Speaker: – US Food and Drug Adminstration
### @@@ Andrew Babiskin, PhD – US Food and Drug Administration ### 584226###Government Speaker###Lead Chemist###US Food and Drug Administration###Government Speaker: – US Food and Drug Administration
### @@@ Stephanie Barrett, PhD – Merck & Co., Inc. ### 466169###Hot Topic Speaker###Director, Sterile & Specialty Products###Merck & Co., Inc.###Hot Topic Speaker: – Merck & Co., Inc.
### @@@ Naveen Thakral, PhD – Schrodinger, Inc. USA ### 1664123###Hot Topic Speaker###Director, Pharmaceutical Sciences###Schrodinger, Inc. USA###Hot Topic Speaker: – Schrodinger, Inc. USA
### 3:30 PM – 4:30 PM ET
Important Role of UGTs in Drug Metabolism and Drug-Drug InteractionsPartner Presentation Speaker: – Sekisui XenoTech, LLC
Preclinical Development
3:30 PM – 4:30 PM ET
Important Role of UGTs in Drug Metabolism and Drug-Drug InteractionsLocation:360 Stage #2, Exhibit Hall A&BPartner Presentation Speaker: – Sekisui XenoTech, LLC
Preclinical Development
Maciej Czerwinski, PhD – Sekisui XenoTech, LLC ### 1092611###Partner Presentation Speaker###Director, Scientific Consulting###Sekisui XenoTech, LLC###Partner Presentation Speaker: – Sekisui XenoTech, LLC
### 3:30 PM – 4:30 PM ET
Special Poster Collection
3:30 PM – 4:30 PM ET
Special Poster CollectionLocation:Poster Forum #2, Exhibit Hall A&BPoster Collection Host: – Rutgers University
Patrick J. Sinko, PhD – Rutgers University ### 602328###Poster Collection Host###Distinguished Professor###Rutgers University###Poster Collection Host: – Rutgers University
### 3:45 PM – 4:45 PM ET
Happy Hour Sponsored by Agilent Technologies
3:45 PM – 4:45 PM ET
Happy Hour Sponsored by Agilent TechnologiesLocation:Booth #1021, Exhibit Hall A&B
3:45 PM – 4:45 PM ET
Happy Hour Sponsored by COREALIS Pharma Inc.
3:45 PM – 4:45 PM ET
Happy Hour Sponsored by COREALIS Pharma Inc.Location:Booth #916, Exhibit Halls A & BSponsored By COREALIS Pharma
5:00 PM – 6:00 PM ET
AAPS Bioanalytical Community Membership MeetingCommunity Leader: – Labcorp
5:00 PM – 6:00 PM ET
AAPS Bioanalytical Community Membership MeetingLocation:253 ACommunity Leader: – Labcorp
Stephanie Cape, PhD (she/her/hers) – Labcorp ### 627114###Community Leader###Head of R&D - Scientific Affairs, Clinical Trials Testing Solutions###Labcorp###Community Leader: – Labcorp
### she/her/hers5:00 PM – 6:00 PM ET
AAPS Bioequivalence and Bioavailability Science Community Membership Meeting Community Leader: – Sandoz, Inc.
5:00 PM – 6:00 PM ET
AAPS Bioequivalence and Bioavailability Science Community Membership Meeting Location:253 BCommunity Leader: – Sandoz, Inc.
Prasad N. Tata – Sandoz, Inc. ### 1000523###Community Leader###Clinical Development###Sandoz, Inc.###Community Leader: – Sandoz, Inc.
### 5:00 PM – 6:00 PM ET
AAPS Chemistry, Manufacturing, & Controls (CMC) Membership MeetingCommunity Leader: – Pharmalytik
5:00 PM – 6:00 PM ET
AAPS Chemistry, Manufacturing, & Controls (CMC) Membership MeetingLocation:254 BCommunity Leader: – Pharmalytik
Kim Huynh-Ba, MS, PMP, FAAPS – Pharmalytik ### 636579###Community Leader###Managing Director###Pharmalytik###Community Leader: – Pharmalytik
### 5:00 PM – 6:00 PM ET
AAPS Nanotechnology Community Membership MeetingCommunity Leader: – Florida A&M University
5:00 PM – 6:00 PM ET
AAPS Nanotechnology Community Membership MeetingLocation:255Community Leader: – Florida A&M University
Mandip S. Sachdeva, PhD – Florida A&M University ### 848734###Community Leader###Professor###Florida A&M University###Community Leader: – Florida A&M University
### 5:00 PM – 6:00 PM ET
AAPS Pharmaceutical Discovery & Preclinical Development Community Membership MeetingCommunity Leader: – Bristol Myers Squibb
5:00 PM – 6:00 PM ET
AAPS Pharmaceutical Discovery & Preclinical Development Community Membership MeetingLocation:254 ACommunity Leader: – Bristol Myers Squibb
Vibha Jawa, PhD – Bristol Myers Squibb ### 567586###Community Leader###Executive Director###Bristol Myers Squibb###Community Leader: – Bristol Myers Squibb
### 5:00 PM – 6:00 PM ET
AAPS Pharmacokinetics, Pharmacodynamics, & Drug Metabolism Community Membership MeetingCommunity Leader: – Nimbus Therapeutics
5:00 PM – 6:00 PM ET
AAPS Pharmacokinetics, Pharmacodynamics, & Drug Metabolism Community Membership MeetingLocation:253 CCommunity Leader: – Nimbus Therapeutics
Nimita Dave, PhD – Nimbus Therapeutics ### 1650370###Community Leader###Director, Clinical Pharmacology###Nimbus Therapeutics###Community Leader: – Nimbus Therapeutics
### 5:00 PM – 7:00 PM ET
PhRMA Foundation (Invitation Only)
5:00 PM – 7:00 PM ET
PhRMA FoundationLocation:Bullfinch Room, Westin Boston Seaport District Hotel
5:30 PM – 7:00 PM ET
Sustaining Sponsor Reception
5:30 PM – 7:00 PM ET
Sustaining Sponsor ReceptionLocation:Marina 1, Westin Boston Seaport District Hotel
6:00 PM – 9:00 PM ET
2022 Simulations Plus Annual User Forum (Invitation Only)
6:00 PM – 9:00 PM ET
2022 Simulations Plus Annual User Forum (Invitation Only)Location:Douglas Room, Westin Boston Seaport District Hotel
6:00 PM – 9:30 PM ET
American Association of Indian Pharmaceutical Scientist (AAiPS)-Annual Meeting
6:00 PM – 9:30 PM ET
American Association of Indian Pharmaceutical Scientist (AAiPS)-Annual MeetingLocation:Maharaja Restaurant, 57 JFK Street, Cambridge, MA
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