- Sunday, April 23, 2023
8:00 AM – 3:00 PM ET
Exhibitor Move-In
8:00 AM – 3:00 PM ET
Exhibitor Move-In
Location:Franklin Hall, 4th Floor
8:00 AM – 5:00 PM ET
Registration Hours
8:00 AM – 5:00 PM ET
Registration Hours
Location:Franklin Hall Foyer, 4th Floor
12:00 PM – 4:00 PM ET
Speaker Ready Room
12:00 PM – 4:00 PM ET
Speaker Ready Room
Location:Room 406, 4th Floor
3:00 PM – 4:30 PM ET
Opening Plenary
3:00 PM – 4:30 PM ET
Opening Plenary with Dr. Joel Dudley
Location:Salon E, 5th Floor
Joel Dudley, Ph.D. – Innovation Endeavors ### 1835815###Plenary Speaker###Partner###Innovation Endeavors###Plenary Speaker: – Innovation Endeavors
### 4:30 PM – 6:00 PM ET
Welcome Reception in the Solution Center (Sponsored by Regeneron Pharmaceuticals)
4:30 PM – 6:00 PM ET
Welcome Reception in the Solution Center (Sponsored by Regeneron Pharmaceuticals)Location:Franklin Hall, 4th Floor
- Monday, April 24, 2023
8:00 AM – 4:00 PM ET
Speaker Ready Room
8:00 AM – 4:00 PM ET
Speaker Ready Room
Location:Room 406, 4th Floor
8:00 AM – 5:00 PM ET
Registration Hours
8:00 AM – 5:00 PM ET
Registration Hours
Location:Franklin Hall Foyer, 4th Floor
9:00 AM – 9:30 AM ET
Prologue: Overcoming Critical Challenges of Evolving Biologics
9:00 AM – 9:30 AM ET
Prologue: Overcoming Critical Challenges of Evolving BiologicsLocation:Salon C, 5th FloorPrologue Speaker: – Merck & Co.
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Nicole Buist, PhD (she/her/hers) – Merck & Co. ### 1529534###Prologue Speaker###Senior Director###Merck & Co.###Prologue Speaker: – Merck & Co.
### she/her/hers9:00 AM – 9:30 AM ET
Prologue: Overview of Biomarker and Bioanalytical Readouts for Safety and Efficacy Evaluation of AAV Gene Therapy
9:00 AM – 9:30 AM ET
Prologue: Overview of Biomarker and Bioanalytical Readouts for Safety and Efficacy Evaluation of AAV Gene TherapyLocation:Salon D, 5th FloorPrologue Speaker: – Sangamo Therapeutics
Advances in Therapeutic Development Across Modalities
Yanmei Lu, PhD (she/her/hers) – Sangamo Therapeutics ### 821735###Prologue Speaker###VP Biomarker and BioAnalysis###Sangamo Therapeutics###Prologue Speaker: – Sangamo Therapeutics
### she/her/hers9:30 AM – 11:00 AM ET
IP and Patents for Pharmaceutical Scientists & Entrepreneurs
9:30 AM – 11:00 AM ET
IP and Patents for Pharmaceutical Scientists & EntrepreneursLocation:Salon A, 5th FloorCareer Center Speaker: – Rakoczy Molino Mazzochi Siwik LLP (RMMS)
Career Center Speaker: – Rakoczy Molino Mazzochi Siwik LLP (RMMS)
Career Center Speaker: – Rakoczy Molino Mazzochi Siwik LLP (RMMS)
Career Development
Lara E. FitzSimmons, JD (she/her/hers) – Rakoczy Molino Mazzochi Siwik LLP (RMMS) ### 1876534###Career Center Speaker###Partner###Rakoczy Molino Mazzochi Siwik LLP (RMMS)###Career Center Speaker: – Rakoczy Molino Mazzochi Siwik LLP (RMMS)
### she/her/hers @@@ Paul J. Molino, JD (he/him/his) – Rakoczy Molino Mazzochi Siwik LLP (RMMS) ### 1876535###Career Center Speaker###Managing Partner###Rakoczy Molino Mazzochi Siwik LLP (RMMS)###Career Center Speaker: – Rakoczy Molino Mazzochi Siwik LLP (RMMS)
### he/him/his @@@ Thomas H. Ehrich, JD PhD (he/him/his) – Rakoczy Molino Mazzochi Siwik LLP (RMMS) ### 1876536###Career Center Speaker###Of Counsel###Rakoczy Molino Mazzochi Siwik LLP (RMMS)###Career Center Speaker: – Rakoczy Molino Mazzochi Siwik LLP (RMMS)
### he/him/his9:30 AM – 11:00 AM ET
Symposium: Innovation Based on Non-Traditional PlatformsModerator: – Teva Pharmaceuticals
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
9:30 AM – 11:00 AM ET
Symposium: Innovation Based on Non-Traditional PlatformsLocation:Salon C, 5th FloorModerator: – Teva Pharmaceuticals
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Haichen Nie, PhD – Teva Pharmaceuticals ### 1896152###Moderator###Associate Director###Teva Pharmaceuticals###Moderator: – Teva Pharmaceuticals
### 9:30 AM – 10:00 AM ET
Challenges and Strategies in Developing Biosimilar Drug ProductsLocation:Salon C, 5th FloorSpeaker: – Teva pharmaceuticals
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Mehran Yazdanian, PhD (he/him/his) – Teva pharmaceuticals ### 1820685###Speaker###VP###Teva pharmaceuticals###Speaker: – Teva pharmaceuticals
### he/him/his10:00 AM – 10:30 AM ET
Modeling Tools for Predicting Protein-Protein Interactions at High ConcentrationsLocation:Salon C, 5th FloorSpeaker: – University of Delaware
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Christopher Roberts, PhD – University of Delaware ### 624482###Speaker###Professor###University of Delaware###Speaker: – University of Delaware
### 10:30 AM – 11:00 AM ET
Excipient Phase Behavior - Implications on Protein StabilityLocation:Salon C, 5th FloorSpeaker: – University of Minnesota
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Raj Suryanarayanan, PhD (he/him/his) – University of Minnesota ### 1377916###Speaker###Professor###University of Minnesota###Speaker: – University of Minnesota
### he/him/his9:30 AM – 11:00 AM ET
Symposium: Recent Advances in Gene TherapyModerator: – PPD, A ThermoFisher Company
Advances in Therapeutic Development Across Modalities
9:30 AM – 11:00 AM ET
Symposium: Recent Advances in Gene TherapyLocation:Salon D, 5th FloorModerator: – PPD, A ThermoFisher Company
Advances in Therapeutic Development Across Modalities
Catherine Vrentas, PhD – PPD, A ThermoFisher Company ### 1650329###Moderator###Senior Research Scientist###PPD, A ThermoFisher Company###Moderator: – PPD, A ThermoFisher Company
### 9:30 AM – 10:00 AM ET
Immunogenicity Assessment and Mitigation of AAV-Based Gene TherapiesLocation:Salon D, 5th FloorSpeaker: – Janssen Research & Development, LLC
Advances in Therapeutic Development Across Modalities
Tong-Yuan Yang, PhD (he/him/his) – Janssen Research & Development, LLC ### 604583###Speaker###Senior Scientific Director ###Janssen Research & Development, LLC###Speaker: – Janssen Research & Development, LLC
### he/him/his10:00 AM – 10:30 AM ET
Translational and Dosing Considerations for Ocular AAV-Based Gene TherapyLocation:Salon D, 5th FloorSpeaker: – Johnson and Johnson
Advances in Therapeutic Development Across Modalities
Prathap Nagaraja Shastri, PhD – Johnson and Johnson ### 567445###Speaker###Scientific Director###Johnson and Johnson ###Speaker: – Johnson and Johnson
### 10:30 AM – 11:00 AM ET
Biomarker and Bioanalytical Data from imagine-1:assessing PBGM01 for GM1 GangliosidosisLocation:Salon D, 5th FloorAdvances in Therapeutic Development Across Modalities
Yan G. Ni, PhD – Passage Bio ### 803355###Speaker###Executive Director###Passage Bio###Speaker: – Passage Bio
### 10:00 AM – 11:00 AM ET
Coffee Break in the Solution Center
10:00 AM – 11:00 AM ET
Coffee Break in the Solution CenterLocation:Franklin Hall, 4th Floor
10:00 AM – 11:00 AM ET
Hot Topic: Translational Intelligence in Omics: Exploring Advances in Genomics and MetabolomicsHot Topic Moderator: – Janssen BioTherapeutics
Hot Topic Speaker: – University of Florida, Department of Pathology
Hot Topic Speaker: – PPD
Advances in Therapeutic Development Across Modalities
10:00 AM – 11:00 AM ET
Hot Topic: Translational Intelligence in Omics: Exploring Advances in Genomics and MetabolomicsLocation:Salon B, 5th FloorHot Topic Moderator: – Janssen BioTherapeutics
Hot Topic Speaker: – University of Florida, Department of Pathology
Hot Topic Speaker: – PPD
Advances in Therapeutic Development Across Modalities
Sanjeev Bhardwaj, PhD – Janssen BioTherapeutics ### 1464295###Hot Topic Moderator###Senior Scientist###Janssen BioTherapeutics###Hot Topic Moderator: – Janssen BioTherapeutics
### @@@ Timothy J. Garrett, PhD – University of Florida, Department of Pathology ### 803624###Hot Topic Speaker###Associate Professor###University of Florida, Department of Pathology###Hot Topic Speaker: – University of Florida, Department of Pathology
### @@@ Anup Madan, PhD – PPD ### 1663785###Hot Topic Speaker###Director, Lab###PPD###Hot Topic Speaker: – PPD
### 10:00 AM – 4:30 PM ET
Solution Center Hours & Poster Presentations
10:00 AM – 4:30 PM ET
Solution Center Hours & Poster PresentationsLocation:Franklin Hall, 4th Floor
10:15 AM – 11:00 AM ET
Easy Automated Sample Prep for Regulated and Nonregulated Labs
10:15 AM – 11:00 AM ET
Easy Automated Sample Prep for Regulated and Nonregulated Labs Location:Learning Lab, Franklin HallPartner Presentation Speaker: – Agilent Technologies
Advances in Therapeutic Development Across Modalities
Kenda LJ Evans, Ph D (she/her/hers) – Agilent Technologies ### 1947017###Partner Presentation Speaker###Automation Product Specialist###Agilent Technologies###Partner Presentation Speaker: – Agilent Technologies
### she/her/hers11:00 AM – 12:30 PM ET
Light Lunch in the Solution Center
11:00 AM – 12:30 PM ET
Light Lunch in the Solution CenterLocation:Franklin Hall, 4th Floor
11:00 AM – 1:00 PM ET
Dedicated Solution Center Hours
11:00 AM – 1:00 PM ET
Dedicated Solution Center HoursLocation:Franklin Hall, 4th Floor
11:15 AM – 12:00 PM ET
LNP Characterization Using Field Flow Fractionation with Light Scattering Detection
11:15 AM – 12:00 PM ET
LNP Characterization Using Field Flow Fractionation with Light Scattering DetectionLocation:Learning Lab, Franklin HallPartner Presentation Speaker: – Wyatt Technology
Advances in Therapeutic Development Across Modalities
William Penny, PhD – Wyatt Technology ### 1944590###Partner Presentation Speaker###Regional Manager###Wyatt Technology###Partner Presentation Speaker: – Wyatt Technology
### 11:30 AM – 12:30 PM ET
Career Conversation Hosted By NIH/NINDS
11:30 AM – 12:30 PM ET
Career Conversation Hosted by NIH/NINDSLocation:Booth #412, Career Center, Franklin HallCareer Development
12:15 PM – 1:00 PM ET
Chromatographic Methods for the Analysis of RNA Therapeutics
12:15 PM – 1:00 PM ET
Chromatographic Methods for the Analysis of RNA TherapeuticsLocation:Learning Lab, Franklin HallPartner Presentation Speaker: – Waters Corporation
Advances in Therapeutic Development Across Modalities
Matthew Lauber, PhD – Waters Corporation ### 1916559###Partner Presentation Speaker###Senior Director###Waters Corporation###Partner Presentation Speaker: – Waters Corporation
### 12:30 PM – 1:30 PM ET
Special Poster Collection
12:30 PM – 1:30 PM ET
Special Poster CollectionLocation:Poster Forum 1; Franklin HallPoster Collection Host: – Genentech, Inc.
Advances in Therapeutic Development Across Modalities
Katie F. Maass, Ph.D. (she/her/hers) – Genentech, Inc. ### 847055###Poster Collection Host###Senior Principal Scientist, Clinical Pharmacology###Genentech, Inc.###Poster Collection Host: – Genentech, Inc.
### she/her/hers1:00 PM – 2:00 PM ET
Keynote: Bioanalytical and Biomarker Strategies for Sickle Blood Cell Gene Editing Therapies
1:00 PM – 2:00 PM ET
Keynote: Bioanalytical and Biomarker Strategies for Sickle Blood Cell Gene Editing TherapiesLocation:Salon E, 5th FloorKeynote Speaker: – Beam Therapeutics
Moderator: – BioAgilytix Labs
Advances in Therapeutic Development Across Modalities
Priya S. Chockalingam, Ph.D. (she/her/hers) – Beam Therapeutics ### 1820694###Keynote Speaker###VP, Head of Clinical BioAnalytics & Translational Sciences###Beam Therapeutics###Keynote Speaker: – Beam Therapeutics
### she/her/hers @@@ Lynn Kamen, PhD – BioAgilytix Labs ### 1680382###Moderator###Scientific Officer###BioAgilytix Labs###Moderator: – BioAgilytix Labs
### 1:00 PM – 2:00 PM ET
Keynote: Translation of Microneedle Patch Technology into the Clinic
1:00 PM – 2:00 PM ET
Keynote: Translation of Microneedle Patch Technology into the ClinicLocation:Salon C, 5th FloorKeynote Speaker: – Georgia Institute of Technology
Moderator: – Samford University
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Mark R. Prausnitz, PhD – Georgia Institute of Technology ### 605551###Keynote Speaker###Regents’ Professor###Georgia Institute of Technology###Keynote Speaker: – Georgia Institute of Technology
### @@@ Bernadette DSouza, PhD (she/her/hers) – Samford University ### 624468###Moderator###Associate Professor###Samford University###Moderator: – Samford University
### she/her/hers1:30 PM – 2:15 PM ET
Lipids, Learnings and Future Opportunities
1:30 PM – 2:15 PM ET
Lipids, Learnings and Future OpportunitiesLocation:Learning Lab, Franklin HallPartner Presentation Speaker: – Evonik Canada Inc.
Advances in Therapeutic Development Across Modalities
Zahra Merchant, PhD (she/her/hers) – Evonik Canada Inc. ### 1792340###Partner Presentation Speaker###Senior Scientist###Evonik Canada Inc.###Partner Presentation Speaker: – Evonik Canada Inc.
### she/her/hers2:00 PM – 2:30 PM ET
Coffee Break in the Solution Center
2:00 PM – 2:30 PM ET
Coffee Break in the Solution CenterLocation:Franklin Hall, 4th Floor
2:30 PM – 3:15 PM ET
Panel Discussion: Common Challenges in Bioanalytical Assay Validation/Development in CGTP
2:30 PM – 3:15 PM ET
Panel Discussion: Common Challenges in Bioanalytical Assay Validation/Development in CGTPLocation:Learning Lab, Franklin HallPartner Presentation Speaker: – KCAS Bioanalytical and Biomarker Services
Partner Presentation Speaker: – spfarmer@bdatasolutions.com
Partner Presentation Speaker: – Spirovant Sciences, Inc.
Partner Presentation Speaker: – Beam Therapeutics
Partner Presentation Speaker: – PPD Biomarkers
Partner Presentation Speaker: – BioAgilytix Labs
Advances in Therapeutic Development Across Modalities
Carrie A. Vyhlidal, PhD (she/her/hers) – KCAS Bioanalytical and Biomarker Services ### 1916655###Partner Presentation Speaker###Associate Director###KCAS Bioanalytical and Biomarker Services###Partner Presentation Speaker: – KCAS Bioanalytical and Biomarker Services
### she/her/hers @@@ Stephanie A. Pasas-Farmer, PhD (she/her/hers) – spfarmer@bdatasolutions.com ### 590019###Partner Presentation Speaker###President and Principal Consultant###spfarmer@bdatasolutions.com###Partner Presentation Speaker: – spfarmer@bdatasolutions.com
### she/her/hers @@@ Lillian Falese, MS – Spirovant Sciences, Inc. ### 1940580###Partner Presentation Speaker###Director###Spirovant Sciences, Inc.###Partner Presentation Speaker: – Spirovant Sciences, Inc.
### @@@ Kelly Colletti, PhD (she/her/hers) – Beam Therapeutics ### 1940581###Partner Presentation Speaker###Director, Preclinical Bioanalytics###Beam Therapeutics###Partner Presentation Speaker: – Beam Therapeutics
### she/her/hers @@@ David Kuhel, M.S. – PPD Biomarkers ### 1940582###Partner Presentation Speaker###Senior Research Scientist###PPD Biomarkers###Partner Presentation Speaker: – PPD Biomarkers
### @@@ Brian D. Bower, PhD – BioAgilytix Labs ### 1916709###Partner Presentation Speaker###Scientist III, Gene and Cell Therapy###BioAgilytix Labs###Partner Presentation Speaker: – BioAgilytix Labs
### 2:30 PM – 3:30 PM ET
Rapid Fire: Innovation Based on Non-Traditional PlatformsRapid Fire Moderator: – Merck & Co., Inc.
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
2:30 PM – 3:30 PM ET
Rapid Fire: Innovation Based on Non-Traditional PlatformsLocation:Salon C, 5th FloorRapid Fire Moderator: – Merck & Co., Inc.
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Jing Ling, PhD – Merck & Co., Inc. ### 1650352###Rapid Fire Moderator###Associate Principal Scientist###Merck & Co., Inc.###Rapid Fire Moderator: – Merck & Co., Inc.
### 2:30 PM – 2:45 PM ET
Targeted Drug Delivery using Edible Natural ProteinsLocation:Salon C, 5th FloorRapid Fire Speaker: – Philipps Universität Marburg
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Ahmed MA Mohamed (he/him/his) – Philipps Universität Marburg ### 1820667###Rapid Fire Speaker###PhD Candidate###Philipps Universität Marburg###Rapid Fire Speaker: – Philipps Universität Marburg
### he/him/his2:45 PM – 3:00 PM ET
Comparison of Trehalose and Sucrose in Preserving and Stabilizing Lyophilized Therapeutic ProteinsLocation:Salon C, 5th FloorRapid Fire Speaker: – Ashland Specialty Ingredients
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Fengyuan Yang, PhD – Ashland Specialty Ingredients ### 603502###Rapid Fire Speaker###Research Scientist###Ashland Specialty Ingredients###Rapid Fire Speaker: – Ashland Specialty Ingredients
### 3:00 PM – 3:15 PM ET
Mechanistic Understanding of the Impact of Sugar and Buffer Salts on the Physical Stability of solid biologicals formulationLocation:Salon C, 5th FloorRapid Fire Speaker: – Merck & Co., Inc.
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Jing Ling, PhD – Merck & Co., Inc. ### 1650352###Rapid Fire Speaker###Associate Principal Scientist###Merck & Co., Inc.###Rapid Fire Speaker: – Merck & Co., Inc.
### 3:15 PM – 3:30 PM ET
Structural Profiling of mRNA Vaccine Constructs: Applications for mRNA Vaccine Design and Quality AssessmentLocation:Salon C, 5th FloorRapid Fire Speaker: – National Institute of Standards and Technology
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Joshua Imperatore, PhD – National Institute of Standards and Technology ### 1916543###Rapid Fire Speaker###NRC Postdoctoral Fellow###National Institute of Standards and Technology###Rapid Fire Speaker: – National Institute of Standards and Technology
### 2:30 PM – 3:30 PM ET
Rapid Fire: Recent Advances in Gene TherapyRapid Fire Moderator: – Novartis Institutes for BioMedical Research, Inc.
Advances in Therapeutic Development Across Modalities
2:30 PM – 3:30 PM ET
Rapid Fire: Recent Advances in Gene TherapyLocation:Salon E, 5th FloorRapid Fire Moderator: – Novartis Institutes for BioMedical Research, Inc.
Advances in Therapeutic Development Across Modalities
Robert Dodge, PhD – Novartis Institutes for BioMedical Research, Inc. ### 758596###Rapid Fire Moderator###Global Lead, Biologics Bioanalysis###Novartis Institutes for BioMedical Research, Inc.###Rapid Fire Moderator: – Novartis Institutes for BioMedical Research, Inc.
### 2:30 PM – 2:45 PM ET
Emerging Trends for Diagnostic Testing in Gene TherapiesLocation:Salon E, 5th FloorRapid Fire Speaker: – Novartis Pharmaceutical Corp.
Advances in Therapeutic Development Across Modalities
Jim Glick, PhD – Novartis Pharmaceutical Corp. ### 466128###Rapid Fire Speaker###Director, Diagnostic Sciences & Partnerships###Novartis Pharmaceutical Corp.###Rapid Fire Speaker: – Novartis Pharmaceutical Corp.
### 2:45 PM – 3:00 PM ET
Considerations for Developing and Validating an Anti-AAV9 ADA AssayLocation:Salon E, 5th FloorRapid Fire Speaker: – BioAgilytix
Advances in Therapeutic Development Across Modalities
Sara Alhakeem, PhD – BioAgilytix ### 1820681###Rapid Fire Speaker###Scientist/Bioanalytical Project Manager###BioAgilytix###Rapid Fire Speaker: – BioAgilytix
### 3:00 PM – 3:15 PM ET
Novel Alternatives to ELISPOT Assay for AAV Gene Therapy Clinical StudiesLocation:Salon E, 5th FloorRapid Fire Speaker: – Pfizer
Advances in Therapeutic Development Across Modalities
Ayuko Ota-Setlik, MS (she/her/hers) – Pfizer ### 1836158###Rapid Fire Speaker###Biomarker Clinical Assay Lead###Pfizer###Rapid Fire Speaker: – Pfizer
### she/her/hers3:15 PM – 3:30 PM ET
qPCR Biodistribution and Shedding Assessment Strategy in Gene Therapy StudiesLocation:Salon E, 5th FloorRapid Fire Speaker: – BioAgilytix Labs, LLC.
Advances in Therapeutic Development Across Modalities
Amanda L. Hays, Ph.D. – BioAgilytix Labs, LLC. ### 1529523###Rapid Fire Speaker###Scientific Officer###BioAgilytix Labs, LLC.###Rapid Fire Speaker: – BioAgilytix Labs, LLC.
### 3:00 PM – 4:00 PM ET
Hot Topic: Turbocharging Innovation in CMC - Driving Back to Rational Drug Design Hot Topic Moderator: – Merck & Co., Inc.
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
3:00 PM – 4:00 PM ET
Hot Topic: Turbocharging Innovation in CMC - Driving Back to Rational Drug Design Location:Salon B, 5th FloorHot Topic Moderator: – Merck & Co., Inc.
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Wei Xu, Ph.D. – Merck & Co., Inc. ### 567494###Hot Topic Moderator###Director of Preformulation###Merck & Co., Inc.###Hot Topic Moderator: – Merck & Co., Inc.
### 3:00 PM – 3:30 PM ET
CMC Strategy for Antibody Drug Conjugates: Challenges and Regulatory ConsiderationsLocation:Salon B, 5th FloorHot Topic Speaker: – Merck
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Weining Hu, MS (she/her/hers) – Merck ### 1820677###Hot Topic Speaker###AVP###Merck###Hot Topic Speaker: – Merck
### she/her/hers3:30 PM – 4:00 PM ET
Analytical Procedures for Biotherapeutics Product Variants: Scientific and Practical ConsiderationLocation:Salon B, 5th FloorGovernment Speaker: – US Food and Drug Administration
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Jinhui Zhang, PhD – US Food and Drug Administration ### 603101###Government Speaker###Chemist###US Food and Drug Administration###Government Speaker: – US Food and Drug Administration
### 3:00 PM – 4:30 PM ET
Happy Hour Sponsored by B2S Life Sciences and Veloxity Labs
3:00 PM – 4:30 PM ET
Happy Hour Sponsored by B2S Life Sciences and Veloxity Labs
Location:Booth #308/310, Franklin Hall, 4th Floor
3:00 PM – 4:30 PM ET
Happy Hour Sponsored by Certara
3:00 PM – 4:30 PM ET
Happy Hour Sponsored by Certara
Location:Booth #215, Franklin Hall, 4th Floor
3:30 PM – 4:15 PM ET
AAPS Gene and Cell Therapy Products Community Membership Meeting
3:30 PM – 4:15 PM ET
AAPS Gene and Cell Therapy Products Community Membership MeetingLocation:Learning Lab, Franklin HallCommunity Leader: – Passage Bio
Community Leader: – Sangamo Therapeutics
Community Leader: – PPD, A ThermoFisher Company
Yan G. Ni, PhD – Passage Bio ### 803355###Community Leader###Executive Director###Passage Bio###Community Leader: – Passage Bio
### @@@ Yanmei Lu, PhD (she/her/hers) – Sangamo Therapeutics ### 821735###Community Leader###VP Biomarker and BioAnalysis###Sangamo Therapeutics###Community Leader: – Sangamo Therapeutics
### she/her/hers @@@ Catherine Vrentas, PhD – PPD, A ThermoFisher Company ### 1650329###Community Leader###Senior Research Scientist###PPD, A ThermoFisher Company###Community Leader: – PPD, A ThermoFisher Company
### 3:30 PM – 4:30 PM ET
Special Poster Collection
3:30 PM – 4:30 PM ET
Special Poster CollectionLocation:Poster Forum 1; Franklin HallPoster Collection Host: – Rutgers University
Patrick J. Sinko, Ph.D. – Rutgers University ### 602328###Poster Collection Host###Distinguished Professor###Rutgers University###Poster Collection Host: – Rutgers University
### 5:00 PM – 6:30 PM ET
Sustaining Partner Reception (by invitation only)
5:00 PM – 6:30 PM ET
Sustaining Partner Reception (by invitation only)Location:The Gallery, Hotel Main Lobby
- Tuesday, April 25, 2023
8:00 AM – 4:00 PM ET
Speaker Ready Room
8:00 AM – 4:00 PM ET
Speaker Ready Room
Location:Room 406, 4th Floor
8:00 AM – 5:00 PM ET
Registration Hours
8:00 AM – 5:00 PM ET
Registration Hours
Location:Franklin Hall Foyer, 4th Floor
9:00 AM – 9:30 AM ET
Prologue: Adeno-Associated Virus (AAV) Empty / Full Capsid Composition Assay
9:00 AM – 9:30 AM ET
Prologue: Adeno-associated Virus (AAV) Empty / Full Capsid Composition AssayLocation:Salon C, 5th FloorPrologue Speaker: – Bristol-Myers Squibb
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Surendran Rajendran, PhD (he/him/his) – Bristol-Myers Squibb ### 604748###Prologue Speaker###Senior Principal Scientist###Bristol-Myers Squibb###Prologue Speaker: – Bristol-Myers Squibb
### he/him/his9:00 AM – 9:30 AM ET
Prologue: Advances in Therapeutic Development Across Modalities
9:00 AM – 9:30 AM ET
Prologue: Advances in Therapeutic Development Across ModalitiesLocation:Salon E, 5th FloorPrologue Speaker: – Bristol-Myers Squibb Company
Advances in Therapeutic Development Across Modalities
Vibha Jawa, PhD – Bristol-Myers Squibb Company ### 1213957###Prologue Speaker###Executive Director Bioanalysis###Bristol-Myers Squibb Company###Prologue Speaker: – Bristol-Myers Squibb Company
### 9:30 AM – 11:00 AM ET
IP and Patents for Pharmaceutical Scientists & Entrepreneurs
9:30 AM – 11:00 AM ET
IP and Patents for Pharmaceutical Scientists & EntrepreneursLocation:Salon A, 5th FloorCareer Center Speaker: – Rakoczy Molino Mazzochi Siwik LLP (RMMS)
Career Center Speaker: – Rakoczy Molino Mazzochi Siwik LLP (RMMS)
Career Center Speaker: – Rakoczy Molino Mazzochi Siwik LLP (RMMS)
Career Development
Lara E. FitzSimmons, JD (she/her/hers) – Rakoczy Molino Mazzochi Siwik LLP (RMMS) ### 1876534###Career Center Speaker###Partner###Rakoczy Molino Mazzochi Siwik LLP (RMMS)###Career Center Speaker: – Rakoczy Molino Mazzochi Siwik LLP (RMMS)
### she/her/hers @@@ Paul J. Molino, JD (he/him/his) – Rakoczy Molino Mazzochi Siwik LLP (RMMS) ### 1876535###Career Center Speaker###Managing Partner###Rakoczy Molino Mazzochi Siwik LLP (RMMS)###Career Center Speaker: – Rakoczy Molino Mazzochi Siwik LLP (RMMS)
### he/him/his @@@ Thomas H. Ehrich, JD PhD (he/him/his) – Rakoczy Molino Mazzochi Siwik LLP (RMMS) ### 1876536###Career Center Speaker###Of Counsel###Rakoczy Molino Mazzochi Siwik LLP (RMMS)###Career Center Speaker: – Rakoczy Molino Mazzochi Siwik LLP (RMMS)
### he/him/his9:30 AM – 11:00 AM ET
Symposium: Next Generation Gene TherapiesTurbocharging Innovation in CMC: Driving Back to Rational Drug Design
9:30 AM – 11:00 AM ET
Symposium: Next Generation Gene TherapiesLocation:Salon C, 5th FloorTurbocharging Innovation in CMC: Driving Back to Rational Drug Design
Mohamed Hassanein, PhD – Pfizer ### 1328461###Moderator###Director Translational Medicine###Pfizer###Moderator: – Pfizer
### 9:30 AM – 10:00 AM ET
Assessing Immunogenicity for Expressed Biologics in Gene TherapyLocation:Salon C, 5th FloorTurbocharging Innovation in CMC: Driving Back to Rational Drug Design
Weiping Shao, PhD – AstraZeneca ### 1820687###Speaker###Sr. Group Director and Head of US GxP Laboratories###AstraZeneca###Speaker: – AstraZeneca
### 10:00 AM – 10:30 AM ET
Advanced Analytical Approaches for AAV Empty/full Capsid Characterization and QuantificationLocation:Salon C, 5th FloorTurbocharging Innovation in CMC: Driving Back to Rational Drug Design
Joseph Ong, PhD – Novartis ### 1945590###Speaker###Expert###Novartis###Speaker: – Novartis
### 10:30 AM – 11:00 AM ET
Applying in vitro Assays to Assess Immunogenicity Risk of Attribute LevelsLocation:Salon C, 5th FloorTurbocharging Innovation in CMC: Driving Back to Rational Drug Design
Swati Gupta, PhD (she/her/hers) – AbbVie ### 1820665###Speaker###Executive Director###AbbVie###Speaker: – AbbVie
### she/her/hers9:30 AM – 11:00 AM ET
Symposium: The Evolution of Cellular TherapyModerator: – Genentech, Inc.
Advances in Therapeutic Development Across Modalities
9:30 AM – 11:00 AM ET
Symposium: The Evolution of Cellular TherapyLocation:Salon E, 5th FloorModerator: – Genentech, Inc.
Advances in Therapeutic Development Across Modalities
Sebastian Guelman, PhD – Genentech, Inc. ### 1653891###Moderator###Senior Principal Scientist###Genentech, Inc.###Moderator: – Genentech, Inc.
### 9:30 AM – 10:00 AM ET
Potent CRSPR-Engineered Off-The-Shelf CAR-T and TCR-T Cells Evading Host T and NK Cell RejectionLocation:Salon E, 5th FloorSpeaker: – Intellia Therapeutics
Advances in Therapeutic Development Across Modalities
Yuanxin Xu, MD. PhD – Intellia Therapeutics ### 1836159###Speaker###Senior VP###Intellia Therapeutics###Speaker: – Intellia Therapeutics
### 10:00 AM – 10:30 AM ET
Allogeneic Cell Therapy as Transplant Medicine: Replacing or Supporting Cells in Patients That Are Dysfunctional or Absent Due to Degenerative Disease or Traumatic InjuryLocation:Salon E, 5th FloorSpeaker: – Lineage Cell Therapeutics, Inc.
Advances in Therapeutic Development Across Modalities
Brian M. Culley, BS, MS, MBA – Lineage Cell Therapeutics, Inc. ### 1836160###Speaker###Chief Executive Officer###Lineage Cell Therapeutics, Inc. ###Speaker: – Lineage Cell Therapeutics, Inc.
### 10:30 AM – 11:00 AM ET
γδ T Cells – An Unconventional T Cell Platform in Fight Against CancerLocation:Salon E, 5th FloorSpeaker: – Takeda Pharmaceutical Company Limited
Advances in Therapeutic Development Across Modalities
Kondala R. Atkuri, PhD (he/him/his) – Takeda Pharmaceutical Company Limited ### 1836162###Speaker###Director, Global Translational Lead###Takeda Pharmaceutical Company Limited###Speaker: – Takeda Pharmaceutical Company Limited
### he/him/his10:00 AM – 11:00 AM ET
Coffee Break in the Solution Center
10:00 AM – 11:00 AM ET
Coffee Break in the Solution CenterLocation:Franklin Hall, 4th Floor
10:00 AM – 11:00 AM ET
Hot Topic: Turbocharging Innovation in CMC - Driving Back to Rational Drug DesignHot Topic Moderator: – Mercer University
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
10:00 AM – 11:00 AM ET
Hot Topic: Turbocharging Innovation in CMC - Driving Back to Rational Drug Design Location:Salon B, 5th FloorHot Topic Moderator: – Mercer University
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Martin J. D'Souza, PhD (he/him/his) – Mercer University ### 604470###Hot Topic Moderator###Professor/director Of Graduate Programs And Co-Director Of The Center For Drug Delivery Research###Mercer University###Hot Topic Moderator: – Mercer University
### he/him/his10:00 AM – 10:30 AM ET
Relevance of Raw, Starting and Ancillary Materials for Advanced TherapiesLocation:Salon B, 5th FloorHot Topic Speaker: – United States Pharmacopeia
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Ben Clarke, PhD – United States Pharmacopeia ### 1919804###Hot Topic Speaker###Senior Scientist###United States Pharmacopeia###Hot Topic Speaker: – United States Pharmacopeia
### 10:30 AM – 11:00 AM ET
Buccal Drug Delivery System Design for Alternative Pain-free VaccinesLocation:Salon B, 5th FloorHot Topic Speaker: – Mercer University
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Martin J. D'Souza, PhD (he/him/his) – Mercer University ### 604470###Hot Topic Speaker###Professor/director Of Graduate Programs And Co-Director Of The Center For Drug Delivery Research###Mercer University###Hot Topic Speaker: – Mercer University
### he/him/his10:00 AM – 4:30 PM ET
Solution Center Hours & Poster Presentations
10:00 AM – 4:30 PM ET
Solution Center Hours & Poster PresentationsLocation:Franklin Hall, 4th Floor
10:15 AM – 11:00 AM ET
Ultrasensitive bioanalysis & Machine Learning: Case studies
10:15 AM – 11:00 AM ET
Ultrasensitive bioanalysis & Machine Learning: Case studiesLocation:Learning Lab, Franklin HallPartner Presentation Speaker: – Somru BioScience Inc
Partner Presentation Speaker: – Somru BioScience
Advances in Therapeutic Development Across Modalities
Mohammed Moin – Somru BioScience Inc ### 606389###Partner Presentation Speaker###CEO###Somru BioScience Inc###Partner Presentation Speaker: – Somru BioScience Inc
### @@@ Wildemar Carvalho, PhD (he/him/his) – Somru BioScience ### 1961681###Partner Presentation Speaker###Bioanalytical Principal Investigator###Somru BioScience###Partner Presentation Speaker: – Somru BioScience
### he/him/his11:00 AM – 12:30 PM ET
Light Lunch in the Solution Center
11:00 AM – 12:30 PM ET
Light Lunch in the Solution CenterLocation:Franklin Hall, 4th Floor
11:00 AM – 1:00 PM ET
Dedicated Solution Center Hours
11:00 AM – 1:00 PM ET
Dedicated Solution Center HoursLocation:Franklin Hall, 4th Floor
11:15 AM – 12:00 PM ET
Strategies for Measuring Oligonucleotides Using an Automated Microfluidic Immunoassay System
11:15 AM – 12:00 PM ET
Strategies for Measuring Oligonucleotides Using an Automated Microfluidic Immunoassay SystemLocation:Learning Lab, Franklin HallPartner Presentation Speaker: – Gyros Protein Technologies
Advances in Therapeutic Development Across Modalities
John Chappell, BSc CChem CSci FRSC – Gyros Protein Technologies ### 1138154###Partner Presentation Speaker###Sr Global Scientific Support###Gyros Protein Technologies###Partner Presentation Speaker: – Gyros Protein Technologies
### 12:00 PM – 1:00 PM ET
Career Conversation Hosted By resistanceBio
12:00 PM – 1:00 PM ET
Career Conversation Hosted by ResistancebioLocation:Booth #412, Career Center, Franklin HallCareer Development
12:15 PM – 1:00 PM ET
AAPS Bioanalytical Community Membership Meeting
12:15 PM – 1:00 PM ET
AAPS Bioanalytical Community Membership MeetingLocation:Learning Lab, Franklin HallCommunity Leader: – PPD Laboratories
Shoshana Oberstein – PPD Laboratories ### 849030###Community Leader###Senior Group Leader###PPD Laboratories###Community Leader: – PPD Laboratories
### 12:30 PM – 1:30 PM ET
Special Poster Collection
12:30 PM – 1:30 PM ET
Special Poster CollectionLocation:Poster Forum 1; Franklin HallPoster Collection Host: – PPD
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Heather A. Myler, PhD – PPD ### 571991###Poster Collection Host###Executive Director Scientific Affairs###PPD###Poster Collection Host: – PPD
### 1:00 PM – 2:00 PM ET
Keynote: Analytical Challenges with Gene Editing in In vivo and Ex vivo Gene Therapy
1:00 PM – 2:00 PM ET
Keynote: Analytical Challenges with Gene Editing in In vivo and Ex vivo Gene TherapyLocation:Salon C, 5th FloorKeynote Speaker: – Sangamo Thearpeutics
Moderator: – Pfizer
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Michael S. Molony, MA – Sangamo Thearpeutics ### 1880513###Keynote Speaker###Vice President, Analytical Development###Sangamo Thearpeutics###Keynote Speaker: – Sangamo Thearpeutics
### @@@ Mohamed Hassanein, PhD – Pfizer ### 1328461###Moderator###Director Translational Medicine###Pfizer###Moderator: – Pfizer
### 1:00 PM – 2:00 PM ET
Keynote: Evolution of Cell Therapy
1:00 PM – 2:00 PM ET
Keynote: Evolution of Cell TherapyLocation:Salon E, 5th FloorKeynote Speaker: – GentiBio
Moderator: – Genentech, Inc.
Advances in Therapeutic Development Across Modalities
Karen Mueller, PharmD, MS – GentiBio ### 1836163###Keynote Speaker###Vice President of Translational Science###GentiBio###Keynote Speaker: – GentiBio
### @@@ Katie F. Maass, Ph.D. (she/her/hers) – Genentech, Inc. ### 847055###Moderator###Senior Principal Scientist, Clinical Pharmacology###Genentech, Inc.###Moderator: – Genentech, Inc.
### she/her/hers1:30 PM – 2:15 PM ET
Evaluation of Commercial HCP ELISA Kits by HRMS
1:30 PM – 2:15 PM ET
Evaluation of Commercial HCP ELISA Kits by HRMSLocation:Learning Lab, Franklin HallPartner Presentation Speaker: – Prolytix
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
John Maddalena, MEd, PhD – Prolytix ### 1940671###Partner Presentation Speaker###Vice President, Scientific Strategy###Prolytix###Partner Presentation Speaker: – Prolytix
### 2:00 PM – 2:30 PM ET
Coffee Break in the Solution Center
2:00 PM – 2:30 PM ET
Coffee Break in the Solution CenterLocation:Franklin Hall, 4th Floor
2:30 PM – 3:00 PM ET
AAPS Biomarkers and Precision Medicine Community Membership Meeting
2:30 PM – 3:00 PM ET
AAPS Biomarkers and Precision Medicine Community Membership MeetingLocation:Learning Lab, Franklin HallCommunity Leader: – BioAgilytix Labs, LLC.
Amanda L. Hays, Ph.D. – BioAgilytix Labs, LLC. ### 1529523###Community Leader###Scientific Officer###BioAgilytix Labs, LLC.###Community Leader: – BioAgilytix Labs, LLC.
### 2:30 PM – 3:30 PM ET
Rapid Fire: Next Generation Gene TherapiesRapid Fire Moderator: – Merck & Co., Inc
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
2:30 PM – 3:30 PM ET
Rapid Fire: Next Generation Gene TherapiesLocation:Salon C, 5th FloorRapid Fire Moderator: – Merck & Co., Inc
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Xiujuan Jia, PhD – Merck & Co., Inc ### 1821225###Rapid Fire Moderator###Associate Principal Scientist###Merck & Co., Inc###Rapid Fire Moderator: – Merck & Co., Inc
### 2:30 PM – 2:45 PM ET
Enabling Online determination of Size-dependent RNA Encapsulation of Lipid NanoparticlesLocation:Salon C, 5th FloorRapid Fire Speaker: – Merck & Co., Inc
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Xiujuan Jia, PhD – Merck & Co., Inc ### 1821225###Rapid Fire Speaker###Associate Principal Scientist###Merck & Co., Inc###Rapid Fire Speaker: – Merck & Co., Inc
### 2:45 PM – 3:00 PM ET
Elucidation of Reversible-Self Association Interface in Fusion Proteins Using HDX-MS and Computational ModelingLocation:Salon C, 5th FloorRapid Fire Speaker: – AbbVie Inc.
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Ehab Moussa, Ph.D. – AbbVie Inc. ### 1821226###Rapid Fire Speaker###Principal Research Scientist###AbbVie Inc.###Rapid Fire Speaker: – AbbVie Inc.
### 3:00 PM – 3:15 PM ET
Development of Novel BiologicsLocation:Salon C, 5th FloorRapid Fire Speaker: – Shilpa Pharma Lifesciences Limited
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Harshawardhan Bal, PhD (he/him/his) – Shilpa Pharma Lifesciences Limited ### 1820684###Rapid Fire Speaker###President###Shilpa Pharma Lifesciences Limited###Rapid Fire Speaker: – Shilpa Pharma Lifesciences Limited
### he/him/his3:15 PM – 3:30 PM ET
CARTs - A New Vehicle for Nucleic Acid Delivery With a Unique Controllable Release MechanismLocation:Salon C, 5th FloorRapid Fire Speaker: – Evonik Canada Inc.
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Zahra Merchant, PhD (she/her/hers) – Evonik Canada Inc. ### 1792340###Rapid Fire Speaker###Senior Scientist###Evonik Canada Inc.###Rapid Fire Speaker: – Evonik Canada Inc.
### she/her/hers2:30 PM – 3:30 PM ET
Rapid Fire: The Evolution of Cellular TherapyRapid Fire Moderator: – Takeda Pharmaceuticals
Advances in Therapeutic Development Across Modalities
2:30 PM – 3:30 PM ET
Rapid Fire: The Evolution of Cellular TherapyLocation:Salon E, 5th FloorRapid Fire Moderator: – Takeda Pharmaceuticals
Advances in Therapeutic Development Across Modalities
Christopher J. Beaver, PhD (he/him/his) – Takeda Pharmaceuticals ### 1853016###Rapid Fire Moderator###Head Cell Therapy Clinical Immunogenicity###Takeda Pharmaceuticals###Rapid Fire Moderator: – Takeda Pharmaceuticals
### he/him/his2:30 PM – 2:45 PM ET
Clinical Relevance of Immunogenicity for Cell TherapiesLocation:Salon E, 5th FloorRapid Fire Speaker: – Merck & Co., Inc.
Advances in Therapeutic Development Across Modalities
Weifeng Xu, PhD – Merck & Co., Inc. ### 1010838###Rapid Fire Speaker###Director###Merck & Co., Inc.###Rapid Fire Speaker: – Merck & Co., Inc.
### 2:45 PM – 3:00 PM ET
Extending Blood Stability for Clinical ELISpotLocation:Salon E, 5th FloorRapid Fire Speaker: – Janssen R&D
Advances in Therapeutic Development Across Modalities
Xinyuan Li, PhD – Janssen R&D ### 1820668###Rapid Fire Speaker###Senior Scientist###Janssen R&D###Rapid Fire Speaker: – Janssen R&D
### 3:00 PM – 3:15 PM ET
A Robust Adoptive Cell Therapy Phenotyping Panel for Assessing Cerebrospinal Fluid During and After Neurotoxicity by Flow CytometryLocation:Salon E, 5th FloorRapid Fire Speaker: – Labcorp Drug Development
Advances in Therapeutic Development Across Modalities
Jane E. Craig, PhD (she/her/hers) – Labcorp Drug Development ### 1932111###Rapid Fire Speaker###Validation Scientist###Labcorp Drug Development###Rapid Fire Speaker: – Labcorp Drug Development
### she/her/hers3:15 PM – 3:30 PM ET
An Evolution of CARs – Autologous vs Allogeneic StrategiesLocation:Salon E, 5th FloorRapid Fire Speaker: – Labcorp Drug Development
Advances in Therapeutic Development Across Modalities
Keith Rennier, PhD – Labcorp Drug Development ### 1853017###Rapid Fire Speaker###Lead Scientist ###Labcorp Drug Development###Rapid Fire Speaker: – Labcorp Drug Development
### 3:00 PM – 4:00 PM ET
Hot Topic: Intro to Biomarkers: An Expert Panel DiscussionHot Topic Moderator: – BioAgilytix Labs, LLC.
Hot Topic Speaker: – Pharmacadence
Hot Topic Speaker: – Passage Bio
Hot Topic Speaker: – SunPharma Advanced Research Center
Government Speaker: – U.S. Food and Drug Administration
Hot Topic Speaker: – BioAgilytix Labs, LLC.
Advances in Therapeutic Development Across Modalities
3:00 PM – 4:00 PM ET
Hot Topic: Intro to Biomarkers: An Expert Panel DiscussionLocation:Salon B, 5th FloorHot Topic Moderator: – BioAgilytix Labs, LLC.
Hot Topic Speaker: – Pharmacadence
Hot Topic Speaker: – Passage Bio
Hot Topic Speaker: – SunPharma Advanced Research Center
Government Speaker: – U.S. Food and Drug Administration
Hot Topic Speaker: – BioAgilytix Labs, LLC.
Advances in Therapeutic Development Across Modalities
Amanda L. Hays, Ph.D. – BioAgilytix Labs, LLC. ### 1529523###Hot Topic Moderator###Scientific Officer###BioAgilytix Labs, LLC.###Hot Topic Moderator: – BioAgilytix Labs, LLC.
### @@@ Carmen Fernandez-Metzler, PhD – Pharmacadence ### 567498###Hot Topic Speaker###President###Pharmacadence###Hot Topic Speaker: – Pharmacadence
### @@@ Yan G. Ni, PhD – Passage Bio ### 803355###Hot Topic Speaker###Executive Director###Passage Bio###Hot Topic Speaker: – Passage Bio
### @@@ Steven P. Piccoli, PhD – SunPharma Advanced Research Center ### 1010784###Hot Topic Speaker###Head, Clinical Biomarkers and Diagnostics###SunPharma Advanced Research Center###Hot Topic Speaker: – SunPharma Advanced Research Center
### @@@ Abbas Bandukwala, M.S. – U.S. Food and Drug Administration ### 1055951###Government Speaker###Science Policy Analyst Biomarker Qualification Program###U.S. Food and Drug Administration###Government Speaker: – U.S. Food and Drug Administration
### @@@ Amanda L. Hays, Ph.D. – BioAgilytix Labs, LLC. ### 1529523###Hot Topic Speaker###Scientific Officer###BioAgilytix Labs, LLC.###Hot Topic Speaker: – BioAgilytix Labs, LLC.
### 3:30 PM – 4:30 PM ET
Special Poster Collection
3:30 PM – 4:30 PM ET
Special Poster CollectionLocation:Poster Forum 1; Franklin HallPoster Collection Host: – Genentech, Inc.
Katie F. Maass, Ph.D. (she/her/hers) – Genentech, Inc. ### 847055###Poster Collection Host###Senior Principal Scientist, Clinical Pharmacology###Genentech, Inc.###Poster Collection Host: – Genentech, Inc.
### she/her/hers4:30 PM – 8:00 PM ET
Exhibitor Move-Out
4:30 PM – 8:00 PM ET
Exhibitor Move-Out
Location:Franklin Hall, 4th Floor
5:00 PM – 6:30 PM ET
Women in Biotech Reception
5:00 PM – 6:30 PM ET
Women in Biotech ReceptionLocation:Rooms 411/412, 4th Floor
- Wednesday, April 26, 2023
8:00 AM – 2:00 PM ET
Registration Hours
8:00 AM – 2:00 PM ET
Registration Hours
Location:Franklin Hall Foyer, 4th Floor
8:00 AM – 2:30 PM ET
Speaker Ready Room
8:00 AM – 2:30 PM ET
Speaker Ready Room
Location:Room 406, 4th Floor
9:00 AM – 9:30 AM ET
Prologue: Challenges in Development of Novel Biologics
9:00 AM – 9:30 AM ET
Prologue: Challenges in Development of Novel BiologicsLocation:Salon D, 5th FloorPrologue Speaker: – Merck & Co. Inc
Advances in Therapeutic Development Across Modalities
Jainik PANCHAL, PhD (he/him/his) – Merck & Co. Inc ### 1767723###Prologue Speaker###Principal Scientist###Merck & Co. Inc###Prologue Speaker: – Merck & Co. Inc
### he/him/his9:00 AM – 9:30 AM ET
Prologue: CMC Considerations to Improve Complex Manufacturing for Autologous CAR-T Products
9:00 AM – 9:30 AM ET
Prologue: CMC Considerations to Improve Complex Manufacturing for Autologous CAR-T ProductsLocation:Salon C, 5th FloorTurbocharging Innovation in CMC: Driving Back to Rational Drug Design
Mandy Xie, PhD – BMS ### 1820682###Prologue Speaker###Executive Director###BMS###Prologue Speaker: – BMS
### 9:30 AM – 10:30 AM ET
Coffee Break
9:30 AM – 10:30 AM ET
Coffee Break Location:Salon E Foyer, 5th Floor
9:30 AM – 11:00 AM ET
Symposium: Explosion of Cell Therapy Beyond CAR-T Moderator: – Sangamo Therapeutics
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
9:30 AM – 11:00 AM ET
Symposium: Explosion of Cell Therapy Beyond CAR-T Location:Salon C, 5th FloorModerator: – Sangamo Therapeutics
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Savita Nair, PhD (she/her/hers) – Sangamo Therapeutics ### 1880519###Moderator###Associate Director###Sangamo Therapeutics###Moderator: – Sangamo Therapeutics
### she/her/hers9:30 AM – 10:00 AM ET
Leveraging Reagents from Cell-Therapy Process-Development to Support CAR-T BioanalyticalLocation:Salon C, 5th FloorTurbocharging Innovation in CMC: Driving Back to Rational Drug Design
Jiangbo Tang, PhD (he/him/his) – BMS ### 1820689###Speaker###Senior Scientist###BMS###Speaker: – BMS
### he/him/his10:00 AM – 10:30 AM ET
Phase-Appropriate CMC Strategies for Cell Therapy ProductsLocation:Salon C, 5th FloorSpeaker: – National Institutes of Health
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Shekhar Jha, PhD, RAC – National Institutes of Health ### 1921713###Speaker###Scientific Program Manager###National Institutes of Health###Speaker: – National Institutes of Health
### 10:30 AM – 11:00 AM ET
Process Characterization in Cell Therapy: Key to Unlock CAR-T Manufacturing ChallengesLocation:Salon C, 5th FloorTurbocharging Innovation in CMC: Driving Back to Rational Drug Design
Tuhin Bhowmik, PhD (he/him/his) – Arcellx ### 605059###Speaker###Associate Director###Arcellx###Speaker: – Arcellx
### he/him/his9:30 AM – 11:00 AM ET
Symposium: Innovation Based on Traditional ApproachesAdvances in Therapeutic Development Across Modalities
9:30 AM – 11:00 AM ET
Symposium: Innovation Based on Traditional ApproachesLocation:Salon D, 5th FloorAdvances in Therapeutic Development Across Modalities
Seema Kumar, PhD (she/her/hers) – EMD Serono ### 1311047###Moderator###Director and Head of Clinical Bioanalytical Sciences###EMD Serono###Moderator: – EMD Serono
### she/her/hers9:30 AM – 10:00 AM ET
A Renaissance of Antibody Drug Conjugates (ADCs) for CancerLocation:Salon D, 5th FloorSpeaker: – ImmunoGen, Inc.
Advances in Therapeutic Development Across Modalities
Beata Sweryda-Krawiec, PhD (she/her/hers) – ImmunoGen, Inc. ### 862029###Speaker###Associate Director###ImmunoGen, Inc.###Speaker: – ImmunoGen, Inc.
### she/her/hers10:00 AM – 10:30 AM ET
Preclinical Discovery and Development Strategies Developing Heterobifunctional Targeted Protein DegradersLocation:Salon D, 5th FloorAdvances in Therapeutic Development Across Modalities
Steven W. Louie, M.S. (he/him/his) – Novartis ### 1820688###Speaker###Sr. Principal Scientist###Novartis###Speaker: – Novartis
### he/him/his10:30 AM – 11:00 AM ET
Immunogenicity of a Virus-Like Particle Containing an Innate Immune AgonistLocation:Salon D, 5th FloorSpeaker: – Regeneron Pharmaceuticals
Advances in Therapeutic Development Across Modalities
Jenny Valentine, PhD – Regeneron Pharmaceuticals ### 1820680###Speaker###Principal Scientist###Regeneron Pharmaceuticals###Speaker: – Regeneron Pharmaceuticals
### 10:00 AM – 11:00 AM ET
Hot Topic: Bioanalytical Challenges and Strategies for Novel Drug Modalities
10:00 AM – 11:00 AM ET
Hot Topic: Bioanalytical Challenges and Strategies for Novel Drug ModalitiesLocation:Salon B, 5th FloorHot Topic Speaker: – PPD, part of Thermo Fisher Scientific
Hot Topic Speaker: – Genentech, Inc.
Hot Topic Speaker: – Moderna
Hot Topic Moderator: – Moderna Therapeutics
Hot Topic Speaker: – Moderna
Advances in Therapeutic Development Across Modalities
Eric F. Tewalt, PhD – PPD, part of Thermo Fisher Scientific ### 1820669###Hot Topic Speaker###Director###PPD, part of Thermo Fisher Scientific###Hot Topic Speaker: – PPD, part of Thermo Fisher Scientific
### @@@ Sebastian Guelman, PhD – Genentech, Inc. ### 1653891###Hot Topic Speaker###Senior Principal Scientist###Genentech, Inc.###Hot Topic Speaker: – Genentech, Inc.
### @@@ Jason DelCarpini – Moderna ### 1820671###Hot Topic Speaker###Associate Director###Moderna###Hot Topic Speaker: – Moderna
### @@@ Jason Pennucci (he/him/his) – Moderna Therapeutics ### 1853019###Hot Topic Moderator###Director###Moderna Therapeutics###Hot Topic Moderator: – Moderna Therapeutics
### he/him/his @@@ Ling Morgan, PhD – Moderna ### 1944801###Hot Topic Speaker###Director###Moderna###Hot Topic Speaker: – Moderna
### 12:30 PM – 1:30 PM ET
Keynote: CMC Challenges with Cell and Gene therapies
12:30 PM – 1:30 PM ET
Keynote: CMC Challenges with Cell and Gene therapiesLocation:Salon C, 5th FloorKeynote Speaker: – Passage Bio
Moderator: – Pfizer
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Nripen Singh, PhD – Passage Bio ### 1821230###Keynote Speaker###Executive Director###Passage Bio###Keynote Speaker: – Passage Bio
### @@@ Mohamed Hassanein, PhD – Pfizer ### 1328461###Moderator###Director Translational Medicine###Pfizer###Moderator: – Pfizer
### 12:30 PM – 1:30 PM ET
Keynote: Mechanistic Modeling Approaches to Characterize the Clinical Pharmacology of New Therapeutic Modalities
12:30 PM – 1:30 PM ET
Keynote: Mechanistic Modeling Approaches to Characterize the Clinical Pharmacology of New Therapeutic ModalitiesLocation:Salon D, 5th FloorKeynote Speaker: – DSI
Moderator: – Daiichi Sankyo
Advances in Therapeutic Development Across Modalities
Malaz Abutarif, PhD – DSI ### 1820753###Keynote Speaker###Vice President, Head of Quantitative and Clinical Pharmacology###DSI###Keynote Speaker: – DSI
### @@@ Xiaohui Xu, PhD (she/her/hers) – Daiichi Sankyo ### 1853018###Moderator###Director of Clinical Bioanalysis###Daiichi Sankyo###Moderator: – Daiichi Sankyo
### she/her/hers2:00 PM – 3:00 PM ET
Hot Topic: Turbocharging Innovation in CMC - Driving Back to Rational Drug Design Hot Topic Moderator: – Merck & Co., Inc.
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
2:00 PM – 3:00 PM ET
Hot Topic: Turbocharging Innovation in CMC - Driving Back to Rational Drug Design Location:Salon B, 5th FloorHot Topic Moderator: – Merck & Co., Inc.
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Yongchao Su, Ph.D. – Merck & Co., Inc. ### 846667###Hot Topic Moderator###Principal Scientist###Merck & Co., Inc.###Hot Topic Moderator: – Merck & Co., Inc.
### 2:00 PM – 2:30 PM ET
CMC Strategy for mRNA-LNP Vaccines: Challenges and Regulatory ConsiderationsLocation:Salon B, 5th FloorHot Topic Speaker: – Pfizer, Inc.
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Rich Pelt – Pfizer, Inc. ### 1927722###Hot Topic Speaker###Senior Director, Global Regulatory Sciences, Vaccines CMC###Pfizer, Inc.###Hot Topic Speaker: – Pfizer, Inc.
### 2:30 PM – 3:00 PM ET
Enabling mRNA-LNP Drug Products Through Advanced Engineering and CharacterizationLocation:Salon B, 5th FloorHot Topic Speaker: – Moderna Inc.
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Mark Brader, PhD – Moderna Inc. ### 602336###Hot Topic Speaker###Research Fellow###Moderna Inc.###Hot Topic Speaker: – Moderna Inc.
### 2:00 PM – 3:00 PM ET
Rapid Fire: Explosion of Cell Therapy Beyond CAR-T Rapid Fire Moderator: – Arcellx
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
2:00 PM – 3:00 PM ET
Rapid Fire: Explosion of Cell Therapy Beyond CAR-T Location:Salon C, 5th FloorRapid Fire Moderator: – Arcellx
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Tuhin Bhowmik, PhD (he/him/his) – Arcellx ### 605059###Rapid Fire Moderator###Associate Director###Arcellx###Rapid Fire Moderator: – Arcellx
### he/him/his2:00 PM – 2:15 PM ET
Truculture as an Alternative Method to Monitor Recall ResponseLocation:Salon C, 5th FloorRapid Fire Speaker: – University at Buffalo
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Kirk Hofman, MS – University at Buffalo ### 1854283###Rapid Fire Speaker###PhD Candidate###University at Buffalo###Rapid Fire Speaker: – University at Buffalo
### 2:30 PM – 2:45 PM ET
Process Development Challenges in TREG Cell TherapiesLocation:Salon C, 5th FloorRapid Fire Speaker: – Sangamo Therapeutics, Inc
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Nikul Patel, PhD – Sangamo Therapeutics, Inc ### 1880518###Rapid Fire Speaker###Director of Cell Therapy, Technical Development###Sangamo Therapeutics, Inc###Rapid Fire Speaker: – Sangamo Therapeutics, Inc
### 2:45 PM – 3:00 PM ET
Next Generation Potency Assays for Cell TherapiesLocation:Salon C, 5th FloorRapid Fire Speaker: – Sangamo Therapeutics
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Savita Nair, PhD (she/her/hers) – Sangamo Therapeutics ### 1880519###Rapid Fire Speaker###Associate Director###Sangamo Therapeutics###Rapid Fire Speaker: – Sangamo Therapeutics
### she/her/hers2:00 PM – 3:00 PM ET
Rapid Fire: Innovation Based on Traditional ApproachesAdvances in Therapeutic Development Across Modalities
2:00 PM – 3:00 PM ET
Rapid Fire: Innovation Based on Traditional ApproachesLocation:Salon D, 5th FloorAdvances in Therapeutic Development Across Modalities
2:00 PM – 2:15 PM ET
Comparing Three Distinct Radioiodination Methods for in vivo BiodistributionLocation:Salon D, 5th FloorRapid Fire Speaker: – Genentech, Inc.
Advances in Therapeutic Development Across Modalities
Alecia T. Dent, PhD (she/her/hers) – Genentech, Inc. ### 1767302###Rapid Fire Speaker###Scientist###Genentech, Inc.###Rapid Fire Speaker: – Genentech, Inc.
### she/her/hers2:15 PM – 2:30 PM ET
A Streamlined Workflow to Assess the Immunogenicity Risk of BiotherapeuticsLocation:Salon D, 5th FloorRapid Fire Speaker: – EMD Serono, Inc.
Advances in Therapeutic Development Across Modalities
Rita Martello, PhD – EMD Serono, Inc. ### 1820666###Rapid Fire Speaker###Associate Director###EMD Serono, Inc.###Rapid Fire Speaker: – EMD Serono, Inc.
### 2:30 PM – 2:45 PM ET
Modeling Strategy to Guide the Development of Targeted Bispecific AntibodyLocation:Salon D, 5th FloorRapid Fire Speaker: – Genentech - South San Francisco, CA
Advances in Therapeutic Development Across Modalities
Kazi Tasneem, PhD – Genentech - South San Francisco, CA ### 1820675###Rapid Fire Speaker###Senior Scientist###Genentech - South San Francisco, CA###Rapid Fire Speaker: – Genentech - South San Francisco, CA
### 2:45 PM – 3:00 PM ET
Challenges in Developing Robust Hybridization ImmunoassaysLocation:Salon D, 5th FloorRapid Fire Speaker: – Bioagilytix
Advances in Therapeutic Development Across Modalities
Liz Nolff, MS (she/her/hers) – Bioagilytix ### 1820690###Rapid Fire Speaker###Manager II###Bioagilytix###Rapid Fire Speaker: – Bioagilytix
### she/her/hers3:15 PM – 4:30 PM ET
Closing Plenary with Dr. John QuackenbushPlenary Speaker: – Harvard T.H. Chan School of Public Health
3:15 PM – 4:30 PM ET
Closing Plenary with Dr. John QuackenbushLocation:Salon E, 5th FloorPlenary Speaker: – Harvard T.H. Chan School of Public Health
John Quackenbush, Ph.D. – Harvard T.H. Chan School of Public Health ### 1890811###Plenary Speaker###Professor of Computational Biology and Bioinformatics and Chair of the Department of Biostatistics###Harvard T.H. Chan School of Public Health###Plenary Speaker: – Harvard T.H. Chan School of Public Health
###
