- 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
