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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

Favorite

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

Favorite

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 Biologics

Location:Salon D, 5th Floor

Prologue Speaker: Jainik PANCHAL, PhD (he/him/his) – Merck & Co. Inc

Advances in Therapeutic Development Across Modalities

Favorite

Jainik PANCHAL, PhD (he/him/his) – Merck & Co. Inc ### 1767723###Prologue Speaker###Principal Scientist###Merck & Co. Inc###
Prologue Speaker: Jainik PANCHAL, PhD (he/him/his) – Merck & Co. Inc
### he/him/his

9:00 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 Products

Location:Salon C, 5th Floor

Prologue Speaker: Mandy Xie, PhD – BMS

Turbocharging Innovation in CMC: Driving Back to Rational Drug Design

Favorite

Mandy Xie, PhD – BMS ### 1820682###Prologue Speaker###Executive Director###BMS###
Prologue Speaker: Mandy Xie, PhD – 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

Favorite

9:30 AM – 11:00 AM ET
Symposium: Explosion of Cell Therapy Beyond CAR-T
Moderator: Savita Nair, PhD (she/her/hers) – 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 Floor

Moderator: Savita Nair, PhD (she/her/hers) – Sangamo Therapeutics

Turbocharging Innovation in CMC: Driving Back to Rational Drug Design

Favorite

Savita Nair, PhD (she/her/hers) – Sangamo Therapeutics ### 1880519###Moderator###Associate Director###Sangamo Therapeutics###
Moderator: Savita Nair, PhD (she/her/hers) – Sangamo Therapeutics
### she/her/hers

9:30 AM – 10:00 AM ET

Leveraging Reagents from Cell-Therapy Process-Development to Support CAR-T Bioanalytical

Location:Salon C, 5th Floor

Speaker: Jiangbo Tang, PhD (he/him/his) – BMS

Turbocharging Innovation in CMC: Driving Back to Rational Drug Design

Favorite

Jiangbo Tang, PhD (he/him/his) – BMS ### 1820689###Speaker###Senior Scientist###BMS###
Speaker: Jiangbo Tang, PhD (he/him/his) – BMS
### he/him/his

10:00 AM – 10:30 AM ET

Phase-Appropriate CMC Strategies for Cell Therapy Products

Location:Salon C, 5th Floor

Speaker: Shekhar Jha, PhD, RAC – National Institutes of Health

Turbocharging Innovation in CMC: Driving Back to Rational Drug Design

Favorite

Shekhar Jha, PhD, RAC – National Institutes of Health ### 1921713###Speaker###Scientific Program Manager###National Institutes of Health###
Speaker: Shekhar Jha, PhD, RAC – National Institutes of Health
###

10:30 AM – 11:00 AM ET

Process Characterization in Cell Therapy: Key to Unlock CAR-T Manufacturing Challenges

Location:Salon C, 5th Floor

Speaker: Tuhin Bhowmik, PhD (he/him/his) – Arcellx

Turbocharging Innovation in CMC: Driving Back to Rational Drug Design

Favorite

Tuhin Bhowmik, PhD (he/him/his) – Arcellx ### 605059###Speaker###Associate Director###Arcellx###
Speaker: Tuhin Bhowmik, PhD (he/him/his) – Arcellx
### he/him/his

9:30 AM – 11:00 AM ET
Symposium: Innovation Based on Traditional Approaches
Moderator: Seema Kumar, PhD (she/her/hers) – EMD Serono
Advances in Therapeutic Development Across Modalities

9:30 AM – 11:00 AM ET

Symposium: Innovation Based on Traditional Approaches

Location:Salon D, 5th Floor

Moderator: Seema Kumar, PhD (she/her/hers) – EMD Serono

Advances in Therapeutic Development Across Modalities

Favorite

Seema Kumar, PhD (she/her/hers) – EMD Serono ### 1311047###Moderator###Director and Head of Clinical Bioanalytical Sciences###EMD Serono###
Moderator: Seema Kumar, PhD (she/her/hers) – EMD Serono
### she/her/hers

9:30 AM – 10:00 AM ET

A Renaissance of Antibody Drug Conjugates (ADCs) for Cancer

Location:Salon D, 5th Floor

Speaker: Beata Sweryda-Krawiec, PhD (she/her/hers) – ImmunoGen, Inc.

Advances in Therapeutic Development Across Modalities

Favorite

Beata Sweryda-Krawiec, PhD (she/her/hers) – ImmunoGen, Inc. ### 862029###Speaker###Associate Director###ImmunoGen, Inc.###
Speaker: Beata Sweryda-Krawiec, PhD (she/her/hers) – ImmunoGen, Inc.
### she/her/hers

10:00 AM – 10:30 AM ET

Preclinical Discovery and Development Strategies Developing Heterobifunctional Targeted Protein Degraders

Location:Salon D, 5th Floor

Speaker: Steven W. Louie, M.S. (he/him/his) – Novartis

Advances in Therapeutic Development Across Modalities

Favorite

Steven W. Louie, M.S. (he/him/his) – Novartis ### 1820688###Speaker###Sr. Principal Scientist###Novartis###
Speaker: Steven W. Louie, M.S. (he/him/his) – Novartis
### he/him/his

10:30 AM – 11:00 AM ET

Immunogenicity of a Virus-Like Particle Containing an Innate Immune Agonist

Location:Salon D, 5th Floor

Speaker: Jenny Valentine, PhD – Regeneron Pharmaceuticals

Advances in Therapeutic Development Across Modalities

Favorite

Jenny Valentine, PhD – Regeneron Pharmaceuticals ### 1820680###Speaker###Principal Scientist###Regeneron Pharmaceuticals###
Speaker: Jenny Valentine, PhD – 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 Modalities

Location:Salon B, 5th Floor

Hot Topic Speaker: Eric F. Tewalt, PhD – PPD, part of Thermo Fisher Scientific

Hot Topic Speaker: Sebastian Guelman, PhD – Genentech, Inc.

Hot Topic Speaker: Jason DelCarpini – Moderna

Hot Topic Moderator: Jason Pennucci (he/him/his) – Moderna Therapeutics

Hot Topic Speaker: Ling Morgan, PhD – Moderna

Advances in Therapeutic Development Across Modalities

Favorite

Eric F. Tewalt, PhD – PPD, part of Thermo Fisher Scientific ### 1820669###Hot Topic Speaker###Director###PPD, part of Thermo Fisher Scientific###
Hot Topic Speaker: Eric F. Tewalt, PhD – PPD, part of Thermo Fisher Scientific
### @@@ Sebastian Guelman, PhD – Genentech, Inc. ### 1653891###Hot Topic Speaker###Senior Principal Scientist###Genentech, Inc.###
Hot Topic Speaker: Sebastian Guelman, PhD – Genentech, Inc.
### @@@ Jason DelCarpini – Moderna ### 1820671###Hot Topic Speaker###Associate Director###Moderna###
Hot Topic Speaker: Jason DelCarpini – Moderna
### @@@ Jason Pennucci (he/him/his) – Moderna Therapeutics ### 1853019###Hot Topic Moderator###Director###Moderna Therapeutics###
Hot Topic Moderator: Jason Pennucci (he/him/his) – Moderna Therapeutics
### he/him/his @@@ Ling Morgan, PhD – Moderna ### 1944801###Hot Topic Speaker###Director###Moderna###
Hot Topic Speaker: Ling Morgan, PhD – 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 therapies

Location:Salon C, 5th Floor

Keynote Speaker: Nripen Singh, PhD – Passage Bio

Moderator: Mohamed Hassanein, PhD – Pfizer

Turbocharging Innovation in CMC: Driving Back to Rational Drug Design

Favorite

Nripen Singh, PhD – Passage Bio ### 1821230###Keynote Speaker###Executive Director###Passage Bio###
Keynote Speaker: Nripen Singh, PhD – Passage Bio
### @@@ Mohamed Hassanein, PhD – Pfizer ### 1328461###Moderator###Director Translational Medicine###Pfizer###
Moderator: Mohamed Hassanein, PhD – 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 Modalities

Location:Salon D, 5th Floor

Keynote Speaker: Malaz Abutarif, PhD – DSI

Moderator: Xiaohui Xu, PhD (she/her/hers) – Daiichi Sankyo

Advances in Therapeutic Development Across Modalities

Favorite

Malaz Abutarif, PhD – DSI ### 1820753###Keynote Speaker###Vice President, Head of Quantitative and Clinical Pharmacology###DSI###
Keynote Speaker: Malaz Abutarif, PhD – DSI
### @@@ Xiaohui Xu, PhD (she/her/hers) – Daiichi Sankyo ### 1853018###Moderator###Director of Clinical Bioanalysis###Daiichi Sankyo###
Moderator: Xiaohui Xu, PhD (she/her/hers) – Daiichi Sankyo
### she/her/hers

2:00 PM – 3:00 PM ET
Hot Topic: Turbocharging Innovation in CMC - Driving Back to Rational Drug Design
Hot Topic Moderator: Yongchao Su, Ph.D. – 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 Floor

Hot Topic Moderator: Yongchao Su, Ph.D. – Merck & Co., Inc.

Turbocharging Innovation in CMC: Driving Back to Rational Drug Design

Favorite

Yongchao Su, Ph.D. – Merck & Co., Inc. ### 846667###Hot Topic Moderator###Principal Scientist###Merck & Co., Inc.###
Hot Topic Moderator: Yongchao Su, Ph.D. – Merck & Co., Inc.
###

2:00 PM – 2:30 PM ET

CMC Strategy for mRNA-LNP Vaccines: Challenges and Regulatory Considerations

Location:Salon B, 5th Floor

Hot Topic Speaker: Rich Pelt – Pfizer, Inc.

Turbocharging Innovation in CMC: Driving Back to Rational Drug Design

Favorite

Rich Pelt – Pfizer, Inc. ### 1927722###Hot Topic Speaker###Senior Director, Global Regulatory Sciences, Vaccines CMC###Pfizer, Inc.###
Hot Topic Speaker: Rich Pelt – Pfizer, Inc.
###

2:30 PM – 3:00 PM ET

Enabling mRNA-LNP Drug Products Through Advanced Engineering and Characterization

Location:Salon B, 5th Floor

Hot Topic Speaker: Mark Brader, PhD – Moderna Inc.

Turbocharging Innovation in CMC: Driving Back to Rational Drug Design

Favorite

Mark Brader, PhD – Moderna Inc. ### 602336###Hot Topic Speaker###Research Fellow###Moderna Inc.###
Hot Topic Speaker: Mark Brader, PhD – Moderna Inc.
###

2:00 PM – 3:00 PM ET
Rapid Fire: Explosion of Cell Therapy Beyond CAR-T
Rapid Fire Moderator: Tuhin Bhowmik, PhD (he/him/his) – 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 Floor

Rapid Fire Moderator: Tuhin Bhowmik, PhD (he/him/his) – Arcellx

Turbocharging Innovation in CMC: Driving Back to Rational Drug Design

Favorite

Tuhin Bhowmik, PhD (he/him/his) – Arcellx ### 605059###Rapid Fire Moderator###Associate Director###Arcellx###
Rapid Fire Moderator: Tuhin Bhowmik, PhD (he/him/his) – Arcellx
### he/him/his

2:00 PM – 2:15 PM ET

Truculture as an Alternative Method to Monitor Recall Response

Location:Salon C, 5th Floor

Rapid Fire Speaker: Kirk Hofman, MS – University at Buffalo

Turbocharging Innovation in CMC: Driving Back to Rational Drug Design

Favorite

Kirk Hofman, MS – University at Buffalo ### 1854283###Rapid Fire Speaker###PhD Candidate###University at Buffalo###
Rapid Fire Speaker: Kirk Hofman, MS – University at Buffalo
###

2:30 PM – 2:45 PM ET

Process Development Challenges in TREG Cell Therapies

Location:Salon C, 5th Floor

Rapid Fire Speaker: Nikul Patel, PhD – Sangamo Therapeutics, Inc

Turbocharging Innovation in CMC: Driving Back to Rational Drug Design

Favorite

Nikul Patel, PhD – Sangamo Therapeutics, Inc ### 1880518###Rapid Fire Speaker###Director of Cell Therapy, Technical Development###Sangamo Therapeutics, Inc###
Rapid Fire Speaker: Nikul Patel, PhD – Sangamo Therapeutics, Inc
###

2:45 PM – 3:00 PM ET

Next Generation Potency Assays for Cell Therapies

Location:Salon C, 5th Floor

Rapid Fire Speaker: Savita Nair, PhD (she/her/hers) – Sangamo Therapeutics

Turbocharging Innovation in CMC: Driving Back to Rational Drug Design

Favorite

Savita Nair, PhD (she/her/hers) – Sangamo Therapeutics ### 1880519###Rapid Fire Speaker###Associate Director###Sangamo Therapeutics###
Rapid Fire Speaker: Savita Nair, PhD (she/her/hers) – Sangamo Therapeutics
### she/her/hers

2:00 PM – 3:00 PM ET
Rapid Fire: Innovation Based on Traditional Approaches
Advances in Therapeutic Development Across Modalities

2:00 PM – 3:00 PM ET

Rapid Fire: Innovation Based on Traditional Approaches

Location:Salon D, 5th Floor

Advances in Therapeutic Development Across Modalities

Favorite

2:00 PM – 2:15 PM ET

Comparing Three Distinct Radioiodination Methods for in vivo Biodistribution

Location:Salon D, 5th Floor

Rapid Fire Speaker: Alecia T. Dent, PhD (she/her/hers) – Genentech, Inc.

Advances in Therapeutic Development Across Modalities

Favorite

Alecia T. Dent, PhD (she/her/hers) – Genentech, Inc. ### 1767302###Rapid Fire Speaker###Scientist###Genentech, Inc.###
Rapid Fire Speaker: Alecia T. Dent, PhD (she/her/hers) – Genentech, Inc.
### she/her/hers

2:15 PM – 2:30 PM ET

A Streamlined Workflow to Assess the Immunogenicity Risk of Biotherapeutics

Location:Salon D, 5th Floor

Rapid Fire Speaker: Rita Martello, PhD – EMD Serono, Inc.

Advances in Therapeutic Development Across Modalities

Favorite

Rita Martello, PhD – EMD Serono, Inc. ### 1820666###Rapid Fire Speaker###Associate Director###EMD Serono, Inc.###
Rapid Fire Speaker: Rita Martello, PhD – EMD Serono, Inc.
###

2:30 PM – 2:45 PM ET

Modeling Strategy to Guide the Development of Targeted Bispecific Antibody

Location:Salon D, 5th Floor

Rapid Fire Speaker: Kazi Tasneem, PhD – Genentech - South San Francisco, CA

Advances in Therapeutic Development Across Modalities

Favorite

Kazi Tasneem, PhD – Genentech - South San Francisco, CA ### 1820675###Rapid Fire Speaker###Senior Scientist###Genentech - South San Francisco, CA###
Rapid Fire Speaker: Kazi Tasneem, PhD – Genentech - South San Francisco, CA
###

2:45 PM – 3:00 PM ET

Challenges in Developing Robust Hybridization Immunoassays

Location:Salon D, 5th Floor

Rapid Fire Speaker: Liz Nolff, MS (she/her/hers) – Bioagilytix

Advances in Therapeutic Development Across Modalities

Favorite

Liz Nolff, MS (she/her/hers) – Bioagilytix ### 1820690###Rapid Fire Speaker###Manager II###Bioagilytix###
Rapid Fire Speaker: Liz Nolff, MS (she/her/hers) – Bioagilytix
### she/her/hers

3:15 PM – 4:30 PM ET
Closing Plenary with Dr. John Quackenbush
Plenary Speaker: John Quackenbush, Ph.D. – Harvard T.H. Chan School of Public Health

3:15 PM – 4:30 PM ET

Closing Plenary with Dr. John Quackenbush
Location:Salon E, 5th Floor

Plenary Speaker: John Quackenbush, Ph.D. – Harvard T.H. Chan School of Public Health

Favorite

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: John Quackenbush, Ph.D. – Harvard T.H. Chan School of Public Health
###