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Monday, Apr 24
9:00 AM – 9:30 AM ET

Prologue: Overcoming Critical Challenges of Evolving Biologics

Location:Salon C, 5th Floor
Prologue Speaker: Nicole Buist, PhD (she/her/hers) – Merck & Co.
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Monday, Apr 24
9:30 AM – 11:00 AM ET

Symposium: Innovation Based on Non-Traditional Platforms

Location:Salon C, 5th Floor
Moderator: Haichen Nie, PhD – Teva Pharmaceuticals
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Monday, Apr 24
9:30 AM – 10:00 AM ET

Challenges and Strategies in Developing Biosimilar Drug Products

Location:Salon C, 5th Floor
Speaker: Mehran Yazdanian, PhD (he/him/his) – Teva pharmaceuticals
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Monday, Apr 24
10:00 AM – 10:30 AM ET

Modeling Tools for Predicting Protein-Protein Interactions at High Concentrations

Location:Salon C, 5th Floor
Speaker: Christopher Roberts, PhD – University of Delaware
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Monday, Apr 24
10:30 AM – 11:00 AM ET

Excipient Phase Behavior - Implications on Protein Stability

Location:Salon C, 5th Floor
Speaker: Raj Suryanarayanan, PhD (he/him/his) – University of Minnesota
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Monday, Apr 24
1:00 PM – 2:00 PM ET

Keynote: Translation of Microneedle Patch Technology into the Clinic

Location:Salon C, 5th Floor
Keynote Speaker: Mark R. Prausnitz, PhD – Georgia Institute of Technology
Moderator: Bernadette DSouza, PhD (she/her/hers) – Samford University
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Monday, Apr 24
2:30 PM – 3:30 PM ET

Rapid Fire: Innovation Based on Non-Traditional Platforms

Location:Salon C, 5th Floor
Rapid Fire Moderator: Jing Ling, PhD – Merck & Co., Inc.
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Monday, Apr 24
2:30 PM – 2:45 PM ET

Targeted Drug Delivery using Edible Natural Proteins

Location:Salon C, 5th Floor
Rapid Fire Speaker: Ahmed MA Mohamed (he/him/his) – Philipps Universität Marburg
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Monday, Apr 24
2:45 PM – 3:00 PM ET

Comparison of Trehalose and Sucrose in Preserving and Stabilizing Lyophilized Therapeutic Proteins

Location:Salon C, 5th Floor
Rapid Fire Speaker: Fengyuan Yang, PhD – Ashland Specialty Ingredients
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Monday, Apr 24
3:00 PM – 3:15 PM ET

Mechanistic Understanding of the Impact of Sugar and Buffer Salts on the Physical Stability of solid biologicals formulation

Location:Salon C, 5th Floor
Rapid Fire Speaker: Jing Ling, PhD – Merck & Co., Inc.
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Monday, Apr 24
3:15 PM – 3:30 PM ET

Structural Profiling of mRNA Vaccine Constructs: Applications for mRNA Vaccine Design and Quality Assessment

Location:Salon C, 5th Floor
Rapid Fire Speaker: Joshua Imperatore, PhD – National Institute of Standards and Technology
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Monday, Apr 24
3:00 PM – 4:00 PM ET

Hot Topic: Turbocharging Innovation in CMC - Driving Back to Rational Drug Design

Location:Salon B, 5th Floor
Hot Topic Moderator: Wei Xu, Ph.D. – Merck & Co., Inc.
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Monday, Apr 24
3:00 PM – 3:30 PM ET

CMC Strategy for Antibody Drug Conjugates: Challenges and Regulatory Considerations

Location:Salon B, 5th Floor
Hot Topic Speaker: Weining Hu, MS (she/her/hers) – Merck
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Monday, Apr 24
3:30 PM – 4:00 PM ET

Analytical Procedures for Biotherapeutics Product Variants: Scientific and Practical Consideration

Location:Salon B, 5th Floor
Government Speaker: Jinhui Zhang, PhD – US Food and Drug Administration
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Tuesday, Apr 25
9:00 AM – 9:30 AM ET

Prologue: Adeno-associated Virus (AAV) Empty / Full Capsid Composition Assay

Location:Salon C, 5th Floor
Prologue Speaker: Surendran Rajendran, PhD (he/him/his) – Bristol-Myers Squibb
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Tuesday, Apr 25
9:30 AM – 11:00 AM ET

Symposium: Next Generation Gene Therapies

Location:Salon C, 5th Floor
Moderator: Mohamed Hassanein, PhD – Pfizer
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Tuesday, Apr 25
9:30 AM – 10:00 AM ET

Assessing Immunogenicity for Expressed Biologics in Gene Therapy

Location:Salon C, 5th Floor
Speaker: Weiping Shao, PhD – AstraZeneca
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Tuesday, Apr 25
10:00 AM – 10:30 AM ET

Advanced Analytical Approaches for AAV Empty/full Capsid Characterization and Quantification

Location:Salon C, 5th Floor
Speaker: Joseph Ong, PhD – Novartis
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Tuesday, Apr 25
10:30 AM – 11:00 AM ET

Applying in vitro Assays to Assess Immunogenicity Risk of Attribute Levels

Location:Salon C, 5th Floor
Speaker: Swati Gupta, PhD (she/her/hers) – AbbVie
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Tuesday, Apr 25
10:00 AM – 11:00 AM ET

Hot Topic: Turbocharging Innovation in CMC - Driving Back to Rational Drug Design

Location:Salon B, 5th Floor
Hot Topic Moderator: Martin J. D'Souza, PhD (he/him/his) – Mercer University
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Tuesday, Apr 25
10:00 AM – 10:30 AM ET

Relevance of Raw, Starting and Ancillary Materials for Advanced Therapies

Location:Salon B, 5th Floor
Hot Topic Speaker: Ben Clarke, PhD – United States Pharmacopeia
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Tuesday, Apr 25
10:30 AM – 11:00 AM ET

Buccal Drug Delivery System Design for Alternative Pain-free Vaccines

Location:Salon B, 5th Floor
Hot Topic Speaker: Martin J. D'Souza, PhD (he/him/his) – Mercer University
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Tuesday, Apr 25
12:30 PM – 1:30 PM ET

Special Poster Collection

Location:Poster Forum 1; Franklin Hall
Poster Collection Host: Heather A. Myler, PhD – PPD
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Tuesday, Apr 25
1:00 PM – 2:00 PM ET

Keynote: Analytical Challenges with Gene Editing in In vivo and Ex vivo Gene Therapy

Location:Salon C, 5th Floor
Keynote Speaker: Michael S. Molony, MA – Sangamo Thearpeutics
Moderator: Mohamed Hassanein, PhD – Pfizer
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Tuesday, Apr 25
1:30 PM – 2:15 PM ET

Evaluation of Commercial HCP ELISA Kits by HRMS

Location:Learning Lab, Franklin Hall
Partner Presentation Speaker: John Maddalena, MEd, PhD – Prolytix
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Tuesday, Apr 25
2:30 PM – 3:30 PM ET

Rapid Fire: Next Generation Gene Therapies

Location:Salon C, 5th Floor
Rapid Fire Moderator: Xiujuan Jia, PhD – Merck & Co., Inc
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Tuesday, Apr 25
2:30 PM – 2:45 PM ET

Enabling Online determination of Size-dependent RNA Encapsulation of Lipid Nanoparticles

Location:Salon C, 5th Floor
Rapid Fire Speaker: Xiujuan Jia, PhD – Merck & Co., Inc
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Tuesday, Apr 25
2:45 PM – 3:00 PM ET

Elucidation of Reversible-Self Association Interface in Fusion Proteins Using HDX-MS and Computational Modeling

Location:Salon C, 5th Floor
Rapid Fire Speaker: Ehab Moussa, Ph.D. – AbbVie Inc.
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Tuesday, Apr 25
3:00 PM – 3:15 PM ET

Development of Novel Biologics

Location:Salon C, 5th Floor
Rapid Fire Speaker: Harshawardhan Bal, PhD (he/him/his) – Shilpa Pharma Lifesciences Limited
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Tuesday, Apr 25
3:15 PM – 3:30 PM ET

CARTs - A New Vehicle for Nucleic Acid Delivery With a Unique Controllable Release Mechanism

Location:Salon C, 5th Floor
Rapid Fire Speaker: Zahra Merchant, PhD (she/her/hers) – Evonik Canada Inc.
Turbocharging Innovation in CMC: Driving Back to Rational Drug Design
Wednesday, Apr 26
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
Wednesday, Apr 26
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
Wednesday, Apr 26
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
Wednesday, Apr 26
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
Wednesday, Apr 26
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
Wednesday, Apr 26
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
Wednesday, Apr 26
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
Wednesday, Apr 26
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
Wednesday, Apr 26
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
Wednesday, Apr 26
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
Wednesday, Apr 26
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
Wednesday, Apr 26
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
Wednesday, Apr 26
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