Day One Wednesday, September 27 Day Two Thursday, September 28 7:30 am Registration & Morning Coffee 8:20 am Chair’s Opening Remarks Christopher Cheng VP Process Development & RNA Technology, Verve Therapeutics Navigating the Future mRNA Process Development & Manufacturing Landscape to Match Scale, Demand & Development of mRNA 2.0 Medicines 8:30 am Achieving Flexibility in mRNA Process Development for On Demand mRNA-Based Therapeutics Sung-Hye Grieco Vice President, Head of Messenger Ribonucleic Acid PD, Manufacturing, Science & Technology , & Program Management Offices, Nutcracker Therapeutics Synopsis See session details in the Full Event Guide 9:00 am Scaling Up In Vitro Transcription: Key Results & Considerations Sirat Sikka Staff Scientist, Field Applications, Thermo Fisher Scientific Synopsis See session details in the Full Event Guide 9:30 am Establishing a Scalable Next-Generation mRNA Process Bill Grier Associate Director, Drug Substance Process Development, Omega Therapeutics Synopsis See session details in the Full Event Guide 10:00 am Panel Discussion: To GMP or Not to GMP: Establishing Criteria to Meet GMP Requirements from Bench to Market Jin Zhou Executive Director, Technical Development, mRNA & Protein Biologics, Ultragenyx Pharmaceuticals Harshal Zope Director - Manufacturing Science & Technology, Orna Therapeutics Bill Grier Associate Director, Drug Substance Process Development, Omega Therapeutics Darwin Asa Marketing Manager, Thermo Fisher Scientific Shefal Parikh Director - mRNA Process Development, Beam Therapeutics Synopsis See session details in the Full Event Guide 10:30 am Morning Break & Speed Networking TRACK A: RESEARCH SCALE Elvan Cavac Director, Nutcracker Therapeutics Evolving mRNA Drug Substance Design to Optimize Drug Effectiveness 11:30 am Round Table Discussion: Strategizing Methods for Next-Generation mRNA Processes to Improve Research Scale Development Elvan Cavac Director, Nutcracker Therapeutics Synopsis See session details in the Full Event Guide 12:00 pm Comprehensive GMP Manufacturing of mRNA-LNP Drug Products: Sequence-to-Vial Yasser Kehail Product Manager, Aldevron Synopsis See session details in the Full Event Guide 12:30 pm Harnessing a Fingerprinting-Based Method to Obtain Multiple Attributes of RNA & Facilitate mRNA Process Development Xinyue Zhang Manager, GeneLeap Biotech Synopsis See session details in the Full Event Guide TRACK B: IND-ENABLING & CLINICAL SCALE Andreas Kuhn Senior Vice President - Ribonucleic Acid Biochemistry & Chemistry, Manufacturing, Controls Management, BioNTech SE Establishing a Robust Analytical Framework to Ensure a Standardized mRNA Production 11:30 am Leveraging Analytical Control Strategies for Process-Related Impurities in mRNA Vaccines & Therapeutics Yimin Hua Head of Biochemistry – Analytical Development, mRNA Centre of Excellence, Sanofi Synopsis See session details in the Full Event Guide 12:00 pm PCR-Based mRNA Manufacturing for Clinical Development Eike Joest Principal Scientist - mRNA Innovation, MilliporeSigma Synopsis See session details in the Full Event Guide 12:30 pm Developing a saRNA Platform: Considerations for Discovery to Clinical Stage Programs Prakash Koodathingal Director, RNA Therapeutic Development, Immunomic Therapeutics Synopsis See session details in the Full Event Guide TRACK C: COMMERCIAL SCALE Dipendra Gyawali Senior Scientist; Team Lead – Process Development, Moderna Scaling Up mRNA-LNP Chemistry & Characteristics to Ensure Smooth Global Production Harris Makatsoris Professor Of Manufacturing Systems, King's College London 11:30 am The Journey of mRNA LNPs into a Well- Characterized Biologic Joseph Schariter Director – Process Development, Moderna Synopsis See session details in the Full Event Guide 12:00 pm Comparison of Maglev Centrifugal & Diaphragm (4 Piston) Pumping Effects on mRNA encapsulated LNP Mark McElligott Owner and Principal Process Engineer, bioX Synopsis See session details in the Full Event Guide 12:30 pm Revolutionizing mRNA Lipid Nanoparticles by Incorporation of Ionizable Lipids from Bio-Renewable Sources Patrick Arbuthnot Personal Professor & Director, University of the Witwatersrand Synopsis See session details in the Full Event Guide 1:00 pm Lunch Break & Networking Spotlighting Technological Advances in mRNA Drug Development to Improve Efficiency & Control of the Process Burak Yilmaz Co-Founder & President, Kernal Bio 2:00 pm Innovating & Digitalizing Production Processes of mRNA Vaccines & Therapeutics Zoltán Kis Assistant Professor, University of Sheffield Synopsis See session details in the Full Event Guide 2:30 pm Unlocking Access to mRNA-Based Vaccines & Therapeutics Oladimeji Fashola Chief Technology Officer, Quantoom Biosciences Synopsis See session details in the Full Event Guide 3:00 pm Using In Silico Sequence Design Strategies to Simplify the IVT mRNA Production Process & Increase Product Quantity Joseph Parrella VP - CMC, Kernal Bio Synopsis See session details in the Full Event Guide Implementing mRNA Quality Control Considerations to Improve Overall Drug Product & Efficacy Dipendra Gyawali Senior Scientist; Team Lead – Process Development, Moderna 2:00 pm Next generation Self-Replicating RNA (srRNA) Vectors: Overcoming the Manufacturing & Analytical Challenges to Enable Clinical Development Andrew Geall Chief Development Officer, Replicate Bioscience Synopsis See session details in the Full Event Guide 2:30 pm Accelerating mRNA Clinical Development from Start to Finish Jing Zhu VP - Nucleic Acid & Viral Vector Technology, ReciBioPharm Synopsis See session details in the Full Event Guide 3:00 pm Development of an Accurate & Robust Method to Support Process Development in Monitoring mRNA IVT Impurities Andrew Schmudlach Principal Scientist - Analytical Development, mRNA Centre of Excellence, Sanofi Synopsis See session details in the Full Event Guide Improving Cost Effectiveness of mRNA Production & Cold-Chain Stability to Enable Equitable Access Catherine Shi Scientist, Ultragenyx Pharmaceutical 2:00 pm Fireside Discussion: Harnessing Tools to Improve Stability & Drug product Development to Enable Global Access Mohamed ElSayed EVP & CTO, RVAC Medicines Patrick Arbuthnot Personal Professor & Director, University of the Witwatersrand Gautam Sanyal Principal Consultant, Vaccine Analytics Synopsis See session details in the Full Event Guide 2:30 pm Tailoring Production: A Customized Approach to mRNA Manufacturing Scott Alderucci Director, Process Development Science, Curia Global Synopsis See session details in the Full Event Guide 3:00 pm Vaccine Stability & Access Through Manufacturing Technologies & Innovations Ramin Sabet-Azad CMC Lead, CEPI Synopsis See session details in the Full Event Guide 3:30 pm Afternoon Break & Networking Perfecting Purification: Enhancing Current Techniques to Overcome dsRNA Impurities & Increase Yield 4:00 pm Panel Discussion: The dsRNA Debate: Assessing dsRNA Formation Early & Optimizing the Process to Reduce Pressure on Purification Requirements Zoltán Kis Assistant Professor, University of Sheffield Burak Yilmaz Co-Founder & President, Kernal Bio Jin Zhou Executive Director, Technical Development, mRNA & Protein Biologics, Ultragenyx Pharmaceuticals Craig Martin Professor - Chemistry, University of Massachusetts Amherst Andrew Geall Chief Development Officer, Replicate Bioscience Synopsis See session details in the Full Event Guide 4:45 pm Speeding mRNA Process Development & Securing Robust Manufacturing by Using Fast In-Process Analytics: Sponsored by HPNE Aleš Štrancar Executive Managing Director, BIA Separations Synopsis See session details in the Full Event Guide 5:15 pm Novel RNA Manufacturing: Eliminating dsRNA at Synthesis & Reducing Costs Craig Martin Professor - Chemistry, University of Massachusetts Amherst Synopsis See session details in the Full Event Guide 5:45 pm Customized Synthetic DNA to Broaden its Application Scope: From Manufacturing to Therapeutic Uses Julen Oyarzabal CSO & Founder, Syngoi Technologies Synopsis See session details in the Full Event Guide 5:55 pm Chair’s Closing Remarks Andreas Kuhn Senior Vice President - Ribonucleic Acid Biochemistry & Chemistry, Manufacturing, Controls Management, BioNTech SE Synopsis See session details in the Full Event Guide 6:00 pm End of Conference Day One Complimentary Drinks Reception & Poster Session PRE CONFERENCE WORKSHOP DAY TWO
