7:30 am Registration & Morning Coffee

8:20 am Chair’s Opening Remarks

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

9:00 am Scaling Up In Vitro Transcription: Key Results & Considerations

  • Sirat Sikka Staff Scientist, Field Applications, Thermo Fisher Scientific

9:30 am Establishing a Scalable Next-Generation mRNA Process

  • Bill Grier Associate Director, Drug Substance Process Development, Omega Therapeutics

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

10:30 am Morning Break & Speed Networking


TRACK A: RESEARCH SCALE

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

12:00 pm Comprehensive GMP Manufacturing of mRNA-LNP Drug Products: Sequence-to-Vial

12:30 pm Harnessing a Fingerprinting-Based Method to Obtain Multiple Attributes of RNA & Facilitate mRNA Process Development

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

12:00 pm PCR-Based mRNA Manufacturing for Clinical Development

  • Eike Joest Principal Scientist - mRNA Innovation, MilliporeSigma

12:30 pm Developing a saRNA Platform: Considerations for Discovery to Clinical Stage Programs

TRACK C: COMMERCIAL SCALE

Scaling Up mRNA-LNP Chemistry & Characteristics to Ensure Smooth Global Production

11:30 am The Journey of mRNA LNPs into a Well- Characterized Biologic

12:00 pm Comparison of Maglev Centrifugal & Diaphragm (4 Piston) Pumping Effects on mRNA encapsulated LNP

12:30 pm Revolutionizing mRNA Lipid Nanoparticles by Incorporation of Ionizable Lipids from Bio-Renewable Sources

1:00 pm Lunch Break & Networking


Spotlighting Technological Advances in mRNA Drug Development to Improve Efficiency & Control of the Process

2:00 pm Innovating & Digitalizing Production Processes of mRNA Vaccines & Therapeutics

  • Zoltán Kis Assistant Professor, University of Sheffield

2:30 pm Unlocking Access to mRNA-Based Vaccines & Therapeutics

3:00 pm Using In Silico Sequence Design Strategies to Simplify the IVT mRNA Production Process & Increase Product Quantity

Implementing mRNA Quality Control Considerations to Improve Overall Drug Product & Efficacy

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

2:30 pm Accelerating mRNA Clinical Development from Start to Finish

  • Jing Zhu VP - Nucleic Acid & Viral Vector Technology, ReciBioPharm

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

Improving Cost Effectiveness of mRNA Production & Cold-Chain Stability to Enable Equitable Access

2:00 pm Fireside Discussion: Harnessing Tools to Improve Stability & Drug product Development to Enable Global Access

2:30 pm Tailoring Production: A Customized Approach to mRNA Manufacturing

3:00 pm Vaccine Stability & Access Through Manufacturing Technologies & Innovations

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

4:45 pm Speeding mRNA Process Development & Securing Robust Manufacturing by Using Fast In-Process Analytics: Sponsored by HPNE

5:15 pm Novel RNA Manufacturing: Eliminating dsRNA at Synthesis & Reducing Costs

  • Craig Martin Professor - Chemistry, University of Massachusetts Amherst

5:45 pm Customized Synthetic DNA to Broaden its Application Scope: From Manufacturing to Therapeutic Uses

5:55 pm Chair’s Closing Remarks

  • Andreas Kuhn Senior Vice President - Ribonucleic Acid Biochemistry & Chemistry, Manufacturing, Controls Management, BioNTech SE

6:00 pm End of Conference Day One

Complimentary Drinks Reception & Poster Session