Day One

Wednesday, September 27

Day Two

Thursday, September 28

7:45 am Morning Networking & Coffee

8:40 am Chair’s Opening Remarks

Harnessing Current mRNA Process Requirements for Scalable Production of Personalized Medicines

8:50 am Panel Discussion: Accelerating the Analytics, Production & Regulations of Personalized mRNA-Based Drugs for Individual Patient Needs

  • Danny Crawford Director Nucleic Acid Process Sciences, Intellia Therapeutics
  • Andreas Kuhn Senior Vice President - Ribonucleic Acid Biochemistry & Chemistry, Manufacturing, Controls Management, BioNTech SE
  • Nicole Ruggiero CEO, EpiVax Therapeutics
  • Monica Dommel Associate Director - Regulatory Affairs CMC, CureVac SE
  • Joseph Schariter Director – Process Development, Moderna

9:30 am Accelerating Production Systems for Personalized mRNA Manufacturing

  • Simon Unthan Senior Director RNA Manufacturing Technology Development & Automation, BioNTech SE

Synopsis

See session details in the Full Event Guide

10:00 am Optimization of IVT Reaction Using Ambr15® Automated Bioreactor System & Final Filtration for Purifying mRNA Drug Substance

Synopsis

See session details in the Full Event Guide

10:30 am Morning Break & Networking


TRACK A: RESEARCH SCALE

Redesigning Production Processes to Develop High Quality mRNA Drug Substance

11:00 am Benchmarking IVT Reaction Conditions for Optimal mRNA Drug Substance Yield & Quality

  • Hui Zhi Senior Scientist, Beam Therapeutics

Synopsis

See session details in the Full Event Guide

11:30 am Utilizing Trehalose, Sucrose & Amino Acids: Essential Components, Applications, Related Functionalities & Performance in Biologic Drug Product Formulations & mRNA Technologies

Synopsis

See session details in the Full Event Guide

11:50 am Reduction of dsRNA Through IVT & Purification Optimization for Therapeutic Indications

  • Vu Thai Director, Purification Process Development, Ultragenyx Pharmaceutical

Synopsis

See session details in the Full Event Guide

TRACK B: IND-ENABLING & CLINICAL SCALE

  • John Zuris Director - Editing Technologies, Editas Medicine

Redefining mRNA Batch Process Scale-Up to Advance Candidates from Bench to Clinic Whilst Maintaining Quality

11:00 am Accelerating Process & Manufacturing Scale-Up into the Clinic with Next Generation Circular RNA Technology

  • Harshal Zope Director - Manufacturing Science & Technology, Orna Therapeutics

Synopsis

See session details in the Full Event Guide

11:30 am End-to-End Manufacturing of Early-Phase RNA-LNP Candidates

Synopsis

See session details in the Full Event Guide

11:50 am CMC Strategy & Manufacturing Readiness for a Novel Modality at an Emerging Biotech – a Case Study

  • Sujit Jain Director - External Manufacturing, SalioGen Therapeutics

Synopsis

See session details in the Full Event Guide

TRACK C: COMMERCIAL SCALE

Unravelling Manufacturing Considerations to Develop the Best mRNA Drug Product

11:00 am Combating Challenges & Strategic Approaches in the Development of mRNA Vaccines for LMICs

  • Lakshmi Khandke Senior Program Advisor, The PATH Malaria Vaccine Initiative

Synopsis

See session details in the Full Event Guide

11:30 am Track Break

Synopsis

See session details in the Full Event Guide

11:50 am Unlocking Considerations for Early to Late Phase Appropriate mRNA Drug Product Development

Synopsis

See session details in the Full Event Guide

12:20 pm Lunch Break & Networking


Creating the Ultimate IVT Cocktail with Latest Technology Implementation to Streamline mRNA Production

1:20 pm Novel Cap Analogs & Modified NTPs to Enable Therapeutic mRNA Development

  • May Guo Chief Commercial Officer, Areterna

Synopsis

See session details in the Full Event Guide

1:50 pm Round Table Discussion: Optimizing Upstream IVT Through Next-Generation Engineering to Maximise an Efficient mRNA Production Process

Synopsis

See session details in the Full Event Guide

Leveraging Experiences of Scale-Up to Reduce Barriers in Clinical Advancement

  • John Zuris Director - Editing Technologies, Editas Medicine

1:20 pm Harnessing Digital Twin for mRNA Manufacturing

Synopsis

See session details in the Full Event Guide

1:50 pm Round Table Discussion: Scaling up mRNA-Based Therapeutics & Vaccines from Bench to Clinic

Synopsis

See session details in the Full Event Guide

Scaling mRNA Process Development & Manufacturing to Meet the Demands of a Changing Global Market

  • Antonio Grilo Technology Transfer Expert, Medicines Patent Pool

1:20 pm Developing Nucleic Acid-Based Therapeutics in Confidence

  • Lloyd Jeffs Senior Director - Biopharma Services, Precision NanoSystems

1:50 pm Round Table Discussion: Manufacturing mRNA Therapeutics to Combat Scalability Challenges in Low-Middle Income Countries

  • Antonio Grilo Technology Transfer Expert, Medicines Patent Pool

Synopsis

See session details in the Full Event Guide

2:30 pm Afternoon Break & Networking

Achieving a Successful Technology Transfer & Cost-Effective Route from Discovery to Commercialization to Ensure Consistency Across Different Scales of Development

3:00 pm Technical Transfer Knowledge Management Strategies in a Distributed Supply Network

Synopsis

See session details in the Full Event Guide

3:30 pm Discovery Strategy Framework to Set You up for Manufacturing Success

  • Linda Villa Director - GMP Operations and Process Transfer, TriLink BioTechnologies

Synopsis

See session details in the Full Event Guide

4:00 pm Mapping the Ultimate Route to Equitable Global Process Training & Technology Transfer

  • Antonio Grilo Technology Transfer Expert, Medicines Patent Pool

Synopsis

See session details in the Full Event Guide

4:30 pm Chair’s Closing Remarks

4:40 pm Close of 2nd mRNA Process Development & Manufacturing Summit

DAY ONE
FULL EVENT GUIDE