Day One

Wednesday, September 27

Day Two

Thursday, September 28

8:00 am Morning Networking & Coffee

9:00 am Chair’s Opening Remarks

  • Mohamed ElSayed Executive Vice President & Chief Technology Officer, RVAC Medicines

Harnessing Current mRNA Process Requirements for Scalable Production of Personalized Medicines

9:10 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 & Manufacturing, BioNTech SE
  • Nicole Ruggiero Chief Executive Officer, EpiVax Therapeutics
  • Monica Dommel Associate Director Regulatory Affairs CMC, CureVac SE
  • Joseph Schariter Director - Process Development, Moderna

10:00 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

10:30 am Morning Networking Break & Poster Session

Synopsis

As the landscape of innovation is enabling scalable, cost-effective and commercially viable mRNA production, it is more important than ever to collaborate and learn for the growth of this field. Join our dedicated poster session to share your latest data and have a first look into what your peers are working on!


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 II, 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 Associate Director - Purification Process Development, Ultragenyx Pharmaceutical Inc

Synopsis

See session details in the Full Event Guide

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 Session Reserved: CPI

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

COMMERCIAL SCALE

Unleashing Manufacturing Technologies to Develop the Best mRNA Drug Product

11:00 am Harnessing Digital Twin for mRNA Manufacturing

Synopsis

See session details in the Full Event Guide

11:30 am Session Reserved: CATUG

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

  • Akhilesh Bhambhani Executive Director, Biologics & mRNA Drug Product Development, Ultragenyx Pharmaceutical

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 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 Case-Studies from Successful INDSubmissions to Ensure Consistency in Future Filings

  • John Zuris Director - Editing Technologies, Editas Medicine

1:20 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

1:20 pm Session Reserved: Cytiva

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

  • Ike James Head of Technology Transfer, Medicines Patent Pool
  • Antonio Grilo Technology Transfer Expert, Medicines Patent Pool

Synopsis

See session details in the Full Event Guide

2:15 pm Afternoon Break & Networking

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

2:45 pm Mapping the Ultimate Route to Equitable Global Process Training & Technology Transfer

  • Ike James Head of Technology Transfer, Medicines Patent Pool
  • Antonio Grilo Technology Transfer Expert, Medicines Patent Pool

Synopsis

See session details in the Full Event Guide

3:15 pm 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

3:45 pm Chair’s Closing Remarks

  • Mohamed ElSayed Executive Vice President & Chief Technology Officer, RVAC Medicines

4:00 pm Close of 2nd mRNA Process Development & Manufacturing Summit

DAY ONE
FULL EVENT GUIDE