Conference Day One

Wednesday, 26th June

8:00 am Check-In Opens & Light Breakfast

8:50 am Chair’s Opening Remarks

Unlocking the Importance for Adaptability on Release Assays & Explore the Complexities of Potency Assays to Aid Development of Effective Multi-Valent Vaccines

9:00 am Ensuring Adherence to Regulatory Guidelines for Release & Characterization Assays to Optimize Product Quality

  • Kalavathi Dasuri mRNA Analytical CMC Leader-Vaccine Analytical Sciences, mRNA Center of Excellence, Sanofi

Synopsis

  • How can we differentiate the release and characterization assays for mRNA therapeutics?
  • How can we integrate quality target product profiles (QTPP) into release and characterization assays?
  • Emphasize the importance of adaptability to evolving regulatory standards for these assays

9:30 am Addressing the Need for Quantitative Potency Testing for mRNA Vaccines to Enhance Efficacy & Quality of Your mRNA Medicines

Synopsis

  • What is the current state of potency testing and its impact on compliance and vaccine efficacy?
  • What are the challenges of potency testing in mRNA vaccines and what is the need for quantitative assays?
  • How can we find ways to achieve a more accurate correlation between RNA input and protein expression?

10:00 am Morning Break & Speed Networking

Synopsis

This session is the ideal opportunity to get face-to-face time with many of the brightest minds working in the mRNA Quality Control and Compliance field and establish meaningful business relationships to pursue for the rest of the conference

11:00 am Roundtable Discussion: Innovations in Addressing Purification Challenges to Produce High Quality mRNA Therapeutics & Vaccines

  • Craig Martin Professor, University of Massachusetts Amherst
  • Steven Wolk Vice President & Head of Chemistry & Boulder Site, Editas Medicine

Synopsis

  • How can dsRNA effectively target specific mRNA sequences, resulting in increased specificity and accuracy in RNA analysis
  • What are the possible strategies to improve its specificity and reduce the potential for off-target effects
  • What are the regulatory hurdles in the use of dsRNA in mRNA development to ensure safety and efficacy of these technologies
  • What are the current methods and techniques for ensuring a purified final product

12:00 pm Networking Lunch

Advancing Method Validation to Ensure Robustness & Navigate Strategies for Quality Control Testing & Documentation

1:30 pm Diving into Method Validation Challenges & Ensuring Manufacturing Consistency in mRNA Production

  • Yuqing Chang Associate Director, In vivo LNP QC Lead, Beam Therapeutics

Synopsis

  • What is the importance of consistent manufacturing and what are the potential variations that could impact product quality?
  • What are the steps involved in validating manufacturing methods?
  • How to ensure robustness in method validation

1:50 pm Exploring the Dynamic Nature of RNA Quality Control Considering Regulatory Strategies for Different Therapeutic Indications

  • Monica Dommel Associate Director Regulatory Affairs CMC, CureVacSE

Synopsis

  • Discuss the evolving landscape of RNA QC and compliance and highlight the importance of staying with the current regulatory changes
  • Providing a step-by-step roadmap for regulatory compliance in mRNA quality control
  • Discussing strategies for identifying, documenting, and addressing deviations

2:00 pm Implementation of Phase Appropriate mRNA Analytics in a Contract Testing Environment: Balancing the Development & Qualification Approaching a mRNA Program

  • Jeff Heiser Chief Scientific Officer of Microbial and Advanced Therapeutic Platforms, BA Sciences’

Synopsis

  • The analytical requirements for characterization of mRNA Drug Substance and Drug Products have been defined by the USP as well as sponsor companies participating in early phase clinical trials
  • Balancing the effort spent on method development and qualification/validation is critical to keeping with timelines and controlling analytical costs
  • How to utilize a suite of mRNA Analytical platform methods to streamline your process development team’s ability to optimize the scale up and manufacturing process
  • Effective implementation of full cGMP versus process development service analytical offerings in the same lab space

2:20 pm Afternoon Break & Poster Session

Synopsis

By joining our dedicated session, you will have the opportunity to engage in meaningful discussions with your peers about ongoing work in the field of mRNA therapeutics. As the discovery and development of these therapies continues to advance, it is essential to collaborate and share knowledge to streamline the approval process. Share your latest findings and gain insight into the cutting edge work of your peers. The goal of this session is to foster a sense of community and promote collaboration within the field.

Transforming the mRNA Quality Control Field via the Introduction to Platformization & Delving into High Quality Platform Analytics

3:50 pm Innovative Analytical Control Strategy to Produce High Quality mRNA Therapeutics

  • Abhita Malavia Director & Head of Quality Control, Nutcracker Therapeutics

Synopsis

  • An overview of IND enabling Analytical Control Strategy for mRNA based products
  • Discuss challenges associated with building an integrated analytical control strategy
  • Focus on some high throughput analytics for release/characterization of mRNA products

4:20 pm Navigating Regulatory CMC Requirements for Academic Investigator- Sponsored Investigational New Drug Development: Advancing mRNA Personalized Vaccine Innovation

  • Hang Yuan Chief Technical Officer & Co-Founder, Innovac Therapeutics

Synopsis

  • What are the regulatory CMC requirements for successful IND submissions?
  • What are the key regulatory guidelines and expectations related to CMC for mRNA personalized vaccine development?
  • Dentification of common challenges and hurdles encountered during CMC development for academic investigator-sponsored INDs

4:50 pm End of Conference Day One