mRNA Quality Control and Comparability Summit

Memo

Welcome to the mRNA Quality Control and Comparability Summit: Streamlining Regulatory Approval for Superior mRNA Therapeutics and Vaccines There is very little known about the types of parameters that should be included in the quality control and evaluation of mRNA therapeutics and vaccines, and the methods currently used are difficult to standardize and compare. In order to aid the global need for quality assurance of mRNA vaccines, we need a common and mutual understanding with confirmed regulations on the analytical procedures and best practices to support the assessment of common quality attributes of mRNA vaccines. The mRNA Quality Control and Comparability Summit is a platform for industry experts to discuss and share strategies for ensuring the quality and consistency of mRNA-based products throughout their lifecycle, from raw material testing to stability, potency, and purity testing, as well as life cycle management. Join the main industry players as they navigate through their case studies and share their experience! This is a must-attend event for mRNA Quality Control, Quality Assurance, CMC, Regulatory and Analytical Development Scientists - join us in Boston alongside pioneering speakers from innovative biopharma and KOLs of academia. Avoid missing out on networking with those shaping the advancement of standardised regulatory requirements and documentation processes to ensure robust commercial processes are in place for the development of mRNA-based therapeutics and vaccines. Meet your community face-to-face in 2023 to hear how they address the major challenges facing the industry: Improve Stability Testing and Implementation for Optimized StabilityUnderstand ways to set up and implement stability in early phases to match regulatory requirements and allow a rapid approval Deconvolute Critical Regulatory Insights for Guidance on an Efficient ApprovalDiscuss the most updated opportunities and learnings that the regulatory agencies are requesting, as well as leading biopharma companies' strategies to streamline through an approval Review Considerations for Purifying mRNA TherapeuticsExplore the advancements in overcoming purification challenges for mRNA product development to create a successful and purified mRNA medicine Understand Ways to Develop and Manufacture Consistent Quality LNPs for Efficient mRNA Drug DeliveryUncover why the production of LNPs with specific sizes and PDI according to the regulatory requirement remains a challenge in mRNA delivery and what the advances are to overcome this bottleneck Delve into the Analytical Comparability Consideration of mRNA therapeutics from the Early Phase to the Late PhaseReveal ways to manage the qualification of analytical methods during the lifecycle of your mRNA product and understand the comparability considerations that play a role in rapid approval rate Join us June 12-15, 2023 in Boston, MA! URLs:Brochure: https://go.evvnt.com/1529499-0?pid=5569 Tickets: https://go.evvnt.com/1529499-3?pid=5569  Date and Time: On Tue, 13 Jun 2023 08:00 - Thu, 15 Jun 2023 19:00 Venue details: Omni Parker House, 60 School Street, Boston, Massachusetts, 02108, United States Prices:Drug Developer - Conference + Workshop Day: USD 4946.00,Drug Developer - Conference Only: USD 2999.00,Solution Provider - Conference + Workshop Day: USD 6046.00,Solution Provider - Conference Only: USD 3799.00,Academic and Not for Profit - Conference + Workshop Day: USD 4246.00,Academic and Not for Profit - Conference Only: USD 2599.00 Speakers: Adriana Coll De Pena, Biomedical Engineering Ph.D. Candidate, Brown University, Anubhav Tripathi, Professor of Engineering and Medical Sciences, Brown University, Camilla Foged, Professor of Vaccine Design and Delivery, University of Copenhagen, Daniel Hemminghaus, Team Lead in the Bioassay and Impurity Team, Pfizer, Emily English, Vice President - Quality, Cartesian Therapeutics, Gautam Sanyal, Principal Consultant, Vaccine Analytics LLC., Harish Janagama, Associate Director, Analytical Development Head, Strand Therapeutics Inc., Hugues Malonne, Director General, DG "Pre-authorization", Federal Agency for Medicines and Health Products, Jan Michel, Falcke Director Global Analytical Science and Technology, BioNTech, Jean-Francois Dierick, Strategic Analytical Validation and Lifecycle Lead for Analytical R and D, GlaxoSmithKline Plc, Jianmei Kochling, Senior Director, Analytical Development CMC, Sanofi, Karen Rule, Director, Analytical R and D Portfolio Management, Pfizer, Rachel Groppo, Director, Replicon Team Lead, Johnson and Johnson, Steven Wolk, Vice President and Head of Site, Boulder and Analytical Chemistry, Editas Medicine, Susan Qu, Head Of Quality and Analytical Science, RVAC Medicines, Vishal Mukund, Sonje Commercial Manufacturing Lead, CEPI