Event preview of the 6th mRNA‑Based Therapeutics Summit

Unlocking the future potential of mRNA: the leadership perspective

The opening plenary will bring together a cohort of senior mRNA leaders and CEOs to examine the strategic and scientific trajectory of the field amid geopolitical pressures, asset uncertainty, and cost challenges. Moderated by Wolfgang Hofmann (CEO Leon-Nanodrugs), the session will draw on perspectives from Daniel Getts (CEO, CREATE Medicines), Alex Zinoviev (Director of mRNA Platform, Eli Lilly), Peter Weinstein (CEO, Circurna), Priya Mande (CEO, RNAVate), Cory Sago (CEO, Amplitude Therapeutics), Nathaniel Wang (CEO, Replicate Bioscience), Carsten Rudolph (CEO, Ethris), and Randall Hyer (CEO, Merlin Biotech). Discussion will span the comparative efficiency of linear, circular, self-amplifying, and trans-amplifying RNA modalities, the role of recent mRNA and LNP platform acquisitions in shaping next-generation strategies, and emerging opportunities in CAR-T platforms, gene editing, and cancer immunotherapy. The panel will also address how the geographic shift of clinical trials toward East Asia and Australia may accelerate clinical validation across the industry.

Overcoming regulatory hurdles: a global perspective on mRNA therapeutic approval

A fireside discussion on day two, moderated by Sai Prathyusha Bhamidipati (Director of Regulatory CMC Moderna), will offer direct insight from representatives of the world's leading regulatory bodies on the evolving framework governing mRNA therapeutics. Eric Levenson (Biological Reviewer, US FDA/CBER), Marco Cavaleri (Head of Biological Health Threats & Vaccine Strategy, European Medicines Agency), and Ka-Wai Wan (Expert Pharmaceutical/Quality Assessor, Medicines and Healthcare products Regulatory Agency), and Nitisha DeGuire (Director of Global Regulatory Affairs, BioNTech) will address the growing complexity of global policy as mRNA products spanning cancer immunotherapies and cell therapies advance through clinical development. The panel will examine how current government decisions are affecting development timelines, what collaborative frameworks between developers and regulators could improve trust and efficiency, and what scientific or strategic conditions are most likely to support the first mRNA therapeutic market authorization. The session offers a rare opportunity for attendees to engage with regulatory perspectives across three major jurisdictions simultaneously.

Shaping the mRNA industry outlook: partnerships, collaborations, and investment strategies

The day two plenary will also feature a panel discussion that will examine the outlook for biopharma partnerships and collaborations in the mRNA sector. Moderated by Julia Lee (Senior Director, Search & Evaluation, Business Development, GSK), the session will bring together Kathy Fernando (Chief Business Officer, Replicate Bioscience), Christina Vorvis (Director, AbbVie Ventures), David Kolesky (Principal, MPM BioImpact), and Brian Goodman (Managing Director, Vida Ventures). Panelists will draw on recent deal and acquisition experience in mRNA-LNP platforms to inform future risk and decision-making strategies, explore unmet indication areas where mRNA technology may fill gaps, and discuss what data and asset maturity investors and acquirers require before committing to new collaborations. Furthermore, the plenary session will include a presentation by Prashant Nambiar (Chief Scientific Officer, Strand Therapeutics), who will explore the application of synthetic self-replicating mRNA technology in cancer immunotherapy, with a focus on immuno-oncology use cases and immune cell engineering as emerging platforms for therapeutic development.

mRNA discovery, development, and manufacturing

Across both days, attendees will have access to three parallel tracks covering the breadth of the mRNA pipeline. Track A, focused on discovery, will address mRNA design optimization for infectious and rare diseases, novel LNP chemistry, circular RNA platforms for target discovery, and AI-enhanced approaches to cell-specific delivery, with presentations from George Thom (Director of RNA Therapeutics, AstraZeneca) and Priya Mande (CEO, RNAVate), among others. Track B, covering pre-clinical and clinical development, will examine in vivo CAR-T cell programming, self-amplifying RNA vector design, PK/PD modeling in oncology, and mRNA vaccine stability and safety, featuring presentations from Syed Ali (Principal Scientist, Moderna) and Nathaniel Wang (CEO, Replicate Bioscience). Track C, dedicated to manufacturing and CMC, will explore in vitro transcription (IVT) impurity mitigation, digital twins for process monitoring, analytical techniques for mRNA-LNP integrity assessment, and scalable CMC strategies for global access, with insights from Nikhil Adi (Senior Principal Scientist, Pfizer) and Hela Kallel (CMC Technology Lead, CEPI), and other speakers. 

The 6th mRNA-Based Therapeutics Summit brings together 250+ leaders from pharma, biotech, start-ups, regulatory bodies, solution providers, and investors, spanning CEOs to scientists across R&D and business development. With 60+ world-class speakers across three days and a refreshed three-track agenda, the summit covers the end-to-end mRNA value chain from discovery through to manufacturing and CMC, with dedicated focus days on next-generation delivery and AI-driven mRNA sequence design.

As a reader of Nucleic Acid Insights, you’re entitled to a 10% discount on delegate tickets – just use the code BI10! You can find out more about the 6th mRNA-Based Therapeutics Summit here. Additionally, to find out what other nucleic acid events are upcoming, you can find our online Events Calendar here.