Jane True, Dr Andreas Kuhn, and Dr Andy Geall discuss mRNA risks, costs, effectiveness, manufacturing logistics, public messaging, and regulatory challenges.
Buy, Sell, Hold is a rapid-fire expert panel covering a single topic, such as lipid nanoparticle delivery, supply chain resilience, cell and gene therapy (CGT), or aseptic filling. Panelists first respond to quick-hit questions with a buy, sell, hold format before being allotted more time to share more considerate responses to complex topics.
While finance and investment perspectives flavor the discussion, science and pragmatism are the main ingredients driving these dynamic panel discussions.
The lively panel discussion covered risks for genomic integration, pandemic use preparedness, mRNA’s cost effectiveness as a medicine, current effectiveness of LNPs, mRNA's use in tandem for combination therapies – especially gene editing combinations – and the situation around, and need for, standardized potency assays. The panel also delved into the near-term likelihood of miniaturized manufacturing and/or continuous manufacturing, which included mention of BioNTech BioNtainer and Cytiva’s KUBio.
More lengthy responses were given to the role and composition of the Alliance for mRNA Medicines. Building off the strong general vaccine public awareness by using physicians to better message the public – are there better alternative approaches, such as university student advocacy? How to place mRNA as part of the larger push toward synthetic biology and digitalization, and industry 4:0 generally speaking, are covered alongside current regulatory certainty and length to final approval.
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Featured Experts:
Jane True, Vice President for Pfizer mRNA Commercial Strategy & Innovation and Global Pandemic Security Lead
Jane leads a team responsible for mRNA platform, pipeline, and product strategy. Jane’s team has also led the charge on Pandemic Preparedness, preparing the global community for future pandemics and achieving pandemic security. Jane has 20 years of experience in pharmaceuticals with a focus in vaccines commercialization. She has worked with various vaccine manufacturers across pediatric, adult, travel and endemic vaccines. Prior to joining Pfizer, Jane was VP of Commercial Development at Seqirus, Inc. (part of CSL) where she was responsible for portfolio and pipeline strategy including mRNA, global marketing, global market access (pricing, HEOR, access and reimbursement), competitive intelligence, and commercial analytics. Prior to Seqirus/CSL, Jane spent most of her time in strategy and operations consulting as an independent consultant, and also with PwC and Capgemini Consulting. Jane holds a BA and Master of Music degree from Binghamton University (State University of New York) and received her MBA from New York University Stern School of Business.
Dr. Andreas Kuhn, SVP RNA Biochemistry & CMC Management at BioNTech SE, Co-Founder Alliance for mRNA Medicines (AMM)
Andreas has worked in the field of RNA biochemistry and molecular biology for more than thirty years. His work on mRNA-based immunotherapies began in 2007 in the academic group of Ugur Sahin at the University Clinic Mainz, and Andreas joined BioNTech SE shortly after its founding in 2008. In his current role as Senior Vice President, RNA Biochemistry & CMC Management, the main focus is expanding proprietary technologies to increase the efficacy of mRNA-based therapies and to optimize GMP-compatible manufacturing processes for RNA. He has co-authored numerous publications and patents ranging from basic research on RNA to its application as a therapeutic agent.
Dr. Andy Geall, Co-founder and Chief Development Officer at Replicate Bioscience, Inc., Chairman of the Board, Alliance for mRNA Medicines (AMM)
Andy is the Chief Development Officer at Replicate Bioscience and cofounder of the company. Dr. Geall has over 20 years of professional experience in the development of drug delivery systems and is a pioneer in the fields of mRNA vaccines and nucleic acid delivery. He is an inventor on 41 patent families, with 505 applications and 203 issued patents in multiple jurisdictions.
Prior to joining Replicate, Dr. Geall was Chief Scientific Officer at Precision NanoSystems Inc. (PNI). Here, he was focused on the creation of transformative nanoparticle medicines using their proprietary LNP delivery systems and microfluidic formulation platform. He has also held positions as Vice President of Formulations, Analytics and Chemistry at Avidity Biosciences, where he pioneered the development of their antibody-oligonucleotide conjugate delivery platform. As a member of the Executive Management, he helped raise over $100 million in venture capital and take the company public in June 2020 with an initial public stock offering of $259 million. Prior to Avidity, he led mRNA vaccines in the Vaccine division of Novartis. Over 7 years, he created a global team and was Principal Investigator on a Defense Advanced Research Project Agency (DARPA) contract to develop self-amplifying mRNA vaccines. Dr. Geall also had a two-year tenure at Novartis Pharmaceuticals AG, where he was the Global siRNA Formulation Team Leader, responsible for the design and implementation of the siRNA delivery strategy.
Dr. Geall received his pharmacy degree from the University of Bath in the UK and went on to do his pre-registration training, as a hospital Pharmacist, in the aseptic dispensing unit at St Helens and Knowsley Trust Hospitals. He then obtained his PhD at University of Bath in non-viral gene delivery.