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Rise of mRNA manufacturing

Key takeaways:
  • Current state of the market for mRNA-based medicines
  • Techniques to optimize manufacturing and technical operations for mRNA manufacturing
  • Best in class practices for facility planning, operational readiness and startup
  • Strategies for CQV, quality, automation & engineering for mRNA facilities
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Chad Salisbury

Chad Salisbury

SVP, Project Farma

Chad Salisbury joined Project Farma in October 2022 as Senior Vice President. Chad has over 20 years of experience encompassing gene therapy, vaccines, sterile injectables and small molecules, including the delivery of ~$2B USD of greenfield cGMP manufacturing facilities. Chad has held increasingly responsible management positions in manufacturing, quality, engineering and supply chain.

Chad was most recently VP, Manufacturing at Affinia Therapeutics, a company singularly focused on using innovations in gene therapy to lead the fight against devastating rare and prevalent diseases. Prior to Affinia, Chad held progressive roles at CSL Seqirus, Novartis and Eli Lilly in both the US and Europe.

Chad holds an MBA from Purdue University, an MEM from Duke University and a B.A. from Alfred University.

Aaron Allen

Aaron Allen

Director, Global Quality, External Engagement, Moderna

Aaron Allen is an experienced Manufacturing Sciences and Technology professional with more than 25 years of process engineering, manufacturing and MS&T experience. Mr. Allen has transferred and executed process validation for multiple vaccines within Novartis and Moderna. He recently transitioned to a new role as Global Quality External Engagement.

Mr. Allen’s previous experience includes positions with Diosynth, Biogen, Jacobs Engineering and Novartis Vaccines. Mr. Allen holds a bachelor’s degree in Chemical Engineering from the University of California at Santa Barbara.

Venkata Indurthi

Venkata Indurthi

CSO, Aldevron

Venkata Indurthi, Ph.D., joined the Aldevron team in 2016 after receiving his doctorate in pharmaceutical sciences from North Dakota State University, Fargo, ND. He has held a variety of positions of increasing responsibility, including Senior Scientist in product and process design, Director of RNA Operations, Director and then Vice President of Research and Development, before being named Chief Scientific Officer in 2022.

Indurthi received his Bachelor of Science in Biotechnology from SRM University, Chennai, India, in 2010. He has been recognized with several awards and honors from a variety of organizations and has authored or participated in numerous published articles.

Jane True

Jane True

VP, mRNA Commercial Strategy & Innovation and Global Pandemic Security Lead Pfizer

Jane True is the Vice President for Pfizer mRNA Commercial Strategy & Innovation and Global Pandemic Security Lead. She 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.

Andrew Geall

Andrew Geall

Co-founder and Chief Development Officer, Replicate Bioscience

Dr. Andrew Geall is the Chief Development Officer at Replicate Bioscience and co-founder 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 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 took the company public in June 2020 with an initial public stock offering of $259 million.

Prior to Avidity, he led the development of the mRNA vaccines platform 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.

Anshul Mangal
moderator

Anshul Mangal

President & General Counsel, Project Farma

Anshul Mangal is President of Project FARMA and Precision ADVANCE. Anshul founded and grew PF into a leading global biologics and advanced therapy engineering consulting firm. Under Anshul’s leadership, PF has partnered with over 100+ therapeutic innovators, developed state-of-art manufacturing facilities for complex biologics and pioneered the industrialization of advanced therapies including many commercially approved cell and gene therapies. PF was acquired by Precision Medicine Group in 2020 to be the cornerstone of Precision ADVANCE. ADVANCE is a collection of Precision's services uniquely focused on the complexities of research and clinical development, regulatory, manufacturing, and commercial needs to successfully bring an advanced therapy to market. In addition, Anshul is an investor, board member and advisor at several biotech organizations. Prior to PF, Anshul was a patent litigator at Jones Day and a consultant at Morgan Stanley & Discover Financial Services.