Experts at Bio-Manufacturing Event Discuss Bringing Vaccines to Market

Against the backdrop of Pfizer’s announcement this week of a promising COVID-19 vaccine, BioNJ, the trade group for the biotech life science industry in New Jersey, held a virtual event today to discuss a “new normal” in bringing vaccines to market, including how the public and private sectors can work together to make the process faster and more efficient without sacrificing safety and effectiveness of vaccines and therapeutics.

“I’ve been in the business for 40 years, but in looking at speeding up the process, I can say it’s a brave new world for all of us,” said Thomas Warf, a consultant for BARDA (Biomedical Advanced Research and Development Authority), which is part of the US Department of Health and Human Services (HHS). Warf is one of several experts who came out of retirement to help with Operation Warp Speed (OWS), the public–private partnership initiated by the Trump administration to facilitate and accelerate the development, manufacturing and distribution of COVID-19 vaccines, therapeutics and diagnostics.

According to Warf, money and procedures coming from HHS and the Department of Defense (DOD) are being used to ensure on-time delivery of a promised treatment supply, with the DOD playing a critical role in getting materials in short supply across the border. At the same time, OWS will be leveraging lessons learned from H1N1, Ebola and Zika and linking its Enterprise Resource Planning (ERP) with those of the pharmaceutical companies to facilitate the process.

“It’s not just 10 million or 20 million doses – there are 330 million Americans with 660 million doses of the vaccine needed – and 660 million doses has never been done before,” he said. “OWS leadership will continue to engage with key suppliers – many of which are located in New Jersey – to ensure the materials supply as candidates refine their manufacturing plans. It’s not an easy matrix to decide who gets what, especially with many targets, as the virus moves through the country in a third wave.”

Public-private partnerships in the industry are nothing new, Warf said. For more than a decade, Warf has been working with Sanofi, a global biopharmaceutical company focused on human health, with US operations headquartered in Bridgewater Township.

Mireli Fino, Sanofi’s site head, Protein Sciences, spoke at the event about what she called a “crazy nine months” with COVID-19, which has underscored a need to speed up vaccine development and its exploratory, pre-clinical, clinical and regulatory phases.

“There’s been a fundamental paradigm shift; we cannot take 10 years to develop a vaccine for a disease creating such problems for the whole world,” she said. “The question was how to compress the timelines while managing risk.”

According to Fino, Sanofi used its infrastructure and existing platform to deliver a vaccine more quickly, working on developing the vaccine and securing dose access while not yet knowing if the vaccine is safe and effective. “With speed being key, you can’t have endless meetings, so we’re leveraging technology to provide communication, accomplishing the same goals while compressing this step.”

Also during the event, Andrea Gennari, MBA, partner, McKinsey & Company, gave an overview on how biopharma manufacturing is being reimagined in the age of COVID-19 – siting five specific trends: accelerated drug development and speed to market; the explosion of cell and gene therapy, which will account for one-third of product launches with $30 billion to $65 billion forecasted revenues by 2026; new horizons achieved through biopharma, including lowering the cost of raw materials and increasing labor productivity; and the digitalization of manufacturing across the industry.

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