Welcome to CPhI week: The drug manufacturing industry’s premier conference kicks off with the winds of change blowing

November 10, 2021 11:59 AM EST

Welcome to CPhI week: The drug manufacturing industry's premier conference kicks off with the winds of change blowing

Kyle Blankenship

Managing Editor

Welcome to CPhI week!

Tuesday marked the opening of this year’s CPhI Global conference in Milan, Italy, in what marks its return to an onsite event for the first time since 2019.

In many ways, this year’s CPhI is different for us here at Endpoints News. We aren’t on site — as we certainly plan to be next year — so we can’t give you the inside scoop you can expect in the future. However, our team has been closely following the biggest trends from the past year and are staying abreast of what CPhI’s stable of experts are saying about the future of the industry.

First, managing editor Kyle Blankenship dives headfirst into some of the biggest trends from the past 12 months in the manufacturing industry — and a few things to expect in the year ahead.

Then, in the first of a series of trend pieces, manufacturing reporter Josh Sullivan looks at the growth of the CMO industry, which is poised to take its place among the big dogs in terms of manufacturing capacity in the coming years.

Josh then dives into the future of automation in biopharma, the growing role of contract manufacturing in China, the sky-high confidence the industry has going into 2022, and finally the lingering effects an inspection backlog could have on the industry writ large.

As always, if you have any feedback, we’d be happy to hear from you. Enjoy CPhI, and if you’re in Milan: Ciao!

AUTHOR

Kyle Blankenship

Managing Editor

kyle@endpointsnews.com @ka_blankenship

Kyle Blankenship on LinkedIn

Alexander Lefterov/Endpoints News

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He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Graphic: Alexander Lefterov for Endpoints News

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“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Lonza

Portsmouth, NH, USA

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The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Backed by Bayer's Leaps, Boston-based Cellino lands $80M for cell therapy-in-box

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The summer before Cellino CEO and co-founder Nabiha Saklayen started at Harvard, she lost her grandmother following complications to diabetes. Before then, she hadn’t taken a biology class since ninth or tenth grade — the mark of a classic physicist — but it was then she decided she wanted the rest to sit at the intersection of the two for the rest of her career

Combine that with being across the way from the University’s stem cell institute in Cambridge, and you get the birth of Cellino, an autonomous cell therapy manufacturing company that just announced the closing of its Series A.

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The South San Francisco-based company, which landed NIH money in a Shark Tank-style program for Covid-19 testing, announced that it will take on an investment worth $250 million from Casdin Capital and Viking Global Investors. It will also rebrand, and call itself Standard BioTools. The investment will help the company focus on the highest growth areas of discovery and development and expand its CRO and CMO service providers. Right now, the company’s customer reach is limited to basic research, it said.

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January 24, 2022 08:09 AM EST

Manufacturing

FDA's domestic inspection hold will continue until February

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Amid a backlog of inspections, the FDA has announced that it will extend its pause of domestic inspections not considered mission-critical due to the outbreak of the Omicron variant.

While the agency will continue both foreign and domestic inspections deemed mission-critical, others will be paused through at least Feb. 4, and restart as soon as possible after that.

Previously planned foreign inspections will carry on as long as they’re in a country that has been cleared, and are within the CDC’s Level 1 or Level 2 Covid-19 travel recommendation — otherwise, they’ll be rescheduled. The FDA hopes to return to a regular cadence for foreign inspections in April.