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- Issue 4 Week 2
Issue 4 Week 2
Victor Anderson
July 24, 2024
Shop Floor Scoop
Did Yellowstone just explode? Let’s hope there weren’t any skilled operators there because they are a hot commodity today. Also, I need some friends like NIST: good news for a select few, if you can make the cut.
Today’s email includes:
A race for AI grants: NIST is offering $70 million to improve U.S. manufacturing with AI over the next five years.
New biosimilar guidelines: The FDA issued new guidelines to help biosimilar drug makers report changes in their manufacturing process.
Closing the A&D talent gap: The aerospace and defense industry needs to focus on five key areas to find and keep skilled workers.
A RACE FOR AI GRANTS
Scoop Alert: $70M AI Boost for U.S. Manufacturing
Got a passion for AI? The U.S. Department of Commerce’s National Institute of Standards and Technology (or – NIST – if you don’t want to hurt your brain) just dropped some major news that could be your ticket to innovation paradise.
NIST is throwing down a whopping $70 million over the next five years for a new Manufacturing USA institute. The goal? To supercharge U.S. manufacturing with AI, making it smarter, faster, and more resilient.
The Deets:
Funding: Up to $70 million from Uncle Sam, with a catch—you need to bring in some non-federal cash too.
Purpose: Leverage AI to boost manufacturing productivity and resilience, especially when the supply chain gets wobbly.
Target Audience: Accredited universities, U.S.-based non-profits and for-profits, and government bodies.
Why It Matters
According to U.S. Secretary of Commerce Gina Raimondo, AI can be a game-changer for manufacturing. Think better, faster, stronger production lines. But we need to play it smart to maximize benefits and minimize risks.
Laurie E. Locascio, NIST's top dog, says this new institute is all about beefing up the U.S. economy. It's about helping manufacturers use AI to stay ahead, especially when things go sideways.
What’s the Plan?
The institute will focus on:
Tech Development: Pushing the AI envelope in manufacturing.
Workforce Training: Making sure workers have the chops to handle new tech.
Infrastructure: Building the backbone for AI-driven manufacturing.
How to Get in the Game
This is a two-stage competition:
Concept Papers: Due by September 30, 2024. Bring your A-game.
Full Proposals: Only the best concepts move on to this round.
Winners will get to build a public-private partnership, mixing minds from industry, academia, and government. The aim is to create AI-driven manufacturing solutions that are cost-effective and scalable.
Who Can Apply?
Accredited institutions of higher education
U.S.-based non-profit and for-profit organizations
State, local, territorial, and tribal governments
NIST will also host a webinar and an in-person proposer’s day to give you the lowdown on how to apply.
Next Steps
Head over to Grants.gov for all the juicy details. If you’ve got a killer AI idea that can revolutionize manufacturing, this is your shot.
WHAT’S TRENDING?
🚨Breaking News from Yellowstone: Eruption Sends Tourists Running🚨
CHEYENNE, Wyo. (AP) — Imagine this: a peaceful stroll through Yellowstone's Biscuit Basin, when suddenly, BOOOOOM! A surprise hydrothermal explosion at 10 a.m. Tuesday sent steam, water, and rocks flying high into the sky.
Tourists on a boardwalk near the famous Old Faithful Geyser couldn't believe their eyes. As debris started raining down, panic set in. Cries of "Back up!" and "Run, run!" filled the air as people scrambled to safety under a massive cloud of steam.
Thankfully, no one was hurt, but the boardwalk took a hit. Photos show busted guardrails and planks covered in rocks and dirt. The area is now closed for safety.
Scientist Mike Poland from the Yellowstone Volcano Observatory says the explosion was likely caused by a clogged passageway in the park's geothermal system. Think of it like a pressure cooker suddenly releasing steam—BOOM!
Poland estimated the blast shot stuff about 100 feet into the air. While it was a pretty big show, Yellowstone's had bigger. The largest crater from such an explosion is 1.5 miles across and was formed 13,800 years ago.
This latest explosion happened at Black Diamond Pool, enlarging it and turning the water muddy. Park geologists are on the case to figure out what exactly happened.
Yellowstone sits on a huge, dormant volcano, but don't worry—this blast doesn't mean it's waking up. The volcanic system is still at normal levels, according to the U.S. Geological Survey.
A reminder: stick to the boardwalks! At least 22 people have died from thermal feature injuries in Yellowstone since 1890. So, next time you visit, be careful out there!
Stay safe and stay curious!
NEW BIOSIMILAR GUIDLINES
FDA's New Biosimilar Rules
On Monday, the FDA dropped some new draft guidance that’s going to shake up how manufacturers report changes for biosimilar and interchangeable products. Here’s the lowdown.
The Basics: The FDA’s draft is in a Q&A format, addressing all those burning questions about post-approval manufacturing changes. This update is part of a promise they made under the Biosimilar User Fee Act (BsUFA III) for 2023-2027.
What's New?
Reporting Categories – The FDA splits changes into three groups:
Major Changes: Need a Prior Approval Supplement (PAS).
Moderate Changes: Require a Changes Being Effected-30 days supplement (CBE-30).
Minor Changes: Just an annual report will do.
Why It Matters
The draft guidance helps manufacturers understand what they need to do when tweaking their products after they’ve been approved. The rules now also cover interchangeable biosimilars, not just regular biosimilars.
Key Points
Comparability Studies: Manufacturers should use top-notch, in-house reference materials to compare before and after changes.
Multiproduct Manufacturing: There are new rules for introducing a biosimilar or interchangeable product into a facility that makes multiple products. It’s all about managing risks and ensuring quality.
Guidance Galore
The FDA suggests checking out these three key documents for more details:
1997 Guidance: Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products.
2021 Guidance: CMC Postapproval Manufacturing Changes for Specified Biological Products to be Documented in Annual Reports.
2021 Guidance: Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products.
International Tips
They also recommend looking at the International Council for Harmonization’s (ICH) Q5E guidance on biotech comparability from 2005.
If you’re in the biosimilar biz, these changes are a big deal. Make sure you’re up to speed!
CLOSING THE A&D TALENT GAP
Aerospace & Defense Talent Crunch
The aerospace and defense (A&D) sector is hitting some serious turbulence. With air travel bouncing back to pre-pandemic levels and rising geopolitical tensions boosting defense spending, the demand for A&D products is through the roof. But there’s a snag – there’s just not enough talent to keep up.
What’s Happening?
1. Skyrocketing Demand:
Air travel is back.
Defense spending is up, especially in Europe.
Orders for A&D products are surging.
2. Talent Shortage:
Finding skilled workers is tough.
Companies are struggling to compete for top talent.
The result? Production delays and performance issues.
Why It Matters
For A&D companies, the talent gap is a big deal. Those that nail their talent strategy see better returns. Closing this gap could mean over $300 million in potential savings and performance boosts for a mid-sized A&D company.
The Challenges
Skill Shortage: There aren’t enough skilled workers to meet demand.
Employee Retention: Many managers are leaving, taking their expertise with them.
Cultural Differences: In Europe, employees value career growth; in the U.S., flexibility is key.
Five Talent Imperatives
Here’s what A&D companies can do to bridge the talent gap:
Identify Talent Needs: Understand what skills are missing and plan for the future.
Streamline Hiring: Make hiring fast and efficient.
Reskill Employees: Invest in training to upskill current workers.
Boost Culture: Create a workplace where employees feel motivated and valued.
Transform HR: Make HR a strategic partner in talent management.
Looking Ahead
The A&D industry needs to adapt quickly. As older workers retire, new employees bring fresh perspectives, but also challenges. Companies that act now will turn these challenges into opportunities and stay ahead of the curve.
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