2025: Navigating Partnerships Amid Political And Economic Shifts
By Louis Garguilo, Chief Editor, Outsourced Pharma
Buckle up for a potentially turbulent 2025.
That’s the collective message from members of our Outsourced Pharma Editorial Advisory Board.
They reveal a landscape where geopolitical tensions, new political administrations, a slew of emerging technologies and regulatory adaptions affect how you outsource drug development and manufacturing.
You may already consider outsourcing and working with CDMOs as rather challenging, but the road ahead is apt to be somewhat more unpredictable.
For (obvious) starters, the meteoric rise of GLP-1 drugs has spurred a flurry of activity in development and manufacturing. We should expect a surge of "me-too-like" drugs to hit various patient markets.
Whether you are or are not on any such GLP-1-related path, this competitive rush may influence how much capacity is available at CDMOs overall – particularly when simultaneously the BIOSECURE Act’s China-squeeze is in play. (That in a moment.)
Potential silver lining?
This innovative GLP-1 storm – as well as RNA and other cell and gene therapy advancements – may produce breakthroughs in manufacturing efficiencies, and perhaps force the build out of more capacity at CDMOs in the U.S. and Europe.
Presidential Political And Regulatory Acts
Regulatory uncertainty is always a serious contemplation. Now, as we head into a new U.S. presidential term, the stakes are perhaps particularly high.
With once-and-again President Trump – RFK Jr., and new leaders throughout the healthcare-related political infrastructure – the industry can expect bouts of, shall we say, shakeups.
A good strategy as the ground shifts?
Our Editorial Board says stay firmly connected to your CDMO partners.
Whatever does materialize, if you communicate well and stay aligned, you’ll mitigate challenges should they arise.
Oh, and keep an eye trained on the BIOSECURE Act.
If that legislation passes — especially in a more restrictive form — supply-chain scrutiny must intensify (if it hasn’t already).
In fact, one Board member avers the most important question for 2025 is:
“Where is our supply-chain risk analysis?”
Everyone from investors on will demand an elevated diligence from biotechs. Says one Board member: "If I were a VC, I’d absolutely want to see that risk assessment before writing a check to any biotech.”
Supply Chain De-Risking: The China Conundrum
A recent Wall Street Journal headline stated, “US Drugmakers Are Breaking Up With Their Chinese Supply-Chain Partners.” That nicely captures the mood.
Big Pharma, for example, are creating separate supply chains for China markets and all others.
But in 2025 all sponsors – emerging biotechs to Big Pharma – will need to rethink and reconfigure global supply strategies.
Unfortunately, this never comes simply, or cheaply.
Where in fact do you go if China was part of your plan? India maybe, or closer to home?
Some suggest we will see an accelerating trend toward tighter regional supply chains.
But nobody at this point knows if, for example, U.S.-based CDMOs can generate enough capacity – and desirability as partners of choice – to absorb new demand. How about the titans of Europe?
Reshoring today presents significant challenges, for example, in sturdy infrastructure and workforce development. The next few years will reveal the winners and losers in a reshaped global landscape.
I for one suggest there will be more winners than the less fortunate.
Over decades now, our development and manufacturing outsourcing model has proven adaptable, scaleable, resourceful, and resolute in solving for the challenges of the biopharma industry – and patients.
All the challenges being heaped on 2025 and beyond may, conversely, unite us as an industry more than ever before.
AI’s Double-Edged Sword
Obviously, artificial intelligence is another factor poised to insert significant change into our world. But we need to understand the intelligence we are provided.
“AI-infused research and process development will lead to better outcomes in yields and potencies," says one Board member, "but it will also raise numerous questions on how the heck it worked to get us to those outcomes."
For example, mRNA-based technology is a complicated science we’ve developed for some 15 years or more.
“Imagine in a ten-minute AI computer analysis many of our assumptions go right out the window.
"The catch is this ‘black box’ problem. How do you transfer AI-derived insights to CDMOs, or even more importantly, explain them to regulatory agencies?”
The optimistic view is AI will enable “near real-time data sharing between CDMOs and clients,” potentially transforming project management along the way. And AI will better organize and parse our data for the regulatory agencies.
But as we automate, the Board warns, we must be vigilant.
“AI is a tool, not a replacement for human expertise. Scientists, project managers, and agencies still have to clearly understand the science, results, and how we get those results.”
A Call to Action
So as you head out this early January to renew your outsourcing activities, here’s a piece of advice from another Board member.
Be it the BIOSECURE Act or other situations, "what is decided ultimately impacts the drugs and therapies we are able to bring forward in the pursuit of helping patients.”
He encourages everyone to stay engaged with the political process.
“Lobby in your own way for our industry, and patients, who will suffer the most from any lost clinical research or optionality.”
Looking back a decade from now, let’s hope that during this critical period, we don’t recall how political and economical conditions, and our industry’s lack of reactions to them, led to missed opportunities or drug products.
That challenge should be sufficient to get us all going full force into the new year.