A Spy At Moderna
By Louis Garguilo, Chief Editor, Outsourced Pharma
Jason Kerr of Moderna is a snoop, a spy, a watcher of all things.
More officially, he’s tasked by his employer with “monitoring for regulatory changes in the environment.”
“Some folks do call it regulatory surveillance,” he says, playing along with my drama. “Some just regulatory monitoring.”
On the org chart, Kerr is Senior Manager - Regulatory Intelligence and External Engagement.
First (and ongoing), evaluate for any changes in the regulatory environment, whether new laws, regulations, guidance, or documents issued around the world, to assess whether they are or may impact his company;
Then effectively relay that information to Moderna’s key subject matter experts (SMEs) who need to be aware of said alterations.”
For those regulatory and research/data-minded readers who might be thinking, ‘Hey, that sounds like a cool job,” allow me to tell you what qualifications Kerr brings to his role:
- BS, Biochemistry, UCLA
- MBS, Masters of Business and Science, Keck Graduate Institute
- MBA, Quantic School of Business and Technology
- Certificate, Bioscience Industry Law and Practice, Southwestern Law School
Intelligence gathering roles are increasing as company size and complexity in products increases, requiring a vigilant state of monitoring. However, as of today, “It’s definitely not a well-recognized or consistent job posting,” Kerr says.
Those that do deal with regulatory intelligence usually sit on the QA side of things, or in Regulatory Affairs, however, Kerr believes, “Where we sit rarely matters.”
“What matters is being able to monitor for external changes and retrieve information to mitigate risks, especially in accordance with ICH Q10.”
Key areas for monitoring are GDP (Good Distribution Practice) and GMP related developments.
SME Help On The Way
Where Kerr’s accumulated information meets the rubber is with his SMEs at Moderna.
For example, he mentions scientists at Moderna dealing with microbial contamination in facilities or specific batches.
“They're focused on ensuring their contamination program is operating effectively and efficiently, and at our contractors’ manufacturing sites as well.”
“They have competing priorities that may not allow time to constantly read the latest and greatest being pushed out by all these global regulatory agencies. That’s a way I can come in and support my colleagues.”
Other SME colleagues he performs research work for deal with vendor management, stability studies, quality metrics, process development, validation, “all these areas and processes.”
“There are hundreds of regulatory agencies out there,” he says, and mentions in the EU alone there are 27 member states and their equivalent health authorities; “authorities in Canada, Japan, China, and what about the rest of the Asian Pacific – Australia, New Zealand … did I mention the WHO?” he says with a laugh.
“It’s near impossible for our professionals to do this monitoring and perform their daily activities and responsibilities.”
“When I read a particular section of some report that has an impact to a process area, I’ll quickly relay that information to colleagues,” Kerr explains.
“That keeps them in the loop in terms of changing environments, and whether it’s a guidance, law, or regulation, they can assess if it poses a risk or opportunity for us.
“If at times I have more experienced in a particular area, than I’m able to also provide guidance to our SMEs.”
And that info/guidance gets distributed to current CDMOs and all other external partners.
I’ll interject here that if Kerr’s colleagues at Moderna are occupied with daily work and find it difficult to keep up with worldwide alterations in quality and regulatory policy, consider the SMEs at the CDMOs.
From experience (and years following drug development and manufacturing outsourcing in this role), I can attest to the workloads at CDMOs. They should be open-arms to receiving input from a client like Moderna.
Gathering Information
Kerr provided me with the EU’s Annex 1 (Manufacture Of Sterile Products) as an example where he uncovered some “stipulations,” and sent his analysis to experts at Moderna, who then sent it to their CDMOs, with such questions as:
How are you planning to comply with XXX in Annex 1?
What’s your process for implementation?
What are your measurements for completion, and mitigation strategies?
Kerr has also published a paper in a PDA newsletter that touches on how he acquires information. You can access that here, and here. Within he includes sections on tools he uses to monitor for changes of regulations and in guidance documents.
Nomenclature-wise, he rolls all changes up into, simple enough, regulatory information. Information could be sourced from official postings of new laws; agency or other pharma-related blogs; guidance documents; CFR changes; et cetera.
Of course, Kerr says, you can go directly to the relevant regulatory agency’s website. The EMA has a What’s new page. The Federal Register is a “very good place to keep track of any changes in the FDA’s issued guidance documents and other proposed rulemaking.”
Often, regulatory agencies will have their own RSS feed for alerts to many changes.
There are also subscription services. The three major ones that Kerr likes are: Redica Systems, Cortellis (Clarivate), and Tarius (Iqvia).
“I particularly like Redica Systems, because I worked there for a couple of years,” says Kerr. “But all these subscription services can help keep track of the changes in the regulatory environment.”
Mature Intelligence
Gathering intelligence is one thing, “effectively keeping track of it is another ballgame,” Kerr says with a laugh. One technique he uses is what he calls “maturity tracking.”
- A low maturity tracking event is essentially receiving an email of a new change that is forwarded to a process expert to consider. It resides in email if needed again. We all know how easy the Outlook search functionality is to find that email again…
- A higher maturity tracking is, for example, an Excel table for keeping track of changes; a next level maturity could be something such as a SharePoint application hosted on a cloud-server where multiple stakeholders can participate live.
- The highest maturity is a personalized tracking system, or dedicated software application used ostensibly for the entire company to closely track all regulatory information, and how the company is reacting to it and its effectiveness.
Odds are we'll see more positions in our industry – on both the sponsor and CDMO side – for snoops, spies, and watchers of all things, like Kerr at Moderna.
One-hundred percent certain is we will hear more from him in part two.