Striking the Right Balance: Regulating AI in Healthcare with Shannon Klinger, the Chief Legal Officer and Corporate Secretary at Moderna

[00:00:00] Hey, everybody.

[00:00:10] Saul Marquez with the Health Matters podcast.

[00:00:13] I want to welcome you back to another episode of the series.

[00:00:17] We're recording live from Las Vegas at the Health 2023 event.

[00:00:21] And today I have Shannon Klinger with us.

[00:00:24] She's the Chief Legal officer and corporate secretary as chief legal officer

[00:00:28] and corporate secretary Shannon leads Moderna's legal governance and corporate compliance efforts and I'm excited to have her join us again

[00:00:37] It's such a pleasure to see you Shannon. It's great to see you as well. Thank you

[00:00:41] Absolutely and look for said having had a chance to learn about you or listen to the previous interview,

[00:00:48] tell us a little bit about what inspires your work in this business.

[00:00:51] Absolutely. For me, it's personal. And I think a lot of people who are in any aspect of healthcare,

[00:00:56] they get there because of an experience that they had.

[00:00:59] And for me, it was my grandmother being diagnosed with Alzheimer's.

[00:01:01] And that was probably now 15 years ago. I had no idea the devastating impact that disease can have on families

[00:01:08] and it was really only when we were at the funeral for my grandfather. I mean she'd

[00:01:12] been married to for 50 years who was actually my personal hero and she leaned

[00:01:16] over to me during that service and said it's really a shame that your grandfather

[00:01:21] couldn't be here that he had to work. It's such a beautiful service.

[00:01:28] And it was in that moment with the capital M that I realized, the devastating impact that Alzheimer's had for her and ultimately for

[00:01:31] us as a family.

[00:01:32] And she lived for nine more months.

[00:01:34] And every day, grieved the loss of her husband of 50 years.

[00:01:38] And it really pushed me to get out of being a lawyer in a law firm,

[00:01:41] which is what I was doing at the time and come to industry to try to figure out how to leverage my talents to make the greatest impact I could for patients.

[00:01:49] That's amazing, Shannon.

[00:01:50] Thank you so much for sharing that.

[00:01:52] It's a personal story, and I really love your motivation, the drive that you have for the

[00:01:57] work that you do.

[00:01:59] How has AI played a role in the evolution of automation in R&D at Moderna.

[00:02:05] Yes, so if you think about Moderna,

[00:02:07] lots of people know who we are today.

[00:02:09] Not so many people knew who Moderna was in early 2020.

[00:02:13] And so for 10 years, Moderna has been innovating

[00:02:16] in the space of Messenger RNA,

[00:02:19] but as a preclinical company,

[00:02:20] one of the biggest challenges that we had was producing

[00:02:23] small scale batches of RNA for our clinical trials. In fact, we were producing something like 30 batches,

[00:02:29] a month which was not going to be enough to sustain what we needed to do as an organization.

[00:02:34] Moderna has been AI core to its strategy, not something that's adjacent, not something that's

[00:02:39] been fashioned forward, but this company from an AI and digital perspective, it's been core to

[00:02:43] what we do. And really leaning in to think about how to leverage AI,

[00:02:47] algorithms and automation in our research manufacturing

[00:02:50] process allowed us to go from 30 batches of mRNA

[00:02:53] to almost a thousand now.

[00:02:56] And we need to continue that if we think about a company

[00:02:58] that in the next five years is going to have more than 50

[00:03:01] programs in clinical development.

[00:03:04] Another thing that we saw leveraging AI and digital technology was during the COVID pandemic.

[00:03:09] It took 42 days from the time we identified the sequence that was going to be relevant

[00:03:14] for our COVID-19 vaccine. From sequence identification to putting that sequence in phase one clinical

[00:03:21] trial, and we all know how quickly that process went rapidly to help

[00:03:25] really open economies and give health back to people.

[00:03:28] It sounds like it's been core and it continues to be core to the strategy and operation of

[00:03:33] how Moderna works.

[00:03:35] What is AI's potential role in reducing costs?

[00:03:38] That's a topic right now that's hot.

[00:03:41] It is, but I'd like to reframe the question because I really don't think it's about cost.

[00:03:44] I think it's about speed to innovation.

[00:03:47] If you think about who we are as a company,

[00:03:49] Mattana's a platform company.

[00:03:51] That means we merged the best of science

[00:03:54] and the best of technology into a single platform,

[00:03:57] leveraging Messenger RNA,

[00:03:59] that we believe can yield hundreds of treatments

[00:04:02] for patients all over the world.

[00:04:03] And so when we lean in and think about speed and impact to patients,

[00:04:08] that's where we really lean in from an AI perspective.

[00:04:10] Give you a couple of examples.

[00:04:12] We have something that we call the mRNA design studio.

[00:04:15] And that really allows us to integrate our messenger RNA design

[00:04:19] with our automation processes.

[00:04:21] We direct orders through each phase of the clinical development,

[00:04:25] use our high throughput screening and manufacturing process to make sure that we can get mRNA

[00:04:31] constructs to the scientists who need them. That becomes really important because as a platform-based

[00:04:37] technology company that happens to play in the biotech space, we also have a program called mRNA

[00:04:42] Access. This program, we open our platform to researchers

[00:04:47] and academic institutions and government institutions

[00:04:50] around the world to see what might they do with messenger RNA

[00:04:54] to battle infectious diseases, to research things

[00:04:57] for unmet medical need, and to be able to do that

[00:05:00] and deliver for those stakeholders through our automation

[00:05:04] and digital platform

[00:05:05] is critically important.

[00:05:06] That's super fascinating, Shannon.

[00:05:08] It's almost like it's an open platform, right?

[00:05:11] Think of it like coding.

[00:05:12] The mRNA is the code and you're inviting collaboration to come up with new ideas and new applications

[00:05:18] to it.

[00:05:19] What role do you think the government should play in regulating AI?

[00:05:24] That's really great question.

[00:05:25] I think it's really important to balance regulation with innovation.

[00:05:30] This is the same answer.

[00:05:31] Almost anyone would give you a crossed industry.

[00:05:32] When we start to find nascent technologies that have become adopted, and how do we think

[00:05:36] about on the one hand ensuring that we protect people?

[00:05:40] We have transparency around the use, for example, of artificial intelligence that we use those

[00:05:45] applications ethically, and in a way that actually is for the public good, we'll, at the same time,

[00:05:50] understanding that too much regulation will actually cut against that speed to mean.

[00:05:55] And days matter for patients. If you have someone in your family who's suffering from cancer, for

[00:06:00] example, every day matters. If there's the possibility to get to a treatment that either can lead to a cure or lead to more time.

[00:06:06] And so I think what we need to really think about is how do we educate regulators about

[00:06:10] the uses of AI in our spaces, come up with smart regulation that has that balance between

[00:06:17] the need to have speed to innovation and the need to ensure confidence in the processes

[00:06:22] that you're using.

[00:06:23] And I think particularly we're sitting here in the United States.

[00:06:25] If we look back at data privacy as an example,

[00:06:28] Europe came out with GDPR and had a national,

[00:06:31] multinational scheme for privacy.

[00:06:33] In the US, we're still struggling to would regulate it from a state level

[00:06:37] perspective as opposed to at the federal level.

[00:06:39] Can we come up with a common standard to regulate AI so that we have a level

[00:06:43] playing field, but we maximize

[00:06:45] the innovative impact for patients.

[00:06:47] Said Shannon, and look, as a tech first company playing in the biotech space, certainly love

[00:06:53] the work that you guys are doing.

[00:06:55] What closing thought would you leave our listeners with?

[00:06:58] At Medarno, we imagine the impossible and make it possible.

[00:07:02] And so I think just continuing to understand that innovation is gonna move much faster

[00:07:06] than any of us can comprehend.

[00:07:07] How do we leverage that for good?

[00:07:09] How do we all come to work every day,

[00:07:11] knowing that what we wanna do

[00:07:12] is make a tremendous difference for people?

[00:07:15] I'm actually on a panel later this afternoon

[00:07:17] with Vanessa Carey,

[00:07:17] and we're gonna talk about how we leverage

[00:07:19] science and technology to build sustainable

[00:07:21] health systems in Africa.

[00:07:23] And I think the power of technology to democratize in our case

[00:07:27] medicines around the world irrespective of where someone was born,

[00:07:31] that they have access to high quality treatments,

[00:07:33] is something that we're certainly looking forward to.

[00:07:35] I love it, Cannon.

[00:07:36] Always inspired by the vision that you put forth.

[00:07:40] When we do these podcasts with you,

[00:07:42] love the work that Moderna's doing to make health better for everyone,

[00:07:46] and I can't thank you enough for being with us today.

[00:07:48] Thank you so much.