Q&A With Leslie Orne, CEO of Trinity Life Sciences

Earlier this year, Leslie Orne became the new CEO of Trinity Life Sciences, a provider of global life sciences commercialization solutions. She spoke with Pharmaceutical Executive about current trends in the life sciences industry and the ways that companies can react.

Pharmaceutical Executive: What are the most significant trends that you see in the pharma industry for the coming year?

Leslie Orne: That is a big question. We consider ourselves to be market watchers, that’s what we’ve done and that’s what we do. For instance, every year we publish our annual drug index, which looks at that year’s product launches and how they performed in the market. Once the rubber hits the road and the drugs are actually marketed, what goes wrong and what goes right? I can tell you, for the last two years, unfortunately we’ve seen a lot of commercial turbulence facing the market.

Specifically, we’ve seen tremendous scientific innovation going on, including gene therapies, cell therapies, and personalized therapies of all kinds that are reaching very rare patients that didn’t have anything else. The commercial innovation, however, is really lagging. What we’re seeing in the market is that these commercial headwinds for new drugs don’t seem to be going away. We see this continued dichotomy between great science being developed in the lab juxtaposed against this relative difficulty getting those drugs out into the market and wide world.

We’ve been looking a lot at why that might be the case, and I think there are macroeconomic headwinds, interest rates, public markets, global events, and other things that are straining the market. The real change facing commercial assets and biotech today is the payers and, specifically in the US, the inflation reduction act (IRA).

We’re seeing the IRA infiltrate all the way down, impacting what drugs get developed, chosen for launch, and how they’re commercialized. That’s one of the biggest trends we’re going to have to wrestle with, not just in the coming year but going forward. How is the industry going to get ready for potentially reduced margins and profitability as soon as 2026. We see a lot of our clients really digging deep to think about how they make decisions, deploy capital, and how they rewrite a launch playbook.

I don’t think that’s going to go away. If anything, the trend towards commercial innovation has been lacking in recent years. We’re going to have to figure out how to do more with less in terms of getting these great scientific discoveries out into the market. You’re going to see less reps and less mass market, direct-to-consumer campaigns where we know that the ROIs on those campaigns are questionable.

PE: What are some strategies that drug developers can use to stay ahead of these problems?

Orne: Staying ahead is hard in this ever-changing market. Two things come to mind. Number one, we talk about making commercial decisions based on an intensely data driven process. We are big believers in letting the data drive decisions. The second part is being more patient centric. The patient needs to be at the center of the services and models by which we’re engaging with the healthcare community.

The pharma industry is swimming in data right now. This data is coming from every CVS and retail outlet, every supply chain provider, all the way down to unstructured data coming from wearables and physician charts. I don’t think pharma has figured out how to funnel that data into a usable framework. Organizations are going to have to lean into harnessing and democratizing that data and making it available to the lay person who isn’t a scientist.

Pharma companies and all sorts of life sciences companies spend a lot of money trying to service a patient or consumer in ways that they don’t want to be serviced. We really need to put the voice of the patient into the process from clinical trial design, launch planning, and marketing campaigns and really listen to their voices.

PE: Should pharma companies be more willing to share their data?

Orne: There are many types of data. If you’re talking about clinical data, then yes. Governments have been mandating more disclosure. Liberating that data for everyone to learn from is very important. Even more so, people think that data is finished once a study is finished or has wound down, but data is produced for drugs in the real world all along the spectrum.

Once we get in that kind of data, that is actually representative of patients in the wild, we can see that data. It’s becoming more and more available. Once we’re post-market, we can really start to see that data and use it. Nonetheless, it’s so unstructured and plentiful, so people are having a hard time figuring out how to use it. Once we get into that commercial phase, it’s really important to know what question you’re trying to answer. What’s the use case? Is it about optimizing the sales force? Is it about figuring out what channel to get through to patients and demonstrate the value of the drug? How do we prove value-based care?

Data can be used for each of those cases, but not the same data. That’s the challenge.