The future of market access belongs to organizations that plan years in advance. In this episode, Steve Mather, Global Practice Lead of Strategy and Insight at Lumanity, explains why pharmaceutical companies must prepare now for major market access changes coming in Europe and beyond. He highlights that Joint Clinical Assessments for rare disease assets, beginning in 2028, will require earlier planning, stronger governance, and more integrated evidence-generation strategies. Steve also discusses the complexity created by varying country-specific care pathways, limited comparators, and the growing importance of real-world evidence in rare disease development. Across policy shifts like JCA, IRA, MFN, and new European pharmaceutical legislation, the central message is clear: organizations that anticipate earlier will be better positioned to succeed. Tune in to hear how the future of rare disease market access is being reshaped, and why companies that prepare earlier will have a major strategic advantage! Resources: Connect with and follow Steve Mather on LinkedIn. Follow Lumanity on LinkedIn and explore their website! Learn more about this series we&#x27;re doing with Lumanity here: https://lumanity.com/commercialization-podcasts/

Policy Convergence and the Future of Pharma Value Creation with  Steve Mather, Global Practice Lead of Strategy and Insight at Lumanity

Outcomes Rocket

# Full Transcript

**Podcast:** Outcomes Rocket

## Participants

- **Saul Marquez** (Outcomes Rocket)
- **Steve Mather** (Lumanity)
- **Steve Mather** (Lumanity)

## Transcript

Hello, everyone, and welcome back to the Outcomes Rocket. I'm Saul Marquez, and I am so excited to be doing another episode on a series we're doing with the team at Lumanity on building pharma brands that win. It's a six-part series that focuses on commercial success in pharma. And today, I have the privilege of hosting Steve Mather on the podcast. He's the Global Practice Lead for Strategy and Insights at Lumanity.

And we'll be covering volatility to value. It's time to rewrite that playbook for development. So I'm excited to have you on the podcast, Steve. Thank you so much for joining us. Thank you, Saul. Good to be here. Looking forward to hopefully giving some pearls of wisdom and some pointers to people who are listening to us today in thinking through how we make decisions earlier in that process of development and commercialization to get a better result with regards to ultimate value we can put around our assets.

Yeah, it's going to be a value-packed topic. You just sort of came from Reuters where you had this discussion. So I'm excited to have it as an extension of that talk you had there. Before we kick it off, Steve, give us your background. Tell us about you and what brought you into the business.

Very good, Saul. So I've been in the pharma industry knocking on for 40 years now. I came out of an academic background in microbiology. I spent 25 years working in pharmaceutical companies and the bulk of that time was at Sanofi, always in commercial roles.

And about 14 years ago, I made the transition into strategy consulting. And I now lead the business that is Lumanity Strategy Insight Practice that covers our various faces of strategy consulting and primary research function. That's great, Steve. You know, with a background like that, it's definitely a position of trust that you hold. So I'm excited to have this conversation with you.

You know, there's been a lot of policy change happening right now. And the way pharma and biotech need to be thinking about both development of assets and commercialization has fundamentally changed. Talk to us about the implications.

Yeah. So let's first of all, think about the policy changes themselves. You know, the implications of needing to make early commercial decisions is nothing new. That's something that has been developing ever since I came into the industry.

The very specific things that are going on right now. It's almost like an acceleration of climate change for the farmer industry. And it will have that sort of seismic effect in really irreversible impacts that are requiring a rethink in how we create value in our assets and portfolios.

We've got a convergence of multiple policies all at the same time. And I'll speak to a couple of those. We've got the IRA launched several years ago in the States. The impa...

Policy Convergence and the Future of Pharma Value Creation with Steve Mather, Global Practice Lead of Strategy and Insight at Lumanity

Transcript

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Policy Convergence and the Future of Pharma Value Creation with Steve Mather, Global Practice Lead of Strategy and Insight at Lumanity

Transcript

Built for investment professionals

Every day you wait, your competitors are findingedge in conversations you're not hearing.

Every day you wait, your competitors are finding
edge in conversations you're not hearing.