Table of Contents
Paula Brown Stafford, CEO of Allucent, sat down with Onyx for a feature-length interview.
You’re something of a veteran in this industry with a huge breadth of knowledge which we’ll come on to. Drawing on that experience, how different is it for smaller biotechs taking drugs through the clinical stages compared to big pharma?
Well, these small and mid-sized biotechs really hold much of the life sciences industry's intellectual property. But they often lack the large teams needed to take a product through phases 1, 2, and 3. There are different skill sets required, and these companies focus on building product candidates.
It's hard for them to have everything they need in terms of location and skill set because they’re just getting started. We're in a position to help them because we have a broad global reach, and we have the ability to fill the gaps.
We're not one of the big CROs that work only with big pharma companies. We can be nimble with our customers. Once big pharma acquires a product, the pathway is more linear. But for biotechs, it's just not a straight line.
They’re going to need different skills at different times. That's where we at Allucent can provide what these companies need when they need it.
Unfortunately, a lot of small biotechs fail. Why is that?
Drug development is not for the faint of heart. Success depends on so many factors—manufacturing, clinical trials, non-clinical trials, and there are opportunities for failure at every turn.
Biotechs are where innovation is happening. There's high risk, but there's also high reward in bringing a new product to market.
I don't like to talk too much about failures because a failure with one company can become a success with another. I just spoke with a client who aquired three product candidates. They were with a large pharma company that ran a couple of trials in certain therapeutic areas they wanted to target. It wasn't successful.
Somebody else now has that product candidate, and they're seeing clinical trial success in other therapeutic areas that maybe big pharma didn't prioritize at the time.
When I had a phase 3 trial that wasn't successful, I said, 'It's not a failure; it just wasn't successful this time, but we're going to keep going.' That product just got approved. It may have failed in one area, but you just have to keep tackling it from other angles.
While there are failures, there are more opportunities for success. That's what makes this exciting—being able to improve and extend the lives of our loved ones.
So, can you give us a flavor of what's been happening at Allucent, and how you can help biotechs succeed?
Over the last seven years, we've really been focusing the company on two main business units. One is in phase 1 to 3 clinical trial operations and delivery. The other is focused on consulting our customers, starting at pre-IND through phase 3.
The areas of consulting that our small to mid-sized biotech companies often need help with are design and regulatory requirements. We help determine the regulatory path—how to get to phase 1. We have 13 former regulators who came from six different regulatory agencies and that’s incredibly helpful to our customers.
I'm a biostatistician by training, and we have a biostatistical consulting group. A lot of consulting involves protocol design and the statistical design that goes with that, including adaptive designs, which are still relatively new in the industry.
The third consulting areas is clinical pharmacology, which includes modeling and simulation from candidate selection to regulatory approval. So, to recap, there's the consulting business and then there's the operational delivery business. We're focused on using the consulting arm to identify our customers and advise them on the pathway that then brings them to phase 1, where we deliver the clinical trial services. That's one of the big areas for us.
Allucent is purpose-built. We put together a number of different companies, starting with Cato Research, which was a regulatory consulting CRO I've known my whole career. We added Nuventra, which was the clinical pharmacology group, and then Array Biostatistics, which gave us that biostatistics capability. We also added two smaller CROs with clinical trial operations—SMS Global and Pharm-Olam.
We combined these smaller CROs to build a mid-sized CRO that's the right size to deliver. We like to say internally that we're 'big enough to deliver, but small enough to care.' And it really is true. I've been with the big ones and with a really small one and this is the right size of company to be science-centric, to be nimble, and to deliver excellence.
Looking ahead, where are you hoping to take the company?
We're going to continue focusing on what we refer to as our ACEs—Allucent Centers of Expertise. These centers are in oncology, cell and gene therapy, and rare diseases—the three areas where we have most of our experience – and infectious diseases, etc..
But we're gaining steam in the area of neurology. So, in 2025, we'll continue with those three core areas but also progress significantly in neurology.
The other focus is on driving customer loyalty. That's going to come with a focus on delivery, on listening to our customers, and understanding their needs.
What trends in the wider industry are important to watch?
Funding is the biggest issue for biotechs. 2023 was disappointing for the industry. 2024 was lumpy. I'm cautiously optimistic that funding's going to come back in 2025.
I think AI is clearly going to help the industry. It's going to aid in targeting molecules, which happens a lot inside academia and biotech companies.
I want to focus in 2025 on meeting and exceeding expectations for our customers, building customer advocates, and growing our therapeutic expertise beyond our three main areas and extending into neurology. There's been a huge trend in cell and gene therapy and rare diseases. If you look at 2024, oncology is still a big area, but is it growing?
Those are the trends I see—continuing growth in those areas, with specifically bigger growth in neurology. Going to JPM Week, I look forward to meeting with others in the industry and hearing firsthand what they think.
And they’ll be hearing your thoughts too. You’ve had more than 30 years in the industry - that’s a lot of experience?
My CV says 35-plus years, but to be honest, it's 39 years in this broad industry! I spent 31 of those years with Quintiles before it became IQVIA, the world's largest CRO. I was the 23rd employee - when I left, there were 35,000.
After that, I spent one year as a consultant and then seven years with a small dermatology biotech company. In between, I was on the board of a small CRO that the board sold to a mid-sized CRO.
So, I've got decades of experience working at a large CRO, but I've also worked in pharma biotech and at a small CRO. I've really walked in the shoes of the biotech clients that we have.
I'm passionate about this industry. I started working in a pharmacy when I was 15 years old. Now in probably my last decade in the industry, where do I want to make the biggest impact? It really is in bringing innovations to market, and I think at Allucent, I have the opportunity to do that, working with the small to mid-sized biotechs.
Finally, you’re passionate about good leadership. What’s most important to you?
Authenticity. I love to lead. It's one of the things I enjoy probably most. Well, second most. I love the science and delivering in the biopharmaceutical industry.
I wrote a book between leaving Quintiles and joining the biopharma industry called 'Remember Who You Are.' There's a lot of leadership tips I give in there. Every day as I work with people, I just try to be me. I am who I am. I share with anybody if they have a question. I tell stories, I give advice. I love to help others grow.
We grow when we learn, and I'm still learning. I'm learning about cell and gene therapy—that's a new trend. When I was in the CRO business nine years ago, there really wasn't any cell and gene therapy then.
For me, leadership is about opening up opportunities for others. Growing and learning just makes us all better.
