Cracking the code: Navigating the Ever-Changing Biotech Landscape

I had the pleasure of meeting Alison several years ago at their UK office, when Seuss+ was still relatively new and eager to revolutionize how sponsors engage with vendors. We were pitching our ideas to Alison and her team, and to our delight, she gave us a chance — and I can't thank her enough for that opportunity. Supporting and giving chances is just one example of what makes Alison such an exceptional leader.
Alison's journey in the field of life sciences began when she qualified as an MD. She dedicated her time to practicing medicine, specializing in oncology, working at esteemed institutions such as the Royal Marsden in London, before she eventually transitioned into the life science industry, primarily focusing on research and development. Throughout her career, she's held various senior roles, including medical director at Wyeth, and has collaborated with pharmaceutical companies like Roche, AstraZeneca, Novartis, BMS, and J&J, to name a few, serving as a medical director and consultant. With over three decades of experience under her belt, Alison is in her 10th year as CEO of Avilion,
where she has led great successes, including deals with Pfizer, Merck, and AstraZeneca. Avilion is a boutique life science investment firm known for its unique business model, centered around co-developing and financing late-stage pharmaceutical development projects. Historically, Avilion has invested in post-proof-of-concept co-development deals ranging from 50 million to 250 million, taking on all the clinical and regulatory risk associated with getting final approval. Currently, the company is diversifying into the early phases of development and providing consulting services. Alison's influence extends far beyond Avilion, where she serves on the board of directors of Genae and also Navion, and holds the position of non-executive director at Oxonics. Additionally, she's a senior advisor to Blackstone Life Sciences — a testament to her expertise and reputation in the industry.
Alison's journey from practicing medicine to becoming a CEO in the life science investment sector shows her unwavering commitment to advancing healthcare and innovation. Her visionary leadership continues to leave a lasting impact, and inspires others in their professional pursuits. So today, we are embarking on an insightful journey to explore the strategies employed by Alison, and learn from her experiences.

There are many challenges which biotechs deal with, and our quest today leads us to tackle four hurdles that biotech companies encounter in the pursuit of innovation and life-changing breakthroughs. Alison, thanks so much — welcome, and it's a treat to have you on the podcast today.

Thank you, Sabine. I'm delighted to be here. Great to have the conversation today, as we focus on, as you say, some of the challenges biotech are facing. As I reflect on your very kind words, I think the last 10 years have really shown me that with a great team behind you, you really can help accelerate bringing medicines to patients — and that's really been very much my ethos, as well as the culture within Avilion. I know we're going to explore that more as we go into the questions now.

And that we are. So let's dive straight in, and we'll start with the first question I have for you today. We've had several discussions around this, and one of the topics that has come up is around the critical challenges biotechs face in maintaining a diverse portfolio — this balance between putting all your eggs in one basket and avoiding risk. This can happen, we see it often, with founders who are very embedded and dedicated to one therapeutic area or illness. So what I'd be interested to learn about is what strategies and approaches you've seen that are effective at Avilion, and for some of the other companies you sit on the board of, to address this one-compound-asset challenge that many companies face.

No — thanks, it's a great question. A diverse portfolio is certainly where you'd want to be as a biotech, but let's be honest, it isn't always possible, particularly when we consider the financial position of a startup. So platform technology always creates more value, and I think that's important to think through — there are a number of reasons why. Firstly, a platform technology means more shots on goal — I'll come back to that. It's also easier to attract the best candidates in a pretty vibrant life science market, and to retain that team. As we know, success here isn't always just based on the asset itself, but also the team actually delivering that clinical development program.
I think another reason a diverse portfolio is a benefit is from the investor perspective — when we, as Avilion, are looking at biotechs to partner with, we certainly consider counterparty risk. If there's only one asset and one indication, it's very much a binary outcome. I think one of the things Avilion can bring is not only the finances to assist the biotech, but also the team — that means more people working toward a result, but what's most important is that you don't have to distract the biotech's own team from delivering on their one focused area, while the additional funding allows more shots on goal, which is a better value proposition — whether you're looking at patient outcomes in terms of approvals, the investor perspective, or the exit strategy for a biotech, whether they're looking to partner with a big pharma or IPO. Having more clinical development programs running in parallel creates that value proposition.
So those are some of the things we try to assist with and work on with biotechs, to create a hybrid solution where we're working alongside them as their partner.

Yeah. Alison, it's interesting, because Avilion definitely doesn't have this issue, does it? You have a very diverse portfolio. I mentioned in my introduction that you've worked with Merck, Pfizer, and AstraZeneca on some programs, and it'd be interesting to learn what some of the challenges have been — for instance, I know the AstraZeneca project was massive, and I can imagine there are, well, with all of them, but with this one in particular, some challenges around that. Could you share some of those challenges, and potentially how you dealt with them?

Yes, of course — I think every clinical program has challenges. We wouldn't all be spending the hours we do doing clinical research if it were easy, let's be honest, we'd all have the afternoons off. But particularly, if you talk about the AstraZeneca project we've been running with them, which resulted in a Tezspire approval in January this year with the FDA — that was particularly challenging, because Tezspire is focused in the asthma space, and we'd literally kicked off all of the pivotal Phase 3 programs as COVID hit. Now, obviously COVID had many challenges across all of our individual lives, as well as our work and professional lives, but if you can imagine trying to recruit 5,000 patients in asthma, across a respiratory portfolio, for the FDA — and then a COVID respiratory pandemic hits — those were challenges I don't think I ever thought I'd face in my career.
It certainly made us think outside the box in every way. The team suddenly were all working remotely — we have a hybrid model anyway, but suddenly everyone was remote. Then there were issues around how you get drugs to individual patients across the globe, how you ensure patients stay on treatment, and obviously you needed to monitor the data — all incredible challenges. On top of that, the main endpoint in a respiratory program was spirometry, and at that point the American Thoracic Society had told us we couldn't even use spirometry, because of the risk to a patient of going to a hospital to have it done. So there was a short period — as short as possible — where we had to put recruitment on hold, while making sure patients continued to get their drug, which was really important for managing asthma risk. But what we really did was keep a very close eye across the globe, in the countries we were recruiting in, to see which country was coming out of lockdown, so we could get the CRA on board, get investigator discussions going, and really make sure we were appropriately managing the quality of that data — critical to any program — and ensuring very few missed visits. Off the top of my head, I want to say out of all 5,000 patients, we had something like 0.14% missed visits across the entire study — all the studies. So it really shows that when you really have to, you can think outside the box — but it's certainly been the biggest challenge I've faced to date in my career.

That's incredible — definitely sounds like a significant one. And it's interesting, because that kind of leads to this next topic, because without a strong team behind you, you can forget about those kinds of successes, right? I think one of the challenges we all face, specifically coming out of COVID, is that attracting and retaining top talent is definitely a challenge, and potentially even more so for smaller organizations. It's essential that companies sustain growth and success in a competitive industry. How does Avilion tackle the challenge of attracting and retaining talent in the biotech industry, given how competitive it is? It'd be great if you could share some of the strategies you employ to foster loyalty, create a conducive work environment, and keep valuable people within the organization engaged and motivated.

Yeah, Sabine, we really do believe that the people piece at Avilion is probably our USP. We realize there are other companies out there that provide funding, but we really do believe it's the team that provides, if you like, our success story. We've had very, very little turnover, and I do believe that's truly down to the culture, and the fact that we invest in each and every employee — I believe that's paramount to our success.
In our 10 years, with 100% success, it hasn't just been about the diligence on the asset that's made us successful. If you go back to that AstraZeneca example — wherever people were based, whether they were suddenly dealing with children, homeschooling, having to be a parent and a school-parent, all of those other things — and yet still focusing on delivering. I think we've created a culture where we describe Avilion as one big family, and that's really what I'd like to think we still are. That culture piece — we reflect on our values quite often — is really important to remember, even as we scale up. The other piece I try to bring to the whole company is that every single person in this organization matters. You don't have to be the CEO, you don't have to be sitting in the C-suite — with all the other support functions, clinical development, quality, finance, regulatory, and anyone else I've forgotten to mention today — clinical supplies, my PA — I probably wouldn't be having this conversation with you if I hadn't been reminded the time was now. That's the sort of thing I mean — everybody's role is absolutely critical, and the sum is greater than the parts. It's a very synergistic perspective we have at Avilion.
You asked about learnings — I think, as I reflect, you sometimes learn more from mistakes in life than from success, they always say. I had to take this on board post-COVID — we all went back to work, thought, okay, business as usual as much as possible. But I went across and met with our US team, gathered everyone in RTP. And I was pretty shocked that they were quite negative about our organisation and the culture. I was shocked, because I reflected on everything we'd done for them during COVID, and I thought we were a great family. And what they said was, that was great, but suddenly, once we were out of lockdown, it was business as usual, and people within the US organisation felt we'd reverted to becoming quite UK-centric — for example, all the company calls, I'd lead out of the London office, things like that. Sometimes perception is as important as reality. So one of the things I did was really take on board the feedback they gave me — I was shocked, appalled, but I took it on board. We had more C-suite, more senior people regularly engaging, going out to RTP, bringing the team together, and really making sure they felt part of the overall organization.
I think that's particularly important when you have more remote-based individuals — with people coming into the London office, the hub, we're interacting around the coffee machine, etc., but for people working from home in a fairly isolated environment, I think it's additionally key and critical that they actually see us — not just on a Zoom, but actually in the room, spending time flying across and interacting with them.
So that was a really important lesson. And the other really important lesson has been — we obviously do get a few leavers, and I make sure I don't just hear from their direct line manager why the person left, I actually arrange a one-to-one with them, and there's always something I learn from that. Just as an example — in a small company, I'm sure you're familiar with this, sometimes there's just one person in one discipline doing one function. Which is fine, of course, if we're all in Europe, in the same time zone, but as one person rightly said to me, we're a global organization, and if you're reaching out 24/7 and you're not in a C-suite role — and even sometimes when you are — that becomes quite burdensome. Maybe there's an expectation, as you go up in an organization, that you accept some of that, but in different roles, at different levels, that's a pretty tough task, day in, day out.
So for me, there have been some real learnings, whether talking to people about why they're moving on, or just speaking to people in our new work environment — which I think has changed people's — not values, I don't think people's values have changed post-COVID, but I think how we work through work-life balance has become really, really critical.
The other thing we've done is use a company called TenCents — it's a sort of sense-making tool, a diagnostic, and it's totally anonymous feedback that goes into a software diagnostic tool, and it looks at four areas of the company: performance energy, culture and climate, motivation, and team attributes. That's shared, anonymously, with everyone in the organization, and we've used it as a tool at company meetings and in smaller groups, to say, we shouldn't rest on our laurels even when things are great — there's always areas where you might think, maybe I should be concerned, maybe people are under too much pressure, or maybe they don't feel they can challenge. I find those sense-check tools, that occasional pulse check with the organization, incredibly helpful. We've done all of that, as well as, I hope, rewarding people appropriately, and company meetings — during lockdown we had remote sessions in Pilates, nutritional health, and meditation, which I was terrible at — but we had all of those things, and we mentored and buddied people up, with an open-door policy, which I think was also incredibly important.

There are a lot of learnings in that — incredible. I think one of the things that sticks out for me from your response is that information can be diluted as it comes up — what gets to you may not be exactly what's actually happening within the organization. So that's a great point, that you take the time to do the exit interviews with employees — I think that's incredible, because then you get clear feedback. And having those conversations with people, having you in the office, people want the opportunity to shine, and that gives them the opportunity to do that, when you spend time there. And I love the TenCents thing — definitely going to look that up. Do you do that regularly? Several times throughout the year?

Yeah, we've done it when we feel there's a need, but we always have a sense check within the year. I think particularly the lockdown, out-of-lockdown, and then more regular checks has been really valuable. It literally takes five minutes — it's not a McKinsey review, it's literally a quick look.

Yeah, right. Yeah, it's a TenCents quick one — oh, great, I love that, thanks for sharing that. So, people, very, very important. Obviously we're heavily regulated — very, very regulated, to say the least — and this is really a non-negotiable in the industry we're in. In one of our previous conversations, we were talking about all the pieces that are so important for companies, and one that came up is data integrity, and always staying diligent and inspection-ready. We're really interested to hear how Avilion does that, and how you keep your finger on the pulse to make sure the data is well-prepared, that you're ready for any potential inspections, and how you deal with the regulatory compliance issues we see every day in our industry.

I mean, yes, Sabine, it's absolutely critical. Whenever I'm speaking to new potential partners, I always say the Avilion motto is around speed linked to quality — one without the other is absolutely useless. When I reflect on the AstraZeneca piece, it was really about keeping the quality of that data, despite all the challenges we had with lockdowns, etc.
We also really step in and work alongside the CROs and CRAs, because within our model we have a global team of clinical trial liaison managers, and their role, from day one, is very much to ensure our sites are inspection-ready — because, let's be honest, the FDA can inspect anywhere, and I want to make sure our reputation stays intact in terms of the quality of the data and the output. When I reflect that such a small team did an NDA submission to the FDA for Tezspire with AstraZeneca, we obviously have to get the quality piece right. It's a big piece of our organization — whether it's an SOP or a review of an audit plan, I'm always the first one who engages with it, because, from my background as well, I believe quality is a critical piece of any organization.
With that in mind, we obviously do our own audits across our sites, as you'd expect. We engage in closure of CAPA plans with the CROs, and timely completion of those plans, and as soon as there's any finding, one of the things we absolutely do is a sense check that there's no systemic issue — so if there's a finding at a site, we make sure it's not going to recur, etc.
So yes, we regularly review audit schedules — I review all of our audit schedules every month with our VP of Quality Assurance, and I'd say it's very high on our agenda. And with that in mind, you have to look at the outputs of the partnerships we've had, whether with AstraZeneca, Merck, or Pfizer — all published in peer-reviewed journals, from the New England Journal, through to the Lancet, JCO — and that again reflects on the quality.
But I think, to your point, it's harder and harder for CROs, with the turnover of staff, particularly in that CRA space, and that's where the Avilion model of providing additional oversight and support to the sites is absolutely critical — because with everything investigators are having to do now in the clinical research environment, particularly as they embrace different technologies, and the challenge, since COVID, of more and more patients coming through the system — I think everything we can do to support them is really critical, if we want clinical trials to continue to deliver, and patients to be enrolled on them.

Yeah, absolutely — and I think to support them with consistency, right? To your point, trying to get the same staff there over and over again, so they feel comfortable with it — I don't think these relationships with the sites can be underestimated. Some really, really good points. So now we're going to take a bit of a jump — we talked about regulatory, now we're going to talk about digital innovation. Hot topic, sexy, everybody's talking about it, and it really is reshaping the industry, isn't it? Many larger organizations have entire departments, and budgets, for digital innovation. Smaller companies can potentially have some issues around this. So I thought it'd be interesting to dive into this a bit more — what is the actual impact of AI and digital innovation in the industry, and specifically for biotechs? There's a lot out there, and I'm curious to hear how Avilion keeps up to date with these new innovations, because we feel like you're just being bombarded with things daily — how does your team sift through all of that, and determine what's relevant for your projects and teams moving forward?

Yeah, thanks, Sabine. I think this is an area where we're all continuing to learn, and the truth is, we won't know every innovation that's out there. Right now, we're running a decentralised clinical trial for one of our partners, and that's probably, again, been incredibly challenging — new challenges we never thought we'd come up against, in terms of new technologies. The additional work of setup for sites, following on from the last point, I suppose. The additional time it takes a site to actually run a DCT. How do you keep patients interested in your study, if it's much more remote — how do you keep that connection? In some ways the data should be better than remembering from a diary card, because you're automatically collecting it as you go, but how do you make sure you've got the safety of the patient, and the quality, absolutely covered? I think those are all things we're wrestling with — and some of the AI tools that have come out, will they be accepted by the regulators? It's interesting, when I was looking ahead of us speaking today, I think the first DCT study was run by Pfizer, in 2011, and today there's still less than 5% of all studies being run that way.
Some therapy areas have embraced this more than others — particularly CNS, metabolic, and endocrine — but if you look at areas like oncology, it's minuscule, and yet there are masses of oncology clinical trials ongoing. It's interesting to think why — some of the reasons that have been considered are the time it takes for investigators. It seems academia has embraced DCT a bit more than pharma and biotech, and one of the issues has been concern around the regulators — do I want to be the first person to put my head above the parapet, or is it safer to just keep doing what I've always done? And also the increase in time and cost to set up a DCT in the first place.
And I think that's something we, at Avilion, hadn't necessarily fully appreciated, and we still started embarking on recruiting 2,000 patients in a DCT. And I've realized, even in terms of delivery, it's not like getting an Amazon delivery of your favorite pair of shoes to the house — it's quite a bit more complex. How do you ensure the delivery, etc.?
So I think there are many challenges, but I do think we need to learn to embrace it, and be smarter as an industry, and not always just do what we've always done. It's been fascinating — I've been talking recently to some of the AI companies in this space, particularly around rare diseases, and how we can use AI tools to go through masses of phenotype data, and analyze and find the patients we need for rare disease — that's going to be a lot better than anyone trawling through masses of notes, let's be honest. So I think some of the AI tools do make sense. We were recently talking about the Swedish study around mammograms, which showed that it significantly reduced the time and workload on radiographers, when we have a shortage of radiographers — and I think it detected something like another 20% of cancers. So there are those sorts of areas — pathology as well. I think there are some areas we really need to continue to delve into.
But where you're starting from as a small company, it's harder — because we haven't got a whole team of, say, 20 FTEs permanently looking at how things are evolving. So it's really about attending the right conferences, networking, and just trying to be smarter where there are challenges.
I hope we won't all get replaced by ChatGPT — I really hope so — but I do think we need to embrace this, because when I saw it's still under 5%, and way under, for pharma studies and biotech studies, I think there's a long way to go, really, when you think how the rest of our world has changed, with social media, etc. — the fact that we're having this conversation today as a podcast —

I hope so too.

you would think if we can manage to communicate in this way, in this arena, then we should be able to do that in the clinical trial space too.

Yes, absolutely. And you're right, we certainly don't want to be taken over by ChatGPT, but there's so much out there, so much available, that can have huge benefits to patients. If you look at eCOA, if you look at wearables — there's an incredible amount of technology out there that's going to make life easier. And, you know, we touched on COVID earlier — there were so many steps taken during COVID that I hope we can continue to build on, and move forward, rather than falling back into "well, that's what we used to do." It's very easy to do, isn't it, to fall back into old habits.
So, Alison, thank you — I think some of the pieces that really stuck with me in this conversation were around striking the right balance, the risks and rewards of diversifying your portfolio, and what's going to work best for the organization. And the bottom line is your staff — these are the most important people. I think so many companies have this tagline, "it's always about our people," but thanks for sharing some of the ideas of what you actually do within Avilion, because I think that could be very helpful for other organizations, to tap into and continue growing their culture, and work on how the organization communicates with each other — because that's very key, and can easily go awry, especially working remote and far away from each other. And on data integrity and compliance — you listed several points that are just so key there, and some of the steps you've taken to really be, as you said, inspection-ready from day one. That's a nice mantra to have, and I think one that a lot of companies could use as well. And I also know, from experience, that Avilion has a very robust governance structure, and you really rely on that within the organization to be practical and functional, which I think is very key — not just there, but everyone has a function, and everyone has a key piece in that structure.
And on the digital innovation piece — there's a lot out there, keep your eyes open, and talk. I think that's so important, to share new ideas and not hold onto things. Sometimes we get new ideas, we see things, and think, oh, we need to hold these close, because it's going to make us stronger — but I think it's so important, exactly like our conversation today, to share experiences and learnings, because we're all in this industry to treat patients, and if another company can also be smart and learn from that, that's some of the best things we can do. So thank you for sharing those topics and your experiences.

No, it's been great, Sabine, I've really welcomed the discussion.

Okay, but I do have to ask one more question — I hope it's okay, we can cut it out if you don't want to. So, it was a lovely conversation, but I found out something about you, and I just find it super fascinating — I understand you actually used to live on a farm, in an estate in Fife, and bred Highland cattle. What in the world inspired you to do that? If you could just share a couple of sentences about that, I find it fascinating.

Yes, Sabine, I wondered what you were going to say you'd discovered — there's always a moment of trepidation, right? But it's okay, this can be public domain, that's absolutely fine. When I had my son, we decided we were going to have a change of lifestyle — and although I don't sound it, my roots are actually in Scotland. So we moved to a 14th-century castle in Fife, and we had a hundred acres, and when we bought the estate, we inherited some Highland cattle, and it would have been rude not to keep them. Highland cattle — the big, hairy kind — need to be, for Scottish winters. And then, obviously, nature is nature, so we bred them, right, because that's what they do. So we had lots of little Highland calves, which were just incredible, actually, and wonderful. I think they call them "gentleman farmers' pets," if you like, but — lovely to look at.
I always remember one story from when I was doing my ten years of consultancy, before I joined Avilion — I had to say, I was on a call with a big pharma, and I said, "I'm really sorry, I have to go, I have to go and milk the calf" — the calf needed two liters of milk, which wasn't really what they thought I was going off to do — so I always remember there were a few perplexed faces, and no one ever asked me why I was going off a teleconference after that. It was a great way to live — wonderful, wonderful lifestyle.

Wow, that sounds like a wonderful time to live. I love those cows — I've been to Scotland a couple of times, and always just love them, they're gorgeous. So, wonderful, Alison, thank you for sharing that story as well — it's been a real delight to speak to you. Thank you for sharing, and being so open. What I've really valued about this conversation is that — it's easy to talk about the highs when things go well, but it's difficult sometimes to share the challenges we face. So really, thank you for also sharing some of the difficulties and challenges you faced in your tenure at Avilion. Thank you.