ОТНОСТНО ТОЗИ ЕПИЗОД
In this episode, Dr Neil Fish and Dr Ami Patel dive into the real-world challenges of drug development - from early-stage planning to regulatory hurdles and everything in between. Drawing on decades of experience, they share personal stories and expert insights that reveal why a solid strategy and the ability to pivot are essential for success.
They explore the value of strategic flexibility, the importance of engaging with regulators early, and how to approach patent protection and manufacturing for advanced therapies. Whether you're preparing an IND or planning scale-up, this episode delivers clear, actionable guidance grounded in industry know-how.
A must-listen for biotech teams, clinical leads, and anyone involved in the drug development process.
EPISODE OUTLINE
00:00:14 – Introduction to Drug Development
00:00:22 – The Importance of Having a Plan
00:04:27 – Insights from a Successful Company Journey
00:08:22 – Manufacturing Challenges in Drug Development
00:09:11 – Regulatory Strategies for Drug Approval
00:18:03 – The Role of Clinical Strategy in Development
00:26:25 – Conclusion and Future Insights
ВИЖТЕ БЕЛЕЖКИТЕ 🔗
ТРАНСКРИПЦИЯ 🔗
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Hello, and a warm welcome to the latest edition of Conversations in Drug Development,
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brought to you by the team at Boyd's.
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This podcast is for our fellow community of scientists and clinicians working
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in the wonderful world of cell and gene therapy and drug development.
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Thank you for tuning in, and we hope you enjoy the conversation.
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So, welcome to the latest Boyd's podcast.
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My name is Neil Fish. I'm the Chief Business Officer at Boyd's,
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and the podcast is called Don't Do This at Home, How to Avoid the Perils of Drug Development.
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And I'm joined by Ami Patel. Hi, Ami. Hi, Neil.
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Good to be here with you. My name is Ami Patel in the U.S.
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Office of Boids, here to talk about the drug development process and the success.
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Fantastic. Yeah. And between us, we've been doing this forever, haven't we?
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Yes. You're more than me. Yeah. Well, I've been doing it for almost 40 years,
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and we won't go into how long you've been doing it for.
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And I think between us, we've seen almost everything, haven't we?
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We have. So, you know, one of the first things we see is people basically coming
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in and they haven't got a plan. They actually haven't got the first idea of what they're doing.
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So how can we help them? I mean, but also what shouldn't they be doing to start with?
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To really put it simply, honestly, you need a plan.
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Don't wing it. You need to go on a blackboard and sit down and decide exactly
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what is it that success looks like to you.
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What are you looking to get out of in terms of the different milestones from
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an investor perspective and the regulatory milestones,
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and then map out the plan in detail in terms of all the different program aspects
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from beginning to end of whatever that milestone it is that you're looking for.
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It is too often that development, the optimization of the product.
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The formulation development, This is done in a manner, I like to say this often,
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don't turn this into a PhD thesis where you are constantly just,
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oh, maybe if I do this, then it'll work. Or let me tweak this and it'll work.
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But what I really think is that it's really critical that you design every study
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that goes into the program.
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You need to have a detailed map of different studies for preclinical,
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for proof of concept, what are the endpoints that you're looking for,
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what is the result of those studies,
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you are tying the success of your program development that you're looking for
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and have a decision tree around those experiments to progress the program in a positive manner.
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To sum it up, honestly, don't wing it. Have a plan. Have a decision tree.
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Think about each different analytical aspects to characterizing success or the
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marker of what it is that you're trying to develop.
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And if an aspect didn't work, then try to have a meeting or a pause and try
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to dissect why it didn't work before just jumping into the next idea or the
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next experiment without proper thought.
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I think that often in trying to be speedy with the drug development process early on,
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trying to meet some of the milestones to get to an investment phase,
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you overlook some basic development considerations
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that actually would get your drug killed very
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early on before you even get to the proper series
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a fundraising you want to have a designed plan
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and a program and a detailed design of experiment that leads you to a favorable
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outcome for your milestones for regulatory and investor perspective yeah and
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i think also i mean you've got to be flexible haven't you because things are
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going to go wrong this is oh yes development is all about things going wrong isn't it?
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So you're going to need to advise that plan as well, aren't you?
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And you have to be willing to listen to those that have more experience and
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learn from that process.
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It's a very good point. I mean, having these plans, it's really,
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really important, isn't it, to help if you're trying to raise money?
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Because people are going to ask you questions about how long is it going to
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take and how much is it going to cost as well. And that's some of the things
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that we do very early on for our clients, where we develop a regulatory roadmap, a regulatory strategy.
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What does that look like? We help them with a product development roadmap.
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And that really is something that many of our clients have put into their pitch
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deck, and it actually raises their success. And so, Neil, now on to you.
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You've taken a company from startup stage to a quoted company on the London Stock Exchange.
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Can you share insights on how you achieved that and things that work and didn't
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work, your learnings? Yeah.
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No, it was an amazing experience, I think is the first thing to say.
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And it was one of those things that, as I started my career,
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I had no idea where I was going to do this.
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But circumstances about being made redundant in the 90s, and I met someone who
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had an idea for a company, and then two other people joined.
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And I think the very smart thing we all did at one point was to be humble enough
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and look at each other and say, we're not the CEO. We've never done this before.
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I mean, it was very obvious we'd never done this before. When we spoke to a
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venture capital firm, the first thing they wanted to do was replace all of us,
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which obviously didn't go down well.
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And we actually, in the end, managed to get the company financed and floated.
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But i think you know it's really important to not
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be proud to be you know to be humble about this and we
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we were really lucky to find a real superstar
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who just happened to be exiting after a mega
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pharma merger and he wanted to sort of have
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a crack at a young company and yeah i owe him so much for what he taught me
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and i know one of my colleagues does as well we worked together for 10 years
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with this particular person but and he had done it all from like preclinical
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right the way through to getting an MA approved.
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And at every step, he was able to sort of point us in the right direction to plan.
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And frankly, you know, at that early stage, he taught us how to do it as well.
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Things went wrong all the time. And without him, the thing would have collapsed
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literally within months.
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So it was utterly critical to find someone who knows what they're doing.
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And as the company grew and developed, you know, we needed more specialties
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like patent agents and clinical trial specialists.
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And the other clever thing we did was to run a virtual model.
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So we didn't go around trying to recruit hundreds of people because firstly,
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nobody would give us the money to do that anyway.
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But we subcontracted and had all these amazing sort of advisors and people who work with us.
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And for a small company that only ever had 17 people at its maximum.
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It ended up running four clinical programs of which two were in phase three.
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But with all these advisors all around us who knew what they were doing and
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they could absolutely help us. It
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was quite amazing that the firepower and expertise that the company had.
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It was something I'm incredibly proud of.
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But the year before I started it, if you had told me I was going to be doing
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this, I wouldn't have believed you.
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I didn't probably even know how to do it. It was one of those things,
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finding somebody who has the wisdom and the expertise and the knowledge to take
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you on that journey was incredible.
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And I think that's one of the things I love about Boyd's is that we actually
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now also do this with our clients.
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Within Boyd's, within our team, you know, we have a great many people who've done this now.
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And like you, I love working with the people who come in very early preclinical, need that plan.
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And then we help them go, particularly sort of early preclinical to the end of phase two.
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We do a lot of our work with our clients. I think it's just such an exciting
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time and seeing them grow with their companies and learn, etc.
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A great many of them have never done this before, but they are so determined to do it.
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And I feel quite humble talking to them as well because I know how difficult it is.
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Yeah, agreed. It is a proud moment when their products move to the next stage.
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And we can't tout about it publicly, but it is what keeps us going. Yeah.
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So one of the key things when we're doing development, obviously,
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is the CMC, the manufacturing side of everything we do.
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Because obviously, if you can't manufacture your product, well,
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you haven't got a medicine. It's as simple as that.
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And I remember in the early days of my company, when we had our first development
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candidate, and we actually made it with mustard gas, believe it or not. That was a key part.
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And we kind of realized quite quickly, if we're taking this to market,
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we're not going to have to deal with tons of mustard gas to make this product.
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And in the end, we actually made a very simple process using an acid to join
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two chemicals together, which was fantastic.
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So, I mean, what are the challenges you see with manufacturing particularly?
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And I think you nailed it. It's having a lab-based manufacturing process that
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is perfect and gives you the best data.
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But if it can't be translated during tech transfer for commercial stages,
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then that process will have to be redesigned.
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And so with that in mind, you want to always design the process with the goal of end in mind.
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What does this process look like outside your lab?
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What we see on a daily basis here at Boyd's in terms of some of the early companies,
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especially in product development team, is that these are very early state startups,
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two to five team members, sometimes in an incubator lab space or they're in
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an academic or a hospital institution.
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They don't necessarily have all the ideal tools for initial drug development
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and proof-of-concept studies.
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They have to make do with what is available. And with that in mind,
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they designed the process for
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the lab, but the minute it has to be transferred to a different lab or,
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you know, you want to scale it up and try formulating it at a CRO or a CDMO,
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then it does not work. It is not repeatable.
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And I think that's where the entire drug development, that initial R&D stage
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of drug development, that needs to be then repeated to make it work in that stage.
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So very early on, you must think about what would the manufacturing process
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look like outside the lab? What does it need to look like?
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It is imperative that you have a protocol even during the R&D stages where you
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are documenting exactly how you are preparing your R&D formulation for be it
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delivery into mice or rabbits or whatever that in vitro model is that you're
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testing your therapeutic product in.
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But you want to have a process that can be repeatable, not just in the lab,
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but outside your academic or your incubator lab in an appropriate GMP style tech transfer lab.
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One of my early roles during and after my PhD was at a preclinical CRO.
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I had a little bit of exposure to manufacturing at that time,
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and it was incredible how what was made in the lab and tested in the in vitro
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models, how the data had less noise, less variability.
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But the minute that was manufactured at a large scale at a CDMO in a GMP facility,
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the same exact product, you would think that would have the same level of variability or results.
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It was not the same in a nutshell. It was too noisy.
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The data was too noisy. The variability was too high.
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The lot-to-lot variability was too high during manufacturing.
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And we had to then go back, try to minimize some of the factors that were causing
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that variability. And that does end up wasting a lot of time.
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So if you build in the end in mind during your early manufacturing process development
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stage, build in the right CMC characterization parameters, you don't want the whole GMP tool,
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all the GMP tools for analytical characterization, but something that is good
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enough to give you the confidence that your process is working.
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It's repeatable and can be transferred into another lab, another facility,
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and is robust enough to stand the challenges and still give you the same proof
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of concept data outside of that small lab scale formulation or product.
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That is the way to approach manufacturing from very early on.
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It might take a little bit more time in the beginning when you start with that
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approach in mind, but you will save a lot more time down the line.
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And one of the things that always used to bemuse me is that the early stages,
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you don't actually want to make the products as pure as you can make it because
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you need the impurities for the toxicology. Yes.
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I've seen that, that people have made it so pure, right to start with,
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that later on, when they did change the process a little bit,
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they've got all these new impurities that, you know, they probably would have
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got with a dirtier process at the beginning.
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I'm sort of using dirty in a sort of strange way there but
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there's the timing isn't it of how you improve that
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process and get rid of impurities and then
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understand the ones you've got and as you scale
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up isn't it agreed yeah so
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going back to what we were talking we talk about on a daily basis for the most
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part of your career you've been tasked with in licensing products and sourcing
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deals You still do this a lot at Boyd's when we're all doing due diligence and
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preparing some of our clients for investor readiness.
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Can you emphasize a little on the key learnings from that experience?
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Yeah, I mean, I think one of the major ones always for me was to protect the invention.
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You would hope in today's world that everybody is smart enough and wise enough
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to at least file a patent before they go out and publish.
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And I say this because in the past, some of the world's biggest biopharma inventions
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were never patent protected.
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You know these just weren't in the uk particularly the
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probably the most famous one is the underlying technology
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to produce monoclonal antibodies was never patent
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protected it was published and never protected and
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the number of drugs that were developed you have multi multi billion dollar
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drugs from that technology is it's probably quite frightening to think about
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but yes when i was doing a deal you know when doing deals i mean the patent
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life is absolutely critical because first of all, you've got to get the product to market.
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And secondly, how much time have you got left to get the return on the investment
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you've put into the development?
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Ideally, when you're working with a patent agent, trying to get at least a composition
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of matter patent to start with, which is the highest level of protection you get, is critical.
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But then you go down a level of use patents and second use patents.
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And in Europe, sometimes you can get market exclusivity, which runs for sort
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of longer than it does in the United States. And that can be quite useful as well.
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But there are also rare occasions when you don't need patent protection.
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Sometimes, you know, trade secrets can work really well.
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I mean, I think one of the famous examples, non-farmer, is Coca-Cola,
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which still has, I think there's still trade secrets on that and how it's made.
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But, you know, I've seen companies with manufacturing processes that are very
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complicated or there's a particular trick you need and no one ever publishes
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anything, no one ever says anything.
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And that can work surprisingly well as well. So while patents are fantastic,
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there are other ways of protecting it.
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And I've seen some very big factories with literally rooms that you're not allowed
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in to see the magic trick.
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So it sounds a bit strange.
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But I think in today's world, I mean, I think everybody sort of starting off
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knows that the moment they've got a sort of development candidate or a process
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that needs to be protected, they would at least be talking to a patent agent.
00:16:32.895 --> 00:16:36.395
And ideally the sooner you can do that the better because
00:16:36.395 --> 00:16:39.715
how you plan your patent strategy you
00:16:39.715 --> 00:16:42.575
need to basically try to extend the patent life as
00:16:42.575 --> 00:16:45.675
long as possible to get the return on investment i
00:16:45.675 --> 00:16:49.935
mean when you talk you see published figures of how much does it cost to get
00:16:49.935 --> 00:16:55.035
a billion dollar drug to market is it a billion dollars is it two billion it's
00:16:55.035 --> 00:16:59.595
a big number and you need that exclusivity period to sell the product to be
00:16:59.595 --> 00:17:03.635
able to get the return on investment but it doesn't seem to happen as much as it used to.
00:17:03.775 --> 00:17:07.695
I think everybody's learned the lesson, but it's something that's so easy to
00:17:07.695 --> 00:17:11.935
get wrong, particularly in this modern age of social media, et cetera,
00:17:12.095 --> 00:17:15.895
where all of these things count as disclosures, which can invalidate patents
00:17:15.895 --> 00:17:17.635
that you file. You've got to be so careful.
00:17:18.075 --> 00:17:22.935
Yes. And I think one of the things that we often see is that if the patent is
00:17:22.935 --> 00:17:25.695
not being used for the intended purposes.
00:17:26.335 --> 00:17:30.255
Inventors can then also outlicense that and that can be another revenue stream
00:17:30.255 --> 00:17:32.375
that they can they can have if right,
00:17:32.995 --> 00:17:35.815
yeah no you've got a really good patent agent working for you
00:17:35.815 --> 00:17:39.235
you can be it sometimes amazes me how long you
00:17:39.235 --> 00:17:42.195
can get protection for you know can be a very very
00:17:42.195 --> 00:17:47.095
long time and and so certainly some of the more recent sort of blockbuster biological
00:17:47.095 --> 00:17:51.895
products the first wave of maps some of those had patent protection and they
00:17:51.895 --> 00:17:55.935
called it evergreening you know they somehow managed to sort of re-patent it
00:17:55.935 --> 00:17:59.275
almost and extend the patent life to very long periods of time,
00:17:59.735 --> 00:18:02.695
as well as the challenges of actually making these types of products.
00:18:03.615 --> 00:18:07.055
So at Boyd's I mean one of our big things you know we're very strong in the
00:18:07.055 --> 00:18:11.855
regulatory area you know we've got an amazing regulatory team so question is
00:18:11.855 --> 00:18:15.675
what shouldn't you do when you go and talk to a regulatory authority?
00:18:16.578 --> 00:18:19.918
Well, very basic. Don't upset them.
00:18:22.838 --> 00:18:29.178
Be humble. For the most part, regulators around the world are really keen to
00:18:29.178 --> 00:18:31.218
get some of these therapies approved.
00:18:31.418 --> 00:18:33.118
They are keen to work with the
00:18:33.118 --> 00:18:37.298
developers. They are trying to help the developers. That is their intent.
00:18:37.718 --> 00:18:42.318
And it ties in with some of the goals and objectives that they have is to get
00:18:42.318 --> 00:18:45.258
some of these products approved and give access to the patients.
00:18:45.938 --> 00:18:52.358
So with keeping that in mind, it is okay to push boundaries where there are
00:18:52.358 --> 00:18:59.698
no appropriate guidances when you have scientific data to support some of the pathways,
00:19:00.058 --> 00:19:03.878
regulatory strategies and pathways that you are seeking to do something novel
00:19:03.878 --> 00:19:10.318
from a perspective of looking at safety or efficacy or defining a new biomarker,
00:19:10.398 --> 00:19:16.978
which is not as commonly used in in clinical trials and in vitro studies.
00:19:17.298 --> 00:19:23.858
But you do want to still realize and work hand in hand with the regulatory authorities,
00:19:23.858 --> 00:19:27.258
because at the end of the day, if you don't have their buy-in,
00:19:27.358 --> 00:19:29.798
if they don't agree with you, then you don't have a product.
00:19:29.958 --> 00:19:31.378
It's really as simple as that.
00:19:31.738 --> 00:19:37.798
And very often then, it is very rare that the regulators will leave you hanging
00:19:37.798 --> 00:19:43.478
and not give you insights on an alternate way to approach what you are seeking
00:19:43.478 --> 00:19:47.098
in terms of approval if they don't agree with your strategy.
00:19:47.338 --> 00:19:53.718
So we like to say at Boyd's, and I am a strong believer in it from the experience
00:19:53.718 --> 00:19:59.618
throughout my career, is that don't be afraid of approaching the regulators as early as possible.
00:20:00.198 --> 00:20:01.658
Ask the questions.
00:20:02.318 --> 00:20:09.678
Know your product. frame the questions in a way that really just helps the regulators
00:20:09.678 --> 00:20:13.038
answer you as directly as possible.
00:20:13.298 --> 00:20:17.878
One of the biggest mistakes a lot of the clients that we see in some of these
00:20:17.878 --> 00:20:22.238
meeting requests to the FDA is that the questions are so vague and broad.
00:20:23.132 --> 00:20:28.072
You don't really get much out of the communication with the FDA or the EMA or
00:20:28.072 --> 00:20:29.892
the MHRA, which we do routinely.
00:20:30.092 --> 00:20:34.692
So you want to also frame your questions correctly. You want to understand what
00:20:34.692 --> 00:20:40.692
is it that you're trying to get out of your communication with the regulatory agency.
00:20:40.952 --> 00:20:44.292
So they want to help you. They want to work with you.
00:20:44.452 --> 00:20:49.692
It is in their best interest and the patient's interest to get a therapy onto market.
00:20:50.252 --> 00:20:55.772
And with that in mind, be humble, work with them, approach the authorities as
00:20:55.772 --> 00:21:01.252
early as possible in as many stages, get buying from them at every stage.
00:21:01.592 --> 00:21:06.872
And if there are ways where there are places where you don't agree on the first
00:21:06.872 --> 00:21:09.012
instant, we do this often.
00:21:09.212 --> 00:21:13.172
We don't always just take a no for an answer. We listen to them.
00:21:13.452 --> 00:21:20.192
We analyze, We work with the data and we say, what can we give more to get buy-in
00:21:20.192 --> 00:21:21.332
on what we are proposing?
00:21:21.592 --> 00:21:24.592
We go with additional data, additional scientific justification.
00:21:25.052 --> 00:21:31.612
And sometimes the regulators do change their mind and they end up working with our proposed ways.
00:21:31.912 --> 00:21:38.212
So don't be afraid to push back also, but with the appropriate scientific justifications and data.
00:21:38.212 --> 00:21:45.392
But again, keeping in mind that you want to make sure that the goal is,
00:21:45.492 --> 00:21:48.012
the objective is to work hand in hand with them,
00:21:48.412 --> 00:21:54.852
use that strategy from beginning to end and to get to your regulatory milestones,
00:21:54.852 --> 00:21:58.472
which at the end of the day are very much tied to the investor milestones.
00:21:59.272 --> 00:22:04.152
Yeah, no, I've seen over my career a number of examples where CEOs have basically
00:22:04.152 --> 00:22:05.932
picked fights with FDA or EMA.
00:22:06.532 --> 00:22:11.172
They're never going to win. I mean, they don't make the rules.
00:22:11.352 --> 00:22:15.912
I mean, FDA and EMA do that. You know, it's just a fight you're never going to win.
00:22:16.012 --> 00:22:20.412
And I absolutely agree with what you just said, that it's best to be collaborative,
00:22:20.672 --> 00:22:25.392
et cetera, because that's really the only way to go, isn't it? Yeah. Yeah, I agree.
00:22:25.992 --> 00:22:31.152
I wanted to touch a little bit on the clinical development of some of the advanced
00:22:31.152 --> 00:22:33.172
therapies, especially that we work on.
00:22:33.332 --> 00:22:37.952
The clinical pathway for the small molecules is relatively, I wouldn't say simple,
00:22:38.172 --> 00:22:40.012
but relatively well-defined.
00:22:40.232 --> 00:22:44.752
But from a perspective of advanced therapies, cell and gene therapies for some
00:22:44.752 --> 00:22:49.012
of the rare diseases, can you shed some light on what role does the clinical
00:22:49.012 --> 00:22:52.692
strategy and the considerations play into drug development? Yeah.
00:22:53.118 --> 00:22:55.538
Yeah, no, it's an interesting one. Yeah, the clinical development,
00:22:55.718 --> 00:22:58.718
obviously, to get the data you need to get the product to prove is critical.
00:22:58.978 --> 00:23:01.918
And a lot of the rare diseases, particularly with the advanced therapies,
00:23:02.198 --> 00:23:06.318
you're talking about really quite small patient populations to start with.
00:23:06.938 --> 00:23:12.418
That can be incredibly challenging to recruit in an ultra-orphan condition.
00:23:12.998 --> 00:23:16.458
So there's been an example recently in the UK of a company where there were
00:23:16.458 --> 00:23:18.858
only 10 patients in the UK.
00:23:19.558 --> 00:23:22.538
And this particular company was trying to recruit those
00:23:22.538 --> 00:23:25.438
patients and i think they only got one or two and it
00:23:25.438 --> 00:23:28.138
took them so long to recruit eventually in the end of
00:23:28.138 --> 00:23:30.898
the day they ran out of money you've got to get this right there's
00:23:30.898 --> 00:23:34.498
a kind of a balance between having a say
00:23:34.498 --> 00:23:37.158
an indication that is rare enough but not
00:23:37.158 --> 00:23:41.198
too rare that you can actually do the study particularly also because there
00:23:41.198 --> 00:23:45.738
might be other companies also trying to recruit the same patients so yeah you
00:23:45.738 --> 00:23:48.778
might not actually be on your own trying to recruit it can be quite competitive
00:23:48.778 --> 00:23:53.198
how it goes about that i think particularly also in europe this is something
00:23:53.198 --> 00:23:55.738
you've got to get really right and i've seen this
00:23:56.178 --> 00:24:00.438
done badly a couple of times i think that it's a truism that once you've launched
00:24:00.438 --> 00:24:03.278
a product you're probably not going to be able to put the price up very much
00:24:03.278 --> 00:24:07.598
that's just kind of the way europe works so you might have a product which might
00:24:07.598 --> 00:24:12.258
have five indications let's say and and this is what we do at boyd a lot the
00:24:12.258 --> 00:24:15.838
question is which is the best indication to go for first and that's kind of a.
00:24:16.598 --> 00:24:21.278
Balance between the clinical benefit and particularly if it's a rare population but also,
00:24:21.863 --> 00:24:26.723
can you actually also recruit the study? And when we do these exercises,
00:24:26.723 --> 00:24:28.783
sometimes it actually turns out
00:24:28.783 --> 00:24:32.683
to be not the obvious one that is the best indication to go with first.
00:24:33.363 --> 00:24:37.423
And I think also, yeah, so in clinical design as well, I think it's really important
00:24:37.423 --> 00:24:41.183
that you measure things which are clinically meaningful.
00:24:41.483 --> 00:24:45.863
I mean, that sounds obvious, but I think we've all seen plenty of studies that
00:24:45.863 --> 00:24:49.263
are measuring things which really don't have much value, actually,
00:24:49.263 --> 00:24:50.783
when you come to market the product.
00:24:50.963 --> 00:24:55.843
I think collecting that data, which can support particularly a pricing sort
00:24:55.843 --> 00:24:57.963
of strategy, et cetera, is so important.
00:24:58.483 --> 00:25:02.383
And I think I particularly enjoy when we bring in the medics,
00:25:02.523 --> 00:25:06.743
the physicians on our team early on in these conversations, because they chime
00:25:06.743 --> 00:25:11.923
in in that first in human study synopsis that goes into the pre-IND meeting packages.
00:25:12.263 --> 00:25:16.203
And I still, I remember this very clearly. One of the clients had,
00:25:16.403 --> 00:25:20.103
going back to what you're saying about putting in a clinical endpoint in your
00:25:20.103 --> 00:25:23.463
protocol, just from experience of our physicians, they said,
00:25:23.563 --> 00:25:26.323
this is not going to work. It is very hard to get this data.
00:25:26.623 --> 00:25:32.023
It sounds right on a piece of paper, on a protocol, but to execute this, it's not realistic.
00:25:32.463 --> 00:25:36.923
And I think at the end of the day, that that was removed. But building in that
00:25:36.923 --> 00:25:42.123
clinical strategy early on, having an idea of what that clinical trial or first
00:25:42.123 --> 00:25:44.643
in human study or what that patient population looks like.
00:25:44.723 --> 00:25:48.083
I think we also work very closely with patient advocacy groups,
00:25:48.143 --> 00:25:52.443
especially because we work on so many of the rare diseases and the orphan drugs.
00:25:52.583 --> 00:25:56.683
It gives you the ability to understand what your patient population looks like
00:25:56.683 --> 00:26:00.283
and what are you going to be realistically able to recruit.
00:26:00.463 --> 00:26:04.883
And also to design the appropriate inclusion and exclusion criteria because
00:26:04.883 --> 00:26:11.303
sometimes you have a buy-in on a particular synopsis on a protocol for a clinical
00:26:11.303 --> 00:26:15.023
study from the regulators, and you're married to that.
00:26:15.243 --> 00:26:20.003
But then when you start to execute it, you realize that you can't necessarily decide
00:26:20.252 --> 00:26:25.532
recruit those patients based on the inclusion-exclusion criteria that you have set out with. Yeah.
00:26:25.992 --> 00:26:28.532
So, Ami, I think we're coming to the end of the podcast. I mean,
00:26:28.572 --> 00:26:29.892
I've really enjoyed that discussion.
00:26:31.052 --> 00:26:35.072
It's an amazing area we work in. I mean, there's so many, but there's also so
00:26:35.072 --> 00:26:39.052
many things that you can get wrong just because, for what it is,
00:26:39.092 --> 00:26:41.972
it's a complicated industry and there are many pitfalls, aren't there?
00:26:42.132 --> 00:26:46.332
So, I suppose the good news is Boyd's can help, really. Yes.
00:26:46.432 --> 00:26:52.572
And that's the part of the best part of working with you and Boyd's and the team alongside.
00:26:52.792 --> 00:26:58.452
For me personally, it is that we go out there, listen to all these amazing innovations,
00:26:58.452 --> 00:27:00.832
what the developers are trying to do.
00:27:01.092 --> 00:27:07.112
And for the most part, we've been there, done that. And we get a lot of insights from our team.
00:27:07.452 --> 00:27:11.892
And we're learning something new every day. So, like you said,
00:27:12.072 --> 00:27:17.152
Boyd can pretty much help you navigate that complex pathway from beginning to
00:27:17.152 --> 00:27:18.992
end. And I like being a part of that.
00:27:19.232 --> 00:27:22.812
We hope you've enjoyed the podcast as much as we've enjoyed doing it.
00:27:22.952 --> 00:27:27.212
And if you'd like to reach out and meet the Boyd's team, the Boyd's website
00:27:27.212 --> 00:27:30.192
is www.boydconsultants.com.
00:27:30.332 --> 00:27:32.572
And we hope to meet you sometime in the future.
00:27:32.852 --> 00:27:34.812
Bye-bye. Thank you, Neil. Bye-bye. Bye.
00:27:39.112 --> 00:27:40.952
Thank you for listening to Conversations.
00:27:40.880 --> 00:28:04.328
Music.