EU Flagship GMP GDP Clinical Trials Hub in Dublin

Patrick Daly:

Hello, this is Patrick Daly and welcome to Interlinks. Interlinks is a programme about connections, international business, supply chains, and globalisation, and their effects on how we live, work, and travel in the world today. Today on the show we will be talking to Michael O’Kane, commercial strategic director with Yourway Clinical. That is Y-O-U-R way, Yourway, which is a company that describes itself as the biopharma services company. So Michael has spent most if not all of his career in the life sciences sector in various roles, including business development, going back to about 2008, I think, and has worked with companies such as Bio-Trans, MedServ, World Courier, CRYOPDP, Mark, and now Yourway. So welcome, Michael, and thank you very much for being here with us today.

Michael O’Kane:

Patrick, great. Thank you for the invite. Lovely to be on and appreciate the interest.

Patrick Daly:

You’re very welcome. To kick things off, Michael, could you give our listeners a high-level overview of your career to date up to the point, say, that you joined Yourway. We’ll talk about Yourway separately.

Michael O’Kane:

Yeah, so I have been in the specialty pharma supply chain sector for almost 15 years now. And previously to that I was in medical distribution for a Irish company called Screenlink Healthcare where I specialised in the distribution of cervical cancer material across Ireland. And then in 2011 I joined World Courier and have been in the space since then, predominantly on the commercial business development side, but I’ve also been very focused on strategic assessment analysis, market segmentation, and looking at general trends within the industry. So I’m based out of Dublin and with the new Yourway team out of our facility besides the airport here, and I’ve been with Yourway for just over two months, so I’m very new to them but not new to the industry.

Patrick Daly:

What’s the business of Yourway? And tell us about this new facility that you referred to there, the Yourway facility in Dublin, and what does your role as commercial strategic director with Yourway involve?

Michael O’Kane:

Yeah, so if I may begin with the facility itself, the facility is positioned strategically beside Dublin Airport and it is the newest flagship depot and a state-of-the-art facility that integrates clinical packaging, temperature-controlled storage, and distribution to support the entire clinical trial value chain with agility, reliability, and efficiency. And we also look at clinical material into commercial as well. And we have the ability to assess, and commercial activity, as well, with a WTA licence via the HPRA. My role is to support the facility and be part of the global strategic team. And where we’re looking at clinical trial requirements and where we know they can be exacting and time-sensitive, so Yourway provides a range of solutions to ensure that the needs of clinical trials are met and yeah, I’m very excited to be part of that team.

Patrick Daly:

And what’s the size of the facility and what’s in it? What are its capabilities and capacities?

Michael O’Kane:

The facility is purpose-built in terms of 70,000 square foot, temperature-controlled storage from control [inaudible 00:04:04] down to minus 185 and it has a 6,000 pallet capacity and with state-of-the-art technology, and it guarantees the utmost safety and security for diverse therapeutics. And as you well know, that is vital, not only here from an Ireland pharmaceutical perspective, but on a global scale. And we focus on security and safety for the efficacy of the material we will be handling.

Patrick Daly:

And who are the target customers or clients for this facility and this service offering, because it’s quite high-end, it’s quite specialised, isn’t it?

Michael O’Kane:

Indeed, yeah. So the facility has been designed with a focus on a couple of categories within the pharmaceutical biotech space. So those that would need to look at clinical material storage and may also need to have clinical packaging, clinical labelling, and clinical project management on a GMP level, because we know GMP speaks to the industry levels of quality expected. And then we also can look at commercial and distribution, as well. So those that may have a commercial material for the medical industry and the Yourway facility can look at that, too.

The facility speaks to the investment of the leadership team based out of Allentown in the U.S. led by Gulam Jaffer, our CEO, and Yourway with its 27 years of experience have been looking closely at a location for a European flagship depot and naturally, having assessed the market and locations, Ireland felt like a perfect fit because of multiple factors to the industry locally and what’s seen here and what has been delivered here over not only the last say 20 years, but the last 50 years and where manufacturing has gone from large bulk and to heavy API and then a progression to more biotech and biologic, and Yourway biopharma services is a perfect fit for what is happening in the industry, not just in Ireland, but on a European and global level.

Patrick Daly:

And when we say clinical, that means we’re talking about R&D, product development, that kind of area. When you preface everything with that word clinical, is that what you’re referring to there?

Michael O’Kane:

Yeah, so I mean precisely that. Clinical in terms of research and development, we know that that is an area that is important in the development of material medicines for patient consumption. But the event, not only will showcase, the event that we’re going to be talking about on the 6th of June about the facility will showcase the reasons why the facility is here and we’ll talk around elements of the clinical world in terms of the role of artificial intelligence and machine learning in optimising clinical trials and we’ll be addressing challenges and opportunities in patient recruitment and retention amidst global conflict, adapting to regulatory changes, navigating the impact of EU clinical trial regulation, CTR and other emerging guidelines, and cell and gene therapy coming of age and its impact on clinical supply chain logistics.

So the facility, when we get to talk a little bit about the event we’re having in June, and it speaks to those areas where having a facility that is GMP compliant and with an awareness of binding and taking on board and managing and distributing as needed clinical material that speaks to the development of a clinical trial from anywhere from phase one, it may even be pre-clinical, right up to phase two to three and into four. So the facility is well positioned to cater for those facets of the clinical trial world and speaking to the areas that I’ve touched on that we’ll see on the 6th of June.

Patrick Daly:

And how unique is that facility in an Irish context, how unique is it in a European context?

Michael O’Kane:

So from an Irish perspective, it’s seen as personally classed for the setup, the structure, the planning that has gone into it. I myself, having been in the industry for 15 years, have not seen such a facility on the market from a local Irish level. So that is quite a statement, because there are many companies in logistics, as you well know, servicing the Irish pharmaceutical industry but there has none been well-placed as this one in terms of predominantly looking at clinical trial storage, clinical trial management, at such a scale. So there are other units across Europe that are reflective of this with other companies, but from an Irish perspective in the Republic of Ireland, predominantly it’s GMP and GDP ability is second to none.

Patrick Daly:

And what’s happening on the 6th of June, you’ve kind of alluded to there, there’s an open day, is that what’s happening on the 6th of June?

Michael O’Kane:

Yeah, so the company and the leadership group and myself and the team here at Dublin, we are planning to invite guests from across the pharmaceutical, biotech, cell and gene, and the advanced therapy manufacturing arena, API, med tech as well, and research institutions all across the country to come along and visit the facility on the 6th of June. And we’re going to have a panel of speakers and we’re going to have a tour of the facility from 10:00 AM to 2:00 PM and we have this on our website, www.yourway.com, you’ll find it on the Dublin Depot part of the website. And you can simply register to attend by populating your name, your details, your work email, and then by doing that, you’ll be able to reserve a seat as such or a spot for the event as I mentioned on the 6th of June.

Patrick Daly:

That’s yourway.com, Y-O-U-R way.com, is that right?

Michael O’Kane:

Exactly. That is it.

Patrick Daly:

So why is cold chain and cold chain logistics so important in biopharma and why is this facility of such strategic importance to both Yourway as a company and to Ireland and the fact that this facility is actually located here in Dublin?

Michael O’Kane:

So it’s a good question and obviously cold chain has evolved significantly with the industry, not only from an Irish perspective, but on a European and a global and further field perspective. Across the sectors, we’ve seen a demand for temperature-controlled cold chain shipping for quite a number of years, predominantly around the areas of refrigerated two to eight and then under minus 20 and then minus 50. But more and more regulatory bodies like the MHRA and HPRA from an Irish perspective the FDA, and then further afield are requiring that companies are monitoring the temperature performance, the stability data of the material across all temperature bandwidths. So controlled ambient has become more of a focus. Even deeper than that, we’re seeing cryogenic and minus 156 temperature requirements, because the stability data of the efficacy of material, whether it is in clinical mode or in commercial stage, it requires that the data is managed, is stored, and can be presented to regulators so when it hits them, the chemist, the pharmacist, and then to a patient, whether that’s a patient in a clinical trial or simply being prescribed medicinal product via their GP or hospitalisation, that everything is serialised, everything is correctly tracked and monitored.

And with that, the cold chain is obviously vital to understanding how it has been monitored from the minute it’s dispatched from a manufacturing site, a clinical investigation research group, and along those different areas and then into the public domain, i.e. a warehouse such as Yourway with a transport team, also with a company like Yourway. And then moving into other parts of the supply chain, i.e. with vehicles, with airlines, also via sea freight or larger road freight, all of that temperature cold chain mapping speaks to a couple of key words: safety and due diligence and key data monitoring.

Patrick Daly:

So it sounds like a real kind of billet to Ireland in its endeavour to push itself up the value chain in pharma. Would that be fair to say?

Michael O’Kane:

Yeah, look, I think it’s credit to Ireland and a testament to how Ireland is perceived across the globe and that a company such as Yourway with a global platform, a global reach, and looked at Ireland in great detail and in that detailed assessment had conversations with people like yourself, foreign direct investment agencies like the IDA, also spoke to Danny McEvoy’s group at BioPharm Chemical Ireland and Enterprise Ireland, and really had a very strong sense from those conversations that Ireland would be very suited to Yourway for investing and presenting such a facility. So Yourway really took a lot of time in understanding that and it made very clear business sense to bring Yourway and at that level to Ireland, Yourway had already been operating in Ireland on a logistical standpoint with clients of different sizes and scale, but they felt they would augment and enhance that activity by presenting this European flagship facility. So really positive news for Ireland and for a company of Yourway’s stature to bring this facility here.

Patrick Daly:

Excellent. So might just shift the focus of the questions just a bit towards yourself and your own views on things. So the industry that you’re in and you’ve been in for decade and a half or so, as you said, is there anything about that industry that troubles you, that you don’t like, that you wish would be resolved? And if there is, what might that be?

Michael O’Kane:

Yeah, so one of the areas that I’m looking at, and I know people are looking at in general is the effectiveness of the service level. So we see across the space, and obviously quality levels are very expected in terms of what we can offer to the industry, but there is a sharp focus currently on the speed of response. So a lot of this work requires human involvement, because it is specialty in nature, so it needs an eyes on, it needs people to be very aware 24/7 in real time of how to ship from A to B. So that is a premium and it comes with additional costs and there is a sense of looking at can we be a little bit more agile and clever in the way that service is provided in speed of response.

Looking at, for example, how we book a shipment, how we get pricing forecasting for a shipment, can we be quicker in response times with technology on that? And then also the update, the communication parts on where a shipment is, why it’s been maybe mishandled or delayed, or if there’s been anything that could jeopardise it, how are we relaying that to the actual client, i.e. the person who has required the shipment, has presented the shipment to companies such as Yourway and giving them the peace of mind that it has been minded and it has been tracked and monitored. So there is no compromising of the shipment. So the technology part, the speed of response part needs to be constantly looked at. Also that it’s speaking to the sustainability requirements from an environmental perspective and carbon emissions. So there are areas that the industry, because it’s been very much hands-on and people-orientated, there’s a sense that we need to find ways to improve that part of the business perhaps with technology and looking at AI to some degree.

Patrick Daly:

And what would be the question that you’d most like to know the answer to from your prospects or from your customers at this point in relation to their current needs?

Michael O’Kane:

Well, from a Yourway perspective, we’re keen to listen to many types of requirements. So what we’re seeing so far with the dialogues we’re having is choice of an alternative that is agile in its makeup and is quicker to respond and can be seen as a very clear expert in guiding companies in how best a shipping solution will fit their needs. So that’s one area that we see as a big demand, the tailoring of the requirement. Because already there’s large interest in the facility, but we’re seeing different and asked about it more than we anticipated, so we had a sense of clinical demand, but now we’ve had people come to us saying, “Well, we have an interest in clinical, but we’d like to look at another facet of our business to see if you could help.” So really being able to listen to people and tailoring solutions that fits needs is a high priority for us.

Patrick Daly:

And that’s quite interesting. And maybe drilling down a bit deeper into yourself, so as I mentioned at the outset, you’ve worked in the sector for many years, you’ve been with different companies, and I think our paths first crossed, it was probably about 10 years ago now. And I’ve seen you progress in your career and ever-increasing levels of responsibility and leadership and so on. So what would you consider to be your most important leadership characteristic that’s kind of enabled you or sustained you through your career over those 15 years or so?

Michael O’Kane:

I think one simple word is tenacity. It’s been, it’s a trait that, I don’t know if it’s just from my work experience, but I’ve had it from my own personal life where I’ve been a competitive swimmer. I played water polo at a high level and I now teach and coach swimming and water polo to different age groups of people. And I think that being able to have that tenacity to overcome obstacles and the industry’s, pharmaceutical specialty industry in general can be challenging and being able to navigate and find ways to overcome barriers to entry and obstacles to success. I think that mindset of, well, you need to be tenacious, you need to be driven, but in a controlled way. You can’t just go about things in a winner-takes-all mindset. You have to be stealth, you have to be prepared to put the work in to see the results.

And so in our industry and the pharmaceutical industry in general, it’s having that respect, that mindset to be professional and to see where you can help, but you need to be driven to perhaps go the extra mile. When we’re working on activity for clients and companies, I take great pride in the tenacity, not just for myself but those I work with, to ensure deliverables. And if we deliver correctly, if we see everything brought to a client and brought to a patient who could be in late stage oncology and needing a material and that tenacity to make sure it’s delivered correctly.

Patrick Daly:

What motivated you at the early stages of your career to take the path that you chose and what motivates you now in what you do? And what part of that motivation has stayed constant over the years and what part of it has changed?

Michael O’Kane:

The motivation part has probably been getting to work with other great people, like-minded people, people like yourself, people like Matt Moran and people across the industry that I’ve met over the years and motivation to be around people like yourself to learn and to listen and to observe has given me in turn motivation to want to give something back then. And I’ve really enjoyed the space to have had the opportunity to become part of the specialty supply chain arena.

When I go to a symposium or when I go to a conference or when I go to a large-scale event, and you hear about the technologies that are being developed and the science behind a new material product that could cure cancer, that could eradicate an issue where there’s a requirement for a vaccine. And the vaccine alone for COVID and the pandemic, and to hear and see everybody working together instead of against each other to find ways to collaborate. So where you had companies at large scale and you’re looking at each other as major rivals, everybody came together incredibly to be a success in finding the solution to tackling what we saw for COVID-19.

Patrick Daly:

And what’s something that you’ve always wanted to do but not done yet, whether in work or in life or in swimming or whatever?

Michael O’Kane:

Well, if this was a swimming interview, I’d have said, of course I would’ve liked to be an Olympian. I was close. I mean, I can say I was close in some regards in the swimming world and to the outside world, it’s like, “Well, if you haven’t made it to Olympics, you’re not maybe such a successful swimmer.” So that would’ve been something I’d aspire to as a young person. But now I just enjoy going and giving back from a swimming level. And in fact, I do believe Ireland will see major success this summer in Paris in the swimming pool and watch out for Daniel Wiffen and Mona McSharry are definitely two names to watch. I can’t say I have anything to do with them except I’m just a big fan.

And then from a business perspective, becoming part of the Yourway team and what that represents and ultimately, I want to become part of the leadership group, whether that’s in managing director mode or, I don’t think I’ll be CEO anytime soon with somebody as dynamic and brilliant as our CEO, Gulam Jaffer, other people like Leandro Moreira and Sane Purvibe and Malia Jefford, there’s really great people here, but I’ll be glad to be part of that team. And it also mentioned colleagues like Kailyn Savage and Christina Pervici, so a really great team here.

Patrick Daly:

Excellent. And well, you mentioned swimming, but what other things you like to do outside of work by way of pastimes or hobbies?

Michael O’Kane:

Yeah. Well, I suppose swimming is probably the biggest one, and then the water polo involvement, as well. I also do open water swimming, well, that’s more in the summertime. And then I have a little interest in the music and the art world when I can. And I go with my wife, travel a little bit, and we like to visit London a little bit and we were there recently, spent some time looking at the V&A and National Portrait Gallery and just looking also at the historical parts to London like Hampton Court. And in fact, we went to the war rooms and we also went to the [inaudible 00:26:57] just to absorb everything that’s going on there.

Patrick Daly:

Excellent. Are you reading or listening to anything interesting at the moment that you’d recommend to listeners?

Michael O’Kane:

I mean, I did pick up A.A. Gill’s autobiography, which I always found him fascinating.

Patrick Daly:

Whose autobiography did you say?

Michael O’Kane:

A.A. Gill.

Patrick Daly:

A.A. Gill, okay.

Michael O’Kane:

Yeah, real fan of him. And then music-wise, gosh, too much to mention, but recently it’s been taking a lot more interest into the archives of the Rolling Stones, digging into their back catalogues.

Patrick Daly:

Excellent. Where can people find out more about you and about Yourway and about the new facility and the open day and so on?

Michael O’Kane:

Yeah, so I’m on LinkedIn as Michael O’Kane and I can share details afterwards. But the main area to look at would be www.yourway.com. You’ll find all about the event on the 6th of June there and also all about our capabilities and across, as I mentioned, logistics, packaging, labelling, clinical project management, and other parts of the biopharma services arena.

Patrick Daly:

Excellent. So many thanks, Michael, for being here with us today. It’s been an absolute pleasure chatting with you.

Michael O’Kane:

Thank you very much, Patrick, and wishing you lots of onward success.

Patrick Daly:

Thanks also to our listeners for tuning in again today and be aware that if you enjoyed this episode, you can find the full series of nearly 150 episodes of Interlinks on Spotify, Apple Podcasts, Acast, and other major podcast platforms. So until next time, keep well and stay safe.