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Accelerating Clinical Trials in Australia and Asia – Presented by Steven Roan at OCT USA

Worth Sharing?

25 September 2020
WEBINAR

SCRIPT

Hello, good morning, good afternoon, good evening.  Thank you very much for taking the time to join the presentation today.  I’m thrilled to be here on behalf of Novotech to present today on Accelerating Clinical Trials in Australia and Asia.

First of all, who am I?  My name is Steve Roan.  I’m Business Development Manager for Novotech.  I’ve been with Novotech for about three years.  I’ve been working in the CRO space for about 15 years, starting my career as a research nurse many, many years ago in Central London, working for a Phase 1 unit, recruiting, dosing and clinical execution of trials on healthy volunteers, so great to be here today.

The presentation should be around about 20 minutes.  I’ve broken it down into three sections:  An introduction to Novotech; how Asia-Pacific is handling the COVID-19 pandemic and what Novotech is doing to support companies as well; and finally talking about the benefits of working in Asia-Pacific for clinical trials.  It’s a very unique time; I certainly miss the opportunity to work with and meet people face-to-face.  It’s a different time, but have to embrace it and make the most of it, so thank you again for dialling in.  I hope we can meet face-to-face at some point in the future.

First of all, a little bit about Novotech:  We’ve been in operations since 1996, so over 20 years.  We started as a small regulatory consulting firm and then we’ve grown to become a full-service CRO.  The headquarters is in Sydney, Australia.  We have offices throughout Australia.  We’ve also got operations in New Zealand, South Korea, China, Hong Kong, Taiwan, Philippines, Malaysia, Singapore and India.  We do not have any operations in Japan; it’s a question we do get asked fairly frequently.

In terms of our service offering, we are a full-service CRO.  We almost exclusively work with biotech companies.  As a result, we work with biotech companies that have a lot of experience, that are well established, but we also work with some biotechs that are very new to the clinical arena, they’ve never delivered a clinical trial before so, as a result, we have a biotech team, or a BioDesk specialist team which is made up of specialist consultants that guide companies in terms of drug development plans, doing reviews of preclinical data, any toxicology data, regulatory affairs specialists as well, so really guiding these smaller biotech companies to get into the clinical phases.

In terms of our therapeutic experience, it’s very diverse.  As I mentioned, we work almost exclusively with biotech companies.  A lot of companies work in the oncology space and, as a result, Novotech; about 30 to 40 per cent of the trials that we execute are oncology trials, so aligning ourselves to what’s actually happening in the biotech space.  Beyond that the experience is pretty broad.  We do a lot of clinical trials and infectious disease supporting biotechs that really need access to patients that really only exist in the Asia-Pacific region.  To date we’ve run over 1,100 projects in the region, and a number of these are pivotal trials supporting multiple FDA/EMA product registrations as well.

In terms of our operating model, Novotech works directly with sponsors, contracting and executing and managing trials directly with the sponsor, but we also certainly operate with our partner CROs around the world, sponsors contacting Novotech to say, “Please, we want to run a trial.  We want to also include some European or US sites.  Can we work with you and can you lead these other CROs?”  And we also work with other CROs who approach us and say that their sponsors would like to open up sites in the region as well and they come to us because of our local knowledge.

Something that’s pretty important to mention, which is quite different to other parts of the world, is that the staff at Novotech are all employees.  We don’t operate with contract CRAs in any of the countries we have operations; all of the staff are employed working under the Novotech SOPs. 

Specifically talking a little bit about China, we’re just moving over to slide 5, you’ll see there a company name called PPC, so I’ll just spend a little bit of time on PPC and China ‘cause China’s certainly top of mind for many, many companies when they approach us for the trial execution.  PPC and Novotech have the same ownership structure, we have the same management structure, […].  The PPC brand name is very strong in China, so we’ve decided to keep that brand name in China, but PPC is essentially Novotech’s delivery arm in China, so collectively we have 1,500 employees, 24 offices across the region, including myself here in the US with colleagues as well.  We have a couple of offices in the US supporting our client-facing staff like myself.  We are certainly seeing a lot of changes in the biotech space within China.  Traditionally, a lot of the Chinese biotechs would only work within China.  Over the last two years, or a little bit longer, they’ve been starting to look outside of only China, so we’re seeing a lot of activity coming from local Chinese biotech companies looking to run clinical trials in the region as well.

Moving on a little bit to spend a little bit of time just talking about COVID-19; I think we’ve all heard about it, we’ve all been impacted in some capacity or another.  Certainly, the origins of COVID-19 pandemic started in Asia.  There was a lot of media report about what was actually happening before it spread into other parts around the world.  I think summarising what’s actually happening now is that the Asian countries are getting a lot of praise for what they’ve done in terms of management of COVID-19.  Certainly, in the US it’s still an ongoing issue and I expect there’ll be continued issues for a little while.  Certainly, in Europe I’m seeing the media reports that there’s spikes across different countries.  It’s not to say that there’s not going to be any continued spikes in the Asian countries as well, but I think the base of where we’re starting from is significantly different.  Certainly, South Korea and Taiwan have been standout countries and well reported in the media in terms of what they’re doing to contain the pandemic.

What is Novotech doing to support clinical trial continuity in the region?  Well, we have seen an impact in some of the sites and some of the hospitals.  I’m just moving over to slide 8 now and looking at the monitoring graph there on the left-hand side.  We’ve certainly had some impacts across some of the countries and sites in terms of monitors not being able to go into sites and restrictions in terms of getting into the hospitals.  We are seeing this bounce back to normalisation and things are starting to open up.  Site initiation; there were certainly some impacts and this is now bouncing back, as is recruitment as well.  As a result, Novotech has seen a lot of activity from global biotechs approaching us to say, “Look, there’s a level of uncertainty in Europe and the US, we understand what’s happening in Europe, there’s a bit of a corner is being turned.  Can we please open up discussions about some risk mitigation strategies about opening up sites in the region?”

What is Novotech continuing to do to support sponsors that are interested and also ongoing sponsors?  Moving over to slide 9, I’d just like to highlight what we’ve been doing and what’s been very, very well received by our sponsors.  Since early March Novotech’s been producing a bulletin every two weeks and making that available to our sponsors on the webpage.  What this bulletin is covering, which is particularly of interest, we’re working with the country managers who are working with local hospitals in each country and we’re getting an update from them in terms of what’s actually happening on the ground, so if we look at the slide here, you can see a little bit of a green and yellow colouring in the slide.  This is pulling out the top 10 recruiting hospitals in Australia and giving an overview of what’s actually happening in terms of monitoring.  Site initiation visits; can they be done face-to-face or does it need to be done remotely?  Is there monitoring?  Is there any impact, et cetera?  We’re producing these and we’ve been seeing some great trends across the region in terms of we’ve gone from lots of yellow to lots of green, so it’s really a testimony to what’s actually happening in some of these countries.  We’ll continue to produce these bulletins for as long as it takes, for as long as the sponsors would like to receive these.  They’re incredibly well received.  Up the top of the page is the web link; please go to our website to access these to take a bit of a look.

We also have an operating group of some clinical staff within Novotech that are across the whole COVID, COVID across Asia in terms of a working group, so we’ve got some key people in these positions keeping an eye on what’s actually happening.  In terms of COVID clinical trials, yes, we’ve certainly seen some activity of companies approaching us to run trials.  Transition has been that there was a lot of COVID early in the piece; this has now changed a little bit.  People are redefining their clinical trials; they’re looking for specific things with the COVID patients, so it’s an ever-evolving space which requires us to be ever evolving in our thinking as well.

Just moving on a little bit to some of the benefits of working in Asia-Pacific, I’m going to focus on slide 11 first.  I won’t spend too much time on this; just to say that Australia has become over the last few years a hugely popular trial destination choice.  There’s three key things that are leading to this:  It’s the practical, pragmatic and simple start-up process in Australia.  I’ll speak about this a little bit more on the next slide.  Combine that with the overall cost of conducting a trial.  I hope you have heard about the Australian R&D rebate; if not, in a quick nutshell, the Australian Government offers an R&D rebate of 43 per cent of clinical costs.  It comes back as part of a cash rebate to sponsors that are eligible that fit the criteria to be able to claim the R&D rebate.  Novotech works with a number of companies that can guide and advise if you are a suitable sponsor for that.  We’re not the tax experts; we’ll encourage you to have a deeper discussion and dialogue with these other companies.  If you can claim it, the cost of running clinical trials in Australia can be significantly cheaper with the R&D rebate and just the general cost effectiveness of working outside of particularly the US.

And then finally the third point which is key; you wouldn’t do a trial in the region if this was not on the list, but it’s the clinical trial data is accepted by the FDA and the EMA, so you can run a trial knowing that the data is going to be accepted by these key authorities.

Moving on to slide 12, just to give you a quick update on the speed of actually start-up.  For many companies a key milestone is getting the study started, getting the first patient in.  Frequently milestone payments or some financing is tied into these milestones.  The quicker this can happen, the quicker that money can come in to the company.  The process in Australia is a little bit different to the US, for example; you do not require an IND.  We work with a lot of US biotech companies that are actually coming to us before they have an IND, starting their clinical trial, starting to collect clinical data, and then they’re moving in towards an IND submission, so different way of thinking.  A lot of companies are taking advantage of this pathway.  In Australia we have a mixture of both public and private sites.  We will always try to identify a private site because they start up approximately four weeks quicker than a public site, so we always go for a combination if possible, of both public and private.  On the slide here you can see that little bit of a visual representation of what the average start-up timeline is in the region.

Moving on to now a little bit; the attractiveness of Asia as a trial destination, referring to slide 13, I think first and foremost its access to patients; 60 per cent of the world’s population is based in Asia-Pacific.  We’ve got some very high-density city living environments; we’ve got some fantastic hospitals, very large teaching institutions with access to a high number of subjects across various indications.  Over the last few years, we’ve got great resources in terms of investigators and KOLs, so for every year of running a trial, for every year of gaining experience, the experience just compounds and becomes even more and more and more.

I’ve already talked about the cost competitiveness of Australia.  On top of that, Asia, compared to other global locations, typically can be anywhere between 15 to 30 per cent cheaper for a clinical trial execution, so all of these things makes Asia really a very good choice for many, many companies as well.

Moving on to the next slide, just speaking in a little bit more detail about why Asia; we talked about recruitment; here’s a bit of a stat on the left-hand side here comparing other locations versus Asia.  The number we’re quoting here is recruitment can be approximately 40 per cent quicker than other countries.  One of the key things that Novotech does extremely well because we work with companies that haven’t worked in Australia, they haven’t worked in Asia before, we invest a lot of time with clients walking them through a feasibility process, we support a lot of feasibilities to give sponsors a real lot of confidence that actually Asia can deliver, so one great example, the path we tend to follow for our oncology work; dose escalation and then expansion studies, part 1 and part 2.  We often run these in Australia for the phase 1 part and then we expand out to Asia.  Australia has some limitations in terms of population size.  We can jump over that, expand out into Asia, get access to significantly more patients and have much higher recruitment rates to bring home studies a lot quicker, so that’s just one example that we use all the time at Novotech in terms of our oncology studies.

Looking in the middle of the graph there, just frankly it’s lower clinical trial density across the region.  You can see the US obviously a key market for most companies, but it’s also very saturated in terms of clinical trial delivery.  If you look across the right-hand side as we go down, some of the other Asian countries represent very good opportunity in terms of less trial density.

I’m just going to spend the final parts of this presentation just highlighting a couple of case studies, evidence of actually successes that our sponsors have had.  Engage Therapeutics has obviously given us approval to use their name in this presentation.  They were running a trial in the US, they were having some site performance issues, a CRO recommended they contact Novotech, and this particular study we managed to get off the ground with three sites in Australia.  The take-home quote from the CEO was the only regret was that they should have started in Australia a lot earlier.  We’ve got so many stories similar to that of companies that have followed a traditional path, they’ve been influenced by people in the industry that have only ever worked in one or two regions, they didn’t have any experience in Asia, they’ve come to us, we’ve opened up their mind in terms of thinking in how to execute clinical trials and we’ve had a lot of success.

And finally, I’m just going to highlight an Asian study that was delivered very successfully.  This was a phase 3 global small cell lung cancer trial.  Now, Korea was the standout country here.  We ran the study in a number of Asian countries; South Korea was a fantastic contributor to the study.  You can see the graph over here; we managed to recruit 84 subjects over a 12-month period which was really leading region for the clinical trial execution of this study.  Korean hospitals; second to none.  The infrastructure’s fantastic, they’re big institutions, they’re well run, very slick institutions in terms of patient recruitment, the KOLs are all very engaged, the feasibility feedback is all very accurate, culturally they’re just good to work with, it’s just a fantastic place to run clinical trials.  If you’ve never worked in Asia, recommend it; it’s worth investigating.

I could spend hours talking about this, I could go into details on every particular country Novotech has operations, I could present numerous different scenarios of running clinical trials; unfortunately, don’t have the time, but would love to actually connect with you if you have any more questions on Novotech, on working in Asia, putting it out there, feasibility.  Feasibility really is the way to go; Novotech’s happy to do that for companies if they haven’t had any experience in the region or if they’re having some troubles delivering any trials.  We’re more than happy to investigate and provide feedback if we can help.

I’ve come to the end of the presentation.  Wishing you a good rest of the conference.  Looking forward to potentially meeting in the future face-to-face; won’t that be great?  Have a great rest of the conference.  Look forward to hearing from you.  Bye for now.

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