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Managing Global Studies with Regional Partners

Worth Sharing?

23 October 2020
WEBINAR

SCRIPT

Arsalan Arif:  Hi everyone, and welcome to our webinar Managing Global Trials with Regional Partners.  It’s sponsored by Novotech and we have three great panellists today, and let me introduce them real quick. 

First up we have Kim Steel, the Project Director at Novotech.  She’s got 15 years of experience in clinical research, including Study Coordinator, CRA, Project Manager and Project Director. 

Next up we have Reena Lynam, Director of Clinical Operations at Leap Therapeutics.  Twenty years in industry with 15 in clinical research, her current role is Head of Clinical Operations at Leap. 

Next up we have Julie Bowman, the Associate Director, Clinical Project Management at Ce3.  Julie has extensive knowledge in clinical project management in phase 1, 2 and post-marketing clinical trials.  She’s worked for global CROs prior to joining her current company and has some interesting views on the operational and structural differences between the two types of organisations. 

We have approximately 20-minute presentation followed by Q&A.  I encourage all listeners and attendees to go and hit that Q&A button at the bottom and submit your questions.  If we don’t get to your question, someone from the Novotech team will follow up with you. 

We’ll start with Kim Steel, so Kim, go ahead and take it away. 

Kim Steel:  Thanks, Arsalan.  As noted, I’m Kim Steel, Project Director with Novotech for around six years.  I’m delighted to be given the opportunity to take part in this webinar and interactive discussion, so very quickly for those who have not yet worked with Novotech, a quick intro and a bit of context from us. 

Novotech has been operating for around 25 years.  We’re a full service Asia Pacific biotech focus CRO and we have local teams on the ground in 11 countries across the region, so that includes Australia and New Zealand where we started out, and then big markets of China, Hong Kong and Taiwan as well as South Korea, and then South-East Asia, Singapore, Malaysia, Thailand, Philippines and lastly, India, so we have experience across an extensive range of therapeutic areas and over 1200 projects. 

Our model has always been to hire a very experienced local full-time regulatory and clinical team on the ground in each country of which we operate and to really help our clients base and navigate the regions in terms of the local requirements, the language, the cultural aspects, et cetera.  Novotech offers an expert consulting service, including the CMC and manufacturing guidance, and also a solid regulatory pathway to gain market approval.  Novotech is also a consistent recipient of the Frost & Sullivan Asia Pacific Biotech CRO Company of the Year Award.  Next slide, thanks. 

The micro trends currently being observed in the biotech sector suggest that about 85% of studies are now focused on later phase studies, predominantly that of phase 3 studies, and about 30% of those phase 3 trials are being managed across two or more regions.  Next slide, thanks. 

Novotech is a successful and nimble CRO.  We understand that every study is really different and that flexibility is key, and so we have a variety of operational models which may at times include collaboration with regional alliance partners, so two models that generally have proven fruitful for us is one in which the sponsor chooses to be the main point of contact for each CRO or alliance in the daily operations; or number (2) where the lead CRO becomes the central and coordinating contact across the regions, and the lead CRO then reports in to the sponsor as the one point of contact for streamlined communication, so ultimately the preference comes down to the management style of the team, time, budget, expertise and ultimately the trust of each party in collaboration with each other. 

That’s all from me for now.  I’m happy to take questions at the later stage of the presentation, but I’ll pass to Julie. 

Julie Bowman:  Thanks so much, Kim.  I really want to talk to you today a little bit about the difference between a regional and a global CRO.  I’ve had the opportunity to work with a large global CRO as the global project leader, and then also working with Novotech and the smaller regional CRO kind of put boots on the ground model, and I can tell you that working with that regional CRO support system can really make or break a study and really can help position us well to support the sponsors who you need to be there through the entire study design.  Just as Kim was mentioning, the flexibility in the model helps us to be able to best meet the needs not only of the sponsor, but also of our sites and our teams that are located in the different regions. 

Some of the things I think that are really critical when we’re working with a regional CRO really ties back to the geographic expertise.  Having folks actually in that region supports our timelines, it supports our ability to more quickly activate sites and get patients enrolled which is ultimately the goal.  Being able to really look at the flexibility of the process in the model that we use makes a huge difference, having that flatter team structure allows us to have direct one-on-one contact with our subject and our functional leads which better supports communication back with our sponsors. 

Something else that I think really makes a big difference working with our regionally-based CROs is the fact that we have more direct access to senior management and that accessibility helps to drive high-level conversations to best support the needs of the sponsor as we’re moving through the process of study activation and study delivery. 

I think also something else that’s really important is we always have to think about cost and we have to think about timelines, which is a real driver for project leadership, and having folks really located right there, understanding the culture, understanding the language makes a huge difference in terms of our success rate.  Next slide. 

Back to the elements to a successful regional alliance model; Kim just kind of referenced this and I agree with everything that she’s got in the slide.  I think it’s critical communication is number 1 though; we have to have effective communication with our teams and with our boots on the ground.  And working with the smaller CROs absolutely gives us that ability to best manage not only the individual functional areas, but the overall study success as well.  Having a successful history of working together, building those relationships to be able to make them transferable from study to study is really critical, and understanding their flexibility and the sponsor flexibility in terms of program management and understanding there’s not one right way to do it.  We really do work a lot in different types of studies, same therapeutic indications, but every study is different and we need to know that we have the flexibility and the support as we move forward to best meet the needs not only of the sponsor to ensure trial success, but we’re always thinking about patient safety, effective documentation and things like that.  Having the ability to work with an organisation that is really about identifying roles and responsibilities that’s logical and that makes sense really supports again the success of the study and then the success of the relationship between the sponsor and its vendors. 

We talked a little bit about the governance structure, the critical nature of having access to high-level management to have those high-level conversations that maybe don’t necessarily need to be held at the study team level, but drives success of the study overall, and then always adapting and following SOPs and identifying what SOPs make the most sense as we move forward.  SOPs in one region of the world may not always be a direct alignment with another region, and having access again to those folks who are based in those regions, understand the culture, understand the whys behind decisions is really critical to the success of the study.  Next slide.  Right, Reena? 

Reena Lynam:  Thanks, Julie.  As Arsalan said, my name is Reena and I work at Leap Therapeutics.  It’s a small biotech company in the Boston area.  There are about 30 of us, so with many small companies we wear many hats and we outsource our studies so we heavily rely on our CROs to run our trials, and here is a trial that we are running with Ce3 and Novotech, and this also is a partnership study with BeiGene. 

Leap company; we are focused on a DKK1 antibody, DKN-01; for short, DKK1, and we are partnering with BeiGene’s tislelizumab PD-1 drug, and this is a phase 1, 2 study in metastatic advanced gastric GEJ adenocarcinoma patients.  If you look at the diagram, I’m going to start with cohort 2 in the green, so for cohort 2 we are enrolling first-line patients and we are looking to per protocol enrol 20 patients in this group.  The second part, cohort 1, is second-line patients, and for this part of the study we had to validate an assay because there is a requirement for patients to be DKK1 high; they need to overexpress DKK1.  DKK1 overexpression is associated with poor overall survival in gastric cancer patients.  In Asian populations specifically, DKK1 expression is a prognostic factor for predicting tumour reoccurrence and survival in patients with resected advanced cancer, and that is how we reached out to Novotech, Ce3, and we reached out to Novotech so we could add in the South Korea portion of the study because in addition to requiring this DKK1 overexpression, we have to look at the patients, meet the initial criteria of that biopsy and then send it to the vendor and test to ensure that they meet that criteria, then they screen for the study, so we are looking at about 33% of gastric patients having this overexpression so we would have to involve about 140-44 patients to get to our 40 patients, so the study overall is of about 72 patients, but because of the pre-screening it increases the number which, as anyone who has experienced a rare disease, you have to go out to more sites to get your patients and so we have about 37 sites selected for this with 12 being South Korea, and very exciting that we achieved our FPI in September and so we are starting in the enrolment phase and working with both Novotech and Ce3 to have South Korea join in in the study and to work on the next phase of the trial. 

Arsalan Arif:  Now it’s time for some questions and I have lots of questions for you all over here.  Actually, with Reena; let’s start with you. 

Question:  When it comes to CRO choices, you talked about it a little bit, but what are the key elements that you’re looking for? 

Reena Lynam:  Besides cost?  I’m going to put the cost aside ‘cause every sponsor wants the lowest price they can get.  The experience of the CRO is important to know how much experience they have in indication in the various phases, project management.  The elements that you are looking for your study, to look at those qualifications, but also look at them overall as a CRO and their experience and the bigger picture because we don’t like to always go out for every trial and look for a new CRO so we want to build a partnership.  Large pharmas have those; small biotech also want those partnerships with equivalent sized CROs who can help them.  Also processes; understanding the processes because you’ll understand how the CRO works, and does that match up with how you would do your processes or would you be having a tug of war throughout the whole process of the study because you don’t agree with the processes.  And then a partnership; definitely a partnership so you can be transparent and not make it a blame game, but make it a ‘we’re doing this together and our end goal is the success of this trial’. 

Arsalan Arif:  Right.  You mentioned something about not wanting to go out and see so many CROs, but can you speak to any of the advantages on choosing a regional partner like that over than, let’s say, one of the giant CROs that are supposedly everywhere? 

Reena Lynam:  Yes, so there are pros and cons to both of them, but the advantages I see to the regional CROs is that they’re flexible, they give you the attention you need and this is where else a lower cost, they’re more reasonable, they fit into our brackets of what we’re looking for from a finance perspective.  And like Julie said, you have access to senior management.  The team is so busy working on the study and getting the pieces done that you need to have that higher level of intuit to see how things are going, and if it’s not working out, it doesn’t mean that there’s something wrong with the relationship, it may be a disagreement in how the process is, and so if you have that escalation piece to hash it out, it makes it much smoother and you come back with quicker decisions than you would with the bigger CRO. 

Arsalan Arif:  Let me ask you about, so as a small company it’s so important to pick that CRO; right?  It’s so important, so how are you assessing the quality of their past work? 

Reena Lynam:  Audits; definitely audits to qualify them, and when you audit them it’s not only you’re quality auditing them.  I’m going to go back to the processes that your cross-functional team, biometrics, clin ops, medical safety should be looking at this, reviewing the SOPs and processes as well with your QA to make sure they understand it and ask the questions upfront in that qualification, and then also word of mouth.  I reach out to colleagues I worked with at biotech companies, pharma companies and ask them, “Hey, have you heard of Ce3?  What do you think of them?” and also asking the CROs for their references for companies that are similar to your size. 

Arsalan Arif:  Okay, very helpful, thank you.  Kim, we’ve got a couple of questions for you. 

Question:  Can you share some examples, Kim, of how regional CRO specialists can maintain that flexible approach for biotechs that have larger trials? 

Kim Steel:  Yes, so from my perspective we’re all looking for fast, accurate and focused responses in the daily management of trials, so the regional CRO has a better capability, as Reena has mentioned, of being able to have a flatter structure […] pathways, so I believe in all of that.  The Novotech QMS and related processes that we have means that we can assure quality whilst being flexible in what we need for our sponsors.  I guess we also have the right amount of SOP direction, but also equally adaptable and flexible structures to support and assist with rapid start up and equipment, so easier accessibility to staff means that your start-up timelines are going to be reduced and that accountability amongst the different teams is much higher, and I think that really assists. 

Arsalan Arif:  Well, with that flexible model with what you’re speaking, how do you maintain a consistent quality among all these different organisations in this model that you’re talking about? 

Kim Steel:  Sorry?  My connection has stopped, Arsalan.  Can you hear me? 

Arsalan Arif:  Yes.  I’m going to try that question again.  Can you hear me now? 

Kim Steel:  Yes, it’s just a wee bit mumbled.  Yes, go ahead. 

Question:  Here’s my question:  With this flexible model that you have working with these different partners, how are you able to ensure consistency in quality among all these different facets? 

Kim Steel:  I think in the very first instance you really have to get the project off to the really best start that it can be, and that comes down to a solid kick-off meeting and a really committed project manager so I think they understand then the scope of work and are in the know of the lines of communication and the responsibilities of everyone including vendors or other services that are needed is critical at that point, and then the commitment from all parties is key for quality and that includes an individual’s ability to be adaptable to change, and I guess that’s been achieved in my experience through engagement, so the models that we presented before, as much as project management is very focused on study timelines, deliverables, budget, as Reena mentioned, it’s really highly focused on people management and consistency, and consideration of cultures and working styles and to get the best out of everyone in the team, so I think again you must keep team members accountable for milestones, processes, training; everyone has to be on the same page, and that comes down to really good project management and just being a project manager making the time to put the quality checks in place to ensure that the processes are being followed, and having a robust risk management plan to manage any issues and inconsistencies proactively if they were to arise, having that governance structure that Reena also spoke of so that you can reach the hierarchy faster if there are any issues to resolve them quicker, and then also I think quality comes across in a trial, and these models, you have to be able to cope with staff turnover and so you have to have these seamless handovers and ensure that all the background information’s been passed on as well, so it’s keeping your eye on all the balls and just to keep it rolling. 

Arsalan Arif:  It seems like a lot of project management over there to keep on top of that, right.  And some of these, if Julie or Reena you have anything to add onto any of that on really consistency because I guess that’s the driving factor here working with regional partners.  Anything to add to that, Julie or Reena? 

Julie Bowman:  Yes, absolutely.  I think one of the critical pieces there is having all of your access to the subject matter experts and having that oversight by a project manager at that local CRO is huge.  It ensures consistent updates from the study team and it ensures smooth communication between the different vendors and the sponsor because at the end of the day we’re all working toward the same goal, and that’s a successful outcome, and so we need to make sure that we have everything in place with all of our partners in order to do that. 

Arsalan Arif:  All right, great.  Let’s see so there’s a follow-up here. 

Question:  I have several questions here on the additional burden on managing multiple CRO partners?  Julie, do you have any tips on that? 

Julie Bowman:  I think it’s interesting because at the end of the day managing CRO partners is part of vendor management and that is really a core part of being a project manager and managing these global studies, and it’s about perspective, so it’s understanding that by having these regional CROs that can own all of those details and those pieces that encompass culture and language, and regulatory requirements and the day-to-day operations of these sites and these studies, there’s a lot of burden associated with that, but by having a regional CRO to own that piece of it, my role as more of a global oversight is going to be that I’ve got somebody whose boots are on the ground, he’s doing the work providing the updates to me so the level of burden for me is minimised and yet we still have an outstanding product at the end of the day, so I don’t even see it as burdensome, I see it as really a strategic decision to support a positive outcome for our sponsors. 

Arsalan Arif:  Interesting; must be the mindset over there, some have it.  Reena, here’s a question. 

Question:  How does the process of involving sites in Australia and Asia differ from North America?  ‘Cause obviously you’re in Boston right now; right? 

Reena Lynam:  Yes. 

Question:  I guess the question here is really speaking to the regional challenges of being a Boston biotech company and what’s the differences in involving sites in Australia and Asia from that in North America?  Any particular challenges you’ve faced? 

Reena Lynam:  I know Julie probably has some thoughts on what I’m going to say.  I think the biggest challenges; the team as a sponsor, we have our hands all over North America sites.  We will pick up the phone, call them ourselves and our CRO will be like, “That is our job; stop.”  It’s that urgency as a sponsor that when your CEO walks in, ‘cause you’re so small, and says, “Oh, what’s the update on this patient or your CMO?” you’re like, “Oh, I’ll call the site.”  And I know from a CRO perspective I do get my hand slapped, so it is something that you like because you can get the answers to your senior management quicker and it’s ex-US you cannot do that; (1) it’s the time zone difference; and (2) there is a cultural difference you have to respect based on the region and you have to learn at the beginning how that relationship is set up, and you also have to think about when we start a study, in my experience at small companies, most of them, not all, have started in the US, you had their KOL and so your focus is very North America, US, Canada focus, and then when you go ex-US you start learning about the differences; for example, chemotherapy is standard of care and so on a trial, okay, the sites will take care of it, we’re not going to procure it, we’re not going to pay for it, it’s covered by insurance.  Then you can into another region, some countries in Asia, and even if it’s standard of care, it’s a trial so you are responsible for paying for the drug, so it’s starting to understand and work in on that, and even how you answer questions; some countries deviations are very sensitive if they have a deviation and how you handle it, so it’s taking that step back and trusting your CRO, which at regional CROs like Novotech have the expertise to tell you, “This is how we would do it, this is how it fits in culturally,” and for us to say, “Okay, this is different, but we totally understand and we respect that region.” 

Arsalan Arif:  Julie, anything to add to that? 

Julie Bowman:  Yes, I think that Reena brought up a great point.  When you’re working with a biotech, they tend to be a smaller organisation, and we understand the nuances of a small organisation needing access and wanting to have access to all of the different folks that help drive the success of their study.  And I think when you work with a regionally-based CRO that is a smaller organisation as well, there is a little bit of a kinship there and they appreciate the need to be able to more effectively and efficiently communicate with upper management.  When you work with a larger global CRO, we’re still multiple layers away from upper management and executives and so we don’t tend to have to deal with the day-to-day questions coming from our CRO, “What’s going on?  What’s the enrolment numbers look like?”  Being able to appreciate the position that our teams are in that we’re supporting, I think from a regional CRO perspective, it really does help further support that relationship which again drives success for the study. 

Arsalan Arif:  All right.  Here I’ve got a question; I think this is probably more for Julie and Kim, so here I’m going to read the question. 

Question:  What are the driving factors in country selection or does CRO selection determine country selected? 

Kim Steel:  Yes, so Julie, do you want me to start? 

Julie Bowman:  I’ll let you start and I’ll follow up. 

Kim Steel:  Okay.  I think it’s a mixed decision based on recommendations of the persons conducting the feasibility.  Obviously you’ve got budgets, et cetera, to consider as well, and you also have to think about the prevalence of the disease or condition in a certain country, so the start-up and the regulatory timelines are also going to impact on that decision, as well as any key opinion leaders, so you might also want to think about how the current standard of care might differ between countries and how that might impact on the sponsor’s protocol that’s been developed, and then I guess from Novotech’s perspective as well, we have a major influence in different regions and that can assist, and we have that visibility that we can give those recommendations to determine a country, but yes, Julie will gladly take you from here. 

Julie Bowman:  Yes, I completely agree with what you said, and I think when we’re partnering with sponsors, especially in the repeat customers, but even with new potential sponsors, something we really push for at the beginning is for them to think about what is the need and the outcome of the study, what are those four timelines, does it make sense to assess a global perspective?  The reality is we are in a global environment today and so to not have that conversation upfront I think is a missed opportunity.  We don’t want to lose the opportunity to find the right patients and to be able to get the data as quickly as possible, and being able to move to a more global perspective I think really supports that, but it all comes down to having the right conversation at the right time at the beginning when decisions are still being made, and our Leap study is a perfect example.  I think there were conversations, Reena, about possibly going global, but when we started out on the study it was going to be US only and we assessed the needs at that point and determined that it did make sense to move into Asia Pacific.  And so it’s not that you can’t change your mind, but any discussions and decisions you can make upfront I think has a huge impact to the overall timeline of the study. 

Reena Lynam:  And I think as a sponsor to share with your CROs your thought process----- 

Julie Bowman:  Absolutely. 

Reena Lynam:  -----is helpful; I think that’s what made it successful for us to add South Korea earlier on with the study. 

Julie Bowman:  Agreed. 

Arsalan Arif:  With South Korea, can you tell us a little bit more about South Korea specifically, Reena?  I mean was there anything different between South Korea and the US?  Any sort of cultural stuff on the trials or anything that you could comment on there? 

Reena Lynam:  For South Korea, the reason why we decided to go, the prevalence of gastric cancer is higher than the US and we want to maintain timelines and think outside the box how to keep things moving, and South Korea came up as one of the options, and culturally there are differences, for example, in feasibility process we are in COVID world so I will also say South Korea, Asia is packed as an area because of the way they managed COVID so it was a plus for South Korea, is the feasibility piece of it of how it’s more formal than it is in the US and in sitting down with your PI or meeting them at a conference, it’s more that face-to-face, so we’re all going rush, rush, rush, let’s  […] get the answers, let’s move on, and you have to take that step back and make sure you have that quality piece done which carries over to the US then as well that okay, we’re doing this process, let’s keep some consistencies, so I think our quality is important so we follow those cultural differences. 

Question:  Moving on to our next question here, or it looks like a statement, perhaps, it speaks to an element of friendly competition between regional partners who are vying to maximise recruitment in their region.  Kim, is this something that you have seen or could you comment on that on how that works? 

Kim Steel:  Sure.  Absolutely I’ve seen it, I came across it, I work with it daily, so everyone wants to deliver on the project together which is the common bond between everyone, and more so we want to keep the key opinion leaders or partnerships in check, and really all the CROs, they have their relationships with their sites, no-one wants to damage that, we’ve all worked really hard to keep those, so I guess it’s critical that everyone is briefed on the study expectations and any promises that may have been made.  In my experience some KOLs or some doctors might have helped with the protocol generation, they might want to take part in this study, but they might want the first patient or they might want to just enrol in a certain cohort, or they might just have time for two months instead of six months, so we need to be aware of all of that so that we can manage the expectations, and we need to do that between partners and have that open conversation otherwise it could have a negative impact, but in my experience it really does work well as long as everyone just chats and all the information is shared. 

Arsalan Arif:  Anything to add to that, Julie? 

Julie Bowman:  I agree with that completely.  Could not have said that better. 

Arsalan Arif:  All right.  Julie, what do you think is the best practice when it comes to managing global studies with regional partners? 

Julie Bowman:  I think effective communication 100% is what’s going to make or break it.  I think building that relationship and establishing those roles and responsibilities, and understanding who’s doing what, who owns what, and how are you going to provide those updates?  I think the flexibility; when we’re working with regional partners the reality is one of the biggest issues we run into is that time zone difference, you know, working with sites in South Korea, we have a 12 to 14-hour time zone difference.  We need to be able to be fluid and open and consistent so that when issues arise no-one’s left feeling like I’m just out here and I have no support for the next 12 hours because no-one in the US is open, things like that, so really just like what Kim mentioned; having a really strong kick-off meeting and establishing those guidelines and those rules and responsibilities, but at the end of the day it is ensuring that we make ourselves available, we’re flexible, we understand that it’s not an ideal time maybe for everybody to meet, but let’s bend that flexibility and let’s get ourselves together so we can stay in touch with each other and use that effective communication because at the end of the day we are all again working towards that same outcome and that successful end point for our sponsor. 

Arsalan Arif:  Okay.  Well, let me question you on that a little bit, Julie, because you’re working at a regional partner right now, you’ve got that environment right now, but I understand you work for some larger CROs? 

Julie Bowman:  Absolutely. 

Arsalan Arif:  What’s the difference here?  Are they not doing that?  Give me your point of view on what the difference is out here? 

Julie Bowman:  I have run global studies where I did not have a regional footprint, so sitting in Midwest USA and I’m trying to support studies in Europe, I’m starting to support studies in Asia Pac, and so what I really found was that I was burning the candle at both ends, and so that wears on me as a project leader who’s responsible and accountable to support all of those different team members.  And even though I did have team members in those different regions, what I found was I wasn’t able to give 100% to my regional teams because I wasn’t available during the hours that they were available.  It was a lot of acknowledgement of their email, but ‘it’s going to be tomorrow before I have a response to you,’ and as we all know, oftentimes emails and issues come up that don’t have a 12-hour window that they can wait; they really do need kind of immediate response.  And while I think our teams from a global perspective understand that the time zones are just an unfortunate reality for the world that we live in, I also think that we have to be willing to think about the fact that sitting in the middle of the United States and I’ve got patients and I’ve got team members in Asia or in Eastern Europe that need specific answers quickly, I think again we have to go back to we are now working in a global marketplace, we have to provide those services in a much more timely manner, and I think these regional CROs do exactly that. 

Arsalan Arif:  All right, okay.  I’ve got a question for you, Reena, here. 

Question:  We’ve had a few QA and GCP-related queries here, so is there anything specific – there’s probably a quick answer – but anything specific to consider from your side to ensure you’re doing your due diligence and following all the ICH guidelines? 

Reena Lynam:  Yes, so it’s the regional guidelines that as a sponsor we perform ICH and GCP across the board, we try to maintain that regardless of the region.  However, when you get into outside of the US it’s more you have to follow it; it’s not a guide in, so like GDRP patient confidentiality, understanding import/export licences if you’re shipping samples from ex-US into the US, or kits are going from the US to ex-US, although those have guidelines around it and regionally can be different, and so those are important, and I think spending the time at the beginning to understand with your CRO, your regional CRO, including your global CRO if you have that PM, is to walk through it and understand it at the beginning so you can mitigate and start thinking about timelines. 

Arsalan Arif:  All right.  Anything to add to that?  All right, let’s see.  I think the panellists – I don’t remember who – kind of mentioned something about feasibility which can be complex for cross-regional trials, right, so could you tell us a little bit more about how feasibility is run for these global trials? 

Kim Steel:  Yes, I can start.  Novotech has a dedicated feasibility team to start.  We also have a platform that we use  […] which keeps all the information for us so it’s widely available to the team.  I guess my motto is always that feasibility isn’t at one point in time.  Often people will do it at the start of a study and the study could go on for two years, three years, things change; you see that more so with COVID-19 as well, but PI might change, the capabilities might change, the structure of a hospital might change, so you need to be across what’s happening there, and it’s educating your CRAs to be asking the right questions at the right time, so from the point, you know, from the start of the study, yes, you’ve got a dedicated team, we have our knowledge, we can guide where we think the best places are you should go.  A sponsor would give us the timelines of when they hope to enrol in and we say, “Well, we think you should go to country A, B and C, rather than just four sites somewhere.”  We have that knowledge to do that, but I think it’s an ongoing process that I think everyone can always do a little bit better just to keep on track of where we’re up to, and I think that’s half the battle with keeping trials on track and being able to move and change with that. 

Arsalan Arif:  Julie, anything you want to add  […] 

Julie Bowman:  I think that’s a great point and I think we rely on capability upfront on studies to help identify target site selection, but feasibility; there’s a lot to balance between what we’d like to be able to enrol versus the reality of what we may enrol, and so a lot of decisions are based on that initial feasibility that goes out to the sites, and so I think the point we do need to follow up and we need to assess where were we 18 months ago versus where we are today.  This  […] has opened up a litany of questions that none of us had prepared for in any of these upcoming studies or studies that are currently actively enrolling, so we need to appreciate what the feasibility questionnaires provide us, and then we also need to take it and follow up on that and see how that they look today compared to 18 months ago, and where are they going to look 18 months from now? 

Arsalan Arif:  I just want to remind the audience before I go into my next set of questions here to keep on sending the questions, hit the Q&A button at the bottom.  We’re grouping a lot of these questions together here, but if there’s something that we don’t get to, someone will definitely get back with you.  I encourage you to ask our experts here some of these questions.  I’m going to group a bunch of these COVID-related questions into one and this is generally for the panel here and for each of your expertise and each side of the table that you sit on. 

Question:  Questions on COVID, impact on sites; can actually each of you speak to how sites have adapted, how you’ve adapted to the situation across the different regions?  Maybe Julie can go first? 

Julie Bowman:  I can go first.  Interestingly enough, when COVID hit we were in a situation where we had studies in various stages; we had studies in close-out, studies in start-up, and it came down to us understanding the impact, us understanding the FDA guidance so that we knew that we were addressing and approaching our sites in an appropriate way.  The big things, the takeaways, we came out of the initial when COVID first really hit was a lot of our sites were not necessarily ready to move into a remote model.  That has since changed; most of our sites now can readily accept remote monitoring, can accept remote drug accountability, can even from a patient perspective with virtual visits, things like that, so over the last six to seven months we have seen a huge increase.  The sites have really made an effort to be able to position themselves for this to have the most minimal impact to our patients which ultimately is always the goal.  And I think that the FDA really supported us in that.  I think from a US perspective we really were able to smoothly transition through the process, and I know, Reena, for our study it really hasn’t impacted significantly.  It’s probably had a little bit of an impact from a slower site start-up process because of staffing and resourcing issues, but again it’s been all about communication and asking the right questions at the right time. 

Arsalan Arif:  Kim?  Or Reena?  Reena, yes, could you speak to that? 

Reena Lynam:  I’ll go.  […] brought up our study and I agree with you that it’s been learning as we’re going along ‘cause sites are learning as well, not knowing when they’re going to go back into the office when initially this all started.  It’s a lot of unknown, and working with those sites and to say we understand, and we had another study where we locked it and to go through that process of understanding remote monitoring and ensuring that patient confidentiality is kept, you’re not transferring data with patient information on it and working with sites for what kind of systems they have, and then also I know a couple of sites for us for this current phase 1, 2 gastric study, we – not turned away – but we were looking at sites and assessing if they don’t have an electronic system and they’re only paper, we didn’t only look at that, but that was something that you start looking at now and assessing is this the right fit and talking to them and be like, “If this happens, what’s going to happen?”  Because we have to do our oversight, and Ce3 and Novotech have to do the monitoring phases of it and we need to ensure patient safety, and if we can’t have access to the data, we’re not going to be able to do that. 

Arsalan Arif:  Are there any other aspects of COVID that have impacted studies like this?  Like even Reena, from your perspective, how you said earlier that you really want to be hands on if they were in the US and touching all those points over there, what has happened now with the way that we’re all working now that you don’t want to change when we all have a vaccine in our arm and things go back to normal?  What are some of the things that you don’t want to change? 

Reena Lynam:  Well, it’s nice to see Julie and Kim’s faces.  […] small biotech company and sponsor world that you have companies who support the remote and some that weren’t really into it, and COVID I think it has shown that we all are professional and can do our jobs from home and you don’t have to be in the office, and I think it’s given respect for people who work remotely to remember them, and so I don’t want to change this dynamic where if we’re in a meeting and we’re talking about something, and it’s like, “Well, let’s Zoom Julie or Kim and talk about this,” versus saying, “Oh, well, they’re remote; we forgot about them.” 

(43:12 indistinct).  

Reena Lynam:  Yes, so I’m hoping that this stays, this piece of it stays, yes. 

Arsalan Arif:  Kim? 

Kim Steel:  I guess I’ve learned a lot with the COVID-19 management.  We have a taskforce at Novotech, but we even came down, to speak to Reena’s point before, it wasn’t until everyone started to get into the nitty-gritty about remote SDV, will sponsors accept remote source data review versus verification and how that impacts database law, et cetera, but we worked hard to get our vendors in place so that for sites that aren’t able to get all their ducks in a row straight away, we can offer vendors that do IP that can go perhaps directly to patients at home without us getting involved obviously, or in-home care where you just need to get some safety bloods done to keep your study ticking over, all of these things, so we’ve managed to get all those things in place and some generic approvals on language for patient informed consent forms or clinical monitoring plans so that we can move ASAP if there’s second, third waves, we’re all much more ready to go, but I agree with Reena as well; it is nice to see all the teams working so remotely, and actually it’s been from our side as well, a really kooky sort of team and a lot more people getting involved and not shying away from the camera and still picking up the phone and anything else which is nice. 

Reena Lynam:  And I think you bring up a good piece about we don’t want to forget all the – we’re behind in technology as an industry and now we are learning those pieces and I love it, like Julie and her – if you want to talk about it – but our remote SIVs, our Webex.  That was a whole new thing and I know you were hands on it versus more than I was, but it was a learning experience and something that I would love to do again. 

Julie Bowman:  It’s interesting; the first time’s always a bit more challenging.  We’re trying to wrap our head around it and really visualise what that was going to look like, and in the end it has proven to really be an effective method.  I think our sites do like it.  It’s also about, because I have been remote based for the last six years and so I’m used to being at home, and the camera’s new; typically I don’t have myself on camera, but then I don’t look camera-ready either, but I think----- 

Arsalan Arif:  […]. 

Julie Bowman:  I made an effort today; that’s all I can say.  But I will say that it has really kind of forced us not only as an organisation ourselves, but as a marketplace, to really start to think outside of the box and to start being a little bit more creative, and dare I say a little bit more daring in trying new things?  And we have a lot of folks are not a spring chicken anymore.  We have a lot of folks that do tend to get set in their ways and this is how we’ve always done it, and it’s hard to sell a new structure, a new idea; COVID kind of played our hand on that.  We were forced to rethink how to do SIVs, Reena, so that we could do it and make the most use of our time, and training opportunities and engagement with our sites because our CRAs are not on site and we all know that that face-to-face interaction is really critical in building relationships, so not that I’m a proponent of a global pandemic in any way, shape or form, but I do think we have to look at some of the positive things that have come out of this and I do hope that as we move forward and we get past this pandemic and the panic behind it that we see that there were a lot of really positive things that did come out of it and we can build upon that moving forward. 

Arsalan Arif:  Right.  You all mentioned some very good points.  Reena and Julie; it seems like you’ve been working from home for a while.  The whole challenge of running a company that has an office and also people that work from home and making sure that they’re not left behind, that they’re also included on the water cooler talk, all those sort of things, and that’s so important and I think that that’s really forced a reckoning among management and how you really include the entire workforce in that kind of thing, so right no-one wants a pandemic, but these are issues that have been surfaced and which you all, all three of you, have been very eloquently speaking about.  Julie, you’ve mentioned so much and so passionate really on project management and communication, and also you mentioned something about some folks who they’re not digital natives; let’s just say that there’s a reluctance there.  Now with the pandemic they’re all kind of forced to do it, but maybe could you just give the audience some practical advice, just some quick practical advice how do you do project management?  How do you do communication that well when we’re in a pandemic here and some people don’t get with the program; what are some strategies you use? 

Julie Bowman:  I’m all about really giving all of the information necessary.  When we’re not having face-to-face calls or in conference rooms where you can read body language and you can interpret how people are, what are they really saying versus the words coming out of their mouth?  We miss that in a more digital model.  And I will say our organisation is even recognising that turning the cameras on is going to really become a critical strategy that we need to implement with our teams to help foster those relationships, but I think really almost – I don’t want to say over-informing, but when you’re communicating in a written format, giving all of the details, making sure that you’re giving them enough information, not so much that you won’t get questioned, but that they have enough information to understand what you’re talking about, I think it’s very easy in our past to rattle off an email that maybe only had part of the information and just assume that our teams are going to understand it because they can just run over to our cube and ask us a question; we don’t have that anymore and so we need to be very strategic in our communication strategies with our team.  We need to understand that documentation is going to remain critical and it’s our due diligence and how we communicate that’s going to ensure success as we move forward, and giving all of the information initially helps, for our teams that maybe are not as digitally savvy, to be a little bit more comfortable because now not only are they struggling with the technology, then I’ve got to figure out what did she really mean by her email?  I think that happens a lot, you know, quite honest. 

Arsalan Arif:  Universal. 

Julie Bowman:  Yes, so I think the more details we can provide and just effective communication is really critical. 

Arsalan Arif:  Kim, can you add something to that? 

Kim Steel:  As a project manager as well, or a project director now, you need to understand that everyone’s different too.  Some people are visual people, some people like a lot of words, some people just close down an email as soon as they see something like  […]  I was trying to reach you, so I think just picking up the phone that you have to know who you’re working with, and to get to that point you need to have that relationship there where you call and say, “How are you?” first, right?  Actually understand who you’re working with and it’s not just work constantly; I think you need that as well, especially remotely. 

Arsalan Arif:  Yes, when people reply with just, “Okay,” you never know  […] ----- 

Julie:  Yes, I’m full of fluff, I’ve got to flower it up so it’s----- 

[…]. 

Arsalan Arif:  Right, I think that’s the safest way, frankly, flowering up, but see some people – Julie, you clearly have a special talent for it; Kim, you too.  I mean that’s a thing that you recognise; so many people are just – I mean I work with people like this in my own organisation and it’s like, “You know what?  I’m busy; I’m picking up the kids, I got one minute to write one line.  Why do people have a problem with that?” 

Julie:  Yes, right, yes.  So----- 

Arsalan Arif:  More common  […].  That’s all right. 

Julie:  It’s a hard balance. 

Arsalan Arif:  Right.  And all these things we’re learning in a pandemic, and we’ve talked about project management, we’ve talked about clear communication, we’ve talked about working with regional partners, we’ve talked about cultural differences between countries.  Everyone who’s in the audience are dealing with these issues right now.  We don’t have a tonne of time here.  I still want to get to some questions here ‘cause there are a few points that I’d like to bring up.  Reena, you mentioned this; I could talk ad nauseam about this of how the industry as a whole is just behind in terms of technology, and this is really up for the whole panellists really. 

Question:  What kind of innovations do you see being very useful for clinical trials in the future?  Reena, you’ve talked about how in other countries some of the stuff is just mandated, and over here where we’re at, things are a little bit more loosey-goosey, but what kind of technology would you like to see?  I know we don’t want to be working on paper or stuff, but what are some emerging technologies that you really see coming out of this? 

Kim Steel:  You’re on mute, Reena. 

Arsalan Arif:  You’re on mute.  I think your microphone might be on mute, but your Zoom is not.  No, we still can’t hear you.  Why don’t we try to troubleshoot that and try to get Julie or Kim to answer that question? 

Kim Steel:  From my perspective I think we have really advanced EDC systems as it is, but actually when you use it on enter if you’re looking to do soft database locks or an interim analysis rather, we still seem to struggle with the capability to have PIs being able to sign off on certain data at certain points, you know, you still have to wait to the end of the study.  That’s quite frustrating and I think if we’re going to do a lot of remote monitoring, there needs to be that there, and especially around data visualisation.  I know that that’s coming out everywhere and I think that’s really important to keep track of where your study’s at and to produce real time reports, especially between the time zones, and not relying on having to email and wait 24 hours for an update, so I think those are really key. 

Julie Bowman:  I think that’s true.  I think another item that I see from a monitoring perspective, a lot of our sites and our hospital systems today use electronic medical records, which is awesome.  It’s amazing, it’s a great process, but I think we sometimes assume that that’s going to make monitoring easier, and that is not always the case.  We have structures in place for protected health information, so being able to get CRAs access to the systems and understanding that the electronic medical record does not naturally align to the flow of a CRF, and so understanding when monitors are remote monitoring or even on site, there’s a lot of effort being put forth to try to go find those lab results or to go find that one data point that might take him 45 minutes to find, so it would be great if we could come up with – and I know there are some organisations out there currently that are trying to find a little bit more of a simpler process that can integrate the EMR with - from a data collection perspective for clinical trials to make the monitoring a bit easier, and that of course will then ensure cleaner data at the end point when we go to lock. 

Arsalan Arif:  Reena, let’s try you again.  No, I think your microphone has locked up on us.  You’ve given us a tonne of insights though, but we only have one last question over here, and Julie and Kim, maybe you could speak to it?  Also, if we didn’t get to your question out in the audience, please hit that Q&A button, make sure that we receive it.  The Novotech team is very responsive; they will get back to you, so please get your question over there. 

Question:  My last question here is:  At what point in development, Julie and Kim, should an early stage company start coming to you to discuss a global trial? 

Kim Steel:  Julie, do you want to start? 

Julie Bowman:  I’ll let you start; the camera’s already on you. 

Kim Steel:  No, Julie, you go; I think you’ve got a very good----- 

Julie Bowman:  Okay. 

Arsalan Arif:  Right.  What stage of development do the early stage company need to be coming to you? 

Julie Bowman:  Once they’ve made the decision that they’re ready to start thinking about this global study, that’s the point where the conversations need to be had.  From a CRO’s perspective, we have longstanding relationships with clients.  For new clients, that’s not a one or two meeting and then a decision’s made; it’s an ongoing conversation where we’re offering our services to support and get the sponsor ready, and for these early companies there’s a huge financial commitment, minimal resourcing on their part, they need someone that has the expertise to be able to kind of walk them through the process, and so it’s never really too early.  I have worked with sponsors in the past where at the point of concept they were reaching out and saying, “Here’s what we’re thinking.  What are your thoughts?  Your teams” – and it was our team along with other CROs – “you have that perspective that we don’t have.”  Having those conversations the earlier the better because it really does position these small companies to be able to make some good decisions that’s going to be financially beneficial and ultimately get them to where they want to be.  I think the fear sometimes is it’s too early to start talking about it, and the reality is it’s not. 

Arsalan Arif:  Can you add to that, Kim or Julie, because that’s the thing is I hear this a lot.  It’s like, “Come to us as soon as you think of it, come to us.”  Why don’t people do that?  Why does this always come up? 

Kim Steel:  We try to encourage it and we try to keep it on the project manager’s radar, but I think sometimes it’s seen as a secret, and actually the CRO is on the sponsor’s side, we want to get you to that point, but to do that we want to make sure that what’s your plan if you’re on phase 1?  What’s your plan for phase 2?  Will you need to compare lots of different programs, data together?  And if so, you can already start to program in the phase 1 portion as to how that data’s going to chat to each other, so all of that.  I think it’s just keeping the open lines of communication; we’re not going to give away anything, but we just want to be part of it.  For the most part when I’m working with a sponsor, I want to be part of that sponsor’s company, I want to know what the reg and the business strategy is so that I can complement it. 

Julie Bowman:  Absolutely.  And I think the other piece to that too is sometimes when sponsors come in and they’re having these initial conversations, one of the best things we can do, as kind of those subject matter experts, is to have them take a step back.  Oftentimes they’re thinking about the day that the patient is going to be dosed with their drug as an approved marketed drug, and oftentimes we work with folks who understand that I have a drug over here and I know it can do great things and I want to give it to people.  I know stuff happens in the middle, but I’m not really sure what that is, and so by asking us those questions upfront we can help them to put the plans in place.  That’s not only about getting their study ready to start, but understanding how far ahead do they need to be thinking?  Because if they’re thinking too far ahead, they’re going to be missing some great opportunities upfront that could really position them well, and so again, just to what Kim was saying, it’s establishing that rapport, it’s building that relationship and helping them to understand that it’s a long-term relationship, like getting those questions out as early as possible is always going to be a win. 

Arsalan Arif:  Very good.  I think what you spoke to, Kim, about it being a secret or being held close to the vest or it’s just they don’t want anyone to know about this sort of thing; there’s usually 10 other people have got that thing, it’s all about that execution usually.  And so that’s actually a great point; people should be coming to you as soon as possible because it’s really in their best interests then and it’s probably not a great secret and you guys will be able to help them.  That’s all the time that we have for today.  I want to thank really a fantastic panel.  I really enjoyed it, hearing from all of you and your perspective, Julie Bowman, Kim Steel and Reena Lynam. 

Julie Bowman:  Thank you so much. 

Arsalan Arif:  Appreciate it. 

Kim Steel:  Thanks. 

Arsalan Arif:  Appreciate it.  I’m Arsalan Arif of EndPoints News; we hope to see you at the next Novotech webinar.  Thank you. 

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