Wound Care Collaborative Community: Post-Summit Interview

© 2024 HMP Global. All Rights Reserved.

Any views and opinions expressed are those of the author(s) and/or participants and do not necessarily reflect the views, policy, or position of the Wound Care Learning Network or HMP Global, their employees, and affiliates.

HMP Global’s Symposium on Advanced Wound Care (SAWC) Spring | Wound Healing Society (WHS) partnered with the Wound Care Collaborative Community (WCCC) to host the inaugural Driving Innovation in Wound Care Summit, addressing public policy challenges related to assuring patients receive access to wound-healing therapies.

Transcript:

Vickie R Driver, DPM, MS, FACFAS:
Good morning. I'm Dr Vickie Driver. I'm the Chair of the Wound Care Collaborative Community. I have with me today the Vice Chair, Dr Lisa Gould; D. Emma Wright, who represents industry, Chief Medical Officer for Mölnlycke; Dr Alisha Oropallo, who is chairing one of our very important work groups.

WCCC represents a collaboration of clinicians, academicians, industry, the FDA, NIH, and CMS, and anyone else that wants to be part of truly changing wound care as we know it today, modernizing process, opening the door for better access to care, better access to innovation, those that we have in clinic today already, and treatments that we haven't thought of yet.

The first question or the first discussion point we're going to have is what effect does the work that WCCC have on industry or what effect can it have? And let's start with Dr Emma Wright.

Emma Wright, PhD:
So thank you Vicki. I think WCCC is a real opportunity, and it's in the name. It's the term collaboration. And we often talk about collaborative efforts, but often they suffer from inertia, which is certainly something WCCC doesn’t suffer from; it’s a very active group. And the reason, as an industry representative, we rarely get to talk to other industry partners. So here’s a great way of having multiple stakeholders from the regulatory agencies, reimbursement, the clinicians, and other industry partners to really come together. We cannot solve the challenges in wound care alone, and this is very much a facilitated and truly collaborative partnership to address the same issue that we’re all driving towards. And I think that’s a really unique opportunity for us as an industry player.

Lisa Gould, MD, PhD:
The thoughts behind the WCCC also were to really drive innovation, because it's difficult and fairly slow to bring new innovations to our patients. And that's what we, our whole mantra has been, is don't let something stand in our way. Let's push the envelope, do quantum leaps and really find out what our patients need and how we can bring it through the FDA to our patients quicker..

Dr Driver:
Yes, thank you. Dr Oropallo, would you like to comment on this?

Alisha Oropallo, MD:
Yes, I think the WCCC does a lot, even a lot more than that. It's really bringing what's important, whether it's the tools, the gaps, what's out there, collaboratively, not only with industry, but even in the patients, the patient care, and how we relate to it. And it's a community that we can all belong to and comment on and bring our is forthward.

Dr Driver:
Yeah, that's a very good point. In fact, WCCC, we're not going to go to Congress and ask for any change in specific laws, but what we are doing is working very hard on changing process. We're doing process improvement. Our goal is regulatory modification so that innovation can be brought to our patients in the form of diagnostics, biologics, drugs, devices, and some changes in standard of care, maybe clinical practice.

Dr Wright:
I've seen so many products over my career that have not made it from bench to bedside and it's rarely the innovation that's the issue. There's a lot of innovation in the space. It's how do you get it to market? How do you get it through the regulatory agencies, ultimately how do you get paid for the product? How do you drive its adoption and changes of standard of care? And I think that, again, is something unique that the WCCC can bring. So many technologies that would have made an impact for positive reasons on the patient have failed to get to market. And having a collaborative partnership where you all work together to address those issues is really going to be key to improving patient outcomes.

Dr Driver:
Yes, and in fact, the main purpose of WCCC, when we say collaboration, as you mentioned, the central word, we comprise clinicians, academicians, industry, the agencies, FDA, CMS, and NIH. And anyone else that wants to belong; we are not exclusive to anyone.

Dr Gould:
I think as we talk about more collaboration we have been working hard to get very organized and have our groups organized and now it's time to bring in the patient voice. I think it's one of the most important voices to bring innovation, and really focusing on patients who have been in clinical trials and what those trials meant to them, and I think that will also help increase patient participation in clinical trials, because they'll understand that it's not so scary and it really is in order to bring innovations to them in a faster manner.

Dr Driver:
In fact, we conducted a clinical trial of over 500 patients, I believe, which they had a chance to say what mattered to them in new treatments and diagnostics. And we published these results. Moreover, just this week, a patient actually sent us a check. They looked at who we were and they said, "We really need you. We need people to pull all of this together for us. And if not just for me," she said, "for my family members who we know there are patients that we don't see with wounds." And I'm guessing based on what she said her family members already have diabetes and she is quite certain that maybe 1 or 2 of them will develop ulcers based on what she knows of the evidence.

Dr Oropallo:
I think making that difference is so important because of the impact, not only the patient, but how the WCCC formulates that in each one of the working groups. And so It's really about collaborating, as you mentioned, and putting together real data, what's really out there, and bringing it forth in a publication so that it can be presented, so people can appreciate the guidelines or the consensus amongst us that needs to move the needle forward.

Dr Driver:
I'm glad you mentioned publication, because we are about conducting, doing the work, conducting the evidence, analyzing it, having third parties weigh in, and then publishing it. And we have several work groups. There are many more than us sitting here today who are working extremely hard on our work groups, our work streams, as you know, that are working every single day to conduct work that matters, that matters in terms of what we know about FDA process. How can we advise industry? How can we advise and work with industry? How can we do the same with academicians and government agencies? I mean, we started the wound care collaborative community at invitation of the FDA. That's how all this began.

Dr Wright:
And I think that's so important, and just to pick up on the points on real data and clinical trials. When you're in a situation where you can talk to the FDA and they work with you to understand maybe what they've asked for in the past isn't real in terms of it's not relevant to the vast majority of wound patients. So to then be able to talk about real world data, registries, the work that's been done on the National History Project. I think it's just so valuable. It will allow more patients into clinical trials. We exclude the vast majority of patients from trials. It will allow us to bring real wound patients into those trials, maximizing their opportunity, even increasing their access to the new innovations that they would have had to wait many years for, potentially afterwards.

Dr Driver:
Yes, in fact, at the summit on Monday, we just heard a first brush of some data from our natural history project that almost 70 % of patients aren't even considered for clinical trials. And that means that the reimbursement won't cover their access. So these patients will be denied this great care that we could potentially give them.
Dr Oropallo:
Yes, and we're always challenging the envelope. In the tools working group, we look at the percent area reduction and percent volume reduction as discussed, really bringing the key points, highlighting what's really important, not only for the consumers, but also industry to appreciate and the FDA.

Dr Gould:
This is the other part of the innovation. As we get patients to talk more and more openly about what really matters to them, thinking of the drainage that they deal with and the odor and why they're isolated because they don't want to get on the bus and they have a device that they have to carry around. As they feel more free to voice that, that will drive innovation to change the products and change our care. I think that that's a real value that they can bring to us and bring to FDA. FDA has shown a very strong interest in wounds, whereas 2 years ago they had a summit when we were all in lockdown they did it online, but they had 4 patients present what a wound meant to them, and I think it was a real eye-opener for them, and that helped us talk more together about the patient and have the patient in the center of everything that we do.

Dr Oropallo:
I think because of the summit FDA is making strives,  they understand and appreciate what we are doing as we represent the community, and they're moving forward to actually accept new ideas as they implement new guidelines.

Dr Driver:
You know that's a great point. You know they are represented on the work groups and work streams including CMS, and they prepare heartily for the summit on Monday. And we learned some things that were really important to us. Dr Gould and I, we've worked for 10 years together now. You know, 7, 10 years ago we started the endpoints work hoping that we could create the evidence that would support additional primary endpoints. We did a whole lot of work with many, many smart people, and we conducted 3 publications. And what we heard on Monday was amazing, which is the FDA said they are absolutely considering additional primary endpoints, which is critically important for patient care, not just complete wound closure.

We also heard that in addition to a randomized clinical trial, you can submit real-world evidence as a secondary aspect for FDA approval. Of course, there are lots of considerations around that, but we have not heard these pieces before. So, to your point, Dr Oropallo, yes, they really have engaged, and Dr Gould, they see the patient now. Dr Wright, I want you to comment on an industry perspective. What do you think some of these changes might mean?

Dr Wright:
I think it will be revolutionary for industry, because they will start to think about the area differently. We often talk about healing and trying to meet the FDA's need for primary endpoints and complete wound closure. We forget about the patient. We forget about who’s having the treatment done to them, how they feel about it, how it impacts their life, their family around them. There’s real opportunities for innovations that are beyond healing and are more representing of the patient’s quality of life and their experience. And not every patient’s the same. Many patients will unfortunately live with wounds. But there’s opportunities for innovations there to make their lives better. Maybe we can’t heal that wound right now, but we can make it livable. So they can get on the bus, they can socialize. They can be an active part of society. And I think that’s something industry needs to think about. It’s not an area, that patient-centric approach has been missed. and I think it’s a real opportunity to open up new opportunities and more than developing products that are in a box that are really driving at primary impulse light wound closure.

Dr Driver:
Yes, well, we know many of these patients their life is all about wounds. They don't just have one. It's not one and done. That's not who they are. And you know, we used to talk about wounds as being a symptom. Well, okay, in some ways, but retinopathy could be considered a symptom of diabetes too, right? But wounds are certainly a disease to patients. Have you asked them, they feel pretty passionate that this is something they want to go away. And it's, they've tried very hard and they've been hospitalized over and over and over.

So, Dr Oropallo, what did you get from Monday's summit that will inspire you?

Dr Oropallo:
I guess hope, really. I mean, it inspired me that we're moving forward and accomplishing so many tasks. I think this was the first that the FDA engaged with any kind of organization and their trust in the WCCC was evident, and so I think that we're on the right track to really making a lot of changes in the future.

Dr Gould:
I was impressed by the people in the room. There are so many passionate people, but incredibly smart people, and they come from all over in different areas, engineering, FDA, regulatory, patient care. It's just, you know, they're very passionate, and they're going to get it done. They saw what we've done so far, and now I think that they're motivated to help us. There were people that have not been traditionally part of WCCC. And I think it really has drummed up some enthusiasm.

Dr Driver:
And, for those that weren't there, it was an 8 1/2 meeting. We had 36 panelists, 150 people in the audience. And, no one left with the exception of a bio break. Now that's exceptional. And it was a really cold room. So there was some, there's glue. I think the success of any meeting is taking all this forward and making something of it. We will have proceedings, as you know. There will be published proceedings. We want more people involved, so please spread the word. And thank you so much for all of your work. It truly is a team, and it takes us all because not any one person is going to get this done.

So if you want to learn more, beyond what we had to say today, we have a website. Woundcarecc.org.

And all you have to do is jump on it and become a member. And then, if you'd like to join a work group or workstream, we'd love to have you in any way, shape, or form, you all matter. We need you all. So thank you.