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Resource Fair: Clinical trial access

Held on November 15, 2023, this Resource Fair was an introduction to free-to-patient resources that enable additional paths to evidence-based investigational treatments. Participating orgs represented a wide variety of such resources that help patients when relevant clinical trials do not seem to be available locally or participating in trials elsewhere seems unattainable:

  • Just in Time Trial Programs
  • Dedicated Research Centers
  • Expanded Access Programs
  • Travel & Expense Assistance

In addition to sharing their organization’s programs, they also provided insight on the types of services they represent. There is an attached resource packet with materials and information on these participating organizations as well as many others in these areas.

The fair participants were (with the noted start times in the attached video):

2:45 – Megan Shulman, Tempus TIME Trial Program
8:20 – Jessica Smalls-Eddy, National Institutes of Health (NIH)
17:20 – Tim Stuhlmiller, XCures
29:30 – Rebecca Fre-Hiwet, Corporate Angel Network (CAN)
39:40 – Tiffany Studebaker-Freeman, Paltown: Second Opinion Project supported by the Lu Family Fund
44:00 – Q&A for all organizations

Julie Clauer  0:00 
Hi, everyone, welcome. I am Julie Clauer. I’m a stage IV patient. I’m also on the Colontown cabinet and lead education efforts for Paltown. And so in those roles, I’m happy to bring you this Resource Fair today. So this is about clinical trials access. And we are featuring resources for additional paths to evidence based investigational treatments. We will have five presenters today. And they’ll each give you a very, very short introduction to what they do. And not necessarily everything they do, but around this specific topic. So we also will be providing materials after and then posting the materials with the presentation, with website addresses and everything so that you can find out more. But these Resource Fairs we started this year and they’re really an introduction to organizations that provide free services to members of our community around a specific area need. So this one in particular is around access to these investigational treatments. And when I’m talking about access, I’m not talking about finding those because that can be a whole other topic in itself. But really about you’re sitting there at your local treatment center, there’s no trials you fit for, you can’t necessarily afford to travel and you just feel like there’s all these clinical trials maybe or treatments on the other side of this door, and you just can’t get out through it. So this is about unlocking that door. So what we have today, in presenting is just a sampling of organizations that are all fantastic, but there’s also more out there. So the resources that we will post will also include other resources in these areas. They’ll talk to you about what they do, but also hopefully this will help build awareness of different paths to help you get into those investigational treatments. So today, we’re going to be talking about Just In Time Trials, Dedicated Research Centers, Expanded Access and Travel & Expense Assistance. So with that, put any questions you have in the chat and we will, at the end, get to those questions. I just want to disclose that some of today’s organizations have in the past provided grants or sponsorships to Paltown. Their financial support has no relevance or impact on their participation today. But I just want to make sure people are aware, If you’d like to see what those are, you can go to the Paltown website. But they were all chosen on the services that they provide to patients. And I’m going to introduce our first presenter, which is Megan Shulman from Tempus. She’s the Director of their Time Program. And many of you probably know Tempus through a lot of different ways, but specifically, she’s going to be talking about Time. So with that, I would like to turn it over to Megan.

Megan Shulman  3:02 
Thank you, Julie. Can you hear me okay?

Julie Clauer 3:05 

Megan Shulman 3:06 
Great. I’m gonna go ahead and share my screen. Thank you to everyone today who has joined. Like Julie said, I work for Tempus. Many of you have probably heard of us. We offer lots of different services. But today I’m going to focus on our Time Trial Program, which is what we call our Just-In-Time Rapid Activation Clinical Trial Model. So many of you may know that the current model of how clinical trials are set up and activated can be quite slow. Oftentimes, the pharmaceutical sponsor will go to a research site, oftentimes a big one like a big AMC, they select the site, and then it takes a long time to negotiate contracts, IRB approval, get all the paperwork in place, yada, yada, yada. It can take up to eight months. We decided to flip the research model on its head, identify a patient first at a research site, and then activate the trial. And we hope to do this in 10 days. I worked for many years as a clinical research coordinator myself. When I interviewed at Tempus I said, I’m not sure if this is going to work. But I’ve luckily been proven wrong. Our average time to open up a clinical trial is about 10 days right now. And we kind of do it through a multitude of different ways, but mostly we’ve streamlined a lot of the contracting and regulatory activities associated with opening up a clinical trial. We also realized that clinical trials are great options for patients who can travel to big AMCs and have access to that, but it’s really tough for patients who go see community oncologists. Oftentimes those sites are not always selected to participate in clinical trials, despite having very, very experienced investigators and research teams. Mostly because a lot of pharma sponsors will go to big sites where they know they can accrue a lot of patients. And so Tempus was really well positioned to be able to identify participants for clinical trials through our Next Generation Sequencing, and other mechanisms. To give you an idea of kind of how expansive our program is, we’ve currently got 87 active research sites, and 55 active clinical trials. Most of these are pharmaceutical sponsored trials, all in oncology, across all disease types. And so it’s been really exciting to kind of see how this is grown across the US.

Megan Shulman  5:40 
As you can see, we sort of have a huge presence here in the Midwest. Tempus is based in Chicago. So that’s sort of where we started and kind of grew out from there. But we’re excited to announce that we’ve got a site in Hawaii and Puerto Rico. So really we go across the US, which is very exciting. And to give you an idea of sort of where we’re at now, we have completed over 200 site activations. And we’re approaching our 1,000th patient consented onto a clinical trial, which has just been really exciting to watch. Interestingly, we really saw a lot of success with this during COVID. I think a lot of sites and sponsors were very willing to be a bit more flexible in requirements of clinical trials. And they were able to do a lot more things remote, like site initiation visits, and what have you. So it’s been a really exciting time, sort of in research to see how flexible we truly can be. And then to give you all sort of an idea of what trials we have, we have phase I through III across all tumor types with urology, peds, solid tumors, hematology and cell therapy coming soon. And so the best way for patients to access this program will be first and foremost, asking your oncologist, “Do you participate in TIME, or truly any other kind of just-in-time trial network?” We don’t care what system you go through, we just want you to go onto trial quickly. Julie will also go ahead and provide a link to one of our nurse navigators. And so if there’s ever an interest in finding a clinical trial, you can go ahead and click on that link, and it will hook you up directly with one of our nurse navigators to check for eligibility there. I’ll just mention that in order to participate in a TIME trial, you do not have to be tested by Tempus, this is open to any patient who’s eligible regardless of their testing. And so that is the end of my presentation.

Julie Clauer  7:51 
Great, thank you so much, Megan. Just the one little note I’d make is that some trials in clinicaltrials.gov will say by invitation, or something of the sort, and that could mean it’s a just-in-time trial. But they’re not all necessarily listed that way. And so knowing that this is an option, and it’s a possibility, I think is a huge benefit. So thank you so much Megan for sharing. Next, we’re going to have Jessica Smalls-Eddy, who’s the contact center lead at the Office of Patient Recruitment at the NIH Clinical Center in Bethesda, Maryland, which is known as America’s Research Center. So a lot of patients know about NCI Centers, but there’s also some fantastic centers that are research only. And the granddaddy of them all in the US is the NIH. So, Jessica, thank you for joining us, and I look forward to hearing about what you all do.

Jessica Smalls-Eddy  8:50 
Alright. Thank you Julie for allowing me and inviting me to participate in the Research Fair. So I do work at NIH, The National Institute of Health. I am located in Bethesda, Maryland, in the Office of Patient Recruitment. I am the contact center lead. Here at The Office of Patient Recruitment, we serve to educate the public about clinical health participation at NIH Clinical Center and our mission is to support Bethesda, Maryland and research performed at the clinical center by coordinating the referral process as the primary point of contact between those seeking to volunteer in clinical studies and the researchers conducting them. So our information specialists are available Monday through Friday to help you find a trial which you can participate in.

Jessica Smalls-Eddy  9:44 
And on the slides you will see that that’s our contact number as well as our scan QR code if you would like to participate or look for any studies with us. So how it works is you would contact us on our 1-800 or our (301)451-4383 phone number. And we can assist you with locating a study if you’re not able to locate a study. We do help 1000s of patients all over the world daily. We have contacts that come into the office through emails, telephone calls, I’m trying to think how else, just word of mouth, everything. And we have our own website where you can look for studies primarily based in our office, which is Search the Studies.

Jessica Smalls-Eddy  10:38 
So this is how our Search the Studies page looks. You will go to clinicalstudies.info.nih.gov. You will click in your keyword, which is whatever is diagnosed. In this instance, it will be colorectal cancer. And you can put the status. You want to say recruiting, because you want all the studies that are recruiting, and you do not have to put in the age group because once you speak with one of us, we will let you know if you qualify for that study or not because some of the studies do have screening questions that we have to ask before we get find out if you’re eligible to participate in the study. And you don’t have to fill out your sex or gender, you don’t have to click the Institute. We will do all that for you. All you have to do is search. And it will populate the studies which you can read further into research to see if that study best suits you. Also, if you do not find any studies on our page, like I said, we have callers and volunteers all over the world and they do go on clinicaltrials.gov, which you can find studies all over the world, all over the country, everywhere to see if you can find a study that you’re looking for. That is also an easy system to navigate as well as ours. Our studies are also located on here as well. But it’s easy to fill out. You just also click on recruiting and not yet recruiting studies, you will put in the condition or disease that you are looking for. If you’re looking for a certain type of study that has a certain drug that you would like to try or an investigator that you heard about that is doing a wonderful job bringing studies out and giving resources and you want to search that investigator, you can do that as well, by going into other terms. You can do the country. It will say United States. And there’s also another tab on here where you can put in the state that you’re looking for. And then you will hit search and it will populate the studies for you as well. And then you can also read those studies as well to see if you would like to participate, if you’re eligible, what’s the criteria. And so it’s really an easy system to navigate. And we’ve also partnered with the Undiagnosed Disease Network. Every year hundreds of patients face uncertainty when healthcare providers are unable to discover the cause of their symptoms. So The Undiagnosed Disease Network is a resource study backed by us, NIH that seeks to provide answers for the patients and families affected by these mysterious conditions.

Jessica Smalls-Eddy 13:23 
So the clinical sites where they’re located, there’s 12 cities across the United States that are with the Undiagnosed Disease Network, and there is actually a site in Los Angeles, California. So if you’re in that area, and you do have an undiagnosed disease, you can also just go on that website here, you can scan the QR Code, or you could go look for the website, type it into your search bar, on your browser. And then you can go there and see where the next available or closest centre or clinical site that you can go to to navigate this issue with. Also, we work closely with Rare Disease Resources. So we do have several networks and websites that we reach out to to help and support and provide the resources for individuals and their families affected by rare diseases. They offer information on specific rare diseases, research initiatives and patients, communities and more. So we have the Genetic and Rare Disease Information Center which is GARD. Then we have the National Organization for Rare diseases. And then we also have RareConnect. So you can go on these websites as well and they can provide you with further guidance and assistance of how you can contact and communicate with them so you can get the assistance that you need.

Jessica Smalls-Eddy  14:58 
And these are how you can stay connected with us on social media because we know this is the social media age. So we like to move with the times. So we do post studies on our websites, and our social media to stay active, to let you know what studies we have. If we have any new upcoming studies, we do post them on our social media. I do advise that you follow us, because some things are here first, before they’re actually posted on other locations or before you may get an email about it. You can always just check here and they’ll let you know what upcoming studies we have coming. It may not be recruiting as of yet, but they are in the future to start recruiting. That way you can keep an eye on a study if you’re interested in it.

Jessica Smalls-Eddy 15:43 
And this is our supervisor here at The Office of Patient Recruitment, Mrs. Nikita Curry. And if you have any questions, please feel free to ask some. And once again, please contact us. Our number is 1-800-411-1222 here at The Office of Patient Recruitment. at NIH in Bethesda, Maryland. Thank you so much.

Julie Clauer 16:07 
Thank you so much, Jessica. One question I know does come up is whether trials at NIH are available to international patients.

Jessica Smalls-Eddy 16:18 
Yes, they are available. And some of our trials do offer travel expenses. It doesn’t let us know how much or what trials do. We do have study contacts who reach out to you once you sign up for a trial. And they’ll go into more detail with that. So we do have volunteers, patients that comes from all over the world. And we do have an inn on our campus that we provide if you need to stay with us while you’re receiving treatment or your family. We do have that on our campus as well. And then some of our studies are paid. They do compensate. So yes.

Julie Clauer  17:05 
Thank you so much, Jessica.

Jessica Smalls-Eddy 17:06 
No problem. Thank you.

Julie Clauer 17:08 
Okay, so now while Jessica stopped sharing and Tim is starting to share, I’ll introduce our next presenter, which is Tim Stuhlmiller who’s the Vice President of Scientific and Medical Affairs at XCures. And also people might be familiar with xCures in various and assorted ways, because they do do a lot. But Tim will be focusing specifically around a couple of their programs that relate to this topic. Welcome, Tim.

Tim Stuhlmiller  17:43 
Thank you, Julie. So yes, I am with xCures, which is a health data technology company, and we really seek to empower patients with more complete information about their medical records, as well as supporting them with access to emerging therapeutics. So I’ll be talking about x-Inform which is our patient portal and expanded access. We run a clinical research platform based on a master observational research protocol called Excelsior. And so patients can go online, they can e-consent to this protocol, and you’re basically donating your data to research. What we do with it downstream of that is annotate our own clinical trial database or a separate database to help enable the clinical studies that we’re running on behalf of pharma and biotech. And so, you know, this is termed, in some ways, decentralized trials or direct to patient clinical research. You can kind of roll all that together into the platform that we’ve built. I kind of talk through a lot of this stuff, but essentially, e-consenting online, you’ll offer a HIPAA release, and then we’ll go and aggregate all of these medical records on your behalf, and utilize those for research purposes. So really quickly, I’ll just go through the portals that we’ve built. And then I’ll talk a little bit more specifically about expanded access. And so we’ve built two different portals. They’re called x-Inform and x-Decide. It’s for patients and providers. And so if you sign up, your provider also has the option to sign up, but those accounts will be linked. What we do is we aggregate all of your medical records from all sites of care, we’re able to do this electronically now. So really we don’t put any burden on patients or providers to do this. We can do it entirely through the electronic systems that are connecting all the EMRs on a national level. We then create a sort of summary of cancer history. We call this the care summary. We’re able to automate a large part of this through the technology that we’ve built. And then we can offer clinical research opportunities. And so we run a series of specifically, clinical studies, about a half a dozen of them. We can also support your oncologist in clinical trial matching and any other types of access, as well as expanded access, which I’ll talk about more specifically. The next two are just a couple of quick screenshots from our platform. This is just showing an interactive browser that we’ve built, as well as listing of many different types of centers where we’re pulling in medical documents for a single patient, as an example.

Tim Stuhlmiller  20:29 
And this is a sample automated care summary that we’ve basically taken all of this medical data, extracted out the structured elements, and then just graphed them onto a timeline. And so all of this is available, obviously, for free. And we’re just kind of improving this month over month, so anyone can sign up. Tthey can just go to our website.

Tim Stuhlmiller  20:53 
So I’ll talk a little bit about Expanded Access. So what is Expanded Access? So the most common pathway to access new therapies and treatments is through traditional interventional clinical trials, like those that Tempus and NIH and others are supporting. Another pathway to access emerging treatments is through Expanded Access. It’s also called Compassionate Use. And this is a very specific regulatory pathway that requires FDA approval through individual protocols to offer access to these investigational, never approved, drugs. And so there’s several different requirements for patients to be able to access these drugs outside of clinical trials. And so they have to have completed standard of care, or there’s no satisfactory options available, maybe the standard of care isn’t even successful. They have to be ineligible for clinical trials or unable to travel to clinical trial sites. And we need to create a unique clinical protocol to permit the treatment of the patient. So, it’s a standalone clinical trial protocol that has to be written. We need company approval to use that medication outside of their other clinical trials. And we need institutions and treating oncologists available to approve that protocol and oversee care. And so there are actually quite a number of steps in order to access therapies outside of clinical trials. So again, clinical trials are always going to be your best option to try to access. But if you’re ineligible, there is this pathway where we can go through directly to the pharmaceutical company to appeal for access to an emerging therapy if it’s really the best option for treatment. So there’s many different types of Expanded Access. There’s single patient protocols, that’s when there’s a very specific situation where one patient, it’s going to be the best treatment for them. This is broken down into emergency and nonemergency, which is kind of nebulous, but there is a way to basically expedite and get access to a drug, basically within two days through the emergency pathway. More traditionally, are intermediate sized, or treatment protocols. And so intermediate sized is for a specific disease state, there’s a lot of different reasons why an intermediate size protocol will be used. Usually, it’s a medium sized population, like it says. A treatment protocol is generally to bridge a successful phase III study to approval. And so if a company has executed a randomized phase III study, and they’re successful, and it looks like their drug is going to be approved, they get approval from the FDA, they can open a treatment protocol before they’re actually marketing that drug to enable access to a large population of patients through that treatment protocol.

Tim Stuhlmiller 23:58 
And so how common is Expanded Access? That bar graph kind of just shows it out of over 6000 currently recruiting interventional trials, only 71 Intermediate Expanded Access Programs. So it’s extremely uncommon. That’s just to get your bearings. And so what do we do? So our team can work directly with your provider to request access to therapies from pharma companies via the single patient pathway. We coordinate with pharma to develop those protocols. We coordinate with IRBs to approve the protocols and we can manage a lot of the paperwork. We can submit protocols to the FDA for approval and we can coordinate with treating oncologists for any safety reporting. And so along with this, we keep a current record of your full cancer history to support your care team in doing this, but again, ultimately it is up to oncologists and the institutions that are managing this care to to enable this. So I want to draw your attention to one very specific program, one of those 71 intermediate programs, which we’re running specifically, this is for Ulixertinib. We’ve partnered with the manufacturer BioMed Valley Discoveries to be able to run this program for, I think, over three years at this point. So we’ve been really, really happy to be able to offer this. And the way that we designed this is kind of unique. And so this is one of these intermediate protocols that, again, is sort of for a very specific disease state. But we’re able to write it very flexibly because it is in the sort of post standard of care, patients are out of options. It enables a really tailored treatment to each individual patient. And so it’s a very broad inclusion. It’s essentially any solid tumor with a MAPK pathway alteration. And this includes biomarkers like KRAS, NRAS, BRAF, MEK, and ERK mutations, which a lot of these are pretty common in colorectal cancer. And it enables combinations with approved therapies at the discretion of the treating physician and approval by BioMed Valley Discoveries. And so, what we’ve seen for colorectal cancer patients is some doublet and triplet therapies combining Ulixertinib with MEK inhibitors or BRAF inhibitors or EGFR inhibitors. And so just to give a better option than just a single monotherapy, targeted therapy, which generally has pretty limited efficacy. And so we hold the IND. We manage all of the entire program kind of end to end, we work directly with institutions to open these studies and manage all the safety reporting. Our goal is to put the least burden as possible on sites and patients and their care team. And so as of today, I just pulled the numbers, we’ve treated 127 patients across 37 sites. We’ve had two complete responses, and I believe probably about two dozen or so patients with stable disease. And obviously, this is going to be extremely dependent on the burden of disease, previous therapies and the actual regimens being used. This is just one example. We published a case report last year on this and so this was a young patient, I believe she was in her 40s, that had atypical BRAF mutation. She didn’t respond to immunotherapy. She didn’t respond to Trametinib, MEK inhibitor, didn’t respond to a vaccine and Pembrolizumab, another immunotherapy. And so she enrolled on Ulixertinib EAP and the physician was able to kind of change the dose up and down and find the optimal dose for her. It was able to shrink her disease so she could have surgery and leave her with no evidence of disease. And afterwards, she started Ulixertinib in combination with immunotherapy for a year to make sure that the tumor remained gone. And she’s still NED today. And so we’re obviously very proud to be able to offer this type of a program that enables access to an investigational drug in flexible combinations that can be moved around and offer these types of opportunities to patients. So that is all. Thank you very much for the opportunity to talk.

Tim Stuhlmiller 28:39 
This link is where you can enroll in our observational protocol, and we can screen to see if you’re eligible for Ulixertinib. And you can also always just email us [email protected] or [email protected] We’re happy to help.

Julie Clauer 28:57 
Thank you so much, Tim. Really appreciate it. And I know that there’s been some things that I’ve sent Tim’s way saying is there any way we can get an Expanded Access on this thing? And they’re extremely helpful and responsive. And I think also just a note that they also can help providers through the process because Expanded Access, it’s not as easy as the provider just saying, I want to give my patient this drug. So that’s helpful for patients to know because a lot of providers don’t know that. Okay, great. So now, we’re going to turn it over to Rebecca Fre-Hiwet who is the Program Manager for the Corporate Angel Network. So now we’re transitioning from different ways to access investigational treatments to supports that can help you with the logistics and cost of doing so. And so there are quite a few resources we’ll have in the packet. But very happy to have Corporate Angel Network here with us today, as they’ve helped many of our Colontown patients. So turning it over to you, Rebecca.

Rebecca Fre-Hiwet 30:05 
Thank you, Julie. Good afternoon, everybody. You can see my screen right?

Julie Clauer 30:12 

Rebecca Fre-Hiwet  30:13 
Okay. Great. Good afternoon. Thank you everybody for joining. Again, Julie, thank you for having us here. My name is Rebecca Fre-Hiwet, and I am the Program Manager for Corporate Angel Network. We are just going to go over briefly what we do, how you can access our program, and obviously, we’ll be open to any questions and can provide further resources after today. We are Corporate Angel Network, we’re a 501c3 nonprofit. Our mission is to help cancer patients access the best treatment available by arranging free travel on corporate aircraft. So I just want to make that known because there are some requirements and eligibility that do come with it. When I say corporate aircraft, we have over 500 partners, business corporations who provide the empty seats on their business jets. So it makes it possible once we receive their schedules to look at where they’re going to and from on the dates that they’re going to, so they actually share their schedules with us. And then we take a look at our patients’ requests and what we need to fulfill and see if we can find a match. So we were founded in 1981. And we’ve done over 67,000 flights in the last 41 years. We average out at about 125 or more flights every month. And this is where we might differ from some of the other nonprofits that do provide this resource as well, we only utilize aircrafts with pressurized cabins and two pilots. So for participation, one of our major requirements is that our patients are fully ambulatory and able to travel without medical assistance. So to break that down, we are putting them on a business jet that does not really have much to provide in the event of a medical emergency. And they are traveling sometimes with the executives of these companies. So when we say fully ambulatory, if that patient needs a wheelchair to get from the lobby of the private hangar to the actual aircraft, that is something that we will allow, it’s just they need to be able to get on the aircraft on their own. And if anybody’s familiar with these private aircrafts, they do have about seven, some of the smaller ones, maybe five, but like about five to seven steps to get up. So the patient would need to be fully ambulatory. But all ages are welcome. If they are an adult patient, they are allowed one adult companion. If they are a child, they’re allowed two adult companions. And it doesn’t have to just be their parents, sometimes, there’s other siblings in the family. So it might be a mom and a grandma or mom and a friend going with the child. There’s no financial limit or requirement to the service. The service is completely free to everyone in the community. We do only transport cancer patients and bone marrow or stem cell donors and recipients. In order to be eligible, we do have a host of volunteers. Once we do receive the request, those volunteers will call those recognized cancer treatment centers and verify the appointment. And then we will also retrieve a medical clearance from a provider that that patient has seen to just confirm that they are ambulatory and do not require any IV or oxygen while flying. So the guidelines, which again I can always go into detail, if anybody ever wants more information regarding our guidelines, all patients must dress in business casual attire. This does scare some people away sometimes, but once they understand what aircraft they are flying on, we’re not asking them to be in suits, we just asked that there’s no tank tops, ripped jeans, flip flops, certain things. We go over this in detail with our patients on the phone prior to them flying. The participating companies are to remain confidential. So we do have them read over our guidelines and sign them and just note that there’s no photos permitted of the aircraft. And that’s just because these, again, are corporations, they have tail numbers that can identify the plane. So we just ask that those are not taken. Sometimes there will be times where you’re on a flight and they will allow you to and then we go over some guidelines with that and where to post and how to post and all of that. So we do transport to the top rated cancer centers in the continental US. Here are just a few that we do provide the flight assistance to. So in Maryland, we’ve had a lot going to NIH. We have Massachusetts going to Dana-Farber, a lot. Minnesota – Mayo Clinic. New York – Memorial Sloan Kettering, which is actually one of our biggest that we fly to. We also have Pennsylvania Children’s Hospital. Ohio –  Cleveland Clinic, Cincinnati Children’s Hospital, and MD Anderson in Texas, just to name a few. But we do not limit where you want to go. It’s just these are the major ones that we do transport to. And then I just wanted you to meet Ava. Ava is one of our longstanding patients. She’s been flying back and forth from Miami to New York. She began with us in 2013. We don’t hear much from her anymore, which is a good thing. But she has flown, I couldn’t even count on my hand how many flights, and we have flown her with her parents, we have flown her with a sibling. We do make exceptions in certain scenarios. And now she’s flying to MSK for just routine checkups instead of her treatments. So we just wanted to share with you the positive on this side. And then Colontown, so how we can work how we work together to make a difference, it’s really big. And that was one of my main points I wanted to say today is to spread the word. A lot of people do not know the resources that are available to them. And we tend to find out that the main way of referral to us is word-of-mouth. It’s a patient sitting in a waiting area next to another patient, and they start having conversation, and they find out about us and they call. We are not a guaranteed service. So we’re not always able to help. But we do refer our patients out to a host of other nonprofits that do the same thing or similar to what we do. So we’re never just saying no to a patient, we always have a backup of where to send them. Sometimes we do get some donations from commercial airlines and we do use those, but we really go over a lot of things before we even bring those up. Because mainly the community we are dealing with is immune compromised. So we try to avoid that at all costs. But if we can’t find something, and they really need to go and they know that they’re going to cancel or it’s a clinical trial, where we know time it’s time sensitive. So it’s one of the things that we really put in front of us when we are looking, we ask it’s one of our questions, when we’re taking a flight request, are you a part of a clinical trial? And if they say yes, we don’t handle them any differently than anybody else, but we make sure that we provide them other resources. So make sure that we provide them resources. Some of you may know, Lazarex, which is a company that does help with clinical trial support, and sometimes helps financially. Again, that’s not always a guarantee. But we do provide them with other things as we look for the flights for them. And we just handle those a little differently because we know they’re time sensitive. We do have some marketing material. There’s printed copies available. If anybody needs them, they can reach out. There’s also digital versions available on our website. And I can also email them. And also just spreading the word. As you know, Jessica had also said, this is a social media era. So tagging Corporate Angel Network in Facebook groups, letting anybody know about it on any of those social media platforms.

Rebecca Fre-Hiwet  38:34 
So here is our URL. So that’s our website. That’s also where our patients can go and place a patient inquiry. And when they fill out that inquiry, it’s very simple, it asks a few questions, it shoots over to us. And we reach out within no more than 24 hours unless it’s the weekend. Or they can call directly. They do not only have to go on our website, they can call us at 914-328-1313. And that is it for my presentation. I am available for any questions or sending any referral resources that I can to anybody who needs them.

Julie Clauer 39:14 
Great. Thank you so much Rebecca.

Rebecca Fre-Hiwet 39:17 
Thank You.

Julie Clauer  39:18 
As Rebecca said, they are a fantastic organization but they also work with others as well to try and get people to their treatments. So I appreciate knowing about you and that that’s how you work. And last we want to introduce Tiffany Freeman. Many of you know her because she’s a Colontown member, she’s also the Operations Manager for Paltown, to share with us about a program that we within Paltown have to support patients on clinical trials.

Tiffany Freeman  39:51 
Yeah, excellent. Hello everyone. Good to see some familiar faces here today. I am talking about The Second Opinion Project, which is funded by the Lu Family Fund. This was set up by Felix Lu, who was a caregiver in Colontown supporting his wife Diana, who passed in 2020. To date, with The Second Opinion Project we are just like a few shy of 200 applicants, so we’re ready to celebrate that any day now. So just to give you an idea of what The Second Opinion Project is, it’s available to all Colontown patients, or if you’re a caregiver, you can apply on behalf of your patient that you’re providing care for. It is for all stage IV patients that are looking to get a second opinion. It can also be used for clinical trial consults. So that’s how this kind of ties into what we’re talking about today. So if you’re looking to go meet with somebody, it’s a distance, you can send in an application. It’s on the Colontown website. There is a page that’s for Second Opinion. And there’s an application at the bottom of that. You just fill out the form and submit it and we’ll get back to you. Almost everyone who applies is approved, other than spam rejections. We really haven’t had any problems with people misusing the program. So we appreciate the folks in Colontown so much. The program covers about up to $500 of travel related costs. It can be airfare or car rental, or train, whatever kind of travel that you’re using to get to your second opinion or your clinical trial consult. It can cover lodging up to two nights, it can cover out of pocket expenses for the appointment itself. So there’s a variety of things that people use it for. They’re just submitted after the appointment and then reimbursed through check. The Mayo Clinic says that about 88% of the time when you receive a second opinion, you receive a refined diagnosis. We’ve had folks in Colontown receive second opinions and have a dramatically different course of treatment. We have had folks get to NED who did not know that that would be a possibility. Our previous Mayor, Lindsey Musick often said that there’s two different successful second opinions and that can be those that lead to a change in treatment and those that are a reminder that you are on the best possible course of action for your present disease scape. So we always remind our folks who apply about that, and we are excited to serve. Felix is a wonderful, wonderful fundraiser. And he often is willing to talk with folks on the phone, give them personal recommendations, help hold their hand in any way possible. He’s very excited. And his number one thing that he always wants people to know is to apply early on. If you are a stage IV patient in Colontown, apply today. Don’t wait until your lines of treatment are exhausted or your disease has progressed to reach out and get a second opinion because the earlier you get it, the more effective it can often be. That’s it for me.

Julie Clauer  43:30 
Great. Thank you, Tiffany. So that concludes our presentations for today. So hopefully, this provided kind of a wide range of the kinds of resources there are. And all great organizations here. There are additional organizations out there. A couple of questions have come in. So I’m gonna start asking those.

Julie Clauer 44:01 
Megan, the first question is for you. And specifically, it asked about examples of trials open to CRC patients, and I know you can’t necessarily share specific trials, but it would be helpful to maybe share a little bit more about the types of trials, like are these just exclusively like, woo-woo trials or like what kinds of trials are there because I think that’s a key question people often have.

Megan Shulman  44:26 

Julie Clauer  44:27 
Not that we would share anything that’s woo-woo in our group, but you know.

Megan Shulman 44:33 
So to be very clear, Tempus really works as what we call like a matchmaker and then a rapid activation specialist team. So all of the trials in our network, I would say 95% of them, are pharmaceutical sponsored. We’ve got a couple that are actually sponsored by Tempus, but they’re observational, they’re not interventional. So like I said, phase I through phase III across all disease types in cancer. Many are solid tumors, including CRC, but we’ve got a couple of trials that have CRC cohorts on there. But yeah, all pharma sponsored trials. And these companies come to us just to really help expand their recruitment efforts. Like I said, oftentimes they do open up at those big centers, which are great, but they’re very willing to open up like a small community site, even if it means they are opening just for one patient, because a lot of these trials are so rare, particularly if they are biomarker driven trials. Not all of our trials are biomarker driven, but quite a few are given Tempus’ position in this space.

Julie Clauer  45:42 
So in that case, right, it’d be the same trials being offered at other centers, but it would be able to be locally, potentially, near somebody in their local center.

Megan Shulman  45:55 

Julie Clauer  45:55 
The same protocol, the same treatment, the same everything.

Megan Shulman  45:58 
Exactly. Because patients oftentimes don’t want to leave their care teams, they’re really comfortable there. They don’t oftentimes want to travel if they could just do the same trial with their own physician and care team. Same exact trial.

Julie Clauer  46:13 
Great. Next question question is for Tim. And it’s about your summary of patient care. This person goes to multiple centers, so loves the idea of having everything in one place. Is that something that you share electronically with care teams? Or how does that work?

Tim Stuhlmiller 46:35 
Yes, so when a patient signs up on our portal, they get access to like a personal login. And so they’ll see all of the medical records that we’ve pulled in, they’ll also see that structured summary. You can’t really download the summary itself into a PDF, it doesn’t really PDF very well. But it’s available electronically. And we can also link your account with multiple different provider’s accounts, so they can log in and see all those records. You know, we’re always improving our processes and what’s available. I believe we have it slated for the middle of next year where we’re going to completely redesign the portal and make much more functionality to it, sort of in the near term. But currently, yes, it’s all available electronically, mobile device or desktop computer.

Julie Clauer  47:34 
Great. Thank you. Any other questions? Those are the two that I received. Are there any other questions people might have? For Jessica, if the NIH could have KRAS be searchable on clinical trials as a target that would help. So within their NIH search tool, I think what she’s saying. So Jessica?

Jessica Smalls-Eddy  48:23 
I did see your message. I will go ahead and share that with the team. What we can do is add that into our keywords, and our diagnosis, because that is how we enter in the study. So I will make sure to let them know to add that in so it can make it easier and more computer savvy friendly to find it because some of these things you have to search through the cracks. I understand completely.

Annie Delores  48:55 
Yeah, it’s just really hard. Like for BRAF and KRAS. It’s all about your KRAS BRAF test and it doesn’t mean it’s a BRAF or KRAS targeted treatment. And that’s 50% of CRC. So having it be a target would be great. Thank you so much. I appreciate that.

Jessica Smalls-Eddy 49:12 
No problem, no problem.

Jessica Smalls-Eddy  49:13 
A follow up to Jessica in terms of timing. So from the time that someone contacts you, so if somebody calls and contacts your center, and then being connected to the appropriate clinical trial team, I’m sure it varies, but any general sense of how long that takes?

Jessica Smalls-Eddy 49:33 
So depending on what study it is, it does give us a range of days that we let you know that they will be in contact with you. So sometimes it’s typically one to two or three to five business days, pertaining to or some studies we do have, as soon as we send the referral, they’ll contact you that same day. But once you call in that with that study, we will let you know because they’ll have it in the referral information that they’re contact you in X amount of days, and then if you expedite it, we will let them know that this needs to be expedited. Some of our studies, we ask for a referral letter from your providers that you’re seeing outside of NIH so we can ask for your records, and we would need your permission to reach out to your doctors.

Julie Clauer  50:22 
Great. And are those referrals do they have to be in person, do you know, once they get referred?

Jessica Smalls-Eddy 50:27 
So it depends. Thanks to COVID, we do have some studies that you do not have to come in to participate in. But the referrals, you just call us on the phone, and we just do it then. So you don’t have to be on site, on campus. You don’t have to report to campus if you have to show up until the study team gives you a date and says, hey, we would like to see you in a month. They’ll set up a schedule with you. They won’t just say we want to see you Monday and it’s Thursday. So they’ll give you enough time to prepare to get everything together.

Julie Clauer 51:01 
Okay, great. Thank you all so very much. I appreciate it to everybody who participated, asked questions and very much to our presenters. So to Rebecca and Jessica and Tim and Megan and Tiffany, thank you very much for what you do and then also sharing with us today. So to everyone watching, we will be taking the recording and posting it the Colontown clinical trials neighborhoods, as well as on Colontown University with the additional resources and resource materials provided by the presenters today. Thank you all very much.

Additional organizations in the materials:
For accessing investigational treatments:

  • Reagan-Udall Foundation Expanded Access Navigator
  • Start Center (a dedicated research treatment center)
  • Sarah Cannon (a dedicated research treatment center)
  • Caris Life Sciences Right-In-Time

For travel support:

  • Lazarex Cancer Foundation
  • American Cancer Society Lodging Programs – Hope Lodge & Extended Stay America
  • Health Hospitality Network
  • Mercy Medical Angels
  • Air Care Alliance (ACA)
  • Angel Flight Locator
  • PALS (Patient Airlift Services)
  • Angel Flight East
  • Angel Flight West

Additional information about this resource fair:

  • This particular fair was not focused on the area of finding trials, but rather how to creatively pursue options beyond what might be found in a search.
  • Most of these specific resources are US-based, though the concepts and some of the programs are available to international patients.
  • Organizations were chosen based on their services offered for patients and found helpful to COLONTOWN members. While some of these organizations have previously provided grants or sponsorships to PALTOWN, such financial support was not considered in selection for this fair. For more information, see paltown.org/partners/
Download materials packet here: 

COLONTOWN University has so much more to offer, from DocTalk videos with CRC experts to easy-to-understand biomarker test breakdowns. We’re here for you! See our list of Learning Centers here.