Cell & Gene Therapy Update with Joe DePinto, InspiroGene by McKesson | TWIRx

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1:21You are listening to the Global Network of Podcasters dedicated to the pharmacy profession. Welcome to the Pharmacy Podcast Network.

2:07Hey, welcome to twerks.

2:17Hope you have had a good week. I've had a monstrous week. We're going to talk about it.

2:26But first up, my friend who put together the first 31-day challenge last year for 2025. And Jesse McCullough is back. Jesse, thanks for being on Twerks today.

2:44Joe DePinto: Hello, This Week in Pharmacy podcast listeners. This is Jesse McCullough back with you with another exclusive challenge as part of the 31-Day Challenge. Before I get to the challenge, I want to give you a little bit of a backstory. Many years ago, I was part of a brand-new endeavor. We were developing a clinical services team for the large chain that I was working for at the time. And when we came in, it was pointed out that there was no training manual for what we were doing. Everything we were doing was brand new, and there was no formal training that would get somebody up to speed because we were essentially learning those things as we were going through it.

3:25Joe DePinto: And the idea came through at that time that perhaps what we should do is just keep a list of the different activities and accomplishments that we were a part of during that time. Wonderful thing to say. It was a difficult thing to do. Um, last week as part of the 31 day challenge, I was having a conversation with a colleague and the question came up, Hey, would you mind sending over your CV? And I said, yeah, I'd be happy to send over my CV. And then I realized I haven't updated my CV in some time. And it's really hard to play catch up with that. I have found, I have found that it's very, very hard to say, okay, what, what all has gone on since the last time that I updated my resume, updated my CV.

4:14Joe DePinto: And so it's from that, that I want to give you this challenge today. I want you to be prepared for the next opportunity that comes down the street for you. I want you to be ready for that. And I think one of the best ways to do that is to be a collector of accomplishments. So the challenge is this, to set a reminder on your phone. Now, this reminder may be something that you do weekly. It may be something that you do daily. I would encourage you to consider this to be a challenge to do more often if you are earlier in your career or you are earlier in a particular role, because you are going to have so many experiences.

4:54Joe DePinto: You're going to have so many new things that happen to you. And when that reminder goes off, I want to encourage you to open a notes, whatever notes app you may have on your phone. And I want you just to jot down some of those accomplishments that you have done. You see, the day will come when you will want to be able to remember those things or you're going to want to be able to quantify and qualify all those things that you have done in your pharmacy career. but don't count on your memory to be the best source of truth for that. The best thing you can do is be collecting those as you go along.

5:33Joe DePinto: Now, you may have a more advanced or a more sophisticated way of collecting those ideas. I would say perhaps the best way to do it is you just have a Word document, and then when it comes time that you need it, you can just cut out the stuff that's not relevant. But you want to have that. It's better to have it than want it in those particular cases. And that's the challenge that I want to extend to you today so that you don't find yourself like I was last week with somebody asking you for a current document and you think to yourself, oh my goodness, I haven't done that in some time. So the challenge is absolutely for you to take a little bit of time, just set the reminder, set the reminder to list your accomplishments wherever that may be.

6:15Joe DePinto: And I want to encourage you to do that because you will find that you will be well served by having that information available to you. With that, I'm going to turn it back to Todd and the This Week in Pharmacy team. Have a great week, everybody, and we will see you again next week. Jesse, thank you so much. You are so committed to our profession and the leadership that you provide. I'm excited to be a small part of that 31-day challenge. We're going to continue to have Jesse back on twerks the entire month of October. October is pharmacist month celebrating our amazing providers, my favorite providers.

6:56This is twerks.

7:01Welcome to this week in pharmacy. Twerks is the weekly pulse of the pharmacy profession. And now here's Pittsburgh native bleeding black and gold, pharmacy's first podcaster and founder of the Pharmacy Podcast Network, the RxPodfather, our host, Todd Urie.

7:27Hey there, welcome to twerks. It is October 9th, 2026. It's Friday. hell hell hells to the hills yeah i don't know if that's a good thing to say on twerks but i was getting too excited because i need a weekend i have been traveling a lot we were in um la los angeles at the usc school of pharmacy man's school of pharmacy what an honor to be part of a panel featuring Robert Nickel, Laura Zakaria, myself, the team at USC School of Pharmacy is just incredible, talking about the innovation of our profession, future opportunities for our students. It was just awesome to be part of that. I am so excited about just it being October, it being pharmacist month, we start voting for the 50 most influential people in pharmacy sometime next week.

8:40I can't remember the exact date, but we're going to be putting a lot of information out. Anybody that's listening, I want to get you excited. I want to get you to nominate someone that is exceptional, someone that is influential, someone that is changing our industry. That's the whole purpose of the Pharmacy 50 Awards. I'm so blessed to have so many friends that have come from the 200 alumni over the last four seasons of the Pharmacy 50 Awards. And anyone that's listening, that you have a story to tell, you feel that you have made an impact. Nominating yourself and then reaching out to pharmacy technicians, other pharmacists, physicians you worked with, nurses, patients, people that you've helped.

9:36Get them to get involved in voting. Share our links. Share the graphics. We're going to be coming up with all of this all about the Pharmacy 50 Awards. I think it's the 5th annual or the 6th annual. It was fifth annual. I can't remember. But we are breaking into Twerks News is up next. And now here's the latest in pharmacy. Coming up on Twerks News.

10:07We are here on Twerks News. We are going to be talking with Vox in the box on Twerks News. Vox, how are you? Ready and in the box. All right. Want me to hit you with the top three? Yeah, let's get in. Let's do the FDA may open a temporary pathway for compounded peptides. One sec.

10:35Okay. So this one's still developing. Here's what's reported so far. The Trump administration is considered temporary pie versus a peptide. It's to be impounded while the FD works on return regs. This hasn't been formally approved yet. It's just under consideration. This could mean new opportunities for compounding pharmacies, but there are also safe concerns here. These compounds don't have clinical evidence behind them, and the FDA has been cracking down on compound GL plans. Seems contradictory, doesn't it? yeah apc ceo scott bruner he's a rock star uh commanding all things uh compounding has confirmed that the apc has met directly with the fda officials on this issue and there's no final policy that's been announced this is based on the washington post and uh vox tell us why this matters Thanks for that on-the-ground detail.

11:38And you're right. This is not final policy yet. Just a report. So why it matters. First, compounders need clarity for planning and compound. Second, patient safety is a real concern here. Peptides within evidence could pose for it even if access expands. And third, there's almost a tension between cracking down on some compounds while possibly opening access. It makes you ask, expanding personalized medicine or blurring safety lines? What do you think? Is compounding keeping up with the pace of dementia and regulation? Appreciate that. And the TORX angle is regulated compounding actually safer than leaving patients to buy peptides from the internet.

12:28I absolutely think that we need pharmacists involved every step of the way before anyone tries to cut corners. I think that our compounders are our protectors in the realm of peptides, bioidentical hormone therapy. Next up on Twerx News, a new GAO report begins to complicate the PBM reform debate. and the GAO publicly released its investigation into vertically integrated Medicare Part D plans. The findings are still unsubstantiated. There's a lot of data that we still need to pull out for the four large vertically integrated plan sponsors. affiliated pharmacies accounted for roughly 28 percent of drug utilization and 24 percent of pharmacy payments there is speculation obviously for roughly half of the 20 highest payment drugs analyzed cost sharing at owned pharmacies could be as much as about $340 higher.

13:42PCMA immediately seized on the reimbursement findings, arguing that it contradicts claims that PBMs systematically underpay independent pharmacies. Both sides of this debate are going to use this report. The PBM industry will say, look, independents were actually paid more. And of course, pharmacy advocates can point to steering, vertical integration, beneficiary costs, and the fact that reimbursement rate alone does not tell you whether a prescription is profitable after the acquisition costs. And what about dispensing fees? What about packaging? What about delivery? And all those other operating expenses.

14:29Twerks take, if independents are supposedly being paid more, why are so many pharmacists still saying they lose money filling prescriptions and why do we have independent community pharmacies throughout the nation continuing to close. I think we know the truth about all this. There will be more upcoming PBM Reform podcasts sponsored by APCI. Thank you APCI for your work and for your coverage. Greg Reibold is an amazing man and an amazing podcaster, part of the PPN. Hey, last news article on Torx News. The FDA approves the first immunotherapy-based regimen for stage 3 colon cancer. This came out yesterday.

15:22FDA approved Genetext medication in combination with other chemotherapy medications following surgery for stage 3 colon cancer and the approval includes the texatrin, texatric, you pharmacists out there know probably what I'm talking about, formulation for appropriate patients and this came from the U.S. Food and Drug Administration report. This precision medicine moving earlier into cancer treatment instead of waiting for advanced metastatic disease biomarker testing for DMMR now directly informs a post-surgery immunotherapy strategy aimed at preventing reoccurrence. Sounds like some good news.

16:20And I'd like to actually bring in a pharmacist to talk more about this cancer treatment. we are entering a new era where the pathogy and biomarker reporting determines treatment almost as much as the cancer diagnosis itself this is exciting we do have an upcoming torx interview with joe de pinto of inspiro gene part of mckesson talking about cell and gene therapy updates. Can't wait for you to hear this one on twerks. We will be right back with Mr. Depinto. This episode is brought to you by Hendren AI. Specialty pharmacy teams are being asked to do more than ever before. Between patient outreach, refill coordination, prior authorizations, and the endless volume of phone calls, valuable clinical and operational time is often consumed by administrative work.

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17:58To learn more, visit Hendren.ai and discover how AI can help your team work smarter, not harder. Back on This Week in Pharmacy, Joe DiPinto from InspiroGene by McKesson. Joe, welcome back to Torx. Thanks for having me again, Todd. Really appreciate it. I tell you what, you're a reoccurring guest now. We really look forward to these updates on where cell and gene therapy is going, how this is going to impact patient care. That's the most important thing, how it's really going to leapfrog some other treatment rollouts over the last 20 years. But I said to you before we were recording, I think of it from a selfish perspective of what this does.

18:42And that's probably a bad word it's probably not selfish but when i think of career paths and i think of pharmacists that really want to dig into what this is going to do for treatment and in team development and in them being experts in in not only the the cell and gene therapy leverage but other ancillary things that are happening this is why i like having you back to go over the 2026 cell and gene therapy report by inspirogene so give us a give us an overview yeah Yeah, thanks. This is the third year of the report, and we're really excited to have it launch earlier this week. And thanks for the opportunity to talk to your audience, because pharmacy will play a critical role in the future of cell and gene therapy.

19:28This year's report, the theme is building the bridge, right? So third year in a row, there's some similarities from the last report, last few reports. One is we continue with our primary research in oncology as well as payers, but we've expanded the report this year to talk about a variety of different therapeutic areas where we see the evolution of the science going. So we continue to do the oncology research, but this year we expanded the research to autoimmune disease and rheumatologists as well as ophthalmologists with the retina space. And we went deep into those two emerging areas because why?

20:08We continue to look at the pipeline, and the pipeline is evolving. Yes, oncology and hematology, late-stage trials continue to be a large growth area. But this year, specifically when we did our research, we found that autoimmune disease was a very large representation of clinical trials in the late stage area for cell and gene therapy. 38 % increase year over year. 77 unique compounds and about like 35, 45 indications. Indications that are much larger than the typical oncology or rare disease. You're talking autoimmune diseases like lupus, myasthenial gravis. So these are large patient populations.

20:53And the gene therapies continue to look in the retinal space, right? You see a lot of gene therapies working in the retinal space with late-stage clinical trials. And with the aging population of Americans, that retinal disease area is a large growth area. So that's something we saw. And we brought in the key opinion leaders again from the marketplace, everybody from the University of Kansas to City of Hope, as well as Florida cancer specialists in the community, because we continue to see cell and gene therapies expanding to the community. And they give you practical insights of, hey, we've been at this for a while.

21:33Here's what we're doing well. Here's what we need to do better to remove commercial access barriers. And then the interactive maps have always been a very strong value proposition for our report. And we also have them on our website at inspirogene.com. We continue to have them broken out by cell and gene therapy. And this year we expanded it to look at clinical trials in the United States. And where are clinical trials being done for cell, gene, and advanced therapies and how many clinical trials? It's really interesting. Large amount of clinical trials. But what really matters is 50 % of the trial volume is coming from about 230 plus centers, right?

22:15In the large geographic metropolitan areas that you well know. Look, there are still, unfortunately, some treatment deserts for patients, right? That have to travel a bit of a distance. But what we're seeing in the work that we're doing here is that we're making progress just not as quickly as we'd like. when you and i first talked about selling gene number one i had no idea what it even was and i think a lot of people in health care uh in pharmacy were head scratching saying you know what what's this going to do for uh for reimbursement for treatment for capacity for for not being able to get product and access and i knew it was a rare disease and specialty sector of of pharmacy but 2026 joe has been it has to have been the most explosive year in cell and gene advancement we have the fda actively trying to speed up cell and gene because they have data now from organizations like you know you from you guys and heavily existing understanding the platform knowledge and prior scientific information and potentially reducing redundant testing so when you when you now have the barriers to treatment moving out of the way 2027 is going to be huge and i just want you to kind of share based on the report what's the outlook look like?

23:50Yeah, so we're really proud of the evolution of the report. It's become a bit of an industry standard report that people across the ecosystem go to to look at for some of the data as well as the insights. And you're right, we talk about the FDA and the approvals. And look, we're going to be on track this year to have around the same approvals as last year. But there's been a lot of change at the FDA, but policy has been produced at the FDA that has eliminated the REMS in the past year, REMS and how long patients have to be followed up, as well as where patients have to stay at the treatment centers.

24:27So there's some strong policies that have really helped. And when we think about the work at the FDA, we really need to sort of continue to see those late stage products move through the regulatory process to commercialization. That's step one. And I think we've made progress there. We continue to see progress in the clinical trial evolution and those policies to help alleviate some of the commercial barriers, especially for the caregivers of these patients and the treatment teams that need to treat these patients. another exercise that before we recorded today i went to the um to the report and was looking through the treatment center and how they've expanded and um you know your map that's uh if you're if you're watching this on clips on youtube or something it's it's i'm going to put this in the link where you can go to inspirogene.com forward slash cgt-report.

25:41Once again, that'll be inside the show notes. But the treatment centers, Joe, is exciting to see this expanding. Are these centers normally part of other health systems who have either volunteered or that your organizations have reached out to to couple what they're doing in the specialty space? You know, what we've seen, the treatment centers commercially for cell and gene therapy tend to be hospital-based. But what we're seeing now is an expansion from the academic centers to community-based hospitals to networks within there. But look, in certain product categories, we're seeing more and more cell and gene therapy being done outpatient.

26:24So now you're starting to see community oncology play a larger role as it expands in that area, right? So we're starting to see more of that. We've really started to see that accelerate in 2025, late early 2026, where that's the time period where we're reporting on in the report this year. And that's just good for patients, right? It's good to be able to get treated closer to home. And based on the target product profile of the individual products, those products can be delivered safely and efficiently in the community setting. And they always have the opportunity to have a referral to a hospital in case of adverse events.

27:05And we continue to see the cell and gene therapy ecosystem expand. It started just in those top tier academic centers way back. Right. And then we move to treatment centers that were within larger networks and then community hospitals and community clinics. And that's where the patients sit, quite frankly. Right. And the ability to treat those patients closer to their home is a huge upside for the patient. Joe, something else I read is how our pediatric division is benefiting from cell and gene therapy advancement. And we're seeing children as young as two years old with sickle cell disease having an opportunity to get a therapy that's never existed.

27:54And that is so exciting. and even if it's not direct or if it's not mainstream per se, it's something that gives us hope in the future for patients that are that young that are suffering with such a rare disease. Yeah, so what we've seen more and more, Todd, in the marketplace is separating cell and gene therapies, right? While they're often put together, they really are very different cell versus gene therapies. And the sickle cell space with ex vivo gene therapy, we have multiple players in that space at this point in time. And you're right. It's been an unbelievable resource for institutions that treat sickle cell.

28:39The ability to treat a patient population and have them not go through crisis and seeking out additional health care is a huge benefit to that patient population. And I think we're in the early evolution of that market, but still great promise there for patients that in the past had to really be challenged by managing their crisis. Yep, exactly. I wonder, we jump ahead three to five years from now and we determine whether cell and gene therapy becomes part of that mainstream specialty pharmacy initiative, the lever that can be pulled when a physician and a specialist kind of realizes, hey, this is a perfect opportunity for cell and gene treatment and the team that then surrounds that patient giving a lower cost of care because you've done it over and over again.

29:37It's just like anything, exercise, podcasting, any job that you have, doing it over and over again makes it better for not only the teams, but obviously the patient. When do you think we can see a little more acceleration in Cell and Gene and plugging it into our hub systems and management of the patient treatment? And where do you see this starting to get even more momentum? Yeah, we're starting to see it right now, right? So we have an integrated value offer that we provide at InspiroGene where it's everything from specialty distribution to hub service to specialty pharmacy. And the hub specialty pharmacy connection is an important one, right?

30:25And we run that through our biologics organization. And we see a lot of activity there in coordination between the hub and the specialty pharmacy in both the cell side as well as the gene therapy side. I think as we look at the therapeutic areas expanding to larger patient populations, you're going to see an acceleration of the utilization of those resources. And it's just natural because the patient populations are larger. Now, granted, there are still some challenges with that, right? We have to sort of make sure we're treating the right patients with the right therapeutic at the right point in time.

31:08But the ability to have the data from the hub and the specialty pharmacy interlinked is really powerful for the providers, for the biopharma organizations, as well as the payers, right? We have all that information coordinated, which is quite powerful. It is. Joe, you really were so appreciative of you. You give us time. You've been updating us now on four different segments of This Week in Pharmacy. This is so important. I'd like to invite a pharmacist that has been in this space to come along with you in the next update from InspiroGene. Joe DiPinto, head of cell and gene in advanced therapies at InspiroGene.

31:56Thank you so much for being on twerks today. Thanks for having me. Always fun. You're listening to this week in pharmacy on the pharmacy podcast network.

32:13hey um before we wrap up today i do want to mention um an article out on medica life if you don't read medica life you're missing out on um a really interesting online magazine online blog source. You can find this at medica.life. Medica is spelled M-E-D-I-K-A.life, Medica Life. And the article title is Rethinking Vaccine Costs, How the More Expensive Vaccine Can Actually Save Health Systems Millions. On This Week in Pharmacy, October 7th, 2026, This was published, and this is an exclusive article authored by Ingenochio Oliveria, and this dives into a new published cost minimization analysis from Argentina, which offers one of the clearest economic assessments to date on how immunization budgets should be evaluated.

33:29this is very interesting reading we will be doing a follow-up interview on this subject but I want to bring that to your attention on This Week in Pharmacy just as another piece of news that you may not have known about and we're hoping that you guys have a fabulous weekend We are headed to the Next Dose Summit by Dr. Jordan Smith. She is an outstanding entrepreneur to put this conference together, the Next Dose Summit. We will be there. I will be there covering the event. We're so excited to be part of it. We'll be leading a panel discussion with some of the most innovative pharmacists and people in pharmacy in our profession.

34:29Go to Google right now and type in the Next Dose Summit. And it's in Covington, Covington. and it pulls right up. The 2026, the Next Dose Summit registration will appear. And I want you to register. I want you to think about going. And if you want more information on this, you are welcome to reach out to me. I'm easy found, easily found. Type in, go to Lincoln, type in Todd Ury, E-U-R-Y. ask me questions about the event or even ask Jordan about this event. This is going to be an exciting time. I think that we are in a major shift in pharmacy and leadership and people that really want to seek new perspectives on our industry.

35:39pharmacy students are welcome to come we encourage you to come pharmacy technicians exploring entrepreneurship exploring how pharmacy is going through a massive transformation and networking together with people like Melinda Fowler Melody Hartzell Dr. Jill White Dr. Tim Ulbrich entrepreneur and pharmacy student Saki Patel, Lisa Fast, the pharmacy badass, Delon Canterbury, the godfather of deprescribing, Samantha Wright, the one and only Jesse McCullough, who's been doing an amazing job, uh uh janan sarwar uh dr sarwar jay phillips known as the pharmacist gladiator pharmacy gladiator lola um alatude as well as neema um atai dr natalie park from tjm labs which will be really interested in listening to her.

36:55Jay Kuntz, Dr. Liz Fredrickson, Nicole Wallace, and Dr. Jackie Boyle. It's going to be a packed lineup. You're not going to want to miss it. Each of these people bring insights in what it took to build their entrepreneurial business and their pathway. once again this is the next dose summit and i'm so proud and so excited to be part of this october 14th 15th in covington kentucky like i said reach out to me um we are excited to be a part of it we are excited that you have been reaching out and have been listening to twerks we have an increase in listeners. Thank you so much for listening. Share Torx with a fellow pharmacist, a pharmacy technician, someone that you want to tag in and understand what's happening in our profession.

37:58And I hope you guys have a great and tremendous week. We're out.