Latest / Pharmacy Podcast Network / Cell & Gene Therapy Update with Joe DePinto, InspiroGene by McKesson | TWIRx

Transcript

Cell & Gene Therapy Update with Joe DePinto, InspiroGene by McKesson | TWIRx · Pharmacy Podcast Network

• 0:05
  Speaker 1: You are listening to the global network of podcasters dedicated
• 0:09
  Speaker 1: to the pharmacy profession. Welcome to the Pharmacy Podcast Network.
• 0:50
  Speaker 2: Hey, welcome to Twerks. Hope you have had a good week.
• 1:02
  Speaker 2: I've had a monstrous week. We're going to talk about it.
• 1:10
  Speaker 2: But first up, my friend who put together the first
• 1:16
  Speaker 2: 31 day challenge last year. for 2025. And Jesse McCullough
• 1:23
  Speaker 2: is back. Jesse, thanks for being on Twerks today.
• 1:28
  Speaker 3: Hello, This Week in Pharmacy podcast listeners. This is Jesse
• 1:31
  Speaker 3: McCullough back with you with another exclusive challenge as part
• 1:36
  Speaker 3: of the 31 Day Challenge. Before I get to the challenge,
• 1:40
  Speaker 3: I want to give you a little bit of a backstory.
• 1:42
  Speaker 3: Many years ago, I was part of a brand new endeavor.
• 1:45
  Speaker 3: We were developing a clinical services team for the large
• 1:48
  Speaker 3: chain that I was working for at the time. And
• 1:51
  Speaker 3: when we came in, it was pointed out that there
• 1:54
  Speaker 3: was no training manual for what we were doing. Everything
• 1:57
  Speaker 3: we were doing was brand new. And there was no
• 2:01
  Speaker 3: formal training that would get somebody up to speed because
• 2:04
  Speaker 3: we were essentially learning those things as we were going
• 2:08
  Speaker 3: through it. And the idea came through at that time
• 2:12
  Speaker 3: that perhaps what we should do is just keep a
• 2:14
  Speaker 3: list of the different activities and accomplishments that we were
• 2:19
  Speaker 3: a part of during that time. Wonderful thing to say.
• 2:23
  Speaker 3: It was a difficult thing to do. Last week, as
• 2:28
  Speaker 3: part of the 31-day challenge, I was having a conversation
• 2:31
  Speaker 3: with a colleague, and the question came up, hey, would
• 2:34
  Speaker 3: you mind sending over your CV? And I said, yeah,
• 2:37
  Speaker 3: I'd be happy to send over my CV. And then
• 2:39
  Speaker 3: I realized I haven't updated my CV in some time.
• 2:45
  Speaker 3: And it's really hard to play catch up with that,
• 2:47
  Speaker 3: I have found. I have found that it's very, very
• 2:49
  Speaker 3: hard to say, okay, what all has gone on since
• 2:52
  Speaker 3: the last time that I updated my resume, updated my CV?
• 2:58
  Speaker 3: And so it's from that that I want to give
• 3:00
  Speaker 3: you this challenge today. I want you to be prepared
• 3:05
  Speaker 3: for the next opportunity that comes down the street for you.
• 3:09
  Speaker 3: I want you to be ready for that. And I
• 3:11
  Speaker 3: think one of the best ways to do that is
• 3:13
  Speaker 3: to be a collector of accomplishments. So the challenge is this,
• 3:18
  Speaker 3: to set a reminder on your phone. Now, this reminder
• 3:22
  Speaker 3: may be something that you do weekly. It may be
• 3:24
  Speaker 3: something that you do daily. I would encourage you to
• 3:27
  Speaker 3: consider this to be a challenge to do more often
• 3:30
  Speaker 3: if you are earlier in your career or you are
• 3:32
  Speaker 3: earlier in a particular role, because you are going to
• 3:36
  Speaker 3: have so many experiences. You're going to have so many
• 3:40
  Speaker 3: new things that happen to you. And when that reminder
• 3:45
  Speaker 3: goes off, I want to encourage you to open a notes,
• 3:48
  Speaker 3: whatever notes app you may have on your phone. And
• 3:51
  Speaker 3: I want you just to jot down some of those
• 3:53
  Speaker 3: accomplishments that you have done. You see, the day will
• 3:56
  Speaker 3: come when you will want to be able to remember
• 3:59
  Speaker 3: those things, or you're going to want to be able
• 4:00
  Speaker 3: to quantify and qualify all those things that you have
• 4:03
  Speaker 3: done in your pharmacy career. But don't count on your
• 4:07
  Speaker 3: memory to be the best source of truth for that.
• 4:13
  Speaker 3: the best thing you can do is be collecting those
• 4:15
  Speaker 3: as you go along. Now, you may have a more
• 4:18
  Speaker 3: advanced or more sophisticated way of collecting those ideas. I
• 4:22
  Speaker 3: would say perhaps the best way to do it is
• 4:24
  Speaker 3: you just have a Word document, and then when it
• 4:26
  Speaker 3: comes time that you need it, you can just cut
• 4:29
  Speaker 3: out the stuff that's not relevant. But you want to
• 4:32
  Speaker 3: have that. It's better to have it than want it
• 4:34
  Speaker 3: in those particular cases. And that's the challenge that I
• 4:36
  Speaker 3: want to extend to you today so that you don't
• 4:40
  Speaker 3: find yourself like I was last week With somebody asking
• 4:44
  Speaker 3: you for a current document, you think to yourself, oh
• 4:46
  Speaker 3: my goodness, I haven't done that in some time. So
• 4:49
  Speaker 3: the challenge is absolutely for you to take a little
• 4:52
  Speaker 3: bit of time to set the reminder. Set the reminder
• 4:56
  Speaker 3: to list your accomplishments wherever that may be. And I
• 4:59
  Speaker 3: want to encourage you to do that because you will
• 5:01
  Speaker 3: find that you will be well served by having that
• 5:03
  Speaker 3: information available to you. With that, I'm going to turn
• 5:07
  Speaker 3: it back to Todd and the This Week in Pharmacy team.
• 5:10
  Speaker 3: Have a great week, everybody, and we will see you
• 5:12
  Speaker 3: again next week.
• 5:14
  Speaker 2: Jesse, thank you so much. You are so committed to
• 5:18
  Speaker 2: our profession and the leadership that you provide. I'm excited
• 5:23
  Speaker 2: to be a small part of that 31-day challenge. We're
• 5:27
  Speaker 2: going to continue to have Jesse back on Twerks the
• 5:31
  Speaker 2: entire month. of October. October is Pharmacist Month, celebrating our
• 5:37
  Speaker 2: amazing providers, my favorite providers. This is Twerks. Welcome to
• 5:45
  Speaker 2: This Week in Pharmacy.
• 5:47
  Speaker 4: Twerks is the weekly pulse of the pharmacy profession. And now,
• 5:52
  Speaker 4: here's Pittsburgh native Bleeding Black and Gold, pharmacy's first podcaster
• 5:56
  Speaker 4: and founder of the Pharmacy Podcast Network, the RxPodfather.
• 6:00
  Speaker 2: Our host, Todd Urie. Hey there, welcome to Twerks. It
• 6:13
  Speaker 2: is October 9th, 2026. It's Friday. Hail, hail, hails to
• 6:21
  Speaker 2: the hills, yeah. I don't know if that's a good
• 6:25
  Speaker 2: thing to say on Twerks, but I was getting too
• 6:27
  Speaker 2: excited because I need a weekend. I have been traveling
• 6:31
  Speaker 2: a lot. We were in um, LA, uh, Los Angeles
• 6:38
  Speaker 2: at the USC School of Pharmacy, Mann School of Pharmacy.
• 6:42
  Speaker 2: What an honor to be part of a panel, uh, featuring, uh,
• 6:47
  Speaker 2: Robert Nickel, um, Laura Zakaria, myself, um, the team at
• 6:53
  Speaker 2: USC School of Pharmacy is just incredible talking about the
• 6:57
  Speaker 2: innovation of our profession, uh, future opportunities for our students, um,
• 7:03
  Speaker 2: It was just awesome to be part of that. I
• 7:08
  Speaker 2: am so excited about just it being October, it being
• 7:14
  Speaker 2: Pharmacist Month. We start voting for the 50 most influential
• 7:20
  Speaker 2: people in pharmacy sometime next week. I can't remember the
• 7:25
  Speaker 2: exact date, but we're going to be putting a lot
• 7:28
  Speaker 2: of information out Anybody that's listening, I want to get
• 7:32
  Speaker 2: you excited. I want to get you to nominate someone
• 7:35
  Speaker 2: that is exceptional, someone that is influential, someone that is
• 7:39
  Speaker 2: changing our industry. That's the whole purpose of the Pharmacy
• 7:42
  Speaker 2: 50 Awards. I'm so blessed to have so many friends
• 7:50
  Speaker 2: that have come from the 200 alumni over the last
• 7:55
  Speaker 2: four seasons. of the pharmacy 50 awards and anyone that's listening, um,
• 8:02
  Speaker 2: that you have a story to tell, you feel that
• 8:05
  Speaker 2: you have made an impact, um, nominating yourself and then
• 8:10
  Speaker 2: reaching out to pharmacy technicians, other pharmacists, physicians, you worked
• 8:15
  Speaker 2: with nurses, um, patients, people that you've helped get them
• 8:20
  Speaker 2: to get involved in voting, share our links, share the
• 8:25
  Speaker 2: graphics where, Going to be coming up with all of this,
• 8:28
  Speaker 2: all about the Pharmacy 50 Awards. I think it's the
• 8:32
  Speaker 2: 5th annual or the 6th annual, 5th annual. I can't remember.
• 8:37
  Speaker 2: But we are breaking into Twerks News is up next.
• 8:43
  Speaker 2: And now, here's the latest in pharmacy. Coming up on
• 8:46
  Speaker 2: Twerks News. We are here on Twerks News. We are
• 8:53
  Speaker 2: going to be talking with Vox in the Box on
• 8:56
  Speaker 2: Twerks News. Vox, how are you? Ready and in the box.
• 9:02
  Speaker 2: All right. Want me to hit you with the top three? Yeah,
• 9:05
  Speaker 2: let's get in. Let's do the FDA may open a
• 9:08
  Speaker 2: temporary pathway for compounded peptides. One sec.
• 9:14
  Speaker 5: Okay. Okay.
• 9:20
  Speaker 2: So this one's still developing. Here's what's reported so far.
• 9:25
  Speaker 6: The Trump administration is considered temporary pie versus peptide. It's
• 9:30
  Speaker 6: to be impounded while the FDA works on return regs.
• 9:34
  Speaker 6: This hasn't been formally approved yet. It's just under consideration.
• 9:38
  Speaker 6: This could mean new opportunities for compounding pharmacies, but there
• 9:45
  Speaker 6: are also safe concerns here. These compounds don't have clinical
• 9:48
  Speaker 6: evidence behind them. And the FDA has been cracking down
• 9:51
  Speaker 6: on compound GL plants.
• 9:53
  Speaker 2: Seems contradictory, doesn't it?
• 9:57
  Speaker 5: Yeah.
• 9:58
  Speaker 2: APC CEO Scott. Bruner, he's a rock star commanding all
• 10:02
  Speaker 2: things compounding, has confirmed that the APC has met directly
• 10:07
  Speaker 2: with the FDA officials on this issue, and there's no
• 10:11
  Speaker 2: final policy that's been announced. This is based on the
• 10:14
  Speaker 2: Washington Post. And Vox, tell us why this matters.
• 10:20
  Speaker 6: Thanks for that on-the-ground detail. And you're right. This is
• 10:24
  Speaker 6: not final policy yet.
• 10:25
  Speaker 2: Just a report. So why it matters.
• 10:28
  Speaker 6: First, compounders need clarity for planning. And second, patient safety
• 10:34
  Speaker 6: is a real concern here. Peptides with thin evidence could
• 10:37
  Speaker 6: pose risk even if access expands.
• 10:40
  Speaker 2: And third, there's.
• 10:41
  Speaker 6: Almost a tension between cracking down on some compounds while
• 10:45
  Speaker 6: possibly opening access laterally. It makes you ask, expanding personalized
• 10:50
  Speaker 6: medicine or blurring safety lines?
• 10:54
  Speaker 2: What do you think?
• 10:55
  Speaker 6: Is compounding keeping up with the pace of dementia and regulation?
• 11:01
  Speaker 2: Appreciate that. And the Torx angle, is regulated compounding actually
• 11:07
  Speaker 2: safer than leaving patients to buy peptides from the internet?
• 11:12
  Speaker 2: I absolutely think that we need pharmacists involved every step
• 11:16
  Speaker 2: of the way before anyone tries to cut corners. I
• 11:21
  Speaker 2: think that our compounders are our protectors in the realm
• 11:25
  Speaker 2: of peptides, bioidentical hormone therapy. Next up on TORX News,
• 11:31
  Speaker 2: a new GAO report begins to complicate the PBM reform debate,
• 11:39
  Speaker 2: and the GAO publicly released its investigation into vertically integrated
• 11:45
  Speaker 2: Medicare Part D plans. The findings are still unsubstantiated. There's
• 11:54
  Speaker 2: a lot of data that we still need to pull
• 11:55
  Speaker 2: out for the four large vertically integrated plan sponsors. Affiliated
• 12:02
  Speaker 2: pharmacies accounted for roughly 28% of drug utilization and 24%
• 12:05
  Speaker 2: of pharmacy payments. There is speculation, obviously, for roughly half
• 12:15
  Speaker 2: of the 20 highest payment drugs analyzed cost sharing at
• 12:20
  Speaker 2: owned pharmacies could be as much as about $ 340 higher.
• 12:26
  Speaker 2: PCMA immediately seized on the reimbursement findings, arguing that it
• 12:31
  Speaker 2: contradicts claims that PBMs systematically underpay independent pharmacies. Both sides agree.
• 12:38
  Speaker 2: of this debate are going to use this report. The
• 12:42
  Speaker 2: PBM industry will say, look, independents were actually paid more.
• 12:48
  Speaker 2: And of course, pharmacy advocates can point to steering, vertical integration,
• 12:53
  Speaker 2: beneficiary costs, and the fact that reimbursement rate alone does
• 12:58
  Speaker 2: not tell you whether a prescription is profitable after the
• 13:02
  Speaker 2: acquisition costs. And what about dispensing fees? What about packaging?
• 13:06
  Speaker 2: What about delivery? and all those other operating expenses. Twerks take.
• 13:14
  Speaker 2: If independents are supposedly being paid more, why are so
• 13:19
  Speaker 2: many pharmacists still saying they lose money filling prescriptions, and
• 13:23
  Speaker 2: why do we have independent community pharmacies throughout the nation
• 13:27
  Speaker 2: continuing to close? I think we know the truth about
• 13:31
  Speaker 2: all this. There will be more upcoming PBM Reform Podcasts.
• 13:36
  Speaker 2: sponsored by APCI. Thank you, APCI, for your work and
• 13:40
  Speaker 2: for your coverage. Greg Reibold is an amazing man and
• 13:46
  Speaker 2: an amazing podcaster, part of the PPN. Hey, last news
• 13:52
  Speaker 2: article on TORX News. The FDA approves the first immunotherapy-based
• 13:59
  Speaker 2: regimen for stage 3 colon cancer. This came out yesterday.
• 14:05
  Speaker 2: FDA-approved Genetex medication in combination with other chemotherapy medications following
• 14:15
  Speaker 2: surgery for stage 3 colon cancer. And the approval includes
• 14:23
  Speaker 2: the Texatrin formulation for appropriate And this came from the U.S.
• 14:36
  Speaker 2: Food and Drug Administration report. This precision medicine moving earlier
• 14:43
  Speaker 2: into cancer treatment instead of waiting for advanced metastatic disease
• 14:50
  Speaker 2: biomarker testing for DMMR now directly informs a post-surgery immunotherapy
• 14:59
  Speaker 2: strategy aimed at preventing recurrence. Sounds like some good news.
• 15:04
  Speaker 2: And I'd like to actually bring in a pharmacist to
• 15:08
  Speaker 2: talk more about this cancer treatment. We are entering a
• 15:15
  Speaker 2: new era where the pathogy in biomarker reporting determines treatment
• 15:21
  Speaker 2: almost as much as the cancer diagnosis itself. This is exciting.
• 15:26
  Speaker 2: We do have an upcoming TORX interview with Joe DiPinto.
• 15:32
  Speaker 2: of InspiroGene, part of McKesson, talking about cell and gene
• 15:37
  Speaker 2: therapy updates. Can't wait for you to hear this one
• 15:40
  Speaker 2: on Twerks. We will be right back with Mr. DiPinto.
• 15:47
  Speaker 1: This episode is brought to you by Hendren AI. Specialty
• 15:51
  Speaker 1: pharmacy teams are being asked to do more than ever before.
• 15:54
  Speaker 1: Between patient outreach, refill coordination, prior authorizations, and the endless
• 15:59
  Speaker 1: volume of phone calls, valuable clinical and operational time is
• 16:03
  Speaker 1: often consumed by administrative work. At Hendren AI, we believe
• 16:07
  Speaker 1: the people caring for patients should spend less time managing
• 16:10
  Speaker 1: workflows and more time delivering meaningful outcomes. That's why we
• 16:14
  Speaker 1: build AI-powered solutions designed specifically for specialty and infusion pharmacy organizations.
• 16:20
  Speaker 1: Our platform helps automate repetitive phone-based and administrative processes, streamline operations,
• 16:26
  Speaker 1: and improve the patient experience while fitting into existing workflows.
• 16:31
  Speaker 1: Hendren AI is focused on a simple mission, turning human
• 16:34
  Speaker 1: labor into software so healthcare organizations can scale more efficiently
• 16:39
  Speaker 1: while keeping patients at the center of care. To learn more,
• 16:42
  Speaker 1: visit Hendren.ai and discover how AI can help your team
• 16:46
  Speaker 1: work smarter, not harder.
• 16:50
  Speaker 2: Back on This Week in Pharmacy, Joe DiPinto from InspiroGene
• 16:55
  Speaker 2: by McKesson. Joe, welcome back to Twerks.
• 16:59
  Speaker 5: Thanks for having me again, Todd. Really appreciate it.
• 17:02
  Speaker 2: I tell you what, you're a reoccurring guest now. We
• 17:04
  Speaker 2: really look forward to these updates on where cell and
• 17:07
  Speaker 2: gene therapy is going, how this is going to impact
• 17:10
  Speaker 2: patient care. That's the most important thing, how it's really
• 17:13
  Speaker 2: going to leapfrog some other treatment rollouts over the last
• 17:18
  Speaker 2: 20 years. But I said to you before we were recording,
• 17:22
  Speaker 2: I think of it from a selfish perspective of what
• 17:25
  Speaker 2: this does. And that's probably a bad word. It's probably
• 17:28
  Speaker 2: not selfish. But when I think of career paths and
• 17:31
  Speaker 2: I think of pharmacists that really want to dig into
• 17:34
  Speaker 2: what this is going to do for treatment and team
• 17:37
  Speaker 2: development and them being experts in not only the cell
• 17:43
  Speaker 2: and gene therapy leverage, but other ancillary things that are
• 17:46
  Speaker 2: happening in This is why I like having you back
• 17:49
  Speaker 2: to go over the 2026 Cell and Gene Therapy Report
• 17:53
  Speaker 2: by InspiroGene. So give us an overview.
• 17:57
  Speaker 5: Yeah, thanks. This is the third year of the report,
• 18:01
  Speaker 5: and we're really excited to have it launch earlier this week.
• 18:04
  Speaker 5: And thanks for the opportunity to talk to your audience,
• 18:07
  Speaker 5: because pharmacy will play a critical role in the future
• 18:10
  Speaker 5: of cell and gene therapy. This year's report, the theme
• 18:13
  Speaker 5: is building the bridge, right? So third year in a row.
• 18:16
  Speaker 5: There's some similarities from the last report, last few reports.
• 18:20
  Speaker 5: One is we continue with our primary research in oncology
• 18:25
  Speaker 5: as well as payers, but we've expanded the report this
• 18:28
  Speaker 5: year to talk about a variety of different therapeutic areas
• 18:32
  Speaker 5: where we see the evolution of the science going. We
• 18:36
  Speaker 5: continue to do the oncology research, but this year we
• 18:39
  Speaker 5: expanded the research to autoimmune disease and rheumatologists, as well
• 18:44
  Speaker 5: as ophthalmologists with the retina space. And we went deep
• 18:49
  Speaker 5: into those two emerging areas because why? We continue to
• 18:52
  Speaker 5: look at the pipeline and the pipeline is evolving. Yes,
• 18:56
  Speaker 5: oncology and hematology, late stage trials continue to be a
• 19:01
  Speaker 5: large growth area. But this year, specifically when we did
• 19:04
  Speaker 5: our research, we found that autoimmune disease was a very
• 19:09
  Speaker 5: large representation of clinical trials in the late stage area
• 19:13
  Speaker 5: for cell and gene therapy. 38% increase year over year,
• 19:15
  Speaker 5: 77 unique compounds, and about like 35, 45 indications, indications
• 19:25
  Speaker 5: that are much larger than the typical oncology or rare disease.
• 19:29
  Speaker 5: You're talking autoimmune diseases like lupus, myasthenia gravis. So these
• 19:35
  Speaker 5: are large patient populations. And the gene therapies continue to
• 19:40
  Speaker 5: look in the retinal space, right? You see a lot
• 19:43
  Speaker 5: of gene therapies working in the retinal space with late
• 19:46
  Speaker 5: stage clinical trials. and with the aging population of America
• 19:50
  Speaker 5: that retinal disease area is a large growth area. So
• 19:53
  Speaker 5: that's something we saw. And we brought in the key
• 19:57
  Speaker 5: opinion leaders again from the marketplace, everybody from the University
• 20:02
  Speaker 5: of Kansas to City of Hope, as well as Florida
• 20:07
  Speaker 5: cancer specialists in the community, because we continue to see
• 20:10
  Speaker 5: cell and gene therapies expanding to the community. And they
• 20:13
  Speaker 5: give you practical insights of, hey, we've been at this
• 20:16
  Speaker 5: for a while. Here's what we're doing well. Here's what
• 20:19
  Speaker 5: we need to do better to remove commercial access barriers.
• 20:23
  Speaker 5: And then the interactive maps have always been a very
• 20:27
  Speaker 5: strong value proposition for our rapport. And we also have
• 20:31
  Speaker 5: them on our website at inspirogene.com. We continue to have
• 20:35
  Speaker 5: them broken out by cell and gene therapy. And this
• 20:37
  Speaker 5: year we expanded it to look at clinical trials in
• 20:40
  Speaker 5: the United States. And where are clinical trials being done
• 20:44
  Speaker 5: for cell gene advanced therapies and how many clinical trials?
• 20:48
  Speaker 5: It's really interesting. Large amount of clinical trials. But what
• 20:51
  Speaker 5: really matters is 50% of the trial volume is coming
• 20:54
  Speaker 5: from about 230 plus centers, right? In the large geographic
• 21:00
  Speaker 5: metropolitan areas that you well know. Look, there are still, unfortunately,
• 21:05
  Speaker 5: some treatment deserts for patients, right, that have to travel
• 21:08
  Speaker 5: a bit of a distance. But what we're seeing in
• 21:12
  Speaker 5: the work that we're doing here is that we're making
• 21:14
  Speaker 5: progress just not as quickly as we'd like.
• 21:19
  Speaker 2: When you and I first talked about Celengene, number one,
• 21:23
  Speaker 2: I had no idea what it even was. And I
• 21:26
  Speaker 2: think a lot of people in health care, in pharmacy,
• 21:30
  Speaker 2: were head scratching, saying, you know, what? What's this going
• 21:34
  Speaker 2: to do for reimbursement, for treatment, for capacity, for not
• 21:41
  Speaker 2: being able to get product and access? And I knew
• 21:44
  Speaker 2: it was a rare disease and specialty sector of pharmacy.
• 21:51
  Speaker 2: But 2026, Joe, it has to have been the most
• 21:55
  Speaker 2: explosive year in cell and gene advancement. we have the
• 22:00
  Speaker 2: FDA actively trying to speed up cell and gene because
• 22:04
  Speaker 2: they have data now from organizations like you, you know,
• 22:07
  Speaker 2: you from you guys and heavily existing understanding the platform
• 22:12
  Speaker 2: knowledge and prior scientific information and potentially reducing redundant testing.
• 22:19
  Speaker 2: So when you, when you now have the barriers to
• 22:23
  Speaker 2: treatment moving out of the way, 2027 is going to
• 22:26
  Speaker 2: be huge and, I just want you to kind of
• 22:30
  Speaker 2: share based on the report, what's the outlook look like?
• 22:33
  Speaker 5: Yeah, so we're really proud of the evolution of the report.
• 22:37
  Speaker 5: It's become a bit of an industry standard report that
• 22:40
  Speaker 5: people across the ecosystem go to to look at for
• 22:42
  Speaker 5: some of the data as well as the insights. And
• 22:45
  Speaker 5: you're right. We talk about the FDA and the approvals.
• 22:49
  Speaker 5: And look, we're going to be on track this year
• 22:52
  Speaker 5: to have around the same approvals as last year. But
• 22:55
  Speaker 5: there's been a lot of change at the FDA. But policy...
• 22:58
  Speaker 5: has been produced at the FDA that has eliminated the
• 23:02
  Speaker 5: REMS in the past year, REMS and how long patients
• 23:06
  Speaker 5: have to be followed up as well as where patients
• 23:08
  Speaker 5: have to stay at the treatment centers. So there's some
• 23:11
  Speaker 5: strong policies that have really helped. And when we think
• 23:16
  Speaker 5: about the work at the FDA, we really need to
• 23:22
  Speaker 5: sort of continue to see those late stage products move
• 23:26
  Speaker 5: through the regulatory process to commercialization. That's step one. And
• 23:32
  Speaker 5: I think we've made progress there. We continue to see
• 23:37
  Speaker 5: progress in the clinical trial evolution and those policies to
• 23:42
  Speaker 5: help alleviate some of the commercial barriers, especially for the
• 23:48
  Speaker 5: caregivers of these patients and the treatment teams that need
• 23:53
  Speaker 5: to treat these patients.
• 23:57
  Speaker 2: Another exercise that before we recorded today, I went to
• 24:02
  Speaker 2: the report and was looking through the treatment center and
• 24:06
  Speaker 2: how they've expanded. And your map, if you're watching this
• 24:13
  Speaker 2: on clips on YouTube or something, I'm going to put
• 24:16
  Speaker 2: this in the link where you can go to inspirogene.com
• 24:21
  Speaker 2: forward slash cgt-report. Once again, that'll be inside the show notes,
• 24:27
  Speaker 2: but the treatment centers, Joe, is exciting to see this expanding.
• 24:33
  Speaker 2: Are these centers normally part of other health systems who
• 24:37
  Speaker 2: have either volunteered or that your organizations have reached out to,
• 24:42
  Speaker 2: to couple what they're doing in the specialty space?
• 24:47
  Speaker 5: You know, what we've seen, the treatment centers commercially for
• 24:50
  Speaker 5: cell and gene therapy tend to be hospital-based. But what
• 24:53
  Speaker 5: we're seeing now is an expansion from the academic centers
• 24:57
  Speaker 5: to community-based hospitals to networks within there. But look, in
• 25:01
  Speaker 5: certain product categories, we're seeing more and more cell and
• 25:05
  Speaker 5: gene therapy being done outpatient. So now you're starting to
• 25:09
  Speaker 5: see community oncology play a larger role as it expands
• 25:13
  Speaker 5: in that area, right? So we're starting to see more
• 25:16
  Speaker 5: of that. We've really started to see that accelerate in 2025,
• 25:21
  Speaker 5: late early 2026, where that's the time period where we're
• 25:25
  Speaker 5: reporting on in the report this year. And that's just
• 25:28
  Speaker 5: good for patients, right? It's good to be able to
• 25:30
  Speaker 5: get treated closer to home. And based on the target
• 25:34
  Speaker 5: product profile of the individual products, Those products can be
• 25:38
  Speaker 5: delivered safely and efficiently in the community setting. And they
• 25:43
  Speaker 5: always have the opportunity to have a referral to a
• 25:46
  Speaker 5: hospital in case of adverse events. And we continue to
• 25:50
  Speaker 5: see the cell and gene therapy ecosystem expand. It started
• 25:56
  Speaker 5: just in those top tier academic centers way back, right?
• 26:00
  Speaker 5: And then we moved to treatment centers that were within
• 26:03
  Speaker 5: larger networks and then community hospitals and community clinics and
• 26:07
  Speaker 5: That's where the patients sit, quite frankly, right? And the
• 26:12
  Speaker 5: ability to treat those patients closer to their home is
• 26:15
  Speaker 5: a huge upside for the patient.
• 26:18
  Speaker 2: Joe, something else I read is how our pediatric division
• 26:24
  Speaker 2: is benefiting from cell and gene therapy advancement. And we're
• 26:29
  Speaker 2: seeing children as young as two years old with sickle
• 26:32
  Speaker 2: cell disease having an opportunity to get a therapy that's
• 26:36
  Speaker 2: never existed. And that is so exciting. And even if
• 26:41
  Speaker 2: it's not direct or if it's not mainstream per se,
• 26:46
  Speaker 2: it's something that gives us hope in the future for
• 26:50
  Speaker 2: patients that are that young that are suffering with such
• 26:53
  Speaker 2: a rare disease.
• 26:55
  Speaker 5: Yeah, so... What we've seen more and more, Todd, in
• 26:59
  Speaker 5: the marketplace is separating cell and gene therapies, right? While
• 27:03
  Speaker 5: they're often put together, they really are very different, cell
• 27:07
  Speaker 5: versus gene therapies. And the sickle cell space with ex
• 27:11
  Speaker 5: vivo gene therapy, we have multiple players in that space
• 27:15
  Speaker 5: at this point in time. And you're right. It's been
• 27:17
  Speaker 5: an unbelievable resource for institutions that treat sickle cell. the
• 27:23
  Speaker 5: ability to treat a patient population and have them not
• 27:28
  Speaker 5: go through crisis and seeking out additional healthcare is a
• 27:32
  Speaker 5: huge benefit to that patient population. And I think we're
• 27:35
  Speaker 5: in the early evolution of that market, but still great
• 27:40
  Speaker 5: promise there for patients that in the past had to
• 27:45
  Speaker 5: really be challenged by managing their crisis.
• 27:49
  Speaker 2: Yep, exactly. I wonder, we jump ahead, three to five
• 27:53
  Speaker 2: years from now and we determine whether cell and gene
• 27:56
  Speaker 2: therapy becomes part of that mainstream specialty pharmacy initiative, the
• 28:03
  Speaker 2: lever that can be pulled when a physician and a
• 28:05
  Speaker 2: specialist kind of realizes, hey, this is a perfect opportunity
• 28:09
  Speaker 2: for cell and gene treatment and the team that then
• 28:14
  Speaker 2: surrounds that patient giving a lower cost of care because
• 28:19
  Speaker 2: you've done it over and over again. It's a just
• 28:22
  Speaker 2: like anything, exercise, podcasting, any job that you have, doing
• 28:27
  Speaker 2: it over and over again makes it better for not
• 28:31
  Speaker 2: only the teams, but obviously the patient. When do you
• 28:35
  Speaker 2: think we can see a little more acceleration in cell
• 28:40
  Speaker 2: and gene and plugging it into our hub systems and
• 28:44
  Speaker 2: management of the patient treatment? And where do you see
• 28:48
  Speaker 2: this starting to get even more momentum?
• 28:52
  Speaker 5: Yeah, we're starting to see it right now, right? So
• 28:55
  Speaker 5: we have an integrated value offer that we provide at
• 28:59
  Speaker 5: InspiroGene where it's everything from specialty distribution to hub service
• 29:03
  Speaker 5: to specialty pharmacy. And the hub specialty pharmacy connection is
• 29:07
  Speaker 5: an important one, right? And we run that through our
• 29:09
  Speaker 5: biologics organization. And we see a lot of activity there
• 29:13
  Speaker 5: in coordination between the hub and the specialty pharmacy in
• 29:17
  Speaker 5: both the cell side as well as the gene therapy side.
• 29:22
  Speaker 5: I think as we look at the therapeutic areas expanding
• 29:27
  Speaker 5: to larger patient populations, you're going to see an acceleration
• 29:32
  Speaker 5: of the utilization of those resources. And it's just natural
• 29:37
  Speaker 5: because the patient populations are large. Now, granted, there are
• 29:42
  Speaker 5: still some challenges with that, right? We have to sort
• 29:46
  Speaker 5: of make sure we're treating the right patients with the
• 29:49
  Speaker 5: right therapeutic at the right point in time. But the
• 29:52
  Speaker 5: ability to have the data from the hub and the
• 29:55
  Speaker 5: specialty pharmacy interlinked is really powerful for the providers, for
• 30:02
  Speaker 5: the biopharma organizations, as well as the payers, right? We
• 30:06
  Speaker 5: have all that information coordinated, which is quite powerful.
• 30:11
  Speaker 6: It is.
• 30:13
  Speaker 2: Joe, you really were so appreciative of you. You give
• 30:17
  Speaker 2: us time. You've been updating us now on four different
• 30:21
  Speaker 2: segments of This Week in Pharmacy. This is so important.
• 30:24
  Speaker 2: I'd like to invite a pharmacist that has been in
• 30:27
  Speaker 2: this space to come along with you in the next
• 30:30
  Speaker 2: update from InspiroGene. Joe DiPinto, head of cell and gene
• 30:37
  Speaker 2: and advanced therapies at InspiroGene. Thank you so much for
• 30:41
  Speaker 2: being on Twerks today.
• 30:42
  Speaker 5: Thanks for having me. Always fun.
• 30:46
  Speaker 1: You're listening to This Week in Pharmacy on the Pharmacy
• 30:49
  Speaker 1: Podcast Network.
• 30:57
  Speaker 2: Hey, before we wrap up today, I do want to
• 31:00
  Speaker 2: mention an article out on MedicaLife. If you don't read MedicaLife,
• 31:08
  Speaker 2: you're missing out on a really interesting online magazine, online
• 31:17
  Speaker 2: blog source. You can find this at medica.life. Medica is
• 31:23
  Speaker 2: spelled M-E-D-I-K-A dot life. And the article title is Rethinking
• 31:32
  Speaker 2: Vaccine Costs, How the More Expensive Vaccine Can Actually Save
• 31:38
  Speaker 2: Health Systems Millions. On This Week in Pharmacy, October 7th, 2026,
• 31:44
  Speaker 2: this was published. And this is an exclusive article authored
• 31:49
  Speaker 2: by Ingenocchio Oliveria. And this dives into a new published
• 32:00
  Speaker 2: cost minimization analysis from Argentina, which offers one of the
• 32:05
  Speaker 2: clearest economic assessments to date on how immunization budgets should
• 32:12
  Speaker 2: be evaluated. This is very interesting reading. We will be
• 32:17
  Speaker 2: doing a follow-up interview on this subject soon. but I
• 32:22
  Speaker 2: want to bring that to your attention on this week
• 32:25
  Speaker 2: in pharmacy, just as another, um, piece of news that
• 32:29
  Speaker 2: you may not have known about. Um, and, uh, we're,
• 32:35
  Speaker 2: we're hoping that you guys have a fabulous weekend. We are, um,
• 32:41
  Speaker 2: headed to the next dose summit by, uh, by, uh, Dr.
• 32:47
  Speaker 2: Jordan Smith, um, and she is an outstanding entrepreneur to
• 32:53
  Speaker 2: put this conference together, the Next Dose Summit. We will
• 32:58
  Speaker 2: be there. I will be there covering the event. We're
• 33:02
  Speaker 2: so excited to be part of it. We'll be leading
• 33:04
  Speaker 2: a panel discussion with some of the most innovative pharmacists
• 33:09
  Speaker 2: and people in pharmacy in our profession. Go to Google
• 33:14
  Speaker 2: right now and type in the next... dose summit and
• 33:23
  Speaker 2: it's in covington covington and it pulls right up the
• 33:29
  Speaker 2: 2026 the next dose summit registration will appear and um
• 33:38
  Speaker 2: i want you to register i want you to think
• 33:42
  Speaker 2: about going and if you want more information on this
• 33:45
  Speaker 2: you are welcome to reach out to me I'm easily found.
• 33:51
  Speaker 2: Type in, go to LinkedIn, type in Todd Ury, E-U-R-Y.
• 33:55
  Speaker 2: Ask me questions about the event or even ask Jordan
• 34:00
  Speaker 2: about this event. This is going to be an exciting time.
• 34:07
  Speaker 2: I think that we are in a major shift in
• 34:13
  Speaker 2: pharmacy and in leadership. and people that really want to
• 34:20
  Speaker 2: seek new perspectives on our industry. Pharmacy students are welcome
• 34:25
  Speaker 2: to come. We encourage you to come. Pharmacy technicians exploring entrepreneurship,
• 34:31
  Speaker 2: exploring how pharmacy is going through a massive transformation, and
• 34:39
  Speaker 2: networking together with people like Melinda Fowler, Melody Hartzell, Dr.
• 34:46
  Speaker 2: Jill White, Dr. Tim Ulbrich, entrepreneur and pharmacy student, Saki Patel,
• 34:55
  Speaker 2: Lisa Fast, the pharmacy badass, Delon Canterbury, the godfather of deprescribing,
• 35:05
  Speaker 2: Samantha Wright, the one and only Jesse McCullough, who's been
• 35:11
  Speaker 2: doing an amazing job, Janan Sarwar, Dr. Sarwar, Jay Phillips,
• 35:18
  Speaker 2: known as the Pharmacist Gladiator, Pharmacy Gladiator, Lola Alatude, as
• 35:27
  Speaker 2: well as Nima Atai, Dr. Natalie Park from TJM Labs,
• 35:36
  Speaker 2: which will be really interesting to listen to her, Jay Kuntz, Dr.
• 35:42
  Speaker 2: Liz Fredrickson, Nicole Wallace, and Dr. Jackie Boyle. It's going
• 35:51
  Speaker 2: to be a packed lineup. You're not going to want
• 35:53
  Speaker 2: to miss it. Each of these people bring insights in
• 35:57
  Speaker 2: what it took to build their entrepreneurial business and their pathway.
• 36:03
  Speaker 2: Once again, this is the Next Dose Summit, and I'm
• 36:09
  Speaker 2: so proud and so excited to be part of this.
• 36:13
  Speaker 2: October 14th, 15th, in Covington, Kentucky. Like I said, reach
• 36:18
  Speaker 2: out to me. We are excited to be a part
• 36:22
  Speaker 2: of it. We are excited that you have been reaching
• 36:27
  Speaker 2: out and have been listening to Twerks. We have an
• 36:30
  Speaker 2: increase in listeners. Thank you so much for listening. Share
• 36:33
  Speaker 2: Twerks with a fellow pharmacist, a pharmacy technician, someone that
• 36:37
  Speaker 2: you want to tag in and understand what's happening in
• 36:41
  Speaker 2: our profession. And I hope you guys have a great
• 36:45
  Speaker 2: and tremendous week. We're out.