Episodes

  • Return of Pipeline 2026 – Cell and Gene Therapies

    Return of Pipeline 2026 – Cell and Gene Therapies
    Dec 9 2025
    In Part 2 of the 2026 pipeline series, host Carolyn Liptak welcomes Dr. Amanda Frick, Senior Clinical Manager, Strategic Clinical Intelligence at Vizient, to explore the advanced therapies pipeline: cell therapies, gene therapies, tissue-engineered products, and combination advanced therapy products. The discussion explores major pipeline trends, six leading products to watch, and the growing innovation expected to shape clinical practice in 2026. Guest speakers: Amanda Frick, PharmD, BCPS Senior Clinical Manager Strategic Clinical Intelligence Spend Management Vizient Host:  Carolyn Liptak, MBA, BS Pharm Pharmacy Executive Director Center for Pharmacy Practice Excellence (CPPE) Vizient Show Notes: 00:05 — Introduction Announcer opens the episode.Host Carolyn Liptak introduces the focus on advanced therapies: cell & gene therapies, tissue-engineered products, and combination products.Guest: Dr. Amanda Frick, Senior Clinical Manager, Strategic Clinical Intelligence at Vizient. 01:07 — Defining Advanced Therapies FDA groups cell and gene therapies within advanced therapies.Total FDA-approved advanced therapies: 46.Amanda monitors 29 drug-like therapies within that group. 02:01 — Pipeline Size and Approval Activity S. pipeline: 264 agents in development.About 10 agents approach FDA decision annually.Actual approvals: 5–7 per year on average. 02:56 — Big-Picture Trends in Cell & Gene Therapy Oncology dominates 40–50% of all CGTs in development.Expanding into autoimmune, neurology, and earlier-phase therapies for diabetes, angina, osteoarthritis. Movement toward allogeneic ("off-the-shelf") therapies Designed to overcome limits of autologous cell manufacturing.Reduces wait time and manufacturing failures. Resurgence of therapeutic vaccines Currently 3 approved (Sipuleucel-T, Talimogene, Papzimeos).20+ vaccines in the pipeline, largely targeted to cancer.CE program coming Jan 29. 06:13 — Therapy #1: Tabelecleucel or Tab-cel (Allogeneic EBV-Specific T-Cell Therapy) First allogeneic T-cell therapy expected in the U.S.For EBV-positive post-transplant lymphoproliferative disorder (PTLD).“Off-the-shelf” and donor-derived. 07:07 — Clinical Need & Outcomes Currentstandard of care: rituximab.After relapse, survival <1 month (HSCT) or <4 months (solid organ).Phase 3 data: 90% one-year survival. Regulatory Status Prior FDA CRL due to manufacturing (third-party issues).Expected approval: January 10, 2026. 09:00 — Therapy #2: Kresladi (Autologous Gene Therapy for LAD-I) Treats severe leukocyte adhesion deficiency (LAD-I), typically diagnosed in infancy.Could eliminate need for stem cell transplant (often limited by lack of matched donors). 11:39 — Clinical Outcomes Phase 1/2 data (n=9): 100% survival at one yearMajor reduction in hospitalizationsDiscontinuation of prophylactic antibiotics Regulatory Status Multiple delays due to CMC (chemistry, manufacturing, controls) questions.Resubmitted Oct 2025; anticipated approval March 28, 2026. 13:27 — Therapy #3: ORCA-T (Enhanced Allogeneic Stem Cell Transplant) Allogeneic hematopoietic stem cells + regulatory and conventional T cells (Tregs + Tcons).Designed to improve: Graft-versus-tumor effectGraft-versus-infection protectionReduction in graft-versus-host disease (GVHD) 14:31 — Clinical Significance Could markedly improve quality of life after transplant. Regulatory Status Anticipated approval: April 6, 2026. 15:01 — Therapy #4: Vusolimogene oderparepvec (RP1) (RP1 — Oncolytic HSV-1 Virus) Off-the-shelf genetically modified HSV-1 oncolytic virus.For advanced melanoma after prior PD-1 inhibitor therapy. 16:17 — Why It Matters Currently, poised to compete with Amtagvi (TIL therapy).TIL therapy is autologous and slow to manufacture; RP1 is ready-to-use and combines with nivolumab (Opdivo). Regulatory Status PDUFA: April 10, 2026. 16:34 — Therapy #5: INO-3107 (Therapeutic Vaccine for RRP) Targets HPV 6 and 11, which cause recurrent respiratory papillomatosis (RRP).Patients can require several surgeries per year to remove papillomas. 17:34 — Vaccine Mechanism DNA plasmid (vs viral vector in PAP).Lower insertional oncogenesis risk.Potentially improved durability of response. Regulatory Status Manufacturer aims to finish BLA by end of 2025.Expected approval (with priority review): mid–late 2026. 19:17 — Therapy #6: Clemidsogene lanparvovec (Intracerebral Gene Therapy for Hunter Syndrome) One-time treatment for MPS II (Hunter syndrome).Designed to deliver therapy directly into the brain to address neurological progression. 21:21 — Competing Agent Emerging New enzyme therapy tivedenofusp alfa crosses the blood-brain barrier — unlike current ERT (idursulfase).Expected approval: April 5, 2026.Raises payer & clinical sequencing questions: One-time gene therapy vs repeat annual enzyme therapyDurability vs cost (ERT ~$500K/year) Regulatory Status Clemidsogene lanparvovec anticipated approval: February 8, 2026. 22:45 ...
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    24 mins
  • Pipeline 2026: The Movers, the Shapers, & What Matters

    Pipeline 2026: The Movers, the Shapers, & What Matters
    Nov 25 2025
    If you're wondering which therapies may influence care delivery, budgets, and decision making in 2026, the pipeline offers an early preview and it points to a year defined by innovation. We're seeing new first in class treatments, thoughtful next generation agents, and a biosimilar market where fewer launches are offset by important competitive shifts driven by recent approvals. John Schoen and Heather Pace from the Center for Pharmacy Practice Excellence join Stacy Lauderdale, Associate Vice President of Evidence-Based Medicine and Drug Information and your Verified RX program host to highlight pipeline agents worth watching and discuss what they may mean for care delivery and spend management in the year ahead. Guest speakers: John Schoen, PharmD, BCPS  Senior Clinical Manager of Drug Information   Vizient Center for Pharmacy Practice Excellence  Heather Pace, PharmD Senior Clinical Manager of Drug Information   Vizient Center for Pharmacy Practice Excellence  Host:  Stacy Lauderdale, PharmD, BCPS  Associate Vice President Vizient Center for Pharmacy Practice Excellence Show Notes: 01:01 — Episode Scope The focus is non-CGT therapies; CGT pipeline will be covered in Part 2. 01:50 — Therapeutic Areas With the Most Approvals Oncology leads the pipeline.Others include infectious disease, neurology, rare disease, endocrine, hepatology, dermatology, and rheumatology. 02:37 — Biosimilars in 2026: Momentum or Headwinds? Discussion of potential “biosimilar void”—only 10% of expiring biologic patents have biosimilars in development.Emerging role of PBM private-label biosimilars. 03:51 — FDA Draft Guidance on Interchangeability FDA exploring interchangeable designation for all biosimilars.Potential shift away from clinical efficacy studies in favor of analytical comparisons.Guidance still in draft and open for public comment. 05:34 — John’s Top Picks for First-in-Class Agents 06:11 — Orviglance First manganese-based, oral MRI contrast agent.Advantages for patients with kidney impairment.Used for liver imaging. 06:20 — Why Non-Gadolinium Matters Lower risk of nephrogenic systemic fibrosis. 06:46 — Tabelecleucel First allogeneic EBV-specific T-cell therapy.For EBV-positive PTLD post-transplant.Could become new standard of care. 07:42 — Tanruprubart First therapy specifically for severe Guillain-Barré Syndrome (GBS). Shows improved outcomes over IVIG and plasma exchange. 08:20 — Comparing to Standard of Care Review of improved real-world data outcomes. 09:03 — Therapies That May Shift Care Delivery 09:32 — Icotrokinra: First oral IL-23 antagonist for plaque psoriasis. 10:00 — Insulin Icodec First once-weekly basal insulin for type 2 diabetes.Resubmitted after safety concerns in type 1 diabetes. 10:59 — Honorable Mentions Camizestrant SERD for ER+/HER2– metastatic breast cancer. Ensitrelvir (COVID-19) Oral option for pre-exposure prophylaxis.Also being evaluated for treatment. Doravirine + Islatravir (HIV) Introduces new NRTTI class. Cefepime + Zidebactam Active against metallo-β-lactamase–producing organisms. 14:05 — Key Biosimilar Launches Omalizumab (Xolair) First biosimilars in asthma/allergy space. Aflibercept (Eylea) High competition expected pending litigation. Pertuzumab (Perjeta) First biosimilar anticipated in oncology. 15:31 — Biosimilars Approved in 2025, Impacting 2026 Ustekinumab (Stelara): first full year of competitionDenosumab (Prolia/Xgeva): 10–15 biosimilars expectedEculizumab (Soliris): notable for rare disease market entry 17:17 — John’s Closing Thoughts Strong mix of first-in-class advances and next-gen convenience therapies. 17:36 — Heather’s Closing Thoughts 2026 will focus on speed and scale after the 2025 biosimilar wave.Pharmacists pivotal in ensuring smooth patient transitions. VerifiedRx Listener Feedback Survey: We would love to hear from you - Please click here Subscribe Today! Apple Podcasts Spotify YouTube RSS Feed
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    19 mins
  • Beyond the Formulary: Evolving Enterprise P&T Committees

    Beyond the Formulary: Evolving Enterprise P&T Committees
    Nov 11 2025

    Pharmacy and Therapeutics (P&T) committees historically operated at the individual hospital level but have evolved into enterprise-wide governance programs due to health system expansion, unprecedented clinical and financial complexity of care, and the emergence of high impact and novel therapeutics.

    To address this, the Vizient Center for Pharmacy Practice Excellence convened an expert panel that concluded health system enterprise P&T committees are uniquely positioned to balance clinical value with financial stewardship and minimize practice variation. They issued best practice considerations representing a dynamic framework designed to evolve alongside emerging therapies, evolving technologies, and the ongoing transformation of health systems.

    Joining us today are two members of the expert panel. We have Conor Hanrahan, AVP, enterprise pharmacy services, medication outcomes and stewardship with Intermountain Health and Prabashni Reddy, who at the time of the panel was the executive director of medication use and policy at Mass General Brigham.

    Guest speakers:

    Prabashni Reddy, RPh, PharmD, MMedSc (former) Executive Director of Medication Use and Policy

    Mass General Brigham

    Conor Hanrahan, PharmD, MHA, MS, BCPS, CPHQ AVP, Medication Policy, Outcomes, and Stewardship

    Intermountain Health, Enterprise Pharmacy Services

    Host:

    Kerry Schwarz, PharmD, MPH 

    Senior Clinical Manager, Evidence-Based Medicine and Outcomes

    Center for Pharmacy Practice Excellence (CPPE)

    Show Notes:

    [01:02-03:38] The value Prabashni and Conor saw in joining the expert panel

    [03:39-05:33] What Prabashni and Conor learned from interactions during the expert panel

    [05:34-10:55] Intriguing actionable enterprise P&T program insights panelists brought to the table that listeners can use

    [10:56-14:01] Use of criteria and principles to create successful and broadly applicable best practices

    [14:56-16:00] How our listeners can put this panel's best practices into action

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    17 mins
  • Challenges with AI in Pharmacy

    Challenges with AI in Pharmacy
    Oct 28 2025

    Artificial intelligence, or, AI is on everyone's minds, and we're all still figuring out how to trust it, teach it, and use it responsibly. Today we take a deep dive into how AI is affecting the education of current and future pharmacy students. With us is Jennifer Trujillo, associate Dean for education and professor in the Department of Clinical Pharmacy at the Skaggs School of Pharmacy and Pharmaceutical Sciences on the University of Colorado Anschutz Medical Campus in Aurora, Colorado, and Logan Tinsen, the clinical pharmacy manager and residency program director at Benefis Hospital in Great Falls, Montana.

    Guest speakers:

    Jennifer Trujillo, PharmD, BCPS, CDCES, BC-ADM Associate Dean for Education

    Professor, Department of Clinical Pharmacy

    Skaggs School of Pharmacy and Pharmaceutical Sciences

    University of Colorado Anschutz Medical Campus

    Logan Tinsen, PharmD, FMPA Clinical Pharmacy Manager and Residency Program Director Benefits Hospitals

    Host: 

    Kerry Schwarz, PharmD, MPH 

    Senior Clinical Manager, Evidence-Based Medicine and Outcomes

    Center for Pharmacy Practice Excellence (CPPE)

    Show Notes:

    [01:02-03:45] Challenges with AI in pharmacy education

    [03:46-05:59] The AI adoption spectrum: Pitfalls of extremes between full and limited adoption

    [06:00-11:18] Approaches to pharmacy education in the early stages of AI

    [11:19-14:55] Guardrails and safeguards

    [14:56-16:29] Key takeaways about AI right now for pharmacy educators

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    17 mins
  • Inside the Clean Room - Safely Handling Cell & Gene Therapies

    Inside the Clean Room - Safely Handling Cell & Gene Therapies
    Oct 14 2025
    From CAR-T therapies to viral vectors, cell and gene treatments are redefining the boundaries of pharmacy practice—but with innovation comes complexity. Host Carolyn Liptak welcomes Dr. Mark Wiencek, Principal Microbiologist with the Technical Services Group at Contec, and Dr. Amanda Frick, Senior Clinical Manager of Market Intelligence at Vizient, to break down the challenges of compounding these advanced therapies. Listen in as they discuss real-world risk assessments, biosafety considerations, and how hospital pharmacies can safely manage these groundbreaking yet high-risk treatments. Guest speakers: Mark Wiencek, PhD Principal Microbiologist, Technical Services Group Contec Amanda Frick, PharmD, BCPS Senior Clinical Manager, Market Intelligence Vizient Host: Carolyn Liptak, MBA, RPh Pharmacy Executive Director Vizient Show Notes: [01:02-01:51] Mark shares his background and experience in microbiology [01:52-04:04] Overview of the types of cell and gene therapies (CGT) currently used in clinical practice [04:05-05:14] Which CGT therapies are most applicable to pharmacy compounding and why [05:15-10:29] Things not on the NIOSH list and the risks [10:30-12:03] Evaluating whether viral vectors can penetrate intact skin and the true occupational exposure risks [12:04-13:18] If hazards are not defined by the NIOSH list, how should these CGT hazards be classified [13:19-15:03] Determining the safest environment for compounding CGT therapies [15:04-20:14] Best practices for decontamination, disinfection, and viral vector handling [20:15-20:59] Do you need a dedicated biosafety cabinet for CGT therapies [21:00-22:55] Recommended resources for further learning Links | Resources: Blind and colleagues (Nationwide): Click hereWang and colleagues (Stanford): Click hereCONTEC HEALTHCARE WEBINAR Using Bugs as Drugs: Compounding Viral Vectors in Cell & Gene Therapy for Hospital Pharmacies, Mark Wiencek, May 13, 2025: Click hereBlind, J.E., Ghosh, S., Niese, T.D., Gardner, J.C., Stack-Simone, S., Dean, A. and Washam, M., 2024. A comprehensive literature scoping review of infection prevention and control methods for viral-mediated gene therapies. Antimicrobial Stewardship & Healthcare Epidemiology, 4(1), p.e15. Click hereDeramoudt, L., Pinturaud, M., Bouquet, P., Goffard, A., Simon, N. and Odou, P., 2024. Method for the detection and quantification of viral contamination during the preparation of gene therapy drugs in a hospital pharmacy. Occupational and Environmental Medicine, 81(12), pp.615-621. Click hereKorte, J., Mienert, J., Hennigs, J.K. and Körbelin, J., 2021. Inactivation of adeno-associated viral vectors by oxidant-based disinfectants. Human Gene Therapy, 32(13-14), pp.771-781. Click here (abstract only; full article available for purchase)Martino, J.G., McConnell, K., Greathouse, L., Rosario, B.D. and Jaskowiak, J.M., 2024. Cellular therapy site-preparedness: Inpatient pharmacy implementation at a large academic medical center. Journal of Oncology Pharmacy Practice, 30(8), pp.1442-1449. Click herePenzien, C., 2023. Safe handling of BioSafety drugs and live virus vaccines. Pharm Purch Prod, 20(4), p.12. Click herePetrich, J., Marchese, D., Jenkins, C., Storey, M. and Blind, J., 2020. Gene replacement therapy: a primer for the health-system pharmacist. Journal of Pharmacy Practice, 33(6), pp.846-855. Click hereWang, A., Ngo, Z., Yu, S.J. and MacDonald, E.A., 2025. Implementing standard practices in the safe handling of gene therapy and biohazardous drugs in a health-system setting. American Journal of Health-System Pharmacy, p.zxaf026. Click here VerifiedRx Listener Feedback Survey: We would love to hear from you - Please click here Subscribe Today! Apple Podcasts Spotify YouTube RSS Feed
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    24 mins
  • Tapping into NTAP

    Tapping into NTAP
    Sep 30 2025

    New data from the summer Vizient Spend Management Outlook show that in the inpatient space, high-cost drugs, especially CAR-T treatments like Yescarta and Breyanzi are major drivers of drug spend. To help offset these costs, certain therapies may qualify for additional reimbursement through the New Technology Add-On payment (NTAP), a program that supports innovations that substantially improve care for Medicare beneficiaries. Carolyn Liptak, Pharmacy Executive Director at the Vizient Center for Pharmacy Practice Excellence joins host Stacy Lauderdale, Associate Vice President of Evidence-Based Medicine and Drug Information at Vizient to cover the purpose of this add-on payment, the criteria necessary for drugs to qualify and strategies to capture its full value.

    Guest Speaker:

    Carolyn Liptak, MBA, RPh Pharmacy Executive Director Vizient Center for Pharmacy Practice Excellence

    Host: Stacy Lauderdale, PharmD, BCP  Associate Vice President Vizient Center for Pharmacy Practice Excellence  Verified Rx Host

    Show Notes:

    [01:02-03:38] Overview of NTAP and why CMS created the program

    [03:39-05:02] How DRG recalibration depends on broad adoption

    [05:03-07:17] Criteria for medications to quality for NTAP status

    [07:18-08:24] Who determines whether a therapy represents substantial clinical improvement

    [08:25-10:05] The value NTAP provides to hospitals

    [10:06-11:51] How to locate products that are eligible for NTAP

    [11:52-16:22] Best practices to ensure that NTAP payment is captured when the drug is used

    [16:23-17:22] Resources for additional information

    Links | Resources:

    • Payment Updates: Preparing for 2026 - On Demand
    • New Medical Services and New Technologies
    • FY 2026 IPPS Final Rule Home Page
    • MAC Implementation File 8 (ZIP) – FY 2026 New Technology Add-on Payment
    • CMS Web Pricer

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    18 mins
  • GLN Changes You Can’t Ignore

    GLN Changes You Can’t Ignore
    Sep 16 2025

    As the Drug Supply Chain Security Act dispenser exemption period winds down, the Vizient Standards implementation team announced an important change to the Vizient Global Location Number (GLN) Management program. The data standards team will inactivate unmanaged GLNs, which will impact pharmacies and other providers who are not currently managing their Vizient assigned GLNs. Two experts leading that conversation, Carl Henshaw, Senior Director, Data Operations, Enterprise Information and Data Management, and Dawn Burtram, Lead Analyst, Standards Implementation at Vizient join host Carolyn Liptak, Pharmacy Executive Director in the Center for Pharmacy Practice Excellence at Vizient to discuss implications.

    Guest speakers:

    Dawn Bertram, MBA

    Lead Analyst Standards Implementation

    Vizient

    Carl Henshaw

    Senior Director, Data Operations, Enterprise Information and Data Management

    Vizient

    Host: 

    Carolyn Liptak, MBA, BS Pharm

    Show Notes:

    [01:08-01:59] Dawn and Carl’s background

    [02:00-02:41] What exactly is a GLN and what does it mean to be self-managed

    [02:42-07:26] Who creates and maintains GLNs in this data hub and the three different GLN products

    [07:27-08:51] How to determine who actually enumerated the GLNs

    [08:52-10:20] Educating and preparing providers for the DSCSA compliance deadline

    [10:21-12:37] The recent decision to inactivate unmanaged GNS and why it's essential to maintaining the accuracy and reliability of GLN data

    [12:38-15:05] What it means to participate in our program and who's eligible to participate

    [15:06-17:51] Why the deadline of November 15th matters

    Links | Resources:

    Vizient GLN Learning Center

    GLN Management Process Education Session (E-Learning)

    VGMP Application

    GS1 What is a GLN and How Do I Get One? 

    Drug Supply Chain Security Act

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    18 mins
  • Inside the New Joint Commission Manual

    Inside the New Joint Commission Manual
    Aug 26 2025

    The Joint Commission’s updated accreditation manual is designed to simplify requirements, enhance clarity, and better support healthcare organizations in survey preparation. In this episode of VerifiedRx, host Carolyn Liptak is joined by Dr. Robert Campbell of the Joint Commission and Diana Scott of Vizient to unpack the most significant changes. From the shift to National Performance Goals and medication safety priorities to the latest challenges in compounding, labeling, and hazardous drug handling, the conversation highlights practical insights to help pharmacy leaders stay compliant and survey-ready.

    Guest speakers:

    Robert Campbell, PharmD, BCSCP

    Sr. Director, Standards Interpretation, Accreditation Decision Management,Medication Safety Division of Accreditation and Certification Operations

    Joint Commission

    Diana Scott, MHA, RN, CPHQ

    Principal, Regulatory and Accreditation Services

    Vizient

    Host:

    Carolyn Liptak, , BS Pharm, MBA 

    Vizient

    Show Notes:

    [01:16-01:51] Diana and Robert Backgrounds

    [01:52-02:43] Changes made to the hospital and critical access hospital manuals

    [02:44-03:09] Changes to the chapters themselves

    [03:10-04:08] National Performance Goals and elaborate on those that are relevant to medication safety and pharmacy services

    [04:09-05:15] The top medication management challenges

    [05:16-06:29] Pain management not being aligned and titration orders

    [06:30-06:56] Insufficient communication between pharmacists, prescribers and nurses when it comes to medication orders

    [06:57-08:02] Themes around labeling requirements for stored medications

    [08:03-08:46] Anything different in removing expired meds from patient care areas and in the pharmacy this area than previous years

    [08:47-10:58] Issues related to storing meds specifically per the package insert

    [10:59-11:55] Common issues seen inside the pharmacy regarding sterile compounding, noncompliance include hand hygiene, garbing, PPE, and cleaning and disinfecting

    [11:56-13:12] More specifics in those area the physical environment and facility cleanliness along with cleaning and disinfection practices

    [13:13-14:55] Explaination of how joint Commission defines and evaluates immediate use compounding

    [14:56-16:09] The minimum required elements for immediate use compounding competency

    [16:10-17:12] Compounding competencies besides immediate use

    [17:13-17:54] Expectations for environmental services training

    [17:55- 20:14] Concerns around hazardous drugs

    [20:15- 21:14] Additional information

    Links | Resources:

    Joint Commission: THE NEW STANDARD: Accreditation 360

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    22 mins