VerifiedRx cover art

VerifiedRx

VerifiedRx

By: Vizient Center for Pharmacy Practice Excellence
Listen for free

About this listen

 Delivering short doses of insight for hospitals’ frontline pharmacy professionals, the Vizient pharmacy team brings together experts to verify best practices for navigating today’s pharmacy practice challenges and accelerating career growth. It’s a prescription for success, delivered by the Vizient Center for Pharmacy Practice Excellence.Copyright 2025 All rights reserved. Economics Hygiene & Healthy Living Management Management & Leadership Physical Illness & Disease Science
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 ...
    Show More Show Less
    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
    Show More Show Less
    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

    VerifiedRx Listener Feedback Survey:

    We would love to hear from you - Please click here

    Subscribe Today!

    Apple Podcasts

    Spotify

    YouTube

    RSS Feed
    Show More Show Less
    17 mins
No reviews yet
In the spirit of reconciliation, Audible acknowledges the Traditional Custodians of country throughout Australia and their connections to land, sea and community. We pay our respect to their elders past and present and extend that respect to all Aboriginal and Torres Strait Islander peoples today.