INSIGHTS ON CELL & GENE COMMERCIALIZATION ISSUES

• An Analysis Of The Gene Therapy Viral Vector Landscape

  Over the last five years, multiple gene therapies have been approved by regulatory agencies and a bolus of late-stage pipeline assets are approaching the market. However, as the first gene therapies began to post early wins, several challenges have emerged. This article discusses the landscape of the viral vector sector.

• Drive Commercial Success

  When patients are waiting for life-altering treatments, every milestone is critical, Precision applies demonstrated expertise from quantifying the burden of disease for narrow patients populations to demonstrating and communicating the economic and clinical value of cell and gene therapies, traversing the commercialization landscapes to improve or save patient lives.

• Beyond 2020: Looking Into The Crystal Ball For Gene Therapy

  Mirror mirror on the wall, what is the promise that Gene Therapy holds for all? The urgency, uniqueness, and uncertainty surrounding gene therapy manufacturing creates many challenges. Let us take a look into the crystal ball of gene therapy to address unanswered questions and plan for what’s next in 2021 and beyond.

• Jumpstart Cell & Gene Therapy Commercialization With SUT Learning

  Single use technologies are expected to play a big role in the commercialization of cell and gene therapies because of their cost, speed, and sterility benefits. 

• Medicare Braces For Expanded Use Of High-Cost CAR T-Cell Therapy

  The Centers for Medicare & Medicaid Services (CMS) established a new reimbursement rate for inpatient CAR T-cell delivery in 2021 designed to more closely reflect the true costs of care and address the financial losses experienced by many healthcare institutions. This article delves into details on this and also discusses another significant change for 2021.

• Cell & Gene Therapy Laboratory Services And Applications

  Our cell biologists and engineers work together to assure your therapy remains unchanged by the clinical and commercial manufacturing processes. Our integrated laboratory services and applications support this effort.

• Perspectives On Gene Therapy: Defining And Demonstrating Value To Payers

  Since August 2017, we have seen the approvals of the first chimeric antigen receptor (CAR) T-cell therapies and the first directly administered gene therapy. Though these novel treatments are offering new hope to patients with unmet medical needs, they come at a significant cost, raising important questions about how novel therapies should be evaluated and paid for. In this white paper, we explore the current landscape of gene therapy to highlight the challenges payers, health systems, and manufacturers face in bringing these innovative medicines to the patients who need them most.

• Ensuring Provider Education And Readiness For Using A Novel CAR T

  A client was launching a novel CAR T-cell therapy in rare hematologic malignancy and needed support to mount an effective launch by mapping the patient journey in this complex CAR T-cell therapy process, identifying the pain points for access to therapy and addressing the educational needs across stakeholders. We were able assist them with a successful launch by designing and implementing comprehensive site training and resources to ensure safe use and patient access.

• The Value Of Gene Therapy In Spinal Muscular Atrophy

  A client was developing a potentially curative gene therapy, they needed to translate the clinical benefit into economic terms to engage payers and health technology organizations. By working with the client to develop a cost-effectiveness and budget impact model for a gene therapy in SMA that overcame unique challenges of modeling an early childhood neuromuscular genetic disorder they were able to change the prevailing mindset on how SMA progression is characterized.

• Mining Stakeholder Insights On Access To Gene Therapies For Hemophilia

  The high cost of hemophilia treatment is a significant cost driver for many employers, despite relatively low disease prevalence. Our client sought to understand how a paradigm shift to a onetime gene therapy may impact employers. Learn how we were able to develop strategic recommendations on opportunities to engage employer groups, coalitions, and benefit consultants through gene therapy education and collaborative partnerships to promote buy-in of this stakeholder as new gene therapy comes to market.