• Bridging The Public Knowledge Gap Around Cell And Gene Medicine
    Bridging The Public Knowledge Gap Around Cell And Gene Medicine

    Cell and gene therapies hold the potential to transform medicine; however, if patients are to gain access to these therapies, we must increase public awareness and understanding of how these therapies can benefit them. According to a review of recent research studies that measured U.S. public opinion related to gene medicine,1 the public is not yet aware of gene medicine; is unfamiliar with the terms being used to describe the topic; and, when faced with multiple therapeutic options, is worried about making informed decisions.

  • CAR-T And The Voice Of The Patient
    CAR-T And The Voice Of The Patient

    Cell & Gene Editorial Advisory Board member answers questions about his message to pharma executives, researchers, scientists, and doctors, what the industry should consider when developing new payment structures, and more.

  • Clinical Trial Networks: Overcoming The Complexities Of Regenerative Medicine Studies
    Clinical Trial Networks: Overcoming The Complexities Of Regenerative Medicine Studies

    The FDA’s RMAT and breakthrough designations have created a streamlined environment for product sponsors. To effectively leverage this regulatory policy environment, sponsors must conduct high-quality clinical trials that are often operationally complex. Clinical trial networks, capable of managing the array of regenerative medicine technologies, are well suited to manage this complexity.

Fibrocell: Where Gene Therapy Meets Synthetic Biology
Fibrocell: Where Gene Therapy Meets Synthetic Biology

“We had to decide whether to spend a lot of money to bring on a sales force and marketing team, and expand manufacturing to meet demand, or take our resources and refocus them on these rare disorders.”  

  • The FDA’s Dr. Peter Marks On The Current State Of Cell And Gene Therapies
    The FDA’s Dr. Peter Marks On The Current State Of Cell And Gene Therapies

    Peter Marks, MD, PhD, Director Center for Biologics Evaluation and Research at U.S. Food and Drug Administration answered some of my questions about the current state of the FDA’s regulations around cell and gene therapies, its stance on international harmonization required to make cell and gene therapies more streamlined, the reasons why it is critical for companies to begin working with the FDA early in the development process, and more. Read on for Dr. Marks' insightful responses.

  • New Approaches To Market Access And Reimbursement For Gene And Cell Therapies
    New Approaches To Market Access And Reimbursement For Gene And Cell Therapies

    Current reimbursement models in general do not accommodate many of the unique factors that are common among gene and cell therapies, including smaller patient populations, shorter treatment windows, potentially curative efficacy, high up-front costs, lack of long-term efficacy and safety data, and fees associated with complex administration, dosing, and patient monitoring requirements.

  • Is Genetic Testing Creating a Moral Dilemma For Clinical Researchers?
    Is Genetic Testing Creating a Moral Dilemma For Clinical Researchers?

    Clinical trials are complex, but adding genomics to the equation has the potential to make them even more complicated. However, much of the genetic testing that is now being performed in the clinical space is done before a trial begins. That means companies need to do some thinking before adding a genetic test to the protocol.

  • A Sit Down With ARM’s CEO, Janet Lambert
    A Sit Down With ARM’s CEO, Janet Lambert

    Janet Lambert, joined the Alliance for Regenerative Medicine (ARM) as CEO just over a year ago. And what a year it’s been. Recently, I had the opportunity to talk to Lambert about her first year as CEO, what ARM is doing in cell and gene therapies from clinical and commercialization points of view, as well as its areas of short-term focus. Here’s what she had to say.

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Cell & Gene Meeting on the Mesa October 3 - 5, 2018
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How FDA and MHRA Decide Which Drug Facilities to Inspect – and at What Frequency October 16 - 16, 2018
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2018 PDA Cell and Gene Therapy Conference October 23 - 24, 2018
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Stem Cell Research, Cell and Gene Therapy November 9 - 10, 2018
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Annual Cardiologists Meeting 2018 November 26 - 27, 2018
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Phacilitate Leaders World January 22 - 25, 2019
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Patients As Partners March 11 - 12, 2019
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Car-T Congress USA March 20 - 22, 2019
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American Society of Gene & Cell Therapy (AGCST) April 29, 2019 - May 2, 2019
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