INSIGHTS ON CELL & GENE COMMERCIALIZATION ISSUES

  • Regulatory Consideration For Biotech Startups

    With the move into clinical studies, emerging biopharmas turn the page to an exciting new chapter in their stories. This is a time of dramatic change, due in no small part to a rapid ramp-up in face time with regulatory agencies and the expectation of data transparency that ensues. Fortunately, the whirlwind of simultaneous activity that biopharma leaders might be seeing for the first time isn’t entirely uncharted territory. We caught up with several startup veterans for insight and inspiration on navigating clinical-stage regulatory considerations.

  • Avoiding The Potholes Along The Pathway To Commercial Cell Therapies Panel Video

    Invetech hosted a panel discussion during the recent International Society Cell & Gene Therapy (ISCT) conference in Melbourne, Australia to explore the main challenges along the pathway from process development to commercial cell therapies. The panel, chaired by Invetech's Jon Ellis, Manager, Cell Therapy, and comprising of Dr. Dawn Driscoll (Cell Therapies Pty Ltd), Dr. Joanne Kurtzberg (Duke University) and Dr. Wen Bo Wang (Fate Therapeutics), explored the main challenges along the pathway from process development to commercial cell therapies.

  • Avoiding The Potholes Along The Pathway To Commercial Cell Therapies

    Invetech hosted a panel discussion during the recent International Society Cell & Gene Therapy (ISCT) conference in Melbourne, Australia to explore the main challenges along the pathway from process development to commercial cell therapies. Read about the panels insightful discussion on the role that considered automation plays in navigating three of the biggest potholes in commercial cell therapies.

  • Got Approval… Now What? Meeting Cell Therapy Market Demand

    The commercial success of a cell-based therapeutic depends on a scalable, automated manufacturing process. But how can companies ensure their manufacturing processes are up to meeting the needs and market demand of the rapidly evolving cell therapy field? This blog highlights the insights from industry experts on the subject at a recent breakfast briefing at Phacilitate 2020.

  • Meeting Cell Therapy Market Demand

    The commercial success of a cell-based therapeutic depends on a scalable, automated manufacturing process. But how can companies ensure their manufacturing processes are up to meeting the needs and market demand of the rapidly evolving cell therapy field? Our annual breakfast briefing at the Phacilitate Leaders World conference 2020 in Miami tackled this and other current topics.

  • Navigate The CMC Regulatory Landscape For Cell And Gene Therapies

    The curing potential of cell and gene therapies is driving the industry to gain a better understanding of the evolving regulatory guidelines for these products, in order to bring them to market faster.

  • How Data Collaboration Is Helping Novavax Accelerate Vaccine Production

    How and why this late-stage biotech implemented a data collaboration platform, Driven by its COVID-19 vaccine development and manufacturing data management complexities.

  • Navigating The Road To Gene Therapy Commercialization

    With increases in development and investments in the gene therapy field, companies will increasingly be looking at manufacturing and commercialization of their therapies. Road to commercialization goes through a series of process validation phases. In this webinar, we take a closer look at the road to commercialization and focus on addressing primary questions.

  • Overcoming Commercialization Challenges For Cell & Gene Therapies

    The early promise offered by cell therapies and gene therapies is tempered by the challenges associated with developing, manufacturing, and delivering the drug product to patients. This panel discussion highlights technical and regulatory hurdles associated with development and manufacturing steps, and strategies and solutions to facilitate development through commercialization.

  • Reducing Cost Of Goods For Gene Therapy

    Frost & Sullivan's Virtual Think Tank brought together leading minds to discuss key challenges and other insights related to reducing the cost of goods (COGs) for gene therapy.