Cell & Gene Therapy INSIGHTS

Clinical Trends April 2020

April 2020

  • Cell therapy’s role in defeating Covid-19

    Y Yanay
    Yaky Yanay
    Co-Chief Executive Officer & President at Pluristem Therapeutics Inc
    YAKY YANAY was appointed as President from February 2014 and as CEO from June 2019, after a period of being Co-CEO since March 2017. Mr Yanay served in variety of executive positions in Pluristem since 2006 including Chief Financial Officer, Chief Operating Officer and Executive Vice President. He is the former Co-Chairman and current board member of Israel Advanced Technology Industries (IATI), the largest umbrella organization representing Israel’s life science and high-tech industries. Mr Yanay has founded several activities and organizations over the years to promote and support the Israeli life science industry. Before joining Pluristem, he was the Chief Financial Officer of Elbit Vision Systems Ltd, a public, machine vision, high-tech company. Prior to that Mr Yanay served as manager at Ernst & Young Israel. He holds a bachelor’s degree with honors in business administration and accounting and is a Certified Public Accountant in Israel.
    18 May 2020
    Interview
  • Trends in cell and gene therapy clinical development for rare and ultra-rare diseases

    S Kili
    Sven Kili
    Principal at Sven Kili Consulting
    Sven Kili provides specialist strategic consulting services to innovative Regenerative Medicine companies. His clients include small and medium sized companies from company formation through to clinical development and commercialisation. He was previously the Head of Development for the Cell and Gene Therapy division of GSK Rare Diseases where he led teams developing ex-vivo Gene Therapies for a variety of rare genetic disorders including Strimvelis®, the first ex-vivo gene therapy to be approved for children with ADA-SCID; Wiskott – Aldrich syndrome (WAS); Metachromatic Leukodystrophy (MLD) and Beta-Thalassemia. Prior to this, he was Senior Director, Cell Therapy and Regenerative Medicine for Sanofi (Genzyme) Biosurgery where he led the clinical development, approval and commercialisation activities of the first combined ATMP approval in the EU for MACI®. His team also prepared and submitted Advanced Therapy regulatory filings for Australia and the US, including health technology assessments and he was responsible for late stage developments for Carticel® and Epicel® in the US. Before joining Genzyme, Sven led the cell therapy activities and oversaw all UK & Irish regulatory functions and was the QPPV for pharmacovigilance for the Geistlich Pharma. Sven trained as an Orthopaedic surgeon in the UK and South Africa and since leaving full-time clinical practise has developed expertise Cell and Gene Therapy in clinical development, regulatory compliance, value creation, risk management and product safety, product launches and post-marketing activities. He sits on the board of CCRM in Canada; Xintela – a Swedish Stem Cell company and is the chair of the CGTAC as part of the UK BIA and the VP of the Standards Co-ordinating Body for Regenerative Medicine. Additionally, he still maintains his clinical skills in the UK NHS and serves as an ATLS Instructor in his spare time.
    29 April 2020
    Commentary

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