The new era in Manufacturing of Gene Therapy


VIRALGEN and VIVEbiotech organize the I Symposium on Gene Therapy Manufacturing with international experts

  • San Sebastián will become the world center of gene therapy on October 21st, with the celebration of the I Symposium on Gene Therapy Manufacturing.
  • Gene therapy will help cure the most important diseases of this century.

VIRALGEN and VIVEbiotech, specialized companies in the production of viral vectors for gene therapy, have organized the First Symposium on Gene Therapy Manufacturing. The meeting will gather in San Sebastian on October 21st a select group of experts from the biopharmaceutical sector worldwide. Among others invites, worldwide experts will join us such as Dr. Jude Samulski —co-founder of AskBio and considered the founder of gene therapy—, as well as Joseph Lillegard —Professor of the Mayo Clinic in the USA, pediatric researcher in gene therapy—. The day will feature international experts in the field who will make presentations on strategic and technical aspects of gene therapy.

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Timothy J. Miller, Ph.D., joined Abeona as President and Chief Executive Officer in 2013 and transitioned to President and Chief Scientific Officer in April 2018, bringing 16 years of experience in scientific research, product development, regulatory and clinical operations, with a focus on transitioning novel biotherapeutics through pre-clinical phases and into Phase 1 and 2 human clinical trials. Dr. Miller served as President and CEO of Red5 Pharmaceuticals from 2013 to 2015 and was Vice President of Business Development at BioEnterprise Inc. in 2015. Prior to Red5 Pharmaceuticals, he served as Senior Director of Product Development at SironRX Therapeutics from 2010 to 2013. Dr. Miller also held various positions at several companies focusing on gene therapy and regenerative medicine from 1996 to 2010. He earned his Ph.D. in pharmacology with a focus on gene therapy and cystic fibrosis from Case Western University. Dr. Miller also holds a B.S. in biology and M.S. in molecular biology from John Carroll University in Cleveland.

Amit is renowned for his pioneering work on gene therapy for haemophilia B, and was first to show successful correction of bleeding diathesis in patients with severe haemophilia B.

Amit is the Director of the Katharine Dormandy Haemophilia Centre at the Royal Free Hospital, and a Senior NIHR Investigator. He is also Professor of Haematology at UCL. He graduated in Medicine from the University of Aberdeen in 1984. In 1997 he moved to St. Jude Children’s Research Hospital, Memphis, USA, to work with Dr Arthur Nienhuis on adeno-associated virus mediated gene transfer. Here he started his pioneering work on gene therapy for haemophilia B.

In 2001 he returned to University College London as a Senior Lecturer in Haematology and a Consultant to the National Blood Services in the UK. He was the first to show successful correction of bleeding diathesis in patients with severe haemophilia B, using a distinct gene transfer approach developed in collaboration with Dr's Davidoff and Nienhuis at St Jude Children’s Research Hospital.

CEO and founder of SIRION Biotech GmbH. 

  • General Management of SIRION Biotech GmbH, a company developing viral vector technology and offering vector development for clinical applications. Responsible for business development and research and development, financial and budget responsibility.
  • Management of external collaborations with academic and industry partners, establishment of strategic collaborations with academic and industry partners. Management and execution of R&D collaborations with large Pharma and US Biotech companies for therapeutic AAV vector development
  • Negotiation of licensing and collaboration contracts
  • Budget responsibility for >€ 3.5 million revenues.
  • Securing financing from venture, private and public investors. Communication with investors and presentation of the company at board meetings.
  • Managing research and development grants (EUROSTARS, BMBF (KMU Net-C), BMWI (ZIM), Bayerische Forschungsstiftung, European Union FP7 and H2020 programs).
  • Recruiting, managing, training and mentoring people.

Dr. Richard Turner is currently a Director and Principal Consultant at Clinical Network Services (UK).  A former Pharmaceutical and Scientific Assessor at the Medicines Control Agency (UK MHRA) Biologics and Biotechnology Division, Dr Turner has over 30 years’ working in the biopharmaceutical development space, with 24 years as a Regulatory Affairs professional. Dr Turner has held senior regulatory positions at a number of small and medium sized biopharmaceutical companies and consultancies including  director at Daiichi Sankyo Development, Head of International Regulatory Affairs at Lonza Biologics,  Direcetor of Regulatory Affairs at ERA Consulting, and Associate Director Regulatory Affairs at Elan.  Dr Turner obtained his PhD from University of East Anglia UK School of Biological Sciences studying microbial biochemistry, specifically the respiratory metalloproteins of bacteria.

Dave Backer has more than 20 years of experience in the cell and gene therapy industry.  He was the founder and President of Molecular Medicine BioServices, a contract manufacturing organization based in Carlsbad, CA.  The company was sold to Sigma Aldrich in 2007 and is now part of MilliporeSigma.  Dave expanded his focus from viral vector manufacturing into gene editing and cell therapy manufacturing while at MilliporeSigma as the head of Commercial Development for the Company’s Gene Editing and Novel Modalities business.  Dave’s work prior to moving into the cell and gene therapy field included stints in research, sales, and marketing with Abbott Labs and Boehringer Mannheim.

Dave has an MBA from the University of Chicago Booth School of Business and a BS in Cellular and Molecular Biology from the University of Michigan.  Dave has a special incentive to support cell and gene therapy as his daughter has Rett Syndrome, a rare neurologic disorder that affects primarily girls.

Dr. Samulski received his PhD in Medical Microbiology and Immunology from the University of Florida. Dr. Samulski’s graduate work (1978-82) demonstrated the first use of AAV as a viral vector and culminated in the first US patent involving non-AAV genes inserted into AAV. After completing post-doctoral training at Princeton, Dr. Samulski was hired to provide his expertise in AAV biology as a member of the scientific advisory board of Avigen, a new AAV research company. Later, in 1993, Dr. Samulski co-founded an AAV-based gene therapy company called Merlin. This research group was headed by Dr. Xiao and was the first group to demonstrate AAV-mediated long-term gene transduction in muscle (J. Virology, 1996). This finding precipitated a merger of Merlin with Somatix, Inc., which then merged in 1995 with Cell Genesys. In total, Dr. Samulski has worked with AAV for 40 years, and for 25 years, was director of the University of North Carolina Gene Therapy Center. Dr. Samulski was the scientific founder of Bamboo Therapeutics, Inc. and served as the Chief Scientific Officer and Executive Chairman of the company until its acquisition by Pfizer in 2016. Upon its acquisition, Dr. Samulski joined Pfizer, as VP Gene Therapy, to ensure the successful transition of Bamboo’s Duchenne Muscular Dystrophy therapeutic. Dr. Samulski is a former member of the Recombinant DNA Advisory Committee (RAC), a committee tasked with assisting the FDA with approving or disapproving gene therapy clinical trials in the United States. Dr. Samulski also frequently serves as a gene therapy consultant to the FDA. In 2008, Dr. Samulski was recognized by the American Society of Cell and Gene Therapy with the Inaugural Lifetime Achievement Award for his work. Dr. Samulski has been invited by Pope Francis to attend the Vatican as recognition for his work in the treatment of Canavans. Dr. Samulski has advanced into human clinical trials therapeutics for hemophilia, Duchenne Muscular Dystrophy, Giant Axonal Neuropathy, and heart failure. Dr. Samulski is the inventor of over 200 patents related to AAV technology.

With more than a decade in biotech business development across the contract testing and manufacturing industries. He has worked with AAV companies bringing therapies to the clinic and market since 2008 and remains as passionate and awestruck about the power of this technolgy as he was when he first had a chance to be a part of it. A native of Atlanta, Georgia,he holds a BSc in Applied Biology from Georgia Tech and calls Raleigh North Carolina home.

Orjana Terova is Senior Product Manager for Purification products within the Bioproduction Division at Thermo Fisher Scientific. Orjana has a M.S. in Chemistry from University of New Hampshire (in 2008). She also has over 11 years of industrial experience at Thermo Fisher Scientific. Her expertise includes a strong technical background in small molecule and bead chemistries, new product development and commercialization. In her current role Orjana is responsible for managing globally the POROS Chromatography product line, including life cycle product management, implementing programs to drive business growth strategy and support of the global sales organization.