Publication date: 29/10/2018
BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces that it has appointed Linda Lebon as Chief Regulatory Officer.
Linda Lebon is a strategic regulatory expert with more than 25 years of experience in regulatory affairs. During her career, she has provided regulatory support to companies in strategic global drug development for both clinical and non-clinical projects. Until recently, she was Vice President Regulatory Affairs at argenx, a clinical-stage biotechnology company focused on developing antibodies for autoimmune disease and cancer.
Linda has held positions in several large pharmaceutical companies as well as senior positions in regulatory CROs and advisory firms, including Quintiles and Voisin Life Sciences. As an independent consultant, she has also supported several notable fast-growing life sciences companies including Celyad, Mithra and iTeos Therapeutics, in their product developments in Europe, America and Japan. In these roles she has been closely involved with the transitional process between R&D activities and the regulatory stage of development.
Linda will play a critical role in defining the regulatory pathway for development and clinical programmes and will support the Company as it advances these programmes toward commercialisation.
Thomas Lienard, Chief Executive Officer of Bone Therapeutics, commented: “We are delighted to welcome Linda as our new Chief Regulatory Officer. She is a highly skilled expert in the regulatory field and her extensive experience with strategic drug development makes her an asset to the Executive Team. As our portfolio of therapeutics for orthopaedics and bone diseases moves through advanced clinical development and towards commercialisation, Linda’s understanding of the unique regulatory challenges will be extremely valuable, and her experience puts her in an excellent position to support our programmes through critical regulatory milestones.”
Linda Lebon said: “It is a pleasure to join Bone Therapeutics. The Company has a highly promising portfolio of cell therapy programmes for orthopaedics and bone diseases, which is moving towards catalytic points in clinical and regulatory development, making it an exciting time for me to be joining.”
Bone Therapeutics is a leading cell therapy company addressing high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy products in clinical development across a number of disease areas targeting markets with large unmet medical needs and limited innovation.
Bone Therapeutics’ technology is based on a unique, proprietary approach to bone regeneration, which turns undifferentiated stem cells into bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery.
The Company’s primary clinical focus is ALLOB, an allogeneic “off-the-shelf” cell therapy product derived from stem cells of healthy donors, which is in Phase II studies for the treatment of delayed-union fractures and spinal fusion. In addition, the Company also has an autologous bone cell therapy product, PREOB, obtained from patient’s own bone marrow and currently in Phase III development for osteonecrosis of the hip, and JTA-004, a viscosupplement in development for the treatment of knee osteoarthritis.
Bone Therapeutics’ cell therapy products are manufactured to the highest GMP standards and are protected by a rich IP estate covering nine patent families. Further information is available at: www.bonetherapeutics.com.