Quality Risk Management ICH Q9 – Revision published for public comments
iPSpine is a consortium including 20 partners across Europe, the United States of America, and China.
Mannheim, Germany – 19 March 2019: PharmaLex Group, one of the most experienced and most successful specialist providers of Development Consulting, Regulatory Affairs, Pharmacovigilance, Epidemiology & Risk Management, and Quality Management & Compliance worldwide, has been selected to support an international 15m EUR, 20-partner project called iPSpine.
iPSpine (Induced pluripotent stem cell-based therapy for spinal regeneration) will use state-of-the art technology to design a novel therapy to restore intervertebral disc function and provide full pain relief for patients with lower back pain. The treatment will use advanced stem cells and smart biomaterials that can be injected into the degenerated discs in the spine to help re-populate regions that have deteriorated, with the goal of returning spinal function.
PharmaLex will be providing their specialist ATMP (Advanced Therapy Medicinal Products) expertise. As the iPSpine product will be classified as an ‘ATMP’ or “combined ATMP”, PharmaLex’s involvement, led by Dr. Zaklina Buljovcic, will be to help investigate and provide regulatory advice to the iPSpine consortium, covering regulatory input to non-clinical trial design and models, manufacturing and characterization aspects, as well as biomaterial development. Working closely alongside PharmaLex are other leading industry experts. Dr. Annelien Bredenoord, Work Package Lead for the project from the University of Utrecht Medical Center in The Netherlands and Dr. Rosario Isasi from The University of Miami in the USA are key opinion leaders in ethics and policy affairs of translational research. Their role will be to oversee all ethics and regulatory affairs associated with the project.
“PharmaLex will be instrumental in enabling iPSpine to promote early interaction with regulatory authorities”, explained Dr Zaklina Buljovcic, Director, Principal Consultant Innovative Therapies, PharmaLex. “We will be advising iPSpine’s interdisciplinary team on the necessary pathways for future ATMP development and commercialization. It is a big advantage for iPSpine development to already closely interact, consult and co-operate with regulators at this early research phase, to reach a common understanding of the benefits and limitations of the new models and tools developed in this project”, she continued.
“To be part of such an important and potentially significant project is a great honor for PharmaLex” explained Dr. Thomas Dobmeyer, CEO PharmaLex. “We pride ourselves on providing specialist technical and hands-on regulatory consulting, by utilizing our international network. By being part of this consortium, we can help streamline the development of this novel iPSpine product using existing regulatory approach, methods and procedures (Scientific Advices and Classification) to guide the consortium through the regulatory field of ATMP during development up to non-clinical PoC”, he concluded.
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About PharmaLex <Confidence beyond compliance>:
PharmaLex is one of the largest providers for Development Consulting, Regulatory Affairs, Quality Management & Compliance and Pharmacovigilance worldwide. Our global teams of experts can take you through early strategic planning activities and nonclinical requirements to clinical development, through regulatory submission processes and finally guide you to market approval and product maintenance post-launch activities. We strive to deliver exceptional results — going above and beyond the standard to deliver tailor-made solutions. We aim to exceed your expectations and live by our values – flexibility, efficiency, passion & dedication.
The PharmaLex Group now has over 850 employees, with 31 offices in 17 countries and more than 600 satisfied clients worldwide.
About iPSpine:
The iPSpine consortium includes 20 partners across Europe, the United States of America, and China. Their expertise includes; Fundamental science (i.e. induced pluripotent stem cells, genome editing, pathobiology, regenerative medicine, intervertebral disc degeneration, bioreactor technology, MRI analysis); Therapeutic design (e.g. biomaterials, safety, clinically relevant animal models, biomechanics, GLP-like biodistribution studies, clinical orthopaedics); Final implementation (e.g. smart business management platforms, ethics, policy and regulatory affairs, stakeholder engagement & dissemination). IPSpine will use state-of-the art technology to design a novel therapy for LBP that will be closer to clinical translation after completion of the project in 2023. The treatment will use advanced stem cells and smart biomaterials that can be injected into the degenerated discs in the spine to help re-populate regions that have deteriorated, with the goal of returning spinal function.
About Horizon 2020:
Horizon 2020 is the biggest EU Research and Innovation program ever with nearly €80 billion of funding available over 7 years (2014 to 2020) – in addition to the private investment that this money will attract.
“This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No° 825925”
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