…these studies face unique challenges due to their patient population and the complex regulatory considerations for these advanced therapies.
April 05, 2021
While treatment of Parkinson’s disease (PD) has traditionally been limited to dopamine replacement therapy to alleviate symptoms, gene therapy studies have recently evaluated both non-disease-modifying and disease-modifying transgenes for PD treatment, with encouraging results.
Non-disease-modifying therapies have improved symptomatology and disease-modifying strategies, including stopping PD-mediated cell death and/or regenerating lost neurons, and show potential in slowing disease progression. However, these studies face unique challenges due to their patient population and the complex regulatory considerations for these advanced therapies.
Conducting these trials requires careful attention to investigator and site selection and adherence to local regulatory and protocol design requirements. The need for long-term patient follow-up, potentially as long as 15 years, puts added demands on patients and sites.
Join expert speakers from Premier Research, Andreas Schreiner, M.D., Vice President, Medical Affairs Neuroscience and Analgesia; and Hanna Wide, M.S., Executive Director, Cell and Gene Therapy, in a live webinar on Wednesday, April 14, 2021 at 11am EDT (4pm BST/UK).
For more information, or to register for this event, visit Pursuing Parkinson’s Disease Gene Therapies: Strategies & Operational Requirements.
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