- Brings over 20 years of clinical experience including management of phase 1-2 clinical trials in various indications such as ophthalmology.
- Oversee all R&D operations with emphasis on clinical development and operations
Kensington, MD, USA – EQS Newswire – October 25, 2023 – Galimedix Therapeutics, Inc. (“Galimedix”), a Phase 2 clinical-stage biotechnology company developing novel oral and topical neuroprotective therapies with the potential to revolutionize the treatment of serious eye and eye conditions. brain diseases, today announced the appointment of Luciana Summo, PhD, as Vice President of R&D Operations. In this newly created position, she will oversee all activities related to R&D operations, with a focus on clinical development and operations. This includes leading the design, planning and execution of clinical trials. Dr. Summo reports to Hermann Russ, MD, PhD, co-founder and chief scientific officer.
“We are delighted to welcome Luciana to Galimedix,” said
Alexander Gebauer, MD, PhD, co-founder and executive chairman. “She brings strong experience in setting up and running clinical trials and ensuring that all appropriate support structures are in place. As we advance our lead product candidate, GAL-101, into Phase 2 trials for the treatment of age-related macular dryness. degeneration, his skills are ideally suited to this next stage of our development. Luciana will play a central role in defining Galimedix’s overall R&D strategy and driving our R&D initiatives. We all look forward to working with her to help advance innovative healthcare solutions that have the potential to improve patients’ lives.
Dr. Summo has over 20 years of experience in clinical development and operations, including management of phase 1-2 clinical trials in multiple indications such as ophthalmology, cardiology and oncology. Before joining Galimedix, she held positions of increasing responsibility in the clinical departments of OMEICOS Therapeutics GmbH, NOXXON Pharma AG and Berlin-Chemie AG/Menarini Group. She is well-versed in setting up and overseeing clinical trials on a global scale and has played a key role in transitioning programs from preclinical to clinical stages. She has experience across the full spectrum of activities related to R&D operations, with a particular focus on clinical development and clinical operations, also including quality management and CMC. She works closely with cross-functional teams, including CROs, scientists, clinicians, regulatory affairs specialists and various stakeholders, to ensure that trials are conducted in accordance with rigorous scientific standards and regulatory guidelines. Dr. Summo has experience submitting Clinical Trial Applications (CTAs) in Europe and Investigational New Drug Applications (INDs) in the United States. He prepared and participated in pre-IND meetings with the US Food and Drug Administration (FDA), as well as regulatory agency meetings in Europe. She also created and led a clinical operations department from scratch.
Luciana Summo, PhD, Vice President, R&D Operationsadded: “I am truly delighted to join Galimedix at this important stage in the Company’s growth. The programs in ophthalmology and Alzheimer’s disease have the potential to change the treatment paradigm, and I look forward to working with the rest of the team to bring them to the clinic.
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