SAN DIEGO, Jan. 16, 2024 /PRNewswire/ — Aspen Neuroscience, Inc., a private biotechnology company developing the first autologous neuron replacement therapies to treat Parkinson’s disease (PD), announced today the appointment of Ana Sousa, MSJ as the company’s Chief Regulatory Officer.
Since 2021, Ms. Sousa has served as Senior Vice President of Regulatory and Quality at Aspen, where she developed the regulatory, quality and project management teams, and as the ANPD001 Project Team Leader, guiding product strategy and taking the company’s lead product from a pre-clinical to clinical stage.
Aspen Neuroscience has appointed Ana Sousa, MSJ as Chief Regulatory Officer.Post this
“Ana is a key member of the executive team and has been instrumental in building our organization and in driving our lead therapeutic candidate to the clinic,” said Damien McDevitt, PhD, Aspen Neuroscience president and chief executive officer. “Under her tenure, we have opened our first US IND and obtained FDA ‘fast track’ status for ANPD001. Now as we enter the clinic and broaden our pipeline, we will look to her continued leadership both in the US and abroad.”
A senior drug development and regulatory executive with more than 20 years of industry experience, Ana has successfully led global regulatory programs and developed key industry talent at Roche/Genentech and Onyx/Amgen, and built global regulatory departments at Principia Biopharma (Sanofi) and several other successful startup companies.
Ana received her undergraduate degree at Pace University, Lubin School of Business, and her Master of Science in Jurisprudence (MSJ) degree with a concentration in Health Law and Intellectual Property at The Seton Hall University School of Law.
ANPD001 is an investigational cell therapy product being studied as an autologous neuron replacement for Parkinson’s disease. Aspen’s personalized 3-step manufacturing approach starts from a small sample of the patient’s own skin cells, followed by reprogramming to induced Pluripotent Stem Cells (iPSCs) and then differentiation into dopaminergic neuron precursors (DANPCs). These DANPCs are then provided to the patient via surgery to replace their cells that were lost or damaged due to disease. The quality of each person’s cells is assessed at every manufacturing stage using Aspen’s proprietary machine learning-based genomics tests.
About Aspen Neuroscience
Headquartered in San Diego, Aspen Neuroscience, Inc. is a clinical development-stage, private company focused on autologous regenerative medicine. The company’s patient-derived iPSC platform is used to create personalized cell therapies to address diseases with high unmet medical needs, beginning with autologous neuron replacement for Parkinson’s disease.
Aspen combines stem cell biology with the latest machine learning and genomic approaches to investigate patient-specific, restorative cell treatments. The company has developed a best-in-class platform to create and optimize pluripotent-derived cell therapies, which includes in-house bioinformatics, manufacturing and QC. For more information and important updates, please visit https://www.aspenneuroscience.com.