Milan, Italy, 1 April 2021 – Enthera Pharmaceuticals (“Enthera”), a biotech company developing disease-modifying biologics for intractable autoimmune conditions, today announces the appointment of Claudia Nardini as Vice President of Research and Development to support the Company’s manufacturing and regulatory divisions.
Claudia has gained 25 years of experience in the biopharmaceutical industry through roles across quality control and management (for both FDA and EMA inspections), operations, R&D, pathogen safety, regulatory affairs, post-marketing surveillance and the marketing of downstream bioprocessing (DSP) bio-solutions.
Most recently, Claudia was Head of Global Purification & Virus Clearance Product Management at Sartorius Stedim Biotech GmbH in Germany. Claudia first started her professional career at Farmabiagini S.p.A in Italy as Head of Production Line for Coagulation Factors and subsequently Head of Process and Analytical Development, before joining Bayer Corporate in the US as Manufacturing Manager. She later supported Kedrion Biopharma across Italy and the US as Product Development Chief Officer Date Global Research Director/GMP, and as Facility Director.
Claudia will supervise development and manufacturing activities for Enthera’s lead candidate, Ent001, which is currently in pre-clinical development for Type 1 diabetes and inflammatory bowel disease. Claudia will also oversee the Company’s regulatory division.
Giovanni Amabile, CEO at Enthera, commented: “Claudia has a strong track record in managing GMP functions within the pharmaceutical industry. Her quality control and management experience will be hugely beneficial for Enthera as we progress our lead Ent001 program for Type 1 diabetes and inflammatory bowel disease. Claudia’s move from Sartorius in Germany is also great validation of Enthera’s work as it demonstrates our ability to attract strong talent from other territories, with international experience across European and US markets.”
Claudia Nardini, newly appointed Vice President of Research and Development at Enthera, stated: “It is an exciting time to join Enthera, as the Company approaches Phase I clinical development with its lead asset. I look forward to bringing my experience and expertise to the clinical and regulatory teams, so that we can work together to help patients with underserved autoimmune conditions.”
Claudia holds a degree in Pharmacy and a PhD in Pharmaceutical Chemistry from the University of Pisa.
Enthera Srl is a biotech company developing first-in-class biologics to transform the treatment paradigm of specific autoimmune conditions by re-establishing stem cell capabilities in a non-traditional way. The Company’s primary target indications are type 1 diabetes (T1D) and inflammatory bowel disease (IBD).
Enthera's pioneering approach capitalizes on the key discovery of the IGFBP3/TMEM219 pathway, which is involved in beta cell and stem cell apoptosis in pancreas and gut, respectively.
The Company is building a pipeline of inhibitory monoclonal antibodies (mAbs) and fusion proteins targeting the pathway via multiple angles. Its lead program Ent001 is the only drug in development with the potential to restore the endogenous pancreatic stem cell compartment in T1D as well as the original intestine structure in IBD, in order to re-establish organ function.
Enthera is a private company headquartered in Milan, Italy and founded in 2016 by Prof Paolo Fiorina and Dr Francesca D’Addio at BiovelocITA, an Italian biotech accelerator. The Company is backed by Sofinnova Partners, AbbVie Ventures, Roche Venture Fund and JDRF T1D fund. Enthera’s discovery engine and assets are protected by a broad portfolio of patents.
For more information, visit https://www.entherapharmaceuticals.com/
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