UTRECHT, Netherlands--(BUSINESS WIRE)--AM-Pharma B.V., an emerging leader focused on the treatment of acute kidney injury, today announced the appointment of Wolfgang Meder, Ph.D., as Vice President, Regulatory Affairs and Quality Management, and Laetitia Szaller as General Counsel & Vice President, Business Development. Dr. Meder, who brings nearly 20 years of expertise in global regulatory affairs, will lead the company’s interactions with regulatory bodies as it advances its acute kidney injury therapeutic through late stage clinical development. Ms. Szaller, benefitting from over 15 years as a legal and strategic advisory executive in the industry, will establish and implement corporate development strategies as well as provide legal counsel.
“Our recent funding rounds have allowed us to strengthen our organization in anticipation of the global pivotal REVIVAL Phase III trial in patients with sepsis-associated acute kidney injury,” said Erik van den Berg, CEO of AM-Pharma. “The appointments of Wolfgang and Laetitia are another critical step in this effort. I value their commitment to building a commercial-ready company with us, leveraging our recAP platform for developing therapies for severe inflammatory disorders.”
Before joining AM-Pharma, Dr. Meder held the position of Head of Regulatory Affairs at Correvio Pharma Corp., a publicly listed specialty pharmaceutical company, which was subsequently acquired by Advanz Pharma. At Correvio, Dr. Meder was responsible for the development and implementation of global regulatory product strategies for Correvio’s commercial products, advising the company on clinical development and leading interactions with regulatory agencies in the United States, Europe and Asia. Prior to that, he held a similar role at Tillotts Pharma, a specialty pharma company developing, licensing and commercializing products for the digestive system such as inflammatory bowel disease. Earlier in his career, Dr. Meder held multiple senior regulatory affairs roles at Vifor Pharma, Actelion Pharmaceuticals and Novartis. Dr. Meder earned a Ph.D. in Biochemistry and a Master degree in Drug Regulatory Affairs from the University of Bonn, Germany.
Ms. Szaller joined AM-Pharma from UCB where she served as Associate General Counsel, Business Development and M&A, Antitrust. At UCB, she was appointed Legal Head for the company’s Belgian Research and Development site, where she significantly improved the legal function. During Ms. Szaller’s tenure, she played a key role in multiple global divesture and licensing deals and supported the business development, M&A and venture funds areas. Before joining UCB, she was Legal Director Emerging Markets at Zoetis, formerly Pfizer’s animal health division, where she built and oversaw the legal support practice and where she was responsible for competition law, trade compliance, litigation and negotiations in over one hundred countries. In addition, Ms. Szaller held senior legal positions at Abbott and American Standard Europe BVBA. Ms. Szaller is a certified attorney in both the United Kingdom and Belgium. She holds a Master degree in International and Comparative Law from the Vrije Universiteit Brussel and a Bachelor degree in English and European Law from the University from the West of England.
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AM‐Pharma is a clinical stage biopharmaceutical company, leading in the development of a treatment for acute kidney injury (AKI) with its innovative recombinant human Alkaline Phosphatase therapeutic (recAP). AKI affects millions of patients worldwide. It is a devastating disease with high mortality rate and no approved pharmacological treatments. AM-Pharma reported positive results from a Phase II study of recAP in patients with sepsis associated AKI (SA-AKI) and the Company is preparing to initiate a pivotal Phase III trial of recAP in patients with SA-AKI. AM-Pharma is also exploring the development of recAP for other indications. Founded in 2001, AM-Pharma is a private company that is based in the Netherlands. The Company is backed by a strong syndicate of international investors, both Venture Capital funds and Corporate Venture Funds, and has raised over €240m in equity and debt to date.
Find out more about us online at: www.am-pharma.com.