Eiger BioPharmaceuticals announced the appointment of Mark Mannebach, PhD, RPh as Vice President of Global Regulatory Affairs. Dr. Mannebach has more than 30 years of experience in the pharmaceutical industry in leadership roles including Parke-Davis, Warner Lambert, Pharmacia, Baxter, and Pfizer. Dr. Mannebach brings extensive global regulatory experience in the development of branded and specialty pharmaceuticals and biologics, including orphan designated products, with global regulatory authority interactions across multiple therapeutic areas leading to over 20 product approvals in his career. Dr. Mannebach spent most of the last decade as Vice President of Global Regulatory Affairs and as a member of the Executive Management Team at Covidien and Mallinckrodt Pharmaceuticals.
"Eiger's pipeline is now late-stage with planned global regulatory activities including an NDA and MAA for Progeria and Progeroid Laminopathies, enrollment of a global Phase 3 study for Lonafarnib in HDV, and End of Phase 2 meetings for Peginterferon Lambda in HDV and Avexitide in Post-Bariatric Hypoglycemia," said David Cory, President and CEO of Eiger. "Mark's global regulatory expertise and experience will strengthen our leadership team and execution. We look forward to Mark's strategic insights and contributions as we evolve into a commercial company."
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"I am excited to join Eiger's leadership team at this pivotal point in the Company's evolution and look forward to working together to advance multiple, first-in-class, rare and ultra-rare disease programs to bring therapies to patients with unmet medical needs," said Dr. Mannebach.
Dr. Mannebach was most recently Vice President of Global Regulatory Affairs and Quality Assurance at Charleston Laboratories where he was a member of the executive team and responsible for global regulatory strategy as well as developing technical requirements of supply and quality management. In the preceding decade, he was Vice President of Global Regulatory Affairs at Covidien and Mallinckrodt Pharmaceuticals, where he built and managed a worldwide regulatory team of 160 employees and was responsible for the filing of several NDAs, ANDAs, and INDs, and leading the company's first FDA Advisory Committee meeting and multiple product approvals. Previously, Dr. Mannebach was Vice President of U.S. Regulatory Affairs and Quality Assurance at Santen Incorporated. Earlier in his career, Dr. Mannebach was at Pfizer for over a decade where he served in multiple operating positions of increasing responsibility. Dr. Mannebach began his industry career at Sanofi in Product Development.
Dr. Mannebach received a PhD in Pharmacy Administration from University of Michigan, an MS in Chemical Engineering from University of Detroit, and a BS in Pharmacy from Wayne State University.