Biothera Names Carey Anderson VP of Regulatory Affairs

EAGAN, Minn.--()--Carey Anderson has joined Biothera as Vice President of Regulatory Affairs for its Pharmaceutical business.

Ms. Anderson has more than 18 years of global regulatory experience. Her previous positions include Director and Global Regulatory Lead at Amgen, Senior Director of Global Regulatory Affairs at Baxter Healthcare, and Director of Regulatory and Quality Assurance at Acceleron Pharma and Merrimack Pharmaceuticals.

“Carey has broad regulatory experience covering all stages of pharmaceutical development and extensive experience negotiating regulatory pathways with the FDA as well as management of global regulatory dossier submissions,” said Dan Conners, President of Biothera’s Pharmaceutical Group. “In addition, her experience in oncology and immunotherapy are a perfect fit for our cancer immunotherapy drug candidate, Imprime PGG.”

Ms. Anderson will oversee all aspects of Biothera’s regulatory affairs for its drug development programs, including oversight for all regulatory matters, including filings and interactions with regulatory authorities.

Ms. Anderson has M.S. degree in Molecular Oncology and Immunology from New York University, Sackler Institute, and a B.S. degree in business administration from Drexel University.

About Biothera

Biothera, a privately held U.S. biotechnology company, is developing Imprime PGG®, a late clinical stage biologic that modulates the immune response to cancer. Data from the most recent randomized phase 3 study of Imprime PGG in first line non-squamous NSCLC was featured as a late-breaking abstract in the Immunotherapy of Cancer session at ESMO 2014. In this study, which evaluated the addition of Imprime PGG to bevacizumab and carboplatin/paclitaxel versus bevacizumab and chemotherapy alone, objective response rate was 60.4% versus 43.5%, duration of response was 10.3 months versus 5.6 months and median overall survival was 16.1 months versus 11.6 months. Similarly encouraging data have been observed in both squamous and non-squamous subjects in a second randomized Phase 2 study in 1st line NSCLC in combination with cetuximab and in studies in high-risk chronic lymphocytic leukemia and metastatic colorectal cancer. Imprime PGG directly modulates the key effector cells of the innate immune system, neutrophils and monocytes/macrophage, enabling them to recognize and kill antibody-targeted cancer cells. In addition, on-going research points to a secondary, bystander effect of Imprime PGG on both innate and adaptive immune cell types known to exist in the tumor microenvironment, including T-cells, dendritic cells, M-2 macrophages and myeloid derived suppressor cells. Imprime PGG is being evaluated in a phase 3 study in late stage metastatic colorectal cancer and planning is underway for an approvable study in NSCLC.

More information is available at www.biothera.com/pharma or follow us on Twitter.

Contacts

Biothera, the Immune Health Company
David Walsh, 651-256-4606
SVP Marketing & Communications
dwalsh@biothera.com

Release Summary

Carey Anderson has joined Biothera as Vice President of Regulatory Affairs for its Pharmaceutical Group. Previously, she was Director and Global Regulatory Lead at Amgen.

Contacts

Biothera, the Immune Health Company
David Walsh, 651-256-4606
SVP Marketing & Communications
dwalsh@biothera.com