Healthcare Industry News: Novartis Oncology
News Release - September 6, 2013
Vital Therapies, Inc. Expands Executive TeamSAN DIEGO, CA--(Healthcare Sales & Marketing Network) - Vital Therapies®, Inc. (VTI), a biopharmaceutical company developing a cell-based therapy targeting the treatment of acute liver failure, today announced recent expansion of the company's executive team.
Andrew Henry has joined VTI as Vice President of Clinical Operations. Mr. Henry has 23 years of experience managing clinical trials in life science companies with roles at Schering-Plough Oncology, Novartis Oncology and MedImmune, the biologics division of Astra Zeneca. Most recently, he served at MedImmune as Senior Director of Global Clinical Operational Strategy and as Senior Director of Clinical Trial Management. He has overseen large departments with more than 30 compounds in development and annual budgets exceeding $375 million. At VTI, Mr. Henry is responsible for global implementation of the company's clinical program.
Andrea Loewen has joined VTI as Vice President of Regulatory Affairs and Quality. Ms. Loewen has 24 years of experience in regulatory and quality management roles, including positions at Baxter Healthcare, Biogen Idec, and Shire Pharmaceuticals. Most recently, she served as the Head of Regulatory Affairs for the Shire Regenerative Medicine business, with responsibility for global regulatory oversight of licensed and development stage combination biologic and medical device products. Her responsibilities at VTI include building out the company's quality and regulatory systems to ensure compliance, and continued development of late-stage regulatory strategies including preparation of global regulatory filings.
Richard Murawski joined VTI as Vice President of Manufacturing. He brings four decades of experience in pharmaceutical manufacturing, including significant recent experience in cellular therapy manufacturing and engineering at Dendreon. His prior manufacturing roles were at Cytogen, Baxter Healthcare and Favrille. In these roles he has developed and overseen international manufacturing organizations and successfully directed the design, construction, validation, regulatory approval, and start up of multiple international biotech manufacturing facilities. At VTI, Mr. Murawski is responsible for manufacturing of the cellular therapy and device components of our extracorporeal liver assist device, ELAD®, a combination product regulated by FDA's Biologics Division.
Terry Winters, Ph.D., the company's Chief Executive Officer and Co-Chairman, said, "Each of our new members holds a wealth of experience in their respective fields. We are fortunate to have a team of this exceptional caliber to oversee our recently-initiated Phase 3 program, anticipated regulatory filings and transition to commercialization."
About Vital Therapies Inc
Vital Therapies, Inc. is a private biopharmaceutical company developing a cell-based therapy targeting the treatment of acute liver failure. The company's lead product-candidate, ELAD, is an extra-corporeal bio-artificial liver currently in phase 3 clinical trials. VTI is based in San Diego, California.
ELAD is a Phase 3 investigational extracorporeal bio-artificial liver therapy designed to supplement hepatic function in order to improve survival rates among patients with acute liver failure. ELAD consists of a re-usable bedside unit attached to four disposable cartridges, which collectively contain thousands of hollow fibers and approximately one pound of immortal human C3A cells from our proprietary cell bank. The patient's plasma flows inside of the hollow fibers to allow two-way transfer of metabolites. The system has been shown to process toxins, and synthesize proteins and metabolites in ways that mimic components of normal human liver function. The ELAD cell cartridges are produced at VTI's GMP-compliant facility in San Diego, California. Moreover, the therapy has received Orphan Designation in both the United States and Europe for the treatment of acute liver failure.
Vital Therapies® and ELAD® are trademarks of Vital Therapies, Inc.
This press release may contain forward-looking statements, including but not limited to statements regarding current and future clinical studies in our Phase 3 program, and ELAD's market launch. These statements relate to future events and are subject to risks, uncertainties and assumptions about Vital Therapies, Inc. These statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these statements. Actual events or results may differ materially. Many factors may cause our actual results to differ materially from any forward-looking statement. We do not undertake to update any forward-looking statements.
Source: Vital Therapies
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