Sanguine Appoints Darlene Rosario, Vice President of Regulatory Affairs & Quality at Biothera, Inc., to Clinical Advisory Board and Ethics Committee
VALENCIA, Calif., Nov. 7, 2012 /PRNewswire/ — Sanguine BioSciences, Inc., a biotechnology company providing transparency to patients in biomedical research, has named Darlene Rosario, Vice President of Regulatory Affairs & Quality at Biothera, Inc., to its Clinical Advisory Board and Ethics Committee. Ms. Rosario’s extensive experience in clinical development and human ethics in clinical trials qualifies her to be the first to join Sanguine’s Clinical Advisory Board and Ethics Committee.
Prior to joining Biothera, Inc., Ms. Rosario held several senior positions with MannKind Corporation, serving as Vice President of the Oncology Research Program and as the World Wide Regulatory Affairs Liaison for Oncology. Throughout her career, she has held leadership positions at Chiron Corporation (acquired by Novartis), Aradigm Corporation, Dura Pharmaceuticals, Inc. (acquired by Elan Pharmaceuticals) and Glaxo Wellcome Inc. At these posts, Ms. Rosario was largely involved with the submission of multiple INDs, NDAs, MAAs in numerous indications, including oncology, immunotherapy and pulmonary.
“I am excited to work with the young, motivated entrepreneurs at Sanguine with the vision of bridging a gap between patients and researchers by collecting biospecimens, characterizing them and making these data available to researchers in an effort to expedite the discovery and availability of new treatments in cancer, among other diseases. I have enjoyed my involvement so far in providing guidance on relevant regulatory topics to ensure compliance with regulatory standards, patient safety, and general advice and direction on activities to move Sanguine forward in their goals and objectives.” – Darlene Rosario, B.S., RAC, Vice President of Regulatory Affairs & Quality, Biothera.
“We are excited to have Ms. Rosario advise us on our Regulatory Affairs and Ethical Compliance efforts. Her experiences to date and her personal passions are a unique fit for the company’s main commitments: the first of which, is to our patients – to be 100% certain that their data and identities are protected at all times, and that the entire research process is completely transparent; the second is to our researchers – to guarantee consistent and high quality patient biospecimen and associated medical data. She has been an asset to the Company by clearly identifying points requiring regulatory and ethical attention, including strategies and operations in Patient Engagement, Laboratory QA/QC, and Data collection and integrity.” – Chief Operations Officer, David Winternheimer, PhD, MBS.
Sanguine BioSciences is a biotechnology company bridging the gap between patients and researchers developing personalized medicine. The company engages patients in biomedical research by delivering transparency throughout the research process. Sanguine collects and de-identifies patient-derived data in the form of biospecimen, and physician and self-reported information. These data are generated and then made available to researchers involved in drug and biomarker research and discovery. www.sanguinebio.com