SAN DIEGO, May 7, 2015 /PRNewswire/ – ProSciento, Inc., an early engagement clinical research organization (CRO) focused on diabetes, obesity and NAFLD/NASH, announced today the appointment of Dr. Michael Trautmann as Senior Director of Drug Development Services and Dr. Gordon Brandt as Senior Director of Clinical Development and Regulatory Affairs to its clinical development leadership team.
Dr. Trautmann joins ProSciento overseeing drug development services. He is working with clients globally to build strategic clinical development programs from early engagement assessment and planning and creation of compound-specific scientific advisory boards through the completion of multi-site clinical trials.
Dr. Brandt joins the company overseeing regulatory services and consulting, including evaluation of IND/CTA and NDA/ANDA readiness, managing all regulatory steps from submission through clinical study reports, and representing clients at FDA and EMA meetings.
ProSciento’s clinical development and regulatory affairs unit has grown significantly in recent years. The company has also benefited from strategic partnerships with pharmaceutical companies, most notably in Asia. Responding to the needs of its clients, ProSciento now offers a full suite of CRO services for metabolic single and multi-site studies for clients seeking a science driven, therapeutically focused partner.
“Michael and Gordon have successful track records in guiding promising compounds and devices from early stages of development through regulatory approval. Their leadership will help us continue to expand our services while maintaining our science driven, therapeutically focused approach, leading to meaningful outcomes for our clients in the biopharmaceutical industry,” said Dr. Marcus Hompesch, ProSciento CEO. “We’re pleased that the addition of Michael and Gordon to our team continues our trend of uniting highly respected, influential scientific leaders within the field of metabolic clinical research and drug development.”
Dr. Trautmann is globally recognized as a highly accomplished scientific leader in diabetes and related metabolic research. His career encompasses leadership roles in the development of a number of FDA and EMA approved drugs, including insulin lispro (Humalog) and the GLP-1 agonist exenatide (Byetta and Bydureon), during a nearly 20 year tenure at Eli Lilly and Company in Germany. Dr. Trautmann trained in Internal Medicine and Diabetology at the Universities Goettingen and Marburg, Germany, and Geneva, Switzerland. He is member of several national and international associations for diabetes and endocrine research and has authored numerous publications in this field.
Dr. Brandt has over 30 years of experience creating and implementing clinical development and regulatory strategies that bring novel medicines and medical devices to market in the US and abroad. Prior to founding the consulting firm Brandt Biotech LLC, Dr. Brandt served as Executive Vice President, Clinical Research and Medical Affairs at MDRNA, Inc., where he led cross functional teams for nine peptide and metabolic drug development programs. Prior to that, Dr. Brandt was Vice President of Clinical and Regulatory Affairs for SONUS Pharmaceuticals, developing drugs and drug delivery systems for oncology and medical imaging applications. He and his teams have received product approvals under NDA, MAA, CE mark, 510k and PMA pathways. Dr. Brandt received his medical degree from the University of California, San Francisco and completed his residency in internal medicine at Kaiser Permanente Hospital in San Francisco.
About ProSciento, Inc.
ProSciento is a metabolism-focused, full scope clinical R&D services provider, with a mission to advance the global development of novel therapeutics for diabetes, NASH and obesity. The company is widely recognized for quality and scientific excellence, an unparalleled methodological toolkit, and extensive experience with virtually all metabolic drug and device classes. Utilizing its scalable R&D services model – combining deep therapeutic area expertise, strategic planning, an unparalleled methodological tool kit, and operational execution from late preclinical to phase III readiness – ProSciento provides highly customizable services for its global client base in today’s rapidly evolving landscape of metabolic drug and device development. For more information, please visit www.prosciento.com.
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