SAN DIEGO, May 7, 2015 /PRNewswire/ – Profil Institute for Clinical Research, 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 Profil Institute 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.
Profil Institute’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, Profil Institute 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, Profil Institute 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 Profil Institute for Clinical Research, Inc.
Profil Institute is an early engagement clinical research organization (CRO) exclusively focused on metabolic diseases, including diabetes, obesity and NAFLD/NASH. The company is recognized globally for its scientific expertise, expanded scope of research methodologies, and experience with every clinically relevant drug class in diabetes. Profil Institute provides a full scope of CRO services from consulting for strategic clinical development and regulatory planning through design and completion of complex clinical trials, including the reporting and publication of final study results.
Profil Institute’s expertise and experience encompasses small and large molecule therapies, biologics and biosimilars through all routes of administration, as well as devices. The company’s clients range from large pharma and drug discovery companies to small virtual companies throughout the Americas, Europe and Asia.
Profil Institute is also widely recognized as an innovator of methodologies, including its Automated Glucose Clamp technology, and for driving new, higher standards in metabolic clinical research through collaborative science with key academic and industry partners.
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