Aastrom has brought together a group of highly skilled individuals from different areas of the industry creating a strong management team that is prepared to lead the Company through the clinical development stage and into the commercial marketplace. The Board of Directors is comprised of individuals with broad experience at both large public and private biotech and pharmaceutical companies, making them excellent representatives for Aastrom's shareholders and key advisors for the Company.
Management Team
Timothy M. Mayleben Chief Executive Officer, President, Chief Financial Officer and Director
Mr. Mayleben joined Aastrom as a member of the Company's Board of Directors in June 2005, and currently serves as Chief Executive Officer, President, Chief Financial Officer and Director. Mr. Mayleben was formerly an advisor to life science and healthcare companies through his advisory and investment firm, ElMa Advisors. Prior to this he served as the President and Chief Operating Officer and a Director of NightHawk Radiology Holdings, Inc. Mr. Mayleben was also formerly the Chief Operating Officer of Esperion Therapeutics, which later became a division of Pfizer Global Research & Development. He joined Esperion in late 1998 as Chief Financial Officer. While at Esperion, Mr. Mayleben led the raising of more than $200 million in venture capital and institutional equity funding and later negotiated the acquisition of Esperion by Pfizer in December 2003. Prior to joining Esperion, Mr. Mayleben held various senior and executive management positions at Transom Technologies, Inc., now part of Electronic Data Systems, Inc., and Applied Intelligent Systems, Inc., which was acquired by Electro-Scientific Industries, Inc. in 1997. Mr. Mayleben holds a Masters of Business Administration, with distinction, from the J.L. Kellogg Graduate School of Management at Northwestern University, and a Bachelor of Business Administration degree from the University of Michigan Ross Business School. He is on the Advisory Board for the Wolverine Venture Fund and serves as a director for several private life science companies.
Peter C. Alain joined Aastrom in August 2007 as Senior Director, Quality Assurance. Mr. Alain has more than 25 years of Quality Assurance (QA) experience in the domestic and international pharmaceutical industries, including GMP/GLP/GCP compliance from drug discovery through post marketing. Prior to joining Aastrom, Mr. Alain held several management level positions at Pfizer, Inc., formerly Warner-Lambert/Parke-Davis, for over 26 years. Most recently, he was the Worldwide Development Quality Assurance Head for the U.S. and Latin America region within Pfizer's Global Research and Development division. During his career, he has been a member of PhRMA's Bioresearch Monitoring Steering Committee, coordinated, facilitated and mediated more than 10 successful domestic and international regulatory agency inspections, established the GMP Roundtable Forum for the production of clinical supplies and established one of the first industry QA groups to ensure electronic data integrity across GMP/GLC/GCP regulated areas. Mr. Alain received a B.S. in Biology from the University of Toronto, Canada.
Ronnda L. Bartel, Ph.D. Vice President, Technical Operations
Ronnda L. Bartel, Ph.D. joined Aastrom in October 2006 and is currently Vice President, Technical Operations. She is responsible for the manufacturing operations of Aastrom's TRC-based cell products as well as the supporting programs in process and product development, engineering and research. Dr. Bartel is a seasoned scientist with more than 20 years of research and product development experience in the biotech, pharmaceutical, diagnostic and device sectors. During this time she held several management positions including: Senior Principal Scientist, Cell Biology at Advanced Tissue Sciences; Vice President, Scientific Development and Senior Director, Stem Cell Development at Stem Cells, Inc.; Senior Director, Science and Technology at SRS Capital, LLC; and, most recently, Executive Director, Biological Research at MicroIslet, Inc. She has also held positions in clinical development, drug delivery, business development and manufacturing. Dr. Bartel holds a Ph.D. in Biochemistry from the University of Kansas, completed postdoctoral work at the University of Michigan and received a B.A. in Chemistry and Biology from Tabor College.
Tod Borton Senior Director, Engineering and Development
Tod Borton joined Aastrom in July of 2006 and is currently Senior Director, Engineering and Development. Mr. Borton has more than 20 years of Product Development and Quality experience in the domestic, international, biotechnology and medical device industries. Prior to joining Aastrom, Mr. Borton held the position of Director of Quality at Terumo Cardiovascular where he was responsible for quality assurance, document control, and sustaining engineering. During his time at Terumo he was instrumental in helping the company through an FDA warning letter and achieving normal status. Prior to Terumo Mr. Borton held the position of Vice President, New Product Development and Advanced Engineering at Pall Corporation where he developed and commercialized many biotech and medical filtration devices. He has authored many patents in the area of biotechnology and medical filtration device technologies. Mr. Borton received a B.S. in Plastic Technology from Eastern Michigan University.
Elmar R. Burchardt, M.D., Ph.D. Vice President, Medical Affairs
Elmar R. Burchardt, M.D., Ph.D. joined Aastrom in July 2006 and was appointed Vice President, Medical Affairs in September 2006. Dr. Burchardt brings over 14 years of experience in the areas of hematopoietic stem cell transplantation, hematology and cardiology to Aastrom. Previously, Dr. Burchardt worked for Miltenyi Biotec GmbH, in Germany, where he served as Medical Director responsible for the worldwide development and market introduction strategy of 10 new clinical cell therapy products, and one of the most extensive cell therapy development programs in cardiac diseases. Prior to that time, he served as Senior Research Group Leader at the Pharmaceutical Research Center of Bayer AG, in Germany. Dr. Burchardt holds M.Sc. and Ph.D. degrees in Biochemistry, as well as an M.D. from Hannover Medical School, West Germany, and is an Associate Professor of Clinical Pharmacology at the University of Witten Herdecke, in Germany.
Julie A. Caudill Controller and Corporate Secretary
Julie A. Caudill joined Aastrom in 1995 and is currently Controller and Corporate Secretary. She is responsible for leading Aastrom's financial reporting and accounting functions, as well as the purchasing function. Ms. Caudill has more than 20 years of business experience in the areas of accounting management and financial reporting. Prior to joining Aastrom, she held various positions in accounting management and financial reporting at KMS Fusion and PALL Corporation (formerly Gelman Science, Inc.). Ms. Caudill received a BBA in Accounting from Eastern Michigan University.
Frances J. Kivel Senior Director, Clinical Trials
Frances J. Kivel joined Aastrom in November 2007 as Senior Director, Clinical Trials. Ms. Kivel has over 20 years of experience in global clinical trial development, execution and reporting from early development through post marketing. During this time, she held several management positions at Pfizer, Inc., formerly Warner-Lambert/Parke Davis. Most recently, Ms. Kivel was an associate director of R&D project management and clinical operations management within Pfizer's Global R&D organization. Her experiences include the development and approval of multiple NDA and MAA submissions, development and implementation of global organizational data standards, evaluation of strategic options within drug development, development portfolio evaluation, and the analysis and reporting of clinical trial data. At various times during her career, she has been a member of the Project Management Institute, the American Statistical Association, the Decision Analysis Affinity Group (founding member) and the Sigma Xi Scientific Research Society. Ms. Kivel received an MS in Biostatistics from the University of Michigan.
Sherrill M. MacKay Senior Director, Manufacturing
Sherrill M. MacKay joined Aastrom in January 2006 and is currently Senior Director, Manufacturing. She is responsible for the global production, quality control, materials management and technology transfer required for Aastrom's TRC-based cell products. She has more than 13 years of GMP manufacturing experience in both domestic and international cell therapy operations. Prior to joining Aastrom, she was responsible for the initial development and manufacturing of a renal bio-replacement cell therapy product at RenaMed Biologics (formerly Nephros Therapeutics). In addition to maintaining internal operations, she has established and maintained international contract manufacturing relationships. Ms. MacKay received an M.S. in Biological Chemistry and a B.S in Chemistry from the University of Michigan. She has authored scientific publications in the areas of bio-replacement therapies and cell culture methodologies.
Kris M. Maly Senior Director, Communications & Administration
Kris M. Maly joined Aastrom in 2000 and is currently Senior Director, Communications & Administration. She is responsible for leading Aastrom's investor and public relations functions, as well as human resources. Ms. Maly has more than 20 years of business experience in public accounting and investor relations. Prior to joining Aastrom, she held various positions in the tax department at C.H. Rubin & Company. Ms. Maly received a BA in English and Art History from the University of Michigan, with additional coursework in accounting and management.
Sheldon A. Schaffer, Ph.D. Vice President, Corporate Development & Intellectual Property
Sheldon A. Schaffer, Ph.D. joined Aastrom in December 2006 as Vice President, Corporate Development & Intellectual Property. Dr. Schaffer has more than 30 years of experience in pharmaceutical and medical diagnostics industries, at both large corporations and entrepreneurial start-up companies. During his career he has been responsible for the development of U.S. and international businesses, in- and out-licensing of technology, intellectual property management, and clinical and pre-clinical drug development and drug discovery management. Most recently, Dr. Schaffer has provided business development consulting services to the pharmaceutical industry. Prior to this he served as President and CEO of Inveresk Research, N.A. He served as Vice President, Pharmaceutical Development at DepoTech Corporation, and as Vice President of Pharmaceutical Development and then as Vice President of Business Development at Cholestech Corporation, a publicly traded medical products company. Previously, Dr. Schaffer served as Director, Inflammation/Atherosclerosis Research at Ciba-Geigy Corporation, a pharmaceutical company, and held senior scientific positions at the Medical Research Division of American Cyanamid Co., a pharmaceutical company. Dr. Schaffer received his B.S. in chemistry from the University of California, Berkeley and a Ph.D. in chemistry from the University of Illinois, and served as a postdoctoral and teaching fellow at Harvard Medical School.
Francisco Vidal Managing Director - Aastrom Biosciences, S.L.
Francisco Vidal joined Aastrom Biosciences, S.L. (Aastrom's wholly-owned subsidiary in Spain) in 2006 as Managing Director after consulting with the company since 2004. Mr. Vidal has more than 20 years of marketing and business development experience in the healthcare and biotechnology industries. Prior to joining Aastrom, he held numerous management positions in immunotherapy and cell therapy business development at Baxter Healthcare, Inc. Prior to this, Mr. Vidal held the position of Marketing Manager at Biosafe SA where he was responsible for developing an EU market for the processing of cellular products. He has authored many publications in the area of biotechnology and autologous bone marrow collection, transplantation, enrichment and cryopreservation. Mr. Vidal received a B.S. in Technical Engineering from the University College of Barcelona. He also completed the Executive Master of Hospital and Healthcare Companies Management program at Escuela de Alta Dirección y Administración (EADA), and earned a Medical Technology and Device Design Development diploma from the Polytechnic University of Cataluña.
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