Alan Donald, MS, MBA, RAC
Vice President, Regulatory Affairs Vital Therapies, Inc. Mr. Donald has over 30 years of FDA and international regulatory/clinical experience in biomedical products including drugs, biologics, in vitro diagnostics, nutraceuticals, combination products, and medical devices across a wide diversity of therapeutic areas. In addition, he has advised financial groups when performing due diligence assessments of biomedical investment opportunities. He was a co-founder of two medical device companies. He is a recognized as an expert witness in FDA compliance, product warnings, manufacturing practices, labeling, etc. in Federal and State courts. Since 2000, he has been an adjunct professor in the Master of Science in Regulatory Affairs program offered through the College of Sciences at San Diego State University. He is on (or have been on) on the board of directors or advisory board of three medical firms and the San Diego Tech Coast Angels. After 18 years in industry, Mr. Donald founded Matrix Medical Consulting, Inc., a business-focused regulatory and clinical consulting firm where he has advised some 75 domestic and international client companies on four continents. He has authored publications and made presentations at industry and legal conferences and workshops. Mr. Donald attended Harvard University and Claremont McKenna College, receiving a bachelor’s degree in biology/physiology. He later attended San Diego State University where he obtained a Masters’s degree in biochemistry/cell biology. In 1996, he obtained an executive MBA in high-tech businesses from the University of California. He is certified by the Regulatory Affairs Professionals Society RAPS) and was recognized as one of RAPS First Fellows in 2010.
Michael Blumenfield, M.D.
Dr. Blumenfield is the Sidney E. Frank Distinguished Professor Emeritus of Psychiatry and Behavioral Sciences at New York Medical College. He currently has a private psychiatry practice in Woodland Hills, California and writes a weekly blog PsychiatryTalk.com Dr. Blumenfield is board certified in Psychiatry and in Psychosomatic Medicine. He has written numerous professional publications and most recently co-authored Practical Guidelines in Psychosomatic Medicine (Wolters Kluwer, 2nd ed, 2009) and co-edited a major textbook Psychosomatic Medicine (Wolters Kluwer, 2006) and a book titled Intervention and Resilience After Mass Trauma (Cambridge Press, 2008). He is a recent Past Speaker of the Assembly of the American Psychiatric Association.
Mark Falkowski, CEO
Mr. Falkowski has experience in building successful capital equipment corporations including being an entrepreneur of my own. His expertise includes product development, manufacturing standardization logistics, customer service and management. Mr. Falkowski has held the positions of Director of Operations, VP of Operations and Chief Operations Officer, Marketing and President and CEO. His responsibilities have included engineering, manufacturing, GMP/ISO, Quality Control, HR and Customer Service worldwide with profit and loss responsibilities.
Rebecca Hathaway, R.N., M.S.N., EDAC, PVDN
Ms. Hathaway is the Founder and President of Bridgestar Consulting, bringing over 35 years experience working in complex healthcare organizations in operational and executive leadership roles. Rebecca is recognized as a visionary thought leader, creating transformation and innovation through the creation of high performance team(s), utilizing Lean tools, evidence based principles, and leveraging technology to support patient centered care, to achieve exceptional outcomes and support business objectives.
Ms. Hathaway earned her Master’s degree from Saint Louis University, is EDAC certified, a member of the Planetree Visionary Design Network and has multiple speaking engagements and publications on these topics.