David B. Kaysen
President, Chief Executive Officer
Mr. Kaysen brings more than 25 years of executive healthcare clinical and regulatory development, commercial execution and publicly traded company achievements. Prior to joining Sun BioPharma, Inc. Mr. Kaysen was an advisor and senior executive for several domestic and European growth-oriented privately-held healthcare companies. From 2006 until 2013 Mr. Kaysen served as President, Chief Executive Officer and Member of the Board of Directors of Uroplasty, Inc., a Minneapolis based publicly traded global medical device company where he guided the company through successful clinical trials, regulatory approvals, raised four rounds of equity capital and grew annual sales to over $23 million. Previously, Mr. Kaysen served as President and Chief Executive Officer of Advanced Duplication Services, LLC, a privately-held replicator and duplicator of optical media; President, Chief Executive Officer and Member of the Board of Directors of Diametrics Medical, Inc. a publicly traded global manufacturer and marketer of critical care blood analysis systems; and President, Chief Executive Officer and Member of the Board of Directors of Rehabilicare Inc., a publicly traded global manufacturer and marketer of neuromodulation devices for rehabilitation and pain management. Mr. Kaysen currently serves on the Board of Directors of four privately-held companies, three of which are in the health care space. Mr. Kaysen received a Bachelor of Science degree in Business Administration from the University of Minnesota.
Michael T. Cullen, M.D., MBA
Co-Founder, Executive Chairman
Dr. Cullen brings 25 years of pharmaceutical experience to Sun BioPharma, including expertise in working with development-stage companies in planning, designing and advancing drug candidates from preclinical through clinical development. Dr. Cullen developed several oncology drugs as Chief Medical Officer for MGI Pharma Inc. from 2000 to 2008, and previously at G.D. Searle, SunPharm Corporation, and as Vice President for Clinical Consulting at IBAH Inc., the world’s fifth largest contract research organization, where he provided consulting services on business strategy, creating development plans, regulatory matters and designing clinical trials for several development stage companies in the pharmaceutical industry. Dr. Cullen was also a co-founder and Chief Executive Officer of IDD Medical, a pharmaceutical start-up company. Dr. Cullen joined 3M Pharmaceuticals in 1988 and contributed to the development of cardiovascular, pulmonary and immune-response modification drugs. Over the course of his career Dr. Cullen has been instrumental in obtaining the approval of ten drugs, including three (3) since 2004: Aloxi®, Dacogen® and Lusedra®. Board-certified in Internal Medicine, Dr. Cullen practiced from 1977 to 1988 at Owatonna Clinic, Owatonna, MN, where he served as president. Dr. Cullen earned his MD and BS degrees from the University of Minnesota and his MBA from the University of St. Thomas and completed his residency and Board certification in Internal Medicine through the University of North Carolina in Chapel Hill and Wilmington, NC.
Vice President and Chief Financial Officer
Ms. Horvath has held both finance and operating positions within pharmaceutical, healthcare and consumer organizations. Most recently she served as Chief Financial Officer of Eyebobs, LLC, a private company focused on the reading glasses industry. Prior to that, Ms. Horvath served as Vice President and Chief Financial Officer of Tenacious Holdings, Inc. (d/b/a ergodyne) a privately held, safety products company designing, manufacturing and selling products to help improve safety and productivity in the work place; Chief Financial Officer and Vice President of Human Resources at Healthsense, Inc., a next generation technology (SaaS) and remote monitoring company focused on providing safety and improving quality of life while reducing overall costs of healthcare for seniors and fragile adults; Chief Financial Officer, Vice President of Operations & Human Resources of Hemosphere, Inc., an early commercialization stage medical device company that manufactured and sold HeRO® – a clinically proven long-term vascular access device for hemodialysis patients; Director of Financial Planning & Analysis and Vice President & Team Leader International of CNS, Inc, a $140 million fast-growing consumer health care products company focused on the development and marketing of strong consumer brands, including Breathe Right® nasal strips, and FiberChoice® daily fiber supplements. Ms. Horvath holds a Bachelor of Science degree in Accounting from the University of Illinois, Champaign, and is a Certified Management Accountant and Certified Public Accountant, inactive.
Thomas X. Neenan, Ph.D.
Co-Founder and Chief Scientific Officer
Dr. Neenan is an entrepreneur and scientist with extensive chemistry and business development executive experience with AT&T Bell Labs, Geltex, Genzyme, Trine Pharma, Warwick Effect Polymers, Gelesis and Proxy Biomedical. Dr. Neenan most recently served as Founder and Chief Technology Officer of Sideris Pharmaceuticals Inc, raising $32M in equity financing in 2013 Dr. Neenan holds a B.Sc (Hons) in Chemistry and Math from the University College Dublin in Ireland, a Ph.D in Synthetic Chemistry from Penn State University, and post-doctoral studies in chemistry at Harvard University. Dr. Neenan also brings a wealth of knowledge to the Company on drug manufacture and was instrumental in improving the synthetic process for SUN-101. He is the author of approximately 60 publications in the fields of chemistry and materials sciences and holds approximately 40 US and international patents.
Suzanne Gagnon, M.D.
Chief Medical Officer
Dr. Gagnon has been leading the medical, regulatory and safety aspects of pharmaceutical product development for more than 20 years, including senior management positions as both an academic researcher and in the Pharmaceutical and CRO industries. She served as Chief Medical Officer at Idis, a company focused on providing global access to medicines to patients with unmet medical needs, and at NuPathe Inc., a biopharmaceutical company focused on innovations in neuroscience, prior to its acquisition by Teva Pharmaceuticals. Between 2001 and 2011 she was Chief Medical Officer and Executive Vice President at ICON Clinical Research, a top tier CRO recognized in 2009 as #49 on the FORTUNE list of “100 Fastest Growing Companies.” She began her industry career at Rhone-Poulenc Rorer, currently Sanofi, where she participated in the development of Taxotere® (docetaxel) for the treatment of breast and lung cancer, and led the regulatory approval process in the U.S. and Canada for Venofer® (iron sucrose) as Vice President of Clinical R&D at Luitpold Pharmaceuticals, a Daiichi Sankyo Company. Dr. Gagnon received her medical degree from Boston University School of Medicine, became Board Certified in Internal Medicine at Boston City Hospital and spent several years on faculty at the University of Miami School of Medicine where she published independently conducted clinical research in the New England Journal of Medicine prior to joining the industry. She is an international editorial advisor to Elsevier Publishing, the author or co-author of numerous publications, abstracts and book chapters and a frequent international speaker. She currently holds a position as adjunct Professor in Pharmaceutical Product Development at West Chester University of Pennsylvania.
Ajit Shah, Ph.D.
Ajit Shah has more than 25 years of experience in small and large pharmaceutical companies in the areas of clinical pharmacology, pharmacokinetics and drug metabolism (PKDM). He has expertise in supporting drug development project teams, strategic planning, budget preparation and contracting services, bioanalytical methods, PK-PD data modeling and reporting, regulatory and scientific publications. He is experienced in oncology and supportive care, CNS, inflammation, and small and large molecule new chemical entities. He was a senior director of clinical pharmacology and PKDM group at MGI Pharma (2002-2009) and was responsible for planning, execution, analytical method development, data analysis, reporting, regulatory submissions, and pharmacology publications. He supported regulatory submissions for (INDs/NDAs/MAA) Aloxi™, Dacogen™, irofulven, Saforis™, fospropofol, and AKR-501 as well as an FDA advisory committee meeting on fospropofol. He was an associate director of clinical pharmacology from 1995-2002 at Pfizer. From 1989-1995 he was a senior associate scientist of clinical pharmacokinetics at Marion Merrell Dow Inc. He received his Ph.D. in pharmaceutics (pharmacokinetics) from the University of Minnesota in 1989, and MS in biopharmaceutics from the University of Manitoba, Canada in 1984, M. Pharm (in 1980) and B. Pharm (in 1978) from Nagpur University in India. Dr. Shah has authored more than 80 abstracts and manuscripts. He is a member of AAPS, ASCO and AACR. Currently he is supporting pharmacology and pharmacokinetics for projects at Sun BioPharma, Inc.
Vice President of Operations
Since April 2012, Ms. Groene has provided administrative support and operational management to the Sun BioPharma, Inc. team. Prior to joining Sun BioPharma, Inc., Ms. Groene worked for MGI Pharma, Inc. as the Executive Assistant to the Chief Medical Officer then transitioned into the Marketing Department. Ms. Groene earned her Bachelor of Science degree from St. Cloud State University in St. Cloud, Minnesota.
Anthony L. Kiorpes, Ph.D., DVM
Andy Kiorpes is a graduate of Columbia University (BA Biology, 1970), the University of Wisconsin-Madison (MS Veterinary Science, 1974; PhD Physiology, 1977) Kansas State University (DVM, 1982), and the University of Arkansas (MBA, 1999). He has over 22 years of experience as a toxicologist working in food, pharmaceutical, and medical device development and safety. A former university professor and large animal veterinarian, Dr. Kiorpes has authored/co-authored over 50 scientific articles, abstracts, and book chapters in physiology, toxicology, and veterinary medicine. He has been an invited speaker on topics ranging from the Good Laboratory Practice Act to Carcinogenicity Testing to Toxicokinetics. He has been an active member of the American College of Toxicology since 1998, serving on the Finance Committee from 2006 through 2008 and beginning a three-year term on Council in 2012. A full member of The Society of Toxicology (SOT), The American Physiological Society, and the American Veterinary Medical Association including the Minnesota chapter, he was past president and councilor of the Northland Chapter of SOT and an adjunct professor in the Graduate Toxicology Program at the University of Minnesota. Dr. Kiorpes is currently an Editor-in-Chief of the journal Toxicology and Industrial Health and an independent consultant working with pharmaceutical and medical device clients (River Bluff Associates) and serves on the business advisory board of the University of Minnesota’s office of technology transfer. Dr. Kiorpes is a 1994 diplomate of the American Board of Toxicology.
Michael Walker, M.D.
Director of Pancreatic Research
Dr. Walker graduated from the University of Minnesota in 1986 (BS, Biochemistry) and the University of Minnesota Medical School (MD) in 1990. During his General Surgery residency, he completed a 2 years American Cancer Society clinical fellowship, focusing on pancreatic islets and their molecular physiology. He practiced General Surgery in Minnesota for 11 years before joining Sun BioPharma. Dr. Walker brings a strong background in both the molecular biology of the pancreas and clinical practice caring for patients with pancreas cancer and pancreatitis, including the most severe form of pancreatitis, necrotizing pancreatitis. Dr. Walker holds and appointment in the Medical School at the University of Minnesota. He has several peer-reviewed publications and gave a poster presentation about SBP-101 at the 2017 Digestive Disease week conference. Dr. Walker was an invited lecturer at the most recent Gordon Research Conference on Polyamines, and international gathering of leading scientists in polyamine research.