Steve Carchedi — Chief Executive Officer
Steve, who was named CEO in 2016, was previously Chief Executive Officer and President of Cornerstone Pharmaceuticals, an oncology discovery and development company focused on cancer metabolism. He served as the Senior Vice President and President, Commercial Operations (North America) for Mallinckrodt Pharmaceuticals. Having held key positions at several leading multinational pharmaceutical companies, he brings more than 30 years of commercial industry experience focused in Oncology, Neurology, Urology, Endocrinology and Cardiology. In addition to his industry experience, Steve currently serves on the Board of Directors of Sunesis Pharmaceuticals, Bionumerik Pharmaceuticals, and Apexian Pharmaceuticals. He also previously served on the board of directors for Cornerstone Pharmaceuticals and Picasso Diagnostics. Steve also served as Co-Chair of the BioNJ Personalized Medicine & Diagnostics Committee Council (CMOC), the Ontario Institute of Cancer Research Commercial Committee (OICR) and the Pharmaceutical Industry Board of the American Pediatric Family Foundation.
Steve received a B.S. in Marketing from West Chester University and an MBA in Marketing from Drexel University.
Mark R. Kelley, PhD. – Chief Scientific Officer
Mark is currently the Betty and Earl Herr Chair in Pediatric Oncology Research and Professor, Departments of Biochemistry & Molecular Biology and Pharmacology & Toxicology, Indiana University School of Medicine. He is also the Associate Director, Herman B Wells Center for Pediatric Research and the Associate Director for Basic Science Research at the IU Simon Cancer Center.
Mark completed his postdoctoral Fellowship at The Rockefeller University, New York, NY after earning his M.S. and Ph.D. from Louisiana State University, Baton Rouge, LA in 1984.
Mark holds numerous patents related to the use of DNA repair targets for cancer and has published over 166 articles in peer reviewed journals as well as 28 reviews and book chapters in numerous national and international journals. He also serves on the consulting and scientific boards of several biotechnology companies and serves on various NIH/NCI study sections and Cancer Center review panels. He was chair of the Cancer Etiology Study Section at NIH. He has also reviewed for international agencies. He is a member of American Association for the Advancement of Science, American Association for Cancer Research, Society for Pediatric Research, and American Society of Clinical Oncology.
Mark also serves on the editorial board of Frontiers in Bioscience, Journal of Pharmacology and Experimental Therapeutics, Mutation Research; Molecular and Fundamental Mechanisms (Assoc Editor) and Current Molecular Pharmacology.
Richard A. Messmann, M.D., M.H.S., M.Sc. — Chief Medical Officer
Richard is an NCI fellowship-trained medical oncologist with extensive experience in clinical trials in oncology and radiologic imaging. He served as Deputy Associate Director of the NCI Developmental Therapeutics Program (DTP) managing the division’s personnel, natural products group, biological and pharmaceutical laboratories at Ft. Detrick, MD, as well as being an attending physician for DTP Phase I clinical trials. After government service, Richard was an academic oncologist at Michigan State University, heading the breast cancer team as Principal Investigator for several National Surgical Adjuvant Breast and Bowel Project (NSABP) cooperative group trials. His pharmaceutical and biotech experience includes being a clinical research physician at Eli Lilly and Company and serving as Vice President for Medical Affairs at Endocyte, Inc. where his leadership supported a successful IPO for the company (Feb 2011) and a $1B licensing partnership with Merck (March 2012).
Prior to joining Apexian, Richard was the Chief Medical Officer for ProNAi Therapeutics directing development of a BCL2-targeted therapeutic agent, closing on the largest single round of venture capital funding in Michigan’s history, a series D round of $59.5 million before taking the company public in July 2015, raising $158.4 million in the IPO. He has degrees in electrical and computer engineering (B.S., Oakland University), health science and clinical research (M.H.S., Duke University) and biochemistry and medicine (M.Sc. and M.D., Wayne State University). Residency training included anesthesiology and critical care (Georgetown University and University of Michigan) and Internal Medicine (Michigan State University) where he served as chief resident. Richard is a member of the American Society of Clinical Oncology, American Association for Cancer Research, American Society of Hematology and European Society for Medical Oncology. He is the author of numerous peer-reviewed articles and book chapters.
Roger Miller – Chief Operating Officer
Roger Miller is an experienced pharmaceutical and biotechnology executive with broad general management experience. He joined Apexian as the Chief Operating Officer in November 2014.
Roger started his career with Eli Lilly and Company in research and development as an physical chemist before transitioning into a variety of general management roles in operations, human resources, manufacturing, and quality. He also had the opportunity to build the technical due diligence processes supporting technology assessments for Lilly’s business development organization. Roger has held significant leadership positions across a variety of biotechnology companies and start-ups, including Chief Operating Officer at Targanta Therapeutics, developing gram positive anti-infective agents; Vice President of Development for Beta Cat and Salarius Pharmaceuticals, developing oncolytic agents for colon cancer; and Chief Operating Officer at BioCritica, developing therapeutics for the critical care hospital setting.
Roger received both B.A. and M.S. degrees in chemistry from Indiana University (IUPUI). When his career moved into general management at Lilly, he obtained a M.S. degree in management (MBA) from Purdue Krannert Graduate School of Management.
Bill Current – Vice President of Regulatory Affairs
Bill Current joined Apexian in December 2014. He brings significant regulatory, discovery, and development experience in the pharmaceutical and biotechnology industry.
Prior to joining Eli Lilly and Company as a Senior Research Scientist, Bill was a Professor at Auburn University. At Lilly, he was Team Leader for numerous infectious disease research programs and Chairman of the Antifungal and Opportunistic Pathogens Research Group. He also served as Senior Regulatory Advisor (Director) and the Regulatory Coordinator responsible for the strategy and leadership of Global Regulatory Affairs sub-teams that provided regulatory oversight for more than 25 drug and device development teams and for more than 30 marketed drugs.
He has served as VP of Regulatory Affairs for Targanta Therapeutics (anti-infective biotech), and BioCritica (critical care biotech); as Acting Vice President or Regulatory Affairs for Malinta (formerly RibeX, anti-infective biotech); and as a Senior Regulatory Consultant for the Autoimmune Platform of Lilly (three Phase 3 teams).
Bill has served on the editorial boards of four refereed journals and has been a reviewer for another 10 refereed journals. He served on numerous NIH and USDA Study Sections, Review Committees, and Working Groups. He has authored or co-authored more than 300 publications that include 81 refereed journal articles, 37 invited publications and book chapters, 70 papers presented at meeting, and 93 invited lectures, symposium papers, and workshops. Bill received a B.S. in Biology from New Mexico State University, an M.S in Parasitology from Eastern Washington State University, and a Ph.D. in Life Sciences from The University of Nebraska.
Jan Elkins, RN – Director of Clinical Operations
Jan joined Apexian in July of 2015. She has experience in all phases of Clinical Trials Operations including monitoring, project management, auditing, quality assurance, and fiscal management. Her global and domestic experience encompasses tenure at both pharmaceutical and medical device companies.
Prior to joining Apexian, Jan held positions as a consultant for study management and process auditing, subsequently serving in Senior Management positions in the areas of contract and budgets and project management.
Jan holds a Bachelor of Science in Nursing and a Masters in Business Administration from Indiana Wesleyan University.
Roberta Smithey – Director of Regulatory Affairs and Project Management
Roberta joined Apexian in December of 2014. Her experience in regulatory affairs, clinical research and product development, ranging from large multinationals to start-ups, allows her to bring tremendous focus and perspective to the team.
For the past five years, Roberta has served on the Pearl Pathways IRB and consulted with several small companies to develop their submission strategy, document management systems and deliver global electronic submissions. Previous to that, she was Director of Regulatory Affairs for BioCritica and Targanta Therapeutics.
Roberta spent the majority of her career at Eli Lilly and Company in the planning, implementation and completion of numerous global regulatory submissions. She provides expertise on CTD and eCTD formats, risk management and post submission activities. She was directly involved in most major submissions made by Eli Lilly and Company during her career, including leading the process for Lilly’s first centralized submission team. Prior to her work in regulatory affairs, Ms. Smithey held multiple roles in the Medical division of the company where she worked on protocol development, CRF design, data management, completion of study reports and preparing integrated documents and labels for submissions.
Roberta received a B.S. degree in chemistry from the University of Indianapolis.
James Wikel – Head of Research and Development
Jim served in a variety of positions from the time he joined Eli Lilly in 1971 to 2004 as a scientist and research manager including Head, Structural and Computational Sciences, Discovery Chemistry Research & Technologies as well as Senior Research Scientist.
Jim was Chief Technology Officer of Coalesix Inc. a start up company in Cambridge MA from 2005 until it became a division of Icosystem Inc in December 2006. His experiences enable him to understand and translate among the disciplines of chemistry, biology and statistics to enable medicinal chemists to optimize molecules for drug development using both predictive models and empirical approaches. Jim has a Bachelor of Science degree in Chemistry and Master of Science degree in Organic Chemistry, both from Marshall University.