Jay P. Shepard
President and Chief Executive Officer
Jay has more than 33 years of experience across pharmaceutical, biotechnology and drug delivery companies, most recently as an Executive Partner at Sofinnova Ventures, a healthcare-focused venture capital firm, where he leveraged his industry expertise in support of the firm’s portfolio companies and served as Executive Chairman of the Versartis Board of Directors since early 2014. Previously, he was President and CEO of NextWave Pharmaceuticals, a pediatric-focused company acquired by Pfizer; President and CEO of Ilypsa, a nephrology company acquired by Amgen; and interim President and CEO of Relypsa (Ilypsa’s spin-out company). Jay has extensive commercial experience, helping lead over 17 product launches and establishing and coordinating multiple sales and marketing operations. He previously served as Vice President of Commercial Operations at Telik, where he oversaw all commercialization and market planning activities for the company’s oncology programs. Jay was one of the early commercial executives at Alza Pharmaceuticals, where he was Vice President in the Commercial Operations group, having held leadership roles of increasing responsibility in its establishment, operations and commercial presence. Alza was acquired by Johnson & Johnson in late 2001. He began his career in the pharmaceutical industry at Johnson & Johnson and Syntex Labs. Jay is a board member of Christopher & Dana Reeves Foundation and the Santa Clara University Entrepreneurial School. Jay holds a BS in Business Administration from the University of Arizona.
Vice President, Finance
Kevin has more than 20 years of experience in the high tech and biotech industries combined, 15 years of which have most recently been in the biotech industry with both large commercial and small emerging companies. He joined Versartis as a consultant in December 2013, became the Corporate Controller in January 2014 prior to the Company’s IPO and served in that capacity until December 2017. Kevin joined Versartis from InterMune, Inc., where he spent 8 years. Prior to its acquisition by Roche Holdings, Inc., he served in various financial management roles, including Director of Financial Reporting and most recently as Director of Financial Planning, where he was instrumental in building out the finance infrastructure in preparation for the European launch of Esbriet®. Prior to his tenure at Intermune, Kevin spent three years at Gilead Sciences, Inc. through the approval and launch of Viread®. He also spent eight years at Cisco Systems, Inc. in various capacities in finance, including a central role where he lead the financial integration of in excess of thirty acquisitions during a period of rapid growth. He began his career in public accounting with Grant Thornton, LLP. Kevin holds a B.S. in Business Administration, emphasis Accounting, from Western State Colorado University, where he graduated cum laude and was an Academic All-American in the sport of basketball his senior year.
Robert Gut, MD, PhD
Chief Medical Officer
Dr. Robert Gut has nearly 20 years of experience in the biopharmaceutical industry, leading clinical development and medical affairs initiatives for GH and other products. Prior to joining Versartis, Dr. Gut served as Vice President, Global Medical Affairs and Development at Radius Health. Over the past decade, his contributions in regulatory activities have helped achieve four U.S. Food and Drug Administration (FDA) product approvals and three new product indications. He has supported the launch of seven new products, overseeing activity including medical science liaison team building, health economics and outcomes research, and market access. He has also served as a member of the Advisory Committees for Reproductive Health Drugs and Drug Safety and Risk Management for the FDA’s Center for Drug Evaluation and Research. For the majority of his career, Dr. Gut served as Vice President, Clinical Development & Medical Affairs at Novo Nordisk Inc. He headed the company’s U.S. Biopharm Medical organization with leading products in endocrinology, hemophilia and women’s health (Norditropin®, NovoSeven® and Vagifem®), totaling approximately $1.6 billion in U.S. revenue. He is a recognized author of more than 90 publications and is a member of numerous professional organizations, including The Endocrine Society (ENDO). Dr. Gut received his Doctor of Medicine degree from the Medical University of Lublin, and his Doctorate degree from Lublin Institute of Medicine, Poland. He has attended postgraduate programs and trainings at Wharton, Stanford and Harvard Business School.
Senior Vice President and Chief Business Officer
Paul joined Versartis from Bayhill Therapeutics, where he was the Vice President of Business Development responsible for the company’s licensing activities and was a key contributor to its private equity fundraisings, IPO preparations and operational activities. Most notably, Paul led and closed a transformational $350M+ licensing deal with Genentech/Roche for Bayhill’s novel Phase 1/2 program in type 1 diabetes. Prior to Bayhill, Paul was the Vice President of Business Development at Novacea, where he was responsible for closing multiple transactions including the in-licensing of two clinical-stage oncology products. In addition, he was a key contributor to Novacea’s successful fundraising efforts, which resulted in approximately $100M from private equity financings and IPO. Previously, Paul held managerial positions at Deltagen, Collabra Pharma and Aviron, where he was responsible for establishing transactional, business development and financial planning operations, respectively. Earlier, Paul held positions of increasing responsibility at Genentech, including Manager, Project Finance and Manager, Financial Planning and Analysis. He began his career advising clients on product and company valuation, technology assessment and commercialization issues. Paul holds an MBA from the Haas School of Business at the University of California, Berkeley and a BA in Applied Mathematics from the University of California, San Diego.
Chief Commercial Officer
Tracy has over 20 years of experience in the pharmaceutical and biotech industries. She is recognized for building effective sales and marketing teams and developing strategies for product launch and commercial success, most notably with long-acting formulations. Most recently she served as the Chief Commercial Officer of KemPharm where she was responsible for building and managing the KemPharm commercial organization to support the company’s product pipeline. Prior to that, she held the role of Vice President, Sales & Marketing for NextWave Pharmaceuticals, where she worked on the commercial preparation of the first once-daily, extended-release liquid methylphenidate drug in the U.S. to treat ADHD, now being marketed as Quillivant XR CII by Pfizer following its acquisition of NextWave. Ms. Woody founded TMW Consulting, Inc., a provider of consulting services for emerging biotech and medical device companies. As a consultant, Ms. Woody served as acting CEO for one of the firm’s clients, RetroJect, Inc., a private ophthalmic medical device company focused on the treatment of glaucoma. Ms. Woody spent eight years at Greer Laboratories as part of the executive management team. Earlier in her career, Ms. Woody was Director of Marketing for ALZA Corporation, and Marketing Manager in Pfizer’s U.S. Pharmaceuticals Group, where she helped lead the launches of Concerta and Zoloft, respectively. Ms. Woody received a B.S. in Health Promotion and Applied Physiology from East Carolina University with a Minor in Business Administration.
Shane M. Ward
Senior Vice President and General Counsel
Shane is an attorney and corporate executive with 20 years of pharmaceutical and biotechnology industry experience, having served as an in-house lawyer in large and small public companies as well as working in a specialty FDA practice group at a global law firm. Shane joined Versartis from Dynavax Technologies Corporation, where he was Vice President, Compliance and Associate General Counsel, also serving as the Compliance Officer and Assistant Secretary. Previously, he was Associate General Counsel, Assistant Compliance Officer and Assistant Secretary at Human Genome Sciences, Inc. until its acquisition by GlaxoSmithKline for $3.6 billion. In that role, he established a commercial legal function and all elements of a comprehensive global compliance program prior to the launch of HGS’ first commercial product, Benlysta®. At Gilead Sciences, Inc., Shane directed the regulatory law and healthcare compliance team within the Legal Department and prior to that he served as Senior Counsel, Legal Regulatory & Compliance at Abbott Laboratories. Shane received his JD cum laude from Georgetown University Law Center and his BA from the University of Virginia.
Michael Burdick, RAC
Senior Vice President, Regulatory Affairs
Mike has more than 30 years of experience in regulatory affairs and drug development in pharmaceutical and biopharmaceutical industries. During his career, Mike has worked in multiple therapeutic areas including metabolic and endocrine disorders, and has led dozens of successful regulatory submissions in the US, Europe and other countries. Mike joined Versartis in 2015 from SteadyMed Therapeutics, where he led the regulatory development activities for SMT-101, an investigational drug-device combination product for the treatment of pulmonary arterial hypertension. Previously, Mike was Vice President, Product Development at NextWave Pharmaceuticals, where he led NDA submission and approval activities for Quillivant XR. Prior to that, he served in senior management positions in Regulatory Affairs, Quality Assurance & Project Management at Relypsa, Ilypsa and CV Therapeutics. Mike began his career at The Upjohn Company where he held positions of increasing responsibility during the company’s evolution through mergers with Pharmacia, Searle and lastly Pfizer, where he was Director, Global Regulatory Affairs for Respiratory, Metabolic and Women’s Health Products. Mike has a BS in Biochemistry from Michigan State University and has received RAC certification from the Regulatory Affairs Professional Society.
SVP, Technical Operations
Dr. Stout is an industry veteran with 25 years of experience in the development and commercialization of biologics. He joined Versartis from San Bio, where he was Senior Vice President of Manufacturing and led the process development, manufacturing, and quality assurance groups supporting the development of an innovative stem cell therapy for patients recovering from stroke. Prior to San Bio, Dr. Stout served as Global Process Team Lead at Amgen for Enbrel, an anti-TNF product, and as Global Technical Lead at Merck for Keytruda (pembrolizumab), which was the first anti-PD-1 therapy approved in the United States and was awarded Breakthrough designation. Previously, he served as Executive Director of Merck’s Center for Biopharmaceutical Manufacturing, and was Executive Director of Amgen’s Manufacturing Sciences and Technology Group. Earlier in his career he started and directed Pfizer’s Biologics Development Group. Dr. Stout received a Ph.D. in Chemistry and Biochemistry from the University of Nebraska-Lincoln, and a BS, MS in Chemistry from the University of Iowa.
Vice President, Global Clinical Operations
Eric has over 28 years of industry experience in drug development. His focus has been on the conduct of clinical trials with senior management roles in clinical operations at both start-up and large biotech companies. He has held leadership positions in clinical operations at ChemGenex, Genentech, Matrix and SEQUUS. Eric began his career in Clinical Operations at Syntex after six years in supervisory roles of basic animal research. He was responsible for the oversight of all clinical operations activities and management of a $70M operating budget for seven molecules during his five years at Genentech, including Nutropin AQ®, Nutropin Depot®, Raptiva®, Xolair®, Pulmozyme®, TNKase® and Activase®. He held leadership roles on NDA submissions and advisory panel defense teams and has been involved with multiple drug approvals including Xolair®, IntraDose and Synribo®. Eric has extensive experience managing Phase 1 through 4 clinical studies in endocrinology and oncology and has overseen multiple global studies in North America, Europe and Australasia. He holds a BA in Biology and Psychology from the University of California, San Diego and an MBA from the University of Phoenix.
Vinita P. Kumar
Vice President, Quality Assurance and Quality Control
Vinita has 25 years of industry experience in pharmaceutical development at both start-up and large companies. Her experience encompasses working from early phase development to full-scale commercial production both in an in-house and out-sourced environment. She has worked with several contract service organizations and contract laboratories where she has ensured compliance with FDA and EMA standards. Prior to joining Versartis, Vinita most recently served as Vice President of Quality at Relypsa where she built and led the quality organization from early development phase through FDA approval and commercial phase. Her career began as a pre-formulation Scientist at Syntex, followed by 23 years working at Roche, Oread, Telik, Ilypsa (Amgen) and Relypsa. Vinita has provided leadership to the quality organization primarily in small molecule and polymeric drugs. She has hosted several Regulatory Authority Inspections and has been successful in obtaining positive outcomes. She has been involved in marketed drugs such as Naprosyn®, Cellcept®, Toradol® and Veltassa®. Vinita is responsible for the overall quality operations and quality control, including quality management of all GxP Compliance, Validation, QC GMP, QC Clinical and QC Research. She holds two MS degrees: one in Physical Organic Chemistry from Southern Illinois University and another in Organic Chemistry from Patna University.