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 Bullet Biotechnologies, Durect Corporation, Marinus Pharmaceuticals and the Santa Clara University Entrepreneurial School. Jay holds a BS in Business Administration from the University of Arizona.
Joshua T. Brumm
Chief Operating Officer and Chief Financial Officer
Josh has more than a decade of operations, corporate finance and investment banking experience in the life science industry. He was most recently Executive Vice President of Finance and Principal Financial Officer for Pharmacyclics Inc., a NASDAQ-listed biopharmaceutical company. Previously as Chief Financial Officer at ZELTIQ Aesthetics, Inc., a NASDAQ-listed medical technology company, Josh held a number of operational and financial positions in strategic planning, global finance, IT and administration. As Vice President of Corporate Development and Investor Relations, Josh led the company’s successful $105 million initial public offering. Also at ZELTIQ as Senior Managing Director of International Sales and Corporate Development, he led the launch of its first commercial product in all markets outside of the United States and Canada. Prior to joining ZELTIQ, Josh was Director of Finance at Proteolix, Inc., helping in the sale of the company to Onyx Pharmaceuticals; a member of the West Coast Healthcare Team at Citigroup Global Markets, Inc.; and Founder and Chief Executive Officer of Nu-Ag Distribution, LLC, an agricultural consulting company. Josh began his career as a Healthcare Investment Banking Analyst for the West Coast Healthcare Team at Morgan Stanley. He holds a BA in Business Administration from the University of Notre Dame.
Colin Hislop, MD
Chief Medical Officer
Dr. Hislop has over 27 years of drug development experience in a variety of therapeutic areas, including endocrine disease. Dr. Hislop joined Versartis in 2016 from Anthera Pharmaceuticals, where he was a founding member of Anthera’s management team and served as the company’s Chief Medical Officer. Before joining Anthera, Dr. Hislop was Vice President, Clinical Development for Peninsula Pharmaceuticals, Inc., and prior to that Vice President, Clinical Development for CV Therapeutics, Inc. He began his industry career with Eli Lilly & Company as a Medical Director for the endocrine portfolio in the UK before moving to Procter & Gamble Co. to lead the initial risedronate (Actonel™) development program. Over the course of his career, Dr. Hislop has helped secure over $300 million in private and public equity financing, and has supported the in-licensing of compounds for development as well out-licensing and partnership opportunities. He has been involved in numerous regulatory interactions for drugs spanning from pre-IND to advisory committee meetings for approval. Among those drugs with approvals are ActonelTM, which went on to realize $1.0 billion in global sales, and RanexaTM, which was one of the key drivers behind Gilead’s purchase of CV Therapeutics for $1.4 billion in 2009. Colin obtained his medical degree from Middlesex Hospital Medical School, University of London. He also holds a BS in Medical Biochemistry from the University of Surrey.
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.
Bert Bakker, MD, PhD
Senior Vice President, Medical Affairs
Bert is a medical affairs executive and clinical development physician with 16 years of pharmaceutical and biotech experience. He joined Versartis from Novartis Oncology, where he was Global Brand Medical Director, Global Medical Affairs. There he led and developed the global medical affairs strategy for the use of two somatostatin analogs in neuro-endocrine tumors. Previously at Ipsen, Bert was Vice President Medical Affairs and led all activities of the US Endocrine Medical Affairs group. He was a key contributor at Genentech for six years as Medical Director in the Clinical Development group, where he covered all four stages of drug development, from early clinical development to post marketing for products including growth hormone. Prior to Genentech, Bert was Medical Director, Worldwide Medical, Endocrine Care at Pfizer, Inc. and also held positions at Pharmacia and Schwarz Pharma Benelux. He is a European Union board-certified pediatric endocrinologist and began his medical career as an Assistant Professor at the Academic Medical Center, University of Amsterdam, the Netherlands. He received his MD from the Medical School at the University of Leiden, the Netherlands and his PhD in Medical Sciences from the University of Amsterdam, the Netherlands. While completing a fellowship at Stanford University, Bert was the recipient of a Fulbright Scholarship for IGF research. He is widely published and while at Genentech was one of the lead authors of the National Cooperative Growth Study Registry. His most cited publication is on the first-year growth results with daily growth hormone in pediatric growth hormone deficiency.
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.
Vice President, Manufacturing
Pat has over three decades of industry experience in CMC and operations roles including Manufacturing, Contract Manufacturing, Technical Operations, Pilot Plant Operations, Process Development, Analytical and Formulation Development, Pharmaceutical Development, Quality Assurance, Quality Control, Facilities, Engineering, Supply Chain and Logistics, Purchasing, Environmental Health and Safety, Security and Office Management. His experience includes 19 years at Genentech and he also held executive positions at Abgenix, Acologix and Solstice Neurosciences. During his career, Pat managed the manufacture of over 10 marketed and over 20 clinical products, including guiding more than 10 new products from pilot to full-scale commercial production while ensuring both product and facility compliance with FDA, EMA, Canadian, Korean and Japanese standards. Most of these products generated $200M to over $1B in annual revenues. Additionally, he has been responsible for more than 18 facility construction projects totaling more than $250M. He has worked closely with corporate partners located in Europe, Japan and South Korea and been directly responsible for worldwide supplies of clinical and marketed products. Pat holds a BS in Biochemistry from The State University of New York at Binghamton.
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.
Gregory S. Yedinak
Vice President, Device & Pharmaceutical Development
Greg has nearly 30 years of experience in pharmaceutical development and manufacturing, from small-scale quantities to commercial-scale production. His expertise encompasses working closely with contract service organizations including leading teams of manufacturing, quality, regulatory affairs, medical affairs, marketing, clinical development and clinical operations in the development and commercialization of both drugs and devices. Prior to joining the team at Versartis, he was Vice President, Operations at Zosano Pharma, which included management of manufacturing, QA/QC, facilities, engineering, supply chain, process development and system design operations. Previously, Greg was Vice President, Process Sciences and Manufacturing at Nuvelo, Inc., where he was responsible for all process sciences and manufacturing activities for the company’s early and late-stage products using contract services organizations. He also held several manufacturing positions of increasing responsibility at Abgenix, Inc. (Amgen), lastly as Vice President, Manufacturing, Facilities and Engineering. Greg began his career at Genentech, Inc., working for 15 years in various product recovery areas, last of all as Associate Director, Manufacturing Operations. He holds a BS in Biological Sciences from the University of California, Irvine.
Vice President, Project Management
Stacey has over 20 years of industry experience in drug development and lifecycle strategy, moving programs from pre-IND through commercialization. She is recognized as a subject matter expert in project and program management and has led or managed cross-functional teams in Clinical Development, Commercial, Medical Affairs, and Joint Alliances at companies such as BioMarin, Elan, Genentech, and Pfizer. She has worked with growth hormone products Nutropin® and Genotropin®, as well as a broad range of therapeutic areas and products such as Tysabri®, Avastin®, Xolair®, Viagra®, Celebrex®. Stacey spent the last 4 years at BioMarin Pharmaceuticals as a Team Leader for a rare disease biologic therapy for Phenylketonuria, advancing the program from Phase 3 to BLA filing. She also served as a Project Management Group Leader, managing and mentoring other project management professionals. Stacey started her career at Amgen in the technical operations organization manufacturing Epogen® and developing business process improvement strategies. She received a Bachelor’s degree from University of CA, Santa Barbara and has a MBA from Baruch College, Zicklin School of Business in New York.
Vice President, Human Resources
Vicky has extensive experience in building the people strategies for scaling, transforming and globalizing businesses with integrated and comprehensive Human Resources strategies and programs. Her experience in leading the entire spectrum of Human Resources includes rapidly growing and scaling within start-ups, and within companies of all sizes focused on driving business transformations and entrances into commercialization. Prior to joining Versartis, Vicky was head of HR for Santen Inc. She has held executive, specialist and generalist HR roles in life sciences companies including Dey/Merck KGaA, IMPAX Laboratories and Matrix Pharmaceuticals, as well as in the Tech industry for NCR/AT&T, where she worked extensively to integrate its acquired companies of Teradata, Sharebase and Comten.
She has an MBA from the University of St. Thomas, St. Paul, MN, and a Bachelor’s degree in Music Education from the University of Minnesota, Minneapolis.