Ardelyx CEO and leadership

Mike Raab has been Chief Executive Officer and Chairman of Ardelyx since March 2009. Before Ardelyx, Mike was a partner at New Enterprise Associates (NEA) one of the world’s largest and most successful venture capital firms and specialized in healthcare investments focusing on the biotechnology and pharmaceutical sectors. Prior to joining NEA in 2002, Mike spent 15 years in commercial and operating leadership roles in the biotech and pharmaceutical industries. He was Senior Vice President, Therapeutics and General Manager of the Renal Division at Genzyme Corporation. He built the Latin American division for Genzyme and was also Senior Product Manager for Genzyme’s $1+ billion therapies for Gaucher Disease, Ceredase and Cerezyme, and was instrumental in the worldwide launch of both products. Mike also spent two years with Genzyme’s Diagnostic products and services division. Previous to Genzyme, Mike held business development and sales and marketing positions at Repligen and Bristol-Myers. Mike received his B.A. from DePauw University.

Strategic and innovative thinker with a passion for developing, articulating and leading the execution of corporate strategy. Trained as a lawyer, and driven to advance the business interests of the company, I believe that successful leaders identify and respond to risk, but do not allow the presence of risk to solely define their course of action. I currently serve as the Executive Vice President and General Counsel of Ardelyx, Inc., with additional responsibility for human resources and compliance. With over 25 years representing clients in the biopharma space, I have helped lead several companies through the transformation from a privately held research based organization to a publicly traded fully integrated biopharmaceutical company. I have significant expertise in drafting and negotiating complex collaborations, corporate governance, and the operational issues encountered by biopharmaceutical companies in all stages.

Experienced global biotech professional with extensive strategic and operational expertise in the Regualtory, Quality and CMC aspects of drug development. Demonstrated success in leadership, project management and problem solving with a wide range of expertise.-LEADERSHIP: Establish and build the CMC group at Flexion and the Regulatory/QA groups at Ardelyx. At Flexion, deliver drug product candidates from concept to clinical trial ready material to meet company milestones. At Ardelyx, successfully file numerous CTAs, INDs, and submitted company's first NDA which led to company's first market approval.-PROJECT MANAGEMENT: In collaboration with internal groups, directed external CMOs to ensure delivery of API, drug products from clinical to commercial quality in a timely manner. Work with multiple internal functional groups, licensing partners to submit and update regulatory dossiers in US and multiple other countries.-PROBLEM SOLVING: Resolve Health Authority questions in person and in writing to expedite drug candidates through approval process and commercialization.

David has spent the past twenty years developing novel drugs for global registration; during that time he has focused his efforts on non-absorbed, non-systemic new chemical entities. He began his career at Arthur D. Little (ADL), where he was a senior consultant and study director for over a hundred pharmacology and GLP toxicology studies in a wide variety of therapeutic areas. Since ADL, David has spent his career working for start-up and small pharmaceutical companies. Most notably, David was Vice President of Preclinical Research and Development at GelTex Pharmaceuticals, where he was integral in the development and approval of two non-absorbed drugs: RenaGel and WelChol. Most recently, David was Vice President of Drug Development for Trine Pharmaceuticals, where he was developing a novel non-systemic therapeutic for the treatment of IBS. David has filed numerous INDs, met with regulatory agencies around the world, and filed two approved NDAs. David received a Ph.D. in Pharmacology from Boston University School of Medicine; a M.S. in Toxicology from Albany Medical College; and a B.A. in Biology from the University of Pennsylvania.

Mike Raab has been Chief Executive Officer and Chairman of Ardelyx since March 2009. Before Ardelyx, Mike was a partner at New Enterprise Associates (NEA) one of the world’s largest and most successful venture capital firms and specialized in healthcare investments focusing on the biotechnology and pharmaceutical sectors. Prior to joining NEA in 2002, Mike spent 15 years in commercial and operating leadership roles in the biotech and pharmaceutical industries. He was Senior Vice President, Therapeutics and General Manager of the Renal Division at Genzyme Corporation. He built the Latin American division for Genzyme and was also Senior Product Manager for Genzyme’s $1+ billion therapies for Gaucher Disease, Ceredase and Cerezyme, and was instrumental in the worldwide launch of both products. Mike also spent two years with Genzyme’s Diagnostic products and services division. Previous to Genzyme, Mike held business development and sales and marketing positions at Repligen and Bristol-Myers. Mike received his B.A. from DePauw University.