Ardelyx
Biotechnology
Waltham, MA

Overall Rank: 242
Category: Biotech
Category Rank: 76

Profile

Ardelyx is a publicly traded biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. They are dedicated to improving the lives of patients by discovering, developing and commercializing first-in-class targeted therapies that advance patient care. Using their discovery model, Ardelyx scientists identified new biological mechanisms and pathways that enabled us to develop drug candidates designed to address significant unmet medical needs with the goal of improving outcomes for patients.


Visit: www.ardelyx.com


Key Products

IBSRELA


Ardelyx unique discovery platform and deep understanding of the primary mechanism of sodium transport in the intestine resulted in our discovery and development of IBSRELA® (tenapanor), a first-in-class therapy, available in the U.S. and Canada for the treatment of adults with irritable bowel syndrome with constipation (IBS-C). IBSRELA is dosed as one 50mg tablet BID.


Key Executives

Mike Raab, President & Chief Executive Officer


Mike has served as Ardelyx’s President and Chief Executive Officer since March 2009. Before Ardelyx, Mike was a partner at New Enterprise Associates (NEA).


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, of therapeutics and general manager of the renal division at Genzyme Corporation. In this position, Mike launched and oversaw the sales growth of sevelamer with over $1.0 billion in worldwide sales in 2013. Mike was also instrumental in the worldwide launch of Genzyme’s therapies for Gaucher disease, Ceredase and Cerezyme. 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


Robert Blanks, MS RAC, Chief Regulatory Affairs and Quality Assurance Officer


Rob has served as our Chief Regulatory Affairs and Quality Assurance Officer since 2020. Before that, Rob had served as our head of regulatory affairs and quality assurance since August 2013. Rob has over 20 years of experience in the pharmaceutical industry in the quality, regulatory and CMC areas. A majority of this experience has been with small biotech companies, where he has played a critical role in developing companies’ initial drug product candidates, including peptides, monoclonal antibodies and small molecules, from the pre-clinical stage to commercial registration.


Prior to Ardelyx, Rob was vice president of CMC at Flexion Therapeutics and before that he was vice president of quality at Idenix Pharmaceuticals. Previous to Idenix, he served as vice president of technical operations for Trine Pharmaceuticals and earlier was vice president of technical operations and founder of Phaedrus Pharmaceuticals. At GelTex Pharmaceuticals, subsequently purchased by Genzyme, he was a key participant in both the quality and regulatory areas in the development and registration of RenaGel®.


Rob has a B.S. in biology from Bowdoin College and an M.S. in chemistry from Boston College. Rob is regulatory affairs certified.


Elizabeth Grammer, Esq. Chief Legal and Administrative Officer


Liz has served as Chief Legal and Administrative Officer since 2020. Before that, Liz had served as our General Counsel since May 2014. Liz joined Ardelyx as vice president, legal in December 2012 after serving as an independent outside corporate counsel for Ardelyx for three years. Liz brings over 20 years of experience representing privately held and publicly traded life sciences companies in structuring and negotiating strategic transactions, such as collaborations, joint ventures and intellectual property licensing transactions. Liz also brings significant experience in providing legal support in connection with all aspects of the research, development and manufacture of pharmaceutical products.


Prior to joining Ardelyx, Liz served as vice president and general counsel of Trine Pharmaceuticals and as general counsel of GelTex Pharmaceuticals. Liz started her career in the law firms of Ware & Freidenrich in Palo Alto, Calif., and Palmer & Dodge in Boston, in both cases, focusing her efforts on work with emerging life sciences companies.


Liz received her J.D. from Stanford Law School and her B.A. from Boston University.


David Rosenbaum, PhD, Chief Development Officer


David has served as our Chief Development Officer since January 2015, and before that, had served as our vice president, drug development since January 2010. David has spent the past 20 years developing new therapies for global registration and has focused his efforts on non-absorbed, minimally-systemic new chemical entities.


David 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. Notably, David was vice president of preclinical research and development at GelTex Pharmaceuticals. Most recently, David was vice president of drug development for Trine Pharmaceuticals. 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, an M.S. in toxicology from Albany Medical College and a B.A. in biology from the University of Pennsylvania.


Justin Renz, Chief Financial Officer


Justin has served as our Chief Financial Officer since June 2020. Justin brings over 20 years of experience in the biopharmaceutical industry, with an extensive array of financial and operational experience.


Prior to Ardelyx, Justin served as the president and chief financial officer of Correvio Pharma where he led the sale of the company to ADVANZ PHARMA in May 2020. Prior to Correvio, Justin was executive vice president, chief financial officer and treasurer of Karyopharm Pharmaceuticals. Before Karyopharm, Justin was executive vice president and chief financial officer at Zalicus Inc. (formerly CombinatoRx, Inc.), which he joined in 2006. Earlier in his career, Justin held numerous positions of increasing responsibility at EMD Serono Inc., ArQule, Inc., Coley Pharmaceutical Group and Millipore Corporation.


Justin began his career with Arthur Andersen LLP in 1993. He received a Bachelor of Arts in Economics and Accounting from the College of the Holy Cross, a Master of Science in Taxation from Northeastern University, and a Master of Business Administration from Suffolk University.


Susan Rodriguez, Chief Commercial Officer


Susan has served as our Chief Commercial Officer since May 2020. Susan brings over 25 years of industry experience, with extensive leadership across pharmaceutical, biopharma, hospital products, and nutrition segments in U.S. and international markets.


Prior to Ardelyx, Susan served as the founding chief executive officer of Tolmar Pharmaceuticals. Susan was then named President of the branded division upon the formation of the global entity, Tolmar Inc. Prior to Tolmar, Susan held various positions at Abbott Laboratories, most recently divisional vice president of global marketing, where she established the global marketing function for a $3.8 billion international portfolio of nutrition brands. As divisional vice president, she directed strategic brand planning and commercial go-to-market strategies and programs for 11 global product launches. Earlier in her career, Susan held several sales, marketing and commercial positions including, vice president and general manager, Abbott Renal Care, director, managed care at TAP Pharmaceuticals, professional sales representative at Merck Human Health Division and client manager at ARBOR, a pharmaceutical market research firm.


Susan holds a Master’s and Bachelor’s degree in Psychology from the University of Pennsylvania.


Laura Williams, MD MPH, Chief Medical Officer


Laura has served as our Chief Medical Officer since 2021. Before that, Laura served as our Senior Vice President (SVP), Global Therapeutic Strategies and Patient Advocacy since November 2020. Laura is a results-oriented, accomplished, executive leader with 25 years of global pharmaceutical drug development experience both in large pharma and smaller biotech settings, spanning all clinical development phases and numerous therapeutic areas. She has a proven track-record, as indicated by her leadership on and contributions to key regulatory approvals for 7 on-market compounds.


Prior to Ardelyx, Laura served as SVP and Head of Clinical Development and Biostatistics at AMAG Pharmaceuticals. Prior to AMAG, she served as Vice President of Clinical Development at Myovant Sciences. Previously, in her 18-year career at Abbott/AbbVie, she held roles of increasing responsibility, leading multiple global clinical development programs and managing the general medicine therapeutic area.


Laura holds a Bachelor of Science degree from Mississippi State University, a Doctor of Medicine degree from University of Iowa, and a Master of Public Health degree in Epidemiology from University of Washington, where she also completed a clinical fellowship in Infectious Diseases. She completed her Internal Medicine residency at University of Michigan, where she also served as Chief Resident and Junior Faculty.


Company Insights

“All of us at Ardelyx are sincerely grateful to the patients who participate in our clinical studies, as well as their families and caregivers who are with them along their journey. Everyone here at Ardelyx is passionately committed to serving patients in the best way possible, and it’s because of each patient’s individual contribution that we are able to do the work necessary to bring forward important new medicines.” – Mike Raab, President & Chief Executive Officer