Chairman, President and CEO, Intarcia Therapeutics, Inc.Full Bio
Chairman, President and CEO, Intarcia Therapeutics, Inc.
Mr. Graves has been Chairman, President and CEO of Intarcia since April 2012, having previously served solely as Executive Chairman of the company since August 2010, and as Acting CEO since October 2011. During his time at Intarcia, his influence on the Company’s vision, purpose and values has transformed not only its business goals, but also how it goes about its business. Since he joined, Intarcia successfully raised more than $1 billion in capital through very creative financings and strategic partnerships. Mr. Graves was named the 2015 EY Entrepreneur of the Year in New England, and Intarcia was cited as a “Unicorn” company worth watching in a cover story of Fortune Magazine, and a 2015 “Disruptor 50” company by CNBC. Mr. Graves is a global industry leader with more than twenty years of U.S. and global general management experience at top-tier U.S. and European based pharmaceutical and biotech companies. He has successfully built and managed several of the largest multi-billion dollar franchises in the industry and developed and launched more than 10 blockbuster brands in a broad range of general medicine, specialty and orphan disease areas. In addition to driving dynamic top and bottom-line growth in large global pharmaceutical companies, Mr. Graves also played a key leadership role in building two highly successful early stage companies: Astra Merck Pharmaceuticals and Vertex Pharmaceuticals. Prior to joining Intarcia, Mr. Graves was EVP, Chief Commercial Officer, and Head of Corporate and Strategic Development at Vertex Pharmaceuticals. Before his tenure at Vertex, he spent nearly ten years at Novartis Pharmaceuticals, most recently on the Executive Committee as Global Head of the General Medicines Business Unit & Chief Marketing Officer for the Pharmaceuticals division. Prior to Novartis, Mr. Graves held several commercial and general management positions at Merck and Astra Merck/Astra Pharmaceuticals where he spent most of his time leading the GI Business Unit responsible for Prilosec® and Nexium®. In addition to his current responsibility at Intarcia, Mr. Graves serves as Chairman of the Board of Radius® Health, Inc. (RDUS), and as a Director at Achillion Pharmaceuticals (ACHN), and Seres Therapeutics (MCRB). Mr. Graves earned his B.S. in Biology from Hillsdale College and has attended numerous executive leadership programs at Harvard, Wharton School of Management and University of Michigan.
Learn more about Mr. Graves' background and approach in this article from "Life Science Leader."
Vice President, Finance and Operations Chief Financial OfficerFull Bio
Vice President, Finance and Operations Chief Financial Officer
Mr. Ahlers joined Intarcia Therapeutics in March 2000. Mr. Ahlers has served as a financial consultant to public and private biotechnology companies including Cytokinetics, GeneSoft and Tularik. He has extensive experience financing and building the infrastructure of growing pharmaceutical and biotechnology companies. In this capacity, Mr. Ahlers has served as the Director of Finance and Administration and managed the initial public offerings of Ansan Pharmaceuticals and Titan Pharmaceuticals. Previously, he was a member of the audit department in the San Francisco office of Deloitte & Touche and manager of Financial Planning and Analysis at Medco Behavioral Care Corporation. Mr. Ahlers earned a B.S. degree from the University of San Francisco in accounting.
Thomas Alessi, Ph.D.*
Vice President, Development and ManufacturingFull Bio
Thomas Alessi, Ph.D.*
Vice President, Development and Manufacturing
Dr. Alessi joined Intarcia in December 1997 as Executive Director, Regulatory Affairs and Drug Development and was promoted to Vice President, Development in February 2002 with responsibility for the areas of product development, project management, chemistry and manufacturing. Prior to joining Intarcia, Dr. Alessi served as the Senior Director, Regulatory Affairs, Quality Assurance and Project Management at Ansan Pharmaceuticals where he was responsible for successful IND filings and for managing five drug development programs with oversight of vendors for preclinical and clinical studies and manufacturing clinical supplies. Before joining Ansan, Dr. Alessi was Director of Regulatory Affairs and Quality Assurance at Glycomed, Inc. where his duties included oversight and compliance of clinical manufacturing. His previous experience includes regulatory affairs and drug discovery experience in large pharmaceutical companies. Dr. Alessi was Senior Manager of Regulatory Affairs for Schering-Plough working in the Anti-infectives, Allergy Products and Chemisty, Manufacturing, & Controls groups. While at Schering-Plough, Dr. Alessi had regulatory responsibilities for approval and launch of Intron® for hepatitis C as well as for hepatitis B. In his CMC role, he served on separate committees for process development and production of solid oral dosage forms, inhaled products, creams and semisolid products and sterile dosage forms, in addition to regulatory review of the CMC sections of Schering-Plough INDs and NDAs. Prior to joining Schering-Plough, Dr. Alessi invented and patented several new families of antidiabetic drugs while working as a Senior Scientist in the drug discovery group at Wyeth-Ayerst. Dr. Alessi earned a B.S. degree at Allegheny College and an M.S. and a Ph.D. in organic synthetic chemistry from the University of Rochester.
James P. Brady
Vice President, Human ResourcesFull Bio
James P. Brady
Vice President, Human Resources
Mr. Brady joined Intarcia in April 2015 as Vice President, Human Resources. He previously served as Senior Director & Head of Global Industrial Operations Learning & Development at Genzyme, a Sanofi Company, where he supported the manufacture of approximately $3 billion in commercial product with a central team and global network within manufacturing, distribution and core functions. Prior to that, he served as Director and then Senior Director, Leadership & Organization Development at Genzyme. Before that, he was Director, Talent Development and Director, Leadership Development at Thomson Financial, and prior to that, held a variety of educational positions focused on leadership and management-related topics. Mr. Brady holds a Bachelor of Arts degree in History from Marietta College, and a Master of Theological Studies degree from Harvard University. He also completed management and professional learning coursework at MIT’s Sloan School of Management, Babson College’s School of Executive Education and the University of Michigan’s Ross School of Business.
Paul Feldman, Ph.D.*
Head of Discovery and Translational MedicineFull Bio
Paul Feldman, Ph.D.*
Head of Discovery and Translational Medicine
Dr. Feldman joined Intarcia in September 2015 as Head of Discovery and Translational Medicine. Dr. Feldman assumed this new role following Intarcia’s acquisition of Phoundry Pharmaceuticals, Inc., a peptide therapeutic discovery company, where he was a co-founder and CEO. Prior to his work at Phoundry, Dr. Feldman worked for GlaxoSmithKline, ultimately as a senior vice president, and some of his accomplishments included: contributing to the discovery and development of multiple medicines, leading national and international multi-disciplinary discovery and early development groups, managing several key multi-national business collaborations, and serving as the head for GlaxoSmithKline’s Research Triangle Park site. Dr. Feldman has more than 100 scientific disclosures (patents, scientific articles, book chapters, and invited lectures), and has been an adjunct Professor of Chemistry for Duke and North Carolina State Universities. He has served in multiple leadership roles for the executive committee of the Division of Organic Chemistry of the American Chemical Society, and is currently an editor for “Organic Reactions”. He received a B.S in chemistry from Duke University and a Ph.D. in organic chemistry from the University of California, Berkeley.
Fred Fiedorek, M.D.*
Chief Medical OfficerFull Bio
Fred Fiedorek, M.D.*
Chief Medical Officer
Dr. Fred Fiedorek joined Intarcia in August 2018 as the Chief Medical Officer. In this role, Dr. Fiedorek leads the clinical development and related functions, including medical affairs, clinical pharmacology, safety, health economics and outcomes (HEOR) and biostatistics for Intarcia. Fred’s extensive strategic and tactical knowledge in diabetes, cardiovascular, metabolic and endocrine diseases, as well as several other therapeutic areas in drug development, pair well with Intarcia’s pipeline. Prior to joining Intarcia, he served as the Chief Medical Officer at Rhythm Pharmaceuticals, Inc. responsible for the Relamorelin and Setmelanotide therapies. He previously spent 14 years at Bristol-Myers Squibb (BMS), where he most recently served as Senior Vice President and Head of Development - Cardiovascular and Metabolic. His duties and achievements included leading a group of talented MD and PhD clinical staff members in the development programs for apixaban, dapagliflozin, saxagliptin, exenatide (Byetta®/Bydureon®), and metreleptin. While at BMS he also held leadership positions in Exploratory Development and Global Clinical Research. Dr. Fiedorek began his career at GlaxoWellcome, Inc. where his work heavily focused on clinical research and project leadership in the metabolic, cardiovascular, and urology areas. He received his B.A. in English from Yale University and his M.D. from Harvard Medical School. He completed residency and fellowship training in Internal Medicine and Endocrinology & Metabolism at Washington University School of Medicine in St. Louis. He also served on the faculties at the Washington University School of Medicine and the University of North Carolina at Chapel Hill School of Medicine.
Chief Design OfficerFull Bio
Chief Design Officer
Mr. Goldenberg joined Intarcia in January 2017 as Chief Design Officer, where he brings design communication and innovation strategies to the business. Mr. Goldenberg is the founder and chief executive officer of Epic Decade, a design-thinking studio and leader in the field of public engagement. The studio works with companies, cities, colleges, foundations and cultural organizations to leverage design as a process for producing new business models and cultural transformation. Immediately prior to joining Intarcia, Mr. Goldenberg served as chief marketing officer for the State of Rhode Island. Before founding Epic Decade, Mr. Goldenberg worked for Bruce Mau Design, a globally renowned design innovation firm. Mr. Goldenberg has led design innovation processes for CEOs and leaders from American Express, Apple, the City of Liverpool, Boston University and the Oprah Winfrey Network. Mr. Goldenberg holds an undergraduate degree from Rhode Island School of Design (RISD), and a Master degree from the Maine College of Art. His work has been written about in publications such as Fast Company, Huffington Post, The New York Times and WIRED.
Vice President, Global Technical OperationsFull Bio
Vice President, Global Technical Operations
Mr. Hurley is the Vice President, Global Technical Operations. He joined Intarcia in April of 2016, and served as Vice President, Global Commercial Manufacturing and Operations before his role was expanded to include all technical operations in early 2017. Prior to joining Intarcia, Mr. Hurley served as Genentech’s Vice President, Head of Global External Manufacturing – Biologics. He spent the last eleven years of his career at Genentech in positions of increasing responsibility. As part of his role for Genentech’s Biologics CMO network operations globally, Mr. Hurley managed the relationships with more than 40 different CMOs around the world. He joined Genentech in 2005 when he was responsible for the Biologics manufacturing operations in South San Francisco. He then led the Roche Biologics Quality Operations for the Drug Product network beginning in 2010. In June of 2013, he assumed his final role at Genentech leading the Biologics CMO network. Prior to Roche/Genentech, Mr. Hurley worked for GlaxoSmithKline for 17 years, primarily in manufacturing, including five years as Site Director of Upper Merion Operations, in PA. He holds a B.Sc. in Chemical Engineering from CIT, Ireland, and a M.Sc. in Industrial Engineering from Rutgers, The State University, NJ.
Raymond T. Keane, Esq.*
Vice President, General Counsel, and Chief Legal OfficerFull Bio
Raymond T. Keane, Esq.*
Vice President, General Counsel, and Chief Legal Officer
Mr. Keane joined Intarcia in September 2013 as Vice President, General Counsel, and Chief Legal Officer. Prior to joining Intarcia, he served as Senior Vice President, General Counsel, Secretary, and Chief Compliance Officer of ARIAD Pharmaceuticals through its transition from a research and development platform to a fully integrated global commercial organization. At ARIAD, he built and led the global commercial legal team to support the company’s first product approval and launch, and created the corporate structure for European operations. He previously spent 20 years at Bristol-Myers Squibb Company (BMS), initially in corporate litigation and quickly moved to the Worldwide Medicines Group, where he had lead legal responsibility for the US marketing approval and launch of a number of blockbuster drugs in the cardiovascular, oncology and virology therapeutic areas, including Plavix®, Avapro®, Erbitux® and Reyataz®. Ultimately, as the senior lawyer for the Global Marketing and Strategic Development franchise, he and his team supported the global commercialization of three additional drugs/biologics, providing legal oversight for global marketing strategy, launch campaigns, corporate communications, healthcare professional interactions, and worldwide strategic development. Before joining BMS, Mr. Keane was a trial lawyer associated with two major New York City law firms. He received his B.A. in Economics from Fordham College and his J.D. from Fordham University School of Law.
Chief Experience Officer (CXO)Full Bio
Chief Experience Officer (CXO)
Mr. Smith joined Intarcia in December of 2013 as Head of Customer Experience & Outcomes (CXO). It is a new position overseeing a bold new business goal to outperform and redefine industry standards in customer experience optimization. As CXO, Mr. Smith is Intarcia's resident authority and champion fully dedicated to efforts to optimize the positive customer experiences and outcomes with our brands; ITCA 650 and other platform related projects we intend to develop and commercialize. He is 100 percent dedicated to the proactive optimization and continuous improvement of customer experiences with our target patients, providers and payers. With more than 24 years of industry experience in positions of rapidly increasing responsibility, Mr. Smith is eminently qualified for this challenging assignment, having demonstrated world-class success at the senior-most levels of Sales and Marketing at J&J, Novartis and Sunovion (formerly Sepracor). Most recently he served as President at "1-800-DOCTORS," a consumer, patient and physician centric company focused on leveraging technology, including secure digital-video and telephonic platforms, to create the best patient-physician experience possible. In addition to his B.A. in Biology from Westmar College, Mr. Smith successfully completed several executive courses at Harvard, including the 32-week Program for Leadership Development. Outside of work he is extremely versatile in sports, including: an Ironman Triathlete four times, earned a second-degree Black Belt, a former USPT Tennis Professional, and currently a coach of various youth teams. Mr. Smith is married and lives with three teenaged children in Massachusetts.
Andrew Young, M.B., Ch.B. (M.D.), Ph.D.
Vice President, Chief Scientific OfficerFull Bio
Andrew Young, M.B., Ch.B. (M.D.), Ph.D.
Vice President, Chief Scientific Officer
Dr. Young joined Intarcia in September 2015 as Vice President and Chief Scientific Officer. Dr. Young is most recognized for his role in the discovery and development of peptide therapeutics for metabolic diseases. Prior to its acquisition by Intarcia, he co-founded and was CSO of Phoundry Pharmaceuticals Inc., a company dedicated to rendering peptides sufficiently potent for incorporation into innovative delivery systems such as Intarcia’s proprietary mini-pump technology. Dr. Young entered industry from academia 26 years ago as the founding physiologist at Amylin Pharmaceuticals, Inc. There he pioneered work that illuminated the role of the gut in blood glucose control. He co-led different phases of the development of Symlin® and Byetta®, first-in-class medicines for the treatment of diabetes. His roles at Amylin included VP of Research and Senior Research Fellow. In 2008 he co-founded Satiogen Inc., a San Diego startup related to bile salt stimulation of gut hormone secretion, before joining GlaxoSmithKline in RTP, NC, as Head of Enteroendocrine Biology. At GSK he fostered the development of peptide therapeutics as well as non-absorbed medicines acting at gut targets. In 2015 he co-founded Phoundry Pharmaceuticals with five former GSK colleagues. Dr. Young received his medical degree as well as graduate science degrees from the University of Auckland School of Medicine, New Zealand, where he also taught physiology. He worked as a Fogarty Fellow for the NIH in Phoenix AZ, studying diabetes in Pima Indians. He worked as a Von Humboldt Fellow at the Max Planck Institute in Bad Nauheim, FRG, studying sensory neurophysiology. He has participated in the development of five drugs that were commercialized, written over 100 original papers and 37 book chapters or books, and is an inventor on 56 issued US patents.
Chief Marketing Officer (CMO) and Metabolic Franchise HeadFull Bio
Chief Marketing Officer (CMO) and Metabolic Franchise Head
Mr. Wettig joined Intarcia in April 2018 as the Chief Marketing Officer (CMO) and Metabolic Franchise Head. Mr. Wettig is recognized throughout the industry as an accomplished leader with an extensive background in metabolic diseases and diabetes marketing experience. Prior to joining Intarcia, Mr. Wettig served as the Chief Marketing Officer for Lilly Diabetes, where he led new product development, brand management and market research including the creation, launch and evolution of multiple diabetes brands and devices. He also served as the commercial lead for the negotiation, structure and ongoing management of the diabetes alliance between Lilly and Boehringer-Ingelheim. Mr. Wettig began his career at Lilly as a primary care sales rep, and then he pursued his focus on diabetes marketing as the U.S. Brand Leader for Lilly’s insulin brands. Mr. Wettig received his M.B.A. and B.A. in biology from Washington University in St. Louis.
Sunita Zalani, Ph.D.*
Vice President, Global Regulatory Affairs and QualityFull Bio
Sunita Zalani, Ph.D.*
Vice President, Global Regulatory Affairs and Quality
Dr. Zalani joined Intarcia in May 2014 as Vice President, Global Head of Regulatory Affairs and Quality. Dr. Zalani is an experienced regulatory professional with expertise in developing monoclonal antibodies, recombinant proteins and small molecules in multiple therapeutic areas, and has a track record of product approval negotiations with global regulatory agencies. Prior to joining Intarcia, Dr. Zalani was Vice President, Global Regulatory Affairs at Onyx Pharmaceuticals, where she led the regulatory affairs organization and directed the development and execution of global regulatory strategy for pipeline and marketed products in hematology and oncology. Prior to that, Dr. Zalani spent eight years at Amgen, ending her tenure there as Executive Director, Therapeutic Area Head, Global Regulatory Affairs for nephrology, cardiovascular and bone product portfolios. At Amgen, she was a core member of the team executing the development, registration and commercialization strategies for several programs, and provided leadership for global filings, engagement with regulatory agencies, advisory committee meeting preparations and label negotiations to facilitate global regulatory approvals. Prior to that, she was at Eli Lilly and Company for eight years and was responsible for osteoporosis and diabetes product development. There, she provided regulatory support for the global development of several products through various stages of development from IND application to post approval, and she was the regulatory lead responsible for global submissions to facilitate regulatory approvals worldwide. Dr. Zalani conducted her post-doctoral research at the Lineberger Cancer Center in the University of North Carolina at Chapel Hill, and earned her PhD in Biochemistry, and an M.S and B.S from M.S University, India.
*Executive Officer of the Company