Chief Executive Officer (CEO) and President
Joel Lewis is Chief Executive Officer (CEO) and President of Galectin Therapeutics. In this position, Mr. Lewis sets corporate strategy and oversees operations, most importantly Galectin’s global NASH-RX adaptively-designed trial for the prevention of varices in NASH cirrhosis patients using its proprietary galectin-3 inhibiting compound, belapectin (GR-MD-02). Mr. Lewis has served on the Board of Directors for Galectin Therapeutics since 2017. Mr. Lewis is a financial executive with over 25 years of experience, who began his career in public accounting in 1992. From 2007 through 2019, Mr. Lewis acted as the Managing Director of Shareholder Services at Uline, Inc. (a distributor of shipping, packaging and industrial supplies). Prior to his employment with Uline Inc., Mr. Lewis served as a Tax and Accounting Manager for Century America LLC from 2001 to 2006 and a Tax Manager for Deloitte & Touche from 1998 to 2001. Mr. Lewis has a wide range of expertise including working in a variety of industries and disciplines including taxation, restructuring, acquisition, and private equity ventures. Mr. Lewis is a registered CPA in the state of Illinois. He holds a B.S. in Accountancy from the University of Illinois and a Masters in Taxation from DePaul University.
Pol F. Boudes, M.D.
Chief Medical Officer
Dr. Boudes has more than 25 years of experience in clinical drug development in immunology, endocrine, metabolic, orphan, and liver-related diseases, and he has contributed to the approval of multiple drugs, both in the US and globally, across a variety of therapeutic indications. Before joining Galectin Therapeutics, Dr. Boudes was the chief medical officer at CymaBay Therapeutics -- where he worked on the company’s proprietary NASH compound and was instrumental in inventing and launching programs in rare liver diseases. Prior to CymaBay, Dr. Boudes was CMO at Amicus Therapeutics, a company focusing on rare lysosomal storage disorders. His prior positions include clinical development at Bayer HealthCare Pharmaceuticals, Wyeth Research, Hoffman-La Roche, and Pasteur Merieux.
A dual citizen of the U.S. and France, Dr. Boudes earned his MD at the University of Marseilles, France. He completed his internship and residency in Marseilles and Paris, was an assistant professor of medicine at the University of Paris, and also participated in multiple clinical research programs as an investigator. He is certified by the Educational Commission for Foreign Medical Graduates (US) and board-specialized in endocrinology and metabolic diseases, internal medicine, as well as in geriatric diseases (Paris).
Dr. Boudes holds several records of invention and has contributed to multiple peer-reviewed publications, notably on improving the clinical development process, and has served on the editorial review board for La Revue Prescrire -- a leading European Drug Therapeutic Bulletin -- as well as several scientific advisory boards for drug development. He is a member of several professional organizations, including the American Association for the Study of Liver Disease, the European Association for the Study of Liver (Geneva, Switzerland), the American Diabetes Association, the Royal Society of Medicine (London, U.K.), and the American Medical Association.
Jack W. Callicutt, CPA
Chief Financial Officer
Mr. Callicutt became our CFO in 2013 and has over 32 years of public and private company experience including more than a decade of audit, tax and SEC registrant experience with a major accounting firm. Prior to joining Galectin, he was chief financial officer for REACH Health, Inc., a telemedicine firm. Previous positions include chief financial officer of Vystar Corporation, a public medical device company whose latex products are devoid of antigenic proteins, where he led all areas of financial reporting, accounting, treasury, risk management. Previous experiences also include chief financial officer roles at private companies including IVOX and Tikvah Therapeutics, and at Corautus Genetics, a publicly-traded biopharmaceutical company. Mr. Callicutt is a certified public accountant and graduated cum laude with a B.B.A. degree in accounting and computer science from Delta State University.
Steven Schoenfeld, M.D.
Vice President, Clinical Development
Dr. Schoenfeld has over 32 years of broad-based clinical development experience at both large pharma and small biotech companies. His experience in drug development includes NASH, early-stage oncology, rare and orphan diseases, diabetes and lipid disorders, osteoporosis, inflammatory diseases, hormonal therapy, as well as transdermal and needle free injector platforms. He has been the author of 11 allowed INDs and was part of the writing and submission teams on 9 approved NDAs and MAAs, as well several JNDAs.
Immediately before joining Galectin Therapeutics, Dr. Schoenfeld was a Senior Clinical Trial Physician and member of the submission team at Bristol Myer Squibb that successfully submitted a new chemical entity for treatment of plaque psoriasis world-wide and was also responsible for preparation of the Asian bridging report in support of this application for Asian countries. Previous positions included Vice President of Clinical Development for Strongbridge Pharmaceuticals (Cushing’s syndrome), Senior Vice President for Clinical Development at Viking Therapeutics (NASH, Hip Fracture), Vice President at Armagen working on lysosomal storage diseases (Hunter and Hurler syndromes), and Vice President at CalciMedica (CRAC channel inhibitors for inflammatory diseases). Other prior positions in clinical development include Pfizer (both Pfizer UK and Pfizer La Jolla, California), CovX (Pre-Pfizer), Pharmacia, Ionis, Procter and Gamble Pharmaceuticals, Amylin Pharmacueticals, and CIBA-Geigy (Pre Novartis formation).
Dr. Schoenfeld received his M.D. at New York Medical College as part of a combined B.S.-M.D. program, completed residency training in internal medicine at Westchester Medical Center (New York) and a Fellowship in Endocrinology and Metabolism at the University of Washington (Seattle).
Dr. Schoenfeld has been an author on 6 peer reviewed publications, one book chapter, and 57 presented abstracts.
Hugh Huang, Ph.D.
Vice President, Chemistry Manufacturing and Controls (CMC) Pharmaceutical Development
Dr. Huang brings over 20 years of drug product development and leadership experience to Galectin Therapeutics as Vice President, CMC Pharmaceutical Development. Prior to joining Galectin, Dr. Huang served as Senior Director, CMC at Avalo Therapeutics, where he led several early- and late-stage CMC development programs across multiple therapeutic areas. Prior to Avalo, Dr. Huang worked at Imbrium Therapeutics, Purdue Pharma, Johnson & Johnson, and Dow Chemical Company, where he gained in-depth knowledge in large and small molecules and extensive experience in pharmaceutical & analytical development and technical operations. He led CMC activities for four NDAs in the past ten years.
Dr. Huang holds over 20 granted U.S. patents, and his inventions have been used in several commercial products. Dr. Huang received his B.S. in Chemistry from Nanjing University and his Ph.D. in Organic Chemistry from The Ohio State University. He completed his postdoctoral training in Polymer Chemistry and Materials Science at Washington University.
Ezra R. Lowe, Ph.D.
Executive Director, Clinical and Preclinical Pharmacology
Ezra Lowe brings his depth of experience in clinical pharmacology, drug metabolism, and pharmacokinetics to his role as Executive Director, Clinical and Preclinical Pharmacology at Galectin Therapeutics. He has a broad base of experience working with various drug formats across diverse array of therapeutic areas. Prior to joining Galectin Therapeutics, Ezra was Senior Director, Clinical Pharmacology in Global R&D with the Bausch Health Companies, where he was responsible for the execution of clinical pharmacology strategy across all companies of Bausch Health, including Salix Pharmaceuticals, Bausch + Lomb, and Ortho Dermatologics. Before that, he held Clinical and Nonclinical Pharmacology positions at Salix Pharmaceuticals, Bausch +Lomb, and Valeant Pharmaceuticals International, Inc. and spent time as Lead Scientist in Biotransformation and Toxicology at The Dow Chemical Company.
In the course of his career, he has completed 10 different global drug approvals, and he was twice awarded the Bausch Health CEO award.
Ezra holds a B.A. in Chemistry from Colgate University and a Ph.D. in Pharmacology from the University of Michigan. He is also an alumnus of the McKinsey Black Executive Leadership Program.
Vice President, Regulatory Affairs
Susan has over 20 years of domestic and international drug development experience encompassing all aspects of global Regulatory Affairs and Quality Assurance. Before joining Galectin, Susan served as Vice President, Regulatory Affairs and Quality Assurance, at Xeris BioPharma (formerly Strongbridge Biopharma), where she served as a key contributor for the development through approval and launch of the Recorlev® as well as the acquisition and launch of other commercial products. Prior, she held roles of increasing responsibility spanning early-and late-stage development through commercialization of eight NDAs at previous roles including those with Antares Pharma, Aptalis Pharma (formerly Eurand Pharmaceuticals), Barrier Therapeutics, and Teva Pharmaceuticals USA.
Susan received her B.S in Chemistry from Rider University and her M.S. in Quality Assurance/ Regulatory Affairs from Temple University School of Pharmacy.
Executive Director, Clinical Operations
Marla Mills-Wilson is a 24+ year clinical research veteran who brings to Galectin Therapeutics a deep experience in not only program management but also project management, study operations, site management and progression across Phase I to IV in a variety of therapeutic indications, including liver-related diseases, oncology, ophthalmology, and vaccines. Prior to joining Galectin Therapeutics,she spent the previous four years working in the rare liver disease space. She partnered and consulted with CymaBay Therapeutics to lead its global phase III Primary Biliary Cirrhosis program. Preceding CymaBay, Marla collaborated with Intercept Pharmaceuticals, where she was responsible for leading its global phase III fibrosis due to NASH study. Prior positions include serving as Director at INNO Clinical Outcomes, clinical operations management and oversight at Novella, Jubilant Clinsys, Inspire Pharmaceuticals, Glaxo Wellcome and Parexel – working cross functionally in an assortment of roles.
Marla is named as a contributor on multiple ophthalmology manuscripts and posters. She also is a tremendous advocate of process improvement and is lean Six Sigma certified. She holds a B.S. from the University of Tennessee at Chattanooga and continues to be a member of several professional clinical research organizations.
Director Project Management
Sharisse Brutto brings over 15 years of project management experience to her role as Director, Project Management for Galectin Therapeutics. With nearly 10 of these years in the pharmaceutical industry, she specializes in small biotechnology organizations.
She contributes not only a breadth of expertise gained from working in a variety of industries and cross-functional teams, but also an innate passion and enthusiasm for team management, process improvement and organizational methods.
Ms. Brutto most recently lead the project management efforts for Cellectar BioSciences, Inc. She also served as head of project management at Tavanta Therapeutics and as Global Project Manager for Civi BioPharma. Prior to this, she held positions of increasing responsibility at Helsinn Therapeutics.
Ms. Brutto earned her BS in Business Administration and Information Systems from Susquehanna University.