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.
Ezra R. Lowe, Ph.D.
Vice President, 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.
Head of CMC and Pharmaceutical DevelopmentJeff is currently the Head, CMC and Pharmaceutical Development at Galectin. Prior to Galectin, Jeff served as Head, Development at Syntis Bio, a late stage preclinical company developing a new class of therapies through novel formulations that target specific tissues. Prior to Syntis, Jeff was Sr Director of Formulation and Process Development at Lyndra Therapeutics developing long acting oral medicines. Before Lyndra, Jeff was a Director at Agios Pharmaceuticals in their CMC group and helped develop to approval a medicine for AML and cholangiocarcinoma (TIBSOVO®). Jeff spent about a decade at Vertex Pharmaceuticals developing to approval medicines for HCV (INCIVEK®) and CF (KALYDECO®, ORKAMBI®, SYMDEKO®). These were developed via QbD strategies and with advanced manufacturing techniques such as spray drying and continuous manufacturing. Preceding Vertex, Jeff helped start up and incubate Pulmatrix out of Harvard University. He also worked at AIR, a subsidiary of Alkermes, on pulmonary drug delivery systems. Jeff is a trained mechanical/biomedical engineer out of the University of Michigan (Go Blue!). Jeff lives in the suburbs of Boston with his son Jack.
Senior Director, Clinical Operations
Jessica Kopaczewski is an accomplished clinical operations professional with over 25 years diverse experience in the pharmaceutical research industry supporting global study operations, site management, and personnel management across Phase 1 to IV in a variety of therapeutic indications including liver-related diseases, oncology, and infectious diseases. Prior to joining Galectin Therapeutics, she collaborated with CymaBay Therapeutics to manage operational aspects for their global phase III Primary Biliary Cirrhosis study. Before CymaBay, she consulted with Intercept Pharmaceuticals where she was responsible for the clinical operations oversight of their global phase III fibrosis due to NASH study. Prior positions include CRA functional management at PRA Health Sciences where she held a Leadership role within the BRIDGE CRA On-Boarding Program as a certified Barnett International CRA Training Instructor and was a key contributor to the development of a centralized CRA Quality Assessment Visit Team. Jessica also has prior experience managing global clinical teams from site selection through data analysis, monitoring, and study coordination of both pharmaceutical company-sponsored as well as physician written research trials. She is named as a contributor to several abstracts and posters relating to the treatment of NASH Cirrhosis as well as publications in reputable medical journals relating to the treatment of HIV/AIDs. Jessica received her B.S. in Biochemistry and Molecular Biology from the University of Wisconsin-Eau Claire.
Senior Director, Biostatistics
Seth Zuckerman has over 28 years of experience working in the pharmaceutical industry. In addition to functioning as a Statistician for 23 years, he has also worked in Clinical Data Management and Clinical Trial Management. Prior to joining Galectin, Seth was Senior Director of Biostatistics at Cytel Inc. for 13 years, where he led several international projects for numerous pharmaceutical and biotechnology companies. His areas of statistical expertise include adaptive designs, SSRE (sample size re-estimation), interim analyses, regulatory submissions, FDA advisory committee experience and randomization procedures. Seth possesses an in depth understanding of the clinical trial process, having worked in Phases I through IV for pharmaceutical, biotechnology and medical device products. His therapeutic area knowledge includes the following: Gastroenterology, Oncology, Cardiovascular, Psychiatry, Neurology and Immunology.
Seth completed his undergraduate studies at Gettysburg College (Gettysburg, PA) with a BS in Biology and Minors in Mathematics and Spanish. He earned his MS in Statistics from Temple University (Philadelphia, PA).
Seth currently resides in Villanova, PA with his wife Eileen, four children (Erik, Helena, Joseph and Aaron), two cats (Nana and Tiger-Lilly) and one dog (Navi). Outside of work, Seth is an outdoor enthusiast and enjoys mountain biking, road cycling, hiking and ice hockey.
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.