Opening Remarks

Marilyn G. Geller is the CEO of the Celiac Disease Foundation (CDF), the nation’s leading voluntary health organization for celiac disease. For 14 years, her son suffered with debilitating symptoms despite seeking help from innumerable health professionals. A chance blood draw revealed celiac disease was the cause of his suffering. From that day forward, Ms. Geller, a longtime healthcare executive, has been active in celiac disease advocacy, joining the CDF National Board of Directors. In 2012, she succeeded founder Elaine Monarch as Chief Executive Officer.

Sheila Burke is a Strategic Advisor in Baker Donelson’s Washington, DC, office and Chair of the Firm’s Government Relations and Public Policy Group. Ms. Burke brings a deep knowledge of federal policy and programs drawn from her distinguished career in the private and public sectors. In addition to her role at the Firm, Ms. Burke continues as a faculty member at the John F. Kennedy School of Government at Harvard University, where she served as Executive Dean from 1996 to 2000. She also serves as Distinguished Visitor at the O’Neill Institute for National and Global Health Law at Georgetown University.

Mark Van de Water is a Senior Advisor in Baker Donelson’s Washington, DC, office. Mr. Van de Water served as a senior staff member for the Appropriations Committees in both the U.S. House of Representatives and the U.S. Senate. As a political and policy expert, Mr. Van de Water has been quoted and interviewed by Congressional Quarterly, The Wall Street Journal, Marketplace, National Public Radio, The Washington Post, National Journal, The Hill, Newsweek, The Oregonian and Roll Call and The Hill newspaper has named him as one of the top lobbyists in Washington and one of the top “Hired Guns” in the nation’s capital.

Current State of Celiac Disease Diagnosis, Treatment, and Clinical Research

Edwin Liu, MD, serves as the Taplin Endowed Chair for Celiac Disease and Director of the Colorado Center for Celiac Disease at Children’s Hospital Colorado. Dr. Liu is also a Professor of Pediatrics, specializing in Pediatric Gastroenterology, Hepatology and Nutrition at the University of Colorado Hospital. Dr. Liu received his undergraduate degree from Boston University in 1992 and graduated from the Boston University School of Medicine in 1996. Dr. Liu has authored and co-authored many publications, including the TEDDY (The Environmental Determinants of Diabetes in the Young) and DAISY (Diabetes Autoimmunity Study of the Young) studies, long-term prospective birth cohorts examined for the development of Type 1 diabetes and celiac disease due to a genetic risk identified at birth.

Benjamin Lebwohl, MD, is the Director of Clinical Research at The Celiac Disease Center at Columbia University and is the President-Elect of the Society for the Study of Celiac Disease (SSCD). He received his MD from Columbia College of Physicians and Surgeons in 2003, and then completed his internship, residency, and chief residency in internal medicine at Columbia. As a fellow in Digestive and Liver Disease, he also obtained a Masters in Patient Oriented Research from the Department of Biostatistics at the Mailman School of Public Health. He was a post-doctoral fellow in a National Cancer Institute-funded Training Program in Cancer-Related Population Sciences and joined the faculty of the Celiac Disease Center at Columbia University in 2010.

Jocelyn Silvester, MD, PhD, is an attending physician at Boston Children’s Hospital and an instructor of pediatrics at Harvard Medical School. Dr. Silvester chairs the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Celiac Special Interest Group. She completed her PhD in Biology at the University of Cambridge, Cambridge, England, prior to receiving her MD from Dalhousie University in Halifax, Nova Scotia, Canada in 2008. Dr. Silvester completed her residency at the University of Manitoba in Winnipeg, Canada and her Fellowship in Gastroenterology, Hepatology and Nutrition at Boston Children’s Hospital. Dr. Silvester continues to work as a general pediatrician in remote regions of Northern Canada as well as at Boston Children’s Hospital.

Innovations in Drug Development for Celiac Disease

Jennifer Sealey-Voyksner, PhD, Chief Scientific Officer and Co-Founder of ImmunogenX, has over 30 years of experience in academic and commercial research and development in pharmaceutical, environmental and food sciences. Her expertise is the study and analysis of protein biomarkers and allergenic proteins. She has most recently co-founded LCMS Limited, an independent analytical laboratory located in RTP, North Carolina and served as Director of R&D. She received her honours B.Sc. in Chemistry at McMaster University (Canada) and her Ph.D. in analytical chemistry at the University of North Carolina at Chapel Hill.

Francisco Leon, MD, PhD, is the Co-Founder of Provention Bio, Glutenostics and Celimmune, companies dedicated to developing and commercializing medicines, diagnostics and preventative approaches for people with celiac disease and other immunological disorders. Dr. Leon is also Adjunct Professor at Jefferson Medical College (Philadelphia) and has co-authored more than 85 peer-reviewed articles, book chapters and patents. Prior to entering the biopharma industry, Dr. Leon served as a Postdoctoral Fellow at the National Institutes for Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH).

Daniel Leffler, MD, currently serves as the Medical Director at Takeda Pharmaceuticals, Director of Clinical Research at the Celiac Center at Beth Israel Deaconess Medical Center, and as an Associate Professor of Medicine at Harvard Medical School. Dr. Leffler lectures nationally and internationally on patient care, quality improvement initiatives, and research in celiac disease and other digestive disorders.

Kristin Neff serves as the Vice President of Clinical Operations at Anokion. Ms. Neff joins Anokion from Venthera, Inc., a BridgeBio company, where she served as vice president, clinical operations and oversaw all activities supporting the early stage development of the company’s topical PI3K inhibitor. Prior to Venthera, Ms. Neff served as director, clinical operations, program leadership at Biogen, Inc., where she led the strategy, planning and implementation of the global clinical development program operations in MS. Before that, she was vice president, clinical operations and project management at ImmusanT, Inc., where she led the global Phase 2 study of a vaccine to treat celiac disease. Earlier, Ms. Neff held various clinical operations and clinical affairs roles at InVivo Therapeutics, Taris Biomedical, Inc., ConforMIS, Inc., HeartWare, Inc., Boston Scientific Corp., Vertex Pharmaceuticals and Parexel International.

 

 

Engaging Patients as Partners in Research

Lisa Stewart, MA, is a Senior Engagement Officer at the Patient-Centered Outcomes Research Institute (PCORI). She acts as a liaison between the Engagement and Science programs, helping to manage the organization’s research portfolio and supporting the engagement of patient and other stakeholders throughout the course of research studies. Ms. Stewart earned a BA in business administration, marketing and finance from Florida A&M University and a MA in socio-cultural anthropology with a concentration in medical anthropology from the University of Virginia.

Patient Clinical Trial Experience Panel

Jennifer Sealey-Voyksner, PhD

Francisco Leon, MD, PhD

Daniel Leffler, MD

Patrick H. Griffin, MD, FACP, became chief medical officer at 9 Meters Biopharma, Inc in February 2019. Previously, Dr. Griffin served as executive vice president and chief medical officer of Synergy Pharmaceuticals from January 2015 through November 2018, and senior vice president and chief medical officer May 2013 through January 2015. From March 2012 to April 2013, Dr. Griffin served as chief medical officer and senior vice president of development at ImmusanT, Inc. From March 2009 until January 2012, Dr. Griffin served as associate vice president, clinical development and head of external innovation at Sanofi-Aventis (now Sanofi). He is a board-certified physician in both internal medicine and gastroenterology, and is a Fellow of the American College of Physicians. He received his medical degree from Columbia University, completing a residency in internal medicine at Presbyterian Hospital in New York, and a fellowship in gastroenterology at Brigham and Women’s Hospital in Boston. Following his residency and fellowship, Dr. Griffin joined the medical faculty of Columbia College of Physicians and Surgeons, where he held a number of academic, clinical research, teaching and management positions, and a private practice in New York.

John P. Lynch MD, PhD, is a board-certified gastroenterologist and currently the late-phase Clinical lead on the Celiac disease program at Janssen Research & Development. He received his clinical training in Internal Medicine and Gastroenterology at the University of Pennsylvania. He subsequently joined the faculty at the Perelman School of Medicine as a research gastroenterologist, rising to the level of Associate Professor of Medicine while maintaining an NIH-funded laboratory studying intestinal epithelial development, stem cell biology, and carcinogenesis.  He joined Janssen R&D in 2017 as a Director in their Clinical Immunology program where his work is focused on developing novel therapies for immunologically-mediated GI disorders like Celiac disease.

Beth Ann Reedy, BSN, serves as Discovery Medicine Lead at GlaxoSmithKline for their Celiac disease program.  Ms. Reedy has over 26 years of pharmaceutical experience in early and late phase clinical development. She has led the strategy, planning and implementation of global clinical development programs in a wide range of therapeutic areas including Immunology, Gastroenterology, Dermatology, Rheumatology, Neurology, Internal Medicine and Oncology. Ms. Reedy is passionate about her work in clinical development and maintaining focus on the patient in order to bring the right medicine to the patients.

 

Engaging and Strengthening Stakeholders

Joseph A. Murray, MD, Mayo Clinic, is a world-renowned celiac disease researcher who established the celiac disease program at Mayo in 2002. Dr. Murray served as the director of Mayo’s Esophageal Function Laboratory and esophagus section until 2004. He is currently a Professor of Medicine, Mayo Clinic College of Medicine, and a clinician investigator and consultant in the Division of Gastroenterology and Hepatology and Department of Immunology. He is also Adjunct professor of Pediatrics at the University of Southern Denmark. Dr. Murray is a founder and immediate past president of the North American Society for the Study of Celiac Disease and vice chair of the Intestinal Disease Section of the American Gastroenterological Association.

Ritu Verma, MD, is a highly respected pediatric gastroenterologist who provides compassionate, comprehensive care to children suffering from complex gastroenterology conditions. Dr. Verma is a leading expert in celiac disease and works closely with her patients and their families to manage this condition. She is also committed to ensuring pediatric gastroenterology patients have a seamless continuum of care throughout their journey, which includes a coordinated transition from pediatric to adult gastroenterology programs. Dr. Verma serves as the Society for the Study of Celiac Disease (SSCD) Advocacy Liaison.

Vanessa Weisbrod is the Director of the Boston Children’s Hospital Celiac Disease Program. In this role, she works to build a robust community engagement and education program that strengthens the ties between the Boston Children’s Hospital clinical team and the Celiac Kids Connection support group, as well as engage local and national partners. Vanessa comes to Boston Children’s after 12 years as the Director of the Celiac Disease Program at Children’s National Hospital in Washington DC. In her previous role, she led the effort to create national recommendations for managing children with celiac disease in learning environments and research looking at cross contact with gluten in shared kitchens and schools. Vanessa sees herself as a passionate advocate for families living with celiac disease.