Amy Lightner, MD
Chief Medical Officer
Department of Molecular and Cellular Biology
Aline W. Skaggs Chair
Research Focus
The Lightner lab focuses on inflammatory bowel disease, which is on the rise globally, now affecting 1:100 in the United States alone. Despite decades of research, scientists still don't understand what causes inflammatory bowel disease. Treatment options remain limited, placating symptoms rather than curing the disease.
Lightner’s lab uses organoids derived from human tissues taken from surgical patients to study the cause of inflammatory bowel disease and discover potential novel therapeutics that focus on tissue regeneration and restoration. This serves as a model for drug discovery, both in her lab and across collaborations with other labs. Products from her lab are then studied in first-in-human clinical trials to establish and underscore safety in this patient population, with a goal of providing better, more effective treatment options, while simultaneously better understanding the underlying disease.
M.D., Boston University School of Medicine, Boston, MA, 2008
Bachelor of Arts in Human Biology with a focus in Sports Medicine, Stanford University, 2003
Professor of Surgery, Scripps Clinic Medical Group, San Diego, CA
Colorectal Surgeon, May 2023 - current
Chief Medical Officer, Direct Biologics, LLC, Austin, TX and San Diego, CA
Director of Clinical Operations, Medical Affairs, and R&D in late stage Biotech, November 2022-current
Chief Medical Officer, Boomerang Medical, Los Altos, CA
Director of Clinical Operations of a Medtech, In House Residence in Fogarty Innovations, February 2022-current
Cleveland Clinic Center for Regenerative Medicine and Surgery, Cleveland, OH
Director of the Center for Regenerative Medicine and Surgery, January 2020-November 2022
Cleveland Clinic Department of Colorectal Surgery, Cleveland, OH
Associate Professor of Surgery in Cleveland Clinic Digestive Disease Institute, 2019-current
Lerner Research Institute, Cleveland Clinic, Cleveland OH
Associate Professor of Inflammation and Immunity, 2019-current
Center for Regenerative Medicine, Mayo Clinic, Rochester MN
Director of the Translation, Implementation and Practice Platform, 2016-2019
Mayo Clinic Department of Surgery, Division of Colon and Rectal Surgery, Rochester MN
Assistant Professor of Surgery in Mayo Clinic College of Medicine
Senior Associate Consultant in Division of Colon and Rectal Surgery, 2016-2019
Mayo Clinic Department of Surgery, Division of Colon and Rectal Surgery, Rochester MN
Surgical Fellow in Division of Colon and Rectal Surgery, 2015-2016
UCLA Department of General Surgery, David Geffen School of Medicine at UCLA
General Surgery Categorical Resident, 2008-2015
Postdoctoral Fellow, Department of Immunology, Stanford University
California Institute for Regenerative Medicine, 2010-2012, Stanford, CA.
California Institute of Regenerative Medicine, Primary Investigator, Cleveland Clinic, OH, 2020-2023.
Helmsley Foundation, Primary Investigator, Cleveland Clinic, OH, 2020-2023.Rainin Foundation Synergy Award, Primary Investigator, Cleveland Clinic, OH, 2020-2023.
Cure for IBD Foundation Research Grant, Primary Investigator, Cleveland Clinic, OH, 2020-2023.
Digestive Disease and Surgery Institute Internal Funding, Primary Investigator, Cleveland Clinic, OH, 2020-2022.
Litwin Crohns' and Colitis Foundation Research Grant, Primary Investigator, Cleveland Clinic, OH, 2019-2021.
American Society of Colon and Rectal Surgeons Career Development Award, Primary Investigator, Cleveland Clinic, OH, 2019-2021.
Sherman Prize for Emerging Leader in Inflammatory Bowel Disease. Awarded to an emerging leader in inflammatory bowel disease with monetary support for research endeavors. 2018.
Center for Regenerative Medicine Research Award, Primary Investigator, Mayo Clinic, Rochester MN, 2019-2021.
2018 Department of Surgery Small Research Grant, Primary Investigator, Mayo Clinic, Rochester MN, 2018-2020.
2018 Research Career Support and Advancement Award, Primary Investigator, Mayo Clinic, Rochester MN, 2018-2020.
Advance the Practice Research Award, Co-Investigator, Mayo Clinic, Rochester MN, 2018-2020.
Center for Regenerative Medicine 2016 Career Development Regenerative Medicine Award, Career Development Award, Mayo Clinic, Rochester, MN, 2016-2018.
California Institute of Regenerative Medicine (CIRM) Training Grant, Stem Cell Biology (TG2-01159), 2010-2012.
Training Grant, Molecular and Cellular lmmunobiology (5 T32 AI07290), 2010-2011.
Calibr-Skaggs advances CLF065, a regenerative GLP-2 therapy, into two Phase 2 IBD studies
CLF065, a long-acting, once-weekly GLP-2 receptor agonist, advances in two inflammatory bowel disease indications. The studies aim to bring a regenerative treatment option to patients living with IBD, who currently have few therapies that repair the damaged intestinal lining at the root of their disease.
The missing piece in IBD treatment? Regenerating the gut’s protective barrier shows promise
Current therapies for inflammatory bowel disease (IBD) primarily focus on suppressing inflammation. But what if we could repair one of the underlying drivers of disease itself? Researchers at Calibr-Skaggs are developing CLF065, a potential first-in-class regenerative medicine designed to restore epithelial barrier function—the protective intestinal lining that regulates what passes from the gut into the body. CLF065 is designed with a dual mechanism of action: supporting barrier integrity and stimulating regeneration of the gut lining. A Phase 2 clinical trial has recently launched in chronic pouchitis, a painful inflammatory condition that can develop in some people with IBD following surgery. In addition, an Investigational New Drug (IND) application has been submitted to support a Phase 2 trial in Crohn's disease. Learn how regenerative medicine could help shift the treatment paradigm from managing symptoms to repairing the tissue damage at the root of disease.
What’s next for IBD care: Insights from a surgeon-scientist
The data is clear: inflammatory bowel diseases like ulcerative colitis and Crohn’s are on the rise worldwide. In this episode, we sit down with Dr. Amy Lightner—VP of Clinical Development at Calibr-Skaggs and colorectal surgeon at Scripps Clinic—to explore what drives these diseases, an upcoming phase 2 clinical trial for a new regenerative medicine, and how she balances life between the operating room and the research lab.
Viome, Scripps Research collaborate on colorectal cancer testing
GenomeWeb
New test for colon cancer could spot it before it spreads
KPBS
Life beyond Crohn’s disease
After enduring decades of complications from Crohn’s disease, Gary Jacobson received a pioneering treatment from a Scripps Research professor that gave him relief and a renewed sense of control.
Viome and Scripps Research partner to develop first at-home RNA screening test to prevent colon cancer before it strikes
First-of-its-kind 1,000-patient clinical study will use RNA-based stool and saliva tests to detect colon polyps — early warning signs of colorectal cancer — before they become cancerous.Study aims to enhance colorectal cancer prevention by identifying polyp molecular signals, offering improved sensitivity over at-home DNA tests, which have limited ability to detect precancerous lesions.