2014

OpenBiome announces members of its Clinical Advisory Board

The thought leaders on fecal microbiota transplantation (FMT) lend medical guidance to OpenBiome’s production and research activities

September 22, 2014
Contact: info@openbiome.org  |  617 575 2201  |  Twitter: @OpenBiome
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Medford, MA – OpenBiome welcomed the new members of its Clinical Advisory Board, an independent panel of medical and scientific experts who provide clinical advice to drive FMT best practices. The Board provides unbiased input that adds to the decision-making capacity of OpenBiome staff as the organization works to improve the standard of care for FMT.

The members of the Clinical Advisory Board are academic leaders and distinguished clinicians dedicated advancing the research and practice of FMT.  They are:

Dr. Ciaran Kelly

Dr. Kelly is a Professor of Medicine at Harvard Medical School and Chief of the Herrman L. Blumgart Internal Medicine Firm, Director of Gastroenterology Training and Medical Director of the Celiac Center at Beth Israel Deaconess Medical Center, Boston, Massachusetts.  He is an American Gastroenterology Association Fellow and a Fellow of the College of Gastroenterology. He has served as a committee member of the National Institutes of Health, Center for Scientific Review and leads NIH-funded research programs on C. difficile colitis and inflammatory bowel disease.  He heads clinical, research and educational programs in celiac disease as Medical Director of the Celiac Center at BIDMC.  Dr. Kelly is author on more than 100 clinical and basic research book chapters, invited reviews, and peer-reviewed publications appearing in such journals as Infection & Immunity, American Journal of Physiology, Gastroenterology, Journal of Biological Chemistry, Journal of Clinical Investigation, The Lancet and New England Journal of Medicine.

Dr. Colleen Kelly

Dr. Kelly is a gastroenterologist in the Center for Women’s Gastrointestinal Medicine at the Women’s Medicine Collaborative. She is an assistant professor of medicine at The Warren Alpert Medical School of Brown University and a faculty member in the fellowship pathway in women’s gastrointestinal diseases at Alpert Medical School. She is nationally recognized in the field of gut flora and its implication in recurrent C. difficile infection. The focus of her research and clinical practice is fecal microbiota transplant (FMT) and she has assisted many physicians and institutions in developing FMT protocols. Kelly has authored a number of papers and abstracts on the subject and was a member of a working group that drafted a best-practices article for treating C. difficile infection with FMT, published in 2011. She is a principal investigator for the first US clinical trial of FMT to treat relapsing C. difficile infection.

Dr. Daniel Murphy

Dr. Murphy is a gastroenterologist and internal medicine specialist. He served as president of the medical Staff of Forsyth Medical Center and is a member of several medical professional committees and societies.  Dr. Murphy also is a consultant as Investigator to Piedmont Medical Research in Clinical Trials involving areas of constipation, duodenal ulcer, dyspepsia, gastric ulcer, GERD, heartburn, irritable bowel syndrome, and ulcerative colitis.

Dr. Kanchana Amaratunga

Dr. Amaratunga is an Infectious Diseases and Internal Medicine physician. She completed her training at McMaster University, Canada and is Royal College certified in each of these disciplines. She subsequently went on to complete a Master of Public Health at the Harvard School of Public Health with a focus on Quantitative Methods. She currently works as a Medical Advisor for the Centre for Communicable Diseases and Infection Control at the Public Health Agency of Canada and has a focus on hospital acquired infections.

Dr. Michael B. Edmond

Dr. Edmond is the Chief Quality Officer for the University of Iowa Hospitals and Clinics. Previously, he was the Richard P. Wenzel Professor of Internal Medicine in the Division of Infectious Diseases at Virginia Commonwealth University and held a faculty appointment in the Department of Epidemiology and Community Health and served as the Hospital Epidemiologist for the VCU Health System. Dr. Edmond's areas of research focus on the epidemiology of healthcare-associated infections and the public policy implications of infection control. He has published 350 papers, abstracts and book chapters, and co-writes a blog entitled Controversies in Hospital Infection Prevention. Over the past few years, Dr. Edmond has been named to Richmond Magazine's Top Doctors, America's Top Doctors, US News and World Report's Top Doctors, Our Health Richmond Magazine's Best Bedside Manner Award, and Health Leaders Magazine's 20 People Who Make Healthcare Better.

Dr. Neil Stollman

Dr. Stollman is a gastroenterologist and Director of the East Bay Center for Digestive Health Research, Chairman of the Department of Medicine at Alta Bates Summit Medical Center in Oakland, and teaches frequently at medical schools in the region. Previously, he held a faculty position at the University of Miami/Jackson Memorial Hospital and served as Chief of Gastroenterology at the Miami VA Medical Center, and Chief of Gastroenterology at San Francisco General Hospital, and Associate Clinical Professor of Medicine in the Division of Gastroenterology at the University of California San Francisco. Dr. Stollman has authored many book chapters and peer-reviewed articles on diverticular disease, reflux disease, H. pylori, gastrointestinal bleeding, dysmotility, and Barrett's esophagus. 

Dr. Paul Beck

Dr. Beck is a Professor in the Department of Medicine, Division of Gastroenterology at the University of Calgary. He is Director of the Leaders in Medicine MD-PhD/MD-MSc program at the University of Calgary’s Cumming School of Medicine.  Since 1999 Dr. Beck has been on staff as a clinician scientist at the University of Calgary/Foothills Hospital where he is director of research, Gastroenterology Division and GI Fellows Program. He has published over 130 paper and in the past 5 years he has published over 50 papers in top levels journals including Science, Nature Medicine, Gastroenterology, Blood, PNAS and others. He is a recipient of the International Research Mentor Award, from the American Gastroenterology Association Institute Council Immunology, Microbiology and Inflammatory Bowel Disease Section, the Citation Classic Award, University of Calgary for a single paper being cited over 1000 times, and the 2013-2014 Canadian Association of Gastroenterology Visiting Professor Research Lectureship.

Dr. Paul Moayyedi

Dr. Moayyedi is a Professor of Medicine, and the Richard Hunt-Astra Zeneca Chair in Gastroenterology at McMaster University. He became Director of the Division of Gastroenterology at McMaster in 2006. He is the joint Editor-in-Chief of the Upper Gastrointestinal and Pancreatic Diseases Cochrane Group and the joint Editor-in-Chief of the American Journal of Gastroenterology.  He has been involved in the development of several national and international guidelines including the American Gastroenterology Association and the England and Wales National Institute of Clinical Excellence dyspepsia and the American College of Gastroenterology IBS guidelines.  Dr. Moayyedi has over 270 peer-reviewed publications. His work has been cited over 7,700 times with 1194 citations in 2013, and was awarded the 2014-2015 Canadian Association of Gastroenterology Visiting Professor Research Lectureship.

Dr. Richard H. Hunt

Dr. Hunt is a Professor of Medicine Emeritus at McMaster University.  He was the first Director of the Intestinal Disease Research Unit, and of the Division of Gastroenterology.  Dr. Hunt is a Fellow of the Royal College of Physicians of London, Edinburgh, and Canada, and a Master of the American College of Gastroenterology.  He has been recognized with many honors for his work in Gastroenterology, where his special interests focus on the acid related disorders and the clinical pharmacology of treatment of gastrointestinal disease.  He is also widely recognized for an extensive interest in colorectal disease, colonoscopy, and therapeutic endoscopy.  Dr. Hunt has served as President of the Canadian Association of Gastroenterology and of the Canadian Helicobacter Study Group, and Vice President of the Canadian Digestive Health Foundation. Dr. Hunt has been Associate Editor of the Esophagus, Stomach and Duodenum, sections of Gastroenterology, and a member of the Editorial Boards of 20 scientific journals. He has published over 600 papers and abstracts including authoritative papers on clinical pharmacology, peptic ulcer disease, gastroesophageal reflux disease, Helicobacter pylori infection, colonic disease, and colonoscopy.  He is the author or editor of 11 books and 63 chapters, and has produced 20 TV video films on peptic ulcer disease, reflux esophagitis, and colonoscopy.

Dr. Timothy O'Shea

Dr. O’Shea is an Assistant Professor in the Department of Medicine, Division of Infectious Diseases at McMaster University, Canada. He trained in internal medicine, infectious diseases and medical microbiology at McMaster, and is Royal College certified in each of these disciplines. He has served as the International Electives coordinator for the Michael Degroote School of Medicine at McMaster University, and as an internal medicine consultant for the Shelter Health Network in Hamilton. He holds a Masters of Public Health degree from the Harvard School of Public University.

OpenBiome is a nonprofit stool bank dedicated to expanding safe access to fecal microbiota transplantation (FMT) therapies. Founded by a team of microbiologists, public health advocates, and concerned citizens, OpenBiome aims to significantly reduce the practical barriers for clinicians providing FMTs, while connecting scientists across studies and disciplines. 


OpenBiome provides its 1000th treatment

With over 100 hospitals and clinics in OpenBiome’s network, more than 80% of the U.S. population is within a 4-hour drive of an OpenBiome partner

September 16, 2014
Contact: info@openbiome.org  |  617 575 2201  |  @OpenBiome 
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Medford, MA – One year from its public launch, OpenBiome supplied its 1000th treatment for recurrent C. difficile infection via fecal microbiota transplantation (FMT). OpenBiome has supported treatments in over 100 hospitals across 30 states. Patients have been receiving FMT using OpenBiome material since November 2013 via colonoscopy, nasogastric tube, and enema.   

“This milestone represents a significant achievement in the advancement of safe access to FMT,” said James Burgess, co-founder and Executive Director.  “Still, with over 300,000 hospitalizations from C. difficile infection in the U.S. every year, there is much work to be done. OpenBiome has launched a campaign to help ensure that there is a provider of FMT in the 601 U.S. cities with over 50,000 residents one year from now.”

 “I cannot express the relief and gratitude I felt when my doctor told me about OpenBiome,” said Sarah, a patient who received an FMT using OpenBiome material in August 2014.  “Because I was able to have the transplant, I'm healthy.  I'm able to function again. Most importantly, I've regained my independence, which was an extremely difficult physical and emotional loss,” she added.

More patient and doctor testimonials are available at www.openbiome.org/patient-testimonials.

OpenBiome logo

OpenBiome is a nonprofit stool bank dedicated to expanding safe access to fecal microbiota transplantation (FMT) therapies. Founded by a team of microbiologists, public health advocates, and concerned citizens, OpenBiome aims to significantly reduce the practical barriers for clinicians providing FMTs, while connecting scientists across studies and disciplines. 

 

OpenBiome launches its expanded Quality & Safety Program

The Quality & Safety Program builds on OpenBiome’s existing protocols and represents the most rigorous process published for the production of material for fecal microbiota transplantation

August 12, 2014
Contact: info@openbiome.org  |  617 575 2201  |  @OpenBiome
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Medford, MA – OpenBiome launched its Quality & Safety Program (Q&SP) to the members of its clinical network, announcing the consolidated and enhanced protocols that safeguard patient safety from bench to bedside.

The Q&SP spans donor assessment, production control, data collection, and risk mitigation.  Every protocol has been rigorously vetted by leading clinicians and academics in the field of FMT, and represents best practices in the screening and processing of stool for use in fecal transplantation.

As part of the enhancements that OpenBiome has made to its existing quality and safety protocols, members of OpenBiome’s clinical network will have access to the OpenBiome Clinical Advisory Board, a distinguished panel of medical practitioners and researchers, with questions concerning adverse events resulting from FMTs conducted using OpenBiome’s fecal microbiota preparations.  

“OpenBiome is dedicated to a continuous improvement philosophy to safety,” said James Burgess, Executive Director of OpenBiome. “I invite the members of our clinical network and all who are interested to explore the components of the Quality and Safety program, and participate in making safety an everyday priority.”

More information about the OpenBiome Q&SP, including a full packet of all protocols, is available at www.openbiome.org/safety. 

openbiome logo

OpenBiome is a nonprofit stool bank dedicated to expanding safe access to fecal microbiota transplantation therapies. Founded by a team of microbiologists, public health advocates, and concerned citizens, OpenBiome aims to significantly reduce the practical barriers for clinicians providing FMTs, while connecting scientists across studies and disciplines. 

OpenBiome receives grant to support FMT patient safety study

Funds will support data collection of long-term patient outcomes following fecal microbiota transplantation (FMT) treatment for recurrent C. difficile infection

August 7, 2014
Contact: info@openbiome.org  |  617 575 2201  |  @OpenBiome 
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Medford, MA – OpenBiome has received a foundation grant to support a study of the long-term safety profile of FMT as a treatment for patients with recurrent C. difficile infections. The study is a component of a U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) application and will include patient follow-up assessments for at least one year following FMT.  While data from previous small-scale trials for FMT show outstanding efficacy and short-term safety, long-term safety remains a priority area of investigation. 

Given the breadth and diversity of OpenBiome’s clinical and research networks, with over 800 treatments provided to over 80 hospitals in 30 states, this research represents the largest formal data collection effort investigating FMT therapy for C. difficile infection to date.

“We launched OpenBiome to enable safe, accountable, and high-quality treatments for patients,” said Dr. Mark Smith, OpenBiome Co-Founder and President.  “This grant allows us to look into one of the key remaining questions on the role of FMT in the fight against the leading cause of hospital-acquired infections in the U.S.”

 “While the regulatory classification of FMT remains a topic for ongoing discussion, the FDA has requested that safety and efficacy data be collected and reported following the process for investigating new drugs,” said co-founder and Executive Director James Burgess.  “We strongly agree that this reporting process is important to ensure patient safety, and a key step in moving FMT from an experimental to a mainstream therapy, standardizing treatment methodologies, and making this low-cost therapy available to individuals suffering from recurrent C. difficile everywhere.”

OpenBiome Logo

OpenBiome is a nonprofit stool bank dedicated to expanding safe access to fecal microbiota transplantation (FMT) therapies. Founded by a team of microbiologists, public health advocates, and concerned citizens, OpenBiome aims to significantly reduce the practical barriers for clinicians providing FMTs, while connecting scientists across studies and disciplines.