2020 Continuing Medical Education Credits
Because the role of the microbiome has only been deeply investigated since the launch of the Human Microbiome Project in 2007, at present there is no curriculum offered in medical school on the role of the microbiome and there are few resources at present that address this gap. Patients are increasingly bombarded with information about the microbiome, and are taking these questions to their medical professionals. Application of knowledge about the microbiome is applied unevenly across medical disciplines and geographies but physicians are starting to prescribe microbiome based interventions (e.g. the use of probiotics to protect intestinal flora adjunctive to antibiotic use) without reliable information on the actual role of the microbiome in these diseases and applications.
At present there are numerous clinical trials underway looking at things like FMT (Fecal Microbiome Transplant) as a possible treatment for C. diff infections, ulcerative colitis, metabolic syndrome, graft-versus-host disease and autism. A number of medical professional societies have gone so far as to advocate for FMT as standard of care for patients with C diff infections who have not responded to standard therapies. In addition, a variety of LBTs (live biotherapeutics) are being developed to treat these diseases and others, including Parkinson’s and a variety of cancers.
This web-based activity will provide learners with a deeper awareness of the current understanding of the role of the microbiome in cancer and IO therapy, liver disease, Alzheimer’s, vascular disease and metabolic syndrome, lupus and the differential between microbiome testing in vivo and ex vivo. It will also provide learners with first-hand experience of the patient journey in C diff and provide insights into the safety issues of manipulating the microbiome. While there are not yet any practice guidelines for implementing this research into clinical practice, learners will be offered well- curated information and gain knowledge of the current understanding of the role of the microbiome in many of the key diseases they encounter daily.
Physicians and other advanced practice providers, scientists, nurses, pharmacists, clinical trials techs, data analysts, etc. in specialties of allergy & immunology, internal medicine, neurology, pathology, pediatrics, radiology, surgery, microbiology, GI, infectious disease, computer engineering, environmental engineering, and oncology
At the end of this conference, learners will understand:
1) the role of the microbiome in human health and systemic disease
2) the role of the microbiome in autoimmune disease such as lupus
3) the Cancer Research UK project considering the role of the microbiome in cancer
4) the patient journey in recurrent C diff and the impact of the microbiome and antibiotics on the disease
5) the difference in in vitro versus in vivo sampling of the gut microbiome and the impact on our understanding of its role in disease
6) the role of the microbiome in the gut brain axis in such diseases as Alzheimer’s, Parkinson’s, and Autism
7) the role of novel dietary flavonoids and their impact on the microbiome for the prevention of vascular disease in diabetes and metabolic syndrome.
JOINT-PROVIDERSHIP ACCREDITATION AND DESIGNATION STATEMENT
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of the Office of Continuing Medical Education of the University of Virginia School of Medicine and Arrowhead Publishers. The Office of Continuing Medical Education of the University of Virginia School of Medicine is accredited by the ACCME to provide continuing medical education for physicians
The University of Virginia School of Medicine designates this enduring material for a maximum of 7 AMA PRA Category 1 Credits.TM Physicians should claim only the credit commensurate with the extent of their participation in the
activity. (The number of credits offered for this event is subject to change dependent upon future additions/revisions to the agenda.)
The University of Virginia School of Medicine, as accredited provider, awards 7 hours of participation (consistent with the designated number of AMA PRA Category 1 Credit(s)TM ) to a participant who successfully completes this educational activity. The University of Virginia School of Medicine maintains a record of participation for six (6) years.
MOC Part II (ABMS) is awarded up to 7 Self-Assessment Credit (transcript awards both MOC and AMA) per learning activity within. Through the American Board of Medical Specialties (ABMS) and Association of American Medical Colleges’ (AAMC) joint initiative to create a wide array of Maintenance of Certification (MOC) Activities. The Translational Microbiome Conference has met the MOC requirements as a MOC Part II CME activity by the following ABMS Member Boards:
American Board of Internal Medicine
American Board of Pediatrics
DISCLOSURE OF FACULTY FINANCIAL AFFILIATIONS
The University of Virginia School of Medicine, as an ACCME accredited provider, and The University of Virginia School of Nursing Continuing Education as an ANCC accredited provider, endorses and strives to comply with the Accreditation Council for Continuing Medical Education (ACCME) Standards of Commercial Support and with the American Nurses Credentialing Center (ANCC) Content Integrity Standards, Commonwealth of Virginia statutes, University of Virginia policies and procedures, and associated federal and private regulations and guidelines on the need for disclosure and monitoring of proprietary and financial interests that may affect the scientific integrity and balance of content delivered in continuing education activities under our auspices.
The University of Virginia School of Medicine and School of Nursing require that all CE activities accredited through this institution be developed independently and be scientifically rigorous, balanced and objective in the presentation/discussion of its content, theories and practices.
All faculty presenters participating in an accredited CE activity are expected to disclose relevant financial relationships with commercial entities occurring within the past 12 months (such as grants or research support, employee, consultant, stock holder, member of speakers bureau, etc.). The University of Virginia School of Medicine and School of Nursing will employ appropriate mechanisms to resolve potential conflicts of interest to maintain the standards of fair and balanced education to the participant. Questions about specific strategies can be directed to the Office of Continuing Medical Education, University of Virginia School of Medicine or the University of Virginia School of Nursing Continuing Education, Charlottesville, Virginia.
The faculty, staff and planning committee of the University of Virginia Office of Continuing Medical Education and the University of Virginia School of Nursing Continuing Education have no financial affiliations to disclose.
DISCLOSURE OF DISCUSSION OF NON-FDA APPROVED USES FOR PHARMACEUTICAL PRODUCTS AND/OR MEDICAL DEVICES
The University of Virginia School of Medicine and the University of Virginia School of Nursing Continuing Education requires that all faculty presenters identify and disclose any off-label uses for pharmaceutical and medical device products. It is recommended that each clinician fully review all the available data on new products or procedures prior to clinical use.
DISCLOSURE OF FINANCIAL RELATIONSHIPS (FOR EVERY PERSON IN CONTROL OF ACTIVITY CONTENT)
Daewook Kang, PhD has disclosed relevant financial relationship as industry funded researcher/investigator for Finch
Barbara Rehermann, MD has disclosed relevant financial relationship as employer receiving royalties from Taconic Biosciences.
Ze’ev Ronai, PhD has disclosed relevant financial relationship as consultant and stock/ownership of Pangea Therapeutics.
Pamela Silver, PhD has disclosed relevant financial relationship as founder and patent holder of 64-X, KulaBio, General Biologics, M Biome; advisory committee/board of Connagen.
Paul Turner, PhD has disclosed relevant financial relationship as stock/ownership and patent holder of Felix Biotechnology.
The following have disclosed no financial relationship or interest with any proprietary entity producing healthcare goods or services. (* Denotes planning committee)
Garth Erlich, PhD Amy Feehan, PhD Scott Jackson, PhD Sangeeta Khare, PhD
Danish Malik, PhD Samuel Minot, PhD Alba Muhlfeld Mollie Roth, JD*
Gregg Silverman, MD
Anandh Babu Pon Velayutham, PhD John Waslif, MA*
Andrea Zimmerman, EdD*
HOW TO SUCCESSFULLY COMPLETE THE ACTIVITY
How to claim your CE Credit
All learners will need to register and pay the registration fee, watch the video presentation(s), and complete the post-
activity evaluation in order to receive credit for the continuing medical educational sessions of this course.
Go to www.cmevillage.com.
Click on the “Learning Portal” button and select “CE Certificate-Eval for Credit.”
Sign-in with your email and password, if you already have an account, or “Create a New Account.”
Enter CE Activity Code 137611 and click “Submit” and “Continue.”
Complete the course evaluation to proceed to claim CE.
Certificate Preparation; indicate the number of credits you wish to claim for attending this activity (e.g. 7.00).
Click “Print Certificate” or you can access later by visiting our website, Click “Learning Portal”, Sign in at the top
of the page and click “Credit History & Past Certificate.”
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HARDWARE, SOFTWARE REQUIREMENTS
There are no special requirements for access to the event software. All browsers are applicable for this event.
ESTIMATED TIME TO COMPLETE THE EDUCATIONAL ACTIVITY
The estimated time to complete the continuing medical educational activity is 7 hours. Learners may complete the course at their own pace.
DATES OF ORIGINAL RELEASE AND MOST RECENT REVIEW OR UPDATE
April 21-24, 2020
TERMINATION OR EXPIRATION DATE
April 20, 2023
A CONTACT MECHANISM(S) FOR THE LEARNER TO REQUEST TECHNICAL ASSISTANCE AND TO ASK QUESTIONS REGARDING THE ENDURING MATERIAL
The conference platform provides technical assistance. For further assistance, please contact firstname.lastname@example.org.
We can engineer the microbiome to report on the health of the gut microbiome and report on the presence of pathological states such as inflammation. These sensor bacteria can also be engineered to deliver therapeutics on demand. We also use targeted bacteriophage to shape and program the gut microbiome. In doing so, we have developed novel targeted therapeutic strategies.
Pamela Silver, Ph.D., Elliot T. and Onie H. Adams Professor of Biochemistry and Systems Biology, Harvard Medical School
Targeted Delivery and Controlled Release of Bacteriophages and Bacteriocins
This talk will present scalable approaches available for micro- and nano- encapsulation of bacteriophages and bacteriocins. In vitro and in vivo results from studies in mice and poultry will be presented showing the benefits of targeted delivery and controlled release of biotherapeutics to improve bioavailability and overcome environmental stresses including gastric acidity and enzymatic degradation.
Danish Malik, Ph.D., Senior Lecturer, Chemical Engineering Department, Loughborough University
Challenges in Commercially Developing Phage Therapies to Target Drug-Resistant Bacteria
Increasing prevalence and severity of multi-drug-resistant bacterial infections requires novel antibacterial strategies. One possibility is a renewed approach to ‘phage therapy’. This presentation concerns the discovery of phages (bacteria-specific viruses) that associate with virulence factors of target bacterial pathogens. Dr. Turner will present empirical support for this hypothesis, and will showcase results of FDA approved emergency treatment in humans, harnessing various phages that drive evolutionary trade-offs in bacterial pathogens.
Paul Turner, Ph.D., Rachel Carson Professor of Ecology & Evolutionary Biology, Yale University
The Use of Wild Mouse Models to Further Microbiome Research
Laboratory mice are paramount for understanding basic biological phenomena but also have limitations in preclinical studies. Based on the concept that natural microbiota co-evolved with their respective hosts under evolutionary pressure of common environmental immune stimuli, Dr. Rehermann will describe and discuss new mouse models that combine the natural microbiota of wild mice with the tractable genetics of laboratory mice. Wild mouse microbiota are stable over multiple generations in the laboratory mouse colonies, promote host fitness and disease resistance and increase the translatability of immunological results from preclinical studies to humans.
Barbara Rehermann, MD, Section Chief, Immunology Section, Liver Diseases Branch, NIDDK, National Institutes of Health
Standards for Microbiome and Metagenomics
In spite of the huge potential impact of microbiome science, current measurement capabilities are insufficient, particularly for translating discoveries and correlations observed in the lab into commercially viable products and services that improve our quality of life. Data are difficult to compare between experimenters, laboratories, or institutions. Emerging capabilities (e.g., next generation sequencing, metabolomics) are new and not fully characterized for microbiome investigations. Reference samples (i.e., for calibration or quality control) that mimic the complexity of naturally occurring communities are not available. Bioinformatic analysis packages and reference databases remain incomplete.
Scott Jackson, Ph.D., Group Leader, Complex Microbial Systems, NIST (National Institute of Standards & Technology)
Gut Microbiome and Intestinal Permeability as the Novel Criteria for Toxicological Risk Assessment
Exposure to ingested xenobiotics including drugs, as well as, chemical additives/contaminants on edible items could lead to dysbiosis in the gastrointestinal tract. A comprehensive understanding of the toxicologic effects of such exposure on the intestinal microbiome is crucial when evaluating the safety of these products since they play an important role in maintaining health. In this presentation, Dr. Khare will discuss the challenges and opportunities to establish gut microbiota, intestinal permeability - xenobiotic interactions as novel criteria to include in toxicological risk assessments.
Sangeeta Khare, Ph.D., Research Microbiologist, Division of Microbiology, National Center for Toxicological Research, US Food and Drug Administration
Development, Validation, and Unique Applications of Species-specific Microbiome Assay & Database that Together Provide True Pan-Domain Molecular Diagnostics
Garth Ehrlich, Ph.D., Professor of Microbiology & Immunology, Professor of Otolayngology - Head & Neck Surgery, Drexel University College of Medicine
Data Driven Design of Microbiome-Based Therapeutics and Diagnostics Using Gene-Level Metagenomics
The human microbiome contains an incredibly diverse collection of microbes which can have a large impact on host health and disease. Surveys of the microbiome have identified broad associations with disease, but have yet to robustly identify individual strains with probiotic potential. Dr. Minot will discuss innovations in gene-level metagenomic analysis which may enable an entirely new approach to the design of microbiome-based therapeutics and diagnostics.
Sam Minot, Ph.D., Staff Scientist, Microbiome Research Initiative, Vaccine & Infectious Disease Division, Fred Hutchinson Cancer Center
A Survivor’s Perspective: The Bigger Picture of the Patient Journey
Too often, manufacturers of therapeutics forget that the patient is more than simply someone taking a pill, but a person on an often long and arduous journey; a journey in which a therapeutics manufacturer can and often should become more than simply a supplier, but a trusted partner. In this presentation, Nancy C. Caralla, Founder of the C Diff Foundation and three-time C. difficile infection survivor, will share first-hand knowledge of one patient's journey that will bring needed perspective to the audience and new insights that should be front of mind for anyone developing new microbiome therapies.
Nancy Caralla, Founder, C Diff Foundation
Considerations for Gut-Based Brain Research
Much research in neuroscience has neglected the rest of the body, until recently, when the “gut-brain axis” has come to light. From the perspective of a neuroscientist, this talk will cover considerations in clinical trials and basic science research to incorporate questions about the gut to more holistically assess neurological disease. Lessons learned from our research on Alzheimer's disease will serve as a concrete reference.
Amy Feehan, Ph.D., Research Scientist, Ochsner Health System
Gut Microbiota Induces Anti-Tumor Immunity Restricting Tumor Growth – The RNF5-UPR-Inulin Journey
This presentation will highlight studies in which we have demonstrated the importance of the ubiquitin ligase RNF5 in the control of gut microbiota composition with a concomitant effect on anti-tumor immunity and tumor growth inhibition. The role of Unfolded Protein Response in RNF5-mediated changes in gut microbiota and anti-tumor immunity will be discussed, and finally, the identification of prebiotics that are capable of inducing anti-tumor immunity and restrict tumor growth.
Ze'ev Ronai, Ph.D., Professor, Sanford Burnham Prebys Medical Discovery Institute
Gut Microbiota Mediates the Vascular Beneficial Effects of Dietary Anthocyanins
Clinical studies support the cardiovascular benefits of berry anthocyanins. This presentation will focus on how dietary blueberry anthocyanins shift the composition and functional potential of the gut microbiome and improve vascular health in preclinical models. This presentation will also discuss the role of the gut microbiome and anthocyanin-derived microbial metabolites in mediating the vascular effects of blueberries.
Anandh Babu Pon Velayutham, Ph.D., Associate Professor, Nutrition & Integrative Physiology, University of Utah
Long-Term Benefit of Microbiota Transfer Therapy on Autism Symptoms and Gut Microbiome
Over the last couple of decades, autism spectrum disorders (ASD) have become substantially prevalent, but the etiology of these complex neurobiological disorders remain poorly understood. Accumulating evidence revealed that children with ASD have disrupted gut microbiome, which suggests that modifying it is a potential route to improve ASD behavioral symptoms. Thus, we designed and performed an open-label trial of Microbiota Transfer Therapy (MTT) that combined antibiotics and fecal microbiota transplant. Notably, children with ASD experienced significant improvements in GI symptoms and autism-related symptoms, even two years after treatment was completed. Their gut microbiome was transformed toward a healthy one, including significant increases in bacterial diversity and relative abundances of Bifidobacteria and Prevotella. Our observations support MTT as a promising safe and efficient approach to change the gut microbiome and improve GI and behavioral symptoms of ASD.
Dae-Wook Kang, Ph.D., Assistant Professor, Department of Civil and Environmental Engineering, University of Toledo
Lupus and Dysbiosis in the Gut Microbiome: Cause or Effect or Both?
Throughout our lives we are immersed in, and colonized by, immense and complex microbial communities. Yet, at times imbalances within microbiota contribute to metabolic and immune regulatory abnormalities that underlie the development of inflammatory and autoimmune diseases. Recent progress in investigations of the microbiome are beginning to illuminate aspects of the pathogenesis of Systemic Lupus Erythematosus, and may suggest that interconnections with specific disease-associated patterns of dysbiosis within gut communities could be bidirectional and mutually reinforcing.
Gregg Silverman, MD, Professor of Medicine & Pathology, New York University School of Medicine