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March 30, 2021 | Virtual Awards Program Visit to Register March 30, 2021 | Virtual Awards Program Visit www.clinicalresearchforum.org/2021Top10Awards to register. HONORING THE IMPORTANT WORK THAT WE ACCOMPLISH On behalf of the Clinical Research Forum Board of Directors, thank you for supporting and celebrating the achievements of the 2021 Top Ten Clinical Research Achievement Awardees. As researchers around the globe are working around the clock to find ways to stop COVID-19, we are reminded by the great and important clinical and translational research that is done every day. Under tremendous pressure, the pandemic has inspired change, innovation, clinical work and research that has elevated our field. In the midst of this, many of the studies we will honor during the awards program surmounted great time constraints and made impressive discoveries without sacrificing the science and data that legitimizes our profession. In this context, I cannot emphasize enough the pride I feel for the amazing work of all our colleagues and for clinical research as a field. Not only has the nation been dealing with the pandemic, but recent tragic actions have surfaced social justice inadequacies and systemic racism in our culture. As clinical researchers, we are well versed in health disparities and the impact racism has on health. We believe that clinical research can make important contributions to social justice and health equity, as some of our Top Ten Clinical Research Achievement Awardees have shown so brilliantly. To that end, the CR Forum Board of Directors has put together a statement and an action plan to help make a difference. Racism is a disease Americans have failed to address for four hundred years. Racism is a public health crisis, and as such, requires an immediate plan to address its current terrible impact and a long-term sustainable plan to prevent its recurrence. I ask that you visit the Clinical Research Forum website to read the full statement and plan. Please join our community virtually on Tuesday, March 30 to celebrate this year’s Top Ten and continue these important discussions. I look forward to recognizing accomplishments from the past year and celebrating science. Sincerely, Harry P. Selker, MD, MSPH 2 BOARD OF DIRECTORS Chair Vice Chair Harry P. Selker Herbert Pardes, MD MD, MSPH New York-Presbyterian Hospital Tufts Medical Center Secretary/Treasurer William L. Lowe, Jr., MD, Northwestern University Feinberg School of Medicine Members Robert M. Califf, MD, MACC Harry B. Greenberg, MD Arthur H. Rubenstein, MBBCh Verily Life Sciences Stanford University University of Pennsylvania School of Medicine Health System Barry S. Coller, MD The Rockefeller University Rebecca Jackson, MD Anantha Shekhar, MD, PhD The Ohio State University University of Pittsburgh School Anne B. Curtis, MD of Medicine University at Buffalo School Rainu Kaushal, MD, MPH of Medicine and Biomedical Weill Cornell Medicine Ex Officio Sciences Emma A. Meagher, MD Daniel E. Ford, MD, MPH Pamela Davis, MD, PhD Perelman School of Medicine, Johns Hopkins University Case Western Reserve University University of Pennsylvania School of Medicine Maurizio Fava, MD E. Albert Reece, MD, PhD, MBA John I. Gallin, MD Massachusetts General Hospital University of Maryland National Institutes of Health and Harvard Medical School School of Medicine Schedule of Events Tuesday, March 30 Extraordinary Impact on Health Award NEW 10:00 - 11:30 AM EST William Gruber, MD, FAAP, FIDSA, Virtual Program Senior Vice President Vaccine Clinical Research and Development, Pfizer, Inc. Welcome – Harry Selker, MD, MSPH Chair, Clinical Research Forum; Dean, Tufts Clinical Brett Leav, MD, Vice President of Clinical and Translational Science Institute, Tufts University Development, Public Health Vaccines, Moderna Presentation of the Top 10 Awards – Presentation of the Distinguished Clinical E. Albert Reece, MD, PhD, MBA Research Achievement Awards – Executive Vice President for Medical Affairs, UM E. Albert Reece, MD, PhD, MBA Baltimore, John Z. and Akiko K. Bowers Distinguished Presentation of the Herbert Pardes Clinical Professor and Dean, University of Maryland School Research Excellence Award – Herbert Pardes, MD, of Medicine Vice Chairman of the Board of Trustees, New York- Presbyterian Hospital Closing Remarks – Harry Selker, MD, MSPH 3 TOP TEN CLINICAL RESEARCH ACHIEVEMENT AWARDS Anti-Selig-8 Antibody for Eosinophilic Gastritis and Duodenitis Publication: Dellon ES, Peterson KA, Murray JA, ...Hirano I. Anti-Selig-8 Antibody for Eosinophilic Gastritis and Duodenitis. N Engl J Med. 2020 Oct22;383(17):1624- 1634. doi:10.1056/NEJMoa2012047. Summary: Eosinophilic gastrointestinal disorders are an under-recognized cause of gastrointestinal illness. Increasing in incidence for reasons that are unclear, eosinophilic GI disorders have no FDA-approved therapies. Dr. Dellon and his Evan Dellon, MD, MPH colleagues performed a randomized controlled trial of lirentelimab, an anti-Siglec-8 antibody, in patients with eosinophilic gastritis and duodenitis. This monoclonal antibody depletes eosinophils and inhibits mast cells, which are thought to be critical in the pathogenesis of these diseases. After four monthly infusions, patients receiving the monoclonal antibody had an 86 percent reduction in mean eosinophil counts from mucosal biopsies, compared to a nine percent reduction in controls. Additionally, treated patients experienced a 48 percent decrease in a standardized symptom score, compared to 22 percent in the placebo group. Both of these results were highly statistically significant. This study provides a potential therapeutic option for conditions afflicting thousands of patients, for whom other treatments were inadequate or too toxic for long-term use. It also provides proof-of-principle to advance our understanding of the pathogenesis of these conditions and their potential treatments. Given the significant challenges to treating EG and EoD, this study could significantly improve patient care. Author: Dellon ES, Peterson KA, Murray JA, Falk GW, Gonsalves N, Chehade M, Genta RM, Leung J, Khoury P, Klion AD, Hazan S, Vaezi M, Bledsoe AC, Durrani SR, Wang C, Shaw C, Chang AT, Singh B, Kamboj AP, Rasmussen HS, Rothenberg ME, Hirano I Institutions: University of North Carolina at Chapel Hill Funding: Supported by Allakos. The work of Drs. Khoury and Klion is supported by the Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health. Dr. Murray’s work is supported in part by a grant (UL1 TR002377) from the National Center for Advancing Translational Sciences. 4 Evaluation of the Anti-SARS-Cov-2 Humoral Immune Response in a Cohort of COVID-19 Convalescent Individuals Publication: Robbiani DF, Gaebler C, Muecksch F, Lorenzi JCC, Wang Z, Cho A, Agudelo M, Barnes CO, Gazumyan A, Finkin S, Hägglöf T, Oliveira TY, Viant C, Hurley A, Hoffmann HH, Millard KG, Kost RG, Cipolla M, Gordon K, Bianchini F, Chen ST, Ramos V, Patel R, Dizon J, Shimeliovich I, Mendoza P, Hartweger H, Nogueira L, Pack Christian Gaebler, MD M, Horowitz J, Schmidt F, Weisblum Y, Michailidis E, Ashbrook AW, Waltari E, Pak JE, Huey-Tubman KE, Koranda N, Hoffman PR, West AP Jr, Rice CM, Hatziioannou T, Bjorkman PJ, Bieniasz PD, Caskey M, Nussenzweig MC. Convergent antibody responses to SARS-CoV-2 in convalescent individuals. Nature. 2020 Aug;584(7821):437-442. doi: 10.1038/ s41586-020-2456-9. Epub 2020 Jun 18. PMID: 32555388; PMCID: PMC7442695. Summary: In April 2020, during the peak of the novel coronavirus (COVID-19) pandemic in New York City, Dr. Gaebler and his team studied blood samples collected by the Michel Nussenzweig laboratory at Rockefeller University from 149 volunteers who had recovered from COVID-19. While ~75 percent of the individuals had IgG antibodies to the SARS-CoV-2 spike protein and the receptor binding domain (RBD) on the spike protein, the majority generated relatively poor plasma SARS-CoV-2 neutralizing activity as judged by a pseudo virus neutralizing assay developed by Dr. Paul Bieniasz at Rockefeller. The team was also able to identify individual B cells that bound an RBD peptide, and thus could determine from the DNA sequences that antibodies produced by different people had structural similarities. Most importantly, as a prelude to developing monoclonal antibodies (mABs) for therapy and prevention of COVID-19 from the B cells from these patients, they found antibodies that were extremely potent in neutralizing authentic SARS-CoV-2. Moreover, these antibodies could be grouped into ones that can bind simultaneously to the RBD, making it possible to pair such antibodies in ways that will make it much harder for the virus to escape by mutating the RBD. This study lays the groundwork for a major potential addition to resources against the COVID-19 pandemic. At the same time, by rigorously analyzing the antibodies that neutralize the virus at the genetic level, it provides important information for assessing antibody responses to the many vaccines under development. Authors: Robbiani DF, Gaebler C, Muecksch F, Lorenzi JCC, Wang Z, Cho A, Agudelo M, Barnes CO, Gazumyan A, Finkin S, Hägglöf T, Oliveira TY, Viant C, Hurley A, Hoffmann HH, Millard KG, Kost RG, Cipolla M, Gordon K, Bianchini F, Chen ST, Ramos V, Patel R, Dizon J, Shimeliovich I, Mendoza P, Hartweger H, Nogueira L, Pack M, Horowitz J, Schmidt F, Weisblum Y, Michailidis E, Ashbrook AW, Waltari E, Pak JE, Huey-Tubman KE, Koranda N, Hoffman PR, West AP Jr, Rice CM, Hatziioannou T, Bjorkman PJ, Bieniasz PD, Caskey M, Nussenzweig MC Institutions:
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