Dr. Axel Dignass, M.D., Ph.D., Head of the Department of Medicine I and Professor of Medicine and Gastroenterology at the Agaplesion Markus Hospital, Goethe University in Frankfurt and lead study investigator discusses findings from the Phase 2b QUASAR trial evaluating TREMFYA ® (guselkumab) in ulcerative colitis (UC). More than 60% of adults with moderately to severely active UC achieved clinical response with TREMFYA at week 12, the study’s primary endpoint. More than 30% of patients showed endoscopic improvement with TREMFYA at the same timepoint. These data were presented at the 17th Congress of the European Crohn’s and Colitis Organisation (ECCO) 2022 meeting.
Returning guest, Dr. Bruce Sands, MD, MS, Chief of the Dr. Henry D. Janowitz Division of Gastroenterology at the Icahn School of Medicine at Mount Sinai, and the Mount Sinai Hospital discusses findings from the Phase 2 GALAXI-1 trial which showed that the majority of adults with moderately to severely active CD maintained clinical remission and corticosteroid-free remission through 48 weeks with TREMFYA ® (guselkumab). These data were presented at the 17th Congress of the European Crohn’s and Colitis Organisation (ECCO) 2022
Returning guest, Dr. Bruce Sands, MD, MS, Chief of the Dr. Henry D. Janowitz Division of Gastroenterology at the Icahn School of Medicine at Mount Sinai, and the Mount Sinai Hospital and lead study investigator on the VEGA Phase 2a proof-of-concept study discusses data that showed 83.1 percent of patients who received guselkumab and golimumab combination therapy achieved the primary endpoint of clinical response and 36.6 percent of patients achieved clinical remission at week 12. These data were presented at the Congress of the European Crohn’s and Colitis Organisation (ECCO) 2022.
Dr. Vivian Hernandez-Trujillo, a leading pediatric allergist at the Allergy and Immunology Care Center of South Florida discusses guidelines by the National Institute of Allergy and Infectious Diseases (NIAID) that recommend parents and caregivers introduce peanut-containing foods to infants as young as four to six months, to potentially reduce the risk of developing a peanut allergy by up to 80%. She also talks about how infants and toddlers often respond differently to allergens than older children and adults, and the importance of recognizing the signs and symptoms of anaphylaxis, as well as developing an anaphylaxis preparedness plan and carrying an epinephrine auto-injector.
Barbara J. Stegmann, Clinical Lead, Women’s Health at Organon and OB/GYN, discusses the company’s efforts to recognize the growing women’s health inequities exacerbated by the pandemic, including Organon’s decision to declare International Women’s Day (IWD) a paid day off for its employees to focus on their own health. She addresses the major inequities plaguing women’s health today and how healthcare providers can help to close these gaps and ensure women are prioritizing their health.
Dr. Jerome Goldschmidt, MD, an oncologist at Blue Ridge Cancer Care discusses his poster presentation from the American Society of Hematology (ASH) 2021 Annual Meeting titled “Understanding Hematological Adverse Event Management through Health Care Resource Utilization, Costs, and Treatment Patterns of Patients with Extensive-Stage Small Cell Lung Cancer Treated in the Community Oncology Setting”
For patients suffering from rare diseases, the limited number of breakthrough treatments has hindered improvements to their quality of life. While most clinical trials have recruitment and retention challenges, rare disease trials encounter these in addition to unique challenges such as inherently small and geographically dispersed patient populations, more heterogeneity in diagnosis and treatment approaches, patient’s age and impact on the entire family, and other factors. Leanne Larson, SVP, Real-World Evidence and Access at Parexel, and Matthew Gordon, VP, Real-World Evidence Strategy at Parexel, discuss how real-world data/evidence and external control arms provide new hope for patients and developers. For example, with external control arms, researchers are now able to use real-world evidence (RWE) from existing medical records, databases, clinical trial data, etc. to speed up recruitment, an often time-consuming process to drug development. They also discuss the implications and opportunities from the FDA’s planned guidance on the use of RWE in clinical research and what this means for the industry and the rare disease community.
Monica Molenaar, co-founder and co-CEO, and Dr. Sharon Malone, certified national menopause practitioner and Medical Director from Alloy Women’s Health, Inc. discuss menopause and the health issues surrounding menopausal and post-menopausal women. They recommend a three-pronged approach that will offer women the best ways to make informed decisions to address their individual concerns about menopause and take back control of their health.
Dr. Peter Emanuel, a hematologist/oncologist in Little Rock, Arkansas discusses acute hepatic porphyria (AHP), a debilitating, rare genetic disease, and a new film called “Two of Me: Living with Porphyria” that features personal interviews with AHP patients. He is joined by his patient, Megan, who is featured in the film and shares her personal journey.
Diana Peninger, President and CEO of Reproductive Solutions discusses ProteX, a new semen collection method that reduces damage, can be collected at home, and extends viable life to the sperm.