Duke University School of Medicine

WASHINGTON--( BUSINESS WIRE )--ELIQUENT Life Sciences (ELIQUENT), a global regulatory, quality, and safety consulting firm, today announced the appointment of Wendy Sanhai, Ph.D., MBA, to its Board of Directors. A trusted advisor to Fortune 500 pharmaceutical, biotechnology, and medical device companies, Dr. Sanhai’s appointment further positions ELIQUENT to meet the growing global demand for integrated regulatory, quality, and safety solutions across diverse markets. “We are thrilled to welcome Dr. Sanhai to ELIQUENT’s Board of Directors,” said Tim Dietlin, Chief Executive Officer, ELIQUENT Life Sciences. “Her deep understanding of the scientific, clinical, and regulatory landscapes, paired with her strategic expertise at both the board and C-suite levels, will be a catalyst for sustainable growth and lasting impact.” A distinguished life sciences leader and scientific expert, Dr. Sanhai’s professional background spans roles in academia, regulated industry, and senior positions at the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH). As the former Senior Scientific Advisor in the Office of the Commissioner at the U.S. FDA, she spearheaded strategic initiatives to advance medical product development, bridge public health gaps, and improve patient care. During her tenure as Director of Public-Private Partnerships at the Foundation for NIH, Dr. Sanhai led collaborations with industry and external stakeholders to further NIH’s mission of advancing research and improving health outcomes. In private industry, Dr. Sanhai served as Senior Director at GlaxoSmithKline (GSK), where she worked across therapeutic areas and international business units to accelerate drug development and achieve organizational objectives. Most recently, at Deloitte Consulting LLC, she advised senior leaders across NIH, FDA, the Department of Defense, the Veterans Health Administration, and multiple life sciences Fortune 500 companies in crafting innovative solutions and driving operational efficiencies in public health, medical product development, and regulatory strategies. Dr. Sanhai currently serves as a Board member on several organizations, including the Medicines for Malaria Ventures (MMV), University of Maryland Board of Trustees and the Advisory Board of the Robert H. Smith School of Business, and a member of the Burroughs Wellcome Fund Innovation in Regulatory Science, Advisory Committee. She is a Visiting Professor of Practice and Executive in Residence at the University of Maryland, Robert H. Smith School of Business and an Associate Professor (adjunct) at Duke School of Medicine. Dr. Sanhai earned her PhD in clinical biochemistry from the State University of New York at Buffalo, an MBA from the University of Maryland, and a BS from the University of Florida. About ELIQUENT Life Sciences ELIQUENT redefines regulatory consulting with a full-service platform that delivers integrated solutions across the product lifecycle. The firm's unprecedented assembly of regulatory leaders, industry experts, and technical specialists collaborate seamlessly to advise clients on the complex process of bringing new therapies to market and manufacturing them to quality standards. ELIQUENT's platform of regulatory solutions feature the following integrated service offerings: Regulatory Affairs Solutions : From the earliest phases of innovation through regulatory submissions, to post- approval support, ELIQUENT guides companies to approval and beyond. Pharmacovigilance & Risk Management Solutions : With an approach that includes both strategic direction and hands-on global support, customized PV solutions empower companies to operate with confidence. Quality & Compliance Solutions : Highly specialized compliance experts build customized solutions that equip companies with best- in-class strategic support, technical expertise, and project-based solutions. Remediations Solutions : Respected professionals and global experts bring an unmatched level of credibility and trust when interacting with regulators and guiding companies to remediation solutions. Talent Solutions : Whether you need a team of one or 100+, ELIQUENT’s talent solutions gives clients the ability to rapidly scale teams to the right size, with the right level of expertise, in the right locations. ELIQUENT Life Sciences was established by uniting the expertise of six premier consultancies — Validant, Greenleaf Health, DataRevive, Oriel Stat-a-Matrix, RApport Global, and IDEC — into a single, globally integrated organization. THE ELIQUENT team works cross-functionally to deliver the global solutions that pharmaceutical, biotechnology, and medical device companies need to gain and maintain authorization for the products. ELIQUENT’s comprehensive services support innovators across therapeutic modalities, phase-based pathways, and major global markets. ELIQUENT’s continued growth is supported by GHO Capital , the European specialist investor in healthcare. Learn more about ELIQUENT Life Sciences at eliquent.com .

FRIDAY, Dec. 13, 2024 -- A “watch-and-wait” strategy might be the best option for some women with early-stage, low-risk breast cancer. According to two new studies presented Thursday at the San Antonio Breast Cancer Symposium, active monitoring of ductal carcinoma in situ (DCIS) resulted in breast cancer recurrence rates similar to those of women who had surgery to remove their cancer. Not only that, women who were provided such watchful waiting also had a similar quality of life to those who received treatment right away, in terms of physical, emotional and psychological outcomes. “All current treatments for DCIS aim to reduce the risk of future invasive cancer, despite a growing body of evidence that not all DCIS is destined to progress,” said Dr. Shelley Hwang , a professor of surgery and radiology at Duke University School of Medicine in Durham, N.C. “Thus, current practice may result in the over-treatment of women whose tumors are at low risk of progression, leading to chronic pain, altered body image, reduced quality of life and other side effects that may be avoidable,” Hwang added in a meeting news release. DCIS involves abnormal cells found within a milk duct in the breast. It’s an early, noninvasive form of breast cancer that accounts for about 20% to 25% of all new breast cancer cases in the United States, the National Breast Cancer Foundation says. A steady increase in mammography and other breast cancer screening methods has led to the detection of more cases of DCIS, researchers explained in background notes. But DCIS poses little risk to women unless it progresses to invasive disease, raising the question of whether active surveillance would be better than going ahead and getting surgery and radiation. Both of the new studies involved the same clinical trial, which was designed to compare active monitoring against surgery for women diagnosed with DCIS. The first study looked at outcomes related to breast cancer, and the second at outcomes related to quality of life. In the clinical trial, 673 women with DCIS were randomly assigned to either receive active monitoring or have their cancerous cells surgically removed. After two years, nearly 9% of the women who’d gotten surgery went on to develop cancer in the breast where the DCIS was first found, compared with 3% in the watch-and-wait group, results show. Slightly more patients in the active monitoring group received hormone therapy for their DCIS: about 71% compared with 66%, researchers said. Nevertheless, the rate of breast cancer was 7% in those who received hormone therapy and surgery, versus 3% for those simply monitored, results show. “Omission of surgery has been highly controversial, with both patients and providers fearing that it might result in an unacceptably high rate of patients who develop invasive cancer,” Hwang said. “Our findings are reassuring, and longer-term follow up will have important implications for the future inclusion of active monitoring as a treatment option for low-risk DCIS." Those fears were the focus of the second study out of the clinical trial. A common concern is that watchful waiting might make patients feel more anxious about their cancer, harming their quality of life, researchers said. “It is critical that we understand how women feel when they are living with an active-monitoring approach and how it impacts on their overall quality of life, psychosocial health, worries about DCIS, anxiety and depression, and other related symptoms,” explained researcher Dr. Ann Partridge , interim chair of medical oncology at Dana-Farber Cancer Institute in Boston. The study found there were no significant differences between the two groups in terms of physical function, anxiety or depression. “The data suggest that, in the short-term, active monitoring is a reasonable approach in terms of patient experience,” Partridge said. “If longer-term data hold up, this approach could be considered as a management option for women with low-risk DCIS.” The first study was published Dec. 12 in the Journal of the American Medical Association , while the second in the Dec. 12 issue of the journal JAMA Oncology . Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

BRUSSELS, Belgium and CAMBRIDGE, MA, USA I November 19, 2024 I UCB (Euronext Brussels: UCB) and Biogen Inc. (NASDAQ: BIIB) today presented detailed results from the Phase 3 PHOENYCS GO study evaluating dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L drug candidate, demonstrating significant clinical improvement in disease activity in people living with moderate-to-severe systemic lupus erythematosus (SLE). The results were shared during an oral, late-breaker presentation at ACR Convergence 2024, the American College of Rheumatology’s annual meeting, in Washington, DC. “There remains a significant unmet need for additional treatment options for people living with systemic lupus erythematosus and the results we observed in PHOENYCS GO suggest dapirolizumab pegol has the potential to be impactful for this chronic and debilitating autoimmune disease. Across clinical endpoints we observed a positive effect and a favorable safety profile,” said Megan E.B. Clowse, M.D., principal investigator of the study and Associate Professor of Medicine, Chief of the Division of Rheumatology and Immunology at Duke University School of Medicine. “Participants receiving dapirolizumab pegol experienced reduced lupus activity while also tapering steroids, changes important to people living with the disease.” In the PHOENYCS GO study (n=321), dapirolizumab pegol (DZP) was administered intravenously every four weeks. On the primary endpoint measuring improvement of moderate-to-severe disease activity as assessed by achievement of British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) after 48 weeks, study participants receiving DZP plus SOC had a statistically significant 14.6% (95% confidence interval [CI]: 3.3, 25.8; p=0.0110) higher response rate (49.5%) than those receiving SOC alone (34.6%). A higher BICLA response rate reflects a treatment response across all affected organs at baseline and is associated with meaningful clinical benefit. On the first secondary endpoint of BICLA response at Week 24, study participants receiving DZP plus SOC had a 7.9% higher response rate (46.6%) than those receiving SOC alone (38.3%). However, the difference did not reach statistical significance (95% CI: -3.6, 19.4; p=0.1776). Given statistical significance was not achieved for the first key secondary endpoint in the hierarchical testing, analyses for all the subsequent secondary endpoints are descriptive and nominal p-values are included. Subsequent analyses of additional secondary endpoints showed clinical improvements in the DZP group, including SLE Responder Index (SRI)-4 response, corticosteroid tapering, SLE Disease Activity Index-2K (SLEDAI-2K), achievement of Lupus Low Disease Activity State (LLDAS) and prevention of severe BILAG flares: “Due to the varied symptoms and severity by patient, progress in the treatment of lupus has historically been challenging. With dapirolizumab pegol, we believe that our differentiated approach that targets the CD40L pathway results in clinically meaningful improvements across multiple disease domains and could substantially impact the burden of this disease in particular for women, who are disproportionately affected by lupus,” said Fiona du Monceau, Head of Patient Evidence at UCB. “We are highly encouraged by the results we have seen in PHOENYCS GO and are excited to continue the clinical development of dapirolizumab pegol in the second Phase 3 study, PHOENYCS FLY.” The safety profile of dapirolizumab pegol was generally favorable. The safety results were consistent with previous DZP studies and with that in study participants with SLE receiving an immunomodulator. In the PHOENYCS GO study, a higher proportion of patients receiving DZP plus SOC had treatment-emergent adverse events (TEAEs) compared to SOC alone (82.6% vs. 75.0%). The proportion of participants with serious TEAEs was 9.9% in those participants receiving DZP plus SOC compared to 14.8% in those receiving SOC alone. Opportunistic infections were reported in 2.8% of participants receiving DZP plus SOC compared to 0.9% of those receiving SOC alone. Discontinuation of treatment or study participation due to TEAEs occurred in 4.7% (10) of participants receiving DZP plus SOC and 3.7% (4) of participants receiving SOC alone. “At Biogen, we understand that lupus affects everyone differently and are committed to developing treatments as diverse as the patients we serve,” said Diana Gallagher, MD, Head of AD, MS and Immunology Development Units at Biogen. “These results reinforce our belief that dapirolizumab pegol has the potential to change the approach to care of SLE and we are dedicated to advancing this program with our partner UCB.” Participants from the PHOENYCS GO study will continue to be followed in a long-term open-label study. In 2024, UCB and Biogen will initiate a second Phase 3 trial of dapirolizumab pegol, PHOENYCS FLY ( NCT06617325 ). The safety and efficacy of dapirolizumab pegol in systemic lupus erythematosus have not been established, and it is not approved for use in systemic lupus erythematosus by any regulatory authority worldwide. About Systemic Lupus Erythematosus (SLE) SLE is a chronic, multifactorial autoimmune disease that is caused by the activation of autoreactive T, B and antigen-presenting cells, resulting in manifestations across multiple organ systems with periods of illness or flares alternating with periods of inactivity. 1 SLE can present itself in several ways including rash, arthritis, anemia, thrombocytopenia, serositis, nephritis, seizures or psychosis. 2 SLE is associated with a greater risk of death from causes such as infection and cardiovascular disease. An estimated 90% of people living with lupus are women; most begin to see symptoms between the ages of 15-55. 3,4,5 Individuals from populations of African, Hispanic, Asian and Native American descent are at a greater risk of earlier onset and more aggressive disease. 6,7 Pregnancy in women with SLE is high risk, with higher maternal and fetal mortality and morbidity than the general population. 8,9 About Dapirolizumab Pegol Dapirolizumab pegol is a novel investigational humanized Fc-free polyethylene glycol (PEG)-conjugated antigen-binding (Fab’) fragment. Dapirolizumab pegol inhibits CD40L signaling which has been shown to reduce B cell activation and autoantibody production, mitigate type 1 interferon (IFN) secretion, and attenuate T cell and antigen-presenting cell (APC) activation. 10 Dapirolizumab pegol is presently in Phase 3 clinical development for the treatment of systemic lupus erythematosus (SLE) under a collaboration between UCB and Biogen. 11 About UCB UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. UCB is listed on Euronext Brussels (symbol: UCB). About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient’s lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. The company routinely posts information that may be important to investors on its website at www.biogen.com . Follow us on social media – Facebook , LinkedIn , X , YouTube . References: SOURCE: UCB