Systemic Lupus Erythematosus (SLE) clinical trials are complex and can be challenging to conduct. The use of multiple questionnaires, assessing the same symptoms, each with different scoring systems and criteria, can complicate data collection and analysis. But, with direct data capture technology and a fit-for-purpose Electronic Lupus Assessment Suite of tools, clinicians can streamline the data collection process and ensure SLE research is straightforward, efficient and reliable.
Learn from a panel of clinical experts at the forefront of Lupus research, explore traditional data collection challenges that can arise in Lupus clinical trials and hear first-hand experiences solving these challenges.
The featured experts will also discuss the recent US Food and Drug Administration (FDA) guidance and share their vision on the future of Lupus research and opportunities to drive research forward.
Join today and hear from clinical experts on how the Electronic Lupus Assessment Suite helps solve data collection challenges in Lupus clinical trials.
Rinah Yamamoto, Principal Scientist, Clinical Ink
Dr. Rinah Yamamoto holds a PhD in experimental psychology from Tufts University, followed by a postdoc and research position at McLean Hospital focusing on using fMRI to understand substance use and abuse and the evaluation of a novel low field magnetic stimulation treatment for bipolar and unipolar depression. She brings more than 20 years of research experience in the preclinical and clinical environments.
She has been involved in outcomes science for the past six years and has experience in best practices for electronic clinical outcomes assessments, as well as, administering, scoring and training on clinical assessments for clinical trials. Prior to joining Clinical Ink, Dr. Yamamoto specialized in eCOAs, rater training development and delivery, statistical analysis and consulting on eCOA.
Neil Solomons, Chief Medical Director, Aurinia Pharmaceuticals
Dr. Neil Solomons co-founded Aurinia Pharmaceuticals in 2012 where he is currently the Chief Medical Director. He is a pharmaceutical physician with 25 years of clinical development and medical affairs experience in both large pharma and biotech. He is a recognized expert in rare disease drug development and is widely published in this field gaining the US Food and Drug Administration (FDA)’s and European Medicines Agency (EMA)’s approval for Lupkynis in active lupus nephritis.
Prior to founding Aurinia, Neil was at Vifor Pharma, formerly Aspreva Pharmaceuticals (NASDAQ: ASPV) where he held the position of Vice President, Research and Development, being the lead clinician in the development of CellCept® in rare diseases. Neil led the CellCept clinical development teams of over 50 people that saw the completion, reporting and publication of studies in pemphigus vulgaris and myasthenia gravis (both industry firsts), and the successful landmark lupus nephritis study called the Aspreva Lupus Management Study (ALMS). He was responsible for all clinical development activities from Phases I to III, as well as participated in the formulation of R&D strategy, portfolio management and due diligence efforts. Prior to Vifor and Aspreva, Neil held a variety of positions at Roche in both global clinical development and medical affairs in transplantation, virology and autoimmune diseases. While at Roche, Neil led a diverse team in the development and implementation of post-marketing studies for its transplantation (CellCept® and Zenapax®) and virology (Cytovene®) franchises.
Neil qualified in medicine in 1991 receiving his MBBS (MD) at Guy’s Hospital Medical School, London. He subsequently worked as a physician in London UK, completing specialist training in anesthesia and intensive care. His research interests included sepsis and chronic pain.
Ed Vital, Associate Professor in Systemic Lupus Erythematosus, University of Leeds & Chair of BILAG and the Lupus Forum
Ed Vital is an Associate Professor in Autoimmune Connective Tissue Diseases and Honorary Consultant Rheumatologist, at Leeds Teaching Hospitals NHS Trust in the UK. He is the Head of the Leeds Lupus Research Group with interests in early disease, skin disease, musculoskeletal outcome measures, translational immunology, and B cell therapies.
He is chair of the British Isles Lupus Activity Group (BILAG), general secretary of SLEuro, and chair of the Lupus Forum educational website.
Who Should Attend?
Therapeutic area leads for Lupus/immunology from pharma, contract research organizations (CROs) including sponsors, researchers, clinicians, patients and advocates:
- Digital Strategy
- Digital Innovation
- Clinical Operations
- Data Management
- Emerging Bio
- Large Pharma
- Other CROs, research sites, academic researchers
What You Will Learn
Attendees will learn:
- How to overcome challenges innate to common Lupus assessment including inconsistencies, documenting supportive findings and scoring algorithms
- Benefits of capturing data directly during patient exam, including reducing transcription errors, streamlining data collection and results from the workflow validation for the industry-leading Electronic Lupus Assessment Suite (eLAS)
- Opportunities to drive Lupus research forward
Clinical Ink, a global clinical technology company, offers data certainty from source to submission via our Lunexis™ eSource clinical technology and configurable direct data capture, eCOA, ePRO, and eConsent modules. This suite of solutions for capturing and integrating electronic data from sites, clinicians, and patients at its source naturally enhances clinical trial workflows. For virtual, traditional, or hybrid trials, Lunexis technology reduces manual labor and provides anytime, anywhere data access, saving resources as your trials progress. For more information, visit clinicalink.com.
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