Barbara S. Gillespie 医師、医学修士、米国腎臓学会特別研究員（FASN）
Labcorp Drug Development腎臓学担当バイスプレジデント兼治療部門責任者
Dr. Gillespie, board-certified in nephrology, joined Labcorp in 2017 after over a decade of leadership experience at Quintiles, where she held a variety of positions. These duties included reporting directly to the Chief Medical and Scientific Officer and serving as Global Therapeutic Lead for Nephrology and North American Head of the U.S. Internal Medicine team.
Dr. Gillespie serves on the board of directors of the Kidney Health Initiative (a public-private partnership between the FDA and the American Society of Nephrology) as well as on the steering committee for the National Kidney Foundation (NKF) Chronic Kidney Disease Registry. She is also on the board of directors for Nephronet and the Cardio Renal Society of America, has served on several global work groups and advisory boards for academic and trial-related stakeholders (including NKF, NephCure, Kidney Disease Improving Global Outcomes, ISN, Patient-Centered Outcomes Research Institute/University of North Carolina and PREPARE-NS) and has presented in many global forums and renal conferences.
She is also a past associate medical director at a small local dialysis unit and a fellow of the American Society of Nephrology. Dr. Gillespie received board certification in internal medicine in 2004 and in nephrology in 2006 and 2015. She completed her internal medicine residency at University of North Carolina and her nephrology fellowship at Duke.
Jennifer Ennis 医師
Dr. Ennis, board-certified in internal medicine and nephrology, joined Labcorp Diagnostics as a medical director in 2009. In this role, she led the development of Labcorp's suite of laboratory-based clinical decision support offerings, including chronic kidney disease, cardiovascular disease and diabetes. 2020年に臨床およびデジタルソリューション担当の医療ディレクターに就任し、ラボコープのお客様向け技術ソリューションのポートフォリオに、臨床としての方向性と監視を提供しています。現在はポートフォリオのコンテンツを作成すべく、臨床医のグループを指揮しています。 She provides subject-matter expertise for nephrology initiatives throughout the organization and serves as a Labcorp representative on the National Kidney Foundation Laboratory Engagement Committee.
Dr. Ennis is also a clinical associate professor of medicine in the section of nephrology at the University of Illinois at Chicago where she sees patients weekly, lectures and supervises medical trainees. これらの職責に加え、慢性腎臓疾患の臨床研究にも携わり、いくつかの査読済み論文や抄録を執筆しています。
Dr. Ennis earned her MD from the University of Pittsburgh School of Medicine and completed internal medicine residency and nephrology fellowship training at the University of Chicago Medical Center. 米国内科学会のフェローでもあります。
Katherine T. Landschulz 博士
Dr. Landschulz joined Labcorp Drug Development in 2010, after more than a decade as a scientist in discovery through translational medicine roles at Pfizer, Abbott and Eli Lilly. At Labcorp, Dr. Landschulz helped establish the exploratory biomarker laboratory, Translational Biomarker Solutions, and served as associate director of this team prior to joining the newly established Biomarker Solution Center in 2018.
As Renal Disease Therapeutic Area Lead for the Labcorp Biomarker Solution Center, Dr. Landschulz is responsible for the delivery of biomarker strategies for sponsor programs in renal disease indications (e.g., acute kidney injury, chronic/diabetic kidney disease). Dr. Landschulz serves as a consultant to sponsors and teams, advising on matters related to biomarker selection and strategy development, laboratory placement of testing, feasibility designs and overall guidance around translational and exploratory biomarker data in drug development. さらに、スポンサーとラボコープのバイオマーカーサイエンティストたちの質問の窓口となり、両者の間に立つ連絡調整係としても活躍しています。 Finally, Dr. Landschulz participates in enterprise-wide assessments and the licensing and implementation of new laboratory biomarker and tests transitioning from clinical trial to clinical care utilization.
Dr. Landschulz received her BSc in genetics at the University of California, Davis and her PhD in genetics/biology from Johns Hopkins University. 1997年にバイオ医薬品業界に就職する以前は、ジョンズ・ホプキンズ大学とテキサス大学サウスウェスタン医大の両方で博士号取得後の研究を修了しました。
フェーズ I ユニットにおけるファースト・イン・ヒューマン研究の支援から、グローバルなフェーズ II ～フェーズ IV 研究のデザイン、計画、管理、運用に至るまで、当社は腎疾患研究実施のための信頼できるパートナーです。当社の医療および業務的経験には、以下の領域をはじめとする広範な腎臓病学の適応症が含まれますが、これらに限定されているわけではありません。
- Acute kidney injury
- Diabetic kidney disease
- Chronic kidney disease and associated complications (e.g., hyperkalemia and hyperphosphatemia)
- Glomerular disease including focal segmental glomerulosclerosis, IgA nephropathy and lupus nephritis
- End-stage kidney disease: dialysis (and associated complications such as cardiovascular outcomes) and kidney transplant
- Rare renal diseases
- Renal devices
- Renal impairment
- Renal cell carcinoma
Develop new perspectives through proprietary data
患者様の治療経過および関連データの優先順位を決定することは、治験の成功にとって非常に重要です。ラボコープでは、お客様の特定の適応症および患者様集団に該当する戦略を作成し、適用することが可能です。 Starting with vast patient diagnostic data from Labcorp's database of longitudinal patient data and site-specific recruitment metrics from our Central Laboratory and clinical investigator database, we can:
- Design the most efficient trial by focusing on the highest enrolling countries and sites and eliminating nonperformers
- Identify patients meeting your inclusion criteria who are near clinical trial sites and connect them to your trial
- Fully inform your protocol design to maximize recruitment and save time and money
Comprehensive, multifunctional nephrology experience and expertise to deliver better outcomes
Whether your study is looking for a rare population, expecting aggressive enrollment timelines or operating in a highly competitive environment, Labcorp has the expertise, data and experience to support trial design, proactively mitigate risk and deliver results.