SFA Therapeutics Strengthens Management Team With Appointment of Chief Operating Officer
SFA Therapeutics Strengthens Management Team With Appointment of Chief Operating Officer
JENKINTOWN, Pa., July 16, 2024 /PRNewswire/ -- SFA Therapeutics, Inc., a clinical-stage biopharmaceutical company developing oral small-molecule biosynthetic compounds for the treatment of inflammatory diseases, today announced the appointment of James Kirwin, MBA, as Chief Operating Officer. In this role, Mr. Kirwin will lead the identification and negotiation of clinical trial study agreements, collaboration with CMC and regulatory teams, and the development of GMP clinical trial materials with Contract Development and Manufacturing Organizations.
SFA Therapeutics,Inc.宣布任命MBA的James Kirwin先生担任首席运营官。在这个角色中,Kirwin先生将领导临床试验研究协议的制定和谈判、与CMC和监管团队的合作以及与合同开发和制造组织一起开发GMP临床试验材料。SFA Therapeutics是一家研发口服小分子生物合成化合物治疗炎症性疾病的临床阶段生物制药公司。
Mr. Kirwin is a seasoned biopharmaceutical clinical operations leader with over 20 years of experience in directing research and innovation at global pharmaceutical companies as well as emerging biotechnology start-ups. Mr. Kirwin's wealth of expertise spans across multiple managerial and operational functions, including research and development of pre-clinical and clinical assets and the management of complex, high-performing teams.
Kirwin先生是一位资深的生物制药临床运营领导者,在全球制药公司以及新兴生物技术初创公司指导研究和创新方面拥有20多年的经验。Kirwin先生丰富的专业知识涵盖多个管理和运营职能,包括早期临床资产的研发和管理复杂、高绩效团队。
"As we advance SFA-002 and other therapeutic candidates through the clinic, Jim will be an integral member of our team in managing all aspects of Clinical Development Operations. With his exceptional ability to execute strategy with cross-functional teams across a variety of diseases, Jim will bring organizational excellence to SFA Therapeutics as Chief Operating Officer," said Dr. Ira Spector, Chief Executive Officer of SFA Therapeutics. "Jim's strategic direction will be essential to contributing to SFA's mission to bring safe and effective drugs to patients suffering from inflammatory and immunologic conditions."
“随着我们将SFA-002和其他治疗候选药物推向临床,Jim将作为我们团队的重要成员,负责管理临床发展运营的所有方面。凭借他在各种疾病的跨功能团队中执行战略的卓越能力,Jim将为SFA Therapeutics带来组织卓越作为首席运营官,”SFA Therapeutics的首席执行官Ira Spector博士说:“Jim的战略方向将对为患有炎症和免疫性疾病患者带来安全有效的药物的SFA的使命做出重要贡献。”
"As Chief Operating Officer of SFA Therapeutics, I look forward to applying my clinical operations and managerial skillsets to develop industry-leading operations in order to execute clinical trials of SFA-002 and other therapeutic candidates. SFA Therapeutics' novel platform has the potential to tailor many biosynthetic compounds with target-specific adjuvants, and I welcome the chance to help drive this disruptive science through the clinic to patients in need of safer, more efficacious treatments," commented James Kirwin, Chief Operating Officer of SFA Therapeutics.
“作为SFA Therapeutics的首席运营官,我期待运用我的临床运营和管理技能来发展业界领先的运营,以执行SFA-002和其他治疗候选药物的临床试验。 SFA Therapeutics的新颖平台有潜力通过特定靶点的佐剂独特地调整多种生物合成化合物,我乐于借此帮助推动这种具有破坏性的科学通过临床向需要更安全、更有效的治疗的患者推广,”SFA Therapeutics的首席运营官James Kirwin评论道。
Most recently, Mr. Kirwin served as the Executive Director, Global Head of Clinical Operations at Arvinas, where he designed and built the clinical operations organization and initiated clinical programs in breast and prostate cancer as well as neuromuscular diseases. He ensured the smooth transition of the Vepdegestrant breast cancer program to Pfizer in a collaborative development agreement. Prior to this, Mr. Kirwin was the Vice President, Clinical Development Operations and Clinical Alliances at Iterum Therapeutics where he oversaw the anti-infectives global clinical trial program which consisted of three Phase III studies across 240 sites and 2,000 patients. Mr. Kirwin has also held senior positions at Intercept Pharmaceuticals, Taiho Oncology, Medtronic Spine and Biologics, Intrexon Corporation, Pfizer, Wyeth Pharmaceuticals, and AstraZeneca.
Kirwin先生最近在Arvinas担任执行董事,全球临床运营主管,他在乳腺癌、前列腺癌以及神经肌肉疾病方面设计和建立了临床运营组织,并与辉瑞达成了协作发展协议,在Vepdegestrant乳腺癌计划顺利过渡。之前,Kirwin先生曾在Iterum Therapeutics担任临床发展运营和临床联盟的副总裁,监督包括240个研究点和2000名患者在内的抗感染全球临床试验计划中的三个三期研究项目。Kirwin先生还曾在Intercept Pharmaceuticals、Taiho Oncology、Medtronic Spine and Biologics、Intrexon Corporation、Pfizer、Wyeth Pharmaceuticals和AstraZeneca等公司担任高级职位。
Mr. Kirwin received his undergraduate degree in Microbiology and Molecular Biology from Pennsylvania State University and his MBA from the University of Delaware.
Kirwin先生获得宾夕法尼亚州州立大学的微生物学和分子生物学学士学位,以及特拉华大学的商业管理硕士学位。
About SFA Therapeutics
关于SFA Therapeutics
SFA Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing oral small-molecule biosynthetic compounds for the treatment of inflammatory diseases. Based on breakthrough research licensed from Temple University, SFA Therapeutics' platform has the potential to develop safer and more efficacious treatments for a number of chronic inflammatory diseases by uniquely tailoring the effects of patented formulations with target-specific adjuvants. Its lead asset, SFA-002, an HDAC inhibitor in immune cells, is approaching Phase 2 clinical trials and has shown promising Phase 1a and Phase 1b results for the treatment of psoriasis. SFA Therapeutics has also received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to investigate SFA-001N in patients with metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH), with or without fibrosis. SFA Therapeutics has an Orphan Disease Designation from the FDA for SFA-001 in the treatment of hepatocellular carcinoma, the most prevalent form of liver cancer.
SFA Therapeutics,Inc.是一家开发口服小分子生物合成化合物治疗炎症性疾病的临床阶段生物制药公司。基于授权自Temple University的突破性研究,SFA Therapeutics的平台有潜力通过特定靶点的佐剂调整专利配方的作用,以针对多种慢性炎症性疾病开发更安全、更有效的治疗方法。其主要资产SFA-002,免疫细胞中的HDAC抑制剂,正接近II期临床试验,对治疗牛皮癣的1a期和10亿人试验显示有希望的效果。SFA Therapeutics还获得了美国食品和药品管理局(FDA)颁发的调查新药(IND)申请批准,以研究SFA-001N治疗代谢紊乱相关的脂类肝病(MASH)患者,也称非酒精性脂肪肝炎(NASH)伴或不伴有纤维化。 SFA Therapeutics在治疗肝细胞癌方面获得了FDA的特药病情认定,这是最普遍的肝癌形式。
SFA Therapeutics is headquartered in Jenkintown, Pennsylvania. Please visit to learn more.
SFA Therapeutics的总部位于宾夕法尼亚州的Jenkintown。请访问www.sfatherapeutics.com了解更多信息。
Company Contact
公司联系 Marcia Novero Innodata Inc. Mnovero@innodata.com (201) 371-8015
Ira Spector, Ph.D.
SFA Therapeutics, Inc.
+1 267-584-1080
Ira Spector博士。
SFA Therapeutics,Inc。
+1 267-584-1080
Media Contacts
媒体联系方式
Tony Russo, Ph.D.
Russo Partners, LLC
[email protected]
Tony Russo,博士。
Russo Partners, LLC
[email protected]
Maddie Stabinski
Russo Partners, LLC
[email protected]
Maddie Stabinski
Russo Partners, LLC
[email protected]
SOURCE SFA Therapeutics, Inc.
来源:SFA Therapeutics,Inc。