Novartis shuffles AveXis executive team in wake of gene therapy data manipulation scandal

在基因治疗数据操纵丑闻之后,诺华(Novartis)改组了 AveXi 的执行团队

2019-08-14 16:41:00 medcitynews


Swiss drugmaker Novartis has shaken up the management at its gene therapy subsidiary in the wake of the data manipulation scandal that rocked the company last week. The subsidiary, AveXis, said Tuesday it had appointed Page Bouchard as Senior Vice President of research and chief scientific officer, effective Aug. 5. The announcement comes the week after the Food and Drug Administration stated publicly that some preclinical data in the submission package of the gene therapy Zolgensma – approved in May for spinal muscular atrophy in infants – had been manipulated. Bouchard replaces Brian and Allan Kaspar, brothers who had respectively served as head of research and development and chief scientific officer, roles that will be combined into Bouchard’s position. The company said the Kaspars “have not been involved in any operations at AveXis since early May 2019 and are no longer with the company.” Citing an unnamed source, STAT reported Wednesday that the Kaspars were ousted from the company in connection with the data manipulation scandal. In response to a request for comment, a Novartis spokesperson referred to the AveXis announcement and reiterated the timeline of events connected to the data manipulation that the company had provided, but declined to comment further. The FDA had said last week that the Zolgensma application included manipulated mouse data, which Novartis said came from an assay that is no longer used. While the agency said the data manipulation did not raise concerns about benefit-risk profile of the gene therapy, which the agency approved in May for spinal muscular atrophy in infants, AveXis was apparently aware of it as early as March, but did not tell the agency until June. Novartis has said it stands by the therapy and that the delay in disclosing the manipulation was so that it could complete an internal investigation, not for expediency of approval, which the FDA said would have been delayed had the company disclosed the findings ahead of Zolgensma’s approval. The scandal has since led to political fallout. Last week, five Democratic senators – including presidential candidates Bernie Sanders of Vermont and Elizabeth Warren of Massachusetts – sent a letter to FDA acting Commissioner Ned Sharpless urging the agency to take action. Also last week, Sen. Chuck Grassley, R-Iowa, sent a letter to Novartis CEO Vas Narasimhan, calling the allegedly intentional withholding of data “reprehensible” and asking for information on, among other things, when the company learned of the data manipulation and requesting records pertaining to the incident and the investigation. And on Tuesday, The New York Times’ editorial board urged lawmakers and regulators to limit the use of accelerated approval, cap prices for medications whose risk-benefit profiles are not yet proven and demand more data to prove them. Photo: Novartis Promoted 6 reasons why healthcare executives need to adopt weight management programs Think weight management programs for healthcare organizations are nice but unnecessary? A report from Robard Corp. wants healthcare executives to re-assess their assumptions and highlight the value these programs can add. MedCity News Promoted How can payers use automation to improve data accuracy and reduce costs? A health technology company wants to help payers improve the accuracy of their data through automation. Learn how. MedCity News AI & Product Launches: Meeting the Need for Speed In this post, ZS’s experts discuss how AI can be leveraged in pharmaceutical companies for product launches and how AI can make product launches more effective and collaborative. ZS Associates Join Us at MedCity INVEST Digital Health 2019 MedCity INVEST Digital Health , held September 17, 2019 in Minneapolis, will unite active investors with corporate business development executives to facilitate investment opportunities with the most innovative companies from the Digital Health sector. Reserve your place.>> The impact of artificial intelligence on outcomes based contracting Discover insights from decision makers on the trends and challenges of frequently used OBC types. Read the whitepaper. ICON
瑞士制药商诺华制药(诺华(Novartis))上周爆出数据操纵丑闻,震惊了该公司旗下基因治疗子公司的管理层。该子公司 AveXis 周二表示,已任命 Page Bouchard 为研究高级副总裁兼首席科学官,自8月5日起生效。此前一周,美国食品和药物管理局( FDA )曾公开表示,基因治疗佐尔甘斯马( Zolgensma )提交方案中的一些临床前数据已被篡改。佐尔甘斯马于5月份获得批准,用于治疗婴儿的脊肌萎缩症。Bouchard 取代了 Brian 和 Allan Kaspar 这两位兄弟,他们分别担任研究和开发主管和首席科学官员,这些职位将并入 Bouchard 的职位。该公司表示, Kaspas “自2019年5月初以来没有参与任何在 AveXis 的运营,也不再与该公司合作。”STAT 引用了一位未透露姓名的消息人士,周三报道称, Kaspars 因数据操纵丑闻被驱逐出该公司。针对置评请求,诺华(Novartis)的一位发言人提到了 AveXi 的公告,并重申了该公司提供的与数据操纵相关的事件时间表,但拒绝进一步置评。FDA 上周说, Zolgensma 应用程序包含了操纵的老鼠数据,诺华(Novartis)公司说,这些数据来自一种不再使用的检测方法。尽管该机构表示,数据操纵并未引起人们对基因治疗的利益风险状况的担忧,该机构在5月份批准了针对婴儿脊柱肌肉萎缩的基因治疗,但 AveXis 显然早在3月就意识到了这一点,但直到6月才告诉该机构。诺华(Novartis)表示,它支持这种疗法,延迟披露这种操纵行为是为了完成一项内部调查,而不是为了方便审批。 FDA 表示,如果该公司在 Zolgensma 批准之前披露调查结果,就会推迟审批。此后,这起丑闻引发了政治后果。上周,包括佛蒙特州总统候选人伯尼•桑德斯( Bernie Sanders )和马萨诸塞州的伊丽莎白•沃伦( Elizabeth Warren )在内的5名民主党参议员致函 FDA 代理专员 Ned Sharpless ,敦促 FDA 采取行动。也是在上周,森。衣阿华州 R-Iowa 的查克•格拉斯利( Chuck Grassley )致函诺华(Novartis)首席执行官瓦什•纳拉西姆汉( Vas Narasimhan ),称据称故意隐瞒数据“应受到谴责”,并要求提供有关信息,尤其是当该公司了解到数据操纵情况,并要求提供与事件和调查有关的记录时。周二,《纽约时报》的编辑委员会敦促立法者和监管机构限制加速审批的使用,限制风险收益状况尚未得到证实的药物的价格,并要求更多数据来证明它们。图片:诺华(Novartis)公司提出了6个原因,为什么医疗保健管理人员需要采取体重管理计划认为,为医疗保健组织的体重管理计划是好的,但没有必要?Robard Corp .的一份报告希望医疗保健高管重新评估他们的假设,并强调这些计划能够增加的价值。MedCity 新闻促进付款人如何使用自动化来提高数据准确性和降低成本?一家健康科技公司希望通过自动化帮助付款人提高数据的准确性。学习如何。MedCity News AI & Product Launches :满足速度需求在这篇文章中, ZS 的专家讨论了如何在制药公司中利用人工智能进行产品发布,以及人工智能如何使产品发布更加有效和协作。ZS Associates 将与我们一起参与 MedCity INVESTT Digital Health 2019 MedCity INVESTT Digital Health ,于2019年9月17日在明尼阿波利斯举行的会议,将积极的投资者与企业业务开发主管团结起来,与数字健康领域最具创新性的公司一起为投资机会提供便利。保留你的位置.>人工智能对基于合同的结果的影响了解决策者对常用 OBC 类型的趋势和挑战的见解。阅读白皮书。ICON