独家专访 药明康德回应 BIOSCURE 法案
(2024.5.13)
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来自编辑 | 2024 年 5 月 13 日
专访：药明康德回应 BIOSCURE 法案
路易斯-G-照片编辑
作者：Louis Garguilo，《外包制药》主编
里克·康奈尔
里克·康奈尔
在我对里克·康奈尔的独家采访中，他突然做出了这样的承诺：
“我是药明康德美国和欧洲区总裁，在‘做正确的事，做正确的事’的指导原则下管理着一个全球性组织。我可以自信地说，没有任何政府向我们的组织索要或接受过任何客户的知识产权。 没有监管机构要求我们“转移”数据。 没有客户指控我们向中国政府提供知识产权。”
康奈尔对药明康德了如指掌。 这段关系始于 2004 年他在辉瑞公司工作时。
他同意与我坐下来逐条反驳美国国会拟议立法中的指控。 我们稍后会谈到这一点。
首先，了解 Rick Connell 就了解药明康德及其客户对 BIOSECURE 法案中看似错误的未经证实的指控感到震惊。
辉瑞第一
康奈尔于 2018 年 4 月离开辉瑞，担任外部研究解决方案副总裁，进入他认为的半退休状态。 那时，他对药明康德的了解就像对服务提供商的专业外包一样了解。
“我是在 2004 年认识他们的，当时辉瑞公司正在寻求扩大化学产能，”康奈尔在他位于马萨诸塞州波士顿的办公室里说道，“我担任运营职务，负责我们价值数百万美元的采购战略。”
2008 年，作为外部研究解决方案副总裁，他管理所有临床前外包和供应商。 在担任该职位的 14 年期间，他还接受了为期一年的任务，前往上海建立辉瑞研究机构。
“当时和现在对我来说最突出的是，在药明康德的每个会议室里都有一张大海报，上面写着：‘做正确的事，并且把它做对。’
“你可以说这只是一个口号。 但我想说的是，在我管理辉瑞合作的14年里，现在作为药明康德内部的高级领导者，创始人本人所宣扬的那些美德在公司得到了一丝不苟的遵循。
“他们也将指导我们渡过难关。”
稍后退休
2018年，当康奈尔告诉美籍华人企业家、药明康德创始人李革博士，他将从辉瑞退休时，李革回答说，他很欣赏康奈尔如何将辉瑞的全球供应商整合到一个界面中。 李有兴趣聘请康奈尔来做类似的事情。
“我亲眼目睹了在外包、知识产权安全以及组织的其他方面与全球合作伙伴的复杂性中你可以做些什么，”康奈尔回忆道，李说。
康奈尔说，李一直在考虑保护客户的专有技术。
“其他公司——一些离岸公司——也提供了一些探索性的会谈，”康奈尔补充道，“但根据我与众多供应商的经验，我知道质量、基础设施和围绕知识产权保护采取的步骤存在参差不齐。”
“药明康德无疑是该领域的领导者。”
康奈尔接受了这份工作。
生物安全炸弹
在《2024财年众议院国防授权法案》（NDAA）的审议过程中，药明康德惊讶地发现该法案被提及，尽管该法案针对的是一家名为华大基因及其子公司的公司。
华大基因已经受到美国财政部、国防部和商务部的制裁，它显然是目标。
“然而，”康奈尔说，“在文件中，你突然读到这句话，说国防部应该审核药明康德。”
“我们正在阅读该法案的背景，它都是关于人类基因组测序数据的。 我们真的不明白为什么我们会被纳入该法案。”
康奈尔表示，当 2024 财年 NDAA 法案在参众两院会议上最终确定时，“非常合理且务实”，具体公司的名称被删除，取而代之的是，该法案规定国防部应对任何能够以某种方式通过审查的中国生物技术公司进行审计。 对国家安全的威胁。
“我们认为这是一个很好的结果。 我们和其他人一样支持国家安全，并且愿意接受审计。”康奈尔回忆道。
然而，到了 2024 年 1 月，众议院提出了一项新法案，改变了方向。
“现在，令人难以置信的是，药明康德在没有提及审计或正当程序的情况下，被简单地列为国家安全威胁，”康奈尔在描述国会正在审议的《生物安全法案》草案时说道。
“鉴于我作为辉瑞公司客户的药明康德背景，以及作为公司内部领导者对运营的了解，这非常令人沮丧。 现在还有其他毫无根据的指控。”
太极拳
药明康德已尽最大努力与《生物安全法案》的起草者进行对话。
例如，该公司迅速联系了当时的威斯康星州国会议员迈克·加拉格尔的办公室，但没有结果。 加拉格尔是这项立法的带头人。 （加拉格尔于 4 月 19 日离开国会）。
加拉格尔将药明康德推荐给财政部、国防部和商务部，建议他们对公司进行审计，“所以我们给他们发了信，表示我们绝对欢迎任何审计，”康奈尔说。
“去年，我们进行了约 700 名客户审核。 我们进行了近 60 项监管审核——FDA、EMA 等。 2020年，我们甚至接受了美国外国投资委员会（CFIUS）的审计。”
尽管如此，新法案还是在参议院国土安全和政府事务委员会获得通过，没有对药明康德进行任何审计，也没有采取正当程序。
“我们留下的太极拳指控没有得到支持，”康奈尔说。
“如果这就是应对这一问题的必要条件，我们将采取影子行动。
“当我们今天坐在这里时，我再清楚不过了，我不知道他们在立法中谈论什么。
“乱说话很容易。 他们说这是国家安全问题。 我们全力支持国家安全——市场上有一些不良参与者，美国政府应该予以打击。
“我们不在他们之中。”
读者应该考虑的问题是：美国政府正在做正确的事吗？而且做得对吗？
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下一步：康奈尔将逐行反驳 BIOSECURE 法案中的指控。
原文:
From The Editor | May 13, 2024
Exclusive Interview: WuXi AppTec Responds To BIOSCURE Act
louis-g-photo-edited
By Louis Garguilo, Chief Editor, Outsourced Pharma
Rick Connell
Rick Connell
At a point during my exclusive interview with Rick Connell, he breaks out into this pledge:
“I’m WuXi AppTec’s President for the US and Europe, running a global organization under the guiding principle of ‘Doing the right thing and doing it right.’ I can confidently state no government has asked our organization for or received any customer’s IP. No regulatory agency has asked us to ‘transfer’ data. No customer has accused us of providing IP to the Chinese government.”
Connell knows WuXi AppTec inside and out. The relationship started when he was at Pfizer in 2004.
He agreed to sit down with me to present a line-by-line refutation of the charges in proposed legislation in the U.S. Congress. We’ll get to that subsequently.
First, to understand Rick Connell is to understand the shock at WuXi AppTec – and among its customers – over the unsubstantiated allegations seemingly misplaced in the BIOSECURE Act.
Pfizer First
Connell left Pfizer for what he thought was semi-retirement in April of 2018, as VP of External Research Solutions. By then, he knew as much about WuXi AppTec as any professional outsourcing to the service provider.
“I got to know them in 2004, when Pfizer was looking to grow chemistry capacity,” Connell says from his office in Boston, Mass. “I had an operations role responsible for a multimillion-dollar strategy for our sourcing.”
In 2008, as VP External Research Solutions, he managed all preclinical outsourcing and suppliers. During 14 years in that position, he also had a one-year assignment in Shanghai to build out a Pfizer research operation.
“What stood out to me then – and now – is in every conference room at WuXi AppTec there’s a big poster that says, ‘Doing the right thing, and doing it right.’
“You can say that’s just a slogan. But I say in the 14 years I managed the collaboration for Pfizer, and now as a senior leader inside WuXi AppTec, those virtues the founder himself expoused are meticulously followed at the company.
“And they will guide us through this as well.”
Retirement Later
In 2018, when Connell informed Dr. Ge Li, a Chinese American entrepreneur and founder of WuXi AppTec, that he was retiring from Pfizer, Li responded he had appreciated how Connell intergrated Pfizer’s global suppliers into a single interface. Li was interested in hiring Connell to do something similar.
“I've witnessed what you can do within the complexity of outsourcing, IP security, and other aspects of an organization with global partners,” Connell recalls Li as saying.
Li, says Connell, was always thinking about the protection of client knowhow.
“Other companies – some offshore – also offered some exploratory talks,” Connell adds, “but based on my experience with numerous suppliers, I knew there's an unevenness to quality, and the infrastructure and steps taken around IP protection.”
“WuXi AppTec was far and away the leader in the space.”
Connell took the job.
BIOSECURE Bomb
During the process around the FY2024 House National Defense Authorization Act (NDAA), WuXi AppTec was shocked to see it was mentioned, even though the bill was aimed at a company called BGI and its subsidiaries.
BGI had already been sanctioned by the U.S. Treasury, Defense, and Commerce departments, and it was clearly the target.
“Yet,” says Cornell, “further into the document you suddenly read this line saying the DOD should audit WuXi AppTec.”
“We're reading the context of the bill, and it’s all about human genome sequencing data. We genuinely did not understand why we were inserted into the bill.”
When the FY2024 NDAA bill was finalized in a House-Senate conference, “very reasonably and pragmatic,” says Connell, the names of specific companies were removed, and instead the bill stipulated the DOD should audit any Chinese biotech company that could somehow by a threat to national security.
“We thought that was a good outcome. We support national security as much as anyone else, and we are open to being audited,” recalls Connell.
However, come January 2024, a new House bill was introduced that reversed course.
“Now, incredibly, with no mention of audits or due process, WuXi AppTec is simply listed as a national security threat,” Connell says describing that draft of the BIOSECURE Act being considered in Congress.
“Given my background with WuXi AppTec as a customer at Pfizer, and understanding operations as a leader within the company, this is quite upsetting. And now there are other unfounded accusations being floated around.”
Shadow Boxing
WuXi AppTec has done its best to enter into dialogue with the authors of the BIOSECURE Act.
For example, the company quickly reached out to the office of then Wisconsin Congressman Mike Gallagher, but to no avail. Gallagher had spearheaded this legislation. (Gallagher left Congress on April 19th).
Gallagher had referred WuXi AppTec to Treasury, DoD and Commerce to sugget they audit the company, “so we sent them letters to say we absolutely welcome any audits,” says Connell.
“Last year, we had some 700 customer audits. We had close to 60 regulatory audits – FDA, EMA, and so on. In 2020 we even went through an audit with The Committee on Foreign Investment in the United States (CFIUS).”
Despite all this, the new bill passed through the Senate Homeland Security and Governmental Affairs Committee, with no recourse to any audits and no due process for WuXi AppTec.
“We are left shadow boxing accusations that are not supported,” says Connell.
“And we will shadow box if that’s what it takes to fight this.
“As we sit here today, I can't be more clear I don't know what they are talking about in the legislation.
“It's easy to throw words around. They say this is a matter of national security. We fully support national security – there are bad players in the marketplace that the U.S. government should go after.
“We are not among them.”
The question readers should consider: Is the U.S. government doing the right thing, and doing it right?
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Next Up: Connell will present a line-by-line refutation of the charges in the BIOSECURE Act.