Editors' (re)View: FDA shares early AD industry guidance; WuXi-BIO breakup

March 15, 2024
Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of March 11

Editor’s note: Welcome to Editors' (re)View, our editors’ takes on things going on in the pharma world that deserve some extra consideration.

FDA shares early AD industry guidance 

Earlier this week, the FDA shared its draft guidance for the clinical development of drugs targeting early-stage Alzheimer's disease (AD), which outlines the agency's approach for developing drugs addressing the period before overt dementia appears.

The document encourages innovative methods to combat AD early on, and highlights the importance of focusing on stages 1 through 3 of sporadic AD, acknowledging the disease's progression and varied clinical manifestations during these stages.

Emphasizing biologically based diagnostic criteria for trial enrollment, the guidance reflects a shift from concentrating on later stages to incorporating biomarkers that mirror AD's underlying pathophysiological changes. Drugmakers are advised to adapt their trial designs to include patients in these initial stages, which may involve employing sensitive neuropsychological measures and biomarkers for precise patient selection.

The agency also shared updated recommendations for choosing subjects and clinical trial endpoints, including clinical outcome assessments, biomarkers, and the potential for surrogate endpoints to facilitate accelerated approval.

But the shift to focus on early-stage AD is not without its challenges. Targeting early-stage AD, where patients may show minimal or undetectable clinical abnormalities, complicates efficacy demonstration. This requires the development or adoption of trial designs and outcome measures capable of detecting subtle yet clinically meaningful effects, potentially increasing development complexity and costs.

Additionally, the guidance's focus on biologically based diagnostic criteria and the potential need for companion diagnostic device co-development can introduce further complexity. Drugmakers must now evaluate how these requirements may affect their development timelines and strategies. — Andrea Corona 

The WuXi-BIO breakup

In a press release posted on March 13, the BIO trade association officially expressed its support for the BIOSECURE Act — legislation that specifically names a BIO member company, WuXi Apptec, as a “biotechnology company of concern.” 

The release also noted that WuXi Apptec and BIO would officially part ways — but like most breakups, the details on who dumped who are hazy. BIO’s first iteration of the press release said that the group was taking steps to "separate" from Chinese member Wuxi AppTec. The statement was amended the next day to say that it was in fact WuXi that proactively ended its relationship with BIO. (It was reported that WuXi sent a letter to BIO CEO John Crowley, dated March 12, stating the company's plans to immediately terminate its membership.)

Breakup drama aside, the more important question is how did WuXi AppTec along with sister company, WuXi Biologics, CDMO WuXi Biology and all affiliated companies end up on a list of companies that represent a national security threat?

The main issue at play here is data — specifically genetic data from U.S. patients — and the Chinese Communist Party’s potential abuse of data collected by WuXi.

According to a document shared by Washington, D.C.-based think tank, Jamestown Foundation, CCP leaders have a keen interest in biotech, consistently stressing the importance of the industry as a strategic driver of scientific and technological power for China. In addition, security laws in China mandate cooperation with the CCP’s military and intelligence — which is certainly problematic for companies that are collecting health data. The company is said to have strong ties with the Chinese government and WuXi AppTec CEO Li Ge is said to have personally attended and supported CCP activities.

The BIOSECURE legislation has only recently made its way to the Senate floor, so it’s far too early to guess how the final draft will read and if it will become law. But the situation certainly raises tough questions about U.S. companies partnering with Chinese biotechs, and also reiterates the importance of robust data privacy measures. —Karen Langhauser

About the Author

Andrea Corona | Senior Editor

About the Author

Karen P. Langhauser | Chief Content Director, Pharma Manufacturing

Karen currently serves as Pharma Manufacturing's chief content director.

Now having dedicated her entire career to b2b journalism, Karen got her start writing for Food Manufacturing magazine. She made the decision to trade food for drugs in 2013, when she joined Putman Media as the digital content manager for Pharma Manufacturing, later taking the helm on the brand in 2016.

As an award-winning journalist with 20+ years experience writing in the manufacturing space, Karen passionately believes that b2b content does not have to suck. As the content director, her ongoing mission has been to keep Pharma Manufacturing's editorial look, tone and content fresh and accessible.

Karen graduated with honors from Bucknell University, where she majored in English and played Division 1 softball for the Bison. Happily living in NJ's famed Asbury Park, Karen is a retired Garden State Rollergirl, known to the roller derby community as the 'Predator-in-Chief.'