Huang Jiacai imdiately organized the team to study the details of the docunt. The certification conditions are indeed strict: building a data center that ets European Union standards, hiring EU-certified security experts, enduring unannounced audits every quarter, and bearing high compliance costs.
"Preliminary estimates indicate that fully eting these conditions would incur additional costs of over 20 million Euros annually," reported the financial director.
"Invest!" Huang Jiacai said without hesitation, "This is not a cost; it’s a ticket. Furthermore, if we beco the first non-EU dical technology company to be certified, the certification itself will beco a brand asset. We must learn to engage with different markets to go global, while adhering to our principles and becoming familiar with and respecting their regulations. Look at why those multinational giants can operate smoothly in our country. In contrast, our expansion efforts often struggle because most of our companies lack a global perspective and capability."
What he cared about more was the fourth item: data mirror storage.
This ans establishing a mirror center in Europe that continuously synchronizes in real-ti with the main data center in Nandu. Technically feasible, but it ans all complete data of European patients will remain stored within Europe.
"Professor Yang, from a scientific perspective, what impact will this have?" Huang Jiacai asked over the phone.
Yang Ping was analyzing the first batch of data after Shen Guohua’s treatnt, not raising his head: "As long as we can access the core data needed for treatnt decisions in real-ti and anonymized data can be periodically retrieved for research purposes, there is no impact. Furthermore, storing data in the EU could increase the willingness of European research institutions to participate in the analysis. In the long run, this might be beneficial. We must adhere to certain principles, but so matters should not be tackled narrowly."
"Aren’t you worried about the data being misused or used to develop competitive technology?"
"If a little data would lead us to lose technological leadership, shouldn’t we reflect on whether our technology thresholds are too low?" Yang Ping finally raised his head, "Besides, if European scientists can use this data to develop better therapies, it’s the patients worldwide who will benefit. Isn’t this our original intention?"
Huang Jiacai looked at Yang Ping, once again feeling that purity.
In this era where everyone wants to build barriers and protect intellectual property, Yang Ping still thinks about "how best to serve patients."
"Alright," Huang Jiacai said, "Then we shall build the mirror center in Frankfurt, Fujian. Not only will we build it, but we’ll also exceed their requirents, making it a landmark project for Central Europe dical technology collaboration."
A week later, Ruixing reached a cooperation agreent with Deutsche Telekom’s data center to start the construction of the Frankfurt Mirror Center. Lady Windsor’s foundation provided partial funding support and facilitated top research institutions such as Heidelberg University and Pasteur Institute in France to participate as academic supervisors.
anwhile, the European Pharmaceutical Agency (EMA) launched a comprehensive evaluation of K Therapy, planning to start comprehensive clinical trials as soon as possible. Contrary to previous speculation, this evaluation is unusually swift, partly because several top EU officials have relatives eagerly awaiting treatnt.
The evaluation report draft quickly surfaced, with conclusions generally positive but proposing seventeen improvent requirents, including: Increasing long-term safety data for European populations; optimizing carriers to reduce liver first-pass effects; developing solutions to address preexisting immune issues; and establishing an independent European adverse reaction monitoring committee.
These requirents highly coincide with the issues Yang Ping’s team is working on. Huang Jiacai keenly realized this may be guided by an expert within the EMA; they are proposing constructive improvent directions rather than obstructive requirents.
"This is good news," Academician Chen Yongnian said at the joint analysis eting, "It indicates EMA’s professionals truly understand the technology. Their requirents aim to make the therapy more complete and safer. If we can respond and resolve each one, not only will we gain approval, but also earn respect from the European dical community."
Thus, improvent plans were drawn up one by one: Launching a thousand-person long-term safety study in Europe; accelerating the clinical transformation of hybrid carrier libraries; inviting European experts to join the adverse reaction monitoring committee...
"Sotis, the strictest regulations can beco the best driver of technological progress," Huang Jiacai wrote in a letter to all employees, "because they force us to do our best."
...
The seventh day after Shen Guohua received treatnt.
These seven days have been like a rollercoaster. On the second day post-treatnt, he showed expected immune reactions: a high fever of 39.8°C, chills, and severe muscle pain. Doctors used steroids and antipyretics to control the symptoms. On the fourth day, the fever subsided, but jaundice worsened, with total bilirubin soaring from 187μmol/L before treatnt to 312μmol/L.
"Liver inflammatory response," Dr. Li reported to Yang Ping, "The retention of carriers in the liver triggered an immune attack, albeit temporary, it exacerbated the existing liver function damage."
On the fifth day, Shen Guohua began to show early symptoms of hepatic encephalopathy: ntal confusion, disorientation in ti and space. This is a dangerous signal, indicating severely impaired liver detoxification function.
Yang Ping urgently convened a eting to discuss whether to continue supporting the treatnt or switch to palliative care to relieve pain. This is a tough decision.
"From the tumor perspective, the treatnt might be working," Song Zimo pulled up the latest PET-CT images, "The tabolic activity of the primary site in the pancreas has decreased by 30%, and there’s partial response in liver tastases. But the liver itself is severely damaged, which might negate the benefits of tumor treatnt."
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