Former Bayer Global Medical Writing Operations Director Kai Lü Joins Deep Intelligent Pharma to Drive Intelligent eCTD Submissions

Recently, Deep Intelligent Pharma announced that Kai Lv, former Global Director of Medical Writing Operations at Bayer, has joined the company to oversee clinical integration and regulatory submission-related businesses. With over 20 years of experience managing global clinical trials, regulatory submissions, and medical writing teams, his appointment marks a significant milestone in Deep Intelligent Pharma’s global strategy and strengthening of its overseas expert team. This move will further accelerate the company’s deployment of one-stop solutions worldwide across regulatory consulting, content management, regulatory operations, and pharmacovigilance.

Since 2003, drug regulatory authorities worldwide have increasingly adopted the eCTD industry submission standard. Starting in 2019, China also began to gradually implement the eCTD standard, continuously promoting the internationalization and digitalization of registration review. “Judging by the current progress of China’s drug regulatory policies, the informatization sector for eCTD registration submissions in China faces unprecedented opportunities.” This assessment motivated Lv Kai to firmly join Deep Intelligent Pharma, contributing to the development of eCTD in China.

With over 15 years of experience in eCTD electronic submissions, Lu Kai has witnessed and participated in the global promotion of eCTD. In 2006, while leading Bayer’s eCTD project team, Lu Kai selected Lorenz as the partner for Bayer’s global regulatory submission system. However, due to a lack of competition, eCTD products in the industry evolved slowly and featured low levels of automation, causing submission processes to continue consuming significant time and human resources for enterprises. In Lu Kai’s view, “The current mainstream eCTD submission products remain those adopted by Bayer more than a decade ago, such as Lorenz DocuBridge, ISI eCTD Express (which became DXC eCTDXPress after acquisition), and Liquent eCTD Manager (which became Parexel Liquent Insight Publisher after acquisition). These products still adhere to the traditional mindset of merely providing submission functionality, failing to achieve a closed-loop effect across all stages of the regulatory submission process, including writing, translation, knowledge management, publishing, and submission.”

Faced with the implementation of eCTD, some Chinese pharmaceutical companies have fallen into confusion and uncertainty, objectively reflecting a lack of intelligent products on the market that can help them effectively respond to policy changes. Deep Intelligent Pharma has introduced artificial intelligence technology into its eCTD products, striving to help the industry redefine traditional workflows from a new perspective. To this end, Lv Kai joined Deep Intelligent Pharma to lead the development of a next-generation eCTD submission platform. Leveraging his comprehensive and in-depth knowledge and experience in the industry, he is building an integrated intelligent platform for automatic writing, automatic translation, automatic publishing, and regulatory submission for the pharmaceutical sector.

Lv Kai hopes that this platform will address the industry’s long-standing pain points, enhance corporate operational efficiency, help pharmaceutical companies achieve intelligence in clinical and regulatory affairs, and seamlessly adapt to the new era of electronic submissions in China. Currently, Deep Intelligent Pharma has completed its first-generation suite of eCTD submission products, offering powerful features unprecedented in previous solutions—such as automated format validation, automated format correction, and automatic generation of cross-document links—thereby effectively helping pharmaceutical enterprises resolve their key challenges. The second-generation product is also under intensive development, and it is believed that it will significantly advance the intelligentization of eCTD submissions in the future.

Mr. Lu Kai has long resided in the United States and holds an MBA from Rensselaer Polytechnic Institute. Prior to joining Deep Intelligent Pharma, he served as Bayer’s Global Director of Medical Writing Operations, leading teams in Germany, the United States, China, and Finland. During his tenure at Bayer, Mr. Lu oversaw the establishment and operation of global regulatory submission systems, document management systems, and the global electronic Trial Master File (eTMF) system for clinical trials. He has long been dedicated to researching the integration of technology with clinical development and regulatory affairs, possessing deep expertise in the application of cutting-edge technologies within the pharmaceutical industry. Mr. Lu has participated in the development of multiple industry technical standards and serves as a member of the HL7 and PhPMA working groups. In 2005, he received the FDA Commissioner's Special Citation Award for his contribution to establishing the Structured Product Labeling (SPL) industry standard. This award is the highest honor bestowed by the U.S. Food and Drug Administration (FDA) upon individuals or organizations that have made outstanding contributions to public health.

With the addition of Lü Kai and other top international experts, Deep Intelligent Pharma will better advance the global practice of AI-driven new drug R&D, helping clients worldwide accelerate intelligent transformation in medical translation, pharmacovigilance, regulatory submissions, and drug discovery.

Deep Intelligent Pharma is a high-tech innovation company dedicated to empowering the entire new drug R&D process with artificial intelligence technology on a global scale, helping global pharmaceutical companies and their service providers accelerate their transition towards intelligentization. The company is committed to building an end-to-end AI-driven new drug R&D platform that empowers and accelerates global pharmaceutical companies in bringing drugs from the laboratory to market with high quality and efficiency. The team consists of AI experts from top internet companies and pharmaceutical R&D specialists from multinational pharmaceutical enterprises. Deep Intelligent Pharma’s self-developed AI intelligent systems and related services cover the entire chain of new drug R&D, including drug discovery, organic synthesis, clinical trials, pharmacovigilance, registration applications, medical translation, and other stages.

Deep Intelligent Pharma secured nearly $15 million in exclusive Series B financing from Sequoia Capital in September 2018. The company is currently conducting operations and R&D simultaneously in China, the United States, and Japan, having served nearly 100 top-tier pharmaceutical and medical device companies, CROs, and third-party institutions worldwide.