About Lou Honggang

Mr. Honggang Lou is a member of the Committee of Clinical Pharmacology, Chinese Pharmacological Society, member of the Youth Committee of the Committee of Drug Clinical Trials, Chinese Pharmacological Society, Associated Director of the Quantitative Pharmacology Group, Therapeutic Drug Monitoring Research Committee, Chinese Pharmacological Society, and Director of the Pharmacology and Toxicology Committee, Zhejiang Toxicology Society, standing member of the Clinical Trials and Ethics Branch of the Zhejiang Medical Association, member of the Clinical Pharmacology Committee of the Zhejiang Pharmacological Association, and he is listed in the Drug Evaluation Expert Database of the State Drug Administration.

As the Principal Investigator, he presided over and completed the Phase I clinical research of four 1.1 new drugs, and more than 20 bioequivalence trials. He is an expert of the development and application of drug bioanalytical methods, and has rich experience in the phase I clinical and pharmacokinetic research of new drugs. Mr. Lou presided over two research projects granted by Zhejiang Natural Science Foundation and Zhejiang Education Department. As a major participant, he completed a special National 12th Five-year Plan Project "Major New Drug Development", and projected granted by the National Natural Science Foundation, Zhejiang Education Department, the Analysis and Testing Bureau of Zhejiang Department of Science and Technology, and Science and Technology Plan and Zhejiang Province Science and Technology Department. He has published more than 30 research papers, including more than 10 SCI-indexed papers. As a main member, he was awarded the second prize of Zhejiang Medical and Health Science and Technology Award in 2010 and the Chinese Medical Science and Technology Award in 2011.

Interview with Lou Honggang

Question 1: Please briefly introduce your laboratory and some important developments in recent years.

The Pharmaceutical Bioanalysis Laboratory of the Second Affiliated Hospital of Zhejiang University has an area of ​​500 m2 and was established in 1984. It is the first pharmaceutical bioanalysis laboratory in Zhejiang Province that passed the CNAS17025 certification. The Pharmaceutical Bioanalytical Laboratory is equipped with high-precision analytical instruments and equipment, e.g. AB SCIEX QTRAP® 5500 Triple Quadrupole-Linear Ion Trap Mass Spectrometer System and Thermo Scientific AccelaTM Triple Quadrupole Mass Spectrometer System, Eppendorf Automatic Pipetting Workstation, LABCONCO® Cryogenic Concentrator, and Mettler-Toledo electronic balance, as well as modern software systems such as Watson LIMS and Biovia workbook. After 2015, more than 30 methodological developments and verifications, and more than 20 Phase I and bioequivalence determination projects have been completed by the laboratory. We completed the method development, verification and biological sample determination for the consistency evaluation of 4 generic drugs. The laboratory is very experienced in analytical techniques and experience, and provides strong technical support for early clinical trials and pharmacokinetic analysis .

Question 2: What do you think are difficult in the IT construction of clinical biological analysis laboratories?

I believe there are several difficulties involved: 1. Product selection and personalized implementation; 2. Seamless integration of information systems and the instruments and equipment in data collection; 3. The interconnection between various information systems; 4. The 3Q verification of information systems; 5. Approval of information systems by the authorities.

Question 3: In view of the above difficulties, do we have solutions or research projects going on?

To tackle these difficulties, we first did a research of the existing products in the market, selected suitable products for personalized secondary development and customization, and conducted 3Q verification based on our development and customization. Our research was supported by the 13th Five-Year Plan Major New Drug Development Project (Grant No .: 2019ZX09201022).

Question 4: You mentioned that there is a major new drug development project going on, supported by the National Science and Technology’s 13th Five-Year Plan (Grant No .: 2019ZX09201022). Could you please introduce the background and progress of the project in detail, especially the benefits provided by an advanced laboratory?

We applied for a special project of New Drug Clinical Evaluation Platform Construction. Our laboratory has undertaken and completed a Special "12th Five-Year Plan" Major New Drug Development Project. At present, our new "13th Five-Year Plan" Project has just started and will be implemented in 2020. This project aims to create platforms for new drug research and development, so as to improve new drug research and development in China to international standards. The project will greatly promote our laboratory.

Question 5: The State Drug Administration and the Food and Drug Inspection Center are now committed to promotion of new drug development in order to meet the public demand for high quality drugs. How would such trends influence your laboratory?

We have to accelerate IT system construction, standardize the experimental process, try to accelerate the eCTD verification process and speed up the review and approval of new drugs.

Question 6: You mentioned that the construction of future laboratory takes three steps: compliance of standards, automation, and intelligence. What services are added or updated in intelligent labs, if compared to automatic laboratories?

Intelligence mainly involves using artificial intelligence in judgments and standardize analysis processes. By doing so, we can avoid miss operations and conduct research in compliance with the standards. It is beneficial to the registration and declaration of new drugs. At the same time, the experimental records, operations, reports are handled by the intelligent system, which greatly decreases the workload of our staff and improve our work efficiency.