Leading the nuclear medicine track, opening the road of RLT commitment to China

organizer

Pharmaceutical Chemical Industry Committee of China Chemical Enterprise Management Association

Pharmaceutical Materials Information Technology (Beijing) Co., Ltd.

 

All relevant units

Innovative drug research and development involves multiple fields and links, including efficacy, pharmacokinetic, safety evaluation, clinical, etc. Each link has its own special requirements and challenges. To improve R&D efficiency and quality and accelerate the process of listing, non-clinical and translational medicine research plays a vital role in biopharmaceutical R&D.

At the same time, in recent years, my country has issued a series of policies and guidelines for the non-clinical and translational medicine research of innovative drugs, aiming to standardize and guide non-clinical and translational medicine research activities and ensure the safety and effectiveness of new drugs. At the same time, my country has also increased its support and encouragement for non-clinical and translational medicine research of innovative drugs, providing a good environment for innovation and development.

How to improve the quality and differentiation of innovative drugs, how to optimize the strategies and methods of non-clinical and translational medicine research, how to cope with the ever-changing regulatory requirements and review standards, etc. To this end, we have specially invited a number of experts with rich experience and expertise in the field of non-clinical and translational medicine research to bring you a wonderful training.

To this end, we will hold an online "Special Training Course on Non-clinical and Clinical Bridging and Clinical Pharmacology of New Drugs" in May 2024. This training will focus on the four main aspects of non-clinical and translational medicine research of innovative drugs: efficacy, pharmacokinetics, safety evaluation, and clinical bridging. It will introduce relevant theoretical knowledge, experimental techniques, data analysis, case sharing, etc., aiming to help everyone master the basic principles and methods of non-clinical and clinical research and improve research capabilities and levels. This training is suitable for scientific researchers, technicians, managers, etc. who are engaged in or intend to engage in non-clinical and clinical research of new drugs.

 

Meeting schedule

Meeting location: Tencent Meeting (supports 5 ports for simultaneous online learning)

Meeting time: May 25-26, 2024

 

First day of the conference      

May 25

09:00-12:00         13:30-16:30

 

Conference content   

Day 1 9:00am-12:00pm 

Special Topics on Pharmacology and Efficacy

1 Introduction: Animal Models and Clinical Validity

2 Introduction: Biology based on extrapolation of efficacy models

3. Mechanism of action of drug targets and selection of drug efficacy models (case data analysis)

4. Development and application of drug efficacy models

5MOA mechanism and autoimmune diseases

6 Exploration of the mechanism of pharmacological efficacy

7. Case analysis of drug efficacy of marketed or product

Lecturer: Dr. Wang Shan

Doctor of Biology, Director of Shanghai Ouyi Biopharmaceuticals, proficient in experimental techniques in preclinical drug development, such as drug target screening, in vitro and in vivo efficacy tests, pharmacokinetic tests and toxicology research tests, especially proficient in biomarkers for drug efficacy screening using omics. He has been engaged in gene therapy drug research for neurodegenerative diseases and tumor diseases for many years.

Day 1 afternoon 13:30-16:30   

Drug Analysis-Pharmacokinetics

1 Bioanalytical methods

1.1 Chromatographic method and LBA method

1.2 Selection of key reagents and platform technologies

1.3 Analysis mode selection

1.4 Methodological Validation

1.5 Sample testing

1.6 Technical Case Sharing

2 Immunogenicity analysis

2.1 Concept and overall considerations of immunogenicity analysis

2.2 Positive control antibody selection

2.3 Multi-domain considerations

2.4 Neutralizing Antibody Analysis

2.5 Analysis Model and Methodology

2.6 Case Analysis

3 Non-clinical PK studies of biopharmaceuticals

3.1 PK properties of biopharmaceuticals

3.2 Research strategies for biopharmaceutical PK

3.3 Design and considerations of PK studies

3.4 Analysis and reporting of PK data

3.5 PK Case and Discussion

Typical cases and discussion questions

Lecturer: Dr. Deng Pan 

Distinguished Professor of School of Pharmacy, Suzhou University. Professor Deng Pan received his bachelor's degree and master's degree from the School of Pharmacy, Shenyang Pharmaceutical University. In 2011, he obtained a doctorate in pharmaceutical analysis from the Shanghai Institute of Materia Medica, Chinese Academy of Sciences, and then worked at the Drug Metabolism Research Center of the Shanghai Institute of Materia Medica as an assistant/associate researcher. From 2015 to 2020, he engaged in postdoctoral research at the Stable Isotope Metabolomics Research Center and Superfund Research Center of the University of Kentucky, USA. From 2020 to 2021, he served as an assistant professor at the School of Pharmacy, University of Kentucky, USA. Professor Deng Pan joined the School of Pharmacy of Soochow University as a teacher in 2022. He is currently mainly engaged in research on the metabolism and pharmacokinetics of innovative drugs. He has extensive experience in bioanalysis of macromolecule drugs and identification of metabolites. He has published more than 50 academic papers, including communication/first author. He has authored more than 20 articles and co-edited 3 monographs.

 

 

Arrangements for the second day of the meeting       

May 26

09:00-12:00         13:30-16:30

 

Conference content

9:00-12:00 AM the next day 

Safety Assessment Special

1 Overview of innovative drug research and development and progress in safety research

2 Introduction to ICH S series guidelines

3 Principles of toxicology experimental design

4 Interpretation of toxicological data Main contents of toxicological test design plan

5 Key points of toxicology test design

6 Comprehensive analysis of toxicological results

6-1 Safety Range and Therapeutic Index

6-2 Toxic reactions and toxic target organs

6-3 Reversibility and irreversibility of toxicity

6-4 NOAEL

Lecturer: Researcher  Liao Mingyang

He has worked at the Institute of Drugs and Toxicology, Academy of Military Medical Sciences, as a researcher and doctoral supervisor, and as the chief expert and QA director of the National Beijing New Drug Safety Evaluation Research Center. He is a drug review expert of the National Drug Administration, a health food review expert of the National Drug Administration, a GLP inspection expert of the National Drug Administration, and a health-related product review expert of the Ministry of Health. He enjoys special government allowances .

 

Second day afternoon 13:30-16:30 

Special Topics in Clinical and Clinical Pharmacology

1. Non-clinical to clinical translation model

2. Key points to consider in early clinical development of new drugs

3. Focus on clinical pharmacology in new drug development

4. Population Pharmacokinetics (PopPK) and Clinical Development (including NONMEM software demonstration)

5. PK-PD model and MIDD

6. Clinical pharmacology modeling and simulation and model verification

7. FIH and clinical dose recommendations

8. Clinical development strategy and case analysis of special products

Lecturer: Dr. Huang Zhiwei  

Participated in more than 60 Phase I/II clinical studies as a researcher, most of which were new drugs, including COVID-19 vaccines, COVID-19, neutralizing antibodies, monoclonal antibodies, cell therapy, PET/CT research, aerosols, gels, powders, tinctures, etc., covering infection, neurology, psychiatry, tumors, skin, digestion and other fields. Responsible for managing the implementation of 2 clinical trials and participated in 2 CDE communication meetings; wrote 7 quantitative pharmacology-related reports and participated in more than 10 reports, including in vitro PK-PD, animal PK-PD, clinical PPK and PK-PD

 

Conference Fees

Conference fee: 4,000 yuan/unit - supports five online learning ports (conference fee includes: training, seminars, electronic materials, video playback, training certificates, etc.);

Remittance Account

Please note for remittance: Online non-clinical

Company Name: Yaochengcai Information Technology (Beijing) Co., Ltd.

Company account number: 0200316909100078392

Bank of Account: Industrial and Commercial Bank of China Limited, Fangshan Branch, Liangxiang Branch

(The invoice shows that the account was opened at Industrial and Commercial Bank of China Limited, Beijing California Shuijun Branch)

Conference Contact 

❖ Scan the QR code below to register online.

 

❖ Organizer responsible person : Li Jing 17812038015

❖ Scan the QR code below to consult and reserve your spot.

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