organizer

Pharmaceutical and Chemical Industry Committee of China Chemical Enterprise Management Association

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

all relevant units

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

At the same time, in recent years, China has issued a series of policies and guiding principles in the field of non-clinical and translational medicine research for 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, China has also increased its support and encouragement for non-clinical and translational medicine research on innovative drugs, providing a good environment and opportunities for innovation and development.

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

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

meeting arrangements

meeting place:Tencent Meeting (notify the specific address to registered personnel)

meeting time:May 25 - 26, 2024

training syllabus

Day 1 09:00-12:00 13:30-16:30

The first day 9 am:00-12:00 Pharmacological and pharmacodynamic topics

1 Introduction:Animal Models and Clinical Effectiveness

2 Introduction:Biology based on extrapolation of pharmacodynamic models

3 Mechanism of action of pharmacodynamic targets and selection of pharmacodynamic models (case data analysis)

4 Development and application of pharmacodynamic models

5MOA mechanism and autoimmune diseases

6 Exploration of the mechanism of pharmacological efficacy

7 Case analysis of marketing or product efficacy

the instructor:Dr. Wang Shan, PhD in Biology, Director of Shanghai Ouyi Biomedicine, is proficient in testing techniques in preclinical drug development, such as drug target screening in drug development, in vivo and in vitro efficacy tests, pharmacokinetic tests and toxicology research tests, etc., especially proficient in using omics to screen biomarkers such as efficacy. He has been engaged in gene therapy drug research for neurodegenerative diseases and tumor diseases for many years.

13 pm on the first day:30-16:30 Drug Analysis-Pharmacology Topic

1 Bioanalytical methods

1.1 Chromatographic method and LBA method

1.2 Key reagent and platform technology selection

1.3 Selection of analysis models

1.4 methodological validation

1.5 sample detection

1.6 Technical case sharing

2 Immunogenicity analysis

2.1 Concepts and overall considerations of immunogenicity analysis

2.2 Positive control antibody selection

2.3 Considerations for multiple domains

2.4 neutralising antibody analysis

2.5 Analytical models and methodology

2.6 case analysis

3 Non-clinical PK studies of biological drugs

3.1 PK characteristics of biological drugs

3.2 Research strategy for biopharmaceutical PK

3.3 Key points for PK experiment design and considerations

3.4 Analysis and reporting of PK data

3.5 PK Cases and Discussions

Typical cases and discussion answers

The next day 09:00-12:00 13:30-16:30

9 am the next day:00-12:00 Safety Review Topic

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

2 Introduction to the ICH S series of guidelines

3 Principles for designing toxicology experimental plans

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

5 Key points of toxicological test design

6 Comprehensive analysis of toxicological results

6-1 Safety margin and treatment index

6-2 Toxic reactions and toxic targets

6-3 Toxicity reversibility and irreversibility

6-4 NOAEL

13 pm the next day:30-16:30 Clinical and Clinical Pharmacology Topics

1. Transformation model from non-clinical to clinical
2. Points for consideration 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. Modeling and model verification of clinical pharmacology
7. FIH and clinical dose recommendations
8. Clinical development strategies and case analysis of special products

Introduction to the lecturer

the instructor:Dr. Deng Pan

Distinguished Professor, School of Pharmacy, Soochow University. Professor Deng Pan graduated from the School of Pharmacy of Shenyang Pharmaceutical University with a bachelor's degree and master's degree. In 2011, he obtained a doctorate in drug 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. 2015-2020 He worked as postdoctoral research at the Stable Isotope Metabolics Research Center and the Superfund Research Center at the University of Kentucky in 2020-2021, and served as an assistant professor at the School of Pharmacy at the University of Kentucky in 2020-2021. Professor Deng Pan joined the School of Pharmacy of Soochow University in 2022. He is currently mainly engaged in innovative drug metabolism and pharmacokinetics research. He has rich experience in bioanalysis and metabolite identification of macromolecular drugs. He has published more than 50 academic papers, including newsletters/first works. More than 20 articles and participated in 3 monographs.

the lecturers: Researcher Liao Mingyang

He has worked in the Institute of Pharmaceutical and Toxicology, Academy of Military Medical Sciences, as a researcher and doctoral supervisor, chief expert and QA director of the National Beijing New Drug Safety Evaluation Research Center. Drug review experts from the State Food and Drug Administration, health food review experts from the State Food and Drug Administration, GLP inspection experts from the State Food and Drug Administration, and health-related product review experts from the Ministry of Health. Enjoy special government allowances.

the instructor:Dr. Wong Chi-wei

Participated in more than 60 Phase I/II clinical studies as an investigator, 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, neurological, mental, oncology, skin, digestion and other fields, responsible for managing the implementation of 2 clinical trials, and participating in 2 CDE communication meetings; He was the author of 7 quantitative pharmacology related reports and participated in more than ten reports, including in vitro PK-PD, animal PK-PD, clinical PPK and PK-PD

meeting notes

1. Theoretical explanation, case analysis, special lectures, interactive Q & A

2. The keynote speakers are all senior experts in the industry. Welcome to inquire.

3. Enterprises need internal training and guidance, please contact the conference team

training costs

conference fee:4000 yuan/account meeting fee includes:Training, Q & A, electronic materials, video playback, etc.)

remittance account

Please note for remittance: Online non-clinical

unit name:Pharmaceutical Materials Information Technology (Beijing) Co., Ltd.

Company account number:0200316909100078392

opening bank:Industrial and Commercial Bank of China Co., Ltd. Fangshan Branch Liangxiang Branch

(The invoice shows that the bank opening is Industrial and Commercial Bank of China Co., Ltd. Beijing California Shuijun Branch)

Registration method

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contact:Lu Yao 13910496728 (WeChat synchronization)

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