DDI in Drug Development Seminar

【HiRO and Beijing Friendship Hospital Research Ward】Jointly Organize

   2022.01.17

BACKGROUND

In clinical practice, patients often use multiple drugs at the same time, and these drugs may produce drug-drug interactions (DDI), which may cause adverse events or lead to reduced efficacy, thereby changing the outcome of treatment, which is one of the common problems in drug therapy and a key factor for the drug development.On January 26th, 2021, the Center for Drug Evaluation, National Medical Products Administration officially issued the "Technical Guidelines of Drug Interaction Studies (Draft)", which further encourages and guides applicants to carry out drug interaction studies in an efficient and standardized manner.

Therefore, on January 17th, 2022, HiRO and the research ward of Beijing Friendship Hospital will hold a seminar to discuss the application of DDI studies in drug development, the requirements of DDI studies by regulatory agencies such and practical experience.

AGENDA

SPEAKER INTRODUCTION

【吕文旭 博士】

Wenxu Lyu,PhD 

Principal Consultant, Regulatory Affairs and Strategy. As Subject Matter Expert for non-clinical/CMC/clinical pharmacology and responsible for the consultation / strategy for the product development and IND enabling related tasks as well as relevant documents authoring. Involved small molecules, antibodies, vaccine, cell & gene therapeutic, rare disease and others

• Ph.D. in Pharmacology/Pharmacokinetics, SIMM, Chinese Academic Science. More than 20 years experience in biomedicine, including 8 years of clinical pharmacy in hospital and 13 years of new drug R&D in CRO 
• Gap analysis and project evaluation for IND & NDA,30+; US & China IND documents writing (CMC/PD/PK/TOX/IB)10+
• Screening ADMET/DMPK 100+ and IND enabling DMPK/ADME package, achieved CTA 20+
• IND enabling pre-clinical package, achieved CTA 10+

【李江硕 博士】

Jiangshuo Li, PhD

Research pharmacist in the Beijing Friendship Hospital Research Ward Affiliated to Capital Medical University

• Graduated from the Institute of Materia Medica, Peking Union Medical College
• Mainly responsible for the management of drugs and samples in clinical trials
• Engaged in the development of LC-MS/MS based quantitative analysis method for small molecule drugs and endogenous metabolites
• Participated in the establishment and improvement of the laboratory quality control system

HiRO is a China-based globally oriented innovative clinical research organization (CRO) with its headquarters in Shanghai, China. With global operations and integration capabilities, the company is dedicated to providing its clients with a full range of solutions and services. HiRO strives to become a market-leading, integrated global clinical research organization that works hand-in-hand with biotech companies and pharmaceutical companies to bring new products from the laboratory to the market, providing more effective solutions for patients worldwide.

HiRO acquire PharmaSols in 2021, making full use of more patient resources, professional medical knowledge and excellent operational services in New Zealand and Australia to provide more professional services to customers.

The Beijing Friendship Hospital Research Ward is one of the first demonstration units of research ward in Beijing. The ward covers an area of 2000 m², with 74 special beds and 46 shared beds. The condition platform covers an area of 1650 m² and it is equipped with drug concentration quantitative analysis  laboratory, isotope  tracer ward and cardiotoxicity evaluation ward. The research ward adopts  the "sharing and integration" mode to provide one-stop service of institution project initiation, material submission and agreement signing and ethical approval/agreement review; standardize the forms for clinical trials and unify the contract template; the information technology represented by 2E technology, clinical trial decision support system and the standardized excellent and effective cooperation mode of clinical specialty + research ward are adopted to shorten the project implementation period and create a high-quality and efficient clinical research platform.