Day 1 :
Keynote Forum
Bernard M Y Cheung
University of Hong Kong, Hong Kong
Keynote: How are new drugs registered and regulated in Hong Kong, a special administrative region of China?
Time : 10:00-10:40
Biography:
Bernard M Y Cheung Completed Study from the University of Cambridge. In 2007-2009, he held the chair in Clinical Pharmacology and Therapeutics in Birmingham. He is currently the Sun Chieh Yeh Heart Foundation Professor in Cardiovascular Therapeutics at the University of Hong Kong and Heads the Division of Clinical Pharmacology and Therapeutics. He is an Honorary Consultant Physician of Queen Mary Hospital and the Medical Director of the Phase 1 Clinical Trials Centre. He is the Editor-in-Chief of Postgraduate Medical Journal. He has 270 publications, 7500 citations and an h-index of 43.
Abstract:
Hong Kong is a special administrative region in South China enjoying a high degree of autonomy. Its GDP per capita is about the same as the European Union average and higher if adjusted for purchasing power parity. Despite its high population density and unequal wealth distribution, infant mortality is low and life expectancy is long. The hospital-based health service is well-developed but health service delivery in the community is not, and relies on private medical practitioners. This model has its deficiencies but is clearly cost-effective while maintaining high professional standards. Drug registration takes reference from American and European requirements. Hong Kong is part of the Pharmaceutical Inspection Co-operation Scheme. Drug regulation is rigorous, as shown in the recent orderly recall of contaminated generic Valsartan. The Hong Kong Hospital Authority Drug Formulary is also closely regulated. New drugs have to demonstrate not just safety and efficacy, but also advantages over existing drugs and in some instances, cost-effectiveness. Hong Kong is also a national and regional centre for clinical trials because the subjects are mostly Chinese while protocols in English do not need to be translated. There are two clinical trials centres in university hospitals that also run phase 1 and pharmacokinetic studies. The ethical framework and pharmacy support for clinical trials is well established.
Keynote Forum
Waad Hasan Alkathiri
King Saud University Medical City, KSA
Keynote: Impact of clinical pharmacist in the emergency department of an academic hospital at the Kingdom of Saudi Arabia
Time : 10:40-11:20
Biography:
Abstract:
- Clinical Pharmacology | Drug Safety Reporting | Hospital Pharmacy & Health Practice
Session Introduction
Bernard M Y Cheung
University of Hong Kong, Hong Kong
Title: Clinical therapeutics in Hong Kong
Biography:
Abstract:
- Pharmacy Education and Practice | Pharmaceutical Care and Health Systems | Pharmacology and Toxicology
Session Introduction
Sayantani Dasgupta
MSD KK, Japan
Title: Stakeholder engagement in rapidly changing digital world in the pharma industry
Biography:
Abstract:
Jeremy Choo
Republic Polytechnic, Singapore
Title: Design, develop and evaluate dispensary software in RP-KTPH teaching dispensary
Biography:
Abstract:
Sonia Shastri
University of Tasmania, Australia
Title: Therapeutic effect of idebenone in murine colitis
Biography:
Abstract:
Takahiro Iwamiya
Metcela Inc, Japan
Title: Cardiac fibroblasts expressing VCAM-1 improve function recovery of the infarcted heart
Biography:
Abstract:
Takahiro Iwamiya
Metcela Inc, Japan
Title: Cardiac fibroblasts expressing VCAM-1 improve function recovery of the infarcted heart
Biography:
Abstract:
Bin Chen
Clinical Sciences Bayer, China
Title: Demystifying opportunities and conquering challenges in the development of innovative biologics in China
Biography:
Bin Chen is currently the Head of Clinical Sciences China in Bayer. He has the overall responsibilities to lead a team of dedicated physicians and scientists as well as a group of clinical operations in planning and conducting clinical pharmacology and experimental medicine studies in Asia (except Japan). Prior to Bayer, he was a Scientific Director within Janssen BioTherapeutics (JBIO) of Johnson & Johnson. He led teams consisting of functional area experts in biologics discovery, toxicology, translational PK/PD, bioanalysis and project management to design and execute the integrated JBIO strategy from target identification to First-in-Human (FIH). From 2015 to 2017 he served as a Director and Early Development Scientific Leader for JBIO in China, overseeing the technical and scientific aspects for Janssen’s early development efforts in China. Dr. Chen joined J&J Pharmaceutical Research & Development in 2008 as Associate Director/Director and Clinical Pharmacology Leader to support early and late-stage clinical programs in immunology, cardiovascular and metabolism therapeutic areas. He holds a BS degree in Mechanical Engineering from Nanjing University of Aeronautics and Astronautics in China. He received his PhD in Biomedical Engineering from University of Nevada, Las Vegas, and afterwards completed a post-doctoral fellowship in the Ohio State University College of Pharmacy.
Abstract:
Therapeutic biologics hold significant promise to achieve breakthrough innovation and to address largely unmet medical needs in many disease areas. To ensure a successful IND application and eventually get the novel biologics to the patients faster, it becomes more and more critical to streamline the transition from biologics discovery to preclinical development and then to a Fist-in-Human (FIH) study. This presentation will share with the audience Janssen’s experience in implementing key strategies and critical development activities during this stage of drug development. Firstly, a brief introduction will be given to biologic discovery process from target identification, to lead generation and optimization, to preclinical enabling, and to clinical candidate selection. Secondly, special considerations in a biologic toxicology package will be presented due to the unique characteristics of biologics related to their pharmacologic activity, structure, and production. Lastly, general considerations of biologic FIH study design and dose selection will be discussed with case studies in which PK/PD modeling approach is utilized. In summary, seamless integration of biologic discovery, toxicology and clinical pharmacology is the key to drive a successful IND application of novel biologics.