Day 2 :
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 ClinicalPharmacology 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 administration region in Southern China enjoying a high degree of autonomy. Despite its high population density and unequal wealth distribution, infant mortality is low and life expectancy is highest in the world. The health service is however more hospital and clinic based than community-based. Primary care is largely private while over 70% of inpatient care is in public hospitals. This health infrastructure seems cost-effective. Professional standards are high and rigorously maintained. Doctors, nurses, pharmacists and other health professionals are well-remunerated even in the public sector. Drug registration follows American and European requirements. Hong Kong is part of the Pharmaceutical Inspection Co-operation Scheme, which brings with it a high standard of drug regulation. Hong Kong is a centre for clinical trials because the subjects are Chinese and protocols in English do not need to be translated. There are also two well-established clinical trials centres in university hospitals that also have a phase 1 clinical trials centre. The Hong Kong Hospital Authority is the largest customer of pharmaceuticals, and so to ensure appropriate use of drugs, there is a territory-wide drug formulary and guidelines for its hospitals and clinics, based on clinical need, and the efficacy, safety and cost-effectiveness of the drugs.
- 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:
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 administration region in Southern China enjoying a high degree of autonomy. Despite its high population density and unequal wealth distribution, infant mortality is low and life expectancy is highest in the world. The health service is however more hospital and clinic based than community-based. Primary care is largely private while over 70% of
inpatient care is in public hospitals. This health infrastructure seems cost-effective. Professional standards are high and rigorously maintained. Doctors, nurses, pharmacists and other health professionals are well-remunerated even in the public sector. Drug registration follows American and European requirements. Hong Kong is part of the Pharmaceutical Inspection Co-operation Scheme, which brings with it a high standard of drug regulation. Hong Kong is a centre for clinical trials because the subjects are Chinese and protocols in English do not need to be translated. There are also two well-established clinical trials centres in university hospitals that also have a phase 1 clinical trials centre. The Hong Kong Hospital Authority is the largest customer
of pharmaceuticals, and so to ensure appropriate use of drugs, there is a territory-wide drug formulary and guidelines for its hospitals and clinics, based on clinical need, and the efficacy, safety and cost-effectiveness of the drugs.
- 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:
Sayantani Dasgupta is currently working as an Associate Director Customer Engagement and Strategy in MSD based in Tokyo. She has spent over 20 years in
the pharmaceutical and healthcare sector in both global and emerging markets in Switzerland, Germany, India, etc. Her passion is to drive customer centricity and
enable commercialization of life saving therapies to the right patients at the right time.
Abstract:
Jeremy Choo
Republic Polytechnic, Singapore
Title: Design, develop and evaluate dispensary software in RP-KTPH teaching dispensary
Biography:
Jeremy Choo Tze Yang has graduated with a Bachelor of Science from University of Melbourne with a major in Medical Microbiology in 2003. After which, he went on to obtain a professional degree, Master of Pharmacy from Murdoch University in August 2007. After graduation, he tutored and demonstrated various aspects of biomedical sciences including pharmacology to both local and overseas tertiary institutions (Anderson Junior College, Temasek Polytechnic, Singapore Institute of Science, Raffles Education Corporation and Edith Cowan University in Perth). As a Registered and Practicing Pharmacist in Singapore (Airport Pharmacy, THK Hospital, NHGP, Guardian) and Australia, he was certified nationally by WSQ to be curriculum developer, trainer and assessor, leadership and people management,as well as having professional knowledge in medication management review (Australia), ambulatory care, smoking cessation, counselling (Singapore), as well as anticoagulation studies (USA). Furthermore, he has additional certification in Career Coaching and Healthcare Management, as well as having a strong belief in lifelong learning and a fascination with infectious agents. With a keen research interest in medication adherence and pharmacy automation, he had collaborated with Epilepsy Care Group, KTPH, i3 Precision and Guardian Health and Beauty to work on these projects. Moreover, he has a keen interest in stage hosting and radio production.
Abstract:
Background: Recent pedagogical approaches within the field of applied sciences incorporate problem-based learning and hands-on training. Republic Polytechnic’s School of Applied Sciences (SAS) in collaboration with the School of Engineering and the School of Info COMM, has developed RPMED, a user-friendly and efficient dispensing software as a learning platform to hone student’s clinical and dispensing skills. By embracing new technologies and automation such as RPMED, students will be inculcated with the values and principles of pharmaceutical care such as medication safety, patient care continuum,dispensing process efficiencies and documentation procedures.
Methods: Developing RPMED requires a system of IT improvements. First, the students review current dispensing software issues raised by previous development teams. Next, students from SAS address these issues in collaboration with teams from the School of Infocomm. The third phase involves enhancing and implementing new features in RPMED. Lastly, end users feedback surveys are prepared, designed, conducted and reviewed by SAS students to determine RPMED software usability and future enhancements.
Results: Three improvement processes within RPMED had been identified and implemented: A barcode system, a drug interaction matrix and drug imaging. Implementing barcode systems on pharmaceutical products reduces medication
selection errors, thereby improving dispensing accuracy and efficiency. A drug interaction matrix improves medication safety by allowing concurrent checks for drug interactions when new medications are added to patients’ drug chart. A pop-up alert will appear when drug interactions are found. Drug imaging incorporates reference images within the software for quick and accurate identification and selection of medicines. End users feedback surveys showed widespread acceptance and usability among students.
Conclusion: Developing and using RPMED allows students to appreciate the verisimilitudes with commercially available dispensing software. The system of checks and balances within RPMED allow students to gain insight into the complexities involved in IT use within pharmaceutical care.
Sonia Shastri
University of Tasmania, Australia
Title: Therapeutic effect of idebenone in murine colitis
Biography:
Sonia Shastri is currently a PhD candidate at University of Tasmania, Australia. She holds Master’s degree in Pharmaceutical Science from the University of Tasmania and Bachelor of Pharmacy degree from Kurukshetra University, India. Her research focuses on investigating the efficacy of antioxidant drug in ulcerative colitis.
Abstract:
Idebenone, short chain quinone, has been described as a potent antioxidant and mitochondrial electron donor. Its therapeutical potential has been described extensively in numerous pathological conditions ranging from neurodegenerative,neuromuscular to diverse metabolic conditions. There is also some emerging evidence that idebenone has some antiinflammatory activity. Oxidative stress is one of the key players of the inflammatory cascade responsible for the initiation of Ulcerative Colitis (UC). Therefore, we investigated the anti-oxidative and anti-inflammatory properties of idebenone in dextran sodium sulfate (DSS)-induced mouse model of acute colitis. Acute colitis was introduced in female C57BL/6J mice by administering 2.5% of DSS in autoclaved water continuously for 7 days. Changes in body weight, Disease Activity Index (DAI), colon length and histopathological parameters were evaluated and scored. Colonic contents of Malondialdehyde (MDA), a marker of lipid peroxidation were also examined as a parameter of disease-associated redox state. Protein expression of the oxidative stress induced redox factor NAD(P)H dehydrogenase quinone-1 (NQO-1) was determined by western blot, while the levels of various pro-inflammatory cytokines were quantified using Bio-Plex assay. Oral administration of idebenone at a dose of 200 mg/kg body weight significantly against body weight loss, improved DAI, colon length and histopathology. Idebenone also significantly reduced MDA content as well as pro- inflammatory cytokine levels such as IL-1α, TNF-α, G-CSF, GM-CSF,MIP-1α, MIP-1β, RANTES and EOTAXIN; furthermore, idebenone upregulated NQO1 protein levels. These results suggest that idebenone could represent a promising therapeutic strategy to interfere with disease pathology in UC by inducing antioxidative and anti-inflammatory pathways.
Takahiro Iwamiya
Metcela Inc, Japan
Title: Cardiac fibroblasts expressing VCAM-1 improve function recovery of the infarcted heart
Biography:
Takahiro Iwamiya has completed his PhD from Tokyo Women’s Medical University and Project Research Associate studies from Institute for Advanced Biosciences,Keio University. He is the Co-Founder & Co-CEO of Metcela Inc. He has published three patents and has been developing novel cell therapy products for heart failure patients
Abstract:
Cardiac fibroblasts are interstitial cells showing substantial self-duplication ability and having a critical role in heart function through interactions with the myocardial compartment. Recently, they have been extensively used for creating functional bioengineered cardiac tissues and are considered attractive candidates for cell-based therapies. However, both in health and disease, cardiac fibroblasts present heterogeneous characteristics according to the development stage of the heart and the associated molecular mechanisms leading to the improvement of tissue properties are not fully understood. Here we show that a specific type of human cardiac fibroblasts expressing VCAM-1 (VCFs) can stimulate human cardiomyocyte proliferation in vitro and that both human and rat cells allow substantially improved recovery of heart function after surgically induced ischemic injury in vivo. One week after ischemia-reperfusion injury, rats received VCFs or medium by injections in the infarcted area. Eighteen (18) weeks after injections, echocardiography revealed an improvement of Left Ventricular Ejection Fraction (LVEF) by 32.6% in rats having received VCFs compared to controls. Moreover, systolic and diastolic functions in rats injected with VCFs or with cardiomyocytes show no significant differences. These results suggest a direct effect of fibroblasts on resident myocardial cells. Overall, these findings show that VCFs have a significant therapeutic potential making them advantageous for cost-effective cell-based therapy for heart failure linked to ischemic diseases.
Takahiro Iwamiya
Metcela Inc, Japan
Title: Cardiac fibroblasts expressing VCAM-1 improve function recovery of the infarcted heart
Biography:
Takahiro Iwamiya has completed his PhD from Tokyo Women’s Medical University and Project Research Associate studies from Institute for Advanced Biosciences,Keio University. He is the Co-Founder & Co-CEO of Metcela Inc. He has published three patents and has been developing novel cell therapy products for heart failure patients
Abstract:
Cardiac fibroblasts are interstitial cells showing substantial self-duplication ability and having a critical role in heart function through interactions with the myocardial compartment. Recently, they have been extensively used for creating functional bioengineered cardiac tissues and are considered attractive candidates for cell-based therapies. However, both in health and disease, cardiac fibroblasts present heterogeneous characteristics according to the development stage of the heart and the associated molecular mechanisms leading to the improvement of tissue properties are not fully understood. Here we show that a specific type of human cardiac fibroblasts expressing VCAM-1 (VCFs) can stimulate human cardiomyocyte proliferation in vitro and that both human and rat cells allow substantially improved recovery of heart function after surgically induced ischemic injury in vivo. One week after ischemia-reperfusion injury, rats received VCFs or medium by injections in the infarcted area. Eighteen (18) weeks after injections, echocardiography revealed an improvement of Left Ventricular Ejection Fraction (LVEF) by 32.6% in rats having received VCFs compared to controls. Moreover, systolic and diastolic functions in rats injected with VCFs or with cardiomyocytes show no significant differences. These results suggest a direct effect of fibroblasts on resident myocardial cells. Overall, these findings show that VCFs have a significant therapeutic potential making them advantageous for cost-effective cell-based therapy for heart failure linked to ischemic diseases.
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.