5^th World Congress on Advanced Clinical Trials and Clinical Research May 14-15, 2018 Singapore

Biography:

Dr. Serban ARDELEANU is an internal medicine and nephrology specialist from Romania. Since 2013 he works in Reunion Island at AURAR Dialysis Centers and is the main nephrology responsible of Research Pole in Aurar team. His main interest fields are cardiology and nutritional impact of renal disease in hemodialysis patients. His PhD thesis is focused on cardiologic abnormalities in dialysis patients. He also is an assistant professor at the University of Medicine in Iasi, Romania, with years of experience in research, evaluation, teaching and administration both in hospital and education institutions. Tony WONG is a nephrologist with much experience in AURAR Dialysis Centers, while Suren BUDHAN is the head of the Research Pole in Aurar team.

Abstract:

Statement of the problem: Cardiovascular (CV) disease represents the main cause of morbidity and mortality in end-stage renal disease (ESRD) patients. Left ventricular mass (LVM) is constantly growing with the progression of GFR deterioration. Left ventricular hypertrophy (LVH) is a powerful predictor of CV events. In Reunion Island (French overseas territory in Indian Ocean) we prospectively studied the trends in LV structure and function and evaluated the risk factors for progression of LVM derived from serial echocardiographic measurements. Methods: Seventy-two patients from 3 dialysis centers in southern part of Reunion Island were enrolled at baseline, between May 2009 and September 2017. Eight patients withdrew from the study (transplantation or transfer) and 12 patients died during the follow-up period of minimum 12 months. Fifty-two patients were included in the final analysis (mean age 57.6 years, mean dialysis duration 98.23 ± 42.61 years). Echocardiography analysis was performed at study inclusion and at least once during the follow-up. Biochemical, blood pressure, electrocardiographic parameters and medication history were collected, and the mean monthly values were used. Results: At baseline, 72,4% of patients had LVH (48,6% concentric hypertrophy, 26.4% eccentric hypertrophy and 4,2% concentric remodeling). Serial echocardiographies were performed (257 in total). At follow-up (mean period 52,69 ± 29,73 months) only 51,5% had LVH, with only 29,6% concentric hypertrophy; LVM index (LVMI) lowered from a mean of 163,8 g/m2 to 144,8 g/m2. 56% of patients were considered 'regressors' (delta LVM index < 0). Baseline LVMI significantly correlated with age, hemoglobin and albumin levels. LVMI at follow-up correlated to systolic BP and mean level of serum phosphate. Independent predictors for LVMI (multiple regressions) were anemia and mineral metabolism markers. Conclusion: The rate of LVH and other echocardiographic abnormalities is high in dialysis patients in Reunion Island, but a holistic interventional approach, targeting various pathogenic mechanisms, as per guidelines, can elicit at least a partial regression in LV structural and functional abnormalities in these patients.

Biography:

After completion of his postdoctoral training at University of Texas MD Anderson Cancer Center, Dr. Gautam Sethi joined Department of Pharmacology, Yong Loo Lin School of Medicine, National University of Singapore in 2008 as an Assistant Professor and was promoted to Associate Professor in 2015.  The focus of his research over the past few years has been to elucidate the mechanism (s) of activation of oncogenic transcription factors such as NF-kB/STAT3 by carcinogens and inflammatory agents and the identification of novel inhibitors of these proteins for prevention of and therapy for cancer. The findings of his research work have so far resulted in more than two hundred scientific publications in high impact factor peer reviewed journals (with h index = 71) and several international awards. He currently serves as an Academic Editor for PLOS, editorial board member of Scientific Reports, Pharmacological Research, BMC Cancer, Frontiers in Pharmacology, Frontiers in Oncology, Journal of Natural Products in Cancer Prevention and Therapy, and ad-hoc reviewer for several other prestigious international journals.

Abstract:

Gamma-tocotrienol, a member of Vitamin E superfamily has attracted great attention of late for its anti-proliferative and anti-carcinogenic potential against different cancers. For example, our group has recently reported that anti-proliferative and chemosensitizing effects of g-tocotrienol are associated with its ability to suppress activation of signal transducers and activator of transcription 3 (STAT3), a pro-inflammatory transcription factor that plays a pivotal role in the survival, proliferation, angiogenesis and chemoresistance of hepatocellular carcinoma. However, the potential of gamma-tocotrienol to overcome chemoresistance in gastric cancer, which is one of the deadliest cancers in Asia-pacific region, has never been explored before. Hence, we investigated the efficacy of gamma-tocotrienol in combination with capecitabine to modulate tumor growth and survival in xenograft mouse model. Gamma-tocotrienol also inhibited expression of various oncogenic proteins, induced PARP cleavage and inhibited NF-κB activation in gastric cancer cells. In vivo studies using xenograft model of human gastric cancer demonstrated that gamma-tocotrienol alone suppressed tumor growth and this effect was further potentiated in conjunction with capecitabine. As compared to the vehicle control, gamma-tocotrienol further suppressed the NF-κB activation and expression of cyclin D1, COX-2, ICAM-1, MMP-9 and survivin in tumor tissues obtained from treatment groups. Additionally we noted, that gamma tocotrienol can function as a potent inhibitor of angigogenesis in both HUVEC and HCC cells. Overall our results suggest for the first time that gamma-tocotrienol can potentiate the effects of chemotherapy through modulation of multiple biomarkers of proliferation, and angiogenesis in diverse cancers.

 

Biography:

Dr Jean Saunders is a C.Stat and C.Sci from the Royal Statistical Society, London, UK. As well as running a busy Statistical and Research Methodology Consultancy within the University of Limerick in Ireland she has particular interests in Research Ethics and Patient Participation in Medical Research. She has been a Board Member for IPPOSI (Irish Platform for Patients’ Organisations with Science & Industry) for the last 2 years. She has published over 100 papers in peer-reviewed journals as well as contributing towards many other reports/bulletins. She currently provides Statistical Consultancy Services to the Local Health Executive as well as Pharma.

Abstract:

Clinical Trials were originally designed and developed with input from various experts, statisticians, clinicians, nurses etc. Gradually there was a recognition that maybe the patients (or participants) in the actual trial could contribute although at first this was mainly limited to their involvement in the choice of outcome measures. The difficulty of involving patients in clinical trial design was mainly attributed to patients not having sufficient understanding of the trials to be able to make more than simple design changes. However Patients’ Organisations have developed within Ireland and Europe and have become more and more influential at all levels of treatment and health provision. However the patients/organisations still had very little influence over clinical trial design leading to the patients’ organisations criticising the trials when they were taking place or completed. This has led recently to the idea of the ‘expert’ patient. This is the concept that patients often know quite a lot about their disease so the only thing stopping them from providing useful input into a clinical trial is their comparative lack of knowledge of interpreting the medical literature and/or the design of efficient and valid clinical trials. To address this various programmes of education for patients have been devised in Ireland and within Europe training them how to ‘read’ medical papers and understand clinical trials. This talk provides the history behind these initiatives and the (successful) results obtained. Now very few trials are planned in Ireland and the EU without some input from patients or patient groups.

Biography:

Eunho Shin is the Head of Solution Consultant for Asia Pacific (except Japan) at Medidata. In his role he is responsible for consulting and advising Pharmaceuticals, contract research organizations (CRO), and other healthcare providers on clinical trial processes, clinical trial IT systems and infrastructures.Eunho has over 10 years of experience in the clinical trial field across monitoring, project management, and people management. Prior to Medidata, he was a Senior Clinical Research Manager, and Regional Lead of the Embedded Program at ReSearch Pharmaceutical Services Inc. (RPS), a functional service provider of global pharmaceutical companies in Korea, China, Taiwan, Singapore, and Australia.

Abstract:

In the future, patients may no longer be required to physically visit clinical research centers during clinical trials. This could have huge benefits, not only for the sponsors in terms of cost and time, but also for the patients who take on additional commitments to participate in these trials - including their time. While traditionally this has not been possible, by leveraging high end technology such as mobile apps, wearable devices, and clinical ecosystem, we have seen some progress. We’ve even seen the possibility of running virtual clinical trials by monitoring patient condition remotely. We are only scratching the surface today, and there are still many challenges ahead, specifically around quality and regulations. In this presentation we want to show you what the future of clinical trials look like, including the benefits and challenges of future virtual trials.

Biography:

I was born in 1967, Amasya, TURKEY. I got my licence education between 1986 and 1990 in Hacettepe University TURKEY. I finished my first Masters degree from Gazi University in 1997 and the second one from Gulhane Faculty of Nursing in 2005. The subject of my Masters degree thesis is about diabetic patients. I got my PhD. Degree from Gulhane Faculty of Nursing. The title of my dissertation is “Development of an assessment scale for treatment compliance in type 2 Diabetes Mellitus in Turkish population: Psychometric evaluation.” I developed a scale to assess the compliance of the patients for Turkish Population. My general subjects of interest are Nursing care in Diabetes Mellitus, Geriatry, Methabolic Syndrom, Chronic obstructive Pulmonary Disease, and Diseases of Cardiovascular system. I currently work in Gulhane Faculty of Nursing, University of Health Sciences, TURKEY, as a Faculty Member. I am married.

Abstract:

Objectives: Compliance to the treatment is important for the management of the type 2 diabetes mellitus and prevention of complications. The purpose of the study was to develop a scale and test the psychometric properties of it for the treatment compliance of diabetic Turkish Population.

Methods: This multi center study was conducted in four training and research Hospitals. The sample was consisted of 350 convenient type 2 diabetic patients. Items of the scale were determined after a literature review and qualitative interviews with the patients. Items were psychometrically analized. Content validity of the scale was evaluated using the opinions from experts and pilot study. Principal component analysis and the varimax rotation technique were used to evaluate the construct validity in exploratory factor analysis. Criterion validity was evaluated with the Diabetes Care Profile. Reliability was evaluated with Cronbach’s α coefficient and test-retest  analysis of internal consistency.

Results: The scale consisted of 7 factors that explained 47.36% of the total variance. The KMO test was conducted to determine whether the sample size was sufficient or not before the factor analysis. The KMO test result of the study was 0.75. The Cronbach’s α value of the sample was 0.77. The test-retest reliability analysis result was r=0.991. We found a positive correlation between the total scores of the developed scale and Diabetes Care Profile (r=0.31).

Conclusion: The results of the study demonstrate that the scale with 30 items is a “valid” and “reliable” scale in the evaluation of patient compliance with type 2 DM treatment. Thus, nurses and healthcare providers can evaluate the compliance of the type 2 diabetic patients to the treatment with this scale.

Biography:

President, Business Development and Strategic Initiatives at GlobalCare Clinical Trials, Ltd

Abstract:

Patient recruitment and retention are key factors in establishing the objectives and ultimate success of clinical trials.  These can be particularly challenging in studies where patients reside distant to investigator sites and may suffer from debilitating diseases making travel difficult.  Patient advocacy groups have been playing a more influential role in drug development and commercialization.  Advocacy groups represent the voice of the patient contributing to better clinical trial design by helping to remove barriers that made participation difficult or impossible.   But many challenges remain.  A patient-centric service model has evolved over the past years allowing study visits to be conducted at the patient's home where it is more convenient and comfortable than at the investigator site.

By conducting selected protocol visits at home, workplace or other alternate location, ambulant healthcare providers offer a way for patients to participate in trials regardless of:

• Study duration
• Frequency of visits
• Disease state
• Distance to site
• Family, school, work or community obligations

By making trials more convenience and comfortable for patients, more patients are willing and able to participate and remain in the study.

This innovative service model is available on a global basis and has been shown to triple enrollment rates and reduce patient dropout rates to 3 percent.  Services include study drug administration, blood draws, clinical assessments, patient training and education and study compliance checks in all age groups, a variety of therapeutic areas and in all phases of development.  This ambulant care service model provides a win-win benefit for all stake holders by providing patient's a convenient and comfortable way to participate in studies, offering investigators the ability to recruit patients from broader geographic areas, reducing development times for sponsors developing new therapeutics and ultimately getting life enhancing products to consumers sooner.

 

 

Biography:

Dr Bickkie Nguyen is currently the Vice President of Pharmacy at Apria Healthcare. She is concurrently a Clinical Assistant Professor of Pharmacy Practice and Administration at Western University of Health Sciences and University of Southern California. She is also the CEO/Founder/Consultant Pharmacist/Leadership Coach at Ivy League Healthcare Management LLC. Dr Nguyen was previously the Director of Pharmacy at University Hospital and Medical Center (Florida), Promise Hospital of East Los Angeles and Suburban Medical Center (California), Western Arizona Regional Medical Center (Arizona) and Cardinal Health, Inc (Virginia). She is experienced in both inpatient (small, medium, large, level 1 trauma academic, long term acute care) and outpatient settings and home infusion. Her consulting specialty and experiences is in turnaround pharmacy management, business strategies development, pharmacy operations, personnel management, regulatory compliances, sterile compounding and drug purchasing/distribution best practices. She currently holds clear and active Registered Pharmacist licenses in 8 US states and is on the editorial board of multiple pharmacy journals.

 

Abstract:

There is a high turnover of hospital pharmacy leadership, typically Director of Pharmacy, due to stress, long hours, constant deadlines, high responsibilities, multiple supervisors, demanding and challenging job to perform well, constant clinical/regulatory/technological changes in the industry to be compliant with, tight budgets/deadlines, and retiring baby boomers. This leads to the need for interim leadership focusing on turnaround change management for poor performing hospitals.

 

In USA, the new and unexplored trend is consultant pharmacist in leadership and turnaround management (interim management). Traditionally, consulting pharmacist roles is in medication therapy management, long term care facilities and clinically oriented. Typically, interim management is stigmatized as incompetent and cannot get a permanent job. Fact is, to be an effective and high impact interim leader, the pharmacist must be very experienced, skilled and talented to turnaround the pharmacy that’s failing in a very short time period with limited resources and minimal relationships with staff/other hospital leaders for support. The modern concept of lean and high impact giant healthcare organizations in USA is getting experienced interim leaders in making assessments, formulating an action plan, rapidly developing and implementing the action plan in a brief time frame of usually 3-6 months. They then move the leader around in their organization to facilities/pharmacies that are performing poorly to turn it around. This business strategy is also applicable at the executive CEO level for the whole hospital.

 

This presentation explores the new US business strategy and techniques to improve medium performing and rescue failing healthcare businesses, change management challenges and how to overcome them, clinical/regulatory compliance and best practices, personnel management, work flow to improve productivity, use of technology in healthcare, inventory management, quality assurance and cost reduction in all aspects of the pharmacy operation. The concepts can be extrapolated across other industries and sectors of healthcare. The presenter will conclude with motivational/inspiring key messages and why this is a very rewarding unexplored new field of pharmacy practice as well as resources to help the audience achieve the comparable results in their practices.

 

Biography:

Dr. Vani Nilakantan is the Vice President, Research at Allina Health System, Minneapolis Minnesota. Dr. Nilakantan has over 25 years research experience in academic and hospital based settings. At Allina Health, she is the head of research for the health system, provides executive level leadership for clinical and basic research within an integrated hospital system environment and is the authorized organizational representative and signatory for system. Dr. Nilakantan Provides visionary perspective on the future of research at a major health care institution. She also sets strategic direction for research and reorganized research structure for Allina Health System. Prior to joining Allina, Dr. Nilakantan was the Director of Investigator Initiated Research and Sponsored Programs Office at Aurora Health Care. At Aurora Health Care, she had oversight of basic science, pre-clinical, translational and clinical research, innovation in alignment with Aurora Health Care mission and strategic priorities. She also created effective collaborative relationships with senior administrative leadership and clinical system program leaders and medical staff. Her responsibilities included oversight of the grants management for the system.

Abstract:

There has been a shift in clinical research from traditional academic medical centers to community hospital settings in the United States.  There are multiple benefits to hospitals that conduct clinical research as it provides them the opportunity to participate in studies that are leading edge thereby enhancing the reputation of the hospital system.  In addition, clinical research also enables the hospital to prevent patient out-migration and increase patient in-migration thereby increasing market advantage.  The risks associated with clinical research will be discussed with particular emphasis on indemnification, conflicts management and subject injury.  Lack of physician time and physician revenue and productivity models are often not conducive to conducting clinical research. Despite these challenges, having a robust, highly visible and strong research program can help to obtain institutional commitment and executive leadership support for research in hospitals.

Support systems such as statistical support, grant and contract support for busy physicians are critical to the success of the overall research program.  Quality assurance and Research governance e.g. through a strong Research Compliance Program, education and training for human subject research protection and grant management, and a Research Steering Committee Having a vetting process through the establishment of research councils which can make informed decisions on trial portfolio (both industry sponsored clinical trials and investigator initiated research) is important to consider for research portfolio.  The decision making process should typically include both front end and back end processes such as research protocol reviews, and constant review of studies that are slow-accruing and not cost effective.  This review process will ensure that the research program has a focused portfolio that can be self-sustaining.

Funding for clinical research programs comes from various sources - e.g. industry sponsored clinical trial revenue (typically 50—60% of portfolio), operational/institutional support (approximately 30%), grant funding through government and industry, intellectual property and patents, foundation support and individual donor funds. Research and Philanthropy are often strong partners in raising dollars for innovation and research.

Biography:

Abstract:

Patient recruitment and retention are key factors in establishing the objectives and ultimate success of clinical trials.  These can be particularly challenging in studies where patients reside distant to investigator sites and may suffer from debilitating diseases making travel difficult.  Patient advocacy groups have been playing a more influential role in drug development and commercialization.  Advocacy groups represent the voice of the patient contributing to better clinical trial design by helping to remove barriers that made participation difficult or impossible.   But many challenges remain.  A patient-centric service model has evolved over the past years allowing study visits to be conducted at the patient's home where it is more convenient and comfortable than at the investigator site.

By conducting selected protocol visits at home, workplace or other alternate location, ambulant healthcare providers offer a way for patients to participate in trials regardless of:

 

• Study duration
• Frequency of visits
• Disease state
• Distance to site
• Family, school, work or community obligations

 

By making trials more convenience and comfortable for patients, more patients are willing and able to participate and remain in the study.

This innovative service model is available on a global basis and has been shown to triple enrollment rates and reduce patient dropout rates to 3 percent.  Services include study drug administration, blood draws, clinical assessments, patient training and education and study compliance checks in all age groups, a variety of therapeutic areas and in all phases of development.  This ambulant care service model provides a win-win benefit for all stake holders by providing patient's a convenient and comfortable way to participate in studies, offering investigators the ability to recruit patients from broader geographic areas, reducing development times for sponsors developing new therapeutics and ultimately getting life enhancing products to consumers sooner.