Pharmacovigilance and Clinical Trials

Vladimir Shnaydman, Ph.D, is President of ORBee Consulting. Vladimir has BS & MS Electrical Engineering & Computer Science, MS in Applied Mathematics & Operations Research, and Ph.D. in Engineering. He contributed to many industries such as biotechnology, computer networking, data storages, water resources planning and management, telecommunications, transportation, and others. Dr. Shnaydman published more than 50 papers. He is co-author of three books.

biotechnology, computer networking, data storages, water resources planning and management, telecommunications, transportation, and others

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.

Dr. Vani Nilakantan completed her PhD in Toxicology from the University of Kentucky in 1997. She was a researcher/faculty member at the Medical College of Wisconsin (MCW) until 2010. At MCW, her research focused on oxidative stress in acute kidney injury and cardiac/kidney transplantation. She further continued her research on acute kidney injury at Aurora Health Care, where she worked with data scientists to develop a predictive model for early diagnosis of acute kidney injury She has over 50 abstracts/presentations and over 30 peer-reviewed manuscripts and has been funded through internal foundations, the American Heart Association and the National Institutes of Health.

Gautam Sethi, is a prolific Academician and Researcher currently serving as Associate Professor at Department of Pharmacology, Yong Loo Lin School of Medicine, National University of Singapore. He has completed his postdoctoral training at University of Texas MD Anderson Cancer Center. 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 novel findings of his research till date has resulted in 150+ research papers in high impact Scientific Journals and some various prestigious International Awards.

Oncology, Pharmacology

PJ Chen currently is President, United Biopharma (UBP) China responsible for overall development strategy of UBP pipeline and business operation. Previously PJ severed as VP, global clinical development at Unite Neuroscience. Prior to that, PJ was executive director at PPD as area head for North Asia clinical management. In this role, he provided overall business support for clinical management group in China, Hong Kong, Korea and Taiwan. After completion of his graduate training at MIT, PJ worked at MGH/HMS/MIT Martinos Center for Biomedical Imaging in Boston. PJ was actively involved in biomarker/MR imaging research with particular focus on oncology clinical research. After years of working in Boston, PJ returned to Asia and have worked with CRO and Pharma companies with increasing responsibilities. In addition to CRO project management and business development experiences, PJ was Respiratory & GI portfolio development lead responsible for successful value delivery of new drugs in China at AstraZeneca and developed comprehensive knowledge for the drug development environment in APAC.

Clinical Research

Dr. Myat Thu Thu Win was graduated M.B.,B.S in 2001 and Master of Medical Science (Pharmacology) in 2005 from Institute of Medicine I, Yangon. She got Japanese government (MEXT) scholarship from 2009-2013. She finished her Ph.D in 2013 from Kanazawa University Graduate School of Medical Science and postdoctoral fellow in the same department for 3 months. She had more than 8 years of teaching and clinical experience as well as 6 years of research experience. She published research and review papers. She is now doing as a senior lecturer Pharmacologist in the Faculty of Medicine, Asian Institute of Medicine Science and Technology (AIMST) University. She got ‘Outstanding award in Medical Science’ from Venus International Foundation and ‘2000 Outstanding Intellectuals of the 21st Century award’ in 2017. She also involved as invited speaker in Contemporary Academic Meet, Chennai, India as well as in International Conference on Toxicology and Clinical Pharmacology, Rome, Italy in 2017.

Clinical Trials, Toxicology

Bharat Bhushan is a Ohio Eminent Scholar and The Howard D. Winbigler Professor and Director of Nanoprobe Lab for Bio- & Nanotechnology and Biomimetics, Dept. of Mechanical and Aerospace Eng., and Graduate Res. Faculty Advisor, Dept. of Mater. Sci.and Eng., Affiliated Faculty, Battelle Center for Science & Technology Policy, John College of Public Affairs, Ohio State University.

Fundamental studies in the interdisciplinary areas of bio/nanotribology/nanomechanics and nanomaterials characterization in bio/nanotechnology and biomimetics with a focus on scanning probe techniques. EDUCATION

Dr. Sadiyo Siad - Born out in the horn of Africa, she fled to Denmark as a refuge and later moved to the UK for her studies. She is a medical multi-specialist, lecturer, consultant, entrepreneur and philanthropist. Her Medical education includes a PhD in Tuberculosis and Immunology, Master’s Degree in Infectious Diseases and Immunology, another Master Degree in Medical Diagnostics, a PGD in Medical Pathology and also finished Honors in an Undergraduate Degree at the University of Leicester and Cranfield University, and a Diploma in Nursing from her early work as a nurse and midwife assistant. Currently, she is serving as a lecturer in infectious diseases and Immunology and is also a Chancellor at Hano Academy.

Infectious Diseases, Immunology, Preventive Medicine, Healthcare System

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.

Turnaround pharmacy management, Business strategies development, Pharmacy operations, Personnel management, Regulatory compliances

Michael Coyle, Founder & Principal at VivoScientia, is one of the reputed Medical researchers, Entrepreneur. He finished his B.S. in Biology from Butler University and later went on to pursue M.S in Motor Control and PhD in Human performance from Indiana University. After completion of Doctoral research he carried out a Post-doctoral research in Respiratory Physiology in 2006 at Harvard T.H. Chan School of Public Health. Before setting VivoScientia, previously he has been associated with VivoMetrics as VP, Clinical Development, Director at Culver Academies, Interim CEO at Safe Responder. He also has experience as an Academician at Indiana University. In the year 2009 Michael started his venture VivoScientia and he has been carrying a great amount of work with his Organization till date. He possesses an exceptional ability to communicate complex medical concepts, methods and results.

Clinical Trials and Clinical Development

An experienced pediatrician with intuitive and comprehensive medical communicating skills. Being on both sides of the table- pharmaceutical/biotech and healthcare professionals/hospitals, Namrata understands and comprehends the requirement and delivers spot on. Her forte initiates from being a part of the initial planning to delivering the final customized solutions. She has experience and expertise across all major medical documents (publication, regulatory and marketing) and all major therapeutics areas. As an entrepreneur and trainer, she is always ready to explore new ideas and opportunities which will impact the way scientific evidence is communicated. Turacoz Skill Development Program, a wing of Turacoz Healthcare Solutions, takes initiatives to full fil the gap between the academic curriculum and the industry requirements and have customized and specialized training solutions in the form of seminars, workshops, and e-learning modules for healthcare and pharmaceutical professional, pharmacy students, researchers and scholars. In total, Dr. Namrata has experience of more than 50 trainings, workshops and seminars to educate industry people.

Healthcare, Clinical Research

Dr. Allen Lai is now the senior vice president of ACT Genomics Singapore, strategizing corporate development, planning and execution of cancer genomics clinical & research projects in Southeast Asia. He holds several high key profile roles as Advisor Board of ISPOR Asia Consortium, President of ISPOR Singapore and concurrently Senior Consultant, Ministry of Health and Social Welfare, Taiwan. He received his Ph.D. and MPA, from Lee Kuan Yew School of Public Policy, National University of Singapore, M.Sc. (Preventive Medicine) from National Taiwan University and M.D. from Chung Shan Medical Dental University, Taiwan. He was the principal consultant at IMS Health Asia, and the director of Institute of Health Economics & Management and the academic director of MSc Management of Health Industries in ESSEC Business School.

Preventive Medicine, Infectious Diseases

Dr. Suriyon Tengyai, Professor at Walailak University,Thailand, has an extensive background in both Research and Academic Pharmacology and Medicinal Chemistry. Having served for more than 10 years in Walailak University he holds immense knowledge and keen interest in Medicinal Chemistry, Pharmaceutical Analysis, Clinical Pharmacokinetics, Chemistry of Natural Products. In past he has published more than 20 papers on Pharmacokinetics and Chemistry of Natural Medicinal products in reputed journals around globe.

Medicinal Chemistry, Pharmaceutical Analysis, Clinical Pharmacokinetics, Chemistry of Natural Products.

Oleg V. Tcheremissine, M.D., Professor of Psychiatry and Research Director at the Carolinas HealthCare System Department of Psychiatry, has an extensive background in research, education and academic medicine. He has more than 25 years in treating neurodegenerative diseases and severe persistent mentally ill patients while applying the guiding principles of functional recovery. He has been the Principal Investigator for numerous Phase II-IV clinical trials across a wide range of therapeutic indications. He is an expert and key opinion leader in the field of Clinical Psychopharmacology. He has more than 40 published papers and serving as an editorial board member of repute.

Novel therapeutics for the treatment of Alzheimer’s Disorder, Schizophrenia, and Treatment-Resistant Depression

Paul Michael Ramirez is Professor of Neuroscience/Neuropsychology, Psychopathology and Psychopharmacology within the Doctoral Program in Clinical Psychology and an Adjunct Professor in the College of Pharmacy and Health Sciences at Long Island University in New York City. Dr. Ramirez completed his doctoral degree in Psychology at The City College of The City University of New York with a specialization in Clinical Neuropsychology and a sub-specialization in Clinical Psychopathology, while on a National Science Foundation Fellowship. He later completed a Postdoctoral Program in Psychopharmacology at Fairleigh Dickerson University. Dr. Ramirez also earned an M.Phil. in Neuropsychology from the Graduate School & University Center, City University of New York, an M.A. Degree in Psychology from the City College of New York, and an M.A. Degree in Reading Disabilities with a postgraduate year studying Learning Disabilities at New York University. He currently serves on the Board of Advisors at the Center for Advanced Studies in India (CASII-Bhuj, Kutch (also called Kachchh) in the District of Gujarat) as a clinical trial expert, is Past Vice President of the New York Academy of Traumatic Brain Injury and has recently completed a second 5-year term on the State Board for Psychology by the New York State Board of Regents, where he served as Chairman of the Board. Recently, Dr. Ramirez was elected President of the Southeastern Biofeedback and Clinical Neuroscience Association. Dr. Ramirez has made over 200 professional presentations and, over the past 25 years, has provided Rater training for CNS scales and in the assessment of cognitive disorders for Clinical Trials throughout North America, South America, Central America, Asia, Eastern and Western Europe, Scandinavia and South Africa. He is the President and CEO of CNS Ratings, a global Clinical Trials Rater Training Company. He is also a former co-founder and CEO of the Prophase Training Group (now doing business as ProPhase). Dr. Ramirez has published numerous papers on major mental disorders and has been Principal Investigator on grants from the National Institute of Health (NIH), National Cancer Institute (NCI), The National Institute of General Medical Sciences (NIGMS) and pharmaceutical industry sponsors. He is also on the editorial board of Dataset Papers in Medicine (Psychiatry) and is also a contributing author of the Positive and Negative Syndrome Scale (PANSS), a co-author of the Informant Questionnaire for the PANSS (IQ-PANSS) and a co-author of the official Japanese translation of the PANSS.

Clinical Neuropsychology, Clinical Neuroscience, Psychopathology, Psychopharmacology, Clinical Trials, Biofeedback, Hypnosis, Major Mental Illness, Traumatic Brain Injury, Schizophrenia, Cross-Cultural Issues and Health Psychology, Clinical Education Films

David is a well-known leader and change agent in the clinical research industry. He was born and raised in New Orleans, Louisiana. He has a Master’s degree in both Social Work and Business Administration and holds the additional status of Certified IRB Professional (CIP) and Regulatory Affairs Certification (RAC). He is the Responsible Executive for Clinical Research for Hospital Corporation of America (HCA). He is and has been in many industry leader roles both in the United States and globally, including Chair of the Board of Trustees for the Association of Clinical Research Professionals (ACRP). He is also the President of the Nashville Angel Capital Group. He is married with 2 children and lives south of Nashville, Tennessee where he involves himself in work, family life as well as other charitable and entrepreneurial opportunities. David was recently honored with the “Outstanding Speaker” award, presented at the 2015 MAGI West conference.

Clinical Research, Regulatory Affairs

Nicki Norris is the CEO of Symphony Clinical Research, a provider of specialized in-home and alternate-site clinical services. Nicki brings 30+ years of experience as a healthcare executive. She spent 20 years at Baxter, lead a high growth dialysis company; a blood collection/processing organization; and a gold-standard laboratory accrediting organization. Nicki has an MBA from the UofI Urbana-Champaign, passed the CPA exam, and serves as VP of the Chicago chapter of the HBA. She has spoken at dozens of industry conferences (DIA, Outsourcing, Innovations in Clinical Trials, CenterWatch, Site Solution Summit, SCOPE, CBI Rare Disease, NORD conference on Rare Diseases).

Trials.ai is Kim’s 3rd company yet her passion for fixing logistical problems with clinical trials drives her as if it were her first. Her expertise in organizational development enabled her build Corporate Development Programs for companies like Pfizer, Merck and Wyeth Ayerst. Ms Walpole understands the complex clinical trials space and the needs of sponsors, CROs and sites. Her goal is to use technology to as a catalyst for helping organizations in study design and execution so that patients can be exposed to better quality treatments, faster.

JoAnn Pfeiffer completed a Doctorate of Science, in Regulatory Science from the University of Southern California. She is currently the Director and an Associate Professor, in the Clinical Research Managment Graduate Program at Arizona State University. She has published several books related to managing contracts and budgets in clinical trials, conducting clinical trials at study sites, as well as articles in peer reviewed journals. Her expereince includes over 20 years in the management of clinical trial operations in both academic and non-academic settings.

conducting clinical trials, budgets in clinical trials

Milan Satia is a Ph.D. in Pharmacology with more than 22 years of experience working across the local pharma majors and CRO industry, playing key leadership roles. Dr. Satia has led Operations at R&D for a pharma major & CROs, setting up of a Pharmacokinetic cell within technology centre, managed client relationship, and has led teams of expert and played important role in contributing to strategies, developing new business opportunities and to provide scientific knowledge base. He is having a wide knowledge base and experience of varied facets of pharmaceutical research including Pharmacology, Toxicology, Bioavailability & Bioequivalence Studies, Clinical Trials, Medical Writing and exposure to various international Audits. Also conversant with Regulatory framework globally and a crucial member for setting up of CROs in India. Currently, Dr. Satia is a CEO of Ethicare clinical trial services since 2009 and located at Ahmedabad, India. He is providing services from Phase I Bioequivalence study in special patient population to Phase II proof of concept study to Phase III and Phase IV studies including Pharmacovigilance and also provide Clinical Data Management services.”

Scott Gelfand received his Ph.D. in Philosophy from the University of Maryland and his J.D. from Georgetown University Law Center. He is a tenured professor and Head of the Department of Philosophy at Oklahoma State University. His research is focused primarily on issues in biomedical ethics and research ethics. In 2010 he received an NSF grant to develop a novel research ethics course for scientists and engineers.

Biomedical ethics, Research ethics

Wessam Sonbol is a biopharmaceuticals and healthcare solution strategist, focusing on life science process improvement. Wessam has extensive experience in Phase I-IV, IDE and 510(K) clinical research and healthcare business operations, having running a Data Management Organization and worked with some of the top-500 organizations Medtronic, Abbott Vascular and J&J. Wessam merges technical methods from 17 years of data management and operational experience into clinical operations, and has demonstrated successful results in improving clinical trial and healthcare business outcomes via breakthrough strategies.

clinical operations, healthcare business

IAP activities-Executive Board Member, central IAP Since 1992 for 9 terms. Worked on various committees of IAP like Human Lactation Management , Adolescent Health, Polio Eradication , Committee On Immunization 1999-2001, West zone co-ordinator Adolesence chapter 1999-2004, National co-convener Art & Science of Pediatric Practice (ASPP) 2007, National Jt. Coordinator Rational Antibiotic Practice (RAP) 2014, Vice President Infectious Diseases Chapter 2009 & 2013, President IAP (Pune) 2006 –07 National Trainer for Ask- IAP, Science of Vaccinology (SOV), Asthma Training Module(ATM), Allergic Rhinitis& Co-morbids (ARCTM), Resp.Tract Infections(RTI), Golden hour Emergency Management(GEM), Navajaat Shishu Suraksha Karyakram (NSSK), How do I Investigate, How do I manage, Mission Kishore Uday( MKU). Faculty in over 600 National and International conferences Publications in National Journals & Chapters in Paed.Textbooks Editor, Pediatric Review Journal since 1985 Conference organization- Org. secy- 4th Nat. Conf. Ped. Inf. Dis.-NCPID( 2001), Org.Chairman, National Conference on Pediatric Critical Care-NCPCC(2005), MAHAPEDICON(2009), AWESOME(2012), PEDGASTROCON(2013), ADOLESCON (2013), ID CME Pune (2014)

Entsuah Anthony Richard is a fellow of the American Statistical Association and presently an Executive Director of Late Development Statistics at Merck Research Labs and Head of Research Group 4 (Neuroscience, Respiratory and Immunology areas). Previously, he was an Assistant Vice President of Biostatistics at Wyeth Research Labs (Pfizer). Prior to joining the industry in 1988), he was an Assistant Professor of Biometry at University of Illinois in Chicago. He has published extensively both in statistical and clinical journals and has given many presentations over the years. He has led approval of various compounds as the statistical lead and has been an invited seminar presenter at the US FDA.

Prof. Piyush Trivedi is an renowned academician, educationist and eminent scientist. He is a professor at School of Pharmaceutical Sciences, Rajiv Gandhi Technical University (RGTU), the technological university of the state of Madhya Pradesh, India. Prof. Trivedi is high profile researcher with more than 100 publications in high impact journals. He also holds one US patent and seven Indian patents related to new drug discovery and development. Prof. Trivedi research focuses on new drug discovery and development for diseases like Cancer, Diabetes, and Alzheimer’s disease. Prof. Trivedi has mentored 13 Ph.D scholars and more than 100 postgraduate students of pharmaceutical chemistry. Prof. Trivedi is also the longest serving Vice-Chancellor (8 yrs) of RGTU, India. He has also served in various national committees dealing with technical education and development of educational policies and has won several awards for his visionary leadership skills and for excelling technical education in India.

Pharmaceutical Sciences

Dr. Katja Reuter is Assistant Professor of Clinical Preventive Medicine at the Institute for Health Promotion and Disease Prevention Research at the Department of Preventive Medicine, Keck School of Medicine of the University of Southern California (USC), and Director of Digital Innovation and Communication at the Southern California Clinical and Translational Science Institute at USC. She is a scientist, educator, and communications professional trained and employed in Germany, New Zealand and the United States of America (U.S.) with over 15 years’ experience. Dr. Reuter received her PhD in developmental neuroscience from the Free University in Berlin, Germany.

Katarzyna Anna Rygiel has completed her Ph.D in medical sciences: “ATHEROGENIC DYSLIPIDEMIA INDEX AMONG THE ADULT PRIMARY CARE PATIENT POPULATION IN POLAND” from Silesian Medical University (SUM). She is affiliated with the Department of Family Practice, SUM in Katowice-Zabrze, Poland, and she has background in anesthesiology, primary care, preventive medicine, and research collaboration. She serves as an instructor for International Medical Students, and Pharmacy Postgraduate Education. She has published 2 books and 30 papers on interdisciplinary topics, relevant to cardiovascular diseases, cancer, depression, dementia, obesity, and other diseases of civilization, in reputed journals.

Joao Paulo Tardivo is assistant professor of angiology and vascular surgery and director of the Center for the Treatment of Diabetic Foot in the Faculty of Medicine of ABC. He graduated in medicine from the Medical School of ABC in 1976 and obtained his Master in Health Sciences in 2004 and PhD in 2013 in the same institution. Expert in vascular surgery since 1979, began his studies with medical lasers in 1987. In mid- 1999 began to be interested in Photodynamic Therapy in Dermatology and superficial tumors and since 2009 has been doing research with the use of Photodynamic Therapy to treat Diabetic Foot. He has published 14 papers in reputed journals and developed an Algorithm to treat Diabetic Foot with Photodynamic Therapy.

Alejandro Sosnik is Associate Professor of the Department of Materials Science and Engineering of Technion-Israel Institute of Technology since early 2014 where he founded the Laboratory of Pharmaceutical Nanomaterials Science. His current research lines comprise drug self-assembly and crystallization phenomena and processing, polymer and macromolecular chemistry, biomaterials science, colloidal chemistry (drug and polymer self-assembly), mucoadhesive drug delivery systems, nanomedicine (drug encapsulation, release and targeting), therapy of poverty-related diseases (HIV, tuberculosis), pediatric cancer, intestinal diseases and pharmacokinetics (oral, inhalatory and intranasal administration routes) in both preclinical and clinical trials. Prof. Sosnik is co-author of over 110 peer-reviewed articles, reviews, editorials and book chapters in areas of pharmaceutical research and development and innovation, and co-inventor in three patents and patent applications related to biomedical and pharmaceutical innovation.

Amr Amin has completed his PhD at University of Illinois at Chicago, and received a post-doctoral training in the field of molecular genetics at the University of Pennsylvania School of Medicine. He started his academic career at UAE University where he serves now as a Graduate Professor of Cell & Molecular Biology. Amr’s research focuses on ways to control cancer, particularly liver cancer. He published many research articles & reviews and serves as reviewer and as an editorial member of many specialized peer-reviewed journals. He is also a member of many specialized societies and the sole recipient of many national and international scientific awards.

Dr. Noreddin received his Ph.D. in pharmaceutical Sciences from the University of the Pacific, California and received research training as a visiting scholar at the Department of Medicine, Stanford University. He had postdoctoral fellowship (Pharmacokinetics and Pharmacodynamics of Antimicrobials), Department of Medical Microbiology, University of Manitoba followed by an American College of Clinical Pharmacy postdoctoral fellowship (Infectious Diseases). Dr. Noreddin’s research interest includes Pharmacoklinetic/Pharmacodynamic modeling of anti-infective and anti-cancer therapy, clinical simulation and Monte Carlo analysis and bacterial resistance in biofilm studies. Dr. Noreddin has outstanding records of scientific and academic accomplishments with multiple research funding, numerous publications in highly prestigious journals and various presentations in both national and international conferences. He served as a scientific reviewer for the NIH as well as other national and international research institutions.

1. Pharmacokinetic/Pharmacodynamic modeling of anti-infective and anti-cancer therapy 2. Clinical simulation and Monte Carlo analysis 3. Bacterial resistance in biofilm studies 4. Cancer epigenetic studies

ROSEANE SANTOS, graduated at Federal University of Rio de Janeiro, Rio de Janeiro, Brazil, as Pharmacist and as Biochemical-Pharmacist, a 5-year program. Before coming to United States, she worked as Hospital Pharmacist at the Federal University of Rio de Janeiro where she had the opportunity to be involved with different aspects of clinical research and drug monitoring. Her passage by the food and drug regulatory agency of Brazil, Division of Medicines (DIMED) and as consultant for Pharmaceutical Industry strengthened her skills on regulatory affairs. She also obtained her Master Degree in Hospital Pharmacy and accepted the position as Assistant Professor of Pharmacology at private and federal universities. In 1999, she was awarded a 4-year scholarship from Brazilian Government to study abroad and came with her family to USA for PhD. Program at State University of New York at Buffalo, from where she graduated on November of 2004. Her thesis involved the knowledge of basic molecular biology techniques as cloning, immunoassays, and state-of-the-art technology such as micro-arrays, gene sequencing and real-time PCR, looking to the most different aspects of the gene expression of interferon-beta induced genes, whether playing a role in therapeutic response or as disease biomarkers. After graduation she was appointed as Assistant Professor at Pharmaceutical Sciences Department of Nova Southeastern University College of Pharmacy, Fort Lauderdale, FL. At the present, she is Assistant Professor at South University School of Pharmacy, teaching in the area of main expertise – pharmacology. Dr. Santos research laboratory is focused in the area of Coffee and Health and her major interest is on recently discovered bioactive compounds present in coffee known as chlorogenic acids and lactones and their effects on human health. Her research focus is into the characterization of a biomarker for coffee intake to provide the necessary bridge between clinical studies (epidemiologic) and basic science (molecular biology). It will make possible to correlate coffee consumption biomarker levels of specific target study population, as to potential health effects. She also works in the development of healthy byproducts from coffee, such as functional and fortified coffee and serves as consultant for coffee industry.

Major interest is on recently discovered bioactive compounds present in coffee known as chlorogenic acids and lactones and their effects on human health. Her research focus is into the characterization of a biomarker for coffee intake to provide the necessary bridge between clinical studies (epidemiologic) and basic science (molecular biology)

Stig Larsen has completed his DSc in Clinical Research Methodology at Ullevål Hospital, Oslo University Norway. He is professor at the Norwegian University of Life Science and has published more than 300 papers in international medicine and clinical research methodological journals.

Endoscopy
Gastrointestinal Diseases
Pancreatic Diseases

Dr. Jack Salmon is a professor of health policy and administration at UIC School of Public Health. Dr. Salmon has been serving in his position for the past 29 years and has become an integral part of the school’s success. An expert on corporate for-profit health care developments, he has been concerned with equity in access for vulnerable populations here and internationally. Dr. Salmon is tasked with researching corporate medicine and pharmacy, alternative medicine, urban health systems, international health, and managed care pharmacy, teaching public health policy and administration, writing and publishing books, and consulting. He attributes his success to his hard work. Looking toward the future, Dr. Salmon will continue to teach, consult and conduct research.

Health Education and Promotion, Public Health, Health Outcomes, Health Disparities, Higher Education, Public Management, Health Promotion, Healthcare Quality, Hospitals, Health Management, Health Education, Healthcare Management, Preventive Medicine, Public Health Education, Healthcare, Pharmacy, Pharmacy Education, Health Systems, Pharmaceutical Care, Health Policy, Health Care , Delivery, Public Policy Analysis, Pharmacy Practice, Clinical Pharmacy, Global Health, Health Care Administration, Health Planning, Public Health Administration, Health Care Administration, Health Equity

Roger S. Klotz obtained his degree in pharmacy at the University of Illinois College of Pharmacy in Chicago. He is an Associate Professor of Pharmacy Practice and Administration at Western University of Health Science in Pomona, CA. Western University of Health Sciences require that all students in the 9 healthcare professional colleges successful complete the Inter-professional Education curriculum. Professor Klotz has published 82 pre-reviewed papers and contributed to 9 textbooks. Professor Klotz has provided anticoagulation services to patients referred by their physician since July 2009

His research interests are in the area of pharmacy practice as it relates to clinical and economic outcomes analysis. The areas of pharmacy practice Professor Klotz is interested in focusing on are in drug and nutrition therapy management, in particular that which focuses on specific disease states. The addition of a third class of drugs and the impact of the pharmacist's management now offers a whole new area of research in managing disease.

Dr. Yousef Alomi, Head of General Administration of Pharmaceutical Care Administration, and Head of National Drug Information Center, MOH Saudi Arabia Dr. Alomi is a product of King Saud University confirmed with the degree of Bachelor of Pharmaceutical Sciences in the year 1992. After six-years of higher study, he earned his Master of Clinical Pharmacy from the same university in the 1998. He is an affiliated clinical instructor of Purdue University in the USA. He is adjunct assistant professor of King Saud University college of Pharmacy. Dr. Alomi worked as clinical pharmacist in critical care area and nutrition support. He is He is establish and implement several programs at MOH Hospitals at first time; Clinical Pharmacy Program, Medication Safety Program, Pain Management Program, Anticoagulation Program and Pharmacy Infection Control, including 30 Adult and 20 Pediatrics Clinical Pharmacy Program; he founder of Mass Gathering Pharmaceutical Care in Saudi Arabia. He became a member of advisory board of the Arab Pharmaceutical Journal in 2010. He became as Pharmacy Board Member of Saudi Commission of Health Care Specialities2010-2013. He had several research papers in clinical Pharmacy and Pharmacy practice published in ACCP and ISPOR conferences; He had several presentations in the clinical pharmacy and pharmacy practice at several conferences in and outside Saudi Arabia.

clinical pharmacy, pharmacy practice

Céline Moch has completed his PhD at the age of 30 years from University Claude Bernard of Lyon (France). He is hospital pharmacist at Hospices Civils de Lyon. She has published around 10 papers in reputed journals.

Pharmacology, Pharmacy, Clinical Pharmacology.

Edward Greg Koski is a Co-Founder, President and CEO of Alliance for Clinical Research Excellence and Safety. Internationally-recognised leader in clinical research championing a systemic approach to transforming the infrastructure and ecosystem for conducting clinical research globally; and a "culture of conscience" in human research, focusing on prevention of harm and quality improvement beyond regulatory compliance.First Director of Office for Human Research Protections (OHRP) at U.S. Department of Health and Human Services; created Program for International Activities within OHRP. Consultant to World Health Organization (WHO) to coordinate and strengthen global mechanisms for ethical conduct of human research; and engaged with World Medical Association (WMA) on revisions of the Declaration of Helsinki. Faculty: Harvard Medical School, Boston University School of Medicine, Vienna (Austria) School for Clinical Research; guest lecturer at more than 100 academic institutions globally, including Rockefeller University, UCSF, Emory, Wayne State, Beijing University, Columbia, University of Chicago, Royal College of Physicians. Keynote speaker at Conferences across Europe, Latin America, and Asia.

Lee Truax-Bellows is a Founder, President and CEO of Norwich Clinical Research Associates Ltd. (NCRA). NCRA is a full service clinical contract research organization (CRO) based in upstate NY. She has an extensive background in the pharmaceutical and medical device industries, having worked for both industry and a CRO as a Monitor, Medical Communications Associate, Project Manager, Senior Quality Auditor, GCP Trainer, and Regulatory and SOP Consultant. She has been involved in regulated research the past 25 years and currently specializes in product development, GCP auditing, and SOP development and training on regulated research and Good Clinical Practice. She is an active member of the Association of Clinical Research Professionals (ACRP), New York State MedTech Association and Society of Quality Assurance (SQA). She is ACRP certified as a Certified Clinical Research Associate (CCRA) and registered through SQA as a Registered Quality Assurance Professional in Good Clinical Practices (RQAP-GCP).

James J. Hickman is the Founding Director of the NanoScience Technology Center and a Professor of Nanoscience Technology, Chemistry, Biomolecular Science, Physics, Material Science and Electrical Engineering at the University of Central Florida. Previously, he held the position of the Hunter Endowed Chair in the Bioengineering Department at Clemson University. Dr. Hickman has a Ph.D. from the Massachusetts Institute of Technology in Chemistry, as well as BS and MS from Penn State University in Chemistry. For the past twenty-five years, he has been studying the interaction of biological species with modified surfaces, first in industry and in the latter years in academia. While in industry he established one of the first bioelectronics labs in the country that focused on cell-based sensors and their integration with electronic devices. He has extensive experience in surface modification and surface analysis for biological and neuroscience applications, and the integration of these systems with MEMS devices and components for human body-on-a-chip applications. He is also the founder and current Chief Scientist of a biotechnology company, Hesperos, that is focusing on cell-based systems for drug discovery and toxicity. He has 110 publications and 18 book chapters, in addition to 26 patents.

Noémi Császár Nagy: Work experience 1994 - 1997: Occupation or position held Post-gradual scholar (Academic Research and Education), Main activities and responsibilities- Education and research 1998 – 2006: Occupation or position held- Psychologist, Main activities and responsibilities- Psychological diagnostics and therapy 2000 - 2010: Occupation or position held- Academic Lecturer, Docent (Associate Professor), Main activities and responsibilities- Education 2006 → Occupation or position held- Leader Psychologist, Head of Psychotherapy Department, Main activities and responsibilities- Department Leading, Supervision 2010 → Occupation or position held- Psychologist, Manager, Main activities and responsibilities Leading of the Psychosomatic Ambulance Kft, Supervision Education and training: 1988 – 1994: Title of qualification awarded- Psychologist, Name and type of organization providing education and training, Eötvös Loránd Science University, Department of Psychology (University) 1994 – 1997: Title of qualification awarded- PhD Behavioral Sciences, Principal subjects / occupational skills covered Behavioral Sciences, Empirical Psychology, Differential Psychology, Hypnosis, Name and type of organization providing education and training- School of Psychological Ph.D. Studies, Eötvös Loránd Science University 1996 – 1998: Title of qualification awarded Hypnotherapist (Trainer-Hypnotherapist), Name and type of organization providing education and training, Hungarian Association of Hypnosis 2002 – 2004: Title of qualification awarded- Psychotherapist, Name and type of organization providing education and training Psychosomatic and Psycho-therapeutic Department of National Rehabilitation Institute of Tündérhegy 2006–2009: Title of qualification awarded, Expert Witness in Adult Clinical Psychology 2007 – 2011: Title of qualification awarded, TANDEM Hypnotherapist, Principal subjects / occupational skills covered Training in Trans-natal (TANDEM) Hypnosis, Name and type of organization providing education and training Hungarian Association of Hypnosis

Adnan Qureshi is a Professor of Neurology, Neurosurgery and Radiology and Program Director of the Endovascular Surgical Neuroradiology Program at the University of Minnesota. His practice is primarily affiliated with the University of Minnesota Medical Center, Fairview where he is Director of Interventional and Endovascular Procedures. He currently serves as President of the International Society of Interventional Neurology as well as Executive Director of the Minnesota Stroke Initiative. Adnan Qureshi is also the Associate Head of the Department of Neurology at the University of Minnesota.

Adnan Qureshi's research interests include the acute treatment of hypertension in stroke, the endovascular treatment of ischemic stroke, and the treatment of intracerebral hemorrhage.

Dr. Qureshi is the Medical Director of the Health Sciences Division at PSI INTERNATIONAL Inc. Her responsibilities include directing all client support activities and keeping abreast of issues and trends related to pharmacovigilance worldwide. She is also responsible for supporting the development of corporate strategies for technical investments, client support and strategic alliances. She is a physician and is also pursuing an advanced degree in Regulatory Science at the prestigious Johns Hopkins University Dr. Qureshi’s assignment to both federal and commercial projects in support of drug safety have made her proficient in performing drug-related risk assessment and risk intervention support. She has developed outstanding capabilities in her positions as a medical director, manager, risk management specialist, and trainer at PSI INTERNATIONAL, Inc. She also is an expert in various dictionaries, including the Medical Dictionary for Regulatory Activities (MedDRA), the World Health Organization Drug Dictionary (WHO-DD) and International Classification of Disease (ICD 9/10). She has supported Pharmacovigilance activities at a senior level with over 20 pharmaceutical clients, the World Health Organization- Uppsala Monitoring Center as well as the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Adverse Events Reporting Programs Support; National Institutes of Health (NIH); and at U.S. Army Medical Materiel Development Activity (USAMDA) providing training to data management staff; She frequently attends conferences at the Institute of Medicine and the National Science Foundation on subjects such as Sentinel and various Electronic Health Information related initiatives in government and industry.

Galya Naydenova Atanasova completed her Ph.D. training in Cardiology from Department of Cardiology, Pulmonology and Endocrinology at Pleven Medical University, Bulgaria. She is a General Practitioner and Cardiologist in Trainee at Pleven Medical University, Bulgaria. She specialized in General Medicine from Pleven Medical University, Bulgaria during 1993. She has attended to many International Events and presented her research work. She did many researches on metabolic syndrome and myocardial infarction of heart.

Ayman M. Noreddin received his Ph.D. in pharmaceutical Sciences from the University of the Pacific, California and received research training as a visiting scholar at the Department of Medicine, Stanford University. He had postdoctoral fellowship (Pharmacokinetics and Pharmacodynamics of Antimicrobials), Department of Medical Microbiology, University of Manitoba followed by an American College of Clinical Pharmacy postdoctoral fellowship (Infectious Diseases). Noreddin’s research interest includes Pharmacoklinetic/Pharmacodynamic modeling of anti-infective and anti-cancer therapy, clinical simulation and Monte Carlo analysis and bacterial resistance in biofilm studies. Noreddin has outstanding records of scientific and academic accomplishments with multiple research funding, numerous publications in highly prestigious journals and various presentations in both national and international conferences. He served as a scientific reviewer for the NIH as well as other national and international research institutions

1. Pharmacokinetic/Pharmacodynamic modeling of anti-infective and anti-cancer therapy 2. Clinical simulation and Monte Carlo analysis 3. Bacterial resistance in biofilm studies 4. Cancer epigenetic studies 5. Minority health care studies

Arun Aggarwal received his Ph.D. in 2004 from the University of Sydney. He is currently working as a Visiting Neurologist at Concord hospital, a Chronic Pain Specialist at the RPAH Pain Clinic and a Rehabilitation Specialist at Balmain hospital. He is a member of the Royal Australasian College of Physicians, Australasian Faculty of Rehabilitation Medicine and the Australasian Faculty of Pain Medicine. His research has included Electrophysiological Studies in Familial Amyotrophic Lateral Sclerosis with his primary paper, "Detection of pre-clinical motor neuron loss in SOD1 mutation carriers using motor unit number estimation" being widely cited in the international literature. He was awarded the Australian Association of Neurologists Young Investigator Award for his presentation of this paper in 1999 and was nominated for the Delsys Prize in 2012. He has written 3 book chapters on this subject and has also published widely on a number of different topics. He currently has a number of research projects in the areas of Chronic Pain and Parkinson's Disease. He is on the Editorial board of the Journal of Clinical Trials. He is the current Chairman of Australian & NZ Association of Neurologists Neuro-Rehabilitation Sub-Committee and on the Medical Advisory Board of Trigeminal Neuralgia Association (Australia).

Dr. Rucha Majmundar Mehta is practicing as an independent GCP Auditor (Free Lancer) based in India and conducting Audits for Multi National pharmaceutical Companies across Asia Pacific and European Region including UK. She has developed a Clinical Research Site in a privately owned small sized hospital and heading the site till date. She was providing QA consultation and training to various study sites and QA department of Pharmaceutical Companies. She conducts GCP Sessions during Investigators Meetings globally.