16^th Global Pharmacovigilance & Clinical Trials Summit

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).

Michael is Vice President of Global Compliance and Risk Management at Clinical Supplies Management, Inc. Michael is responsible for the oversight of CSM's global compliance, risk management, process excellence and quality programs. Michael has over 28 years of Compliance experience in the pharmaceutical industry. Prior to joining CSM, Michael held various R&D, Manufacturing and Global Compliance positions during his 26-years at Merck & Co. Inc.

Dr. Thomas E. Serena MD FACS, Founder and Medical Director of SerenaGroupâ„¢, a family of wound, hyperbaric and research companies. Dr. Serena completed his residency in Surgery at the Hershey Medical Center. To date he has opened and operates wound care centers across the United Sates and globally. He has been the lead or Principal investigator in over 100 clinical trials and is recognized internationally as an expert in the field of wound healing: He has more than 100 published papers and has given more than 1000 invited lectures throughout the world. He has been a member of the Board of Directors of the Wound Healing Society and served two terms on the board of the Association for the Advancement of Wound Care (AAWC) and is now the President-Elect. He has also been Vice-President of the American College of Hyperbaric Medicine and President of the American Professional Wound Care Association.

Jody M. Ehrhardt is a certified clinical research coordinator with over 20 years of experience in the clinical research industry. Throughout her career Ms. Ehrhardt has worked in phase I-IV human trials as a clinical research coordinator, data coordinator, project manager, and Director of Research Services. She also consults for a major animal pharmaceutical company as a regulatory and development specialist. In 2012 Ms. Ehrhardt used the experience she gained from working in numerous roles, therapies, and industries and founded her own clinical research facility.

Joe Martinez serves as the CEO of Center Point Clinical Services. He brings over 30 years of successful leadership experience in the pharmaceutical, biotech and Medicaid industries. Joe instituted novel industry programs utilizing RWE (real world evidence) and health outcomes information to communicate product value information to health care decision-makers. His research abstracts and poster presentations have been accepted by national and international associations including ADA, ASCP, AMCP, AGS, AADE and AACE.

Prior to founding One Source Consulting and Management OSCM in 2006, Mr. Hakim Mohamed held key positions with several Research Sites as Administrator and Chief Financial Officer. Prior to this, he held senior positions with Bayview Behavioral Campus, San Clemente Hospital and California Pacific Medical Center. He is currently the Co-Founder and CEO of Clinical Research Sites; HEALTH RESEARCH INNOVATION, BIOSOLUTIONS CLINICAL RESEARCH CENTER, TRIWEST RESEARCH ASSOCIATES, PRECISION RESEARCH INSTITUTE and NAVARRO RESEARCH GROUP Mr. Hakim earned a bachelor Degrees in Finance from San Diego State University, a Master Degree in Business Administration from Almeda College & University, and currently is working on his Doctorate in Business Administration. Mr. Hakim also earned Graduate Certificates in several advanced courses including; Certified Medical Compliance Officer from San Diego County Medical Association. Certificate in Clinical Trial Administration from University California San Diego, Certificate in Site Operations and SOPs from University of Rochester School of Medicine and How to Manage Site Financials Certificate from Clinical Research Site Training Institute. Mr. Hakim specializes in site start up, business development, staff training, budget and contracts negotiations, regulatory submission and financial consulting.

Tamera Norton Smith has twenty-six years of experience investigating and auditing severe GCP noncompliance. Tamera began her career in GCP and GMP environments in 1990 with the USFDA's Atlanta and Buffalo Districts. Her passion for FDA's mission led her to found her own business in 1999 to audit independently and teach responsible research conduct and ethical research practices. She founded Norton Audits in 1999. Norton was founded on the sole principle that research participants and patients should be safe and protected while vital and effective products are investigated with complete and accurate results and outcomes. Norton Audits provides independent facts for transparent decisions for GCPs.

Dr. Stephen Hsu earned a bachelor’s degree in biochemistry from Wuhan University, a Master of Arts degree in molecular biology from Montclair State University and a Ph.D. in cell biology and anatomy from the University of Cincinnati, College of Medicine. He completed a postdoctoral fellowship at Memorial Sloan-Kettering Cancer Center in New York City. Dr. Hsu joined the Augusta University, formerly the Medical College of Georgia, in 1999 and is currently a tenured professor. He is a world-renowned expert in green tea polyphenol research and inventor of green tea technology-derived products and medications, which treat dry mouth, dandruff, hair loss, cold sores, and viral infections with natural ingredients. Dr. Hsu received the Ruth L. Kirstein Research Service Award from the National Cancer Institute. He was awarded a number of patents on novel technologies targeting autoimmune diseases, herpes simplex virus, virus-induced infections, and salivary dysfunction (xerostomia or dry mouth). Dr. Hsu has been selected as a TED Talk speaker in 2014. He received the International Association for Dental Research (IADR)/GSK Innovation in Oral Care Award in 2011. In 2015, he received Georgia Bio Innovation Award for his unique inventions. Also in 2015, Dr. Hsu received Oral Discoveries & Inventions Award from Georgia Dental Association. Dr. Hsu is also a recipient of two overseas talent award (Wuhan 3551, and Hubei Chu-Tian Scholar) from China.

After obtaining his medical degree, Ayad continued his speciality training in the UK in Immunology and Oncology. He obtained, the PhD, MSC, MRCPath and FRCPath. His areas of interest included Immunotherapy and BMT. Over the past 24 years he worked in the Biopharmaceutical industry, across the US and Europe, during which he built and lead Medical Affairs and Clinical Development in companies, such as Serono, Berlex, Biogen and Astellas. Ayad also pioneered cancer immunotherapy by treating the first ever patient with a therapeutic antibody for cancer. He is regarded as a Medical Leader by the World leading experts in MS

His areas of interest included Immunotherapy and BMT.

Adam Chasse, MHA is the President of OnPoint CRO, a boutique CRO that provides services to small pharma/biotech/device firms. At OnPoint, Mr. Chasse applies his two decades of experience in the clinical research industry to help OnPoint’s clients conduct their studies quickly and with high quality. From 2011-2015 Mr. Chasse was President of RxTrials, a leading site network and consulting firm. Prior to RxTrials, he served in various roles over 16 years at Quintiles, including Global Head of the Prime Site program, a strategic initiative that developed and implemented research infrastructure at large health systems throughout the world. Mr. Chasse holds a Master of Healthcare Administration degree from the Gillings School of Global Public Health at the University of North Carolina-Chapel Hill, and is a member of the Delta Omega public health honorary society.

Ramona Kanters is a thirty-nine year old (mother of two) who was diagnosed with Systematic Sclerosis at the age of 32. (Systematic Sclerosis is a rare autoimmune decease that occurs in one out of 10.000 people. It involves the thickening and scarring of the skin, muscles, joints and organs.) After a year of extensive chemotherapy and a stem cell transplantation (that saved her life) she decided to devote herself to the support and accompaniment of fellow patients and their partners. For this purpose she established a foundation to enhance the awareness concerning this grave but rare disease. She provides lectures, workshops and counselling sessions at home and abroad, and has recently published a care report in which the system of care surrounding Systemic Sclerosis is analysed, which has been internationally published. During her activities Ramona has found that it is of crucial importance to involve patient in their own care. She advocates that when patients, physicians and pharmaceutical companies will start to work as a unity, care can be greatly optimized. Ramona: ‘Give patients a voice, let doctors and those working in pharmaceutics see the person behind the patient and let the patient see the real person behind the physician. This will make an enormous difference in their wellbeing’. In 2015 Ramona started her own company which she called OPEN for its focus on open communication: OPEN, to listen to one another; OPEN, to communicate; OPEN to participate and OPEN to learn from one another. One of her primary activities is finding patient panels for patient participation programmes in all different areas. She represents a great range of relatively unknown and known illnesses. OPEN is currently working with several pharmaceutical companies and market research bureaus who have already recognized the great value of patient participation and she hopes to continue doing so in future.

Saul Alvarez Gomez is the chief executive officer (CEO) and founder of Hippocrates Clinical Research (HCR), a late phase research center located in Hialeah, Florida, USA. Using his keen business skills and extensive knowledge in the biopharmaceutical industry, Mr. Alvarez founded HCR in 2015. Since its founding, HCR has succeeded under Mr. Alvarez’s exceptional leadership and strategic vision. Today, HCR possesses over 7,000 diverse patients and are all attended by HCR’s dedicated and trained staff. Mr. Alvarez has over ten years of experience in the clinical research industry. He is a certified clinical research associate (CCRA), certified clinical research coordinator (CCRC), and a license practical nurse (LPN). He is a member of Clinical Research Society, an international society for clinical research sites, and the U.S. National Institute of Health. Mr. Alvarez has also written multiple industry-related works, including “Communication: The Key to Becoming an Exceptional Clinical Research Professional,” an article published by Clinical Research Society. Before HCR’s establishment, Mr. Alvarez held several administrative positions. Most recently, Mr. Alvarez served as chief operating officer (COO) for Elite Research, a Phase I unit in Miami, Florida with 150 beds. There, he directed more than 35 Phase I trials. Before that, he worked as site director for Community Medical Research, a multi-location research facility that specializes in advanced outpatient trials for Phase II, III, & IV trials. He also performed numerous trials as site director in Future Care Solutions, a Phase I-IV research unit.

Dr. Bazarbashi received his MB,BS degree from King Saud University School of Medicine in Riyadh, Saudi Arabia in 1982. He completed his internal medicine residency and hematology/Medical oncology fellowship at Wayne State University School of Medicine in Detroit, Michigan on 1991. He obtained his American board diploma in internal medicine in 1988 and in medical oncology in 1991 and Hematology in 1992. Dr Bazarbashi, then was appointed as consultant in medical oncology at King Faisal Specialist hospital and Research center in 1991 till present. In 1998, He was appointed as head, Section of medical oncology at KFSH&RC till present. And in 2012, he was appointed as associate professor in Alfaisal University till present. Dr Bazarbashi served as Chairman for the Saudi Cancer Registry from 2001 till 2013. He was a founding member of the Saudi Oncology society and the deputy chairman since 2009 to date. He also served as medical director for home-health care at KFSH&RC in 2001 till 2012. Dr Bazarbashi established the GI and GU multi-disciplinary guideline groups for the Saudi Oncology Society in 2011. He has published extensively in GI and GU cancer as well as clinical guidelines, with more than 125 abstract and more than 70 publications in peer reviewed journals. He is on the editorial board of local journals and a reviewer for many local journals. He is also on the steering committee of international trials and member of NCCN-MENA colon cancer committee.

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.