Dr James Whalen is Board-Certified in Adult Psychiatry and is also a Certified Principal Investigator (CPI). Dr. Whalen completed his medical and psychiatric training at the Brown University School of Medicine and his Fellowship training at Harvard University in Forensic Psychiatry. Since 1993, he has continued to provide psychiatric care to patients in Rhode Island and is also licensed to practice medicine in Massachusetts and Connecticut. He has been actively involved in Clinical Research since 1994. In addition to research work,
Dr. Whalen directed coursework in Forensic Psychiatry and provided supervision to psychiatry residents at the Brown University School of Medicine. He is a consultant in Forensic Psychiatry to the Office of the Chief Medical Examiner in Providence, Rhode Island. Dr. Whalen is a Fellow of the American Psychiatric Association, a member of the Rhode Island Psychiatric Society, and an international member of the Royal College of Psychiatrists.
Admasu T. Mamuye (MD, MSc) is a consultant physician and assistant professor of medicine and infectious diseases at the College of Health Sciences, Addis Ababa University where he is also served as head of the clinical epidemiology unit (CEU). He also works at the Armauer Hansen Research Institute (AHRI) in coordinating the nationwide Clinical Trial activities in Ethiopia. Additionally, he has served as an adjunct lecturer and as a research coordinator at Karolinska Institutet, Sweden.
Admasu has been involved in many clinical research projects in the academic and pharmaceutical industry environments including 14 months as a WHO-TDR clinical research and development fellow at Novartis Pharmaceuticals in Basel, Switzerland. During his TDR fellowship, he served as a clinical sciences associate director of drug development projects for multidrug resistant TB (MDRTB) and Malaria. Admasu is passionate about building sustainable and resilient health research capacity in Africa and is actively involved in several capacity building projects including a North-South multi-institutional consortium named Collaboration for Evidence Based Healthcare and Public Health in Africa (CEBHA+). His experience over the past several years as an online learner, content developer and trainer has inspired him to focus on unleashing the full potential of information technology and the internet for developing core competencies of clinical research among healthcare professionals in low and middle income countries particularly in Africa.
In addition to his clinical credentials, Admasu holds a Master of Science in Pharmaceutical Medicine from Hibernia College Dublin, Ireland. His research interests are development of infectious diseases therapeutics with a special affinity to host directed therapies including vaccines.
Dr Gabriela Zepeda Orozco has over 16 years of clinical practice supporting families and children to continue a healthy physical and emotional development. Gabriela was a Sub-investigator for phase III studies with vaccines, antibiotics and antimycotic drugs. She supported the implementation of the GCP quality system in the CPO of Novartis Mexico. She is a GCP certified trainer who has attended over 18 GCP, PV, POP, Compliance and GMP audits. She has supported the implementation of local phase II-IV studies from different Medical Affairs roles.
In addition, Gabriela has over 9 year’s experience working in the pharmaceutical industry as Medical Therapeutic Area Head of the Cardiovascular and metabolism group, Field Medical Excellence Manager/MSL Manager, Medical Information Manager, CPO Development Quality Assurance Manager, Medical GXP Training Manager, as well as Medical Scientific Liaison (MSL) in Diabetes and Hypertension.
Gabriela was a Sr. External Lecturer of Karolinska Institutet and the National Institute of Pediatrics. She has been an invited lecturer to universities, hospitals and congresses on diverse pediatric and infectious diseases topics.
Professor Bernhards R. Ogutu is a Kenyan paediatrician/Clinical pharmarcologist, currently Chief Research Officer at CCR, KEMRI and lead collaborator on the KEMRI/USAMRD-K research program. He has led several clinical trials on malaria drug and vaccine development. Since 2006 Dr. Ogutu has been the Senior Clinical Trialist with the INDEPTH-Network coordinating the clinical trials capacity building across 10 African countries through the INDEPTH program Malaria Clinical Trials Alliance. This created the platform that is conducting the largest phase III RTSs malaria vaccine clinical trial. The capacity building was in partnership with MMV, MVI and several Northern institutions with funding from the Gates Foundation. Dr. Ogutu co-founded the Malaria Diagnostic Centre in response to problems in malaria diagnosis as an endpoint determinant in clinical trials for malaria product development.
He has seen the expansion of MDC activities to support research institutions across Africa and beyond and lately National Malaria Control Programs in several Africa countries. Dr Ogutu led the MDC team that participated in WHO malaria diagnosis guidelines and bench aids. Dr. Ogutu co-founded Centre for Research in Therapeutic Sciences (CREATES), a consortium involving 4 institutions (KEMRI, Strathmore University, African Centre for Clinical Trials and CSIR of South Africa) to champion product development in Africa with malaria as the flagship program. He is the scientific team leader of the consortium and adjunct Prof. of Therapeutics at Strathmore University. Dr. Ogutu is a member of several National and international scientific technical committees. He received his MBChB, MMed and PhD from the University of Nairobi.
Dr Pol Vandebroucke is Vice President, Medical Strategy, Pfizer Inc., in charge of Global Patient Affairs, the Centers of Excellence for Pediatrics, Diversity in Clinical Trials and Healthy Aging, and the External Bioethics Advisory Panel.
Member of the Advisory Board of the Steve Biko Centre for Bioethics, University of the Witwatersrand, Johannesburg, South Africa, and of the Keck Graduate Institute, Claremont, CA; Fellow of the Faculty of Pharmaceutical Medicine of the Royal Colleges of Medicine of the United Kingdom and member of its Fellowship and Awards Committee; Module Coordinator Medical Affairs in Medicines Development, IFAPP Academy and King’s College London.
Dr. Vandenbroucke’ s career has been dedicated to Clinical Development and Medical Affairs in the U.S., Europe, Asia, Latin America and Africa. Before his current position, he was responsible for Medical Affairs of Pfizer’s Essential Health portfolio in North America and he previously also led Clinical Development of all Pfizer compounds in Asia, Central and Eastern Europe, Latin America, and Africa-Middle East and of Pfizer’s Established Products globally. He was also responsible for developing compounds specifically for diseases of the developing world, such as malaria and river blindness.
Prior appointments include Vice President, Medical and Regulatory Affairs, Canada/Latin America/Africa-Middle East, Senior Vice President, Medical Division Pfizer Japan, based in Tokyo, Director of Medical Operations, Asia and Australia/NZ for Pfizer, based in Hong Kong, and Medical Director, Lipitor based in New York, responsible for the international clinical development program of Lipitor.
Before joining Pfizer, Dr. Vandenbroucke was Medical Director, Sterling-Winthrop International, Cardiovascular and CNS Disease Manager at Novartis Mexico, and Professor at the Instituto Tecnológico Autónomo de México (ITAM).
He holds a Medical Degree from the Catholic University of Louvain (Belgium), an MBA degree from the Instituto Tecnológico Autónomo de México (ITAM), and an MSc (First Honors) from Hibernia College (Ireland). He is a member of the Pfizer Latino PCC Leadership Team. He is fluent in Dutch, Spanish, English, French, German and basic Japanese.
Professor David Sheehan is Distinguished University Health Professor Emeritus at the University of South Florida College of Medicine. He was Professor of Psychiatry, Director of Psychiatric Research and Director of the Depression and Anxiety Disorders Research Institute at the University of South Florida College of Medicine and Professor of Psychology at the University of South Florida College of Arts and Sciences.
Professor Sheehan completed his residency training in psychiatry at Massachusetts General Hospital and Harvard Medical School. At Harvard Medical School, where he was Assistant Professor of Psychiatry, on the full-time faculty for 12 1/2 years. He was the Director of Anxiety Research and Director of the Psychosomatic Medicine Clinic at Massachusetts General Hospital. He received his M.B.A. (summa cum laude) from the University of South Florida. He served as Director of Psychiatric Research for the Department of Psychiatry and Behavioral Medicine at the University of South Florida College of Medicine from 1985-2007. He has written over 550 abstracts and 280 publications including a bestseller The Anxiety Disease. Cumulatively, his publications have been cited over 13,000 times in peer-reviewed journals. He has been awarded over $20 million for 130 research grants. He was awarded a patent by the United States Patent Office in 1996, and has given expert testimony to the United States Congress.
Dr. Sheehan has been a consultant to the World Health Organization, the World Federation of Societies of Biological Psychiatry, the International Academy for Biomedical and Drug Research, the US Food and Drug Administration, and was a research grant reviewer for the National Institute for Mental Health (NIMH). He was a consultant to the American Psychiatric Association (APA) Working Group to Revise DSMIII Anxiety Disorders, the APA Task Force on Benzodiazepine Dependency and the APA Task Force on Treatments of Psychiatric Disorders. He has also served on the national and international advisory boards of numerous pharmaceutical companies and of non-profit foundations including the National Anxiety Foundation, the National Depressive and Manic-Depressive Association, the Council on Anxiety Disorders, the Anxiety Disorder Association of America, and the Council on Anxiety Disorders and The Foundation for Improving Data Quality.
He has been invited to give lectures in 68 countries throughout the world on anxiety and mood disorders, suicidality, measurement based care, psychopharmacology and biological psychiatry. He was elected as a member of the American College of Psychiatrists and is a Distinguished Life Fellow of the American Psychiatric Association and is a Charter Member of the National Academy of Inventors. Among other honors, he has been included in “The Best Doctors in America” published by Woodward/White Inc. every year from 1992 until his retirement in 2010.
Sinéad Whitty is the Director of Digital Learning at FCD. Previously she was the Pedagogy Coordinator at the Department of Medicine in Karolinska Institutet where she was responsible for the design, development and delivery of a suite of online, post-graduate capacity development programs in Pharmacometrics, Bioequivalence, Meta-analysis and Clinical Trial Management.
With a background in Leadership and Modern Languages, Sinéad has twenty years’ experience teaching face to face, blended and online. She is an advocate for technology that supports good teaching and learning practices. Sinéad’s programs are designed to align teaching, learning and the practical skills required to develop personal capacity. The programs are student-centered, outcomes-based and rooted in constructivism. Her research interests include universal design, learner support and virtual teamwork.
Dr Dawit Ejigu is an associate professor of pharmacology at St Paul’s Hospital Millennium Medical College, Addis Ababa. He also works in various clinical trials of psychiatry including trials of repurposed drugs and service trials. He also gives courses on GCP and GCLP in collaboration with the Armauer Hansen Institute (AHRI), Ethiopia. Dr Dawit has experience working on clinical research/ clinical trials for the last 14 years in the areas of tuberculosis, HIV, malaria and psychiatry studies. During these years he has developed expertise through hands on experience and training in the areas of project management, clinical trial management, monitoring, quality assurance and data management. Dr Ejigu is also a reader in biostatistics.
Dr Ejigu was a fellow at GSK-biologicals working on tuberculosis vaccine from 2007 -2008. He has also worked in various international positions such as project manager at European Vaccine Initiatives (EVI), Clinical Trials Coordinator at African Malaria Network Trust and quality assurance Manager at the Statens Serum Institut (SSI). He has authored co-authored 10 publications.
Dr Brenda Okech works as a Lecturer at Makerere University in the Biochemistry Department in the College of Natural Sciences. She mainly lectures in Immunology and Clinical trial related courses. She has been involved in examining Masters student’s dissertation for College of Veterinary medicine of Makerere University and also for Public Health for Mount Kenya University in Kigali.
Dr Okech has experience as a scientist as well as Manager of Research with a passion for mentoring younger Scientists. Both at Med Biotech and at AMANET, she had the opportunity to mentor upcoming Scientists. She is also advisor of students carrying out their dissertation work and special projects. She obtained mentoring skills training at the British Council through being part of a mentoring program. She previously worked for EVI as Vaccine Manager Assistant on a consultancy basis. She obtained her PhD from the London School of Tropical Medicine and Hygiene in Malaria Immunology, and has previously worked at Med Biotech Laboratories, in Uganda as a Senior Scientist, mainly assessing natural human responses to malaria vaccine candidate antigens. Brenda was trained by WHO/TDR for one year on malaria clinical trial management training at GlaxoSmithKline in Belgium. She also received Project Management training at EVI, and worked with malaria vaccine clinical trials for African Malaria Network Trust in Tanzania as Project Manager, and for Statens Serum Institute, Copenhagen while based in Uganda. She has Clinical trial monitoring experience and has worked as a monitor for GSK, WHO/TDR and AMANET.
She is a trainer on Project Management, SOP development and has been a trainer on Good Clinical Practice and Good Clinical Laboratory Practice.
Dr Soumya Hazra is Clinical Research Manager at PATH’s Center for Vaccine Innovation and Access for last five years, based in New Delhi, India. Prior to PATH, he worked as a Senior Clinical Research Associate-2 with Quintiles India for close to 5 years.
Overall he is having 12 years of experience in Clinical Research from Phase I to Phase IV in different therapeutic areas specially Vaccine, Psychiatry, Respiratory system, Neurology, Cardiology, Oral health care and Homoeopathy within PATH, Quintiles, Glaxo Smith Kline Consumer Health care, etc.
He is an experienced monitor, who performed numerous monitoring visits from start-up to project close-out in many multi-national studies and also successfully handled multiple Audits & Inspections.
He is a graduate from Indian Systems of Medicine and Homoeopathy (BHMS) and an MD with two years private practice experience.
Currently his responsibilities include developing and implementing plans and procedures for efficient clinical research operations and communications among PATH, Clinical Research Sites, CRO, laboratory and other partners.
Professor Florence Oloo received her Bachelor of Science degree in Chemistry from the University of Nairobi, followed by a Master’s of Science degree in Chemistry from the University of Ibadan in Nigeria her and doctorate in Chemistry from Jomo Kenyatta University of Agriculture and Technology. Prof Oloo’s principal area of academic study is Electrochemistry. Prof Oloo also pursues academic interests in professional ethics and rural and women’s issues. She spent her sabbatical year in 2011, at the Council for Scientific and Industry Research (CSIR), South Africa, within the drug delivery group with a special interest in Encapsulation of Malaria drugs while undertaking lecturing as an Associate Professor in Chemistry, at the Technical University of Kenya, (TUK)
Prof Oloo is the Platform Coordinator of the Centre for Research in Therapeutic Sciences and the Director of Global and Community Engagement at the Technical University of Kenya (TUK)
Tom Kauki is a Registered Pharmacist with the Pharmacy and Poisons Board of Kenya.
He has a Bachelor of Pharmacy degree from the University of Nairobi and a M.Sc. in Pharmacy Administration and Policy Regulation, University of the Western Cape, South Africa. Tom has over 14 years experience in the Kenyan pharmaceutical sector, firstly, as a Hospital Pharmacist in several public hospitals in Kenya and now as a Pharmaceutical Inspector and Head of the Pharmacy and Poisons Board Central Region office where he is engaged in dossier evaluation, pharmacovigilance, Good Distribution Practices, clinical trials and administration. Tom participated in the 2016 Karolinska Institutet online Bioequivalence course by tutoring lessons on the Regulatory Environment, underlying the application of bioequivalence in the generic drug approval process. Tom has additional interests in the application of ICT tools, regulatory harmonization in the East Africa Community and Healthcare legislation.
Gavin Chait is an economist, engineer, data scientist, sometime-traveller, and author. He spent more than a decade in economic and business development initiatives in South Africa before moving to the UK. He was the commercial lead of open data projects at the Open Knowledge Foundation, and led the implementation of Edo State, Nigeria's first open data portal (a World Bank project), the Pakistan Education Data Portal for HTSPE (a DFID project), Tanzania’s open data project (with the World Bank), open access research data for public health with the WHO, and numerous other open data projects around the world. He leads Whythawk for consulting, and developed Pikhaya.com, a business intelligence web service built from open data. https://gavinchait.com/
Dr Eva Maria Hodel obtained her diploma in pharmaceutical sciences and the federal diploma for pharmacists from the University of Basel, Switzerland. She received her PhD in Epidemiology at the Swiss Tropical and Public Health Institute at the University of Basel. She was working with Novartis as Medical Scientific Liaison Manager in the therapeutic area of arthritis and bone before moving back into academia. Her research focus is drug safety in vulnerable subpopulations with poverty related diseases. She has been involved in designing, running and analysing several pharmacokinetic studies in low- and middle income countries.
Dr Tim Grant is a graduate of the University of Wisconsin-Madison with a PhD in Educational Psychology and a MSc in Biostatistics. He has over 15 years experience designing and analysing clinical trials most of which is for the pharmaceutical industry. In addition to experience with randomized controlled trials, Tim has also worked on various health research studies which includes, survival analysis, meta-analysis, and epidemiological studies. He regularly teaches as an external lecturer at Trinity College Dublin and has contributed to on-line course development to Hibernia College and Karolinska Institute. He is currently working in the area of health economics providing statistical support to decision making process.
Jeremy Whitty is the Program Director at FCD. Previously he was the Director of Capacity Development at the Department of Clinical Epidemiology at Karolinska Institutet. An expert in capacity development, Jeremy currently leads a team delivering capacity building programs in clinical research operations for study coordinators, clinical trial management, research data management and analysis and model based drug development.
With his colleagues, Jeremy has developed effective, evidence based methods to build scientific capacity in low and middle income countries. He is the Visiting Professor of Quality and Operations in the Life Sciences at IE Business School, Madrid. Previously Jeremy was co-director of the M.Sc. in Regulatory Sciences at the University of the Western Cape, South Africa and Director, School of Health Sciences at Hibernia College, Dublin, Ireland.
Goonaseelan (Colin) Pillai PhD, is the founder of CP+ Associates, a social venture that drives programs to develop scientific capability in low and middle-income countries. A clinical pharmacologist who trained in Durban, South Africa, Colin previously worked at the corporate headquarters of Novartis and Roche in Switzerland. In Pharma, he played leadership roles in bringing internal and external acceptance of applying mathematical models to decision making in drug development. His most recent Pharma role involved establishing programs that allowed sharing scientific expertise and infrastructure with researchers and institutions in LMIC. He has a specialist interest in the application of non-linear mixed effects models to pharmacokinetic-pharmacodynamic data across a wide range of therapeutic areas.
Colin has held teaching, research and management positions at the Universities of Durban-Westville and Witwatersrand. He acquired his clinical and research experience in hospital and community pharmacy and as a consultant with the South African Medical Research Council’s Tuberculosis Research program, where he ran a unit conducting Phase 1 clinical trials. Colin continues to maintain active academic links with numerous institutions in Africa including via formal Honorary Professorships and Board Member status.
Russ Orrico, is a Clinician in Essential Health Clinical Affairs, Pfizer, Inc. where he leads several Post-Marketing studies in the gastrointestinal therapeutic area. His responsibilities include study design, data review, and reporting, in addition to providing clinical support for regulatory and operations activities.
Prior to this current role, Russ was a Lead Clinical Scientist of Phase 2-3 studies in inflammatory diseases and infectious diseases including nosocomial infections, malaria, and onchocerciasis.
Prior to joining Pfizer, Russ was a Clinical Research Coordinator at the Herbert Irving Comprehensive Cancer Center, New York Presbyterian Medical Center. He then managed clinical oncology studies at Johnson ＆ Johnson Pharmaceutical Research ＆Development.
He holds a Bachelor of Science from Muhlenberg College, United States, and a Master of Science in Pharmaceutical Medicine from Hibernia College, Ireland.