Dr. Andy Stergachis

Dr. Andy Stergachis, PhD, BPharm, is Professor of Pharmacy and Global Health and Adjunct Professor of Epidemiology and Health Services, Director of the Global Medicines Program, and Associate Dean for Research, Graduate Studies and New Initiatives, School of Pharmacy, University of Washington (UW), where he teaches courses in global pharmacovigilance. He was founding director for the UW Pharmaceutical Outcomes Research and Policy Program (now in its 20th year and developed into the CHOICE Institute). He directs the WHO Collaborating Center on Mass Gatherings Public Health at UW and collaborates with the UW Institute for Health Metrics and Evaluation on mapping and monitoring the global burden of antimicrobial resistance. He is an author of 154 peer-reviewed publications in areas such as pharmacovigilance, pharmacoepidemiology, and clinical epidemiology and serves as Editor-in-Chief of the Journal of the American Pharmacists Association. His global drug safety research and training activities have been supported, in part, by the Bill and Melinda Gates Foundation, USAID, the Barr Foundation, the Partnership for Quality Medical Donations, and USP. He directed a pharmacovigilance pregnancy registry study on the safety of first trimester antimalarials conducted in sub-Saharan Africa countries and has developed novel approaches for HIV pharmacovigilance and strengthening pharmacy services.

His work supported by USAID over a 10-year period involved strengthening pharmacovigilance systems in multiple low- and middle-income countries through the Systems for Improved Access to Pharmaceuticals and Services Program (SIAPS) and its predecessor, Strengthening Pharmaceutical Systems Program (SPS). He is Chair of the Expert Panel to Review Surveillance and Screening Technologies for the Quality Assurance of Medicines for USP, Chair of the Low-dose Primaquine Safety Study Group for the Worldwide Antimalarial Resistance Network (WWARN), and Member of the Access and Product Management Advisory Committee for Medicines for Malaria Venture (MMV). He was senior advisor to the BMGF Safety Surveillance Working Group, Chair of the Malaria in Pregnancy Consortium Safety Working Group, and Member of the Drug Safety and Risk Management Advisory Committee, US FDA. Dr. Stergachis is an elected member of the National Academy of Medicine and is a Fellow of the American Pharmacists Association and of the International Society for Pharmacoepidemiology. He has conducted pharmacovigilance trainings and related pharmaceutical systems strengthening activities in numerous low- and middle-income countries, e.g., Ethiopia, Eritrea, Uganda, Kenya, Tanzania, Rwanda, Namibia, Zimbabwe, China, India, Kenya, Bangladesh, Vietnam, Philippines, and Ukraine.

RESEARCH INTERESTS

Dr. Stergachis' research focus is pharmacoepidemiology, global drugs and vaccine safety, pharmaceutical outcomes research, and public health systems research. He directed a pharmacovigilance pregnancy registry study on the safety of first trimester antimalarials conducted in three sub-Saharan African countries. He is one of very few pharmacists ever elected to the National Academy of Medicine. His research has been supported, in part, by the Bill and Melinda Gates Foundation, USAID, the Barr Foundation, the Partnership for Quality Medical Donations, and USP.

He is a Fellow of the International Society for Pharmacoepidemiology, Chair of the Expert Panel to Review Surveillance and Screening Technologies for the Quality Assurance of Medicines for United States Pharmacopeia, Chair of the Low-dose Primaquine Safety Study Group for the WorldWide Antimalarial Resistance Network and member of the Access and Product Management Advisory Committee for Medicines for Malaria Venture. He has conducted pharmacovigilance trainings and related pharmaceutical systems strengthening activities in numerous low- and middle-income countries (e.g., Namibia, Vietnam, Rwanda, Ethiopia, Zimbabwe, China, India, Kenya, Bangladesh, Eritrea, Philippines, Uganda, and Ukraine). Through his affiliation with the Northwest Center for Public Health Practice, he also works on workforce development and research in emergency preparedness with the public health community.

Dr. Bruce Ovbiagele

Bruce Ovbiagele, MD, MSc, MAS, MBA, was appointed as the new Associate Dean of the San Francisco VA Healthcare System (SFVAHCS), effective August 9, 2018. Dr. Ovbiagele also assumed the role of Chief of Staff at the SFVAHCS. In his Associate Dean role, Dr. Ovbiagele serve as the liaison between the SFVAHCS and UCSF, to ensure the SFVAHCS remains an excellent site for the teaching of medical students and residents and supports the acquisition of new knowledge through the clinical and basic research done by UCSF faculty.

SFVAHCS has National Centers of Excellence in the areas of Epilepsy Treatment, Cardiac Surgery, Post Traumatic Stress Disorder, HIV, and Renal Dialysis, and is designated as one of only five VA Centers of Excellence in Primary Care Education. SFVAHCS has one of the largest funded research programs in the Veterans Health Administration.

Dr. Ovbiagele comes to UCSF from the Medical University of South Carolina, where he most recently served as professor and chairman of the Neurology Department. He is a clinical epidemiologist and global health scholar, with a focus on reducing the burden of stroke in the United States and Sub-Saharan Africa.

Dr. Ovbiagele maintains several National Insititutes of Health funded research programs, focused on improving outcomes for those with, or at risk for stroke, including the largest study of stroke in Sub-Saharan Africa, to-date. In 2008, his work was recognized by the American Academy of Neurology with the Michael Pessin Stroke Research Leadership Award.

Dr. Ovbiagele is an elected fellow of the Royal College of Physicians (London), American Academy of Neurology, American Neurological Association, American Heart Association Stroke Council, American Association of Physician Leadership, and European Stroke Organization, as well as an AAMC Council of Deans Fellow. He is also the immediate past chair of the International Stroke Conference, the premier scientific stroke conference in the world, and is a National Spokesperson for the American Stroke Association, interpreting the latest stroke science for medical professionals and the lay public

Dr. Ovbiagele earned his MD from the University of Lagos, Master of Science in Clinical Research (MSc) from UCLA, Master of Advanced Studies (MAS) from UCSD, MBA from the University of Massachusetts, Amherst, and an Executive Certificate in Public Leadership from the John F. Kennedy School of Government at Harvard University.

Dr. Loice Kikwai

Managing Partner / Ex-US FDA, Consultant/Educator Saudi FDA, US Pharmacopeia & CePAT. Unique expertise in registration of devices and medicinal products

Loice Kikwai is the managing parter at LCK Pharmaceutical Consulting. She has twelve years experience in the field of pharmaceutical drug regulation and standardization. Recently, Dr. Kikwai has served as a consultant and educator of global pharmaceutical best practices at the Saudi FDA and at US Pharmacopeia – Ghana: Center for Pharmaceutical Advancement and Training (CePAT). Prior to that, Dr.Kikwai worked at the US FDA, Office of Generic Drugs as a bioequivalence dossier assessor and at US Pharmacopeia as a scientist setting standards for Dissolution Apparatus and Franz Diffusion Apparatus.

She has developed a comprehensive understanding and knowledge of US FDA regulations and guidances, EMA regulations and guidelines, US Pharmacopeia Compendial analytical methods, Saudi FDA regulations and guidelines, ICH, cGMPs, and cGLPs as they pertain to the safety and effectiveness of human drug products, particularly in the area of generic drugs.

Dr. Eric Karikari Boateng

Dr. Paula O’Connor

Dr. Paula O’Connor, MD, is a hematologist oncologist with significant clinical expertise in Oncology drug development. She has exceptional leadership skills and a strong record of accomplishment, delivering results in over 15 years working in the biotechnology field. Most recently, Dr. Paula has served as the Executive Vice President of Clinical Development at Coherus Biosciences, a company dedicated to developing biosimilars in Oncology and Immunology. Prior to joining Coherus, Dr. Paula held positions of increasing responsibility within Clinical Development and Medical Affairs at several biotechnology companies focused on Oncology, including Medivation, Genentech, Onyx Pharmaceuticals and Clovis Oncology. She served as the Global Development Leader, responsible for the clinical development strategy and implementation of several high profile assets, including Rituxan and Tarceva, and for the investigational agents, Talazoparib and Oprozimib. In addition to leading clinical development programs, Dr. Paula has spearheaded numerous post-marketing initiatives including disease and treatment registries, expanded access and Investigator Initiated Trials programs; all aimed at addressing critical clinical data gaps to enhance commercialization.

Dr. Paula earned her MD degree from Stanford Medical School and her BA from Yale University. She did her training as a hematologist and oncologist at the Mass General (MGH) and Brigham & Women’s Hospitals and the Dana Farber Cancer Institute. She was on staff at MGH, focused on Non-Hodgkin’s Lymphoma, before embarking on a career in the industry.

Dr. Patrick Lukulay

Dr. Lukulay has decades of experience in pharmaceutical drug development and analytical research. He has held a number of leadership positions at Wyeth Pharmaceuticals and Pfizer in the United States as lead scientist and group leader of analytical teams involved in analytical research and development. After his career in the pharmaceutical industry, he joined United States Pharmacopeia (USP) where he served as director of the premier initiative known as the Drug Quality and Information program which later became the Promoting Quality of Medicines program (PQM). He later became Vice president of the Global Public Health Division where he pioneered the establishment of the USP Centre for Pharmaceutical Advancement and Training in Accra, Ghana, now known as USP-Ghana.

Dr. Lukulay has recently established Technology Solutions for Global Health LLC (Tech4Health) where he serves as the Founder and President with the focus to use technology as an enabler to facilitate capacity building and technology transfer in the regulatory and pharmaceutical industries. He has authored over 24 publications in reputable peer-review journals and is a frequent speaker at national and international conferences on pharmaceutical analysis using chromatographic and spectroscopic techniques.

He is a member of the American Chemical Society, and a member of the board of directors for the Professional Science Masters (PSM) program for major Universities in the United States. His professional interest includes partnering with development partners to pioneer advancement in the pharmaceutical industry and build human resource capacity for the industry as well as for the regulatory agencies.

Patrick received a B.S degree (Hons) from the University of Sierra Leone, an M.S. degree in Analytical Chemistry from the University of Aberdeen in Scotland and a Ph.D. in Analytical Chemistry from Michigan State University.

Dr. Sidney Spector

Dr. Spector is a board-certified Neurologist with a post doctorate degree in kinesiological sciences. He currently serves as a Clinical Associate Professor at the University of Arizona College of Medicine and practices in the Department of Neurology at the Veterans Affairs Medical Center in Phoenix, Arizona.

He has spent the last 15 years as a medical consultant in the biotechnology field, providing expertise and strategic support for early and late phase drug development, medical affairs and business development. His work has included development of advisory boards with key opinion leaders; preparation of regulatory documents in the drug development process; identification of new indications for pre- and post-marketed medicines; engagement key opinion leaders regarding research and education opportunities; and support business development functions to identify novel, pre-clinical and clinical targets for in-license opportunities.

Dr. Spector lectures on topics including work- and sports-related concussion, carpal tunnel syndrome, spinal cord injury, musculoskeletal disorders of the neck and lower back, traumatic peripheral nerve injury, migraine, seizures, stroke, multiple sclerosis and neurodegenerative disorders.

He earned an MS and PhD at the University of California, Los Angeles and an MD from the Sackler School of Medicine. He performed his residency in neurology at the Barrow Neurological Institute in Phoenix and fellowship training in neuromuscular diseases at the NIH before beginning clinical practice.

Dr. V. Reggie Edgerton

Dr. V. Reggie Edgerton, has 40 years of expertise in the recovery of sensory and motor function following spinal cord injury. At UCLA, he serves a Vice Chairman and Distinguished Professor of Neurobiology and Integrated Biology and Physiology, and Member of the Brain Research Institute.

Dr. Edgerton has 430+ peer-reviewed publications in the physiology of neural control of movement and neuromuscular plasticity, and is widely considered the world’s foremost expert in these fields. In addition to being a member of the UCLA faculty since 1968, he has also served as a visiting professor at the University of Goteborg in Sweden, Tokyo Metropolitan Neuroscience Institute, and the Panum Institute of the University of Copenhagen. Professor Edgerton served as a panelist for the National Academy of Sciences task force Decadal Report for NASA.

Dr. Edgerton’s awards include the Annual National Paralysis Foundation Christopher Reeve Award, the University California Irvine/Christopher Reeve National Paralysis Foundation Spinal Cord Research Award, and the National Spinal Cord Injury Association L.W. Freeman Award. He is also the recipient of a Citation Award by the American College of Sports Medicine, has served NASA in a number of roles, and is currently on the Scientific Advisory Boards of the American Paralysis Association and the Christopher and Dana Reeve Foundation.

Dr. Edgerton received a Ph.D. in Exercise Physiology at Michigan State University. He joined the faculty of UCLA in 1968.

Dr. Menghis Bairu

Dr. Menghis Bairu, M.D. is a physician, business executive, editor, author, and philanthropist. He has more than 25 years of international experience in the biotechnology, pharmaceutical, drug delivery and device, global health, and non-profit arenas.

Dr. Bairu is Executive Chairman of Treos Bio, a start-up company that uses computational biology to develop precision cancer immunotherapies tailored to patients' genetics. In addition, he is Founder and Chairman Emeritus of Serenus Biotherapeutics, an emerging markets focused specialty biopharmaceutical company. In that role he raised up to $43 million in series A funding.

Prior to that, Dr. Bairu concurrently served as Executive Vice President, Chief Medical Officer, Head of Global Development for Elan and President/CEO of Speranza Therapeutics, Elan’s wholly owned subsidiary formed to develop new therapies for multiple indications. As EVP and CMO, Dr. Bairu was member of the Elan’s Operating Committee. He successfully led corporate R&D due diligence processes that resulted in a transaction with J&J at a value of approximately $1.5 billion. In 2013, he also led corporate R&D due diligence resulting in the sale of Elan to Perrigo for $8.6 billion. The combined company incorporated in Ireland as Perrigo plc with a marketing capitalization of approximately $20 billion.

Prior to joining Elan, Dr. Bairu worked at Genentech for more than six years in a number of managed care, medical, and commercial roles (Rituximab, Herceptin, TNK, tPA, Growth Hormone: current aggregate sale over $10 billion per year). He also served on the board of directors of various companies, including One World Health, a non-profit drug development company funded by the Bill and Melinda Gates Foundation; A-Cube, a privately held biotechnology start-up company; and a member of the board of directors of Dubai-based NewBridge Pharmaceuticals.

Dr. Bairu currently serves as Adjunct Professor at the University of California, San Francisco School of Medicine where he lectures on global clinical trials’ design, development, and conduct.