Patricia A. Bradford is the owner of Antimicrobial Development Specialists LLC, a consulting company that focuses on the late-stage development of antibiotics. Prior to this she was at AstraZeneca and was responsible for the microbiology support contributing to the successful development and approval of ceftazidime-avibactam. Before joining AstraZeneca, Dr. Bradford worked in antibiotic research for Novartis, Wyeth Pharmaceuticals and Lederle Laboratories. During her tenure at Wyeth she worked on a number of antibiotic projects and was instrumental in the team that wrote the dossier for the registration and approval of tigecycline. She was also heavily involved in the studies for several sNDA applications for piperacillin-tazobactam.
Dr. Bradford is fellow in the American Academy of Microbiology, has over 100 publications in peer-reviewed scientific journals and has written several review articles and book chapters. She served as an editor for Antimicrobial Agents Chemotherapy 2001-2011 and is currently a Senior Editor for ASM’s newest journal, mSphere. She is also an active participant with the subcommittee on Antimicrobial Susceptibility Testing of the Clinical Laboratory Standards Institute.
Prior to working industry, she worked as a clinical microbiologist at Nebraska Methodist Hospital in Omaha. Dr. Bradford received a B.S. in Medical Technology from the University of Nebraska Medical Center, Ph.D. in Medical Microbiology from Creighton University and completed a post-doctoral fellowship in β-lactamase research.
Philippa serves as the Project Coordinator for Vivli. She holds Master’s Degree in Public Health from Tulane University and a Bachelor’s Degree from Loyola University New Orleans. She studied Political Science for one year at Umeå University in Sweden. Prior to joining Vivli, she worked at Georgetown University School of Medicine in Washington, DC., Planned Parenthood, and The Louisiana Department of Health and Hospitals. She served as a teaching assistant at Tulane University and focused her Public Health Analysis on women’s health disparities in the United States.
Lydia is a Clinical Trial Disclosure Associate for Vivli where she supports global data sharing efforts by managing research data access requests and ensuring alignment with contributor requirements.
Prior to this role, Lydia was a Presidential Management Fellow (PMF) at the National Institutes of Health (NIH), completing rotations across several institutes. Following her fellowship, she transitioned to a permanent role at the Fogarty International Center at NIH as a Health Science Policy Analyst, where she led strategic initiatives to advance global health research. Lydia holds a Master of Public Health in Global Health Epidemiology and Disease Control from George Washington University and a Bachelor of Health Science in Public Health from the University of Missouri.
Marcia recently retired as a VP of Statistics at Pfizer with responsibility for clinical development in the CVMET therapeutic area and globally sponsored Pfizer’s China Research & Development Center (CRDC) Statistics organization. While at Pfizer Marcia led the global biometrics organization for Pfizer’s marketed medicines clinical research programs and established regional biometrics centers for Latin America, Europe, Asia and China. Marcia has extensive experience in the analysis and interpretation of clinical trial data across numerous therapeutic areas, particularly in Cardiovascular and Anti-infectives. She has served as the statistical leader for regulatory submissions with the responsibility of ensuring biometrics business support of the global pharmaceutical product portfolio. In addition to her role leading Statistics groups, Marcia was a member of Pfizer’s team for the clinical trial disclosure policy, and played a key leadership role in defining Pfizer policy on the issue. She was a member of Pfizer’s internal steering committee for their Bioethics Advisory Panel and a member of Pfizer’s Clinical Trials Policy Group. She is a member of the Stevens Institute Business Intelligence & Analytics Program Advisory Board, which she joined in 2012. She is a member of the ASA Committee on Professional Ethics. Marcia holds BS degrees in Mathematics and Life Sciences from MIT, an MS in Biostatistics form UNC, and an ScD in Biostatistics from Harvard University. She received a Masters in Bioethics form U Penn in 2012.
Frank has had diverse research interests and consulting experience in industry and academia including clinical trials design, data monitoring, data standards, benefit/risk, real world evidence, cardiovascular research, and, most recently, safety and pharmacovigilance. He has been a leader in the scientific community in promoting data disclosure and transparency in clinical research. Frank is a full-time Professor of Biostatistics and Bioinformatics at Duke Clinical Research Institute. He is also a Managing Partner of HunterRockhold, Inc., which provides strategic consulting to Industry, Government, and Academia in the areas of clinical trials, pharmacovigilance, data disclosure, and transparency. Frank’s 40-year career includes senior research positions at Lilly, Merck, and GlaxoSmithKline, where he recently retired as Senior Vice President of Global Clinical Safety and Pharmacovigilance. He has held faculty appointments at six different universities. Frank served for 9 years on the board of directors of the non-profit CDISC, most recently as Chairman, and is past president of the Society for Clinical Trials. He is a member of the PCORI Clinical Trials Advisory Panel and is on the board of the Frontier Science and Technology Research Foundation. Frank is widely published in major scientific journals across a wide variety of research topics. He holds a BA in Statistics from The University of Connecticut, an ScM in Biostatistics from the Johns Hopkins University, and a PhD in Biostatistics from the Medical College of Virginia. Frank is a Fellow of both the American Statistical Association and the Society for Clinical Trials and an Accredited Professional Statistician, PStat®.
