Pharmacovigilance and Risk Management Strategies Conference
Stella Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP
- Vice President, Strategic Operations
- IQVIA, United Kingdom
Dr Stella Blackburn. MB BS, MA, MSc, FRCP(Ed), FISPE, FFPM, DLSHTP, Dip Pharm Med.VP, Global Head of Early Access & Risk Management, Real World Insights at IQVIA. Stella studied medicine at Cambridge and Guys and worked in hospital medicine before joining the pharmaceutical industry. She has worked in pharmacovigilance and pharmacoepidemiology for 30+ years: in industry (11+ years) as a regulator (nearly 17 years) and CRO (6+ years).She has an MSc in Epidemiology from the London School of Hygiene and Tropical Medicine. In 1997 she joined the European Medicines Agency (EMA). Stella developed EU policy on risk management and helped implement the 2010 PhV legislation. She now advises companies on early access and navigating the EU system.
Mariette Boerstoel-Streefland, MD, MBA, MS
- Senior Vice President Patient Safety, Chief Safety Officer
- AstraZeneca, United States
Mariette Boerstoel-Streefland, MD, MBA, MS(epi) is SVP, Chief Safety Officer at AstraZeneca following the Alexion acquisition in 2021. Prior to her current role she was SVP Global Safety at Alexion Pharmaceuticals, Inc. Before that Mariette was SVP, Head of Global Drug Safety at Shire, having been appointed to lead the safety organization after the Baxalta acquisition in 2016. She joined Baxalta two years prior to establish their safety department with the split off from Baxter. Mariette joined the pharmaceutical industry from clinical practice and had a progressive career, holding various leadership positions in drug safety and medical affairs at Organon (now Merck), Mayne Pharma (now Hospira), Forest Labs (now Allergan) for 30 years.
Gerald J. Dal Pan, MD, MHS
- Director, Office of Surveillance and Epidemiology, CDER
- FDA, United States
Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. In this capacity, he is involved in both the premarket and postmarket regulation of drugs and therapeutic biologics, and in the implementation of the drug safety provisions of the Food and Drug Administration Amendments Act and other initiatives.
- Deputy Director of Patient Safety Monitoring
- Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Mick Foy has been with the MHRA for more than 30 years, he is a member of the MHRA’s Senior Leadership team and has recently been appointed Deputy Director of Patient Safety Monitoring . Amongst his responsibilities is to lead MHRA efforts to build PV capabilities in other countries particularly low and middle income countries as part of a global initiative with the Bill and Melinda Gates Foundation. Mick continues to have responsibility for the UK Yellow Card scheme with regard to the vigilance of medicines, medical devices and blood. Mick is Chair of the MedDRA Management Committee.
E. Stewart Geary, MD
- Senior Vice President
- Eisai Co., Ltd., Japan
E. Stewart Geary, MD, is Global Safety Officer at Eisai Co., Ltd. He is a Councilor of the Japanese Association of Pharmaceutical Medicine and serves on the Editorial Advisory Board for the Journal of Pharmaceutical Medicine. A member of CIOMS XII, he also served on the CIOMS VII Working Group on the Development Safety Update Report, CIOMS VIII on Signal Detection, CIOMS on Standardized MedDRA Queries, CIOMS IX on Medicinal Product Risk Management and CIOMS Working Group on Drug-Induced Liver Injury. Dr. Geary is a DIA Fellow, a Fellow of the Academy of Physicians in Clinical Research and an IFAPP Global Fellow in Medicines Development. He earned a BA from Harvard and MD from Stanford Medical School.
William Gregory, PhD
- Senior Director, Safety and Risk Management
- Pfizer Inc, United States
He received formal training in infectious diseases and molecular mechanisms of pathogenesis and has more than 15 years of experience directing global product development and registration programs. He also has extensive experience in pharmacovigilance and health informatics as well as the evaluation and exchange of safety data. He has served with other experts and senior scientists on many consensus panels, including ICH, CIOMS, ISO, and HL7.
Lisa Melanie Harinstein, PharmD
- Team Leader, Division of Pharmacovigilance, FDA
- FDA, United States
Lisa Harinstein is a Team Leader in the FDA-CDER Division of Pharmacovigilance. She received her Doctor of Pharmacy degree from the University of Michigan and completed a Pharmacy Practice and Critical Care Residency at the University of Pittsburgh Medical Center. She worked as a Surgical ICU Clinical Specialist at Cleveland Clinic prior to working at the FDA.
Stephen Knowles, MD, MRCP
- Chief Medical Officer
- Halozyme Therapeutics, United States
Steve received his MD from the University of Newcastle Upon Tyne, UK and worked in the UK National Health Service for 17 yrs. He joined Halozyme in 2018 as Vice President, Drug Safety & Pharmacovigilance and became Chief Medical Officer in January 2020, with responsibility for Drug Safety, Medical and Regulatory. Prior to this, Steve worked at Eli Lilly for 16 years, 12 years of which was in drug safety in various roles of increasing responsibility involving safety operations and drug safety surveillance
Barbara Morollo, RN
- Head, Pharmacovigilance
- Corbus Pharmaceuticals, United States
Barbara Morollo has over 20 years’ experience in the biopharmaceutical and medical device industry with specific focus on the Pharmacovigilance and Risk Management challenges in the clinical development of rare disease, gene therapy and advanced therapeutics. As a practicing registered nurse, her prior clinical experience encompassed a broad range of critical care settings. She is currently Head, Pharmacovigilance at Corbus Pharmaceuticals, a clinical-stage company focused on treating inflammatory and fibrotic diseases by targeting the endocannabinoid system.
Simone Pinheiro, PhD
- Lead Epidemiologist
- FDA, United States
Michael Richardson, MD, FFPM, FRCP
- Senior Vice President, WorldWide Patient Safety
- Bristol-Myers Squibb, United Kingdom
Michael Richardson has many years of global management experience in research based life Sciences companies. He has worked in major multinational companies’ across the globe both at a Regional management level and heading up Research and Development in Asia. Currently Head of Bristol Myers Squibb’s Pharmacovigilance Function. Prior to this role he headed BMS and Eli Lilly’s Development and Medical Organization across Asia Pacific. Before joining Lilly he worked in a joint venture in Japan, Fujisawa-Fisons setting up their development and quality control organisations and prior to that with Organon laboratories in the UK as Medical Director.
Annette Stemhagen, DrPH, FISPE
- Chief Scientific Officer
- UBC, United States
Dr. Annette Stemhagen is an epidemiologist, with over 30 years of public health research experience, including 20 years in the biopharmaceutical industry. She provides strategic consulting in epidemiology, pharmacovigilance, and risk management, and works with UBC teams to develop and implement creative and innovative study design solutions. She has specific expertise in REMS. She has designed and directed implementation of risk intervention programs, risk management evaluation studies, Risk Evaluation and Mitigation Strategies (REMS), and risk minimization programs for EU Risk Management Plans for more than 120 products. She was appointed as the first Industry Representative to the FDA Drug Safety and Risk Management Advisory Committee.
Lesley Wise, PhD, MSc
- Managing Director
- Wise PV&RM Ltd, United Kingdom
Lesley Wise has nearly 20 years of experience in pharmacovigilance both in medicines regulation at the MHRA, and in the pharmaceutical industry as vice-president and global head of Risk Management Centre of Excellence and Pharmacoepidemiology where she worked closely with colleagues to ensure a companywide approach to Benefit - Risk Management and to maintain compliance with regulatory requirements. Lesley has liaised regularly with regulators, including meetings with PRAC, CHMP and FDA.
Bruce Donzanti Donzanti, PhD
- PV Consultant
- Self, United States
Bruce has a PhD in pharmacology/neuroscience with almost 30 years of experience in the pharma/biotech industry. Prior to industry, he performed research on mechanisms of neuronal degeneration and neurotoxicology and lectured in neuropharmacology to graduate and medical students while in academia. He continued his research in industry before moving over to clinical development and eventually Medical Affairs. Bruce has held various positions in industry, including Head of Drug Safety at Genentech and now Senior Group Director of Pharmacovigilance Innovation Policy in Global Regulatory Affairs. In this role, Bruce focuses on current challenges in pharmacovigilance, such as predictive drug safety and quality of safety data sources.
Hans-Georg Eichler, MD, MSc
- Consulting Physician
- Austrian Association of Social Security Bodies, Austria
Dr. Eichler is responsible for coordinating activities between the European Medicine Agency's (EMA) scientific committees and giving advice on scientific and public health issues. Prior to joining EMA, Dr. Eichler was professor and chair of clinical pharmacology and vice-rector at the Medical University of Vienna. Other positions held include President of the Vienna School of Clinical Research and co-chair of the Committee on Reimbursement of Drugs of the Austrian Social Security Association.
- Vice President, Head of PV and Epidemiology
- Allogene Therapeutics, United States
Sean Khozin, MD, MPH
- Executive Vice President of ASCO; Chief Executive Officer
- CancerLinQ, LLC, United States
Dr. Khozin is the Chief Executive Officer of CancerLinQ, LLC, and Executive Vice President of ASCO. He has more than a decade of leadership experience in health technology, regulation, clinical research, and data science, including the application of artificial intelligence and machine learning in biomedical research, therapeutic development, and care delivery.
Christine McSherry, BSN, RN
- Chief Executive Officer
- Casimir LLC, United States
Christine McSherry is the executive director of Jett Foundation, a non-profit dedicated to Duchenne muscular dystrophy, and the co-founder of Casimir Trials, a CRO that designs patient, caregiver, and observer reported outcomes that support regulatory approval and reimbursement. Christine began working in rare disease in 2001 when her son, Jett, was diagnosed with Duchenne muscular dystrophy, and has become an advocate for including the patient voice in every stage of drug development.
Sandra Mitchell, PhD
- Research Scientist & Program Director, Outcomes Research Branch
- Division of Cancer Control and Population Sciences National Cancer Institute, United States
Dr. Sandra A. Mitchell is a Research Scientist and Program Director in the Outcomes Research Branch in the Healthcare Delivery Research Program. Her work focuses on the measurement of symptoms and impairments in physical functioning, and the testing of interventions to improve these outcomes, especially in vulnerable populations, including older adults and patients with multimorbidity. Dr. Mitchell serves as the NCI Scientific Director for the development and testing of the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). PRO-CTCAE is a new measurement system designed to integrate patient-reporting of symptomatic adverse events into cancer clinical trials.
Eric D. Perakslis
- Senior Vice President, Informatics at Takeda Pharmaceuticals
- Takeda Pharmaceuticals, United States
Eric is currently Chief Science Officer at Datavant, an innovative new company with the mission to organize the worlds healthcare data. Eric is also Visiting Scientist in the Department of Biomedical Informatics at Harvard Medical School and a frequent volunteer advisor to Médecins Sans Frontières and other international aid and relief NGOs. Most recently Eric was Senior Vice President and Head of the Takeda R&D Data Science Institute where he built an integrated institute of more than 165 multi-disciplinary data scientists serving all aspects of biopharmaceutical R&D and digital health.
Mark Perrott, PhD
- Managing Partner
- Axian Consulting Ltd, United Kingdom
Mark is Head of Development Consulting and leads a team of Benefit-Risk and Risk Minimisation professionals. He has a >20 year pharma career has included industry (Wellcome, GW, GSK and AZ) and consultancy roles (WCI, Foresight, PopeWoodhead and Huron). He is now focusing on the opportunities presented by new benefit-risk management approaches to improve development decision-making and enhance the interactions of industry and customers to maximise B-R balance. From January 2021, Mark and the existing team of benefit:risk and digital design and development colleagues will be starting-up a new company called Axian Consulting which will further develop the focus on the use of digital to enhance patient safety.
Amanda Marie Roache, MS
- Senior Director, Science and Regulatory Advocacy
- Pharmaceutical Research and Manufacturers of America (PhRMA), United States
Amanda Roache, MPP, is a Senior Director in PhRMA’s Science and Regulatory Advocacy Department. She leads PhRMA’s work under the International Council for Harmonisation (ICH) as well as key science and regulatory activities related international regulatory policy, advocacy in regional platforms such as APEC, and international priority markets.
Shinobu Uzu, MSc
- Senior Executive Director
- Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Mr. Shinobu Uzu is senior Executive Director, PMDA since April 2020. As Chief Safety Officer, PMDA, he was responsible for post-market surveillance and GMP/QMS audit of pharmaceuticals, medical devices regulated by Pharmaceuticals and Medical Devices Law until March 2018. Mr. Uzu took Master degree of Pharmacy from graduate school of the University of Tokyo. He has over twenty years’ experience in Ministry of Health, Labour and Welfare and dealt with pharmaceutical and food safety affairs including international pharmaceutical affairs and food standard issues.
Gary K. Zammit, PhD, MS
- President and CEO
- Clinilabs Drug Development Corporation, United States
Gary Zammit, PhD, is the President & CEO of Clinilabs, a full-service CRO that provides clinical drug development to industry, focusing on CNS therapeutics. He also is an Associate Clinical Professor of Psychiatry, Icahn School of Medicine at Mount Sinai (New York, NY), where he provides physician education in the field of sleep medicine.Dr. Zammit earned a Ph.D. degree in clinical psychology from the University of Toledo (Toledo, OH), where he won both the Turin Service Award and the Leckie Scholar Award. He completed an internship and clinical research fellowship in the Department of Psychiatry at the New York Hospital - Cornell University Medical College (White Plains, NY), where he won the Alumni Award for Excellence.
Jaspal (JP) Ahluwalia
- Medical Officer, OBE, CBER
- FDA, United States
Jaspal (JP) Ahluwalia is a physician working on post marketing safety within FDA CBER. He also reviews pharmacovigilance plans for new BLAs. His professional career began with an eight-year stint in the US Army where he served as a medical officer at the Defense Department’s premier biological research facility at Ft. Detrick, Maryland. Dr. Ahluwalia received his undergraduate and medical degrees from The Ohio State University and his Masters in Public Health from Johns Hopkins University. He is currently an officer in the US Public Health Service and has attained the rank of Commander (O-5).
Steven A. Anderson, PhD
- Director, Office of Biostatistics and Epidemiology, CBER
- FDA, United States
Steven Anderson, Ph.D., M.P.P., is currently the Director of the Office of Biostatistics and Epidemiology (OBE) at the FDA Center for Biologics Evaluation and Research (CBER). He provides leadership for all CBER statistical, epidemiological and risk assessment programs. He was previously the Associate Director for Risk Assessment and established a program in quantitative risk assessment for biologics and has led numerous risk assessment projects and epidemiological studies.
Robert M Baker
- Deputy Chief Medical Officer
- Eli Lilly and Company, United States
Robert Baker is a VP of Eli Lilly and Company and leads several groups within its Medicines Development Unit: Global Patient Safety, Clinical Development Design Hub, and Clinical Pharmacology Medical/Design Group. Robert has been at Lilly for 18 years in various roles across Drug Discovery, Drug Safety, and Medical Affairs. Prior to joining Lilly he was an Academic Psychiatrist studying schizophrenia and substance abuse. Robert completed medical school at Northwestern University and psychiatry training at the University of Pittsburgh.
Melissa Hunt, MSc
- Health Canada, Canada
Melissa Hunt joined Health Canada in 2005. She holds a Bachelor of Science in Life Sciences from Queen’s University and a Master of Science in Pharmacology from the University of Toronto. Prior to working at Health Canada, Melissa worked for several years within the pharmaceutical industry. At Health Canada she has held a number of positions, including in the the Marketed Health Product Directorate (MHPD), and in the core team for the "Regulatory Review of Drugs and Devices" initiative. Since 2018 she has held the position of Director of the Bureau of Metabolism, Oncology and Reproductive Sciences within the Pharmaceutical Drugs Directorate (PDD) and recently took on a 3-month assignment as the Acting Director General of PDD.
Jeremy Jokinen, PhD, MS
- Vice President and Head, Global Risk Management & International Patient Safety
- Bristol-Myers Squibb Company, United States
Jeremy is the Vice President and Head, Global Risk Management and International Patient Safety at Bristol Myers Squibb. In this role, he leads a global team of risk management and safety science leaders responsible for insights, evidence generation, and risk minimization efforts ensuring the safety of patients worldwide. Jeremy is also active within numerous cross-industry pharmacovigilance initiatives and is a deputy topic lead for ICH expert working group E19. Jeremy has over 20 years of experience as a statistician in early phase to post-market pharmaceutical, biological, and medical device research. He holds MS and PhD degrees in quantitative psychology from Ohio University.
Tamy Kim, PharmD
- Director, Regulatory Affairs/ Regulatory Policy, Oncology Center of Excellence
- FDA, United States
Tamy Kim is the Associate Director for Regulatory Affairs (ADRA) in the Office of Oncology and Hematology Products (OHOP) and Acting ADRA in the Oncology Center of Excellence (OCE) at the FDA. In OHOP, her responsibilities include developing policies related to review processes, including for breakthrough therapies, expedited reviews and safety. In the OCE, Dr. Kim is responsible for developing policies and procedures affecting the review of products under the OCE across CDER, CBER and CDRH.
Sara Loud, MBA, MS
- Chief Operating Officer
- Accelerated Cure Project, United States
As COO of Accelerated Cure Project, Sara Loud ensures delivery of research resources to scientists studying multiple sclerosis. Passionate about the integration of people into “people-powered” research, Sara combines a love of technology, business expertise, and social enterprise into her work, most recently focusing on the development of iConquerMS, a people-powered research network. Sara holds a BS/MS in electrical engineering from Northeastern University and a MBA from Babson College.
Jacques P. Tremblay, PhD
- Deputy Editor, Molecular Therapy and Cell Transplantation;Professor, Department
- Laval University, Canada
Dr. Jacques P. Tremblay received a PhD in Neuroscience from the University of California at San Diego in 1974. Since that time, he has been at Laval University as a postdoctoral researcher, Professor and Director of the Department of Anatomy. He is currently Full Professor in the Department of Molecular Medicine. He has published over 250 scientific articles on hereditary diseases. He has worked specifically on myoblast transplantation as a treatment for Duchenne muscular dystrophy. For the last 3 years he also worked on gene correction with the CRISPR/Cas9 technology for Duchenne muscular dystrophy, Friedreich's Ataxia and Alzheimer’s disease.
Ellis Unger, MD
- Principal Drug Regulatory Expert
- Hyman, Phelps & McNamara, P.C., United States
Dr. Ellis Unger is a Principal Drug Regulatory Expert at Hyman, Phelps & McNamara. A cardiologist with 24 years of FDA experience in drug regulation, safety, clinical trial design, and analysis, he started as a Medical Officer in CBER, ultimately serving 8 years as the Director, Office of Drug Evaluation-I, and, after the 2020 reorganization, as Director of the Office of Cardiology, Hematology, Endocrinology, and Nephrology in CDER’s Office of New Drugs. He played major roles in developing several FDA Guidances and ICH Guidelines, including ICH E2F (DSUR), E2C(R2) (PBRER), and E19 (Safety Data Collection). Before joining FDA, Dr. Unger led a translational research effort on angiogenesis in the National Heart, Lung, and Blood Institute, NIH.
John Barlow Weiner, JD
- Associate Director for Policy, Office of Combination Products, OCPP, OC
- FDA, United States
John Barlow Weiner is the Associate Director for Policy in the Food and Drug Administration's Office of Combination Products, which is tasked with ensuring the sound and consistent regulation of combination products and also with the classification and assignment for regulation of medical products (drugs, devices, biological products, and combination products).
Jeffrey Anderson, MD, PhD
- HCC Program Lead Oncology Clinical Development
- Bristol-Myers Squibb, United States
Jeffrey Anderson, MD-PhD, leads the global clinical development for Immuno-Oncology agents in gastrointestinal tumors at Bristol-Myers Squibb.He is also a core member of the BMS Medical Surveillance Team, which is responsible for the pharmacovigilance and safety signal detection in ongoing clinical trials.Jeffrey has been involved in early and late-stage clinical development in Virology and Immuno-Oncology with the goal of helping patients prevail over serious diseases.Jeffrey received his MD-PhD from West Virginia University. He completed Internal Medicine residency training at University of Michigan and Infectious Diseases fellowship training at UNC Chapel Hill.
Shaun Comfort, MD, MBA
- Principal Science Enablement Director
- Genentech, A Member of the Roche Group, United States
Dr. Comfort is a Principle Scientific Enablement Director for Roche in Science Enablement and Processes, leading innovation work supporting Pharmacovigilance. He is a Board Certified Neurologist with 20 years combined biopharma industry/regulatory experience. Dr. Comfort’s current work focuses on developing machine-learning models to evaluate Drug-Adverse Event causality and predict Project/Phase Probability of Success. Recently he published his first book focused on using mathematical estimation in healthcare: How Much Is that Cure in the Window? Simple Math Solutions for Complicated Problems in Biology, Medicine, and Healthcare.
Adrian Dana, MD
- Vice President, Global Patient Safety and Risk Management
- Aimmune Therapeutics, United States
Dr Adrian Dana is the VP of Global Patient Safety and Risk Management for Aimmune, a leader in the development of treatments for food allergies. In this role, she is building an innovative safety organization to support the development of these new therapies. Her past positions include VP of Global Patient Safety and Risk Management at Alnylam, where she built the safety organization to support the development of innovative RNA interference therapies. Prior to that she was VP, Safety Science Oncology at Genentech/Roche, and spent 10 years at Merck in Clinical Safety and Risk Management. Her experience includes multiple therapeutic areas encompassing vaccines, infectious diseases and oncology. Adrian is a pediatric infectious disease MD
Suranjan De, MBA, MS
- Deputy Director, Regulatory Science, OSE, CDER
- FDA, United States
Mr. De is the Deputy Director of CDER’s Office of Surveillance and Epidemiology, Regulatory Science Staff at FDA. He provides expert advice and technical direction on regulatory science for developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products. He has over twenty years of experience with the FDA, the NIH & in the pharmaceutical industry. His current work includes compounding reporting guidance, data management of FAERS system, Safety Reporting Portal for mandatory post-marketing electronic submissions and the FAERS Public Dashboard.
Vicki Edwards, RPh
- Vice President, Pharmacovigilance Excellence and International QPPV
- AbbVie, Inc., United Kingdom
Qualified as a pharmacist in 1981 and started her career in hospital pharmacy. In 1983 she specialised in Drug Information Services and moved to Kuwait to set up and run the first National Drug Information Centre. On her return to the UK, Vicki spent the next four years in community pharmacy. In 1996 Vicki joined GlaxoWellcome and started her career in pharmacovigilance. In 2002 she moved to AstraZeneca UK Ltd as the Drug Safety Manager moving on to become Head of Drug Safety & Medical Information. Vicki joined Abbott in 2005 as European Qualified Person for Pharmacovigilance (EU QPPV). In 2013 moved to AbbVie as EU QPPV and Head of Affiliate Safety Excellence (ASE) and is now VP, Pharmacovigilance Excellence and I-QPPV.
- Director, Medical Information and Marketed Product Safety
- IQVIA, United Kingdom
Simon Johns has over 25 years of experience supporting global pharmaceutical customer projects. As Director of Medical Information (MI) and Marketed Product Safety at IQVIA, he manages global MI projects focused on process optimization and technology enablement to drive enhanced efficiency and customer engagement. Simon is a member of the European DIA Medical Information and Communications Training Team, advising pharmaceutical companies on best industry practices, innovation and automation. He speaks regularly on topics ranging from combined human and AI conversational agent models for MI to the benefits and increased value of integrating MI and pharmacovigilance.
Sadiqa Mian, MD, MPH
- Executive Medical Director, Head Safety Management
- Amgen Inc., United States
Sadiqa Mian MD MPH currently works as an Executive Medical Director, heading Safety Management Team in Global Patient Safety Department at Amgen. Her current areas of responsibilities include Signal and Benefit Risk Management, Medical Review and Aggregate Reports. She has been at Amgen for 4 and half years. Prior to Amgen, her industry experience includes working at Geznyme, Sanofi and Boston Scientific.
John Peters, MD
- Deputy Director, Office of Generic Drugs, CDER
- FDA, United States
John R. Peters, MD graduated from the George Washington University School of Medicine. He is a Family Physician certified in Forensic Medicine with a Certification in Public Health from Georgetown University. He practiced Family and Emergency medicine in MN, later joining the US Army FP residency teaching staff at DeWitt Army Hospital Ft Belvoir and Uniformed Services University of Health Science. In 1992 he moved to the FP residency program of Georgetown University. He has been Director of Managed Care and Associate Director of an MCO. In 2006 he joined the FDA 2009 where he is currently the Deputy Director of the Office of Generic Drugs.
Peter Verdru, MD
- Vice President, Head of Patient Safety
- UCB Biopharma S.P.R.L., Belgium
Peter Verdru, MD was trained as neurologist and joined UCB in 1997. He is heading the global Patient Safety team since 2015. Prior to his current role, Peter was heading the Therapeutic Area CNS in Medical Affairs and Clinical Development.
Elenee Argentinis, JD
- Offering Management Leader
- IBM Watson Health, United States
Elenee is an attorney with 15 years experience in biopharmaceutical commercial leadership roles spanning COPD, Type II Diabetes and Atrial Fibrillation. Elenee leads Watson for Patient Safety (WPS), a solution that applies cognitive computing and the Watson Platform for Heath to pharmacovigilance to add speed, consistency and insight to adverse event processing. She is also guiding the development of signal detection and advanced causality solution using several big data sets including EHR and administrative claims data.Elenee is also the Watson Health Life Sciences Academic Collaborations Lead where she has forged novel partnerships to pilot and evaluate Watson Life Sciences Solutions.
Khaudeja Bano, DrMed, MD, MS
- Vice President, Combination Product Quality
- Amgen, United States
Dr. Bano is the Vice President of Combination product Quality at Amgen. She is a Physician, with a Masters in Clinical Research (UCSD), Pharmaceutical engineering Certification, a Database Administrator and a certified Project Management Professional. She is an Abbott President’s award winner, avid Toastmaster and a certified coach. Khaudeja has more than 25 years professional experience, including patient care. She has held several global safety positions at Guidant, Abbott (multiple divisions like Vascular, Diagnostics, and Established Pharma), and AbbVie Inc. She currently serves as the working group chair of the Combination Product Coalition's Post-marketing Safety Reporting team.
Michelle Bulliard, BSN
- Vice President, Global Head Real-World Evidence Strategy Unit
- IQVIA, Switzerland
Ms. Bulliard has over 20 years’ experience in conducting real-world & late-phase studies, patient registries, safety studies, and other specialized real-world programs for orphan drugs, disease and medical device studies including studies measuring effectiveness of risk minimization measures. With an extensive global portfolio, specialising in post-authorisation safety studies, she has conducted many large and successful programs for a wide range of life science and healthcare organizations. Michelle is responsible for real-world evidence program strategy translating evolving methodological observational research standards into effective delivery strategies.
Howard Chazin, MD, MBA
- Director, Division of Clinical Safety and Surveillance, OSCE, OGD, CDER
- FDA, United States
Dr. Chazin joined FDA in 2002 and has held several leadership positions related to clinical policy and safety of new drugs, biologics and generics. He is the Director of the Division of Clinical Safety and Surveillance in the Office of Generic Drugs' Office of Safety and Clinical Evaluation. He leads several multidisciplinary teams of physicians, pharmacists, nurses, and data analysts tasked with identifying and assessing emerging complex safety issues related to potentially inferior generic drug products and addressing all Risk Evaluation and Mitigation Strategies for generic drugs. He also provides oversight on assessment of critical aspects related to challenging, controversial and sensitive generic drug safety issues.
- Cluster Safety Lead
- Pfizer LLC, Russia EAEU/Ukraine QPPV, Russian Federation
Graduated from Russian Medical University, specialized in medicinal biophysics. Have a PhD scientific work on human brain with a morphometric studies of brain cortex (speech-motor areas), with 8-year experience in light microscopy in National Brain Research Institute (Moscow, Russia). Have a 15-year experience in pharmaceutical industry, working in clinical studies (Novartis), Drug Safety and Medical Quality Oversight (Pfizer). Now as a Drug Safety Unit Head, EAEU/Ukraine QPPV (Pfizer), with oversight on countries under the Eurasian region (Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russia) and CIS countries not included in the EAEU (Azerbaijan, Georgia, Mongolia, Uzbekistan, Turkmenistan, Tajikistan).
Valerie E. Simmons, MD, FFPM
- Senior Medical Fellow, Global Patient Safety
- Eli Lilly and Company Ltd, United Kingdom
Dr. Simmons is currently Senior Medical Fellow (formally the EU QPPV) in Global Patient safety for Eli Lilly & Company Ltd. She is a registered physician from the University of London and, since joining the pharmaceutical industry in 1987, she has focused her career drug safety through senior management positions in Glaxo/Glaxo Welcome and Eli Lilly and Co. Val is also an active member of various expert working groups , including the EFPIA Pharmacovigilance Expert Working Group, ICH E2D, E2F, E2C (R2), CIOMS VII and IX and speaks extensively on pharmacovigilance and risk management
Robert Ball, MD, MPH, MSc
- Deputy Director, Office of Surveillance and Epidemiology, CDER
- FDA, United States
Robert Ball MD, MPH, ScM is Deputy Director, Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), FDA. Dr. Ball shares in the responsibilities for leading OSE staff evaluating drug and biologic product safety and effectiveness using Real World Evidence, including managing the Sentinel System.
- All Session Speakers, United States
On-Demand Complimantary Webinar
Preconference Short Course Options
Pharmacovigilance and Risk Management Planning
Pharmacovigilance Inspections Part 1: Readiness, Conducting, Findings, and Report-Outs
Pharmacovigilance Inspections Part 2: Response, Measurement, Resolution, and Tracking