Pharmacovigilance and Risk Management Strategies Conference
Stella Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP
- Senior Advisor Regulatory Science
- NEWDIGS at Massachusetts Institute of Technology, 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.
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.
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.
Cheryl Campbell, MS
- Associate Director of Executive Operations/Outreach and Communications, OSE,CDER
- FDA, United States
Cheryl L. Campbell, M.S., joined the Food and Drug Administration in 2001. She started at FDA’s Center for Biologic Evaluation and Research (CBER) as a Consumer Safety Officer. She was responsible for the regulatory review of FDA applications for in vitro diagnostics. In 2007 she joined the Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE). Currently she is the Associate Director of Outreach and Communications in OSE where she manages and coordinates regulatory policy and communications projects. She has a B.A. degree from Temple University, and a M.S. in Regulatory Science from the University of Maryland.
- 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
Stewart Geary, MD, is Global Safety Officer and a Senior Vice President at Eisai Co., Ltd. He is a Councilor of the Japanese Association of Pharmaceutical Medicine and serves on the Editorial Advisory Boards for Applied Clinical Trials and 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.
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.
- Risk Management Analyst
- FDA, United States
CAPT Robert Pratt, USPHS, received his undergraduate degree from Penn State University and his Pharm.D. from the University of Florida. His career includes 9 years as a clinical pharmacist with the Indian Health Service on reservations in Arizona and New Mexico and 19 years of experience with the FDA. He has held various regulatory review positions in the Agency with the Office of Orphan Products Development, the Division of Pharmacovigilance in CDER, and the Division of Risk Management. His current responsibilities are focused on the review and development of REMS.
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
- Senior Vice President and Chief Science 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.
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. He received his MD from Columbia University College of Physicians and Surgeons and his Master of Health Science in Clinical Epidemiology from the Johns Hopkins University School of Hygiene and Public Health. He completed residency training in Internal Medicine at the Hospital of the University of Pennsylvania and in Neurology at the Johns Hopkins Hospital.
Robert Reynolds, DrSc, MSc, FISPE
- Vice President, Epidemiology, Worldwide Regulatory and Safety
- Pfizer Inc, United States
Dr. Reynolds is Vice President, Epidemiology in Worldwide Safety at Pfizer. He heads a group of epidemiologists and statistical analysts responsible for developing epidemiologic programs to support drug development and safety assessment. He is also an Adjunct Associate Professor of Epidemiology at Tulane School of Public Health and Tropical Medicine where he teaches pharmacoepidemiology. He is a Fellow and former Board member of the International Society for Pharmacoepidemiology. He holds a BA in Biology from Bard College and a MSc in Epidemiology and ScD in Population and International Health from the Harvard School of Public Health.
Martin Cheatle, PhD
- Associate Professor of Psychology in Psychiatry
- Perelman School of Medicine, University of Pennsylvania, United States
Dr. Cheatle is an Associate Professor of Psychology in Psychiatry, Perelman School of Medicine, University of Pennsylvania. Dr. Cheatle specializes in the evaluation and treatment of chronic pain disorders from a biopsychosocial perspective and has been involved in extensive research including a currently funded NIH/NIDA grant assessing phenotypic and genotypic markers of prescription opioid abuse. His main focus of research is pain management and substance use disorders in vulnerable populations (HIV/AIDS, psychiatric patients) and pain and suicidal ideation and behavior.
Karin Coyne, PhD, MPH
- Vice President, Research
- Evidera, United States
Dr. Coyne is Vice President, Patient-centered Research at Evidera, a health outcomes research organization. She has over 25 years’ experience in clinical and health outcomes research specializing in clinical outcome assessment development and validation. Karin has extensive experience in qualitative and quantitative methodologies and expertise in regulatory strategy regarding the inclusion of COA as primary or secondary endpoints in clinical trials.
- American Chronic Pain Association, United States
Nicole Kelly is a communications strategic planning consultant and writer who is retired after 18 years as a Principal and Communications Practice Leader for Buck Consultants and William M. Mercer, Pittsburgh.
Sudip Parikh, PhD
- Senior Vice President and Managing Director, DIA Americas
- DIA, United States
Sudip S. Parikh, PhD, serves as Senior Vice President and Managing Director for DIA Americas. He previously served as Vice President and General Manager of Health & Consumer Solutions at Battelle, leading its Healthcare Improvement, Public Health Research, and Consumer, Industrial, and Medical Technology Development teams in R&D supported by government and commercial clients. Dr. Parikh is a board member of Research America, the Friends of Cancer Research, and the Food Innovation Center. He was a Presidential Management Fellow at the National Institutes of Health, and was awarded a National Science Foundation Graduate Research Fellowship while earning his PhD in Macromolecular Structure and Chemistry from The Scripps Research Institute
Paula Rausch, PhD, RN
- Director, Division of Health Communications, Office of Communications, CDER
- FDA, United States
Paula Rausch, PhD, RN, is Associate Director of Research and Risk Communications in FDA’s Center for Drug Evaluation and Research Office of Communications, where she oversees development of the Drug Safety Communications, CDER’s primary tool for communicating new safety information to the public. She also directs the office’s social science research program, conducting formative and evaluative communication studies.
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.
Krisztina L. Debreczeni, MD
- Head, Medical Safety Review and Expedited Safety Reporting
- Bristol Myers Squibb Co., United States
Krisztina has been working at BMS for 15 years. In the past eight years, she has been leading a team of physicians responsible for the medical assessment of ICSRs as well as a team of scientists responsible for the preparation of expedited safety reports. Krisztina also oversees the Company's large ICSR processing outsourcing operation for medical review and expedited safety reporting. Krisztina has been serving as a subject matter expert on Reference Safety Information for several years, working closely with internal and external experts on this topic.
Quynh Nhu Nguyen, MS
- Associate Director for Human Factors, DMEPA, CDER
- FDA, United States
CDR QuynhNhu Nguyen is an engineer officer and has been with FDA for more than 13 years. She began her work at FDA evaluating human factors (HF) and use safety of medical products with the MedSun project in Office of Surveillance and Biometrics, then with the Human Factors Premarket Evaluation Team in Office of Device Evaluation within the Center for Devices and Radiological Health, and now with the Division of Medication Error Prevention and Analysis (DMEPA).She currently serves as the Associate Director for Human Factors for DMPEA and her current responsibilities include developing policy and best practices for HF reviews to ensure clarity and consistency within the Division.
Cathy W Critchlow, PhD, MSc
- Vice President, R&D Data Strategy
- Amgen, United States
Dr. Critchlow leads R&D Data Strategy, focusing on synergizing cross-functional capabilities in multi-omics, clinical trial and real world data (RWD) to increase the probability of success in bringing innovative medicines to patients. She previously led Amgen’s Center for Observational Research, providing strategic leadership in use of RWD to inform decision-making by multiple internal and external stakeholders. Prior to joining Amgen in 2004, Dr. Critchlow was on the Epidemiology faculty at the University of Washington. Dr. Critchlow earned her bachelor’s degree from Stanford University, and her MS in Biostatistics and PhD in Epidemiology from the University of Washington.
Oswaldo L Bracco, MD
- Associate Vice President Oncology Early Phase and External Collaborations
- Merck & Co, United States
MD, MSc Associated Vice President Oncology Early Phase Clinical Safety and Risk Management Merck
Madhavi Gidh-Jain, PhD
- Medical Writing Head
- Sanofi, United States
Madhavi Gidh-Jain has more than 20 years of experience in designing, writing, and reviewing medical and regulatory documents for pharmaceuticals, biologics, devices, and combination healthcare products. Currently, Madhavi is the Head of Medical Writing for multiple therapeutic areas at Sanofi. Her work at various pharmaceutical and biotech companies includes digital innovation, process management, and preparation of marketing applications for Health Authorities.
Danijela Stojanovic, PharmD
- Research Officer, OSE, CDER
- FDA, United States
Danijela Stojanovic is an epidemiologist on the Sentinel Core Team in FDA’s Office of Surveillance and Epidemiology. Her background is multidisciplinary, including prospective cohorts, administrative claims data, pharmacoepi methods, pharmacovigilance, and clinical pharmacy. She has been at FDA since 2014 and worked in the Divisions of Pharmacovigilance and Epidemiology. Dr. Stojanovic has a BS in Chemistry and a PharmD from the University of Texas and a PhD in pharmacoepidemiology from the University of Florida.
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.
Deborah Ashby, PhD, MSc
- Professor of Medical Statistics and Clinical Trials
- Imperial College London, United Kingdom
Professor Deborah Ashby is Director of the School of Public Health and holds the Chair in Medical Statistics and Clinical Trials at Imperial College London. Her research interests are in clinical trials, risk-benefit decision making for medicines, and the utility of Bayesian approaches in these areas. She was founding Co-Director of Imperial Clinical Trials Unit. Professor Ashby is President of the Royal Statistical Society for 2019 and 2020 and is Chair of the Population Research Committee for Cancer Research UK. She was awarded the OBE for services to medicine in 2009, was appointed an NIHR Senior Investigator in 2010, and elected to the Academy of Medical Sciences in 2012.
Larry Bauer, MA, RN
- Senior Regulatory Drug Expert
- Hyman, Phelps & McNamara, P.C., United States
Larry Bauer is an independent rare disease drug development consultant. Prior to that, he was an FDA Regulatory Scientist in the Center for Drug Evaluation and Research, Office of New Drugs Immediate Office (CDER, OND IO) in the Rare Diseases Program. He was one of the original members of the Rare Diseases Program where he worked from 2010-2018. In that role, he provided regulatory expertise internally and externally regarding FDA laws, regulations, guidances and policies and supports the overall work of the Rare Diseases Program. Prior to coming to the FDA, he worked for 17 years at the National Institutes of Health Clinical Center.
Michael Forstner, PhD
- Head of Clinical and Patient Safety
- Biogen BBU, Switzerland
Michael's main focus areas are the planning, development, implementation and evaluation of benefit-risk management solutions, as well as the optimization of processes around benefit-risk management. He is engaged in developing and applying (benefit-) risk analysis methodologies in order to make RM planning more formally reproducible. Furthermore, he supports the development, implementation and evaluation of effectiveness of additional risk minimization and PV measures in the context of RMPs, as well as post-authorization studies to optimize the benefit-risk profiles of medicines.
Katherine A. High, MD
- President and Head of R&D
- Spark Therapeutics, United States
Dr. Katherine High is currently President and Head of R&D at Spark Therapeutics, a biotech company that she co-founded in 2013. Under Dr. High’s leadership, Spark received FDA approval of the first AAV gene therapy product in the US, a treatment for a rare form of congenital blindness. Dr. High was formerly a Professor at the Perelman School of Medicine at the University of Pennsylvania, an Investigator of the Howard Hughes Medical Institute, and the Founding Director of the Center for Cellular and Molecular Therapeutics at the Children's Hospital of Philadelphia.
Raj Long, MEd, MSc
- Deputy Director, Safety and Pharmacovigilance
- Bill and Melinda Gates Foundation, United Kingdom
Raj is currently a Senior Regulatory Officer at the Bill & Melinda Gates Foundation (BMGF) responsible for Malaria and Neglected Diseases medicines portfolio. In 2014 Raj was invited by the UK Secretary of State to be a member to the World Dementia Council (WDC) she is also appointed by the UK Government as Director, Integrated Development to lead innovative approaches in the regulatory development of clinically relevant therapies for dementia.
- Chief Medical Officer
- FDA/CBER, United States
- Associate Medical Director, Medical Safety Assessment
- Bristol-Myers Squibb, United States
David Paar M.D. is board certified in Internal Medicine and Infectious Diseases. He has pharmacovigilance experience in infectious diseases, immuno-oncology and immunosciences. He is currently employed at Bristol-Myer Squibb.
Sebastian Schneeweiss, DrSc, MD
- Professor, Medicine and Epidemiology; Chief of the Div of Pharmacoepidemiology
- Harvard Medical School and Brigham and Women's Hospital, United States
Dr. Schneeweiss's research focuses on assessing the effectiveness and safety of biopharmaceuticals in clinical practice. He has developed analytic methods to improve the accuracy of estimating causal treatment effects of new drugs using complex digital healthcare databases. His work is published in >500 articles and is used for regulatory and coverage decision making around the globe. He is funded by NIH, PCORI, IMI, and FDA where he is also a voting consultant. He is Principal Investigator of the FDA Sentinel Innovation Center and co-leads the RCT-DUPLICATE initiative to understand when and how real-world evidence studies can reach causal conclusions.
- Associate Director, Office of the EU QPPV
- Merck Sharp & Dohme Limited, United Kingdom
Dionne Usher works in the Office of the EU QPPV and is based at MSD in the UK. Primary responsibilities are managing the Company’s EudraVigilance Access, Steward for the Company’s Pharmacovigilance System Master File and other ad hoc EU QPPV Office projects and activities.
Andrea Best, DO, MPH
- Executive Medical Director
- AbbVie, Inc., United States
Dr. Andrea Best is an Executive Medical Director in Pharmacovigilance and Patient Safety at AbbVie in the suburbs of Chicago where she is responsible for Clinical Trial Safety Excellence and International Product PV. Andrea has over 20 years of experience in academia and industry across a variety of roles (clinical development, medical affairs and pharmacovigilance) and spanning numerous therapeutic areas including oncology, immunology, anti-infectives, renal, anesthesia, general medicine and devices. She has led discussions with global regulatory authorities on a variety of issues and has participated on several external collaborations related to regulatory system strengthening and pharmacovigilance in developing countries.
- 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.
Karen Feibus, DrMed, MD
- Lead Medical Officer, Drug-Device Combination Team, Division of Therapeutic Perf
- FDA, United States
I practiced obstetrics and gynecology for 9 years before joining FDA as a medical officer (MO). I worked in the Office of Nonprescription Products for 3 years and then served as Lead MO of OND's Maternal Health Team for 5 years. I joined the Veterans Administration as the Office of Women's Health Services' Deputy Director of Reproductive Health. I returned to FDA in October 2014 as a clinical reviewer in the Office of Generic Drugs and joined the Clinical Safety Surveillance Staff in 2017.
- Ovid Rx, United States
Bill is a biotech safety professional with more than 13 years’ experience in the industry with expertise in pediatrics, public health, epidemiology, and benefit-risk management. He is head of Safety at Ovid Therapeutics, a small biotech focused on therapeutics for neurologic conditions. Previously, he was at Biogen as Global Safety Lead for Tysabri. Prior to this he was a Global Safety Officer at Amgen for 10 years in roles of increasing responsibility leading teams across multiple therapeutic areas including nephrology (Aranesp, Epogen Velcalcetide), heart failure (Aranesp, Omecamtiv), and oncology products (Denosumab, Neulasta, Neupogen).
Jennifer B Hannan, MS
- Director, Pharmacovigilance Business Liaison
- Merck & Co., Inc., United States
Jen leads the development and implementation of pharmacovigilance (PV) standards covering cross-functional activities such as social media, patient support programs, observational studies and other organized data collection schemes at Merck & Co., Inc. Working with colleagues from the business units, she helps incorporate PV requirements into the business process, therefore ensuring consistency and compliance with PV regulations. Prior to Jen’s 20+ years of PV experience, she worked as a microbiologist at Merck’s vaccine manufacturing division. Outside of work, she likes to do anything outdoors: run, ski, yardwork or explore new destinations with family and friends. To contact Jen, please email Jennifer.email@example.com.
- Social Media Director and Board Member
- The Atypical HUS Foundation, United States
Donna Kolp, CPht, Social Media Director and Board Member of The Atypical HUS Foundation. Originally from Orange County, California, and moved to Texas in 2007, Donna is first and foremost, Mom to Jonathan, her only son, who was diagnosed in 1993 with Atypical Hemolytic Uremic Syndrome, an Ultra rare disease. A caregiver, and a Rare Disease advocate, she has made it her life's purpose to advocate, be a voice and share his story in hopes to inspire those facing life challenges. On a professional note, she is a Certified Pharmacy Technician, still focusing her passion in healthcare and caring for others.
- Asia Pacific Site Head
- Roche, China
Han Ma is currently the Asia Pacific (APAC) Site Head of the Safety Risk Management Group of Roche China Pharma Development based in Shanghai. Prior to her current tenure with Roche China, she was a senior safety science medical director in the oncology therapy area with Genentech, a member of the Roche group. She received her medical training in the field of radiation oncology in China and her Ph.D. in molecular pathology in the US.
Rosa Piccirillo, MD
- VP and Global Head, Medical Safety, Core Safety Services
- IQVIA, United States
Dr. Piccirillo is a Sr. Director Medical Safety at IQVIA. Dr. Piccirillo has experience in clinical trial development and implementation, with special focus on safety reviews, post-marketing surveillance, signal detection, risk management, reference safety information review-updates, aggregate review-analysis and post-marketing regulatory concerns.
Arie Regev, MD
- Chair, Liver and GI Safety Committee
- Eli Lilly and Company , United States
Dr. Regev heads the safety advisory hub and chairs the liver and GI safety advisory committee at Eli Lilly. He serves as co-chair of the CIOMS drug induced liver injury (DILI) working group and co-chair of the immunotherapy working group of the IQ DILI initiative. He is an associate professor of medicine at the division of gastroenterology and hepatology of Indiana University School of Medicine. Prior to joining Eli Lilly Dr. Regev was an associate professor of medicine and director of the hepatology fellowship program of the University of Miami School of Medicine.
Mark I. Avigan, MD
- Associate Director, Office of Pharmacovigilance and Epidemiology, OPE, CDER
- FDA, United States
Mark Avigan, MD, CM, is Associate Director for Critical Path Initiatives in the Office of Pharmacovigilance and Epidemiology at the FDA. As a clinical hepatologist with expertise both in drug safety science and cellular regulation, he served as a division director in drug safety at FDA and more recently as an expert consultant for the evaluation of risk surrounding drug-induced liver injury during the life-cycle of drugs and biological agents. Earlier, Dr. Avigan served as a staff fellow at the NIH and then became a faculty member at the Georgetown University Medical Center where he attended patients on the GI/Liver Service. At Georgetown he was also the principal investigator and leader of a NIH-funded lab in cellular regulation.
- United States
"Bethany Lovegrove of Greer, South Carolina, was diagnosed with Crohn’s disease in 1986 and ultra-rare atypical hemolytic uremic syndrome (aHUS) in 2013, for which she receives infliximab and eculizumab infusions. She developed a passion for helping others after becoming caregiver to another adult aHUS patient. She is an advocate for the aHUS community, speaking to patients and caregivers around the country, and administrates a social media group for patients. In her free time, Bethany enjoys helping her 14-year-old son as he builds a small media empire. "
David Martin, MD, MPH
- Vice President, Clinical Safety and Risk Management
- Moderna, United States
David Martin leads clinical safety and risk management including CSRM RWE activities across the pipeline for Moderna. Previously he completed 20 years of active duty service split between the United States Air Force and Public Health Service. At the FDA he led the Division of Epidemiology which assessed benefits and risks for vaccines and other products regulated by the Center for Biologics. Subsequently, he led the Real World Evidence Staff in the Office of Medical Policy and reviewed all submissions containing RWE intended to demonstrate the effectiveness of drugs or biologics regulated by the Center for Drug Evaluation and Research. He is also the originator of the open-source FDA MyStudies mobile application.
Sanjeev Miglani, MD
- Founder and Director
- AWINSA Life Sciences, United States
Dr. Sanjeev Miglani is the founder and Director at AWINSA Life Sciences. Sanjeev is an MD in Internal Medicine and has more than 18 years’ experience in the field of Medicine, Pharmacovigilance and Clinical Research. He has held executive leadership positions in pharmaceutical companies and business process outsourcing firms with responsibilities for Pharmacovigilance, medical writing, medical affairs and Clinical research. Sanjeev was also Senior Resident in the Cardiology and Medicine Departments in renowned hospitals of New Delhi. Sanjeev is also a fellow of IACM.
Naomi Morris, MS
- Head of QPPV Compliance Office
- Pfizer Srl., Italy
Pharmacologist and toxicologist with over 20 years experience in the industry. She started work in the laboratories as a senior scientist and then moved into the field of Pharmacovigilance. She has lived and worked in three countries and was very involved with the implementation of electronic reporting to EMA back in 2005 and has progressed in several management roles to her current role of Head of Compliance in the Global QPPV Office at Pfizer, based in Italy. She is a member of the International Pharmacovigilance Working Group and the sub group SiGiR within EFPIA.
- FDA, United States
James Osterhout, PhD has worked at the FDA as a pharmacologist since 2003. The entirety of his Agency experience has been with the Office of Generic Drugs in both the Division of Bioequivalence, the Division of Clinical Review and the Immediate Office. Prior to joining the FDA, Dr. Osterhout completed a post-doctoral fellowship at the National Institute of Allergy and Infectious Diseases, National Institutes of Health, in Bethesda, MD where he researched G-protein signaling in mast cells.His industry experience includes positions in the fields of pharmacokinetics and drug metabolism at Proctor & Gamble Pharmaceuticals, Astra Zeneca Pharmaceuticals, and Fisons Pharmaceuticals.
Jan Petracek, MD, MSc
- Institute of Pharmacovigilance, Czech Republic
Dr. Jan Petracek has over 20 years of experience in all areas of pharmacovigilance. Between 2000-2010 he worked as a senior regulator, being former Head of Risk Management Section at EMA, Head of Pharmacovigilance and Head of Strategy and Development of the Czech NCA, and member of CHMP Pharmacovigilance Working Party. Between 2010-2020 he was CEO of multiple contract safety organisations, worked as contract EU QPPV for five MAHs, provided design of PV system and strategic advisory in relation to global PV system setups. His current main activity relates to development of International Society of Pharmacovigilance and its Special Interest Group on Career Framework for Pharmacovigilance Professionals.
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
- Vice President, Head of PV and Epidemiology
- Allogene Therapeutics, United States
Irene Cosmatos, MS
- Senior Research Specialist, Database Analytics Automation
- UBC, United States
Ms. Cosmatos is an experienced epidemiology database analyst who supports product training & development within UBC’s Database Analytics Automation team. Irene leads UBC’s retrospective database analytic service activities, which include conducting global database feasibility evaluations, developing appropriate database study designs, and overseeing the execution of database studies. Additionally, Irene provides subject matter expertise to UBC’s software developers as they enhance product capability per user requests. She brings more than 20 years of experience in analyses of large, retrospective patient databases, US and non-US, in support of epidemiologic and health outcomes research for pharmaceutical research and development.
Andrew Robertson, JD, PhD
- Vice President, Head of Global Regulatory Policy and Innovation
- Takeda, United States
Andrew Robertson is the Global Head of Strategy and Transformation for Sanofi-R&D Digital & Data Sciences. Andrew has more than 14 years of collective experience working in life sciences, policy and law, and has authored multiple peer-reviewed articles on topics pertaining to health product development, in vitro diagnostics, health technology law and innovation incentives.