Pharmacovigilance and Risk Management Strategies Conference
Stella Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP
- Vice President, Global Head of Early Access and Risk Management
- 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 (3+ 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, writing the EU guidelines on this topic and was part of the core team implementing the 2010 PhV legislation.
William Gregory, PhD
- Senior Director, Worldwide Medical and Safety
- 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, Global Drug Safety
- Alexion, United States
Mariette Boerstoel-Streefland, MD, MSc, serves as Senior Vice President, Pharmacovigilance & Drug Safety, for Alexion Pharmaceuticals, Inc. An accomplished drug safety executive, she previously served as Senior Vice President and Head, Global Drug Safety, for Shire, and as Vice President and Head, Global Drug Safety, for Baxalta. Dr. Boerstoel-Streefland earned her Medical Degree and Masters Degree in Epidemiology from the University of Utrecht.
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.
- Head of Pharmacovigilance Strategy
- Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Mick Foy is Head of Pharmacovigilance Strategy at the MHRA. Among is responsibilities is the running of the UK ADR reporting system and signal detection activities. Mick is also leads the MHRA's work with WHO and the Bill and Melinda Gates Foundation on capacity building in low and middle income countries. Mick is the current Chair of the MedDRA Management Committee and is a board member of the Uppsala Monitoring Centre.
E. Stewart Geary, MD
- Senior VP, Chief Medical Officer, Director, Corporate Medical Affairs HQ
- Eisai Co., Ltd., Japan
E. Stewart Geary, MD, is Chief Medical Officer and a Senior Vice President at Eisai Co., Ltd. He is a member of the Executive Committee of the Japanese Association of Pharmaceutical Medicine and the Editorial Advisory Boards for Applied Clinical Trials and Pharmaceutical Medicine. A member of the CIOMS Working Group on Drug-Induced Liver Injury, he also served on the CIOMS VII Working Group on the Development Safety Update Report, CIOMS VIII Working Group on Signal Detection, CIOMS Working Group on Standardized MedDRA Queries, and the CIOMS IX Working Group on Medicinal Product Risk Management. Dr. Geary is a DIA Fellow and a Fellow of the Academy of Physicians in Clinical Research. He earned his MD from Stanford Medical School.
Lisa Melanie Harinstein, PharmD
- Safety Evaluator, Division of Pharmacovigilance-I, Office of Surveillance , CDER
- FDA, United States
Lisa Harinstein is a Safety Evaluator 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
- President, Drug Safety, and Pharmacovigilance
- 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. 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 case management and safety surveillance
- Pharmacovigilance and Risk Management Consultant
- United States
Barbara Morollo has over 20 years experience in biopharmaceutical, device, and vaccine Pharmacovigilance and Risk Management. Over the past several years she has focused on the challenges presented by advances therapies. She is currently Head, Pharmacovigilance Operations at Moderna Therapeutics, whose platform mRNA technology encompasses therapeutic and preventative vaccines, and immuno-oncology. Prior to joining Moderna, she lead the Pharmacovigilance and Risk Management function at bluebird bio, a gene therapy and immuno-oncology company.
- 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
- International GPV&E and EU QPPV
- 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, Safety, Epidemiology, Registries, and Risk Management
- UBC, United States
Dr. Annette Stemhagen is an epidemiologist with more than 30 years of public health research experience, including 20 years in safety surveillance of pharmaceutical, biotechnology, and vaccine products. She is the SVP of Safety, Epidemiology, Registries and Risk Management within UBC, where she provides strategic consultative services to biopharmaceutical clients. Dr. Stemhagen has specific expertise in safety surveillance and design, implementation, and analysis of epidemiologic studies, registries, large streamlined safety studies, and actual use and observational studies for products in Phase IIIb and post approval.
Gerald J. Dal Pan
- Director, Office of Surveillance and Epidemiology
- FDA, United States
Gerald J. Dal Pan, MD, MHS, is Director of the Office of Surveillance & Epidemiology in FDA’s Center for Drug Evaluation and Research, where he oversees adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. A member of the WHO Advisory Committee on the Safety of Medicinal Products, he served on the Council of International Organization of Medical Sciences and the International Council on Harmonisation. 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. Before joining FDA, he was a faculty member in Neurology at Johns Hopkins.
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
- 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
- Head of Medical Affairs
- Abbott Laboratories, United States
Dr. Bano is a Senior Medical Director at Abbott. 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
- Group Medical Director, Medical Safety Review, Global Pharmacovigilance and Epid
- Bristol-Myers Squibb Co., United States
Krisztina has started her career in Drug Safety over 14 years ago at a small family-owned CRO in Princeton. After working for 2 years at the CRO, Krisztina joined BMS as a Medical Safety Review Physician responsible for providing medical assessment of individual case safety reports from any source. Over the years, she has taken on increasing responsibilities, including various project works as well as leading the medical review-related quality monitoring efforts for their off-shore single case processing operations. Krisztina has been in her current role for 5 years overseeing medical review physicians and scientists responsible for expedited safety reports.
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.
- Vice President, Center for Observational Research
- Amgen Inc., United States
Dr. Critchlow leads Amgen’s Center for Observational Research, providing strategic leadership to the design & conduct of observational studies for multiple stakeholders. Their Real World Data Platform with data for >160M patients uses a common data model and visualization/analytic tools to generate real world evidence for Clin Dev, Safety, Med Affairs and Commercial teams. Collaborations with academic investigators link to external platforms, providing access to additional data globally.
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
- Senior Director, Head Medical Writing (US)
- Sanofi, United States
Dr. Madhavi Gidh-Jain has experience since 1997 in designing, writing, and reviewing clinical and regulatory documents for pharmaceuticals, biologics, devices, and combination healthcare products. Her work at various pharmaceutical and biotech companies includes process management and preparation of marketing applications for Health Authorities using the CTD format for both paper and electronic submissions. Currently, she is the Senior Director, Head of Medical Writing (US) at Sanofi.
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
- Senior Vice President, Head of Risk Management and Pharmacoepidemiology
- PrimeVigilance, 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
- Senior Regulatory Officer, Integrated Development, Global Health
- 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, MS, FISPE
- Professor of Medicine and Epidemiology
- Harvard Medical School and Brigham & Women's Hospital, United States
Sebastian Schneeweiss, MD, ScD, is a Professor of Medicine and Epidemiology at Harvard Medical School and Chief of the Division of Pharmacoepidemiology, Department of Medicine, Brigham and Women’s Hospital. His research focuses on the comparative effectiveness and safety of biopharmaceuticals. He has developed analytic methods to improve the scientific validity of epidemiologic analyses using complex longitudinal healthcare databases for newly marketed medical products. The overarching theme of his research is applying advanced real-world data analytics for regulatory decision making transparently and in rapid cycles. His work is funded by NIH, PCORI, Arnold Foundation, IMI, and FDA where he is also a voting consultant.
- Senior Specialist, EU QPPV Office
- MSD Ltd, 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. 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.
Vicki Edwards, RPh
- Vice President, Pharmacovigilance Excellence and 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 QPPV. In this g
Karen B. Feibus, MD
- Lead Medical Officer, CSSS, Office of Generic Drugs, CDER
- 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
- Senior Director 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
- Head, Safety Advisory Hub, Chair Liver & GI Safety Comm, Global Patient Safety
- Eli Lilly and Company , United States
Dr. Regev joined Eli-Lilly in a Hepatology Consulting position & as Chair of the Liver & GI Safety Committee in the Global Patients Safety organization. He is currently an adjunct Assoc. Professor of Medicine, Division of Gastroenterology & Hepatology at Indiana University.
Mark I. Avigan, MD
- Associate Director, Office of Surveillance and Epidemiology, OPE, CDER
- FDA, United States
Dr. Avigan is Associate Director for Critical Path Initiatives in the Office of Pharmacovigilance and Epidemiology/OSE at FDA. He is a member of CDER’s Drug Safety Oversight Board and has served as an ex officio advisor for the NIH Drug-induced Liver Injury Network (DILIN). He has co-authored over 100 publications, bookchapters and professional meeting abstracts in the fields of cellular regulation, GI/hepatology and drug safety.
- 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
- Associate Director for Real World Evidence Analytics, OMP, CDER
- FDA, United States
David Martin is the Associate Director for Real World Evidence Analytics, Office of Medical Policy, FDA Center for Drug Evaluation and Research. He oversees demonstration projects intended to support the agency’s evaluation of real world evidence, reviews real world evidence submissions, and contributes to medical policy development mandated by the 21st Century Cures Act. He led the development of the open source FDA MyStudies mobile app. Other key focus areas include FDA-Catalyst and PCORI pragmatic trials as well as replication of clinical trial results with non-interventional study designs. He completed his M.D. and M.P.H. at the Johns Hopkins University and is board certified in Occupational Medicine and Clinical Informatics.
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
- Compliance Head, Global QPPV Office
- Pfizer, 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.
- PRIMEVIGILANCE, Czech Republic
Dr. Jan Petracek qualified as a physician from Charles University in Prague and holds a Master of Science with Distinction in Quality and Safety in Healthcare from Imperial College London. Jan has over 17 years of experience in all areas of pharmacovigilance, being former Head of Risk Management Section at European Medicines Agency, Head of Pharmacovigilance in the Czech Republic, Head of Strategy and Development of the Czech National Authority, and member of CHMP Pharmacovigilance Working Party. He has established guideilnes and registries for PASS at national level back in 2003, and since then he was involved in development of standards and regulations surrounding non-interventional studies in safety areas.
Valerie E. Simmons, MD, FFPM
- EU QPPV, Global Patient Safety
- Eli Lilly and Company Ltd, United Kingdom
Dr. Simmons is currently the EU QPPV 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 focussed her career drug safety through senior management positions in Glaxo Eli Lilly. Val is also an active member of various expert working groups , including the EFPIA Pharmacovigilance Committee, ICH E2D, E2F, E2C (R2), CIOMS VII and IX and speaks extensively on pharmacovigilance and risk management
- Managing Director
- PVSS, 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
- Head, Global Regulatory Science and Policy, NA
- Sanofi, United States
Andrew Robertson is the Head of Regulatory Science and Policy NA at Sanofi, where he heads up regulatory policy initiatives in the US and Canada. 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.