Annette S. Williams, MBA, RPh
Vice President, Pharmacovigilance, IQVIA, United States
Annette Williams, M.B.A. R.Ph, is Vice President, Global Head of Lifecycle Safety, leading IQVIA’s comprehensive Safety organization, consisting of more than 4,000 professionals worldwide, providing services across the PV spectrum, including: case processing, regulatory reporting, aggregate reporting, signal detection, risk management, medical information, local affiliate PV support and safety systems. Williams oversees the development and adoption of innovative technologies to streamline the management of safety information and subsequent data analytics. Prior to IQVIA, she held leadership positions in both CRO and Pharma fields, including Drug Safety Alliance, Teamm Pharmaceuticals, and GSK.
James Buchanan, PharmD
President, Covilance LLC, United States
Dr. James Buchanan is presently an independent drug safety consultant. Dr. Buchanan began his industry career at Genentech where he worked for 9 years in the areas of medical information and drug safety. He subsequently established the drug safety departments at Gilead, Tularik and Nuvelo. Dr. Buchanan next served at BioSoteria as the head of the medical and safety consulting group. Dr. Buchanan is currently president of Covilance, LLC, a drug safety consulting service. He is also a co-lead of the American Statistical Association Biopharmaceutical Safety Working Group Interactive Safety Graphics taskforce that is developing novel, open-source interactive graphical tools to identify and evaluate safety issues during drug development.
Barbara Hendrickson, DrMed, MD
Clinical Associate, Pediatric Infectious Diseases, University of Chicago, United States
Dr. Barbara Hendrickson is a former Vice President of Pharmacovigilance and Patient Safety at AbbVie. She is currently on faculty at the University of Chicago. Dr. Hendrickson is a physician with subspecialty training in pediatrics and infectious diseases and has 19 years of pharmaceutical industry experience. Dr. Hendrickson has been involved in multiple new product and additional indication submissions. She also has participated in several clinical trial safety initiatives related to implementation of internal data monitoring committees and IND aggregate safety reporting procedures. In addition, she co-leads the DIA-ASA Aggregate Safety Assessment Planning Working Group.
Jeremy Jokinen, PhD, MS
Vice President and Head, Safety Evidence and Sciences, Bristol-Myers Squibb Company, United States
Jeremy Jokinen is the Vice President and Head, Safety Evidence and Sciences at Bristol Myers Squibb. In this role, he leads a global team of risk management, epidemiology, and safety science experts responsible for insights, evidence generation, and risk minimization programs ensuring the safety of patients worldwide. Jeremy has led numerous cross-industry pharmacovigilance workgroups and initiatives for DIA, TransCelerate, and ICH, and is a frequent speaker at industry conferences. Jeremy has over 20 years of experience as a statistician in early phase to post-market pharmaceutical, biological, medical device, and patient safety research. He holds MS and PhD degrees in quantitative psychology from Ohio University
Susan Kindig, JD, MD
, United States
Susan currently leads the patient safety department at Halozyme and supports both the medical and regulatory functions there since March, 2022. Prior to joining Halozyme, Susan spent 10 years working in Global Patient Safety at Eli Lilly. She used her clinical experience as an OB/GYN while in pharma to aid in the initial stages of the ConcePTION project, as a working group member for PRGLAC, and most recently on a pregnancy-related TransCelerate project. Susan earned her MD from Indiana University and her JD from Indiana University School of Law – Indianapolis.
Jamie Ridley Klucken, PharmD, MBA, RPh
Safety Evaluator, Division of Pharmacovigilance, OSE, CDER, FDA, United States
Dr. Klucken earned a B.A. in Business Management and Economics (George Fox University), a Masters of Business Administration (Idaho State University), and a PharmD (Idaho State University). She completed a PGY1 and PGY2 Residency at the Boise VA Medical Center. Prior to joining FDA, she served as a clinical pharmacist for several outpatient family practice and community clinics focusing on chronic disease state management and served as an Associate Professor at Shenandoah University BJD School of Pharmacy. She currently works as a Safety Evaluator in the Division of Pharmacovigilance, monitoring postmarketing adverse events. She is a Board Certified Pharmacotherapy Specialist and a Board Certified Ambulatory Care Pharmacist.
Mengchun Li, MD, MPA
Senior Director, Clinical Research, Infectious Disease, Merck & Co., Inc., United States
Dr. Mengchun Li is currently working at Merck & Co., Inc. as a Senior Director, Infectious Diseases. Prior to this, Dr. Li worked at TB Alliance and Janssen Pharmaceutical company (J&J) in Drug Safety and Pharmacovigilance, Clinical Development, and Medical Affairs. Dr. Li is now co-leading the DIA-ASA (American Statistical Association) joint safety working group fostering interdisciplinary collaboration to improve safety evaluation in drug development. Dr. Li received her MD from China Medical University and her Master of Public Administration from Columbia University.
Annette Stemhagen, DrPH, PhD, FISPE
Chief Science Officer, UBC, United States
Dr. Annette Stemhagen is an epidemiologist, with >30 years of public health research experience, including 20+ years in the biopharmaceutical industry. She provides strategic consulting in epidemiology, pharmacovigilance, and risk management. She develops and implements creative and innovative epidemiologic study design solutions. She also has extensive expertise designing and implementing 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.
Head of Vigilance Operations, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Sarah has worked in pharmacovigilance at the MHRA for the past 15 years, her current role is the Head of Vigilance Operations, responsible for adverse incident collection & signal management for medicines and medical devices. Sarah is currently leading on the development and transformation of the Agency's vigilance systems for all medicinal product types.
Jo Wyeth, PharmD
Associate Director for Postmarket Assessments, OMEPRM, OSE, CDER, FDA, United States
Jo Wyeth is the Associate Director for Postmarket Assessments, serving as a senior-level scientist specializing in the application of risk management principles and leading efforts to implement and oversee medication error pharmacovigilance activities, research and quality assurance activities, and assessment of risk mitigation measures. She also performs complex safety analyses, advises Office and Division management, and provides leadership for planning, program development, policy and program analysis, and the implementation of safety initiatives that support OMEPRM.
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's School of Pharmacy.
Stella Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP
Strategy , Consultant, United Kingdom
Dr Stella Blackburn. MB BS, MA, MSc, FRCP(Ed), FISPE, FFPM, DLSHTM, Stella studied medicine at Cambridge and Guys, working in hospital medicine before joining the pharma industry. She has worked in PhV and pharmacoepi for 35 years: in industry (11+ years) as a regulator (16+ years) and CRO (9 years). Following her MSc in Epidemiology from LSHTM, she co-developed their course in PhV and Pharmacoepi. In 1997 she joined the European Medicines Agency (EMA). Stella developed EU strategy and policy on risk management, was lead writer on the EU guidelines on this and was part of the core team implementing the 2010 PhV legislation and ENCePP. She is/was on the CIOMS IX/XI/XIII working parties and is a member of the CIOMS Executive Committee.
Gerald 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.
Executive Director, Global PV Management Dept., Global Safety HQs, Eisai Co., Ltd., Japan
Mamiko Kasho is Executive Director of Global Pharmacovigilance Management in Global Safety HQ of Eisai Co., Ltd, and has been involved in global PV area since she joined the company in 2007. Mamiko has been responsible for PV agreements with licensing partners for 15 years and at the same time in charge of establishing, maintaining the quality management system in PV; and continues working on coordinating activities to comply with regulatory requirements across regions. Mamiko has been participating in several task forces of JPMA PV committee as the team leader, focusing on PV requirements in Europe, US, Asia, and other regions. Mamiko is also the member of MedDRA Management Committee since Mar 2020 as the representative of JPMA.
Mark Perrott, PhD
, Axian Consulting Limited, United Kingdom
Mark is a founder and managing partner at Axian Consulting, where he focuses on improving benefit:risk balance and outcomes for patients through improving communication and adding value using digital approaches. He has a >20 year pharma career which has included industry (Wellcome, GW, GSK and AZ) and consultancy roles (WCI, Foresight, PopeWoodhead, Huron and now is a founder and managing partner of Axian Consulting). He is now focusing on the opportunities presented by improved benefit-risk management approaches to enhance risk management decision-making in development and on adding value to the interactions of industry and customers to maximise B-R balance and improve outcomes in REMS and aRMM programmes.
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.
Mary Thanh Hai, MD
Deputy Director for Clinical, OND, CDER, FDA, United States
Dr. Thanh Hai is currently the Deputy Director for Clinical in the Office of New Drugs Immediate Office. She works directly with the OND Director to oversee the development programs of drugs and biologics regulated by the Center of Drug and Evaluation and Research across 27 review divisions. She also oversees the Office of Drug Evaluation Science including the Drug Development Tool Qualification Programs. Dr. Thanh Hai is an internist/endocrinologist receiving her medical degree from Georgetown University. Over the past 26 years, she has held several leadership positions in FDA including Director of Division of Metabolism and Endocrinology Products from 2006-2013. She served as the rapporteur for development ICH E19 Guidelines.
Sarah Frise, PhD, MS
Global Head Safety Epidemiology and Risk Management, AstraZeneca, Canada
Sarah holds a Masters Degree in Physiology and Phd in Epidemiology. Sarah holds the position of the Global Head Safety Epidemiology and Risk Management at AstraZeneca. She is an active member of many Pharmacovigilance and Safety epidemiology working groups including Beyond Covid Monitoring (BeCOME), ISPE BRACE, IMI Gravitate. In addition to pharmacoepidemiologic methods related to the conduct of Safety Epidemiology studies, she has a special interest in designing and implementing Risk Minimisation/Mitigation Interventions and assessing the effectiveness of these interventions.
Policy and Liaison Lead, QPPV Office, Advanced Accelerator Applications, A Novartis Company, Switzerland
Amalia is a Clinical Pharmacist, with ten years`experience in PV, with a passion for safety in pregnancy. She has completed her second MSc under EU2P program, with the Thesis: ‘Is my treatment harming my baby?`- a critical appraisal of a patient`s journey through pregnancy safety data available publicly. Amalia is currently enrolled in a PhD in PV, focusing her research on safety in pregnancy. Amalia is a member of IMI ConcePTION and is co-leading the development of the ConcePTION pregnancy & breastfeeding information exchange app. She is also the TransCelerate Topic Lead for the IGR PV Topic: Regulations Governing the Use of Medicines in Pregnancy & Breastfeeding. Amalia is currently a Policy & Liaison Lead in the QPPV Office of Novartis
Andrew Bate, PhD, MA
Vice President, Head of Safety Innovation and Analytics, GlaxoSmithKline, United Kingdom
Andrew is Head of Safety Innovation & Analytics at GSK and a member of the Global Safety Leadership team. Previously Andrew was in the Epidemiology Leadership team at Pfizer for a decade. Prior to joining Pfizer, Andrew was at the Uppsala Monitoring Centre for more than 12 years, where he led the Research function. Andrew has over 100 publications on RWE and signal detection and has participated in several international initiatives in the area. Andrew is Honorary Associate Professor of Epidemiology at LSHTM.
Irina Caplanusi, MD, MSc
Signal Management Lead, Pharmacovigilance Department, European Medicines Agency, Netherlands
Dr. Irina Caplanusi is qualified as medical practitioner. She joined the European Medicines Agency in 2009 and is currently working as Signal Management Lead in the Pharmacovigilance Department. She has broad experience in signal management (leading on Signal Procedures at the Pharmacovigilance and Risk Assessment Committee) and incident management (including Emerging Safety Issues and the Incident Management Plan). In the recent years she worked extensively in the pharmacovigilance of COVID-19 vaccines, from safety monitoring to leading on high profile signal procedures.
Jacqueline A. Corrigan-Curay, JD, MD
Principal Deputy Center Director, Center for Drug Evaluation and Research (CDER), FDA, United States
Jacqueline Corrigan-Curay, JD, MD, serves as Principal Deputy Center Director in the Center for Drug Evaluation and Research, FDA. Dr. Corrigan-Curay provides executive leadership on strategic initiatives that advance CDER's mission to deliver safe, effective and high-quality medications including serving on executive governance committees and overseeing policy development on real world evidence, prescription drug promotion, clinical trial oversight and innovative trial design.
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 work includes compounding reporting guidance, data management of FAERS system, Safety Reporting Portal for mandatory post-marketing electronic submissions and the FAERS Public Dashboard.
James Duhig, PhD
Director, Patient Integration, PSEQ, AbbVie, United States
Dr. James (Jay) Duhig, Ph.D., is director of Patient Integration for AbbVie Pharmacovigilance and Patient Safety. Dr. Duhig is an expert in the application of human factors and health literacy in the investigation of medication errors and in the development of drug and device instructional materials for patients and healthcare professionals. In his role with AbbVie’s International Pharmacovigilance Network, Dr. Duhig works with physicians, nurses, pharmacists, engineers, and others in the evaluation of multiple sources of post-marketing safety data. He is a passionate advocate for the use human factors and health literacy to problem-solve the needs of patients not just at the hospital and doctor’s office but at the kitchen table.
Sara L. Eggers, PhD
Director, Decision Support and Analysis Team, OSP, CDER, FDA, United States
Sara Eggers leads the Decision Support and Analysis Team withing FDA’s Center for Drug Evaluation and Research. This team contributes to the development and implementation of initiatives regarding human drug benefit-risk assessment, patient-focused drug development, risk evaluation and mitigation strategies, regulatory decision support, and other efforts. Before joining FDA in 2011, Sara conducted research and consulting in the area of decision science, stakeholder engagement, and risk communication. She has a Ph.D. in Engineering and Public Policy, with an emphasis on decision science, from Carnegie Mellon University
Director, Offering Management, Vigilance Detect, IQVIA, Ireland
As Director, Offering Management, of IQVIA’s Vigilance Detect (powered by AE Tracker), Marie’s focus is on developing the Detect portfolio and ensuring the offerings meet client and regulatory needs. Marie joined Quintiles Drug Safety over 16 years ago. In her tenure, Marie has successfully held many leadership positions with a key focus on the strategic expansion of IQVIA’s lifecycle safety department, conducting PV landscape assessments and analysis of emerging safety trends. Marie graduated from University College Cork, Ireland, with an MSc in Medical Microbiology. In 2021, she joined the Vigilance Detect team, leveraging her 16+ years of safety experience.
Solomon Iyasu, DrMed, MPH
Principal, Iyasu Epi-RWE Strategy LLC , United States
Dr. Iyasu is a former head of Epidemiology of Merck & Co (2015-2022) and former head of the Office of Pharmacovigilance and Epidemiology at the Center for Drug Evaluation and Research, Food and Drug Administration (2008-2015). He is currently an independent consultant to life science companies on drug safety epidemiology, real-world data (RWD) and real-world evidence (RWE) to support clinical development, regulatory and reimbursement strategies and life cycle management.
Michael Kruczek, MSc
Senior Director, Vault Safety Strategy, Veeva Systems, United States
Angelika Manthripragada, PhD, MPH
Director, Pharmacoepidemiology, Regeneron, United States
Angelika Manthripragada is a Director in the Pharmacoepidemiology group in Global Patient Safety at Regeneron, where she leads the epidemiological strategy and support in the areas of Neurology/Pain and Ophthalmology. Prior to joining Regeneron, she worked in the observational research group at Amgen, and the Office of Surveillance and Epidemiology at CDER, FDA. Angelika received her doctorate in Epidemiology from UCLA, and her MPH from Emory University.
Srikanth S, MPharm
Associate Director, Head - SARA Literature center, Life Cycle Safety, IQVIA, India
Srikanth heads a global team of 120+ literature surveillance scientists located in India, China, & US, oversees vendors from Europe & Asia. In his role as head of a work function, he supports various aspects of the business unit, including strategy, pre-sales, business development, client relationship management, and operations. He works with Fortune 500 client base across Americas, UK, Europe, Japan, China, India, and Singapore to provide them with innovative technology solutions and business models to transform Pharmacovigilance (PV) processes. In his 11 years of Pharmacovigilance experience, he supported various PV domains like case processing, QA, training, literature review, aggregate reporting & signal detection.
Matthew Schrag, MD, PhD
Assistant Professor of Neurology & Director, Cerebral Amyloid Angiopathy Clinic, Vanderbilt University Medical Center, United States
Uwe Trinks, PhD, MS
Global Practice Lead IQVIA PV Technologies, IQVIA, United States
Dr. Uwe Trinks, Global Practice Lead, PV Technology at IQVIA serves as Drug Safety and Risk Management Subject Matter Expert with over 32 years of life sciences experience. Prior to joining IQVIA, he served as Partner and Director of Foresight Group International for 10 years and as CIO of Sentrx for 10 years. Prior to that, he served as the Executive Director and Head of Research Information Management USA for Novartis. Dr. Trinks earned a M.S. in Organic and Natural Products Chemistry, and a Ph.D. in Organic Chemistry from the Federal Institute of Technology (ETH) in Zurich, Switzerland. He has also completed Postdoctoral Research in Biochemistry at Stanford University.
Yijing (Hellen) Zhang, MPharm
Executive Director, Global Patient Safety , Beigene, China
Executive Director head of Individual Case Safety, Medical Review & Aggregate Safety Reporting team, PV responsible person in China.
Cameron Zimmermann, MBA
Director, Kite Safety and Pharmacovigilance, United States
Father of 2, runner and very fortunate to serve patients with grievous illnesses. Seeking out positive environments to continue to learn about drug development. Twenty plus years of patient safety experience with the hope of more to come. Excited to spend time with colleagues, have fun and grow.
Catherine Baldridge, MSc
Head of Safety, Fusion Pharmaceuticals, United States
Catherine Baldridge is the Sr. Director of Global Safety and Pharmacovigilance, Head of Safety, at Fusion Pharmaceuticals. She has more than 20 years of experience and serves as an executive consultant to the industry providing leadership and support in Pharmacovigilance Operations, development, training, regulatory, and inspection readiness. She has a Bachelors degree in Neuro Psychology from Hollins University and a Masters of Science in Clinical Investigation and Patient Research from the University of Virginia. Catherine was a former adjunct faculty member at Temple University, teaching several courses in pre and post marketing safety and Pharmacovigilance, and former chair of the DIA Clinical Safety and Pharmacovigilance Community.
Greg Ball, PhD
Safety Data Scientist, ASAPprocess, United States
Greg served in the Navy and taught HS math and physics before earning his PhD in biostatistics from the University of Texas. He co-led a crossfunctional company initiative at Merck to develop and implement the Aggregate Safety Assessment Planning (ASAP) process. His research on blinded safety monitoring procedures is being developed in collaboration with statistical and clinical scientists at several pharmaceutical companies (including AbbVie and Merck). Greg co-leads, with Mary Nilsson and Scott Proestel, the PHUSE Safety Analytics working group; he established (with Bill Wang) the ASA Biopharm Safety Monitoring working group; and he pioneered the joint DIA-ASA Interdisciplinary Safety Evaluation (DAISE) scientific working group.
Alie Banner Simpson
Scientific Assessor, Benefit and Risk Management Group, Unit 1, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Global Strategic Solutions, Clinical Operations Lead, DEICT , Inspired Health Strategies, United States
She is currently working with industry sponsors to develop and implement diversity in clinical trials efforts.
Nicole Duarte Vigar Baker, PhD
CEO, Biologit, Ireland
Alisa Marie Hummings
Sr. Director, CEVA and Medical Information, IQVIA, United States
Alyson Karesh, MD
Director, Division of Clinical Trial Quality, Office of Medical Policy, FDA, United States
Alyson Karesh is the Director of the Division of Clinical Trial Quality in the Office of Medical Policy at the U.S. Food and Drug Administration (FDA), where she leads policy development activities that enhance the quality and efficiency of clinical trials. Dr. Karesh previously served in multiple roles in the Office of New Drugs at FDA. Prior to joining FDA, Dr. Karesh worked as a hospitalist and as a general pediatrician. Dr. Karesh received her undergraduate degree from the University of Virginia and her medical degree from the Medical College of Virginia, and she completed her pediatric internship and residency at Children’s Hospital of Pittsburgh.
Hu Li, MD, PhD
Sr. Director, Real-World Evidence, Gilead Science Inc., United States
Lacey Leigh Lucree, MPH
Co-Founder and Partner, Truliant Consulting, United States
Lacey possesses more than 20 years' experience in the pharmaceutical R&D space, including 10 years working in industry in various pharmacovigilance (PV) roles. Lacey transitioned to pharmaceutical consulting in 2011 and further refined her tactical and strategic management skills while assuming lead roles on PV projects including pharmacovigilance system implementations and business process harmonization/optimization, compliance oversight and risk management/risk minimization initiatives. Lacey is a Co-Founder and Partner at Truliant Consulting. She is currently based in New York, NY.
Tom Paternoster-Howe, MSc
Scientific Administrator, Data Analytics & Methods, Task Force, Healthcare Data, European Medicines Agency, Netherlands
Tom Paternoster-Howe joined the EMA in 2004, where he has worked ever since. His work at the EMA has focused on the quality and analysis of data in Eudravigilance and he is currently the lead scientific administrator for both the Medical Literature Monitoring service & the Eudravigilance data management contract. Prior to joining the Agency, he worked for 3 years in the industry & at the MHRA in pharmacovigilance.
Aaron Pawlyk, PhD
Chief, Obstetric and Pediatric Pharmacology and Therapeutics Branch, NIH/NICHD, United States
Dr. Aaron Pawlyk is the Chief of the Obstetric and Pediatric Pharmacology and Therapeutics Branch at the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Dr. Pawlyk is a pharmacologist with decades of leadership experience in drug discovery and pre-clinical development, pharmacogenomics, and mathematical modeling across multiple therapeutic areas. Under his leadership, the OPPT Branch aims to assure that there are safe and effective therapeutics for children and pregnant and lactating women and that these medications are used optimally according to individual needs. Before joining the NIH, he held multiple positions in the pharmaceutical sector.
Y. Veronica Pei, MD, MEd, MPH
Acting Associate Director, Biomedical Informatics and Regulatory Review Science , FDA, United States
Dr. Veronica Pei is a board-certified emergency physician and a commissioned officer in the U.S. Public Health Service currently serving as Associate Director (Acting) of Biomedical Informatics and Regulatory Review Science team in the Office of New Drugs (OND), FDA. In this role, Dr. Pei is involved in development, implementation, and support of bioinformatics initiatives within OND. She is the current FDA topic lead for ICH M11 expert working group on the Structure and Content of Clinical Protocols. Dr. Pei is also the current lead for Standard Tables and Figures and Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of NASH guidance.
Kimberly Smith, MD, MS
Real-World Evidence Analytics Team, Office of Medical Policy, CDER, FDA, United States
Kimberly Smith is a nephrologist with the Real-World Evidence Analytics team in the Office of Medical Policy (OMP), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration. In her current role, she develops and implements programs and policies related to the use of real-world evidence in drug development. Prior to her current role, Dr. Smith served at FDA as team leader for the Division of Clinical Trial Quality in OMP and as the nephrology team leader in the Division of Cardiology and Nephrology in CDER’s Office of New Drugs. Before joining the FDA, she was with the Coverage and Analysis Group at the Centers for Medicare and Medicaid Services.
Christopher Flood, BSN, MBA
Senior Director Safety Operations, Erasca, United States
Nicole Kellier-Steele, PhD, MPH
Senior Director - Global Patient Safety, Eli Lilly and Company, United States
Nicole Kellier-Steele is a Senior Director in the Global Patient Safety group at Eli Lilly and Company. Nicole has expertise in epidemiological methods and has worked in the Lilly Global Patient Safety group for over 12 years. Nicole received her PhD from Florida International University and her MPH in Epidemiology from George Washington University. Her experience includes design, analysis, execution of non-interventional studies across multiple therapeutic areas. Nicole supports cross-functional teams and provides epidemiological expertise to for regulatory strategies and obligations for compounds in development, new product launches and marketed products.
Boaz Mendzelevski, MD
Consultant Cardiologist, Cardiac Safety Consultants Ltd., United Kingdom
Niklas Noren, PhD, MSc
Chief Science Officer, Uppsala Monitoring Centre (UMC) , Sweden
Niklas Norén is Chief Science Officer at the Uppsala Monitoring Centre, the WHO Collaborating Centre for International Drug Monitoring, and a member of its executive leadership team. He has published extensively on statistical pattern discovery in observational medical data, primarily adverse event reports and electronic medical records. His research has resulted in scientific papers on duplicate detection and subgroup discovery that have been internationally awarded. He is a member of the editorial board for Drug Safety, and he has led several international collaborative projects in pharmacovigilance.
Simone P. Pinheiro, MSc
Head, PharmacoEpidemiology Center of Excellence (PeCoE), AbbVie, United States
Simone Pinheiro is the Head of the Pharmaco-Epidemiology Center of Excellence (PECOE) in Global Epidemiology at Abbvie. The PECOE brings together experts in regulatory pharmaco-epidemiology, data science and data analytics and serves as a strategic resource for real-world data, analytics, and regulatory pharmaco-epidemiology expertise for the enterprise. Dr. Pinheiro has 15 years of regulatory pharmaco-epidemiology experience. Prior to joining AbbVie, she was the Director of the Division of Epidemiology-I at the Office of Surveillance and Epidemiology at CDER/FDA. Dr. Pinheiro has Doctorate and Master degrees in Epidemiology from the Harvard School of Public Health.
Lauren Shinaberry, MS
Director, Clinical Data and Reporting Standards Function, AbbVie, United States
Lauren is AbbVie’s Director of Clinical Data & Reporting Standards, a global team that defines standards for data collection through reporting. She has been an active volunteer in CDISC since 2004, most recently working with CDISC to define standards for the collection of Sexual Orientation and Gender Identity (SOGI). In 2022, along with AbbVie’s Office of Equity, Equality, Diversity & Inclusion she updated AbbVie’s standards for the collection of demographics data to provide more diverse responses to race, ethnicity, and gender identity. Lauren holds an M.S. degree in Mechanical Engineering and Biomechanics from The University of Toledo and has co-authored several published articles on clinical data standards over her 25 year career.
Susan Colilla, PhD, MPH
Senior Director, Epidemiology Lead, GHEOR & Epidemiology, Teva Pharmaceuticals, United States
Susan is currently at Teva Pharmaceuticals leading its Epidemiology group which provides RWE for Clinical Development, Medical Affairs and PV groups. In 2022, she established a Benefit-Risk Assessment Planning Process at Teva to be used for products from early development stage to post-marketing. Prior to that she was at CSL Behring where she was the Clinical Epidemiology Team Lead and developed an SOP for Benefit-Risk Assessment throughout the drug lifecycle. She has also worked in Epidemiology & Benefit Risk Evaluation and PV groups at Sanofi for over 3 years in rare disease, immunology and neuroscience. She received a Ph.D. in Epidemiology from Univ of Illinois School of Public Health and an MPH from Emory University.
Kevin Freiert, MBA
Owner and Chief Executive Officer, Salem Oaks® Consulting, United States
Kevin is a seasoned drug developer with outstanding people skills. His 30-year career with Pfizer gave him a broad and deep understanding of the Drug Discovery and Development Process. During much of his career he educated colleagues and others about Pharmaceutical R&D, including establishing and running Pfizer Research University. After retiring from Pfizer, Kevin started Salem Oaks® We empower patients to shape the future of medicine® through education about Drug Discovery and Development. He is also the VP/Board Member of Rare New England, a regional non-profit serving the rare community. Kevin also hosts Raising Rare and LEMS Aware podcasts.
Cynthia McShea, MPH
Head, Safety Statistics, UCB Biosciences, United States
Cindy McShea received a BS in Mathematics from East Carolina University in North Carolina, USA and completed an MPH in Biostatistics from the University of North Carolina at Chapel Hill in North Carolina, USA. Cindy is a senior director of Biostatistics at UCB Biosciences where she leads the Safety Statists team within the Biometrics and Quantitative Sciences group. She has over 25 years of experience in the pharmaceutical industry, 20 of which have been spent in statistical and leadership roles within late phase clinical development in neurology and immunology therapeutic areas. She is a contributing member of the Drug Information Association-American Statistical Association Aggregate Safety Assessment Planning Task Force.
Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including technology, processes, and relevant aspects of Pharmacovigilance Legislation. He is now accountable for Patient Safety Monitoring across medicines, vaccines, devices, defects and blood products. Phil was responsible delivery of MHRA systems for COVID-19 vaccine surveillance and their integration into the healthcare system. For several years he has led international projects to develop and deliver tools for global pharmacovigilance.
Paul Hayashi, MD, MPH
Physician Lead, DILI Team, Division of Hepatology and Nutrition,OND, CDER, FDA, United States
I am Physician Lead, DILI Team, FDA. I got my BA in microbiology at UCLA and MD at UC San Diego. After residency and gastroenterology training at UC Davis, I completed a research fellowship at the NIH and a transplant fellowship at the University of Colorado. I received an MPH at Saint Louis University, Missouri. In 2006, I became Medical Director of Liver Transplantation at the University of North Carolina serving in that capacity as associate and then full professor before joining the FDA in 2020. My research and publications have focused on drug-induced liver injury for the last 19 years. I was a Co-Investigator for the NIH Drug-Induced Liver Injury Network and remain Co-Chair of the Causality Committee.
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