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.

Mariette Boerstoel-Streefland, MD, MBA, MSc(epi), has been in the pharmaceutical industry for 30 years, and is currently SVP, Worldwide Patient Safety Officer at BMS. Mariette joined pharma industry from clinical practice in 1989 and held various leadership positions in drug safety at Organon (now Merck), Mayne Pharma (now Hospira/Pfizer), Forest Labs (now Abbvie). In 2014 she joined Baxter to establish a new safety organization for Baxalta, and upon the acquisition by Shire led the new combined safety organizations. In 2018 she moved to Alexion and with the acquisition by AZ was appointed Chief Safety Officer, SVP Global patient safety. In August 2023 she joined BMS. Mariette has an MD degree from the University of Utrecht, a MSc Pharma

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.

Scott Janiczak a Lieutenant Commander (LCDR) in the U.S. Public Health Service, who serves as a safety evaluator in the Office of Surveillance and Epidemiology’s, Division of Pharmacovigilance at FDA. In this role, he works with multidisciplinary scientific review teams throughout the FDA to evaluate adverse drug events detected during postmarketing surveillance activities. Prior to this position, he served as a regulatory project manager with the FDA's, Office of Generic Drugs for 6 years. LCDR Janiczak obtained his Doctor of Pharmacy from Midwestern University and holds a national board certification in Pharmacotherapy from the Board of Pharmacy Specialties.

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.

Susan most recently led the patient safety department at Halozyme and supported both the medical and regulatory functions there from March, 2022 to January, 2024. 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. She is currently starting a foundation to support camps for teens across the country who are interested in medicine.

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.

Joe obtained his BS degree in Pharmacy at Rutgers in 1983 and initially worked in clinical research in the pharmaceutical industry. After 10 years he obtained his PharmD at the University of Maryland. Since then he has had extensive experience in pharmacy benefits management, as a consultant pharmacist, and clinical pharmacy practice. Joe joined the FDA as a REMS assessment analyst in June of 2020 and has been the lead reviewer of assessment reports, methodology submissions, and assessment plan development for several REMS Programs. In July 2023 he transitioned to Associate Director of Medication Error and Risk Management Initiatives within the Office of Medication Error Prevention and Risk Management.

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.

Extensive experience in both post-marketing and pharmacovigilance in clinical trials for over 19 years. In-depth global filing experience as a safety lead for both small molecule and biologics. Instructor in Loyola PV Certificate Course. Co-chair of Cardiovascular Internal Safety Advisory Group at AbbVie. Member of DIA ASA Safety WG (workstream 3). Intimate knowledge of processes and regulations in ICSR, aggregate reporting and signal detection. Current knowledge of PV regulations including EU good pharmacovigilance practices. Comprehensive and current knowledge of Internal Medicine (current Board certification). Comprehensive knowledge of drug development process and conduct and reporting of post authorization.

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.

Dr. Tarek Hammad, VP & Head of Medical Safety for Marketed Products at Takeda Pharmaceuticals, is a renowned expert in drug safety, benefit-risk assessment, and pharmacoepidemiology. With extensive experience at major pharmaceutical companies like Sanofi and Merck, as well as a distinguished 13-year career at the US FDA, he has received numerous awards for his contributions. Dr. Hammad is a sought-after speaker, actively involved in industry initiatives and has held several academic appointments. He has authored over 80 peer-reviewed articles, book chapters, and letters to the editor, offering valuable insights in the field. Learn more at www.DrTarekHammad.com.

Stephanie is Head of the Immunology, Biocompatibility and Non-clinical team in the Safety and Surveillance group at the MHRA. Prior to her current role she held a variety of management and assessor positions in the Agency. She has a masters degree in Clinical Pharmacology and a PhD in Cell Biology. She joined the Agency following a career in academia and has now over 20 years experience in drug regulation with particular experience in post-authorisation procedures and pharmacovigilance.

Sorcha McCrohan is a Specialist of Scientific Programs for the Americas Region at DIA. In her current role, she focuses on content development and strategy for DIA's meetings to improve and facilitate innovation in clinical research, drug development, and the fields of devices and diagnostics. Before joining DIA, she conducted COVID-19 research in Chiapas, Mexico, and worked in marketing within Pfizer's Global Vaccines Meningococcal franchise. Sorcha holds a BA in Sociology from Mount Holyoke College and an MSc in Global Health, Disease Prevention & Control from Georgetown University.

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.

Dr. Marie Bradley is a Senior Advisor on the Real-World Evidence Analytics team in the Office of Medical Policy, Center for Drug Evaluation and Research (CDER), FDA. Her responsibilities related to real-world evidence (RWE) include serving as technical lead for externally conducted RWE demonstration projects, evaluating real-world evidence protocols, participating in internal Agency processes, interacting with stakeholders, and contributing to guidance development. She is a pharmacoepidemiologist and a pharmacist with over 14 years of experience working in regulatory, government, and academic sectors in UK and the US, including 10 years at the FDA.

Dr. Arie Regev is a gastroenterologist and hepatologist. He is a Vice President of Medical Global Patient Safety at Eli Lilly and Company. He heads Eli Lilly’s Safety Advisory Hub and is the chair of Eli Lilly's Liver Safety Committee. Dr. Regev is an associate professor of medicine at the division of gastroenterology and hepatology of Indiana University School of Medicine. He was the co-chair of the CIOMS working group on Drug Induced Liver Injury (DILI) and was the co-author of the CIOMS consensus summary on DILI. Dr. Regev was the founding co-chair of the IQ-DILI initiative, and he currently co-chairs 3 of IQ DILI's working groups. He is the author of more than 150 publications and book chapters in major scientific journals and books.

Conor Wyand currently is the Senior Director of Research Solutions at Truveta where he leads a team responsible for engaging with potential new life science customers. Prior to joining Truveta in 2021, Conor spent six years in various leadership positions at Optum Life Sciences, working with pharmaceutical and medical device manufacturers across the value chain to generate real-world evidence for therapeutics and devices. Conor graduated from Brown University with a bachelor’s degree in applied mathematics and economics.

Priya Bahri, RPh, PostGradDipEpi, PhD, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she also instigates research and regulatory frameworks for risk communication, stakeholder engagement for pharmacovigilance and implementation of risk minimisation in healthcare. Pro bono, she is active in the learned societies ISoP and ISPE and as associated researcher at Utrecht University. She is the editor of the Springer textbook "Communicating about Risks and Safe Use of Medicines - Real Life and Applied Research", published in 2020.

Andrew is VP and 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 AI RWE and signal detection and has participated in several international initiatives in the area. Andrew is Honorary Associate Professor of Epidemiology at LSHTM.. Andrew has and does contribute to several international initiatives and has been a member of the Transcelerate PV Steering Committee since 2020 and sponsor for several Transcelerate workstreams.

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.

Sylvia leads the safety team at BioCryst Pharmaceuticals, a small, rare disease biotech with globally marketed products and a clinical pipeline. She’s worked in industry, both PV and clinical development, for over 20 years, being a lead contributor to 3 NDAs and several sBLAs. With the help of a great team, she built the BioCryst PV function from scratch. Previously, she was the US Head of Safety Knowledge and Reporting at Quintiles (now IQVIA), a Safety Lead at Genentech and Roche, and a Safety Physician at Abbott Laboratories (now AbbVie). Prior to industry, she practiced medicine and taught residents at the Fineberg School of Medicine, Northwestern University. She earned her BS and MD degrees from the University of Miami.

As Practice Leader for Technology Solutions, Dosanjh is responsible for the overarching strategy regarding AI and Machine Learning as it relates to safety/pharmacovigilance. He focuses on the adoption of innovative technologies to help optimize pharmacovigilance activities for better, faster results. He has 25+ years of experience in the management, development, implementation, and operation of processes and systems within the life sciences and other industries. He has worked with WCI, Logistics Consulting Partners, Amersys Systems Limited, and FJ Systems. He holds a Bachelor’s degree in Materials Science from Manchester University and a Master’s degree in Advanced Manufacturing Systems and Technology from Liverpool University.

Dr. Salman Afsar, Senior Director and Signal Management Team Chair at Bristol Myer Squibb, is a distinguished physician specializing in Medical Safety Assessment. With a strong background in the pharmaceutical industry including notable positions at Sanofi and Astellas, Dr. Afsar brings extensive expertise to his role. Before transitioning to industry he made significant contributions in academia and clinical practice, earning him prestigious awards for his exceptional work.

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 signal and benefit-risk management. He is engaged in developing and applying (benefit-) risk analysis and signal management 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.

Dr. Maro is an Assistant Professor in the Department of Population Medicine at Harvard Medical School and the Harvard Pilgrim Health Care Institute. She received her doctorate in Engineering Systems at the Massachusetts Institute of Technology (MIT). She is also the Operations Lead for the Sentinel Operations Center (housed at Department of Population Medicine at Harvard Medical School and the Harvard Pilgrim Health Care Institute) as part of the U.S. Food and Drug Administration’s Sentinel System. The Sentinel Operations Center is responsible for the coordination of data curation, management, and utilization activities among multiple data partner sites covering data on several hundred million patients.

Elspeth McIntosh began her career in the pharmaceutical industry in 1993, initially working in clinical research, before moving into Pharmacovigilance. She has extensive experience of all aspects of pharmacovigilance and has been a small company QPPV since 1999, dealing with innovative, generic and biotech/biological products. Elspeth set up Castle Pharmacovigilance in 2009 and post Brexit she is a UK QPPV and UK National Contact Person for several small pharma companies and provides general PV support to a wide range of pharma companies.

Ed Millikan, PharmD, is the Senior Clinical Informatics Pharmacist in the Office of Surveillance and Epidemiology (OSE), within FDA’s Center for Drug Evaluation and Research. He has over 25 years of experience with healthcare terminologies (e.g., NLM RxNorm, SNOMED CT) and data standards (e.g., NCPDP SCRIPT, HL7® FHIR®), REMS interoperability, and coding. Dr. Millikan currently serves as a champion for the HL7® CodeX® REMS Integration Use Case and is a co-lead for the HL7® Vulcan® Adverse Event project. Dr. Millikan graduated magna cum laude from the Campbell University School of Pharmacy and completed a residency in Drug Information and Pharmaceutical Informatics at the University of California, San Francisco and First Databank.

Frank is a full-time Professor of Biostatistics and Bioinformatics at Duke University Medical Center and Managing Partner of HunterRockhold, Inc., which provides strategic consulting to Industry and Government. His career includes senior positions at Lilly, Merck, and GlaxoSmithKline, where he retired as Chief Safety Officer. He has held faculty appointments at six different universities, served as Chairman of CDISC, and is past president of the Society for Clinical Trials. Frank holds a BA in Statistics and an ScM and PhD in Biostatistics. Frank is a Fellow of the American Statistical Association, The Royal Statistical Society, and the Society for Clinical Trials and is widely published across a wide variety of research topics.

I am a post-doctoral scientist in the Global Patient Safety organization within Eli Lilly supporting pharmacovigilance safety signal management through AI use case development. My prior doctoral research focused on the intersection between nutrition and alcohol-associated liver disease with a focus on bio-active lipid metabolites as exogenous therapies via in vivo models. In my current role, I've taken the lessons and strategies learned from the bench and applied them to PV science to enhance our ability and capacity to manage safety signals.

Ellen Janssen in a Director of Benefit-Risk Assessment/Epidemiology at Johnson and Johnson. In her work she lead structured benefit-risk assessments throughout the product lifecycle and conducts patient preferences studies to inform patient-focused decision making. Ellen is passionate about ensuring that patient-focused decision making is incorporated throughout the medical product lifecycle. She is/has been involved as a preference expert in IMI PREFER, MDIC, BIO Patient Focused Drug Development Task Force, and the ISPOR Taskforce on using patient preferences to inform decision making.

Melvin S. Munsaka is a Senior Director and Head of the Safety Statistics at AbbVie in the Statistical Sciences and Analytics Department. He has a PhD in Mathematical Statistics from Queen’s University in Canada. He has been in the industry for more than 25 years. He co-leads the DIA Bayesian Scientific Working Group Safety Subteam and the ASA BIOP Section Safety Scientific Working Group Methodology Sub-team, and some initiatives of the PHUSE Safety Analytics and the Data Visualization and Open-Source Technology Working Groups. He is the Publicity Chair of MBSW and an Editorial Board Member of Contemporary Clinical Trials and a lecturer at the University of Chicago Graham School.

Victoria Sammarco, PharmD, MBA is a Risk Management Analyst in the Division of Risk Management in the Office of Surveillance and Epidemiology at FDA. As a Risk Management Analyst, she has worked on the design, implementation and evaluation of Risk Evaluation and Mitigation Strategies (REMS) for drugs in a variety of therapeutic areas, as well as in REMS modernization efforts. Previous to this role, she practiced at the Johns Hopkins Hospital for over ten years, serving in range of roles supporting medication safety for children and adults. She received a PharmD and MBA from the University of Maryland/University of Baltimore in 2012 and 2013, respectively.

Jamie Wilkins, Pharm.D. is an experienced pharmacist and former regulator currently responsible for partnering with internal and external stakeholders on delivering innovative, strategic global safety and risk management excellence for Pfizer’s drug and biologics portfolio. Prior to her role at Pfizer, Jamie served as the Deputy Director for the Division of Risk Management (DRM) at the US FDA. She is a two-time recipient of the FDA Francis O. Kelsey drug safety award, and has a deep passion for safety, and risk management science. Jamie earned her Doctor of Pharmacy degree in 2008 from the University of Maryland School of Pharmacy, and in her free time, enjoys spending time with her children and watching softball.

Rob Massouh, is the Head of Safety (PV) Risk Management and Benefit-Risk Evaluation at GSK. In this role, he serves as the subject matter expert in risk management strategy and benefit-risk evaluation. Rob was previously at the MHRA working as a Scientific Assessor within the Benefit Risk Management Group. Rob is a registered Pharmacist and received his MPharm at the University of Manchester.

Gita A. Toyserkani, PharmD, MBA, is the Associate Director for Research and Strategic Initiatives in the Division of Risk Management in FDA’s Office of Surveillance and Epidemiology. She has over 15 years of experience in drug safety and advises on pre and post-marketing activities and policies involving REMS for products regulated by CDER. In her current role, Dr. Toyserkani overseas research activities related to risk minimization. Dr. Toyserkani has led several REMS standardization efforts and initiatives to advance the science of risk minimization. Her career at FDA started in 2005 as a Safety Evaluator in the Division of Pharmacovigilance. Prior to FDA, she was a clinical pharmacist at Walter Reed National Military Medical Center.