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 20 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 aggregate safety assessment plans, internal data monitoring committees, and IND aggregate safety reporting procedures. In addition, she co-leads Workstream One of the American Statistical Association's Biopharma Safety Working Group.

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.

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 studies.

Bethany Van Veen has focused her entire career on pharmacovigilance (PV). In 2017, she founded Perspective Pharmacovigilance, a think tank of PV experts. PPV’s global staff of industry leaders, former PV department heads, and ex-regulators, design innovative solutions to a rapidly changing PV landscape. Bethany is passionate about cultivating PPV’s unique environment where the global team can do the work they love with people they trust. Bethany is also an adjunct professor at San Francisco State University teaching the Safety Monitoring Course for the Clinical Trials Design and Management Certification.

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.

Dr. Kacker is a Pharmacologist by training, having completed his PhD in Pharmacology from All India Institute of Medical Sciences in India. Dr. Kacker switched his interests from academia to pharmaceutical industry more than 18 years ago, and has managed the Regulatory and Pharmacovigilance functions at global organizations. Dr. Kacker is a co-founder of APCER Life Sciences, having started the company out of UK more than 11 years ago. In his current role he operates as the Managing Director and Global Technical Head of APCER. Dr. Kacker has been a Qualified Person/Person Responsible for Pharmacovigilance with experience of more than 17 years as EU-QPPV and in his current role he does operate as the EU-QPPV for some of APCER’s clients.

Stephanie is the Deputy Director of Benefit Risk Evaluation II 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 before earning his MS in statistics from Purdue University and his PhD in biostatistics from the University of Texas. He co-led a 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 with statistical and clinical scientists at several pharmaceutical companies. Greg co-leads the PHUSE Safety Analytics working group; he was instrumental in establishing the ASA Biopharm Safety Monitoring working group; and he helped pioneer the joint DIA-ASA Interdisciplinary Safety Evaluation (DAISE) working group to advocate for aggregate safety assessments and cross-disciplinary scientific engagement.

Tamei Elliott, MS, serves as the Associate Director of Scientific Programs for the Americas region at DIA. In this pivotal role, she is responsible for identifying and prioritizing content areas and topics crucial to DIA constituents. Tamei assesses the implications of significant regulatory and health policy changes, seamlessly integrating relevant content into the development and advancement of DIA conferences and courses. Her responsibilities extend to overseeing content development and strategy within the Americas region.

Jamie is the founder and principal consultant of Cross BioConsulting LLC, providing regulatory services. With a career spanning nearly 25 years, he served most recently as Senior Vice-President of Regulatory Affairs at Asher Biotherapeutics, where he built the Regulatory, Quality, Safety, and Medical Writing functions from the ground up, culminating in the approval of two INDs, thereby transforming the company from a research-stage to a clinical-stage organization. He has held roles of increasing responsibility at large and small companies, including Genentech, Halozyme, Forty Seven. He started his career at the US Food and Drug Administration, Office of New Drugs, supporting drug review activities and policy development.

I am pharmacist with 25 years of pharmaceutical industry experience in pharmacovigilance, medical information, scientific publications, but primarily in Risk Evaluation and Mitigation Strategies (REMS). I have worked as a consultant to pharmaceutical companies who need to develop a REMS program. I am currently working at Bristol Myers Squibb in REMS Strategy & Submissions overseeing several REMS programs.

Dr. Samer El-Kamary is a Medical Director and Global Safety Lead at Takeda Pharmaceuticals, with expertise in epidemiology and drug safety. He brings a wealth of experience from his 14-year tenure as a tenured professor at the University of Maryland and a distinguished 5-year career at the U.S. FDA, where he received numerous awards for his contributions to drug safety, regulatory work, clinical research, education, and mentorship. Dr. El-Kamary has been an invited speaker at international conferences and academic institutions and has authored over 75 peer-reviewed articles, several book chapters and published abstracts. He is a licensed, board-certified pediatrician, and completed his fellowship and M.P.H. at the Johns Hopkins University.

An oncologist and clinical pharmacologist with over 25 years’ experience in drug development and safety of oncology, neurology, and metabolic disease products, Peg developed TAP Pharma's safety review process, led the protocol review team, and has led or supported safety portions of many NDAs and sNDAs. For the past 12 years she has led MedAssessment, a small PVG CRO focused on safety in early development. Peg received her MD & PhD (biochemistry) from U Chicago and boards in Oncology and Clinical Pharmacology.

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.

Tiffany Studebaker Freeman is the Director of Operations & Finance for PALTOWN Development Foundation, where she drives operational excellence and financial management for programs like COLONTOWN, an online community supporting over 13,000 colorectal cancer patients and caregivers across the globe. Previously, Tiffany was a small business owner, professional musician, and homeschooler to six children in the Appalachian Mountains of southwest Virginia, sharpening her skills in leadership, adaptability, and creativity. As a stage 3b colorectal cancer survivor of five years, Tiffany’s personal experience fuels her passion for empowering others and inspiring hope, ensuring that no one faces colorectal cancer alone.

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 is an Honorary Professor of Epidemiology at LSHTM. Andrew has and does contribute to several international initiatives and has been a member of the Transcelerate Intergrated Leadership Team, and PV Steering Committee since 2020.

Over the past 25+ years, CJ Delgra, developed significant expertise in medical safety review, case management and operations, aggregate safety reports, inspection management, vendor oversight and outsourcing, process development, during his time within PV departments at several global companies. Currently a Strategic PV Advisor with Perspective Pharmacovigilance. Previously, CJ was the VP Medical Review & Case Management, at BeiGene (now BeOne) and has worked in leadership positions at Amgen, Genentech/Roche, Merck-MSD, and Celgene/BMS. CJ has been active with Transcelerate PV projects, and a past speaker at ASCO and LUNGevity on compliance with the FDA “Final Rule” and reducing uninformative IND Safety reports to FDA and Investigators.

Balmeet Gurm is an accomplished physician with extensive experience in the pharmaceutical industry, specializing in oncology and cardiovascular therapeutic areas. Currently serving as Executive Director, Therapeutic Area Lead in Patient Safety at Bristol Myers Squibb (BMS), Balmeet brings a wealth of expertise in pharmacovigilance, risk management, and drug development. Balmeet transitioned to the pharmaceutical industry after practicing medicine for a few years and has held critical leadership roles in safety and pharmacovigilance across multiple organizations. Throughout a distinguished career, Balmeet has contributed significantly to advancing patient safety, regulatory compliance, and the successful development of innovative therapie

Lubna is a Director in the Risk Management Center of Excellence at Pfizer, Inc., where she is responsible for the strategy and implementation of risk management plans globally. Dr. Merchant provides global leadership in delivering innovative and strategic risk management excellence, regulatory compliance, effectiveness evaluation, and operational excellence for Pfizer’s portfolio of drug products with risk management programs. Prior to joining Pfizer, Dr. Merchant was the Deputy Director of the Office of Medication Error Prevention and Risk Management in FDA’s Center for Drug Evaluation and Research’s (CDER) where she was responsible for the Center’s programs in risk management and medication error prevention.

My love for patient safety has expanded over 17 years and continues to drive me today. Working with a passion for risk management and ensuring patients are armed with the tools they need to achieve the best results from their therapy is very important. Beginning my career in a lab as many of us scientists have done was instrumental in helping me carve out this niche area of interest in pharma. It gave me insights for this industry by allowing me to see the drug development process from beginning to end. As a chemical engineer in my early days in pharma, I learned about the importance of compliance and material handling for finished products and began to appreciate the need for safety measures throughout the life cycle of a product.

Leo is a native of Montreal, Canada. He completed his medical studies and a residency in Obstetrics and Gynecology at McGill University, followed by a fellowship in Reproductive Endocrinology and Genetics and serving as a faculty member at the Medical College of Georgia. This was followed by a number of roles with increasing responsibility in development, medical affairs at pharmacovigilance at Eli Lilly, Bayer Pharmaceuticals and Gilead Sciences, Inc. He currently is Vice President and Global Head of Patient Safety at Gilead. He is a member and sub-group co-chair of the Council for International Organizations of Medical Sciences (CIOMS) workgroup XII, on Benefit-Risk Assessment of Medicinal Products.

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.

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.

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.

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 Associate 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 a site principal investigator for the U.S. Centers for Disease Control and Prevention’s Vaccine Safety Datalink and also the Operations Lead for the Sentinel Operations Center 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.

Her work focuses on structured benefit-risk (sBR) assessment, leveraging her Ph.D. in Quantitative Research Methodology to drive patient-centric approaches in drug development. She specializes in quantifying uncertainty in benefit-risk trade-offs using methodologies like Bayesian analysis and Multi-Criteria Decision Analysis (MCDA). Jiyoon has contributed to key safety analytics and patient-centered frameworks aligned with regulatory requirements. Her work informs decision-making through innovative tools, automation, and collaboration with cross-functional teams, ensuring optimized therapeutic outcomes and patient safety.

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.

Dr. Zakaria holds a Doctoral degree in pharmacy from Algeria and a Pharmacovigilance certificate from France. He started his career in Pharmacovigilance at Roche Pharmaceutical, where he has also served in different roles in Medical Affairs and Products Quality. Dr. Zakaria joined Boehringer Ingelheim in February 2019 as Pharmacovigilance Manager for the North-West Africa Region and is currently the regional Pharmacovigilance Lead for the IMETA region (India, Middle East, Turkey, and Africa) based in Dubai-UAE.

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.

Dr. Cohen is a Senior Medical Director in Pharmacovigilance at AbbVie Inc. and has served as Chair of AbbVie's Liver Internal Safety Advisory Group (ISAG) since 2017. He completed a Gastroenterology and Hepatology fellowship at Yale-New Haven Medical Center in 2009 and an Advanced fellowship in Transplant Hepatology at Beth Israel Deaconess Medical Center-Boston in 2010. He is a subject matter expert in Drug-induced liver injury (DILI).

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.

Dr. Steve Knowles has 20+ years of experience in the pharmaceutical industry. Currently he is VP Drug Safety & Pharmacovigilance at Crinetics Pharmaceuticals, a clinical stage Biotech company. Prior to this he was Chief Medical Officer and head of pharmacovigilance at Halozyme Therapeutics and prior to that worked at Eli Lilly in various roles of increasing responsibility in Global Patient Safety. Steve earned his medical degree in the UK and worked in the UK Health Service for 17 years.

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.

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.

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.

Ramon Dempers, Founder and President of Invaryant Inc., brings over four decades of expertise in engineering, business, and technology, with the last two plusdecades dedicated to healthcare innovation. With a background that spans leadership roles at Sun Microsystems, IBM Global Services, and the successful founding of three start-ups, Dempers has been instrumental in pioneering technologies that improve patient safety, access, and affordability in healthcare. A thought leader and advocate for patient empowerment, he has developed and patented AI-driven technologies and collaborated with leading institutions to tackle patient safety. Dempers is a globally recognized speaker on ethics in AI and life science and health IT innovation.