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Global Pharmacovigilance and Risk Management Strategies Conference

Stay current with the latest safety regulations from global health authorities and regulatory experts!


Speakers

  • Annette S. Williams, MBA, RPh

    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 5,000 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 how Lifecycle Safety manages safety information and subsequent data analytics on behalf of its clients. Prior to IQVIA, she held leadership positions in both CRO and Pharma fields, including Drug Safety Alliance, Teamm Pharmaceuticals, and GSK.

  • James  Buchanan, PharmD

    James Buchanan, PharmD

    • President
    • Covilance LLC, United States

    After entering drug safety at Genentech, Dr. Buchanan created and led drug safety departments at Gilead, Tularik and Nuvelo. He next served with 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-chair for the American Statistical Association Biopharmaceutical Working Group and co-leads the task force developing open-source interactive safety graphics.

  • Barbara  Hendrickson, DrMed, MD

    Barbara Hendrickson, DrMed, MD

    • Clinical Associate
    • 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 and the implementation of internal data monitoring committees. In addition, she co-leads the DIA-ASA Aggregate Safety Assessment Planning Working Group.

  • Jeremy  Jokinen, PhD, MS

    Jeremy Jokinen, PhD, MS

    • Vice President and Head, Global Risk Management & International Patient Safety
    • Bristol Myers Squibb Company, United States

    Jeremy is the Vice President and Head, Global Risk Management and International Patient Safety at Bristol Myers Squibb. In this role, he leads a global team of risk management and safety science leaders responsible for insights, evidence generation, and risk minimization efforts ensuring the safety of patients worldwide. Jeremy is also active within numerous cross-industry pharmacovigilance initiatives and is a deputy topic lead for ICH expert working group E19. Jeremy has over 20 years of experience as a statistician in early phase to post-market pharmaceutical, biological, and medical device research. He holds MS and PhD degrees in quantitative psychology from Ohio University.

  • Mamiko  Kasho

    Mamiko Kasho

    • 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 13 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  Kindig, JD, MD

    Susan Kindig, JD, MD

    • Executive Director, Medical & Drug Safety
    • Halozyme, 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

    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.

  • Annette  Stemhagen, DrPH, PhD, FISPE

    Annette Stemhagen, DrPH, PhD, FISPE

    • Chief Scientific Officer and Senior Vice President
    • 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.

  • Mengchun  Li, MD, MPA

    Mengchun Li, MD, MPA

    • Director, Phamacovigilance
    • Global Alliance For TB Drug Development, United States

    Dr. Mengchun Li is the Director of Pharmacovigilance at TB Alliance. In this position, Dr. Li chairs the multidisciplinary safety management team for all compounds and is responsible for clinical safety and pharmacovigilance. Prior to this, Dr. Li worked at Janssen Pharmaceutical company (J&J), both in China and in the US, as a Study Responsible Physician in both 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.

  • Sarah  Vaughan

    Sarah Vaughan

    • Head of Vigilance Development
    • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

    Sarah has worked in pharmacovigilance at the MHRA for the past 15 years, with 6 years as the Pharmacovigilance Information Unit Manager. She has been MHRA representative on the MedDRA Points to Consider Group, and worked on implementation of the 2012 EU Pharmacovigilance legislation. Her current role is the Head of Vigilance Development, focussing on the development and transformation of the Agency's vigilance systems for all medicinal product types. Sarah leads on key projects in the Agency's Patient Safety function, engaging with strategic stakeholders in the UK healthcare system for adverse incident data collection and signal management processes.

  • Jo  Wyeth, PharmD

    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

    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

    Stella Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP

    • Vice President, Strategic Operations
    • IQVIA, 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 (8+ 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.

  • Mark  Perrott, PhD

    Mark Perrott, PhD

    • Managing Partner
    • Axian Consulting Ltd, 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 has included industry (Wellcome, GW, GSK and AZ) and consultancy roles (WCI, Foresight, PopeWoodhead and Huron). He is now focusing on the opportunities presented by improved benefit-risk management approaches to enhance development decision-making and add value to the interactions of industry and customers to maximise B-R balance and improve outcomes.

  • Michael  Richardson, MD, FFPM, FRCP

    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.

  • Gerald J. Dal Pan, MD, MHS

    Gerald J. Dal Pan, MD, MHS

    • Director, Office of Surveillance and Epidemiology, CDER
    • FDA, United States

    Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. 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.

  • Shyreen  Kamal, PharmD

    Shyreen Kamal, PharmD

    • Manager, Scientific Programs
    • DIA, United States

  • Sarah  Frise, PhD, MS

    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.

  • Amalia  Alexe

    Amalia Alexe

    • 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

    Andrew Bate, PhD, MA

    • VP, Head of Safety Innovation & 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

    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

    Jacqueline A. Corrigan-Curay, JD, MD

    • Principal Deputy Center Director, Center for Drug Evaluation and Research (CDER)
    • FDA, United States

    Jacqueline Corrigan-Curay, J.D., M.D., 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

    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 current 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

    James Duhig, PhD

    • Director, Patient Integration
    • 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.

  • Marie  Flanagan

    Marie Flanagan

    • 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

    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

    Michael Kruczek, MSc

    • Senior Director, Vault Safety Strategy
    • Veeva Systems, United States

  • Hu  Li, MD, PhD

    Hu Li, MD, PhD

    • Sr. Director, Real-World Evidence
    • Gilead Science Inc., United States

  • Srikanth  S, MPharm

    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

    Matthew Schrag, MD, PhD

    • Assistant Professor of Neurology & Director, Cerebral Amyloid Angiopathy Clinic
    • Vanderbilt University Medical Center, United States

  • Uwe  Trinks, PhD, MS

    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.

  • Catherine  Baldridge, MSc

    Catherine Baldridge, MSc

    • Head of Pharmacovigilance Affairs, Principal Consultant
    • RegDev, Inc., United States

    Catherine Baldridge has more than 18 years of experience in safety and pharmacovigilance, and currently 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 and a Masters of Science in Clinical Investigation and Patient Research from the University of Virginia. Catherine is an Adjunct Faculty member at Temple University, Graduate School of Pharmacy, instructing courses in Good Pharmacovigilance Operations and collaborating with several leading experts in updating relevant textbooks in field.

  • Greg  Ball, PhD

    Greg Ball, PhD

    • ASAP Expert
    • ASAP Process Consulting, United States

    Greg served in the Navy and taught HS math and physics before earning his MS in statistics from Purdue and PhD in biostatistics from the University of Texas. 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). He co-leads, with Mary Nilsson, the PhUSE Safety Analytics working group. Greg established, with Bill Wang, the ASA Biopharm Safety Monitoring working group and has been pioneering the joint DIA-ASA Interdisciplinary Safety Evaluation (DAISE) scientific working group, to advocate for aggregate safety assessments and cross-disciplinary scientific engagement.

  • Alie  Banner Simpson

    Alie Banner Simpson

    • Scientific Assessor, Benefit and Risk Management Group, Unit 1
    • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

  • Nicole  Baker, PhD

    Nicole Baker, PhD

    • CEO and Co-Founder
    • biologit, Ireland

  • Alisa Marie Hummings

    Alisa Marie Hummings

    • Sr. Director, CEVA and Medical Information
    • IQVIA, United States

  • Nicole  Kellier-Steele, PhD, MPH

    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

    Boaz Mendzelevski, MD

    • Consultant Cardiologist
    • Cardiac Safety Consultants Ltd., United Kingdom

  • Tom  Paternoster-Howe, MSc

    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

    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

    Y. Veronica Pei, MD, MEd, MPH

    • Associate Director of Biomedical Informatics, OND, CDER
    • 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 for Biomedical Informatics (ADBMI) for the Division of Gastroenterology (DG) and Division of Hepatology and Nutrition (DHN) 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.

  • Simone P. Pinheiro, MSc

    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

    Lauren Shinaberry, MS

    • Director, Clinical Data & 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.

  • Yijing(Hellen)  Zhang

    Yijing(Hellen) Zhang

    • 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.

  • Christopher  Flood, BSN, MBA

    Christopher Flood, BSN, MBA

    • Senior Director Safety Operations
    • Erasca, Inc., United States

  • Alyson  Karesh, MD

    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.

  • Lacey Leigh Lucree, MPH

    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.

  • Angelika  Manthripragada, PhD, MPH

    Angelika Manthripragada, PhD, MPH

    • Director, Pharmacoepidemiology
    • Regeneron, United States

  • Kimberly  Smith, MD, MS

    Kimberly Smith, MD, MS

    • Real World Evidence Analytics Team, Office of Medical Policy, Center for Drug Ev
    • FDA, United States

    Kimberly Smith is a nephrologist with the Real-World Evidence Analytics team in the Office of Medical Policy, 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 was 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 (CMS).

  • Mary  Thanh Hai, MD

    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 24 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.

  • Phil  Tregunno

    Phil Tregunno

    • 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 eighteen 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.

  • Cameron  Zimmermann, MBA

    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.

  • Susan  Colilla, PhD, MPH

    Susan Colilla, PhD, MPH

    • Senior Director and Head of Epidemiology
    • Teva Pharmaceuticals, United States

    Susan is currently at Teva Pharmaceuticals leading its Epidemiology team within GHEOR group, supporting RWE needs in Clinical Development, Medical Affairs and PV groups. Recentlly she has established a Benefit-Risk Assessment Planning Process at Teva. 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 Pharmacovigilance teams groups at Sanofi for over 3 years in rare disease, immunology and neuroscience. She received a Ph.D. in Epidemiology from UIC School of Public Health and an MPH from Emory School of Public Health.

  • Sara L. Eggers, PhD

    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

  • Kevin  Freiert, MBA

    Kevin Freiert, MBA

    • Owner and Chief Executive Officer
    • Salem Oaks® Consulting, United States

    Kevin is a seasoned drug developer with outstanding people skills. During his 30-year career with Pfizer, he held many varied roles that have given 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® Our purpose is to empower patients to shape the future of medicine® by providing education about Drug Discovery and Development. He is also the VP and Board Member of Rare New England, a regional non-profit serving the rare community. Kevin also hosts Improbable Developments, Raising Rare and LEMS Aware podcasts.

  • Paul  Hayashi

    Paul Hayashi

    • DILI team Lead, Division of Hepatology and Nutrition, Office of New Drugs, CDER
    • FDA, United States

  • Niklas  Noren, PhD, MSc

    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.

  • Dyan  Bryson

    Dyan Bryson

    • Founder, Patient Engagement Strategist
    • Inspired Health Strategies, United States

    Dyan Bryson is a patient engagement strategist and has forged the way for the patient engagement space since 2007. After spending 20+ years in traditional sales, sales leadership and marketing at Merck and Ciba-Geigy (now Novartis) Dyan has spent the last 15 years laser focused on patient engagement, patient advocacy, patient-centricity. Dyan makes the life sciences industry talk of being patient centered very real. In the last 2 years Dyan has used this patient centered lens to drive work in helping companies ensure diversity in clinical trials. She is currently working with ICON to support Janssen to develop and implement diversity in clinical trials efforts.

  • Cynthia  McShea, MPH

    Cynthia McShea, MPH

    • Safety Statistical Standards Lead
    • 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 director of Biostatistics at UCB Biosciences where she leads the Safety Statistical Standards team within the Statistical Sciences and Innovation 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.