Speakers

Stephen Knowles, MD, MRCP

Chief Medical Officer
Halozyme Therapeutics, United States

Steve received his MD from the University of Newcastle Upon Tyne, UK and worked in the UK National Health Service for 17 yrs. He joined Halozyme in 2018 as Vice President, Drug Safety & Pharmacovigilance and became Chief Medical Officer in January 2020, with responsibility for Drug Safety, Medical and Regulatory. Prior to this, Steve worked at Eli Lilly for 16 years, 12 years of which was in drug safety in various roles of increasing responsibility involving safety operations and drug safety surveillance

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.

Mariette Boerstoel-Streefland, MD, MBA, MS

Senior Vice President Patient Safety, Chief Safety Officer
AstraZeneca, United States

Mariette Boerstoel-Streefland, MD, MBA, MS(epi) is SVP, Chief Safety Officer at AstraZeneca following the Alexion acquisition in 2021. Prior to her current role she was SVP Global Safety at Alexion Pharmaceuticals, Inc. Before that Mariette was SVP, Head of Global Drug Safety at Shire, having been appointed to lead the safety organization after the Baxalta acquisition in 2016. She joined Baxalta two years prior to establish their safety department with the split off from Baxter. Mariette joined the pharmaceutical industry from clinical practice and had a progressive career, holding various leadership positions in drug safety and medical affairs at Organon (now Merck), Mayne Pharma (now Hospira), Forest Labs (now Allergan) for 30 years.

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.

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.

E. Stewart Geary, MD

Senior Vice President
Eisai Co., Ltd., Japan

E. Stewart Geary, MD, is Global Safety Officer at Eisai Co., Ltd. He is a Councilor of the Japanese Association of Pharmaceutical Medicine and serves on the Editorial Advisory Board for the Journal of Pharmaceutical Medicine. A member of CIOMS XII, he also served on the CIOMS VII Working Group on the Development Safety Update Report, CIOMS VIII on Signal Detection, CIOMS on Standardized MedDRA Queries, CIOMS IX on Medicinal Product Risk Management and CIOMS Working Group on Drug-Induced Liver Injury. Dr. Geary is a DIA Fellow, a Fellow of the Academy of Physicians in Clinical Research and an IFAPP Global Fellow in Medicines Development. He earned a BA from Harvard and MD from Stanford Medical School.

Jeremy Jokinen, PhD, MS

Vice President and Head, Global Risk Management and International Patient Safety
Bristol Myers Squibb, 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 for DIA, TransCelerate, and ICH. 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.

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.

Linda J. Scarazzini, MD, RPh

Vice President, Pharmacovigilance and Patient Safety
AbbVie, United States

She is currently Vice President, Head of Pharmacovigilance and Patient Safety at AbbVie. Prior to joining AbbVie, Dr. Scarazzini served as Director of the Division of Pharmacovigilance in the Office of Pharmacovigilance and Epidemiology, CDER, FDA. She began her career in pharmacovigilance at Sanofi-Aventis, ultimately serving as Associate Vice President of Pharmacovigilance and Risk Management. In 2016, she was selected by her industry peers to serve as the BioPharma Representative on FDA Drug Safety and Risk Management Advisory Committee. Dr Scarazzini’s publications include the recently-released textbook “Pharmacovigilance: A Practical Approach,” as co-author and co-editor along with members of her AbbVie PV team

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.

Annette Stemhagen, DrPH, PhD, FISPE

Chief Science Officer
UBC, United States

Dr. Annette Stemhagen is an epidemiologist, with >30 years of public health research experience, including 20+ years in the biopharmaceutical industry. She provides strategic consulting in epidemiology, pharmacovigilance, and risk management. She develops and implements creative and innovative epidemiologic study design solutions. She also has extensive expertise designing and implementing risk intervention programs, risk management evaluation studies, Risk Evaluation and Mitigation Strategies (REMS), and risk minimization programs for EU Risk Management Plans for more than 120 products. She was appointed as the first Industry Representative to the FDA Drug Safety and Risk Management Advisory Committee.

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.

Updesh Dosanjh

Practice Leader, Technology Solutions
IQVIA, United States

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.

Courtney Granville, PhD, MPH

Director, Scientific Affairs
DIA, United States

Dr. Granville provides insight, guidance, and a collaborative approach to build DIA’s thought leadership, research and content strategy to support innovation and building efficiency in drug, device and diagnostics development. She brings 2 decades of regulatory science-related research experience to her role at DIA. Her research career focused on developing data to support regulatory decision making in the fields of tobacco regulatory science, preclinical and molecular toxicology, nonclinical drug development, and public health. She holds a BS in Biology from Yale University, an MSPH in Environmental Health from UNC Chapel Hill and a PhD in Biochemistry and Molecular Genetics from George Washington University.

Jamie Portnoff

Partner, Co-Founder
Truliant Consulting, United States

Jamie Portnoff is a Founder and Partner at Truliant Consulting. Prior to founding Truliant Consulting, Jamie served as Vice President, Business Transformation at Foresight Group International AG and Senior Director and Global Practice Leader at IQVIA. Jamie held various pharmacovigilance operations and compliance roles at Elan Pharma and Hospira. Over the course of her consulting career, Jamie has led and supported large and small-scale transformation projects in pharmacovigilance, regulatory affairs and manufacturing. Jamie graduated from Northwestern University and holds her Regulatory Affairs Certification (RAC-US).

Chelsea O'Connell, MS, RAC

Director, Global Regulatory and R&D Policy
Amgen, United States

Chelsea O’Connell, MS, RAC, joined Amgen in 2011 and is currently a Global Regulatory and R&D Policy Director, where she advances strategic regulatory policy goals by engaging with regulatory authorities, industry, professional associations, and other stakeholders across various policy topics. Prior to joining Policy, she led regulatory teams and developed filing strategies across various therapeutic areas and product presentations including companion diagnostics, combination products, and software. Prior to joining Amgen, she worked for ophthalmic and cardiac medical device companies. She earned a B.S./M.S. from California Polytechnic State University, San Luis Obispo in Biomedical Engineering.

Barbara Hendrickson, DrMed, MD

Clinical Associate, Pediatric Infectious Diseases
University of Chicago, United States

Dr. Barbara Hendrickson is a former Vice President of Pharmacovigilance and Patient Safety at AbbVie. She is currently on faculty at the University of Chicago. Dr. Hendrickson is a physician with subspecialty training in pediatrics and infectious diseases and has 19 years of pharmaceutical industry experience. Dr. Hendrickson has been involved in multiple new product and additional indication submissions. She also has participated in several clinical trial safety initiatives related to implementation of internal data monitoring committees and IND aggregate safety reporting procedures. In addition, she co-leads the DIA-ASA Aggregate Safety Assessment Planning Working Group.

Vera Liang, MD

Sr. Director, Drug Safety Unit Regional Head - APAC
Pfizer (China) R&D Co., Ltd., China

Vera is a pharmaceutical physician with more than 20 years’ experience in the pharmaceutical industry. She joined the industry after receiving her Medical Degree from the Medical School of Fudan University in China. Vera currently works for Pfizer, managing all country safety organizations across the APAC region. Prior to her current role, she was the Disease Area Cluster Lead (DACL) within the global Safety Surveillance and Risk Management organization in Pfizer. Vera is a well-recognized drug safety expert. She has been active in partnering with Chinese Health Authorities, academia, and varied organizations to grow the PV expertise in China.

George N. Pajovich, RPh

VP, Head of Safety Quality and Risk Management
Pfizer Inc, United States

Geo Pajovich is currently Vice President, Head of Product Safety Surveillance and Reporting within the Pharmacovigilance group at Pfizer, Inc. His main responsibilities include systems and processes for ICSRs and aggregate reports. Geo holds a bachelor of Science degree in Pharmacy with over 22 years of experience in Signal Detection, Risk Evaluation and Risk Management, adverse event reporting, Project Management, quality systems, audits/inspections, and training within the pharmaceutical industry.

David G Rand, PhD

Erwin H. Schell Professorship & Professor of Management Science, Sloan School
Massachusetts Institute of Technology, United States

Carrie Scott

Director, Safety Compliance, Pharmacovigilance and Patient Safety
AbbVie Ltd, Portugal

Currently Director of Global Safety Compliance, with responsibility to set strategic direction for an optimised pharmacovigilance quality management system. Carrie holds a BSc Biochemistry with Pharmacology. Carrie worked at the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, holding a variety of positions, including Pharmacovigilance Inspectorate Operations Manager & Senior Pharmacovigilance Inspector, and other roles in the Enforcement and Post-Licensing Divisions. Carrie took a lead role in the publication of the MHRA's Good Pharmacovigilance Practice Guide and also contributed to the development of the EU Good Vigilance Practice modules. Carrie has also held other PV Compliance and Quality Assurance roles.

Patrick M. Caubel, MD, PhD, MBA

Chief Safety Officer
Pfizer, United States

M.D. degree, with specialization in Gynecology, Obstetrics & Oncology, from the University of Paris XIII, followed by a Ph.D. in Clinical and Experimental Pharmacology from the University of Paris VII and later an M.B.A from Rutgers University. He worked in positions of increasing responsibility first in academia, and subsequently for Merck KgaA in Germany followed by Johnson & Johnson in the United States. Patrick led Global PV at Sanofi-Pasteur (vaccine division of the Sanofi group), before being promoted to Sanofi-Pharma as Global Head of Pharmacovigilance & Epidemiology. Patrick Joined Pfizer in 2014, has numerous publications in the areas of reproductive medicine, epidemiology and pharmacovigilance.

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.

Georgy Genov, MD

Head of PHV Office, ad-interim Head of Quality & Safety of Medicines Department
European Medicines Agency, Netherlands

Dr Georgy Genov is qualified as medical practitioner. He joined the pharmaceutical industry in 1998. Since then he has gained experience in Drug Development, Medical Affairs and Pharmacovigilance. In 2010, he joined the Pharmacovigilance and Risk Management team of the European Medicines Agency. In 2011 Dr Genov was appointed Head of Pharmacovigilance Office, which provides leadership and coordination across the pharmacovigilance activities of the Agency, including coordinating the EMA pharmacovigilance matrix and the EU-level activities across the Member States.

Cynthia LaCivita, PharmD

Director, Division of Risk Management, OMEPRM, OSE, CDER
FDA, United States

Cynthia LaCivita earned her undergraduate degree in microbiology and Doctor of Pharmacy from the University of Maryland (U of MD) and completed an oncology residency at the University of Maryland Cancer Center (UMCC). She was an assistant professor in the Department of Pharmacy Practice and Science at the U of MD School of Pharmacy and assistant professor of Oncology at UMCC, Director of Clinical Standards and Quality for the American Society of Health-System Pharmacists (ASHP) and Director of Education and Special Programs for the ASHP Research and Education Foundation. In April 2010 she joined the Food and Drug Administration, she has served as the director of Division of Risk Management (DRM) since 2015.

Mengchun Li, MD, MPA

Senior Director, Clinical Research, Infectious Disease
Merck & Co., Inc., 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.

Makoto Miyazaki, MSc

Medical/Data Science, Safety Risk Management, Pharmacovigilance, Japan Developme
MSD K.K., Japan

Makoto Miyazaki (Pharmacist) is currently working as an associate director, Drug Safety / Pharmacoepidemiology at MSD K.K. He earned both Bachelor and Master degree in pharmacology from Tokyo University Japan. In 2011, after experiencing activities for safety and quality of pharmaceutical products in Eli Lilly Japan, he joined MSD K.K. for pharmacovigilance activities of various therapeutic areas including vaccines / infections. He is recently focusing on optimizing a utilization of real-world data (e.g. claims, electronic health records and DPCs) into pharmacovigilance activity, based on his background expertise of pharmacoepidemiology.

Magnus Nord, MD, PhD

Vice President, Global Patient Safety BioPharma
AstraZeneca, Sweden

As Vice President Global Patient Safety BioPharma Magnus leads an organization with physicians & scientists across US, Spain, India and Sweden responsible for clinical safety and PhV from first time in man to post-market surveillance. Magnus joined industry in Early Clin Development. After a period as Project Director at a Swedish government health agency, he rejoined AstraZeneca and has since then held safety roles of increasing seniority in CNS, Respir&Immunol/Inf/Vaccines and CVRM Therapy Areas, as well as in Enabling Safety Science. Magnus has a strong academic background with an adjunct Professorship at the Karolinska Institute where he, before joining industry, led basic-translational-clinical research in parallel to clinical work.

Sandra Quinn, PhD, MEd

Chair, Family Science and Senior Associate Director, Maryland Center for Health
University of Maryland School of Public Health, United States

Nusrat Sultani

Associate Director Safety Compliance
Abbvie, United States, United States

I have been in the pharmaceutical industry for 20 years. About half the time focused in clinical trial management and the recent half focused on compliance, mainly supporting PV related audits and inspections. I find inspections and audits to be truly learning experiences and a chance to showcase how well your system and processes function but to also learn what can be even better.

Lothar Tremmel, PhD

Vice President, Quantitative Clinical Sciences and Reporting
CSL Behring, United States

Dr. Tremmel worked in the pharmaceutical industry for over 25 years, where he built and led highly effective groups of statisticians, programmers, and data managers. He is currently the VP of Quantitative Clinical Sciences and Reporting at CSL Behring. Recent appointments include Statistical Head for Astra Zeneca’s Diabetes Portfolio, and VP of Statistics and Programing at Incyte. Dr. Tremmel provided technical leadership for >10 successful new drug applications and label extensions in the areas of CNS/Pain, Oncology, digestive / metabolic disease, and orphan diseases. Dr. Tremmel holds a Ph.D. from the university of Giessen, Germany, and he an active contributor to the DIA Safety Statistics Working group.

Howard Chazin, MD, MBA

Director, Division of Clinical Safety and Surveillance, OSCE, OGD, CDER
FDA, United States

Dr. Chazin joined FDA in 2002 and has held several leadership positions related to clinical policy and safety of new drugs, biologics and generics. He is the Director of the Division of Clinical Safety and Surveillance in the Office of Generic Drugs' Office of Safety and Clinical Evaluation. He leads several multidisciplinary teams of physicians, pharmacists, nurses, and data analysts tasked with identifying and assessing emerging complex safety issues related to potentially inferior generic drug products and addressing all Risk Evaluation and Mitigation Strategies for generic drugs. He also provides oversight on assessment of critical aspects related to challenging, controversial and sensitive generic drug safety issues.

Julio Guy Ciolfi Pinto, MD, MBA

Director, Regional Safety Excellence LATAM
Brazil

Julio Ciolfi, MD, MBA is Director, Regional Safety Excellence Latin America at AstraZeneca Rare Disease, world leader in the rare disease segment. Coming from clinical practice as a neurologist, Julio has 19 years of experience in the pharmaceutical industry, having held many local and regional leadership roles with increasing responsibility at Schering AG, Merck Sharp and Dohme and Bayer in Medical Affairs, Clinical Operations and Pharmacovigilance.

Marianne Hamilton Lopez, PhD, MPA

Research Director, Value-Based Payment Reform
Duke-Margolis Center For Health Policy, United States

Marianne Hamilton Lopez, PhD, MPA is Research Director of Value-Based Payment Reform at the Duke-Robert J. Margolis, MD, Center for Health Policy. She focuses on value-based payment models for medical products; oversees a multi-stakeholder Consortium; and partners with faculty and external health experts to advance this work. Dr. Hamilton Lopez was previously with the National Academy of Medicine, AcademyHealth, the US Cochrane Center, and US Department of Health and Human Services.

Viola Macolic Sarinic, DrSc, MD, MSc

PRAC Scientific Lead
European Medicines Agency, Netherlands

Viola Macolic Sarinic is a medical doctor, clinical pharmacologist by specialisation who holds a PhD in Pharmacogenomics applied to Biosciences and a master’s in Clinical pharmacology (pharmacokinetics). More than 20 years’ experience as a clinical pharmacologist and pharmacovigilance specialist, both in university hospital and in the medicines regulatory authority in Croatia working at the positions of a clinical and pharmacovigilance assessor, head of the PV department, national PRAC and CHMP member at the European medicines agency (EMA) and served for four years as the director of the Croatian medicines agency (HALMED). Currently at EMA as the PRAC Scientific Committee Lead and Scientific adviser on safety of medicines in the PV office.

Carrie Nielson, PhD, MPH

Observational Research Senior Manager
Amgen, United States

Carrie focuses on design and analytic methods for RWD in the Center for Observational Research at Amgen. Her experience includes descriptive and comparative effectiveness studies to support new indications, label expansion applications, and post-marketing drug utilization and comparative safety studies. In the Center for Observational Research, she guides innovative study designs and analytic methods to combat confounding, time-related biases, and misclassification of exposures and outcomes.

Sophie Radicke, MSc

Head of GPvP and Senior Pharmacovigilance Inspector
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Sophie is a senior pharmacovigilance inspector at the MHRA with 4.5 years' experience in leading complex and technically diverse inspections. In addition, she is regularly involved in the training and mentoring of trainee inspectors as well as stakeholder engagement and education via symposia, training courses and published guidance. Prior to joining the GPvP Inspectorate, Sophie was responsible for the assessment of safety variations in the MHRA’s Product Information Quality Unit for two years. Sophie started her career in the pharmaceutical sector when she worked on a regulatory affairs project for a mid-sized pharmaceutical company in Germany. Sophie has an MSc in Forensic Anthropology and a master’s degree in Human Biology.

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.

Rebecca Webb

Director, Pharmacovigilance Quality Assurance
Abbvie, United Kingdom

Rebecca is the Director of Pharmacovigilance Quality Assurance at AbbVie, having joined in January 2016. Prior to this Rebecca spent 10 years at the UK Medicines and Healthcare products Regulatory Agency (MHRA) in variety of operational roles within the Vigilance and Risk Management of Medicines division and later as a Senior Pharmacovigilance Inspector within the Inspection, Enforcement and Standards division.

Steven A. Anderson, PhD

Director, Office of Biostatistics and Epidemiology, CBER
FDA, United States

Steven Anderson, Ph.D., M.P.P., is currently the Director of the Office of Biostatistics and Epidemiology (OBE) at the FDA Center for Biologics Evaluation and Research (CBER). He provides leadership for all CBER statistical, epidemiological and risk assessment programs. He was previously the Associate Director for Risk Assessment and established a program in quantitative risk assessment for biologics and has led numerous risk assessment projects and epidemiological studies.

Michele Peake Andrasik, PhD, MEd

Director, Social & Behavioral Sciences and Community Engagement
Fred Hutchinson Cancer Research Center, United States

Dr. Michele Andrasik (she/her) is a clinical health psychologist working to build and enhance partnerships with marginalized communities in clinical research, with a focus on ongoing vaccine trials for HIV and COVID-19. She is the Director of Social Behavioral Sciences and Community Engagement for the Fred Hutchinson-based HIV Vaccine Trials Network (HVTN) and the COVID-19 Prevention Network, Senior Staff Scientist in the Fred Hutchinson Vaccine and Infectious Disease Division and an Affiliate Clinical Professor in the Departments of Global Health and Occupational and Environmental Medicine at the University of Washington.

Martin Holm-Petersen

CEO
Insife Inc, United States

Narayan Nair

Division Director, Division of Epidemiology, CBER
FDA, United States

Narayan Nair, M.D. is the Director of the Division of Pharmacovigilance in the Center for Biologic Evaluation and Research at the FDA. He oversees the Division that performs pharmacovigilance activities for vaccines and other biologic products regulated by FDA. Dr. Nair is a Board-Certified Internal Medicine Physician. He obtained his undergraduate degree from Saint Louis University and his medical degree from the Uniformed Services University of the Health Sciences in Bethesda, Maryland. He spent 29 years in the U.S. Public Health Service. Prior to joining the Division of Pharmacovigilance, he was the Director of the Division of Injury Compensation Programs.

Patrick Spracklin, MBA

Senior Director, PV Process, Technology, Data and Innovation
AbbVie, Inc., United States

Pat leads the Process, Technology, Data, and Innovation organization at Abbvie. In this position Pat leads efforts to continuously improve and innovate across Abbvie's PV System. Pat has a BS in Manufacturing Engineering from Bradley University in Peoria, Illinois and an MBA from Lake Forest Graduate School of Management.

Krista F. Huybrechts, PhD, MS, FISPE

Associate Professor of Medicine and Epidemiology
Harvard Medical School, Harvard T.H. Chan School of Public Health, United States

Krista F. Huybrechts is an Associate Professor of Medicine and Epidemiology at Harvard Medical School and Harvard T.H. Chan School of Public Health. She co-directs the Harvard Program on Perinatal and Pediatric Pharmacoepidemiology. Her research centers on generating evidence regarding the safety and effectiveness of prescription medications during pregnancy. Her work focuses on the use of advanced epidemiological and statistical methods applied mainly to large databases derived from health data collected in the context of routine medical care to help address the unique questions regarding benefit-risk trade-off for prescription medication use faced by pregnant women and their providers.

Walter Straus, DrMed, MD, MPH, FACP

Vice President, Safety and PV
Moderna, United States

Dr. Straus’ team oversees global clinical safety for investigational products as well as post-licensure safety monitoring and assessment for the Merck portfolio in vaccines and infectious disease therapeutics. He is trained as an internist, gastroenterologist, and epidemiologist. He is actively involved in human research subject protection, and a member of US Health & Human Services Secretary's Advisory Committee on Human Research Proion (SACHRP), as well as in professional groups working in infectious disease and pharmacoepidemiology.