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Pharmacovigilance and Risk Management Strategies Conference


Speakers

  • Stephen  Knowles, MD, MRCP

    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

  • Lesley  Wise, PhD, MSc

    Lesley Wise, PhD, MSc

    • Managing Director
    • Wise PV&RM Ltd, United Kingdom

    Lesley Wise has nearly 20 years of experience in pharmacovigilance both in medicines regulation at the MHRA, and in the pharmaceutical industry as vice-president and global head of Risk Management Centre of Excellence and Pharmacoepidemiology where she worked closely with colleagues to ensure a companywide approach to Benefit - Risk Management and to maintain compliance with regulatory requirements. Lesley has liaised regularly with regulators, including meetings with PRAC, CHMP and FDA.

  • Mariette  Boerstoel-Streefland, MD, MBA, MS

    Mariette Boerstoel-Streefland, MD, MBA, MS

    • Senior Vice President Global Drug Safety
    • Alexion Pharmaceuticals, Inc., United States

    Mariette Boerstoel-Streefland, MD, MBA, MS(epi) is SVP, Head of Global Safety at Alexion Pharmaceuticals, Inc, a world leader in rare diseases. Prior to her current role, 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.

  • 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.

  • E. Stewart  Geary, MD

    E. Stewart Geary, MD

    • Senior VP, Global Safety Officer, Director, Corporate Medical Affairs HQ
    • Eisai Co., Ltd., Japan

    E. Stewart Geary, MD, is Global Safety Officer and Senior Vice President at Eisai Co., Ltd. He is a Councilor of the Japanese Association of Pharmaceutical Medicine and serves on the Editorial Advisory Board for 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.

  • Lisa Melanie Harinstein, PharmD

    Lisa Melanie Harinstein, PharmD

    • Team Leader, Division of Pharmacovigilance, FDA
    • FDA, United States

    Lisa Harinstein is a Team Leader in the FDA-CDER Division of Pharmacovigilance. She received her Doctor of Pharmacy degree from the University of Michigan and completed a Pharmacy Practice and Critical Care Residency at the University of Pittsburgh Medical Center. She worked as a Surgical ICU Clinical Specialist at Cleveland Clinic prior to working at the FDA.

  • Jeremy  Jokinen, PhD, MS

    Jeremy Jokinen, PhD, MS

    • Vice President, Epidemiology, Safety Science, Capabilities and Innovation
    • Bristol-Myers Squibb Company, United States

    Jeremy is the Vice President of Epidemiology, Safety Sciences, Capabilities and Innovation at Bristol-Myers Squibb. In this role, he leads a team of scientists responsible for insights and evidence generation ensuring the safety of patients worldwide. Jeremy is also active within numerous TransCelerate PV initiatives and is a deputy topic lead for ICH 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.

  • Annette  Stemhagen, DrPH, FISPE

    Annette Stemhagen, DrPH, FISPE

    • Senior Vice President and Chief Scientific Officer
    • UBC, United States

    Dr. Stemhagen is an epidemiologist with over 30 years of public health research experience, including 20 years in safety surveillance of pharmaceutical, biotechnology, and vaccine products. She is the SVP of Safety, Epidemiology, Registries and Risk Management and Chief Scientific Officer at UBC, where she provides strategic consultative services to Sponsors, particularly in the areas of REMS, observational studies and RWE. Dr. Stemhagen has specific expertise in safety surveillance and design, implementation, and analysis of epidemiologic studies, Risk Evaluation and Mitigation Strategies (REMS) registries, large streamlined safety studies, and actual use and observational studies for products in Phase IIIb and post approval.

  • Sarah  Vaughan

    Sarah Vaughan

    • Pharmacovigilance Information Unit Systems Manager
    • 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. The unit has responsibility for handling Adverse Drug Reaction (ADR) data, signal management processes and the detection & evaluation of safety signals for established medicines. Alongside this Sarah has been an MHRA representative on the MedDRA Points to Consider Group, and has worked on implementation of the 2012 EU Pharmacovigilance legislation. Her current role is as a Systems Manager in the Vigilance, Intelligence and Research Group working specifically on pharmacovigilance IT projects.

  • 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 4,000 professionals worldwide, providing services across the pharmacovigilance spectrum, including: case processing, regulatory reporting, aggregate reporting, signal detection, risk management, medical information, and safety systems. Williams oversees the exploration 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.

  • 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, 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.

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

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

    • Vice President, Global Head of Early Access and Risk Management
    • IQVIA, United Kingdom

    Dr Stella Blackburn. MB BS, MA, MSc, FRCP(Ed), FISPE, FFPM, DLSHTP, Dip Pharm Med.VP, Global Head of Early Access & Risk Management, Real World Insights at IQVIA. Stella studied medicine at Cambridge and Guys and worked in hospital medicine before joining the pharmaceutical industry. She has worked in pharmacovigilance and pharmacoepidemiology for 30+ years: in industry (11+ years) as a regulator (nearly 17 years) and CRO (6+ years).She has an MSc in Epidemiology from the London School of Hygiene and Tropical Medicine. In 1997 she joined the European Medicines Agency (EMA). Stella developed EU policy on risk management and helped implement the 2010 PhV legislation. She now advises companies on early access and navigating the EU system.

  • William  Gregory, PhD

    William Gregory, PhD

    • Senior Director, Safety and Risk Management
    • Pfizer Inc, United States

    He received formal training in infectious diseases and molecular mechanisms of pathogenesis and has more than 15 years of experience directing global product development and registration programs. He also has extensive experience in pharmacovigilance and health informatics as well as the evaluation and exchange of safety data. He has served with other experts and senior scientists on many consensus panels, including ICH, CIOMS, ISO, and HL7.

  • Valerie E. Simmons, MD, FFPM

    Valerie E. Simmons, MD, FFPM

    • Senior Medical Fellow, Global Patient Safety
    • Eli Lilly and Company Ltd, United Kingdom

    Dr. Simmons is currently Senior Medical Fellow (formally the EU QPPV) in Global Patient safety for Eli Lilly & Company Ltd. She is a registered physician from the University of London and, since joining the pharmaceutical industry in 1987, she has focused her career drug safety through senior management positions in Glaxo/Glaxo Welcome and Eli Lilly and Co. Val is also an active member of various expert working groups , including the EFPIA Pharmacovigilance Expert Working Group, ICH E2D, E2F, E2C (R2), CIOMS VII and IX and speaks extensively on pharmacovigilance and risk management

  • 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, is Director of the Office of Surveillance & Epidemiology in FDA’s Center for Drug Evaluation and Research, where he oversees adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. A member of the WHO Advisory Committee on the Safety of Medicinal Products, he served on the Council of International Organization of Medical Sciences and the International Council on Harmonisation. He received his MD from Columbia University College of Physicians and Surgeons and his Master of Health Science in Clinical Epidemiology from the Johns Hopkins University School of Hygiene and Public Health. Before joining FDA, he was a faculty member in Neurology at Johns Hopkins.

  • Krisztina L. Debreczeni, MD

    Krisztina L. Debreczeni, MD

    • Senior Director, Medical Safety Review, Global Pharmacovigilance
    • Bristol-Myers Squibb Co., United States

    Krisztina has started her career in Drug Safety over 15 years ago at a small family-owned CRO in Princeton. After working for 2 years at the CRO, Krisztina joined BMS as a Medical Safety Review Physician responsible for providing medical assessment of individual case safety reports from any source. Over the years, she has taken on increasing responsibilities, including various project works as well as leading the medical review-related quality monitoring efforts for their off-shore single case processing operations. Krisztina has been in her current role for 6 years overseeing medical review physicians and scientists responsible for expedited safety reports.

  • Sevan H. Kolejian, PharmD, MBA, RPh

    Sevan H. Kolejian, PharmD, MBA, RPh

    • Team Leader, DMEPA, OSE, CDER
    • FDA, United States

    Sevan Kolejian is a Team Leader in the Division of Medication Error Prevention and Analysis (DMEPA), Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Sevan oversees the DMEPA team responsible for the pre- and post-market safety review of Antiviral, Psychiatry, General Endocrinology, Dermatology and Dentistry products. She received her Doctor of Pharmacy degree from VCU/ MCV School of Pharmacy and completed an Executive Fellowship in Patient Safety at VCU Williamson Institute for Healthcare Leadership. Prior to joining FDA, she was a full time clinical pediatric pharmacist at Johns Hopkins Hospital. She is a Board Certified Pediatric Pharmacy Specialist.

  • Jay P Dave, MSc

    Jay P Dave, MSc

    • General Manager Pharmacovigilance
    • APCER Life Sciences, India

  • David  Spiegelhalter, PhD

    David Spiegelhalter, PhD

    • Chair of the Winton Centre for Risk and Evidence Communication
    • Cambridge University, United Kingdom

    Professor Sir David Spiegelhalter FRS OBE is Chair of the Winton Centre for Risk and Evidence Communication in the Centre for Mathematical Sciences at the University of Cambridge. He retired from being Winton Professor for the Public Understanding of Risk in 2019, His background is in medical statistics, and he is the author of The Art of Statistics. He was elected Fellow of the Royal Society in 2005, awarded an OBE in 2006, and knighted in 2014 for services to medical statistics. He is a Fellow of Churchill College Camridge, was President of the Royal Statistical Society for 2017-2018, and became a Non-Executive Director of the UK Statistics Authority in 2020. He is @d_spiegel on Twitter.

  • Matthew  Barlow, BSN, RN

    Matthew Barlow, BSN, RN

    • Human Factors Reviewer/Safety Evaluator
    • FDA, United States

    Matt Barlow is a human factors (HF) reviewer in the Division of Medication Error Prevention and Analysis (DMEPA) since 2014. Matt is responsible for reviewing HF submissions for drug and biologic/device combination products. Prior to joining DMEPA, Matt was clinical nurse on the intermediate care unit at the University of Maryland Shock Trauma Center in Baltimore for 4 years. It was there where he first discovered his interest surrounding medication error prevention. Matt graduated from the University of Maryland School of Nursing in 2009.

  • Kenneth  Lipetz, MD, PhD, MBA, MSc

    Kenneth Lipetz, MD, PhD, MBA, MSc

    • GPS Medical Business Advisor
    • Eli Lilly and Company, United States

    Kenneth J Lipetz, PhD, MBA, HCLD is currently the Global Patient Safety (GPS) Medical Business Advisor/Process Owner for GPS Medical and Benefit Risk Management, Eli Lilly and Company, Indianapolis, Indiana. In the 20 years he has been with Eli Lilly and Company, Ken has had a number of key strategic, technical and administrative roles in Clinical PM, Clinical Data Management, Data Privacy, Drug Safety, Pharmacovigilance and Drug Development. Ken is also a Certified Lean/Six Sigma Black Belt working on multiple process improvement projects.

  • Anne M Ambrose, MPharm, MSc, RPh, RAC

    Anne M Ambrose, MPharm, MSc, RPh, RAC

    • Specialist in Post Authorisation Operations and Safety Issues
    • Medicines & Healthcare Products Regulatory Agency, United Kingdom

    Anne Ambrose is an Expert Pharmaceutical Assessor and Specialist in Post Authorisation Operations and Safety Issues in the Vigilance and Risk Management of Medicines (VRMM) Division, MHRA, UK. She is a qualified pharmacist and has worked in hospital and retail pharmacy and the pharmaceutical industry. She worked for a number of years in Regulatory Affairs in the pharmaceutical industry before joining the Medicines Control Agency (now MHRA) in January 1995 as a pharmaceutical assessor. Anne was a UK expert to CMDh 2005-2020 and was involved in various CMDh working groups and was chair of the CMDh Working Party on Pharmacovigilance Procedures Worksharing (formerly EU PSUR Work Sharing Group) 2010-2017.

  • Achint Kumar  Gupta, DrMed, MD

    Achint Kumar Gupta, DrMed, MD

    • EU QPPV - Safety & Benefit-Riak Management
    • Biogen, United Kingdom

  • Vineet  Kacker, PhD

    Vineet Kacker, PhD

    • Managing Director
    • APCER Life sciences, United Kingdom

    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.

  • Fernando  Pereira, RPh

    Fernando Pereira, RPh

    • Director, Regional PV Lead Latin America (PACoE)
    • Abbvie, Brazil

    Pharmacist and Lawyer - Director of Pharmacovigilance for Latin America Countries - Abbvie Brazilian - located in Sao Paulo - Brazil

  • Larry  Smith, PhD

    Larry Smith, PhD

    • Consultant
    • Consultant: COVID-19 Countermeasures, United States

    Biotech executive with over 25 years’ experience from translational-stage to late-stage product development of biologics and small molecules for infectious disease indications. Former SVP of Research at Vical Incorporated and subject matter expert in immunology, infectious diseases, molecular biology, gene therapy, and vaccine development. Participated in the conduct of 20 Phase 1 – Phase 3 clinical trials including several first-in-human pandemic influenza vaccine trials. Previously served as the Director of Viral Vaccines Immunology at Wyeth (Pfizer) Vaccines. Currently a consultant for various clients developing immunologically-based biologics to prevent or treat COVID-19, including SARS-CoV-2 vaccines and monoclonal antibodies.

  • Melissa  Burns, MS

    Melissa Burns, MS

    • Senior Program Manager, Office of Combination Products, OCPP, OC
    • FDA, United States

    CAPT Melissa Burns is a Senior Program Manager in FDA’s Office of Combination Products (OCP). In this role, she is responsible for coordinating activities related to combination product review and regulation including development and review of guidance documents, regulations, and procedures and policies. Prior to joining OCP, Melissa worked for several years in FDA CDRH. Melissa worked for several years in the private sector including positions with a medical device manufacturer, a hospital, a healthcare architecture firm, and a consulting firm. Melissa received a Bachelor of Science degree in Mechanical Engineering from Virginia Tech and a Master of Science degree in Biomedical Engineering from The University of Connecticut.

  • John  Concato, MD, MPH, MS

    John Concato, MD, MPH, MS

    • Associate Director for Real-World Evidence Analytics, OMP, CDER
    • FDA, United States

    Dr. Concato is Associate Director for Real-World Evidence Analytics in the Office of Medical Policy (OMP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA). After generating research for more than 25 years—as an independent investigator and research center director at Yale University & the Department of Veterans Affairs—he now works to develop, coordinate, and implement medical policy programs and strategic initiatives. These efforts seek to improve medical product development and post-marketing processes, with a focus on real-world evidence.

  • Representative Invited

    Representative Invited

    • AbbVie, Inc., United Kingdom
  • Mamiko  Kasho

    Mamiko Kasho

    • Executive Director, Global PV Management Dept., Global Safety HQs
    • Eisai Co., Ltd., United States

    I have been involved in global pharmacovigilance area since I joined Eisai Co., Ltd in 2007. I have been responsible for global pharmacovigilance agreements with licensing partners for 12 years and at the same time I am responsible for establishing, maintaining the quality management system within the company; and coordinating activities to comply with regulatory requirements across regions. I have been participating the several task forces of JPMA PV committee as the team leader, focusing on PV requirements in Europe, US, Asia, and other regions.

  • Peter W. Marks, MD, PhD

    Peter W. Marks, MD, PhD

    • Director, Center for Biologics Evaluation and Research
    • FDA, United States

    Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in January 2016.

  • Hina  Mehta, PharmD

    Hina Mehta, PharmD

    • Medication Error Safety Reviewer Team Lead, OMEPRM, OSE, CDER
    • FDA, United States

    Hina Mehta is a Team Leader in the Division of Medication Error Prevention and Analysis (DMEPA), Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Hina oversees the DMEPA teams responsible for the pre- and post-market safety review of Malignant Hematology, Nonmalignant Hematology, Imaging and Radiation medicine, and Cardiology and Nephrology products. She received her Doctor of Pharmacy degree from Shenandoah University School of Pharmacy. Prior to joining FDA, she was a full time clinical pharmacist at a specialty pharmacy.

  • Meredith  Smith, DrPH, PhD, MPA

    Meredith Smith, DrPH, PhD, MPA

    • Director, Risk Management, Global Drug Safety, Research and Development
    • Alexion Pharmaceuticals, United States

    Meredith Smith is Risk Management Director at Alexion, Inc. where she leads a team responsible for medicinal product benefit-risk management. She is a behavioral scientist and health services researcher by training with over 15 years of experience in the pharmaceutical industry. She has served on numerous FDA expert panels, on CIOMS Working Groups VIII, IX and XI, and IMI-PREFER. Currently, she is the Pharmacovigilance Track Chair for the 2019 DIA Annual Meeting Planning Committee. Recently, she led the effort to develop the RIMES Statement, a set of quality reporting guidelines for risk minimization evaluation studies.

  • Anja  Van Haren, MSc

    Anja Van Haren, MSc

    • EudraVigilance Coordinator
    • Medicines Evaluation Board (MEB), Netherlands

    Anja van Haren holds a Master in Health Policy and Management from the Erasmus University in Rotterdam. Her career at the Medicines Evaluation Board (MEB) in the Netherlands started in 1998 as a Pharmacovigilance assessor. Since 2004 she has been responsible for technical and procedural aspects of expedited Adverse Drug Reaction reporting in pharmacovigilance. In her current position at the MEB as EudraVigilance Coordinator the focus of her work is on ADR reports, signal detection and signal management. Anja is co-chair of the EudraVigilance Expert Working Group, co-chair of the Pharmacovigilance Business Team and representative of the EU in the ICH E2B(R3) and ICH E2D(R1) Expert Working Groups.

  • Howard  Chazin, MD, MBA

    Howard Chazin, MD, MBA

    • Director, Clinical Safety Surveillance Staff, Office of Generic Drugs, CDER
    • FDA, United States

    Dr. Chazin joined FDA in 2002 and has held several mid-level and senior leadership positions related to clinical safety of new drugs, generic drugs and biologic drug products. Since 2016, he has been the Director of the Clinical Safety Surveillance Staff in the Center for Drug Evaluation and Research's Office of Generic Drugs. He leads a multidisciplinary team of physicians, pharmacists and data analysts tasked with identifying and assessing emerging complex safety issues related to potentially inferior generic drug products. As Director, he also provides oversight on assessment of critical aspects related to challenging, controversial and sensitive generic drug safety issues.

  • Janine  Collins, MD, LLM

    Janine Collins, MD, LLM

    • Executive Director Safety, Epidemiology , Registries and Risk Management
    • United BioSource Corporation, Switzerland

    Dr Janine Collins is a graduate of St. George’s Hospital Medical School, London and obtained a Master’s Degree in Legal Aspects of Medical Practice from Cardiff Law School. Along with 16 years of clinical practice, she has more than 19 years of industry experience in Drug Safety, Risk Management, Medical Affairs and Clinical Research. Dr Collins is Executive Director of Safety, Epidemiology, Registries and Risk Management at UBC where she provides consultant services focusing on Risk Management including the associated activities such as post approval safety studies, educational programs for risk minimization and assessment the effectiveness of risk minimization. She has extensive experience in both the European Union and Canada.

  • Jason  Flint, MBA, PMP

    Jason Flint, MBA, PMP

    • Human Factors Reviewer, CDER, OSE, OMERPM, DMEPA
    • FDA, United States

    Jason Flint is a human factors reviewer with the Division of Medication Error Prevention and Analysis (DMEPA). He recently completed a detail as the Acting Associate Director for Human Factors, and is the scientific lead for ongoing human factors research on training decay. Prior to joining the DMEPA team, Jason spent 13 years planning and conducting medical device human factors testing for the Air Force.

  • Vita M. Petrik, BSN

    Vita M. Petrik, BSN

    • Senior Director, PV Processes, Partnerships and Contracts
    • Astrazeneca Pharmaceuticals, United States

    Vita is a registered nurse by training spending the first part of her career working at The Childrens Hospital of Philadelphia. She worked bedside as well as in management and QA. She moved into the pharma world beginning on the CRO side as a CRA, then a PM and then as a safety monitor. After joining AZ Vita has had many roles. In the most recent reorganization Vita has landed as a leadership team member within the PS Center of Excellence leading the Process, partnership and contracts team. It is this role that has lead her to the role of Project VIP Business lead. In this role Vita has accountability to deliver the infrastructure to successfully support the PV activities around AZD 1222, AZ's Covid vaccine.

  • Ellis  Unger, MD

    Ellis Unger, MD

    • Director, Office of Cardiology, Hematology, Endocrinology, and Nephrology, OND
    • FDA, United States

    Ellis F. Unger is the Director, Office of Cardiology, Hematology, Endocrinology, and Nephrology, Office of New Drugs, Center for Drug Evaluation and Research, FDA. His Office oversees the regulation of drugs for cardiovascular, renal, endocrine, and hematologic disorders. Dr. Unger is a board-certified internist and cardiologist. Prior to coming to CDER in 2003, previous positions included director of a translational angiogenesis program at NHLBI, NIH; and Medical Officer, Team Leader, and Deputy Division Director in CBER.

  • Celeste  Karpow, PharmD, MPH

    Celeste Karpow, PharmD, MPH

    • Acting Team Leader, DMEPA, OMEPRM, OSE, CDER
    • FDA, United States

    Celeste Karpow is currently an acting team leader in the Division of Medication Error Prevention and Analysis (DMEPA). She also has postmarket experience working on DMEPA's Rapid Response Team which included monitoring medication errors for drug products used under emergency use authorizations during the COVID-19 pandemic. Prior to joining DMEPA, Celeste completed the FDA/ISMP Safe Medication Management Fellowship, where she gained valuable experience focused on medication error prevention and safe medication use. She earned her Doctor of Pharmacy and Master of Public Health degrees from the University of Connecticut and completed her PGY-1 Pharmacy Practice residency at Henry Ford Hospital.

  • Francois  Audibert, MSc

    Francois Audibert, MSc

    • VP US Operations
    • Vitrana, United States

    As a young graduate, François Audibert was working for a non-profit in modelization and automation using personal computers (greenhouses, forest replantation, harvesting, etc.) using what was then AI. Having joined a consulting company, Francois developed expertise in large and complex transactional systems used by very large corporations attaining the role of program manager and Solutions Architect. Life led to working in Drug Safety for Relsys, Oracle, Highpoint Solutions, and eventually for the Safety and Clinical Space at BioClinica. Since 3 years, Francois is helping Vitrana to develop advanced solutions and services using AI technologies, specifically to make knowledge available when, where to whom it’s needed most.

  • Gita  Toyserkani, PharmD, MBA

    Gita Toyserkani, PharmD, MBA

    • Associate Director, Research & Strategic Initiatives
    • FDA, United States

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

  • 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.

  • Kendal  Harrison

    Kendal Harrison

    • Pandemic Systems Delivery Manager
    • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

  • Jane  Reed, PhD

    Jane Reed, PhD

    • Director, Life Science
    • Linguamatics, United Kingdom

    Jane Reed is Director of Life Science at Linguamatics, an IQVIA company. She is responsible for leading the strategic vision for Linguamatics product portfolio and business development for the pharma and biotech market. Jane has 20+ years’ experience in vendor companies supplying data products, data integration and analysis, and consultancy to pharma and biotech—with roles at Instem, BioWisdom, Incyte, and Hexagen. Before moving into the life science industry, Jane worked in academia with post-docs in genetics and genomics. Jane holds a MA from Cambridge University and a PhD from Birmingham University.

  • Oanh  Dang, PharmD

    Oanh Dang, PharmD

    • Regulatory Science & Applied Research
    • FDA, United States

    Oanh Dang leads multiple projects for regulatory science and applied research in pharmacovigilance at the FDA's Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research. Her research focuses on the application of artificial intelligence that aim to improve the efficiency and effectiveness of pharmacovigilance processes. She also worked as a post market surveillance safety reviewer in the FDA CDER Division of Pharmacovigilance. Prior to joining the FDA, Oanh had a decade of experience in clinical hospital pharmacy. Oanh received her Doctor of Pharmacy degree from the University of Utah and completed a Pharmacy Practice Residency at the University of Washington. She is a Board Certified Pharmacotherapy Specialist.

  • Allan  Fong, MS

    Allan Fong, MS

    • Research Scientist and Data Scientist
    • Medstar Health National Center For Human Factors In Healthcare, United States

    Allan Fong focuses on developing, integrating, and applying advanced technologies and techniques to study and improve healthcare systems. Allan has a background in engineering, computer science, and human factors, and is particularly interested in natural language processing, predictive analytics, information visualization, and sensor integration to understand clinical workflow and promote patient safety and health literacy. Allan received a master’s degree in aeronautical and astronautical engineering from Massachusetts Institute of Technology, a master’s degree in computer science from University of Maryland College Park, and a bachelor’s degree in mechanical engineering from Columbia University.

  • Aaron Zachary Hettinger, MD, MS

    Aaron Zachary Hettinger, MD, MS

    • Director of Cognitive Informatics
    • Medstar Health National Center For Human Factors In Healthcare, United States

    Aaron Zachary Hettinger, MD, MS, is an assistant professor of emergency medicine at Georgetown University of School of Medicine and the director of cognitive informatics of the National Center for Human Factors in Healthcare, MedStar Health. He is a dual board certified in emergency medicine and clinical informatics. In these roles, Dr. Hettinger has the opportunity to translate between the languages of medicine, informatics and human factors with the goal of improving patient safety and healthcare processes. His primary interests include health information technology usability, adverse event analysis and data visualization in reference to reduce hazards in healthcare. He has received funding from the NIH, ONC, AHRQ,