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01: ClinSafety-PV [clear filter]
Monday, June 24
 

11:00am

#105: Addressing Heterogeneity of Real World Evidence in Drug Safety
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-522-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session addresses the concern of inconsistent real world evidence in drug safety by presenting 1) epidemiological approaches for assessing inconsistent findings in observational studies, 2) lessons learned from observational studies in a distributed research network and 3) challenges using methods that synthesize findings from observational studies.

Learning Objectives

Identify possible study factors contributing to heterogeneity of real world evidence using claims databases; Discuss lessons learned from observational studies in a distributed research network regarding heterogeneity of RWE; Describe methods for synthesizing findings from observational studies and their limitations.

Chair

Michael Blum, MD, MPH

Speaker

Epidemiological Approaches for Assessing Inconsistent Findings in Observational Studies
Huei-Ting Tsai, PhD, MS

Minimizing Heterogeneity in Distributed Research Networks: Examples from the Canadian Network for Observational Drug Effect Studies
Adrian Levy, PhD, MSc

Challenges with Methods Used to Synthesize Findings from Observational Studies
Alicia Gilsenan



Speakers
avatar for Michael Blum

Michael Blum

Deputy Director, Office of Pharmacovigilance and Epidemiology, CDER, FDA
Michael Blum, MD, MPH is currently Deputy Director, Office of Pharmacovigilance and Epidemiology in FDA CDER. He is a pediatric infectious diseases specialist. Dr. Blum worked as a medical reviewer in the CDER Division of Anti-Infective Drug Products, followed by over 20 years in... Read More →
avatar for Alicia Gilsenan

Alicia Gilsenan

Senior Director, Epidemiology, RTI Health Solutions
Alicia Gilsenan, PhD, is a Senior Director of Epidemiology within RTI-HS and a licensed pharmacist. Dr. Gilsenan’s primary area of expertise is pharmacoepidemiology and therapeutic risk management and the structured benefit-risk assessment of medications. Since joining RTI in 1997... Read More →
avatar for Huei-Ting Tsai

Huei-Ting Tsai

Epidemiologist, Office of Surveillance and Epidemiology, CDER, FDA
Huei-Ting Tsai, Ph.D., is an Epidemiologist in the Office of Surveillance and Epidemiology in FDA CDER. Prior to joining FDA, she was an Assistant Professor at the Georgetown University Medical Center and served as the principle investigator of multiple grants to assess effectiveness... Read More →
avatar for Adrian Levy

Adrian Levy

Professor, Department of Community Health and Epidemiology, Dalhousie University
Adrian R. Levy PhD is Professor in the Department of Epidemiology and Community Health at Dalhousie University. He is author of over 150 peer reviewed publications (https://bit.ly/2CBWeI5) and is the co-editor of two volumes in the Springer Handbook of Health Services Research entitled... Read More →


Monday June 24, 2019 11:00am - 12:00pm
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:15pm

#135: Using Real World Data to Develop a Safety Monitoring Program and Ensure Pre- and Post-Market Continuity
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-538-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss proactively planning and pilot-testing high-quality safety monitoring programs in the pre-marketing phase to ensure timely implementation of monitoring programs and post-marketing safety studies.

Learning Objectives

Describe the role of real world data in active safety monitoring, strengths, and limitations of real world data, and basic pharmacoepidemiological study design considerations; Recognize analytic and logistical considerations in planning and testing a safety monitoring program based on use case examples and translate lessons learned to your own pharmacovigilance team.

Chair

Jeremy Rassen, DrSc, MS

Speaker

Academia Perspective
Noelle Cocoros, DrSc, MPH

Industry Perspective
Kimberly Brodovicz, DrPH



Speakers
KB

Kimberly Brodovicz

Executive Director of Global Epidemiology, Boehringer Ingelheim
Kim Brodovicz is Executive Director, Late Stage Cardiometabolism Team Lead in Global Epidemiology and Real World Evidence at Boehringer Ingelheim. Kim has supported drugs and vaccines from early development to post-approval in a variety of therapeutic areas and has conducted numerous... Read More →
NC

Noelle Cocoros

Research Scientist, Department of Population Medicine, Harvard Medical School
Noelle Cocoros is an epidemiologist with a broad background in public health surveillance, pharmacoepidemiology, and infectious disease epidemiology and has expertise in the use of claims, electronic health records, and registry data for surveillance (FDA's Sentinel System; ESPhealth.org... Read More →
avatar for Jeremy Rassen

Jeremy Rassen

Co-Founder, President and Chief Science Officer, Aetion
Jeremy A. Rassen, MS, ScD is a pharmacoepidemiologist with 25 years of academic and industry experience. He is co-founder, president, and chief science officer at Aetion, a health care technology company that delivers real-world evidence for life sciences companies, payers, and regulatory... Read More →


Monday June 24, 2019 2:15pm - 3:15pm
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Real World Evidence,Regulator Thinking,Innovative Trial Design,Generics,What's Next
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

3:30pm

#155: Incorporating Systems-Theory and Human Factors into the Investigations of Serious Harm in Clinical Research
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-570-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss how to complement existing activities and regulations, we propose an additional approach blending evidence derived from pharmacological and organizational science which addresses human factors and transparency to enhance organizational learning and continuous improvement. This systems approach should be seen as an additional way to understand how problems occur and how they might be prevented in the future.

Learning Objectives

Identify evidence-based techniques for better defining causal factors in system failure; Recognize that those techniques which can be used now; Appraise how we should best develop these concepts, identify best practice and engage all stakeholders; Discuss how to volunteer to join the team aiming to improve the safety of the system for clinical research.

Chair

Brian Edwards, DrMed

Speaker

Applying CAUSAL Analysis System Theory to the TGN1412 First-In-Human Clinical Trial
Brian Edwards, DrMed

Innovation in First-in-Human Safety
Howard Greenberg, DrMed, MD, MBA, MS

Investigators from the Warfarin-Stimulated Frail Hospitalized Patients Project
Nichola Crust, MSc



Speakers
NC

Nichola Crust

National Investigator, Healthcare Safety Investigation Branch
Nichola has worked at a strategic level in a variety of healthcare settings spanning primary and secondary care. Her roles have included professional nurse leadership and mentoring of nursing teams, mobilisation of new services including service and workforce redesign, and training... Read More →
avatar for Brian Edwards

Brian Edwards

Principal Consultant, Pharmacovigilance and Drug Safety, Vice-President ACRES, NDA Group
After his training in hospital medicine and clinical research for 14 years, Dr. Edwards joined the UK Medicines Control Agency (MHRA) in 1994 where he had various responsibilities as a pharmacovigilance assessor. In 1999 he joined Parexel to become Senior Medical Director before joining... Read More →
avatar for Howard Greenberg

Howard Greenberg

Medical Safety Officer, Janssen Research and Development, LLC
Dr. Greenberg is a Medical Safety Officer for Janssen Pharmaceuticals R&D, and Adjunct Associate Professor in the Department of Pharmacology & Experimental Therapeutics of Thomas Jefferson University. He is a Clinical Pharmacologist with education and experience in chemical engineering... Read More →


Monday June 24, 2019 3:30pm - 4:30pm
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics What's Next,Patient Focused
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session
 
Tuesday, June 25
 

8:00am

#202: Updates and Lessons Learned from Novel Approaches to Pharmacovigilance Collaboration
Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-573-L04-P; CME 1.25; IACET 1.25; RN 1.25

Following the initial success of an unprecedented collaboration between nineteen sponsors to address major pharmacovigilance challenges with regulators, this session will provide lessons learned and an update on an increasing scope of collaborative work. Join the Clinical Safety & Pharmacovigilance Community for a follow up Round Table discussion on Tuesday, June 25, 3:15-4:15PM in the DIA Community Zone 1, Sails Pavilion.

Learning Objectives

Identify expert perspectives on the future of the field of clinical safety and pharmacovigilance, with a focus on trends, challenges, and how collaborations can work to advance the industry in this space; Discuss strategies to address pharmacovigilance challenges in the long-term.

Chair

Jose Vega, MD

Speaker

The European IV Iron PASS Consortium: Experiences from Coordinating a Multi-Company, Multi-Registry PASS
Michael Forstner, PhD

Regulator Observations and Feedback
Gerald J. Dal Pan

Advancing Safety Analytics
Paul Chang, MD

Intelligent Automation in Pharmacovigilance
Songlin Xue, MD, PhD



Speakers
PC

Paul Chang

Chief Safety Officer, Janssen Pharmaceuticals
Dr. Paul Chang is the Chief Safety Officer at Janssen, the Pharmaceutical Companies of Johnson & Johnson, where he is responsible for all aspects of patient safety and pharmacovigilance. Paul joined J&J in 2006, and has held various leadership positions including the Head of Cardiovascular... Read More →
avatar for Michael Forstner

Michael Forstner

Senior Vice President, Head of Risk Management and Pharmacoepidemiology, PrimeVigilance
Michael's main focus areas are the planning, development, implementation and evaluation of benefit-risk management solutions, as well as the optimization of processes around benefit-risk management. He is engaged in developing and applying (benefit-) risk analysis methodologies in... Read More →
avatar for Gerald Dal Pan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, FDA
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... Read More →
avatar for Jose Vega

Jose Vega

Vice President, Chief Safety Officer, Merck & Co., Inc.
José M. Vega is Vice President, Global Clinical Safety and Pharmacovigilance (GCS&PV) and Chief Safety Officer at Merck Research Laboratories (MRL). He also serves as Chair of the TransCelerate Pharmacovigilance Steering Committee and as Merck's representative on the Clinical Trials... Read More →
avatar for Songlin Xue

Songlin Xue

Executive Vice President and Global Head of Pharmacovigilance, Astellas Pharma US, Inc.
Songlin Xue, M.D., Ph.D., is Executive Vice President and Head of the global Pharmacovigilance in Astellas. In this position, he leads a global pharmacovigilance organization that includes pharmacovigilance operation and processes, medical safety, risk management, and epidemiology... Read More →


Tuesday June 25, 2019 8:00am - 9:15am
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

8:00am

#211: Pharmacovigilance Reporting and Quality
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-579-L04-P; CME 1.25; IACET 1.25; RN 1.25

Expectations for quality and compliance in pharmacovigilance process and systems continues to rise Having a comprehensive quality system, including a robust CAPA process, is now essential for both good quality management and to drive continuous improvement. CAPA is also a focus of inspection by many key regulatory authorities. Meanwhile, the global expansion pharmacovigilance and evolving safety requirements continue to add complexity, increasing the challenge of executing consistently in a compliant manner. This is exemplified in the challenges presented by assuring proper distribution of safety report to the right person at the right time as well as in the management of Reference Safety Information (RSI) and Investigator's Brochures (IBs) according to the EU requirements.

This session will explore these hot topics in pharmacovigilance quality and compliance and provide insight on current expectations.

Learning Objectives

Describe the trending of PV audit findings and how to detect systemic issues before the proliferation of conflicting or redundant CAPA and constructing CAPA hygiene; Discuss how to develop a CAPA at the right level of detail, with reasonable timelines and root cause classifications; Identify the changing landscape related to Reference Safety Information (RSI) and perspectives on navigating RSI complexities in light of new EU requirements; Discuss approaches for consideration in context of global

Chair

Matthew Krumrai

Speaker

CAPAs, CAPAs Everywhere: How Effective are They and How Can they be Improved?
Kelly Traverso

Optimizing Global Safety Reporting in Clinical Trials Using Local Laws
Steven Beales

Global Clinical Trials and the Complexities of Reference Safety Information (RSI)
Andrea Best, DO, MPH



Speakers
avatar for Steven Beales

Steven Beales

Senior Vice President, Scientific and Regulatory, ePharmaSolutions, a WIRB-Copernicus Group Company
Steven Beales is the SVP of Scientific and Regulatory at WCG and co-chair of the Safety Reporting Reference Model working group. Steven has led the implementation of Clinical Trial Safety Portals for over 100 countries, working with 1 each of the top 3 Pharmaceutical, Biotech and... Read More →
avatar for Andrea Best

Andrea Best

Executive Medical Director, AbbVie, Inc.
Dr. Andrea Best is an Executive Medical Director in Pharmacovigilance and Patient Safety at AbbVie in the suburbs of Chicago where she is responsible for Clinical Trial Safety Excellence. Andrea has over 20 years of experience in academia and industry across a variety of roles (clinical... Read More →
avatar for Kelly Traverso

Kelly Traverso

Consulting Specialist Leader, Deloitte
Kelly has over 17 years of industry and consulting experience in Life Sciences. She has significant consulting experience in the areas of Quality, Pharmacovigilance, R&D and Regulatory Affairs. Projects she has led and provided extensive subject matter expertise on include, Process... Read More →
avatar for Matthew Krumrai

Matthew Krumrai

Director, Clinical Quality Assurance, AbbVie
Matthew Krumrai is a Director of Clinical QA at AbbVie. Matt’s responsibilities include oversight of the clinical auditing program as well as process ownership of auditing within AbbVie R&D. Other responsibilities include inspection support as well as the QA therapeutic lead for... Read More →


Tuesday June 25, 2019 8:00am - 9:15am
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

9:30am

#223 RT: Round Table Discussion: Interpretation of New Pharmacovigilance Regulations: Key Insights
Component Type: Session
Level: Basic

Round table discussion tied to session #136: Interpretation of New Pharmacovigilance Regulations: Key Insights (Monday, June 24, 2:15-3:15PM). Seating is limited. To include special guests from the session: Ajay Singh, Jane Carroll.

Chair

Jeremy Jokinen, PhD, MS


Speakers
avatar for Jeremy Jokinen

Jeremy Jokinen

Senior Director, Decision Sciences, AbbVie, Inc.
Jeremy is the Senior Director, Decision Sciences, within the Safety Sciences organization of AbbVie Inc. In this role, he leads a team of data scientists, statisticians, and data managers developing novel approaches and methodologies to improve patient safety. Jeremy has over 20 years... Read More →


Tuesday June 25, 2019 9:30am - 10:30am
Community Zone Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#228: Emerging Safety Challenges in New Oncology Treatments
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-591-L04-P; CME 1.00; IACET 1.00; RN 1.00

Immuno-oncology (IO) agents are emerging as essential tools to treat a wide range of solid tumors and their indications for use continue to expand. However, the antitumor immune activity of these agents can also be a threat to healthy tissue, resulting in novel presentations of adverse reactions, sometimes with highly undesirable outcomes. Early recognition and intervention can have a dramatic effect outcomes, particularly for very rare events that are progressive. However, presentation can mimic other less serious conditions that do not require early intervention. Thus, these immune-mediated phenomena have become the focus of intense exploration.

This session will provide a very brief conceptual overview of these agents, followed by two presentations. the first presentation will include methodological considerations for identifying potential predictors, such as transcriptomic biomarkers or specific interleukins, etc., that might aid prevention, facilitate early detection, or predict mortality. The second presentation will provide regulatory considerations in ensuring that benefits of these products outweigh their risks. Both presentations will include examples to illustrate key points. The session will conclude with an opportunity for Q&A.

Learning Objectives

Outline basic mechanistic aspects related to the efficacy and safety of immuno-oncology agents; Describe methodological considerations when identifying utility of markers that can help in the prevention or early diagnosis of IO-associated adverse events; Discuss considerations in benefit-risk assessment and communication for these agents.

Chair

William Gregory, PhD

Speaker

Checkpoint Inhibitor-Associated Myocarditis: Prevention or Early Detection?
Tarek Hammad, MD, PhD, MS, MSc, FISPE

Regulatory Challenges in Benefit/Risk Assessment and Labeling of Immuno-Oncology Agents
Meredith K. Chuk, MD, MHS



Speakers
MC

Meredith Chuk

Acting Associate Director for Safety, OHOP, CDER, FDA
avatar for William Gregory

William Gregory

Worldwide Medical and Safety, Pfizer Inc
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... Read More →
avatar for Tarek Hammad

Tarek Hammad

Therapeutic Area Strategy Lead, Global Pharmacovigilance, Sanofi Genzyme
Dr. Hammad joined Sanofi-Genzyme, in 2019, as a Therapeutic Area Strategy Lead in the Global Pharmacovigilance group. Prior to this, he served as the Head of Signal Detection and Benefit-Risk Assessment in Merck KGaA/EMD Serono. Previously, he was an Executive Director of Pharmacoepidemiology... Read More →
MC

Meredith Chuk

Acting Associate Director for Safety, OHOP, CDER, FDA
Dr. Meredith Chuk is the Acting Associate Director for Safety in the Office of Hematology and Oncology Products in CDER at the FDA.


Tuesday June 25, 2019 10:30am - 11:30am
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#254.1 RT: Round Table Discussion: Current Initiatives on Patient Involvement in the Medicinal Product Lifecycle: CIOMS XI
Component Type: Session
Level: Basic

Join DIA Clinical Safety & Pharmacovigilance Community for a round table discussion tied to the session #154: Current Initiatives on Patient Involvement in the Medicinal Product Lifecycle: CIOMS XI (Monday, June 24, 3:30-4:30PM). Seating is limited. To include special guests from the session: Meredith Smith, Marc Boutin, Herve Le Louet, Theresa Mullin, Kerry-Leeson-Beevers.

Chair

Judith Zander, MD


Speakers
avatar for Judith Zander

Judith Zander

Director, Office of Pharmacovigilance and Epidemiology, OSE, CDER, FDA
Judy Zander is the Director of the Office of Pharmacovigilance and Epidemiology (OPE), in the Office of Surveillance and Epidemiology (OSE), in the Center for Drug Evaluation (CDER) at the U.S. Food and Drug Administration (FDA).She oversees the Divisions of Pharmacovigilance 1 and... Read More →


Tuesday June 25, 2019 2:00pm - 3:00pm
Community Zone Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#264: Immuno-Oncology Product Development: Overcoming Scientific and Regulatory Challenges
Component Type: Session
Level: Advanced
CE: ACPE 1.25 Application UAN: 0286-0000-19-615-L04-P; CME 1.25; IACET 1.25; RN 1.25

The development of immuno-oncology products has spanned decades, culminating in approvals for the use of immune modulating cytokines, monoclonal antibodies, fusion proteins, genetically modified T cells, cancer vaccines and oncolytic vectors, for the treatment of cancer. Currently there are hundreds of immuno-oncology products in clinical trials.

This session will provide an overview of immuno-oncology products, highlighting the relevant preclinical safety regulations and potential safety concerns ascribed to different categories of products. Preclinical development challenges, such as, selecting the relevant pharmacology and toxicology models, distinguishing pharmacologic from toxicologic responses, and justifying first in human dose, will be discussed. Case examples highlighting the preclinical testing strategies that are being applied to evaluate the pharmacology and safety of immuno-oncology drugs will also be presented.

Learning Objectives

Describe immuno-oncology products, including the potential safety concerns ascribed to different immunotherapeutic modalities; Identify the regulatory requirements (and/or challenges) associated with preclinical safety evaluation for different modalities of immuno-oncology drugs; Discuss the preclinical testing strategies that are being applied to evaluate the pharmacology and safety of immuno-oncology products through case study presentations.

Chair

Laurie Iciek, PhD

Speaker

New Challenges for Developing HER2-Targeted Cancer Immunotherapeutics
Karin Staflin, PhD

Strategies for Preclinical Safety Assessment of Immune-Oncology Biologics
Simone Nicholson, PhD

Challenges in Predicting Animal-to-Human Safety for Immune-Stimulatory Agents from Toxicology Studies
Theresa Sweeney, PhD



Speakers
avatar for Laurie Iciek

Laurie Iciek

Senior Consultant, Nonclinical, Biologics Consulting
Laurie is currently a Sr. Nonclinical Consultant for Biologics Consulting. Previously she spent 17 years in industry as a lead Toxicologist for MedImmune/AstraZeneca, Abbott Laboratories, and Bristol-Myers Squibb. Her academic training is in cellular and molecular immunology and her... Read More →
SN

Simone Nicholson

Toxicologist, AstraZeneca
Simone is a Toxicologist at MedImmune/AstraZeneca, she supports the safety assessment of multiple biologics modalities at all stages of development. Prior to her time at MedImmune, Simone performed in vivo pharmacology and safety studies at Dyax, the antibody library company. She... Read More →
KS

Karin Staflin

Senior Scientist, Genentech, A Member of the Roche Group
Dr. Karin Staflin, PhD., DABT., is a Development Toxicologist within the Safety Assessment Group at Genentech. She is responsible for the safety assessment of early- to late-stage large and small molecule therapeutics, within a range of disease areas. Before joining the Development... Read More →
avatar for Theresa Sweeney

Theresa Sweeney

Vice President, Safety Assessment, Nektar Therapeutics
Dr. Sweeney is currently the Vice President of Safety Assessment at Nektar Therapeutics where she leads a team responsible for evaluating the safety of both large and small molecule drugs. She has more than 25 years of drug development experience at Nektar and Genentech. Her professional... Read More →


Tuesday June 25, 2019 2:00pm - 3:15pm
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:15pm

#276 RT: Round Table Discussion: Updates and Lessons Learned from Novel Approaches to Pharmacovigilance Collaboration
Component Type: Session
Level: Basic

Round table discussion tied to session #202: Updates and Lessons Learned from Novel Approaches to Pharmacovigilance Collaboration (Tuesday, June 25, 8:00-9:15AM). Seating is limited. To include special guests from the session: Songlin Xue, Michael Forstner, Jose Vega, Paul Chang.

Chair

Jill Notte


Speakers
avatar for Jill Notte

Jill Notte

Associate Director - Marketing, Cognizant
Jill Notte is a communications professional who has focused on drug safety for nearly 20 years. In 2001, she joined one of the first firms to offer adverse event case processing services and safety system hosting to pharmaceutical companies. She helped establish pharmacovigilance... Read More →


Tuesday June 25, 2019 3:15pm - 4:15pm
Community Zone Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#298: Clinical Safety Assessment: What’s a Statistician Got to Do with It?
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-637-L04-P; CME 1.25; IACET 1.25; RN 1.25

Statistical attention to safety data is often times left to routine, basic calculations and tabulations. Absent statistical input, the data run the risk of being presented in ways that are unintuitive, uninformative, or in the worst case, deceptive. Speakers in this session will present examples where statisticians are collaborating with clinical colleagues and data scientists to more effectively analyze and clinically interpret safety data.

Learning Objectives

Recognize the importance of statistical engagement in the assessment of clinical trial safety data; Apply appropriate statistical methods in the analysis of safety data; Identify the need to work collaboratively with clinicians and data scientists.

Chair

Mat Soukup, PhD

Speaker

Improving Analyses and Displays for Clinical Trial Safety Data
Mary Nilsson, MS

ASA/DIA Safety WG Presents: Finding Safety Signals During Clinical Development with R Shiny
Susan Duke, MSc

FDA Perspective
Matthew Guerra, PhD



Speakers
avatar for Susan Duke

Susan Duke

Mathematical Statistician, OB, OTS, CDER, FDA
Susan became involved in safety related industry-wide graphics in 2009 when she joined the FDA/Industry/Academia Safety Graphics WG. She is currently a Mathematical Statistician reviewer in CDER and member of a cross-functional safety monitoring WG co-sponsored by DIA and ASA Biopharm... Read More →
MG

Matthew Guerra

Mathematical Statistician, OB, OTS, CDER, FDA
Matthew is a senior statistical reviewer supporting the Division of Dermatology and Dental Products (DDDP) in the Center for Drug Evaluation and Research (CDER) at the FDA. Matthew joined the FDA in 2011 immediately after receiving his Ph.D. in Biostatistics from the University of... Read More →
avatar for Mary Nilsson

Mary Nilsson

Statistician, Eli Lilly and Company
Mary received a MS degree in statistics from Iowa State University in 1989. She has been employed at Lilly since 1989 and is currently a research advisor in the Safety Analytics group within the Statistical Sciences function. She consults with compound teams on safety analysis planning... Read More →
MS

Mat Soukup

Deputy Div. Director, Div. of Biometrics VII, Office of Biostatistics, OTS CDER, FDA
Following his educational endeavors in statistics at the University of Minnesota-Morris and the University of Virginia, Mat joined FDA/CDER in September 2004. His first 6 years were spent reviewing dermatology and dental products before joining the Division of Biometrics 7 as Team... Read More →


Tuesday June 25, 2019 4:15pm - 5:30pm
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Regulator Thinking,Innovative Trial Design
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session
 
Wednesday, June 26
 

8:00am

#302: Triple-s (3S) Smart Safety Surveillance
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-682-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will inform attendees about the 3S project. Funded by the Bill and Melinda Gates the WHO are working with low and middle income countries with a high disease burden in specific areas that are subject to new treatments to increase their pharmacovigilance capabilities. MHRA are collaborating in the project to ensure regulatory pharmacovigilance capacity is increased to collect, analyse and act on safety data.

Learning Objectives

Describe the rationale for 3S; Discuss how industry is key to the success of PV in low and middle income countries; Identify the need for robust regulatory frameworks for PV.

Chair

Mick Foy

Speaker

Smart Safety Surveillance (TripleS)- Pharmacovigilance Strengthening in Low- to Middle-Income Countries (LMIC)
Raj Long, MEd, MSc

Panelist
Andrea Best, DO, MPH



Speakers
avatar for Andrea Best

Andrea Best

Executive Medical Director, AbbVie, Inc.
Dr. Andrea Best is an Executive Medical Director in Pharmacovigilance and Patient Safety at AbbVie in the suburbs of Chicago where she is responsible for Clinical Trial Safety Excellence. Andrea has over 20 years of experience in academia and industry across a variety of roles (clinical... Read More →
avatar for Mick Foy

Mick Foy

Head of Pharmacovigilance Strategy, Vigilance Intelligence, and Research Group, Medicines and Healthcare Products Regulatory Agency (MHRA)
Mick Foy is Head of Pharmacovigilance Strategy at the MHRA. Among is responsibilities is the running of the UK ADR reporting system and signal detection activities. Mick is also leads the MHRA's work with WHO and the Bill and Melinda Gates Foundation on capacity building in low and... Read More →
avatar for Raj Long

Raj Long

Senior Regulatory Officer, Integrated Development, Global Health, Bill and Melinda Gates Foundation
Raj is currently a Senior Regulatory Officer at the Bill & Melinda Gates Foundation (BMGF) responsible for Malaria and Neglected Diseases medicines portfolio. In 2014 Raj was invited by the UK Secretary of State to be a member to the World Dementia Council (WDC) she is also appointed... Read More →


Wednesday June 26, 2019 8:00am - 9:15am
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Advanced
  • Featured Topics Regulator Thinking
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

8:00am

#301: So Much Data, So Little Time: Hot Topics in Benefit-Risk Assessment
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-646-L04-P; CME 1.25; IACET 1.25; RN 1.25

Both regulators and sponsors are increasingly using structured frameworks to assess the benefit-risk profile of medicinal products. Such frameworks can accommodate a variety of data sources and can be supplemented by an array of graphical presentations. As experience with using structured benefit-risk assessment (SBRA) frameworks in both the pre- and post-market context accrues, a number of important questions remain, including: 1) What has been learned by FDA and EMA in regard to using a structured benefit-risk assessment framework for new drug application assessments? 2) How are these regulatory authorities continuing to train and support their reviewers in conducting such assessments? 3) What are the challenges involved in incorporating real world data into structured benefit-risk assessment analyses? 4) What are good practices in terms of evaluating the impact of different types of uncertainty on the quality of the benefit-risk assessment decision?

Learning Objectives

Describe the FDA’s and EMA’s experiences to date in implementing structured approaches to benefit-risk assessment, including the use of the Effects Tables and other tools; Discuss the key considerations in evaluating the impact of uncertainty on the quality of the benefit-risk assessment decision; Identify the challenges involved in incorporating real world evidence into a structured benefit-risk assessment.

Chair

Meredith Y. Smith, PhD, MPA

Speaker

FDA's Experience to Date Using the Structured Benefit-Risk Assessment Framework to Support Regulatory Decision-Making
Graham Thompson

Use of Real World Evidence in Personalized Benefit-Risk Assessment: Closing the Knowledge Gap
Tarek Hammad, MD, PhD, MS, MSc, FISPE

EMA Perspective
Douwe Postmus, PhD, MSc



Speakers
avatar for Tarek Hammad

Tarek Hammad

Therapeutic Area Strategy Lead, Global Pharmacovigilance, Sanofi Genzyme
Dr. Hammad joined Sanofi-Genzyme, in 2019, as a Therapeutic Area Strategy Lead in the Global Pharmacovigilance group. Prior to this, he served as the Head of Signal Detection and Benefit-Risk Assessment in Merck KGaA/EMD Serono. Previously, he was an Executive Director of Pharmacoepidemiology... Read More →
avatar for Douwe Postmus

Douwe Postmus

Researcher, University Medical Center Groningen
Dr Douwe Postmus is employed as a researcher at the Department of Epidemiology of the University Medical Center Groningen, The Netherlands. His research focuses on applying quantitative modeling techniques to decision making problems in health care, including regulatory, reimbursement... Read More →
avatar for Meredith Smith

Meredith Smith

Global Risk Management Officer, Global Patient Safety, Amgen Inc.
Meredith Smith is Global Risk Management Officer at Amgen, Inc. where she leads a team of 6 scientists responsible for medicinal product benefit-risk assessment and risk management. She is a behavioral scientist and health services researcher by training with over 15 years of experience... Read More →
GT

Graham Thompson

Operations Research Analyst, OSP, CDER, FDA
Graham Thompson joined FDA in 2012 and currently serves as an operations research analyst for the Decision Support and Analysis Team (DSAT) in FDA’s Center for Drug Evaluation and Research (CDER). He works on CDER projects and initiatives related to benefit-risk assessment and supporting... Read More →


Wednesday June 26, 2019 8:00am - 9:15am
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#327: Digital Risk Minimization: The “Next Generation” Risk Management Tools
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-664-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will describe the process of conceptualizing, implementing, and evaluating digital risk minimization tools, using several real world examples. Join the Clinical Safety & Pharmacovigilance Community for a follow up Round Table discussion on Wednesday, June 26, 4:15-5:15PM in the DIA Community Zone 1, Sails Pavilion.

Learning Objectives

Describe the process of developing a digital risk minimization tool; Outline considerations for the effective implementation and evaluation of a digital risk minimization tool.

Chair

Meredith Y. Smith, PhD, MPA

Speaker

Leveraging Digital for Effective Risk Minimization Tools: Operational and Policy Considerations
Simon Ingate, PhD, MBA

One Company's Perspective on Implementing Digital Risk Minimization Tools Globally
Sarah A. Frise, PhD, MS

Applying the Diffusion of Innovaton Theory Framework to the Implementation of Innovative Digital Risk Minimization Measures
Carmit Strauss, PharmD



Speakers
avatar for Simon Ingate

Simon Ingate

Director, Huron Consulting Group
Simon Ingate is a Principal Consultant at Huron Consulting Group (Formerly Pope Woodhead) where he develops and implements risk management/minimisation (RM) strategy and programmes. Simon leads teams developing new approaches for disseminating and evaluating risk minimisation measures... Read More →
avatar for Meredith Smith

Meredith Smith

Global Risk Management Officer, Global Patient Safety, Amgen Inc.
Meredith Smith is Global Risk Management Officer at Amgen, Inc. where she leads a team of 6 scientists responsible for medicinal product benefit-risk assessment and risk management. She is a behavioral scientist and health services researcher by training with over 15 years of experience... Read More →
avatar for Carmit Strauss

Carmit Strauss

Global Benefit Risk Management Scientist, Safety Management, Amgen Inc.
Carmit Strauss, PharmD, is currently a Benefit Risk Management Scientist at Amgen. Dr. Strauss obtained her PharmD at the University of Southern California and completed her industry Post-Doctoral fellowship in medical affairs at Baxter Bioscience. Dr. Strauss has a global medical... Read More →
avatar for Sarah Frise

Sarah Frise

Global Director Risk Management, AstraZeneca
Sarah holds a Masters Degree in Physiology and Phd in Epidemiology. Sarah holds the position of the Global Director, Risk Management at AstraZeneca and a faculty position in Epidemiology at the University of Toronto. She is an active member of many Pharmacovigilance working groups... Read More →


Wednesday June 26, 2019 10:30am - 11:30am
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#336: Exploring the Evolving Requirements for the Clinical Assessment of Abuse and Dependence Potential of CNS-Active Drugs
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-678-L04-P; CME 1.00; IACET 1.00; RN 1.00

Drug scheduling is implemented by regulatory agencies to mitigate the risk of drug abuse. Learn about the pivotal clinical studies required to evaluate the abuse and dependence potential of CNS-active drugs and the evolving regulatory requirements.

Learning Objectives

Describe the most recent FDA recommendations for the clinical evaluation of abuse and physical dependence of CNS-active drugs; Discuss how this data is used to determine drug scheduling and the implications of controlled substances;Evaluate the best strategies to design robust abuse/dependence potential clinical trials.

Chair

Beatrice Setnik, PhD

Speaker

Panelist
Jack Henningfield, PhD

Panelist
Beatrice Setnik, PhD



Speakers
avatar for Jack Henningfield

Jack Henningfield

Vice President, Research, Health Policy, and Abuse Liabiliy, Pinney Associates
Professor Adjunct, Johns Hopkins School of Medicine, past chief Abuse Potential and Clinical Pharmacology, NIDA. 400+ articles and books related to drug abuse & regulation, public health, and neuropharmacology. My PinneyAssociates focus is on drug development, risk management, and... Read More →
avatar for Beatrice Setnik

Beatrice Setnik

Dept of University of Toronto; VP, Scientific and Clinical Strategy, Early Phase, Syneos Health
Dr. Setnik has been working in the area of CNS research and clinical drug development for over 16 years and is an expert in the area of abuse and dependence potential evaluation of drugs. Dr. Setnik is currently the Vice President of Clinical Pharmacology at INC Early Phase and oversees... Read More →
avatar for Beatrice Setnik

Beatrice Setnik

Dept of University of Toronto; VP, Scientific and Clinical Strategy, Early Phase, Syneos Health
Dr. Setnik has been working in the area of CNS research and clinical drug development for over 16 years and is an expert in the area of abuse and dependence potential evaluation of drugs. Dr. Setnik is currently the Vice President of Clinical Pharmacology at INC Early Phase and oversees... Read More →


Wednesday June 26, 2019 10:30am - 11:30am
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics What's Next,Regulator Thinking,Innovative Trial Design,What's Next
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

12:45pm

#351 RT: Round Table Discussion: An Industry Collaboration on Pharmacovigilance Analytics
Component Type: Session
Level: Basic

Join DIA Clinical Safety & Pharmacovigilance Community for a round table discussion tied to session #229: An Industry Collaboration on Pharmacovigilance Analytics (Tuesday, June 25, 10:30-11:30AM). Seating is limited.

Chair

Jill Notte


Speakers
avatar for Jill Notte

Jill Notte

Associate Director - Marketing, Cognizant
Jill Notte is a communications professional who has focused on drug safety for nearly 20 years. In 2001, she joined one of the first firms to offer adverse event case processing services and safety system hosting to pharmaceutical companies. She helped establish pharmacovigilance... Read More →


Wednesday June 26, 2019 12:45pm - 1:45pm
Community Zone Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#375.1 RT: Round Table Discussion: The Elephant in the Room: Meaningful Communication of Near Synonyms as Suspected Adverse Reactions
Component Type: Session
Level: Basic

Join DIA Clinical Safety and Pharmacovigilance Community for a round table discussion tied to the session #282: The Elephant in the Room: Meaningful Communication of Near Synonyms as Suspected Adverse Reactions (Tuesday, June 25, 4:15-5:30PM). Seating is limited.

Chair

Judith Jones


Speakers
avatar for Judith Jones

Judith Jones

Principal Consultant, Pharmacovigilance, Epidemiology, and Risk Management, PharmaLex
Dr. Jones is a clinical pharmacologist/pharmacoepidemiologist trained in geriatrics and internal medicine with a longstanding interest in the study of adverse drug reactions, drug utilization, and drug development and regulation. She received her medical training at Baylor College... Read More →


Wednesday June 26, 2019 2:00pm - 3:00pm
Community Area Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#356: Involving Patients in Medicinal Product Benefit-Risk Communication: How're We Doing?
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-732-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will explore the state-of-the-science in regard to patient involvement in benefit-risk communication for medicinal products. Interactive audience engagement will occur throughout the session to stimulate dialogue on implications for advancing the science and practice in this area. Questions will include: • What steps are regulators taking to involve patients in benefit-risk communication? • What new tools are being developed to educate patients about the benefits and risks of drugs, and how effective are they? • What are the current challenges and barriers that impede greater patient involvement in benefit-risk communication of medicinal products? How can they be addressed? • What are promising avenues for further advancing the science of patient involvement in benefit-risk communication?

Learning Objectives

Describe the state-of-the-science in terms of patient involvement in benefit-risk communication of pharmaceutical products; Discuss challenges and solutions for enhancing patient involvement in benefit-risk communication and for improving how such information is provided to them; Identify pragmatic scientific approaches for enhancing patient involvement in benefit-risk communication and the role of new types of interactive digital educational tools for patients.

Chair

Meredith Y. Smith, PhD, MPA

Speaker

Trends in the Use of Interactive Digital Tools to Educate Patients Regarding Safe and Appropriate Use of Drugs: What Has Been Learned to Date?
Meredith Y. Smith, PhD, MPA

Patient Engagement in Pharmacovigilance and Benefit-Risk Communication: Update from EMA
Tânia Teixeira, PharmD

Involving Patients in Benefit-Risk Communication: What are the Opportunities? What are the Challenges?
Marc M. Boutin, JD



Speakers
avatar for Marc Boutin

Marc Boutin

Chief Executive Officer, National Health Council (NHC)
Marc M. Boutin, JD, is the Chief Executive Officer of the National Health Council. He has been a leading voice for greater patient involvement at every stage of the health care continuum. Boutin has been actively involved in patient advocacy organization management, health advocacy... Read More →
avatar for Meredith Smith

Meredith Smith

Global Risk Management Officer, Global Patient Safety, Amgen Inc.
Meredith Smith is Global Risk Management Officer at Amgen, Inc. where she leads a team of 6 scientists responsible for medicinal product benefit-risk assessment and risk management. She is a behavioral scientist and health services researcher by training with over 15 years of experience... Read More →
avatar for Tânia Teixeira

Tânia Teixeira

EMA Liaison Official at FDA, European Medicines Agency (EMA)
Tania Teixeira is the EMA Liaison Official to FDA. She started her career in the pharmaceutical industry and joined EMA in 2004. She held positions as a Head of service for Referrals, dealing with emerging concerns which require a harmonised position across the EU, and as Product... Read More →


Wednesday June 26, 2019 2:00pm - 3:15pm
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:15pm

#377 RT: Round Table Discussion: Pharma and Regulatory Perspectives on Machine Learning Applications in Pharmacovigilance
Component Type: Session
Level: Basic

Join DIA Clinical Safety & Pharmacovigilance Community for a round table discussion tied to session #255: Pharma and Regulatory Perspectives on Machine Learning Applications in Pharmacovigilance (Tuesday, June 25, 2:00-3:15PM). Seating is limited. To include special guests from the session: Bruce Donzanti.

Chair

Jill Notte


Speakers
avatar for Jill Notte

Jill Notte

Associate Director - Marketing, Cognizant
Jill Notte is a communications professional who has focused on drug safety for nearly 20 years. In 2001, she joined one of the first firms to offer adverse event case processing services and safety system hosting to pharmaceutical companies. She helped establish pharmacovigilance... Read More →


Wednesday June 26, 2019 3:15pm - 4:15pm
Community Zone Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:30pm

#398 RT: Round Table Discussion: Digital Risk Minimization: The “Next Generation” Risk Management Tools
Component Type: Session
Level: Basic

Round table discussion tied to session #327: Digital Risk Minimization: The “Next Generation” Risk Management Tools (Wednesday, June 26, 10:30-11:45AM). Seating is limited. To include special guest from the session: Carmit Strauss, Simon Ingate, Meredith Smith.

Chair

Karen Ward, MS


Wednesday June 26, 2019 4:30pm - 5:30pm
Community Zone Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Thursday, June 27
 

9:00am

#403: Successes and Challenges in Pharmacovigilance for Biologics and Biosimilars
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-718-L04-P; CME 1.25; IACET 1.25; RN 1.25

With the advent of biosimilars on a global scale and thus the introduction of multi-source biological products, the importance of accurate pharmacovigilance and unique product traceability cannot be understated. Not only do these efforts support detection of adverse drug reactions, they give confidence to providers and patients in the safe and appropriate use of these medicines. Various approaches have been taken in attempts to facilitate unique product traceability and improve risk minimization.

This session will focus on some of these approaches and their effectiveness and will highlight the role of National Regulatory Authorities and evolving technology infrastructure to improve traceability and enable global harmonization in these approaches.

Learning Objectives

Describe the current state of pharmacovigilance efforts for biological products in various regions; Identify different approaches to unique product traceability and determine their effectiveness; Discuss how to help to identify opportunities for global harmonization to facilitate unique product identification.

Chair

Brad Jordan, PhD

Speaker

Analysis of Biosimilars Approved in EU and US: Insights into Risk Minimization Strategies
Kalindi Hapani, MPharm

Biosimilars: Should They Have a ‘Similar’ System to the Originator?
Brian Edwards, DrMed

FDA Perspective
Lubna Merchant, PharmD, MS

Biologic and Biosimilar Nomenclature: How Important is Distinguishability and International Harmonization?
Philip J Schneider, MS, RPh



Speakers
avatar for Brian Edwards

Brian Edwards

Principal Consultant, Pharmacovigilance and Drug Safety, Vice-President ACRES, NDA Group
After his training in hospital medicine and clinical research for 14 years, Dr. Edwards joined the UK Medicines Control Agency (MHRA) in 1994 where he had various responsibilities as a pharmacovigilance assessor. In 1999 he joined Parexel to become Senior Medical Director before joining... Read More →
avatar for Kalindi Hapani

Kalindi Hapani

Assistant Manager, Pharmacovigilance, APCER Life Sciences
Kalindi is a Registered Pharmacist, having done Masters in Pharmacy. With stint as Lecturer for initial years (4 years in academics), she pursued Post Graduate Diploma in Clinical Research and Pharmacovigilance. She has 9 years of global experience with 4 years concentrated in pharmacovigilance... Read More →
avatar for Brad Jordan

Brad Jordan

Director, Global Regulatory and R&D Policy, Amgen
Dr. Brad Jordan is a Director of Global Regulatory and R&D Policy at Amgen where his role focuses on global technical regulatory policy relating to biologics and biosimilars. Dr. Jordan joined Amgen in 2006, and prior to his role in Policy, spent 10 years in the Discovery Research... Read More →
avatar for Lubna Merchant

Lubna Merchant

Deputy Office Director, OMEPRM, OSE, CDER, FDA
Dr. Merchant currently serves as the acting Director of the Division of Medication Error Prevention and Analysis. She is also the Deputy Director of the Office of Medication Error Prevention and Risk Management in FDA’s Center for Drug Evaluation and Research’s (CDER) where she... Read More →
avatar for Philip Schneider

Philip Schneider

Advisory Board Chair, Alliance For Safe Biologic Medicines
Philip J. Schneider is founder and principal of MediHealthInsight, which provides consultation to the industry and others on matters related to improving the use of medicines including the application of new technologies in healthcare. He is also Chair of the International Advisory... Read More →
avatar for Philip Schneider

Philip Schneider

Advisory Board Chair, Alliance for Safe Biologic Medicines
Philip J. Schneider is founder and principal of MediHealthInsight, which provides consultation to the industry and others on matters related to improving the use of medicines including the application of new technologies in healthcare. He is also Chair of the International Advisory... Read More →


Thursday June 27, 2019 9:00am - 10:15am
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

9:00am

#410: Advancing Benefit-Risk Assessment to Support FDA’s Regulatory Review of Human Drugs and Biologics
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-724-L04-P; CME 1.25; IACET 1.25; RN 1.25

FDA currently uses a structured, qualitative framework for benefit-risk assessment of human drugs and biologics. This session will cover FDA’s efforts to enhance this qualitative framework and explore more advanced benefit-risk assessment methods.

Learning Objectives

Describe FDA’s approach to benefit-risk assessment under PDUFA V and VI; Discuss efforts to continue enhancing FDA’s methodological approach to benefit-risk assessment; Summarize findings from analysis of BRFs in 2017 novel drug approvals.

Chair

Graham Thompson

Speaker

Implementation of a Structured Benefit-Risk Framework into FDA's Human Drug Review
Leila Grace Lackey, MHS, PhD

CBER’s Experience with Benefit-Risk
Hong Yang, PhD

Planning and Assessing Benefit-Risk Quantitatively in the Next Decade
Susan Duke, MSc

Best Practices for Quantitative Benefit-Risk Assessments
Tommi Tervonen



Speakers
avatar for Susan Duke

Susan Duke

Mathematical Statistician, OB, OTS, CDER, FDA
Susan became involved in safety related industry-wide graphics in 2009 when she joined the FDA/Industry/Academia Safety Graphics WG. She is currently a Mathematical Statistician reviewer in CDER and member of a cross-functional safety monitoring WG co-sponsored by DIA and ASA Biopharm... Read More →
avatar for Leila Lackey

Leila Lackey

Operations Research Analyst, OPSA, OSP, CDER, FDA
Dr. Lackey has a Master of Health Science from Johns Hopkins in Environmental Health Sciences and a doctorate from UCLA in Environmental Science and Engineering. Professionally, she has worked for the Environmental Protection Agency and for the Food and Drug Administration leading... Read More →
avatar for Tommi Tervonen

Tommi Tervonen

Research Scientist, Evidera, PPD
Tommi Tervonen, PhD, is an Associate Director of Patient Preferences and Research Scientist at the Patient-Centered Research team of Evidera in London, UK. Dr. Tervonen joined Evidera in September 2015 after leaving his position of Assistant Professor at the Erasmus School of Economics... Read More →
GT

Graham Thompson

Operations Research Analyst, OSP, CDER, FDA
Graham Thompson joined FDA in 2012 and currently serves as an operations research analyst for the Decision Support and Analysis Team (DSAT) in FDA’s Center for Drug Evaluation and Research (CDER). He works on CDER projects and initiatives related to benefit-risk assessment and supporting... Read More →
avatar for Hong Yang

Hong Yang

Biologist, Office of Biostatistics and Epidemiology, CBER, FDA
Dr. Hong Yang is a senior regulatory scientist in the Office of Biostatistics and Epidemiology, CBER, FDA. She holds Ph.D. degree in Biological Engineering. Dr. Yang has expertise in benefit-risk assessment of biological products. She has been devoted in regulatory review, as well... Read More →


Thursday June 27, 2019 9:00am - 10:15am
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA