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Drug-Induced Injury of Liver, Heart, Kidney, and Skin: Employing Recent Advances to Improve Patient Safety and Speed Up the Pipeline

May 7 2014 7:30AM - May 9 2014 1:15PM | Bethesda North Marriott Hotel and Conference Center 5701 Marinelli Road, North Bethesda, MD 20852 USA

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Overview 

Establishing safety of new drug candidates remains a major challenge at every stage of the development process.  This conference will explore the current state of the art as well as how our evolving understanding of underlying mechanisms is leading to new strategies for risk assessment and mitigation. This includes the application of novel translational biomarkers and other personalized medicine approaches.

The focus will be on drug injury to the liver, heart, kidney and skin. Within each organ system, what is worth doing? What is possible to predict about organ toxicity… before a compound is synthesized? …in non-clinical assessments? …in high-throughput assays?  Having identified an important risk, should development be abandoned or can it proceed? Can personalized medicine be applied to risk management? Can patients be protected by monitoring organ function or by assaying new translational biomarkers? Benefit must outweigh risk to patients across the entire product life cycle. Do the strategies used in clinical development translate to the post-marketing setting?

This is the one conference that should be attended by all those with responsibilities that span the entire life cycle of a drug, whether those responsibilities are directly in drug safety or are in related departments.  In just two and a half days your team will receive the latest updates on drug-induced organ injury from the US, Europe, and Japan.

This program is developed by the DIA Clinical Safety and Pharmacovigilance Community in collaboration with Academia, Regulators and Industry Experts.

Who Should Attend 

Professionals with intermediate to advanced knowledge in assessing drug safety during the entire life cycle of the drug, including:

  • Risk identification, characterization, and management
  • Non-clinical safety and toxicology
  • Overall medical product safety assessment
  • Safety signal detection, assessment, and management
  • Benefit-risk assessment
  • Regulatory affairs
  • Clinical research, including Investigators, clinical trial sponsors, statisticians
  • Contract Research Organizations (CROs), and others following Good Clinical Practices (GCPs)
  • Study design, protocol preparation, and data analysis
  • Informed Consent preparation, Institutional Review Board (IRBs) activities, or independent Data Safety Monitoring Boards (DSMBs)
  • Medical writing
  • Pharmacoepidemiology
  • Medical product labeling and communication of safety information
  • Health outcomes research
  • Translational medicine
  • Chemistry, Manufacturing & Controls  (CMC)
  • Pharmacology
  • Pharmacokinetics/ Pharmacodynamics (PK/PD) and Adsorption, Distribution, Metabolism, and Excretion (ADME)
  • Pharmacovigilance
  • Clinical Quality Assurance and compliance
  • Hepatology
  • Cardiology
  • Dermatology
  • Nephrology

Learning Objectives 

At the conclusion of this program, participants should be able to:

  • Recognize how to better handle cases of suspected drug-induced liver injury, including causality assessment and use of new biomarkers
  • Describe the importance of prioritizing drug-induced heart injury
  • Discuss drug-induced kidney injury and the use of novel biomarkers for early detection
  • Recognize the essential features of drug induced kidney injury
  • Discuss population differences and genetic markers of risk for severe drug-induced skin injury and how benefit-risk profiles may differ by population for a given compound
  • Discuss essential requirements for assessment of drug-induced organ injuries from a regulatory reviewer's perspective
  • Identify common pitfalls and potential approaches to causality assessment for drug-induced organ injury
  • Apply a strategy early in the product life cycle for handling possible drug-induced organ injury

Special Offers 

Group Discounts Available! Register 3 and Get the 4th FREE!

Hotel & Travel 

The conference will be held at the Bethesda North Marriott Hotel and Conference Center. 
A limited number of rooms are available at the reduced rate shown below (DIA rate is guaranteed until April 7, 2014, or until room block is filled). Please Note: In order to receive the reduced room rate, hotel reservations must be made through Travel Planners, and not directly with the hotel.  Contact information for Travel Planners is as follows: Attendees can follow this link or call +1.212.532.1660 or 1.800.221.3531 in the U.S.When calling please select option 1 for “Hotel Reservations”, inform the phone agent that you are making a reservation for Event #14010

Standard Room Rate $209

Hotel Address: 5701 Marinelli Road, North Bethesda, MD 20852

PLEASE READ
Warning: Unauthorized Solicitation

The most convenient airport is Washington Dulles International Airport – IAD or Ronald Reagan Washington National Airport - DCA and attendees should make both airline and hotel reservations as early as possible

Contact Information 

Registration Questions
Customer Service Department
Phone: +1.888.257.6457 | +1.215.442.6100
Fax: +1.215.442.6199
CustomerService@diahome.org

Agenda Details
Karen Tenaglia
Phone +1.215.442.6196
Fax +1.215.442.6199
Karen.Tenaglia@diahome.org

Event Logistics
Ellen Diegel, Event Planner
Phone +1.215.293.5810
Fax +1.215.442.6199
Ellen.Diegel@diahome.org

Continuing Education 

This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Postgraduate Institute for Medicine (PIM) and the Drug Information Association. PIM is accredited by the ACCME to provide continuing medical education for physicians.

PIM designates this live activity for a maximum of 16.5 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

The Postgraduate Institute for Medicine (PIM) and DIA require instructors, planners, managers and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest they may have as related to the content of this activity. All identified conflicts of interest are thoroughly vetted by PIM and DIA for fair balance, scientific objectivity of studies mentioned in the materials or used as the basis for content, and appropriateness of patient care recommendations.

The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program is designated for 16.5 contact hours or 1.65 continuing education units (CEU’s).

Type of Activity: Knowledge

ACPE Credit Request Update
DIA is required by the Accreditation Council for Pharmacy Education (ACPE) to report pharmacy-requested CEUs through the CPE Monitor system. All ACPE-certified activity credit requests need to be submitted through DIA’s My Transcript within 45-days post activity. Pharmacists will need to provide their National Association of Boards of Pharmacy (NABP) e-Profile ID and date of birth (MMDD) to ensure the data is submitted to the ACPE and NABP properly. If you need to obtain your NABP e-Profile, please visit www.cpemonitor.net.

Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1760 Old Meadow Road, Suite 500, McLean, VA 22102; +1.703.506.3275.

As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer 1.7 CEUs for this program. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded.

This program is part of DIA’s Certificate Program and is awarded the following:
• Clinical Research Certificate Program: 10 Elective Units
• Clinical Safety and Pharmacovigilance Certificate Program: 4 Elective Units
• Regulatory Affairs Certificate Program: 10 Elective Units

For more information go to diahome.org/certificateprograms

Name Credit Type Max Credits CEU
Drug-Induced Injury of Liver, Heart, Kidney, and S ACPE 16.50 1.650
Drug-Induced Injury of Liver, Heart, Kidney, and S CME 16.50 0.000
Drug-Induced Injury of Liver, Heart, Kidney, and S IACET 16.50 1.700

Disclosure Policy:

It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.

Statement of Credit:

If you would like to receive a statement of credit, you must attend the program, sign in at the DIA registration desk each day of the program, and complete the credit request process through My Transcript. To access My Transcript, please go to www.diahome.org, select “Login to My DIA” and you will be prompted for your user ID and password. Select “My Transcript” (left side bar) and “Credit Request” to process your credit request. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests on Friday, May 23, 2014.

Pharmacy Credit Allocation:
· Day 1: 6.25 contact hours or .625 CEUs; 0286-0000-14-040-L04-P
· Day 2: 6 contact hours or .6 CEUs; 0286-0000-14-041-L04-P
· Day 3: 4.25 contact hours or .425 CEUs; 0286-0000-042-L04-P

View DIA’s Grievance Policy, please visit www.diahome.org/CE

Program Committee 

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Agenda  

Day 1 Wednesday, May 07, 2014

  • 7:30AM - 8:20AM

    Registration and Continental Breakfast
  • 8:20AM - 8:30AM

    Welcome and Opening Remarks

    Speaker(s):

    • William W. Gregory, PhD
      Senior Director, Worldwide Safety and Regulatory
      Pfizer Inc, United States
    • Susan Cantrell
      Senior Vice President and Managing Director, DIA Americas
      DIA, United States
  • 8:30AM - 10:00AM

    Impact on Drug Development of Novel Translational Safety Biomarkers for Improved Detection of Drug-Induced Acute Kidney Injury


    Session Chair(s):

    • No-image Aliza M. Thompson, MD
      Clinical Team Leader, Division of Cardiovascular and Renal Products, OND, CDER
      FDA, United States

    The first speaker will describe the scientific and business benefits being realized from qualifying improved translational kidney safety biomarkers for drug development, focusing on animal study data that have been developed to support the claims that several novel biomarkers can outperform conventional biomarkers for monitoring potential drug effects on renal function. The second speaker will discuss initial experiences of using novel renal biomarkers in early clinical studies, highlighting some of the challenges and presenting options for optimizing early clinical study designs. The third speaker will discuss how kidney safety biomarkers are being used in drug development programs and share her perspective on interpreting biomarker findings in clinical studies.

    Speaker(s):

    • Preclinical Evidence for the Value of New Translational Biomarkers to Monitor Renal Safety in Early Drug Development
      Yi-Zhong Eddie Gu, PhD
      Principal Scientist, Systems Toxicology, Safety Assessment
      Merck Research Labs, United States
    • Optimizing the Design of Early Clinical Trials Using Novel Biomarkers to Monitor for Tubular Toxicity
      Stefan Sultana, MD
      Senior Medical Director, Companion Diagnostics
      Novartis, United States
    • A Regulatory Perspective on the Role of Translational Renal Safety Biomarkers in Drug Development
      Aliza M. Thompson, MD
      Clinical Team Leader, Division of Cardiovascular and Renal Products, OND, CDER
      FDA, United States
  • 10:00AM - 10:30AM

    Refreshment Break
  • 10:30AM - 12:00PM

    The Promise of Improved Longitudinal Assessment of Kidney Health Status Using New Kidney Safety Biomarkers


    Session Chair(s):

    • Gary S. Friedman, MD
      Director, Clinical Affairs, Specialty Care Medicines Development Group
      Pfizer Inc., United States

    The first speaker will describe how volume depletion, altered renal hemodynamics and the inhibition of specific renal transporters can impact serum creatinine levels. Whether or not changes in serum creatinine caused by these physiologic responses are associated with renal injury, and whether drugs with pharmacologic activity on kidney function are associated with renal injury. Data from animal toxicology studies of drugs with pharmacodynamic activity on renal blood flow and glomerular filtration and the association of translational kidney safety biomarkers with renal histopathology will be presented.

    The second speaker will describe the promise of new translational renal biomarkers for detecting drug induced kidney injury that occurs (1) after chronic exposure and is slow to develop but is progressive with continued exposure (e.g. lithium toxicity) and (2) in patients with underlying chronic kidney disease. In both of these clinical scenarios, recognition that specific injury is occurring would permit dose adjustments or modifications to the drug regimen. Further understanding how biomarker thresholds might track with severity and course of injury might be helpful in determining appropriate therapeutic interventions and/or predict the prognosis for the kidney injury.

    The third timeslot in this session will be used to introduce a panel and audience discussion on the opportunities with novel kidney safety biomarkers to improve detection of drug induced kidney injury. This panel will include members of academia, industry and a regulatory authority. They will take questions from the audience and further discuss the application of translational kidney safety biomarkers to drug-induced kidney injury and the drug development process. The expertise on the panel will be able to discuss a broad range of topics ranging from the practical use of biomarkers in preclinical and clinical drug development through to the qualification of preclinical and clinical biomarkers for use in regulatory decision making.

    Speaker(s):

    • Drugs Can Affect Renal Hemodynamics and Serum Creatinine, but Is the Kidney Injured?
      Jonathan Barasch, MD, PhD
      Associate Professor of Medicine and Anatomy & Cell Biology
      Columbia University, United States
    • Role of Kidney Biomarkers for the Detection of Drug-Induced Kidney Injury
      Ravindra L. Mehta, MD, FACP, FRCP
      Professor Clinical Medicine, Assoc. Chair, Clinical Research - Dept of Medicine
      University of California, San Diego, United States
    • Panelists:
      Yi-Zhong Eddie Gu, PhD
      Principal Scientist, Systems Toxicology, Safety Assessment
      Merck Research Labs, United States
    • Stefan Sultana, MD
      Senior Medical Director, Companion Diagnostics
      Novartis, United States
    • Jonathan Barasch, MD, PhD
      Associate Professor of Medicine and Anatomy & Cell Biology
      Columbia University, United States
    • Ravindra L. Mehta, MD, FACP, FRCP
      Professor Clinical Medicine, Assoc. Chair, Clinical Research - Dept of Medicine
      University of California, San Diego, United States
    • Aliza M. Thompson, MD
      Clinical Team Leader, Division of Cardiovascular and Renal Products, OND, CDER
      FDA, United States
    • Melanie Blank, MD
      Medical Officer, Division of Cardiovascular and Renal Products, OND, CDER
      FDA, United States
  • 12:00PM - 1:30PM

    Luncheon
  • 1:30PM - 3:00PM

    Prediction and Prevention of Serious Drug-Induced Skin Injury


    Session Chair(s):

    • No-image Stewart Geary
      Senior Vice President, Chief Medical Officer
      Eisai Co., Ltd., Japan

    Serious skin reactions are rare but can be life-threatening and leave patients with lasting disabilities. Reports of these reactions tend to cluster around certain drugs or drug classes. Biomarkers of risk for Stevens Johnson Syndrome or Toxic Epidermal Necrolysis (SJS/TEN) based on HLA subtype have shown some usefulness in identifying patients at risk of these reactions but the utility of the biomarker tested varies by ethnic group. This session will discuss what is currently known about biomarkers for risk of serious skin reactions, identification of patients or drugs at greatest risk for these reactions and what can be imputed about the mechanisms of these reactions.

    Speaker(s):

    • What Do We Know About Serious Skin Reactions and Causality?
      Manfred Hauben, MD, MPH
      Senior Director, Safety Risk Research
      Pfizer Inc., United States
    • Biomarkers for Risk of SJS/TEN in Japanese Compared to Other Populations
      Ryosuke Nakamura, PhD
      Chief, Division of Medicinal Safety Science
      National Institute of Health Sciences, Japan
    • Practical Issues in Applying Biomarkers for Significant Skin Reactions During Clinical Development and Post-Marketing
      Stewart Geary
      Senior Vice President, Chief Medical Officer
      Eisai Co., Ltd., Japan
  • 3:00PM - 3:20PM

    Refreshment Break
  • 3:20PM - 3:30PM

    Drug-Induced Heart Injury

    Speaker(s):

    • Norman Stockbridge, MD, PhD
      Director, Division of Cardiovascular and Renal Products, OND, CDER
      FDA, United States
  • 3:30PM - 5:00PM

    Models and Biomarkers of Drug-Induced Cardiac Injury


    Session Chair(s):

    • Brian R. Berridge, DVM, PhD
      Director, World Wide Animal Research Strategy
      GlaxoSmithKline R&D, United States

    This session will explore bench to bedside approaches to identifying and monitoring drug-induced cardiac injury. Novel approaches to in vitro modeling will be explored as well as assessing changes in cardiac structure and function in nonclinical studies. Translational approaches to non-invasive detection and monitoring injury and dysfunction will be discussed as will clinical strategies for detecting and managing cardiac liabilities.

    Speaker(s):

    • Cardiotoxicity of Oncology Drugs; High Content Screening of Bioenergetic Modulation of Kinase Inhibitor Mitochondrial Toxicity in hESC Derived Cardiomyocyte
      Nick Thomas, PhD
      Principal Scientist
      GE Healthcare, United Kingdom
    • Integrated Approaches to in Vivo Nonclinical Modeling of Cardiovascular Liabilities
      James Turk, DVM, PhD
      Pathologist Director
      Amgen Inc., United States
    • Advances in Translational Biomarkers of Cardiac Injury and Dysfunction
      Dana B Walker, DVM, PhD, MS
      Director, Translational Safety Biomarkers
      Novartis Institutes for BioMedical Research, Inc., United States
    • Nonclinical Modeling of Patient Susceptibility to Drug-induced Cardiotoxicity
      Brian R. Berridge, DVM, PhD
      Director, World Wide Animal Research Strategy
      GlaxoSmithKline R&D, United States
  • 5:00PM - 6:00PM

    Networking Reception

Day 2 Thursday, May 08, 2014

  • 7:30AM - 8:30AM

    Registration and Continental Breakfast
  • 8:30AM - 10:00AM

    Proarrhythmia


    Session Chair(s):

    • Norman Stockbridge, MD, PhD
      Director, Division of Cardiovascular and Renal Products, OND, CDER
      FDA, United States

    This session introduces two very different concepts for non-clinical assessment of proarrhythmic risk, one highly integrative, the other highly mechanistic. Then, two very different approaches to clinical assessment of risk are presented--both very different from the “Thorough QT Study"—one obtaining QT information from early phase studies conducted for other purposes, the other seeking to get mechanistic insight from a more detailed analysis of the ECG than just the QT interval.

    Speaker(s):

    • Assessment of Dysrhythmic Potential in Isolated Cardiac Myocytes
      Blake D. Anson, PhD
      Product Manager, iCell Cardiomyocytes
      Cellular Dynamics International, Inc, United States
    • Comprehensive Mechanistic Assessment of Proarrhythmic Potential of Drugs
      Gary Gintant, PhD, MA
      Research Fellow
      AbbVie Inc., United States
    • Early QT Assessment - "Thorough QT" - Like Assessment in Phase 1 Clinical Studies
      Börje C. Darpö, MD, PhD
      Global Medical Director
      iCardiac Technologies, Sweden
    • Going Beyond QT to Improve the ECG Assessment of Proarrhythmic Risk
      David Strauss, MD, PhD
      Medical Officer, CDRH
      FDA, United States
  • 10:00AM - 10:30AM

    Refreshment Break
  • 10:30AM - 12:00PM

    Drug-Induced Liver Injury (DILI) in Clinical Trials and Post Marketing


    Session Chair(s):

    • No-image Paul B Watkins, MD
      Dir, Hamner - UNC Inst. Drug Safety Sciences, Prof Med, Pharmacy & Public Health
      University of North Carolina - Chapel Hill, United States

    DILI remains one of the most frequent injuries that result in termination of clinical development programs, and regulatory actions on drugs post-approval. The costs and other consequences of discovering significant liver safety concerns rises exponentially at each successive stage in clinical development. It is therefore essential to detect and interpret liver safety signals as early as possible during clinical development. This session will cover current approaches to collecting, managing and interpreting liver safety data at each stage in the clinical life of a new drug candidate. This session will end with a panel discussion.

    Speaker(s):

    • Using Data from Controlled Clinical Trials to Evaluate the Risk of Serious Liver Injury and Dysfunction
      John R. Senior, MD
      Associate Director for Science, Office of Surveillance and Epidemiology, CDER
      FDA, United States
    • Detecting, Assessing, and Reporting DILI for Approved and Marketed Drugs
      Mark I. Avigan, MD
      Associate Director, Office of Surveillance and Epidemiology, OPE, CDER
      FDA, United States
    • The Future
      Paul B Watkins, MD
      Dir, Hamner - UNC Inst. Drug Safety Sciences, Prof Med, Pharmacy & Public Health
      University of North Carolina - Chapel Hill, United States
  • 12:00PM - 1:30PM

    Luncheon
  • 1:30PM - 3:00PM

    Causality Assessment for Suspected Drug Induced Liver Injury (DILI)


    Session Chair(s):

    • No-image Arie Regev, MD
      Head, Safety Advisory Hub, Chair Liver & GI Safety Comm, Global Patient Safety
      Eli Lilly & Co., United States

    Causality assessment for suspected DILI is a major challenge in clinical practice and during drug development. In contrast to many other liver disorders, there is currently no specific biomarker or a combination of tests that will establish the diagnosis of DILI and differentiate it from other causes of liver injury. DILI may resemble almost any type of liver disease, and the clinicopathologic spectrum may range from nonspecific injury, to acute and chronic hepatitis, granulomatous liver disease, cholestasis, fatty infiltration, vascular lesions, and hepatic tumors.

    The diagnosis of DILI is therefore virtually always presumptive, as it is based on clinical assessment and exclusion of other possible causes rather than on absolute criteria and specific diagnostic tests. Abnormal liver tests may be caused by numerous liver disorders as well as extra-hepatic disorders, many of which are considerably more common than typical DILI. It is therefore critical to exclude other liver diseases before attributing a liver injury to a drug. Exclusion of other causes requires detailed information pertaining to the patient’s clinical course and laboratory data. Failure to test for other causes may result in assigning guilt by association which may often be erroneous.

    This session will address three topics pertaining to causality assessment during drug development. The first session will focus on common pitfalls and potential solutions, the second session will address causality assessment in patients with underlying hepatitis B and C, and the third session will address the use of the Roussel Uclaf Causality Assessment Method (RUCAM) versus expert opinion for causality assessment during drug development.

    Speaker(s):

    • Causality Assessment for Suspected DILI During Drug Development: Common Pitfalls and Potential Solutions
      Arie Regev, MD
      Head, Safety Advisory Hub, Chair Liver & GI Safety Comm, Global Patient Safety
      Eli Lilly & Co., United States
    • Causality Assessment in Patients with Hepatitis B and C
      James H Lewis, MD, FACP
      Professor of Medicine, Georgetown Univ School of Medicine, Dir of Hepatology
      Georgetown University Hospital, United States
    • RUCAM versus Expert Opinion for Causality Assessment
      Leonard B. Seeff, MD
      Consultant in Hepatology
      Former VA, FDA and Hill Group, United States
  • 3:00PM - 3:30PM

    Refreshment Break
  • 3:30PM - 5:00PM

    Risk Factors for Idiosyncratic DILI


    Session Chair(s):

    • No-image John R. Senior, MD
      Associate Director for Science, Office of Surveillance and Epidemiology, CDER
      FDA, United States

    A great unknown challenge is how to identify the patient who is especially susceptible to drug-induced injury, or who may not be able to adapt to the drug after an initial mild injury and thenceforth be able to tolerate the drug, before giving the drug, or in time to stop it before irreversible damage occurs. Serious DILI is usually rare, but we have no biomarker, genetic test, or other way to know who will get it in advance. We rely on observation of the patient's response to the new (for them) drug . Whether early symptoms, such as nausea, fatigue, right upper abdominal discomfort, or some other symptom may come first, or whether slight elevations of serum transaminase activity(or gammaglutamyl transpeptidase, or other) activity comes first, we don't yet know. For now, either symptoms or serum enzyme elevations should be reported very promptly and rechecked within a few days to find out whether they are worsening or improving, and what can be learned by additional tests, questions, or other ways to diagnose the most likely or probable cause of the abnormalities. In this session, we shall explore the question of whether underlying liver diseases of various types (fatty liver-steatohepatitis, alcoholic liver disease, or viral hepatitis C, B or other) can be distinguished from drug-induced injury, i.e., acute-on-chronic injury, and if the diseases may either enhance or diminish drug-effects. These difficult distinctions will be discussed by master clinicians whose work it is to make such diagnoses in practice, or in evaluation of new drugs.

    Speaker(s):

    • Non-Alcoholic Fatty Liver Disease/Non-Alcoholic Steatohepatitis (NAFLD/ NASH) and the Risk of Idiosyncratic DILI
      Raj K. Vuppalanchi, MD
      Associate Professor of Medicine, Division of Gastroenterology
      Indiana University School of Medicine, United States
    • Alcohol/ Concomitant Drugs and the Risk of Idiosyncratic DILI
      James W. Freston, MD, PhD
      Emeritus Professor of Medicine and Clinical Pharmacology
      University of Connecticut Health Center, United States
    • The Risk of Idiosyncratic DILI in Patients with Viral Hepatitis B and C
      Kendall Marcus, MD
      Deputy Division Director Antiviral Products, CDER
      FDA, United States
    • Utility of Data Standards: Learning from Hepatitis C
      Jeffry Florian, PhD
      Reviewer, Division of Pharmacometrics, CDER
      FDA, United States

Day 3 Friday, May 09, 2014

  • 7:30AM - 8:30AM

    Registration and Continental Breakfast
  • 8:30AM - 10:00AM

    Drug-Induced Liver Injury: Models and Biomarkers


    Session Chair(s):

    • No-image Mark I. Avigan, MD
      Associate Director, Office of Surveillance and Epidemiology, OPE, CDER
      FDA, United States

    One of the key challenges for prediction and assessment of idiosyncratic DILI in drug development is the lack of suitable models and safety biomarkers. This session will present examples on recent advances in both areas based on collaborative research. The first talk will focus on a mechanistic simulation platform being developed at the Hamner Institute, supporting decision-making at transition from preclinical to clinical development. The second talk will present an overview on current work surrounding the development of in vitro models using induced pluripotent stem cells to investigate human diversity as a basis of idiosyncratic DILI. It is hoped that such cell systems will be eventually applied as screening tools for new drugs in development regards their potential to induce DILI. The third speaker will provide background information on and discuss initial results of the work of the Predictive Safety Testing Consortium (PSTC) in the US and the IMI SAFE-T consortium in Europe, both precompetitive consortia collaborating closely on preclinical and clinical qualification of new safety biomarkers for DILI.

    Speaker(s):

    • In Silico Models: Where are we Today?
      Brett A. Howell, PhD
      Lead Scientist and Manager, DILI-sim
      The Hamner- UNC Institute for Drug Safety Sciences, United States
    • Advanced In Vitro Models: Induced Pluripotent Stem Cells as a Model of Human Diversity in DILI
      Edward L. LeCluyse, PhD
      Associate Investigator, Institute for Chemical Safety Sciences
      Hamner Institutes for Health Sciences, United States
    • New Translational DILI Biomarkers: The Predictive Safety Testing Consortium (PSTC) and the IMI Safer and Faster Evidence-based Translation (SAFE-T) Collaboration
      Jeffrey W. Lawrence, PhD
      Director, Biochemical Toxicology
      Amgen Inc., United States
  • 10:00AM - 10:30AM

    Refreshment Break
  • 10:30AM - 12:00PM

    Herbal (including Dietary Supplement)-Induced Liver Injury [HILI] and Other Organ Injuries: How that May Impact Rx Benefit-Risk?


    Session Chair(s):

    • No-image Pradip Paul, MD, MS
      Consultant
      Strategic Pharmacovigilance and Risk Management, United States

    Recent DILIN data indicates about 25% of the DILI are due to herbals. If the natural health products (NHP) or herbals are natural – why one should expect liver injury? However, the US Drug Induced Liver Injury Network (DILIN) findings are factual data. This session will discuss in depth “Herbal-Induced Liver Injury (HILI)”. The first speaker will discuss the historical perspective, prevalence of use and regulation of herbals and dietary supplements in liver injury to set the platform for the second speaker who will describe the experience of the Drug Induced Liver Injury network study with liver injury from herbals and dietary supplements. The third speaker will discuss the possible impact of the HILI on the benefit-risk in Rx products.

    Speaker(s):

    • Historical Perspective, Prevalence of Use and Regulation of Herbals and Dietary Supplements
      Leonard B. Seeff, MD
      Consultant in Hepatology
      Former VA, FDA and Hill Group, United States
    • Herbal (including Dietary Supplement) Induced Liver Injury: Challenges in Diagnosis
      Victor J. Navarro, MD
      Chair, Hepatology
      Einstein Medical Center, United States
    • Can Rx Benefit-Risk Be Impacted by HILI?
      Pradip Paul, MD, MS
      Consultant
      Strategic Pharmacovigilance and Risk Management, United States
  • 12:00PM - 1:00PM

    Emerging Cross-cutting Approaches to Assessment of Drug Safety


    Session Chair(s):

    • Robert J. Temple, MD
      Deputy Center Director for Clinical Science, CDER
      FDA, United States

    This session will present ideas for novel approaches to assessment of drug safety. One relevant to the earliest stages of development—selecting lead compounds on the basis of the activity of structurally related compounds—and the other relevant to post-marketing surveillance—based on systematic data mining of electronic medical history data. This session will end with a panel discussion on how innovations get incorporated into standard practice.

    Speaker(s):

    • Quantitative Structure-Activity Relationships (QSAR)
      Naomi L Kruhlak, PhD
      Senior Staff Fellow, CDER
      FDA, United States
    • Future Role of Electronic Medical Records (EMR) Data in Postmarketing Safety Surveillance
      Sandra S. Garrett, PhD
      Executive Chair
      Global Record Systems, LLC, United States
    • Panelists
      John R. Senior, MD
      Associate Director for Science, Office of Surveillance and Epidemiology, CDER
      FDA, United States
    • Paul B Watkins, MD
      Dir, Hamner - UNC Inst. Drug Safety Sciences, Prof Med, Pharmacy & Public Health
      University of North Carolina - Chapel Hill, United States
    • Norman Stockbridge, MD, PhD
      Director, Division of Cardiovascular and Renal Products, OND, CDER
      FDA, United States
    • Stewart Geary
      Senior Vice President, Chief Medical Officer
      Eisai Co., Ltd., Japan
    • Aliza M. Thompson, MD
      Clinical Team Leader, Division of Cardiovascular and Renal Products, OND, CDER
      FDA, United States
  • 1:00PM - 1:15PM

    Closing Remarks

    Speaker(s):

    • William W. Gregory, PhD
      Senior Director, Worldwide Safety and Regulatory
      Pfizer Inc, United States

Registration Fees 

Member

Member Government
$655.00
Member Academia
$820.00
Member Standard
$1640.00

Non-Member

NonMember Government
$880.00
NonMember Academia
$1045.00
NonMember Standard
$1865.00
Group Discounts

Printable Registration Form

Group Discount

Register three individuals from the same company and receive complimentary registration for a fourth! All four individuals must register and prepay at the same time – no exceptions.

To take advantage of this offer, please make a copy of the registration form for EACH of the four registrants and include the names of all other group registrants in the Group Discount section. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred.

Group registration is not available online and does not apply to the already-discounted fees for government or charitable nonprofit/academia

Register Online

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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