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Benefit-Risk Assessment from Inception to Maturation: Aligning Regulatory and Industry Goals

Feb 10 2014 8:15AM - Feb 11 2014 5:15PM | Hyatt Regency Bethesda One Bethesda Metro Center 7400 Wisconsin Avenue Bethesda, MD 20814-5326

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Overview 

Tutorial: February 9, 2014
Meeting: February 10-11, 2014



Join FDA, EMA, Health Canada, and other regulatory agencies, patient, industry and academic representatives to discuss the progress and application of Benefit-risk assessment throughout the development and post-approval life cycle, including  (i) Emerging sponsor and regulator expectations for Benefit-risk assessment during development, (ii) Practical methods commonly used to characterize benefits, risks and their balance in the peri-approval period, and (iii) Communicating complex assessments transparently across the development life cycle.

Featured Topics 

Learn and discuss processes and methods that help enhance sponsor and regulatory decision making, including:

  • Review of current industry and regulatory initiatives: PDUFA V, IMI,CIRS
  • Engaging multiple stakeholders and their perspectives
  • Quantifying the values  of alternative treatments
  • Evaluating the impact of uncertainty on Benefit-risk decision making
  • Incorporating weighting and patient preferences
  • Providing greater infrastructure and consistency for Benefit-risk throughout an organization
  • Increasing transparency

Who Should Attend 

  • Regulators facing Benefit-risk decisions, as well as regulatory and drug development policy makers
  • Industry scientists involved in the evaluation and communication of the Benefit-risk assessment of products in development or post-approval
  • Patient representatives and advocates who wish to have greater representation of their needs and concerns in regulatory decision making

Professionals involved in:

  • Risk Management/REMS
  • Clinical Safety/Pharmacovigilance
  • Pharmacoepidemiology
  • Regulatory Affairs
  • Legal Affairs
  • Medical Affairs
  • Medical product safety assessment
  • Marketing
  • Clinical Research
  • Medical Communications
  • Statistics
  • Comparative Effectiveness/HTAs/Health Outcomes
  • Brand Commercial Teams

Learning Objectives 

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

  • Discuss the  emerging expectations and requirements for Benefit-risk assessment and their applications by sponsors and regulators
  • Explain when and how to apply methods commonly used to characterize Benefit-risk
  • Identify ways to enhance transparency and communication of Benefit-risk decisions

Special Offers 

Representatives of patient advocacy organizations are eligible for a special discounted rate. Please contact Elizabeth Lincoln at Elizabeth.Lincoln@diahome.org for eligibility and details.

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

Hotel & Travel 

Hyatt Regency Bethesda
A limited number of rooms are available at the reduced rate shown below (DIA rate is guaranteed until January 28, 2014, or until room block is filled). Please note: In order to receive the reduced room rate, hotel reservations must be made with 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,” and inform the phone agent that you are making a reservation for Event #14013.

Standard Room Rate $169

Hotel Address: 7400 Wisconsin Avenue, Bethesda, MD 20814

The most convenient airport is Reagan National Airport and attendees should make both airline and hotel reservations as early as possible.

Contact Information 

Printable Registration Form

Registration Questions
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00 ET
CustomerService@diahome.org

Agenda Details
Jessica McGrory
Phone +1.215.442.6182
Fax +1.215.442.6199
Jessica.McGrory@diahome.org

Event Logistics
Benjamin Zaitz, Event Planner
Phone +1.215.293.5803
Fax +1.215.442.6199
Benjamin.Zaitz@diahome.org

 

Tabletop Exhibit Information
Jeff Korn, Exhibit Associate
Phone +1.215.442.6184
Fax +1.215.442.6199
Jeff.Korn@diahome.org

Continuing Education 

The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. The Drug Information Association designates this educational activity for up to 3 contact hours or .3 continuing education units (CEUs).
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.

DIA’s Certificate Program Statement
This program is part of DIA’s Certificate Program and is awarded the following:
• Clinical Research Certificate Program: 8 Elective Units
• Clinical Safety and Pharmacovigilance Certificate Program: 4 Elective Units
• Regulatory Affairs Certificate Program: 8 Elective Units

For more information go to www.diahome.org/certificateprograms

Name Credit Type Max Credits CEU
Tutorial: Making Better Benefit-Risk Decisions IACET 3.75 0.400
Benefit-Risk Assessment from Inception ACPE 3.00 0.300
Benefit-Risk Assessment from Inception IACET 13.00 1.300

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 and tutorial, if applicable, sign in at the DIA registration desk each day of the program, and complete the on-line 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 Wednesday, February 26, 2014.

To view DIA’s grievance policy, please visit the CE page on the DIA website at www.diahome.org/CE

Program Committee 

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Agenda  

Tutorials Sunday, Feb 09, 2014

  • 1:00PM - 5:00PM

    Tutorial: Making Better Benefit-Risk Decisions through the Development Life Cycle


    Tutorial Registration: 12:00 to 1:00 PM 


    Understanding how to integrate pharmaceutical Benefit-risk processes and methodologies into a coherent whole has become a vital skill for stakeholders. This tutorial will follow the progression of vignettes at three points in the development and post-approval life cycle, showing how a team might utilize various methodologies in context.
     
    (i) Development: As a team locks its assessment content in place, considers what endpoints to use and roughs out an approach for the assessment when only phase 2 data is available
    (ii) Peri-approval: As a team uses all data developed during its clinical program to develop Benefit-risk arguments to use in health authority submissions and advisory committee presentations.
    (iii) Post-approval in preparation for a PBRER: Using post-approval data sources, developing and presenting an integrated Benefit-risk assessment.


     Learning Objectives

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

    • Describe how to integrate pharmaceutical Benefit-risk processes and methodologies into a coherent whole
    • Recognize and gain familiarity with the utility from different methods for Benefit-risk assessment at different points in the development life cycle


    Click here for further information regarding this tutorial

Day 1 Monday, Feb 10, 2014

  • 7:15AM - 8:15AM

    Registration and Continental Breakfast
  • 8:15AM - 8:30AM

    Welcome and Opening Remarks

    Speaker(s):

    • Rebecca A. Noel, DrPH, MPH
      Senior Research Scientist, Global Patient Safety
      Eli Lilly and Company, United States
  • 8:30AM - 10:00AM

    Keynote: Global Views of Benefit-Risk Assessment

    Speaker(s):

    • Global Regulatory Perspective
      Hans-Georg Eichler, MD, MSc
      Senior Medical Officer
      European Medicines Agency, European Union, United Kingdom
    • Global Patient Perspective
      Frank W. Rockhold, PhD
      Senior Vice President, Global Clinical Safety and Pharmacovigilance
      GlaxoSmithKline, United States
  • 10:00AM - 10:30AM

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

    Session 1 - Part 1: Evolving Expectations for Benefit-Risk Assessment


    Session Chair(s):

    • No-image Lawrence Liberti
      Executive Director
      Centre For Innovation In Regulatory Science (CIRS), United States

    In this featured two-part session global regulatory and industry representatives will provide detailed updates on the key benefit-risk initiatives.

    Speaker(s):

    • IMI PROTECT Initiative
      Juhaeri Juhaeri, PhD
      Vice President and Head, Pharmacoepidemiology
      Sanofi, United States
    • Update on EMA Benefit-Risk Initiatives
      Hans-Georg Eichler, MD, MSc
      Senior Medical Officer
      European Medicines Agency, European Union, United Kingdom
    • Health Canada’s New Benefit Harm Uncertainty (BHU) Framework
      Robyn R. Lim, PhD
      Senior Science Advisor, Office of Legislative and Regulatory Modernization, HPFB
      Health Canada, Canada
  • 12:00PM - 1:30PM

    Luncheon
  • 1:30PM - 3:00PM

    Session 2 - Part 2: Evolving Expectations for Benefit-Risk


    Session Chair(s):

    • Rebecca A. Noel, DrPH, MPH
      Senior Research Scientist, Global Patient Safety
      Eli Lilly and Company, United States

    In this session, global regulatory and industry representatives will continue to discuss updates on the key benefit-risk initiatives. Participants will have the opportunity to pose questions to the presenters in a panel forum in this session.

    Speaker(s):

    • CIRS Initiative
      Lawrence Liberti
      Executive Director
      Centre For Innovation In Regulatory Science (CIRS), United States
    • FDA Perspective
      Andrea Tan
      Operations Research Analyst, OSP, CDER
      FDA, United States
    • Panelists
      Hans-Georg Eichler, MD, MSc
      Senior Medical Officer
      European Medicines Agency, European Union, United Kingdom
    • Juhaeri Juhaeri, PhD
      Vice President and Head, Pharmacoepidemiology
      Sanofi, United States
    • Robyn R. Lim, PhD
      Senior Science Advisor, Office of Legislative and Regulatory Modernization, HPFB
      Health Canada, Canada
    • Part 2: Evolving Expectations for Benefit-Risk Assessment
      Lawrence Liberti
      Executive Director
      Centre For Innovation In Regulatory Science (CIRS), United States
    • Andrea Tan
      Operations Research Analyst, OSP, CDER
      FDA, United States
  • 3:00PM - 3:30PM

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

    Session 3 - Widening the Perspective: Reflections from Vital Partners Beyond Industry and Regulators


    Session Chair(s):

    • Robyn R. Lim, PhD
      Senior Science Advisor, Office of Legislative and Regulatory Modernization, HPFB
      Health Canada, Canada

    What do patients consider to be a medicine's most important positive and negative effects and uncertainties? Why do payors decide to reimburse a medicine? This session will reveal some perspectives beyond those of regulators and industry that are vital to achieving a future state in which the health community coordinates itself to best effect. We will explore opportunities for benefit-risk approaches to incorporate and inform patients' views, improve medicines development, enhance medicines management and optimize health outcomes.

    Speaker(s):

    • Payor Perspective
      Edmund J. Pezalla, MD, MPH
      Vice President, National Medical Director, Pharmaceutical Policy and Strategy
      Aetna, United States
    • Patient Perspective
      Louise Binder
      International Community of Women Living With HIV/AIDS, Canada
    • Linda Wilhelm
      Consumer Advisory Council
      Canadian Arthritis Network , Canada
  • 5:00PM - 5:15PM

    Closing Remarks Day 1

    Speaker(s):

    • Lawrence Liberti
      Executive Director
      Centre For Innovation In Regulatory Science (CIRS), United States
  • 5:15PM - 6:15PM

    Reception

Day 2 Tuesday, Feb 11, 2014

  • 7:30AM - 8:15AM

    Registration and Continental Breakfast
  • 8:15AM - 8:30AM

    Opening Remarks

    Speaker(s):

    • Marilyn A. Metcalf, PhD
      Senior Director, Benefit-Risk Evaluation
      GlaxoSmithKline, United States
  • 8:30AM - 10:00AM

    Session 4 - Considerations for the Application of Benefit-Risk Assessment during Development


    Session Chair(s):

    • No-image Isabelle Stoeckert
      Head Global Regulatory Affairs Europe
      Bayer Pharma AG, Germany

    Development of value adding drugs demands a clearly positive Benefit-risk balance during development, approval and life cycle of a medicinal product. Various regulatory relevant documents such as clinical trial applications and Development Safety Update Reports produced by sponsors during the development phase require an explicit statement on benefit-risk. This session will address the challenges for companies to map out and continuously update and benchmark the expected key benefits and risks, whilst maintaining consistency in the relevant documents provided to the regulatory authorities. It will also take into account available regulator's perspectives on how dialogue on the expected benefit-risk balance could be formalized already during development, e.g., during Scientific Advice/End of Phase 2 meetings, and what models or frameworks could be acceptable in this context. Patient centric drug development demands the elicitation of the patient´s perspective at an early stage, preferably prior to finalizing the Phase 3 design, and concrete examples for potential approaches will be provided.

    Speaker(s):

    • Benefit-Risk Approaches as Enabler in Developing Value Adding Drugs
      Leo Plouffe, MD
      Vice President; Head of Risk Management, Global Pharmacovigilance
      Bayer Healthcare Pharmaceuticals Inc., United States
    • Early Dialogue during Development on Expected Benefit-Risk Balance
      Bruno Flamion, MD, PhD
      Professor of Physiology and Pharmacology; University of Namur
      NDA Regulatory Advisory Board, Belgium
    • How Do We Achieve More Patient Centric Drug Development
      Pamela Berry
      GlaxoSmithKline, United States
  • 10:00AM - 10:30AM

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

    Session 5 - Peri-Approval Benefit-Risk Assessment


    Session Chair(s):

    • No-image Bennett Levitan, MD, PhD
      Director, Department of Epidemiology
      Janssen Research & Development, United States

    The culmination of drug and device development entails health authority assessment of a treatment’s benefit-risk balance. Sponsors’ application are increasingly expected to defend whether a treatment’s benefits outweigh its risks, accounting for not just clinical data but the nature of the medical condition, alternative treatments and risk mitigation plans. The growing body of regulatory and industry structured benefit-risk frameworks provide some guidance for this process, but sponsors are struggling with questions on whether and how to prespecify a benefit-risk approach, the balance between qualitative and quantitative approaches for the assessment, whether and how to incorporate patient perspectives, and how to concisely communicate a benefit-risk argument. This session will review principles and examples from health authority submissions, describing methods that have been successful and the processes and practical concerns sponsors need to address to conduct them.

    Speaker(s):

    • Structured Benefit-Risk Assessment as an Inherent Part of a Dossier
      Conny Berlin, MS
      Global Head, Quantitative Safety Function
      Novartis Pharma AG, Switzerland
    • Regulatory Perspective
      Joyce Korvick, MD
      Deputy Director, Division of Gastrointestinal Products, OND, CDER
      FDA, United States
    • Realizing the Potential for Patient-Focused Drug Development
      Kimberly McCleary
      Director of Strategic Initiatives
      FasterCures | A Center of the Milken Institute, United States
  • 12:00PM - 1:30PM

    Luncheon
  • 1:30PM - 3:00PM

    Session 6 - Post-Approval Benefit-Risk Assessment


    Session Chair(s):

    • Qi Jiang, PhD
      Executive Director, Global Biostatistical Science
      Amgen Inc., United States

    This session will address the ongoing collection and use of benefit-risk information for specific applications such as PBRERS and PSURs, as well as more general safety surveillance of post-marketed products. Information will be relevant for mature products, vaccines, and devices.

    Speaker(s):

    • Adaptive Licensing
      John G. Ferguson, MD
      Vice President, Global Head of Pharmacovigilance and Medical Safety
      Novartis Vaccines, United States
    • Benefit-risk Balance Assessment During the Lifecycle of Medicinal Products
      Robert Ball, MD, MPH
      Deputy Director, Office of Surveillance and Epidemiology, CDER
      FDA, United States
    • Capturing Benefits and Risks in the Post-approval Phase-Practical and Regulatory Challenges
      Marilyn A. Metcalf, PhD
      Senior Director, Benefit-Risk Evaluation
      GlaxoSmithKline, United States
  • 3:00PM - 3:30PM

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

    Session 7 - Panel Discussion


    Session Chair(s):

    • No-image Paul D. Huckle, PhD, MPharm, RPh
      Chief Regulatory Officer and Senior Vice President Global Regulatory Affairs
      GlaxoSmithKline, United States

    This session will consist of an open discussion of critical topics. The audience will have the opportunity to ask leading industry and regulatory experts questions on benefit-risk assessment.

    Speaker(s):

    • Panelists
      Robyn R. Lim, PhD
      Senior Science Advisor, Office of Legislative and Regulatory Modernization, HPFB
      Health Canada, Canada
    • Bruno Flamion, MD, PhD
      Professor of Physiology and Pharmacology; University of Namur
      NDA Regulatory Advisory Board, Belgium
    • Kimberly McCleary
      Director of Strategic Initiatives
      FasterCures | A Center of the Milken Institute, United States
    • Andrea Tan
      Operations Research Analyst, OSP, CDER
      FDA, United States
    • Robert Ball, MD, MPH
      Deputy Director, Office of Surveillance and Epidemiology, CDER
      FDA, United States
  • 5:00PM - 5:15PM

    Closing Remarks

    Speaker(s):

    • Bennett Levitan, MD, PhD
      Director, Department of Epidemiology
      Janssen Research & Development, United States

Exhibits  

TABLETOPS JUST ADDED! The Benefit-Risk Assessment from Inception to Maturation meeting offers interested companies the opportunity to exhibit with a tabletop display. Space is very limited.

Tabletop Fee: $1,500

Fee Includes:

  • One six-foot skirted table
  • One chair
  • Standard electricity

Each tabletop rental requires at least one registered attendee to staff the table. All tabletop staff must be registered conference attendees.

Tabletop Exhibit Dates
February 10-11, 2014

Useful Links

  • Quantum Solutions India

Registration Fees 

Member

Charitable Nonprofit/Academia Member
$785.00
Member Government
$630.00
Member Standard
$1570.00

Non-Member

Charitable Nonprofit/Academia Nonmember
$1010.00
NonMember Government
$855.00
NonMember Standard
$1795.00
Registration Fees for Additional Offerings
Tutorial: Making Better Benefit-Risk Decisions - Tutorial Rate
$405.00
Group Discounts

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. 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. To take advantage of this offer, please print a registration form for EACH of the four registrants from your company. Include the names of all four group registrants on each of the forms and return them together to DIA.

Register Online

CANCELLATION POLICY: All cancellations must be received in writing two weeks before
the start of the event. Administrative fee that will be withheld from refund amount:

  • Member or Nonmember = $200
  • Government or Academia or Nonprofit (Member or Nonmember) = $100
  • Tutorial (if applicable) = $50

Cancellations must be in writing and be received two weeks before the start of the event. Registrants who do not cancel two weeks before the start of the event and do not attend the event will be responsible for the full registration fee. Registrants are responsible for cancelling their own hotel and airline reservations. DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants.

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.

Participants with Disabilities:
Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.

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