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Optimizing Financial Management to Maximize Clinical Trial Investments

Nov 11 2014 8:30AM - Nov 12 2014 12:45PM | The Hub Cira Centre 2929 Arch Street Philadelphia, PA 19104

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Overview 

Over the past several years sponsor companies have been searching for ways to reduce clinical study costs and increase efficiency so improvements in return on their clinical development investments can be realized.  Sponsors and CROs have developed unique relationship to help drive this strategy; strategic partnerships, limited preferred providers; many large pharmaceutical companies have come together to harmonize processes and innovative approaches across the industry; and digital technology continues to be implemented and developed to improve study start-up, clinical monitoring and study close-out.  As clinical studies utilize some or all of these approaches it is important to understand and incorporate these into a study budget to ensure the study will meet its budget goals in this environment of increased protocol complexity and increasing costs. The goal of this conference is to provide effective approaches to developing and managing clinical study budgets as development challenges increase and the need for study cost efficiency is required.

Who Should Attend 

Professionals involved in:

  • Clinical Research
  • Clinical Operations
  • Finance
  • Outsourcing
  • Project Management
  • Research and Development
  • Strategic Planning
  • Outsourcing/Procurement

Learning Objectives 

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

  • What key factors from protocol design to study close out should be considered when developing a study budget
  • How could CROs be utilized to optimize study cost and resource allocation
  • Determine what innovative approaches could be implemented to maximize study investment

Special Offers 

EARLY BIRD RATE!
DIA Industry Members who register by
October 22, 2014, save $100!


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

Hotel & Travel 

Meeting Location
The Hub Cira Centre
2929 Arch Street
Philadelphia, PA 19104
Phone +1.267.519.5260

Hotel Information 
Sheraton Philadelphia University City Hotel

Phone: +1.215.387.8000 
Call for reservations

A limited number of rooms are available at the reduced rate shown below (DIA is guaranteed until October 24, 2014 or until room block is filled). Attendees must make their own hotel reservations. When making reservations, mention the Drug Information Association.

Standard Room Rate  $189
Hotel Address: 3549 Chestnut Street Philadelphia PA 19104

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

Contact Information 

Printable Registration Form

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

Agenda Details
Jessica McGrory
In-Company Training Manager
Phone +1.215.442.6182
Fax +1.215.442.6199
Jessica.McGrory@diahome.org

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

Program Committee 

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Agenda  

Day 1 Tuesday, Nov 11, 2014

  • 8:00AM - 8:30AM

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

    Session 1 – Impact of Protocol Design on Study Execution and Costs


    Session Chair(s):

    • Larry A. Blankstein, PhD
      Senior Director Clinical Development
      Genzyme, A Sanofi Company, United States

    This session will explore key protocol design parameters that drive increased site costs and overall study costs. The speakers will discuss the key elements in protocol design that clinical teams need to assess so protocol complexity is reduced to maximize site inefficiency, encourage patient participation and reduce internal costs. The session will describe processes that can be established to develop cost effective protocols to minimize complexity while ensuring data quality, timely study completion and trial success.

    Speaker(s):

    • Stella Stergiopoulos
      Senior Project Manager
      Tufts Center for the Study of Drug Development, United States
  • 10:00AM - 10:15AM

    Refreshment Break
  • 10:15AM - 11:45AM

    Session 2: Investigator Sites (Site Side)


    Session Chair(s):

    • Christine Pierre
      Society for Clinical Research Sites, United States

    This panel of experienced site executives will participate in a vigorous discussion regarding the actual and potential impact of industry initiatives on the sites, using newly-released survey data as a reference. These site executives will primarily focus on sharing and extensively examining realities, as opposed to commonly-held myths or hypotheses, regarding the constraints sites face daily. This rigorous conversation will culminate in astute suggestions for change which could ultimately pave a more sustainable site landscape, and be significantly beneficial to all.

  • 11:45AM - 12:30PM

    Luncheon
  • 12:30PM - 1:30PM

    Technology Vendor Showcases
  • 1:30PM - 3:00PM

    Session 3: Addressing Cost through Collaboration


    Session Chair(s):

    • Igor Gary Altman
      Senior Director, Product Management
      Medidata Solutions Worldwide, United States

    This session will focus on ways in which cross-functional collaboration around clinical trial budgeting, especially for site grants, can enhance cost predictability while optimizing cost for a given trial design. Speakers will present their experiences in this area, processes at their organizations to foster this collaboration, and examples of success. Impact of structured design and data on this collaboration will also be discussed.

  • 3:00PM - 3:15PM

    Refreshment Break
  • 3:15PM - 4:45PM

    Session 4: Cost IS a Factor in Clinical Development-Examine Some of the Biggest Factors and How to Reign Them In


    Session Chair(s):

    • Kevin Williams, MBA, MS
      Vice President - Corporate Development & Marketing, DrugDev
      CFS Clinical, United States

    This session will take a closer look at some of the most significant drivers of cost in clinical studies and identify approaches to manage them. Included in the discussion will be an examination of components that yield the most burden to key stakeholders in the trial process including the investigator sites. Leaders will present an ROI study exploring the crucial benefits and return when leveraging innovation in traditionally overlooked areas of the clinical trial process, including site activation and the investigator payment management process.

Day 2 Wednesday, Nov 12, 2014

  • 8:30AM - 9:00AM

    Registration and Breakfast
  • 9:00AM - 10:00AM

    Session 5 Breakout 1: Outsourcing Models


    Session Chair(s):

    • Larry A. Blankstein, PhD
      Senior Director Clinical Development
      Genzyme, A Sanofi Company, United States

    Sponsors and Providers have developed models to enable Sponsors to control their fixed costs while enabling Providers to more efficiently use their resources and secure committed backlog. This interactive breakout session will review the different models, e.g. strategic partnering, preferred providers, functional outsourcing, etc., and discuss the advantages of the different models, their governance, the relationship management and how these models impact budget considerations.

  • 9:00AM - 10:00AM

    Session 5 - Breakout 2: Finance Models
  • 9:00AM - 10:00AM

    Session 5 Breakout 3: What About Investigator Site Burden?


    Session Chair(s):

    • Stu Thiede
      President, Global Payment Services
      DrugDev, United States

    Poor investigator payment performance continues to be a top concern of investigator sites. How can we best manage financial relationships between sponsors/CROs and sites, and implement impactful solutions to ease their burden.

  • 10:00AM - 10:15AM

    Refreshment Break
  • 10:15AM - 11:15AM

    Session 5: Breakout Session Recap


    Session Chair(s):

    • Amy Y. Grahn, MS
      Senior Vice President, Clinical Development and Operations
      Horizon Pharma Inc., United States

    Each breakout session will give a brief 15-20 minute high level recap of their session for those unable to attend.

  • 11:15AM - 12:45PM

    Session 6: Benefits of Risk Based Monitoring-Performance Quality Cost


    Session Chair(s):

    • Patricia Ward
      Head of Clinical & Postmarketing Safety
      Shire, United States

    This session will explore the key drivers of Performance, Quality and Cost when implementing a Risk Based Monitoring (RBM) program and what happens when these priorities conflict with the needs of the participants in the Clinical Trials process. Panelists representing Sponsors, CROs, CRAs and Sites will discuss the drivers; their importance, potential challenges and conflicts from their own perspectives and how these can be mitigated to ensure success.

Registration Fees 

Member

Member Government
$535.00
Member Academia
$710.00
Member Standard
$1085.00
Member Standard (As of 10/22/2014)
$1185.00

Non-Member

NonMember Government
$760.00
NonMember Academia
$935.00
NonMember Standard
$1410.00
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

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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