ExL Pharma's 12th Investigator Initiated Trials Conference Brochure
Investigator Initiated-Sponsored Research (IISR)
Transcript of Investigator Initiated-Sponsored Research (IISR)
Investigator Initiated-Sponsored Research (IISR)
State of the Industry and the Need for Global Standards and Metrics
Alexander Kostek and DeeAnn Tinjum
Disclaimer
The views and opinions expressed by the presenter and set forth in the following PowerPoint slides are those of the individual presenters and should not be attributed to Pfizer Inc., or any of their respective directors, officers, employees, or any organization with which the presenter is affiliated.
These PowerPoint slides are the intellectual property of the individual presenters and are protected under the copyright laws of the United States of America and other countries.
Objectives Understand the current state of IISR programs globally
and the need for minimum standards and comprehensive programs
Describe the current regulatory and legal environment for IISR programs and understand current industry led initiatives for IISR standards
Explain the mission and vision for IISRA
What is IISR? Investigator Initiated Research/Studies/Trials
Investigator Sponsored Research/Studies/Trials
Physician Initiated Research/Studies/Trials
Physician Sponsored Research/Studies/Trials
Investigator Initiated Sponsored Research (IISR)
Current Global Environment Lack of clear, specific Regulatory Guidelines for IISR Varying global definitions of sponsorship Unfamiliarity with research by Investigators Inconsistencies in Industry policies Inconsistencies in Industry resources & support
Regulatory & Legal Considerations Food, Drug and Cosmetic Act International Conference Harmonization (ICH)/Good
Clinical Practice (GCP) Guidelines US Department of Health & Human Services Federal Code of Regulations (CFR Section 21) OIG: Compliance Program Guidance Sunshine Act
Federal Anti- Kickback Statute
Regulatory & Legal Considerations, cont. False Claims Act (FCA) Foreign Corrupt Practices Act (FCPA) European Unions Clinical Trial Directive European Medical Research Council (EMRC) of the
European Science Foundation PhRMA and AdvaMed Codes
Proposal Submission Identify submission method Ensure transparency & availability to the public
Provide templates and clear directions Document receipt Ensure completeness of proposal
Proposal Review Committee reviews using well defined criteria:
Company Strategy Scientific Merit Patient Safety Fair Market Value (FMV) Expertise of the Investigator Scientific, Legal and Regulatory considerations
Committee decision is documented Decision communicated to the submitter
Example of Review Process Research interest received
Medical Affairs does initial review,
application packet sent if warranted
Submitter completes standard IISR
application form Team Review
Decision communicated to submitter
Denial
Submitter updates proposal
Conditionally Approved
Submitter provided IISR Start Up
Packet
Finalize Contract / Legal Review
Approved (and communicated to submitter)
IISR authorized and research
initiated
Deferred (IISR to be re-evaluated by team)
Proposal Review, cont. Provide a IISR packet Company specific
Review Protocol Prior to IRB/EC submission
Record comments Communicate to submitter
IISR Agreement Develop an IISR agreement template including: ◦ Compliance with laws and regulatory requirements ◦ Support provided by company & how it is provided ◦ IND or IDE submission, if applicable ◦ Registration of study ◦ Safety reporting ◦ Study progress reports from sponsor ◦ Publication expectations ◦ Intellectual Property ◦ Company rights for review prior to submissions ◦ Indemnification ◦ Term and termination
Overall Program Management Communicate with the sponsor-investigator Collect study progress reports Distribute funding and/or product Maintain study documents Ensure Safety Reporting Develop Metrics Obtain deliverables for internal review Perform close out
IISRA - Mission Statement
IISRA is an independent association of professionals dedicated to promoting excellence in investigator initiated-sponsored research (IISR) programs. Our commitment is to support members through the development and implementation of educational activities, professional knowledge standards, and ethical practices.
Membership
Approximately 300 professionals Pharma, biotech, device, academia, CROs, technology vendors,
consultants Growing European Interest
Benefits: Communication forum for consensus building Networking with global IISR professionals Tools and information Access to IISRA Position Statements and Guidelines Stay abreast of new trends/benchmarking Free to join: www.iisra.org.
IISRA Activities Standards and Best Practices Guidance Documents Position Statements
Implementation of IISRA By-Laws Pulse on Compliance/Ethics Issues Surveys and Benchmarking Leadership Presence at National Organizations/Conf. Networking Job Postings (Future)
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2011/2012 Strategic Goals
Broaden Communication Among Members Advance the Value of the IISRA Org Sustain IISRA’s Growth
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Goal: Broaden Communications
Increase IISR presence and community dialogue through on-line media Accomplishments IISRA group established on LinkedIn (Jan 2011) Updated www.iisra.org website (Feb 2011)
Focus IISR presence at industry conferences in the USA Accomplishments (Chair/Speaker/Moderator) Center for Business Intelligence (CBI)
Standards/Best Practice Webinar_Sponsor is SteepRock (Jan 2011) Collaborative Group Initiative (Mar 2011, Oct 2011) CBI IIS Conference (June 2011)
ExL Pharma IIT Conf in USA (Apr 2011, Sept 2011, Apr 2012) Q1 Productions_Medical Device in USA (Sept 2011) DIA - IIS Trial Master File (TMF) Content Model (Jan 2012) ACRP – Abstract and Oral Presentation (April 2012)
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Broaden Communications, Con’t
Support IISRA values Accomplishments Conduct IISRA annual elections (2011; 2012)
IISRA By-Laws (July 2011)
Increase exposure to non-industry partners (government, academia) Future Regulatory links and training slides for Investigators Greater interface and input with FDA
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Goal: Advance Value of IISRA Drive the creation / completion of new position statements and guidelines
Accomplishments Metrics Guidance Document (Mar 2011)
IISRA surveys - future guidance topics (Apr and June 2011)
Ongoing committees:
Industry collaboration with Cooperative Groups
Polaris initiates FMV (interviews in May 2011; draft Jan 2012)
Initiating four new documents
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Advance Value of IISRA (Con’t) Expand the usages / offerings through IISRA.org Future Job postings Networking
Create additional value for the biopharm and device industries, and also for government / academia Future 2012 member survey Links to portals for industry grant applications
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Goal: Sustain IISRA Growth Achieve a target membership of 500 registrations globally
Accomplishment: Membership doubled from approx 180 to 300 members
Increase presence in Europe, Asia/Pacific & emerging markets
Accomplishments: DIA_Europe: Intro of IISRA to EU community (Mar 2011) Q1 Productions (Frankfurt, Germany) – Chair/Speaker IISRA Board increased from one to four EU members
Plan and execute at least two (2) IISRA general sessions 2012 annual meeting via conference attendance and webinar
Build strategic partnerships (FDA, Medical Affairs)
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Initiatives With Other Organizations
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National Organizations
Inter- National Conferences
Industry Leaders Technology Vendors
National Cancer Institute (NCI)
Industry_Posting of Grant Applic. Links
Polaris
Clinical Trials Network (CTN)
Committees for Position/Guidance Docs
SteepRock
DIA (USA) DIA (Europe) MedNet Solutions
ACRP
ExL Pharma IIT ExL Pharma IIT (Europe)
CBI ISS CBI Coop Groups
Q1 Prod (USA) Q1 Prod
IISRA Board of Directors (2012-2013) Chairperson: Karen Bartels (AstraZeneca) Officers: President: Anton Ehrhardt (Sanofi) Vice President: Ran Frenkel (Clinipace_Europe) Treasurer: Nader Molavi Secretary: Patricia Westergren (MedNet) Executive Committee: Executive Director: Alex Kostek (Pfizer) Members: Dan Bromberg (Polaris) Jocelyn Ulrich (HGSI) Ornah Levine-Dolberg (Lundbeck) Jonathan Chambers (Pierre-Fabre) Ouadah Hadjebi (Editor, IST Journal)
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IISRA
Guidance Documents / Position Statements
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Guidance Documents and Position Statements
Completed Documents - Currently Available on the IISRA Website (www.iisra.org) IISRA Mission Statement Standards and Best Practices Metrics Guidelines Setting Up an IISR Program Statement on Fair Market Value Future Documents - IISRA conducted a survey at the ExL Pharma and CBI Conferences in 2011 to determine topics of interest
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Survey Results: Desired Topics New Committee Initiatives: Fair Market Value (FMV) - Initiated Collaborative Initiative with NCI - Initiated Contract Bottlenecks Publications CTMS System for IISR Programs Sunshine Act
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A thank you for their contributions! Cynthia Barbitsch Karen Bartels Shiferaw Kibriye Michael Montgomery Wendy Moore Matthew Silverman DeeAnn Tinjum Mary Voehl Pat Westergren