Collaborative Studies vs. IIS 1
Determining When to Implement Each
Approach
Debbie Kerr-Leathem COP, PMP
Global Operations Lead, IIS
Director, Clinical Program Leader IIS North America
Global Clinical Development Operations-Medical Affairs Operations
Janssen Pharmaceutical R&D
CBI’s 4th Annual Investigator Initiated and Sponsored Research Forum-January 20, 2016
Janssen Research & Development
Disclaimer
The views and opinions expressed by the speaker do not
necessarily represent the official views or policies of Janssen
Research & Development or any of the Johnson & Johnson
Family of Companies.
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January 20, 2016 Janssen Research & Development 2
Agenda
• Background of J&J/Janssen
• Evolution from Company-Sponsored/IIS to Collaborative
Cooperative Studies
• New Way of Working-Collaborative Studies
• Defining the Framework for Collaborative Studies
• Putting the Framework into Use
• Case Studies
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January 20, 2016 Janssen Research & Development 3
Background
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January 20, 2016 Janssen Research & Development 4
Johnson and Johnson
The sixth largest consumer health company
The world’s most comprehensive medical
devices business
The world’s sixth-largest biologics company
The world’s fifth-largest pharmaceutical
company
More than more than 265 operating
companies in more than 60 countries
Employs approximately 126,500 people.
Worldwide headquarters-New Brunswick,
New Jersey, USA.
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Johnson and Johnson
Pharma • Discover and develop prescription medicines for some of
the world’s most serious and prevalent diseases, ranging
from cancer and rheumatoid arthritis to life-threatening
bacterial infections and HIV/AIDS.
• Develops a broad range of products used in the baby care,
skin care, oral care, wound care, women’s health care
fields, nutritional and over-the-counter pharmaceutical
Consumer products, and wellness and prevention platforms.
Medical • Develops a broad range of innovative products & solutions
Devices used primarily by HCPs in the fields of orthopaedics,
neurological disease, vision care, diabetes care, infection
prevention, cardiovascular disease, and aesthetics.
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January 20, 2016 Janssen Research & Development 6
Janssen Pharmaceutical
• Pharma R & D
– Discovers potential drugs
– Conducts clinical trials to gain regulatory approval
• Medical Affairs
– Conducts further research on marketed drugs
• Investigator Initiated Studies
– Advance scientific knowledge about medical products (marketed)
and promising medical interventions through research grants
– Rigorous review and approval process
– Highly regulated by government and local agencies
– Highly scrutinized regarding payments to physicians and
institutions at government and state levels
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January 20, 2016 Janssen Research & Development 7
J&J/Janssen General IIS Philosophy
• Conservative: minimize the risk to the company
– Processes can be put in place to minimize that risk
• Sponsor-Investigator (S-I) is exactly that!
– Assumes all legal and regulatory responsibility
• Avoid performing activities that appear to be co-sponsored
activities
• Oversight to assure that IIS is progressing and adhering to
contractual agreement
• Conditions for support (Drug and/or Funding)
– Provision of appropriate documents
– SAE/AE, product quality complaints/pregnancy reporting
– Registration on a public website
– Annual safety report and a final report including complete
summary of safety information
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January 20, 2016 Janssen Research & Development 8
Evolution from Company-Sponsored Studies
and IISs to Collaborative Cooperative Studies
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Collaborative Cooperative Group Studies
Framework
Company- Collaborative Investigator-
Sponsored Cooperative Group Initiated Study
Study Study Investigator
maintains control
J&J maintains Cooperative group holds and holds all study
control and role of regulatory
holds all related
sponsor, but J&J may responsibilities,
sponsor related assume certain study
responsibilities, related responsibilities or including
share responsibilities development of
including with cooperative group. study protocol.
development of J&J supports study
study protocol financially and/or
and all aspects provides product
of study but remains
execution. “hands off” with
some oversight.
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January 20, 2016 Janssen Research & Development 10
Original Objectives Cooperative Groups
• Define various aspects of how to partner with cooperative
groups
– IIS
– Company-sponsored study
– Cooperative collaborative study
• Recognize and address greater involvement of company in certain
cases, and provide flexibility to do so
• Ensure compliance with GCP while accommodating cooperative group
trial processes/procedures
• Address situations where J&J may want to utilize cooperative group trial
data for registration purposes
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January 20, 2016 Janssen Research & Development 11
Leveraging Current Policy to Address Evolving
Business Needs
• Collaborating with many different types of
groups/organizations (not falling into the cooperative group
definition)
– Research consortia/alliances
– Academic institutions
• Collaborating not necessarily just for studies intended for
regulatory purposes
• Increase in use of collaborative framework for registration
studies
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January 20, 2016 Janssen Research & Development 12
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New Way of Working: Collaborative Studies
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Collaborative Studies
• A partnership between Janssen Pharmaceutical Companies and
a third party (e.g., cooperative group, academic institution, or
other appropriate entity) who are pursuing mutually
interesting and beneficial research.
– Regulatory sponsorship of collaborative studies is held by a third
party. Collaborative studies may be initiated by Janssen
Pharmaceutical Companies or a third party.
• Study is truly collaborative and not simply a way to “get
around” the IIS or company sponsored policies
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Collaborative Studies
• Out of scope:
– collaborations and partnerships with third parties that are broader
than a single study (e.g., strategic collaborations)
– collaborations and partnerships with other pharmaceutical
companies, where Janssen is providing drug and/or input, but is
not the sponsor
– company-sponsored studies where Janssen retains legal and
regulatory sponsorship
– investigator-initiated studies (IIS)
– joint sponsorships (i.e. co-sponsorship)
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Defining the Framework for Collaborative
Studies
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Building the Framework
Regulatory Status •Marketed, non-marketed, both
of Drug
Study Types •Interventional, non-interventional, pre-clinical, etc.
Regulatory •Company, investigator, co-sponsorship
Sponsor •Can data be used?
•What are requirements for regulatory use of data?
Regulatory •Company, institution or combination
Purposes of Data
•How to address if licensing partners are involved
Safety Reporting
Requirements
Licensing
Agreements
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Building the Framework
Delineation of • How detailed
Responsibilities • Transfer of obligations
SOPs/Regulatory • General requirements
Obligations
• Specific SOPs to follow: company's, institution’s,
combination
Confidentiality and • Confidential Disclosure Agreements
• Where is the IP vested (Company)?
Intellectual Property • Evaluate collaborative partner’s policies on IP
Data • Evaluate collaborative partner’s policies on ownership and
Ownership/Control controls of the data
• Access to and/or transfer of study data from the
collaborative partner
Right to Audit and • Company has right or not; may depend on regulatory use of
Monitor data and how extensive
Contracting • Which template to use?
• Company-sponsored, IIS, institution’s or combination
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Putting the Framework into Use
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Collaborative studies are like puzzle pieces; there
are no two alike!
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Now What?
Identify the project “lead”
•Ask all questions to get started and obtain answers
•Obtain answers to questions/issues didn’t expect
Timeline for “start-up”/contract execution will take longer
Review each process to determine if the process step “fits”
•Determine if any POL/SOP/WI deviations are required
•Prepare deviations, if required
Prepare an exception/decision document
•Outlines what exceptions outside the process are made and by whom
•Requires signatures of appropriate personnel
•Provides succinct document for audit purposes
•Dynamic document that may be revised during project
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January 20, 2016 Janssen Research & Development 22
IIS or Co-Sponsored or What?
• Investigator
Determine where the idea came •Company
from
Determine what type of study •Interventional, non-interventional, etc.
(categorization)
Determine if any data will be used
or has the potential to be used for •Will monitoring be needed to assure quality of
registration purposes, submission data?
•What other quality aspects should be considered?
to health authorities or
reimbursement boards
•Investigator or company or co-sponsorship
Determine who is going to be the
regulatory sponsor
Determine what involvement •Minimal, e.g. protocol review, “board
company has had or will have in representative”
•Extensive, e.g. protocol writing, monitoring, etc.
the study
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January 20, 2016 Janssen Research & Development 23
IIS or Co-Sponsored or What?
•Company uses, owns, etc. vs. investigator
Determine what will be done with
the data
Determine who else should be •Legal (Regulatory/Patent), Regulatory, Safety,
involved in decisions Privacy, HealthCare Compliance, QA
•Financial: Finance, Tax
Determine which processes are •More company-sponsored-like or IIS-like
best suited to use as a basis for
the study and best fit for
operational support
Determine what type of • IIS
agreement to use as a starting • Investigator’s/institution?
•Company-sponsored template
point •Hybrid of any of the above
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January 20, 2016 Janssen Research & Development 24
Case Study 1
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Overview
• Supporters/Collaborators:
– Janssen-funding
– Licensing Partner-agent
• Investigator/Institution: Single site in United States
• Interventional study with biomarker component
• Contract in negotiations for 1 ½ years; no operational
involvement
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Preliminary Assessment based on
Protocol/ICF/Draft Contract Review
Area Assessment
Sponsor Investigator
Use for Regulatory Purposes Contract indicates data may be used to support commercial
promotion within approved labeling and used as supplemental
Sponsor Responsibilities (Janssen) for reg filing of agent
Receipt and storage of samples
Operational Oversight and/or Meetings with institution/licensing partner minimally yearly to
Execution discuss progress
Operational Processes Not determined
Not determined
Ownership of Intellectual Property Assuming IP attorney has been involved in review of contract-
Arising IP and Joint Arising IP sections included. Also licenses
for arising IP
Sample Storage, Analysis and Data Janssen to receive samples and store for future use
Interpretation (e.g. biomarkers,
pK,etc)
Data Ownership and Controls Not clear-contract indicates data may be added to research
databases and may conduct additional reviews of the data in
order to study the safety and effectiveness…Data use
agreement may be executed if consent doesn’t address further
research.
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Preliminary Assessment based on
Protocol/ICF/Draft Contract Review
Area Assessment
Sample Storage, Analysis and Data Samples may be provided to Janssen for storage
Interpretation (e.g. biomarkers, and future use.
pK,etc)
Adverse Event Reporting Not determined. Contract indicates AEs to go to
Indicate what GMS SOPs/AE licensing partner. No reporting to Janssen listed.
reporting will be followed? Need to address if there is no safety reporting.
Right to Audit and Monitor Licensing partner has right to audit and will share
results with Janssen. Contract does not list
Janssen as having a right to audit.
Compliance to GCP/ICH or other Listed in contract
regulations
HCC/HCBI Considerations Contract indicates Janssen providing computer
equipment. Current budget may not acceptable to
HCC.
Add additional considerations Subcontract with another vendor that will receive
depending on Study Design data
Privacy issues Agent provided by licensing partner; site to order
Drug provision/ordering directly from licensing partner
Quality Assurance Agreement Potential Privacy Issues/disclosure due to samples
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Other Potential Issues Identified
• Contract language in certain sections needs to be revised
depending which processes will be followed
• Budget/payments
– Budget is not in HCC approvable format
– Not clear if FMV analysis performed
– Payment schedule milestone based vs. per patient/activity based
• No contract clause to allow Janssen to withdraw support at any
time with appropriate notice (only material safety issue)
• Clarify other potential areas of support
– Safety reporting
– Data management
– Sample transfer
– Use of data for future use
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Outcome
IIS
Company
Sponsored
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Case Study 2
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January 20, 2016 Janssen Research & Development 31
Overview
• Supporters/Collaborators:
– Janssen-funding
• Investigator/Institution: Single site in Singapore
• Non-Interventional Study with biomarker component
• No protocol/ICF available at time of discussions
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Preliminary Assessment based on Discussion
Area Assessment
Regulatory Sponsor Investigator
Use for Regulatory Purposes None
Sponsor Responsibilities Protocol design input, receipt, analysis and storage of
(Janssen) biomarker samples
Biomarker samples to be banked at Janssen and
Operational Oversight and/or Institution
Execution Co-authors on publication
Operational Processes Not determined
Ownership of Intellectual Not determined-task list not provided or completed to
Property date
Assuming IP attorney has been involved in review of
Sample Storage, Analysis and contract-Janssen arising IP and Joint Arising IP sections
Data Interpretation (e.g. included. Also licenses for Arising IP
biomarkers, pK,etc) Janssen to receive samples and store for future use
Data Ownership and Controls
IP of data generated from clinical samples by Janssen
should be owned by Janssen.
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Preliminary Assessment based on
Protocol/ICF/Draft Contract Review
Area Assessment
Categorization of Study Study appears to be standard of care with
questionnaire would lend categorization as NIS;
Adverse Event Reporting biomarkers sampling is not SOC so may be
Indicate what GMS SOPs/AE categorized as interventional.
reporting will be followed?
Right to Audit and Monitor Need to address safety reporting if patients on
Janssen drug/safety reporting required or if there
is no safety reporting.
Will need to address in contract
Compliance to GCP/ICH or other Will need to address in contract
regulations
HCC/HCBI Considerations Large upfront payment requested, possible
purchase of equipment to run assays; Singapore
Add additional considerations government considerations
depending on Study Design Privacy issues may be identified due to banking of
Privacy issues human samples
Drug provision/ordering
Quality Assurance Agreement
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Outcome
IIS
Company
Sponsored
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Lessons Learned
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