Title: The SNM Centralized IND
1The SNM Centralized IND Clinical Trials
Network Enabling Implementation
Investigational Approved PET Imaging in Large
Multicenter Clinical Trials
George Q. Mills, MD, MBA September 9, 2009
2Therapeutic Drug Developers Comments
- PET imaging desired for Multicenter Therapeutic
Trials - butnumerous deficiencies
- Lack of
- Limited supply of investigational PET agents
- Standardized PET imaging acquisition protocols
- Harmonized PET imaging report output
- Qualified experienced imaging centers
large (200 sites) multicenter clinical trials - Industry could not effectively implement PET
imaging in multicenter therapeutic clinical
trials
3- SNM Assessment Efforts
- Therapeutic Developers
- Participating PET Imaging Centers
- FDA Pre-IND Process
- Results - Design solutions
-
- Centralized Investigational PET Imaging IND
- to Enable Therapeutic Developers Multicenter
Therapeutic Clinical Trials - Distributed Manufacturing
- Investigational PET imaging Agents
-
4- SNM Centralized IND
- Demonstration Project - Future development INDs
- F-18 FLT first choice available broad
potential -
- Regulatory
- CMC
- Imaging Standardization
5Clinical Trials Sites Network - Registry
- Investigator international site registry
- Forming Pick List - therapeutic developers
- Enrollment qualifications
- Location
- Geography
- Patient population access
- Equipment hardware software
- Personnel
- Access to investigational imaging agents
- Participation phantom program clinical
trials
6- World wide interest - imagers manufacturers
7- Regulatory multicenter IND manufacturing
- Multicenter INDs - Single source
investigational product -
- CMC Investigational F-18 FLT sources
- Multiple production sites multiple methods
- Distributed manufacturing multiple
end-product specs - SNM Centralized IND F-18 FLT
FDA CMC
review of all sources acceptable ranges for
end-product specifications
8Review through submission to IND file directly or
through Drug Master File (DMF) a submission
tool of efficiency for manufacturers
- Information concerning the Chemistry,
Manufacturing and Controls (CMC) of a drug
product or a component of a drug product to
permit the FDA to review this information upon
request in support of a submission
9Types of DMFs
- Five Types
- I Plant information
- II Drug substance, drug product, intermediates
and material used in their manufacture - III Packaging
- IV Excipients
- V Other clinical, tox
10Who must file a DMF?
- CMC information must be available for IND review
- CMC must be in an IND submission or in a DMF
- There is no legal or regulatory requirement to
file a DMF (submission by Holder,ref by
applicant or authorized party) - Applicant submits a Letter of Authorization (LOA)
from the Holder with their IND submission
11Letter of Authorization (LOA) Enabling review
of DMF
- The DMF will be reviewed ONLY when it is
referenced in a submission or another DMF
(initially receives an administrative review) - The Holder MUST submit an LOA (2 copies) to the
DMF and send a copy to the Applicant - The Applicant submits LOA in their submission
the mechanism to trigger review of the DMF by FDA - In Europe, the LOA is called a Letter of Access
12DMF Advantages
- Maintains proprietary information/trade secrets
(e.g. manufacturing procedure) belonging to the
Holder, from being revealed to the Applicant
while permitting review by FDA - Permit review of information referenced by a
number of applicants will be used to support
submissions from many sponsors - Time efficient cost effective
13- Imaging standardization
- Pre-clinical Imaging Standardization - Imaging
Phantom Program - Oncology CNS - Cardiovascular
- Clinical imaging - Standardized protocol
- International imaging clinical site registry (217
sites) documentation of equipment demonstrated
capabilities - Clinical Trials Educational programs
Multicenter Trials
14SNM Imaging Phantom Program
- F-18 fillable phantoms
- Qualitative Quantitative (SUV)
- VA system
- Torso Oncology ?
- Head CNS
- Cardiac
15Selection - F-18 FLT
- Investigational PET imaging biomarker
- Literature reports of potential for
demonstrating tumor proliferation - Potential as a surrogate marker for evaluating
investigational oncology therapeutics as well as
existing therapeutics - Broadly applicable to lung, breast, esophageal,
GI, brain, lymphoma
16- Topics
- Overview Key Elements Centralized IND
- Clinical Trials Network
- Resources
- Sites Registry
- Phantom Program
- Education Training Program
- F-18 FLT selection
17Thank you
George Mills, MD, MBA Vice President, Medical
Regulatory Relations Perceptive
Informatics george.mills_at_perceptive.com
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