# Presentation: 085836

## San Francisco, CA
Wednesday, August 31, 2005

**Wednesday, August 31, 2005**

**CRIX ***FACE-to-FACE MEETING*

## AGENDA 

**Welcome**
- Update on CRIX Initiatives
- CRIX Operational Framework
- Firebird Stakeholder Analysis
- Workshops
- Summary and Next Steps** **

## Meeting Participants

| Christo Andonyadis, NCICB | Pat Skarulis, Memorial Sloan Kettering | Dialing-in/Webcast: |
| --- | --- | --- |
| Sue Dubman, NCICB | Jo Anne Zujewski, CCR | Frank Newby, CDISC |
| Troy Budd, CTEP | Mark Adams, Booz Allen | Sharon Elcombe, Mayo Clinic |
| Deborah Collyar, Patient Advocate | Patrice Clark, Booz Allen | Betsy Fallen, Merck |
| Mary Jo Deering Ph. D, NCICB | Chalk Dawson, Booz Allen | Kim Johnson, Duke University |
| Brenda Duggan, NCICB | Kevin Vigilante, Booz Allen | Donna Marinucci, ECOG |
| Norman Goldfarb, First Clinical Research | Guy Tallent, SIG/SAFE | Beverly Meadows, DCP |
| Diana McKenzie, Amgen/ CTWG Industry Rep |  | Rachel Carle, Biotechnology Industry Organization (BIO) |
| Kamal Narang, CTIS |  | Dianne Paul, Patient Advocate |
| Joyce Niland, COH |  | Gary Secrest, J&J/SAFE |
| George Redmond, CTEP |  | Edmund Verstraete, BIO |

## AGENDA 

**Welcome**
**Update on CRIX Initiatives**
- CRIX Operational Framework
- Firebird Stakeholder Analysis
- Workshops
- Summary and Next Steps** **

## AGENDA 

**Welcome**
- Update on CRIX Initiatives
**CRIX Operational Framework**
- Firebird Stakeholder Analysis
- Workshops
- Summary and Next Steps** **

## CRIX Vision Statement

***To facilitate completely automated and paperless regulatory submission so that information can be efficiently shared across the clinical research community with the appropriate security and intellectual property protection***

***CRIX – a secure, standards-based, clinical research information exchange ...***

**Notes:**
Revisit original CRIX Vision and how this statement embodies that vision
Sustainable, secure and standards-based infrastructure for electronic submissions 
Standards-based repository for data analysis and review
Global registry for commonly used/referenced data 
Common information exchange standards 
Mechanism for secure electronic information exchange
Legally enforceable digital signatures compliant with Title 21 Regulations and other guidelines from the outset

## Key Success Factors

**Define the CRIX Governance Structure**
- Establishes and supports vision that drives the entire project
- Set priorities, establish trust, and get buy-in from stakeholders
- Establish a framework that will permit interoperability
- Facilitates viable business cases for each CRIX component
**Establish a viable business model for each CRIX component**
- Develop Business Case
- Incubate technology (i.e., Scope, Prototype and Pilot)
- Identify funding source(s)/ develop mature technology
- Operationalize component
**Focus on delivering consistent messages to all stakeholders on CRIX initiative goals, desired outcomes and benefits**
**Engage end-users early-on and continually throughout the process**
**Ensure that the value proposition to the customer is Priority 1**

## CRIX Business Strategy Framework  

**CRIX Governance Structure**

**Clinical Research **
**Information Exchange**
**(CRIX)**

**Investigator Registry (Firebird)**

**Trial / Protocol Registry (BRIDG)**

**Clinical Data**
**Repository**
**(Janus)**

**Other**
**Modules**
**(n+)**

_**Analyze / Align Around Initial Modules**_
**Stakeholder Analysis**
**Business Model**
**Operational Requirements**
**Systems operator selection & production deployment**
**Pricing model**
**ROI / User Business case**

_**Establish CRIX Governance & Entity**_
**Overall vision alignment**
**Ownership Structure**
**Baseline standards to ensure interoperability among modules**
**Ensure compliance with Standards and best practices**
**Establish/oversee Incubator Model and investment guidelines**
**Operating entity business model**
**Establishment of Operating entity**

**2**

**1**

_**Develop New CRIX Modules**_
**Future modules developed independently via Incubator Model and then transitioned into CRIX**
**“****Like-minded” development partners collaborate on an individual module**
**Developed in context of CRIX architectural requirements and standards**
**Formal feasibility assessment – conduct Stage 1 analysis for each new module**

**3**

**caBIGTM**
**______**
**CTWG**

## Business Case for CRIX Components

**How it ties to and integrates into CRIX**
- What is it
- How it ties to  CRIX mission/objectives
- How it integrates with other CRIX components
**Focus on answering the who**
- Incubator – developer of component
- Provider – funds development of component
- Consumer – user of component
- System Operator – host component; production operations
**What is the Business Model and ROI**
- Cost of investment
- Value to Consumer
- Pricing Model
- Financial Projections

## Near-term objectives for the CRIX Initiative

**3-month objectives?**
- CRIX Governance Structure defined
- Business Case for Firebird
- ID candidates to host Firebird
- Socialize CRIX Governance Model and Firebird Business Case (3-6 months)
**6-month objectives?**
- Release SOW for 3rd Party to host Firebird (4th month)
- Finalized CRIX as a Business Entity
- Start enrolling NCI Investigators
- Pilot Janus/CRIX (IBM)

**9-month objectives?**
- Award 3rd Party to host Firebird (month 7)
- Firebird launched and hosted by 3rd Party
- Use of electronic signatures via Firebird
- Janus/CRIX Business Plan
**12-month objectives?**
- Continue Firebird roll-out across NCI
- Start bringing on paying users (fee for service)

## Moving Forward... 

**Establish two parallel work streams**
_**Governance Work Stream**_** to create a long term governance model along with formal management and control policies**
_**Firebird Operational Work Stream**_** to create a scalable production environment for Firebird, the FDA investigator registry.**

## Governance Work Stream Milestones

**3-month objectives?**
- CRIX Business Governance Structure defined
- Socialize CRIX Governance(3-6 months)
- Define CRIX as an Enterprise Entity
**6-month objectives?**
- Finalized CRIX as Business Entity
**9-month objectives?**
- Janus/CRIX Business Plan
**12-month objectives?**
- Identify subsequent CRIX modules

## Governance Work stream Activities

**Agree on Business Entity Structure **
**Establish Board Structure  **
**Define Role of Regulators in Relation to CRIX Governance**
**Identify and Agree on CRIX Operating Principles**
**Management and Oversight**
**Define Investment/Incubation Model** **for CRIX Components**
**Determine CRIX Enterprise Formation and Funding **

## Firebird Operations Work Stream Milestones

**3-month objectives?**
- Business Case for Firebird
- ID candidates to host Firebird
- Socialize Firebird Business Case (3-6 months)
**6-month objectives?**
- Write and Release SOW for 3rd Party to host Firebird (4th month)
- Start enrolling NCI Investigators
**9-month objectives?**
- Select 3rd Party to host Firebird (month 7)
- Firebird launched and hosted by 3rd Party
- Use of electronic signatures via Firebird
**12-month objectives?**
- Continue Firebird roll-out across NCI
- Start bringing on paying users for Firebird (fee for service)

## Firebird Operations Work stream Activities

**Stakeholder Analysis**
**Business Case**
**Business Case for Users**
**Business Case for Host**
**Operating Requirements** (who hosts, pricing model)
**Production Deployment Requirements**
**Systems Operator (Host) Selection**

## Work Stream Setup 

**Identify Membership for Each Work Stream**
**Identify Work Stream Lead**
**Develop Plan/Approach to Delivering Milestones**
**Execute And Track Plans Against Milestone Delivery**

## AGENDA 

**Welcome**
- Update on CRIX Initiatives
- CRIX Operational Framework
**Firebird Stakeholder Analysis**
- Workshops
- Summary and Next Steps** **

## Firebird Stakeholder Analysis

|  |  |
| --- | --- |
|  |  |

**BENEFIT**

**Willingness to Pay**

**High**

**Low**

**Low**

**High**

**CROs**
**Academic Centers**

**Individual Investigators**
**CCOPs**

**Subjects/Patients**

**NCI (invest in launch & incubation)**
**Bio-Pharma (Big/Small Pharma)**
**Regulators (e.g., FDA)**

**Insurance Companies**
**Providers**

## AGENDA 

**Welcome**
- Update on CRIX Initiatives
- CRIX Operational Framework
- Firebird Stakeholder Analysis
**Workshops**
- Summary and Next Steps** **

## Workshop Overview

- Two Simultaneous Workshops
- Workshop 1: CRIX Governance Structure
- Workshop 2: Firebird Implementation Analysis
- Participants have been split into workshop groups
- Stakeholder Representation
- Equal number of Participants
- Activities
- Choose a Representative to Report Out
- Discuss and Answer Questions
- Identify Actions / Next Steps

## Where to go...

- Workshop1 102, current conf. line
- Workshop 2 318B, dial-in 1-866-657-9756,PC3145739

## Workshop Breakout

| Workshop 1: CRIX Governance Structure | Workshop 2: Firebird Implementation Analysis |
| --- | --- |
| Facilitators: Guy Tallent/ Mary Jo Deering/ Chalk Dawson | Facilitators: Sue Dubman/ Kevin Vigilante/ Patrice Clark |
| Brenda Duggan, NCICB | Christo Andonyadis, NCICB |
| Frank Newby, CDISC* | Troy Budd, CTEP |
| George Redmond, CTEP | Sharon Elcombe, Mayo Clinic* |
| Deborah Collyar, Patient Advocate | Betsy Fallen, Merck* |
| Mary Jo Deering Ph. D, NCICB | Pat Skarulis, Memorial Sloan Kettering |
| Kim Johnson, Duke University* | Donna Marinucci, ECOG* |
| Norman Goldfarb, First Clinical Research | Beverly Meadows, DCP* |
| Rachel Carle, BIO* | Edmund Verstraete, BIO* |
| Joyce Niland, COH | Dianne Paul, Patient Advocate* |
| Diana McKenzie, Amgen/ CTWG Industry Rep | Gary Secrest, J&J/SAFE* |
|   | Kamal Narang |
| * Participating via Telecon – we will need a second dial-in, unless we put all dial-in participants in one workshop
Workshop1 102, current conf. line
Workshop 2 318B, dial-in 1-866-657-9756,PC3145739 |  |

## Workshop1: CRIX Governance Structure

- Is CRIX needs to be a separate legal third-party entity or is CRIX a collaborate initiative overseen by a board?
- What are the areas of governance that are important to CRIX?
- Who are all the stakeholder Groups for each area that should be involved?
- In which areas (e.g.,  CRIX operations, standards, Component selection, Incubation Model)
- Are there limitations on involvement

## Workshop 2: Firebird Implementation Analysis 

- Who will pay for Firebird?
- What are the characteristics of the pricing model structure?
- What are the requirements for the hosting environment?

**Workshop Results...**

## AGENDA 

**Welcome**
- Update on CRIX Initiatives
- CRIX Operational Framework
- Firebird Stakeholder Analysis
- Workshops
**Summary and Next Steps **

## Next Steps

- Develop a Project Plan that defines the activities needed to accomplish the CRIX milestones over the next 6 months
- Identify leads for each work stream
- Support leads
- Industry leads
- Identify operating norms for the work streams
- Setup a listserv for the CRIX steering committee
- Plan future meetings approximately every six weeks

## Workshop Results Summary

**Workshop 1:**** **CRIX Governance Structure
**Workshop 2:**** **Firebird Implementation Analysis

## Workshop1: CRIX Governance Structure

- Is CRIX needs to be a separate legal third-party entity or is CRIX a collaborate initiative overseen by a board?
- What are the areas of governance that are important to CRIX?
- Who are all the stakeholder Groups for each area that should be involved?
- In which areas (e.g.,  CRIX operations, standards, Component selection, Incubation Model)
- Are there limitations on involvement

**Workshop 1 Results...**

## Workshop 1 Discussion

**Confirm end-state view: 3 types of models - evolution**
- Incubation phase: (Loose to put in place) initiative and framework that coordinates various modules i.e. domain registry, caBIG but NCI decision)
- Production: Stand alone 3rd party non-profit where w/various infrastructure modules are developed and initially operated (outsourced) (i.e. VISA model)
- Standards: Stand alone 3rd party non-profit w/module providers selected, and svc. Quality and interoperability is overseen (bluetooth, GSM).
**Determining factors?**
- Development/implementation speed
- Requirement/desire that svc. Modules by non-profit
- multiple svc. Delivery sources v. sole source
**How to develop into larger scope than clinical research, #2?**

**Workshop 1 Results...**

## Workshop 1 Discussion

**Trade Association /standard Association**
- No equity; founders regain some investment by pricing structures, etc.
- i.e., SAFE: founding members had 3 yr. Brd seat and discount until brd says no
- Members set principles; appt. ED who does everything else
**Non-profits**
- Member – votes on board
- Strg. Committee/board
- Director does work
**What about for-profit?**
- Assumption – a shared svc. For the industry

**Workshop 1 Results...**

## Workshop 1 Discussion

- EX: investigator registry
- Investigator registered w/x.  Pharma only knows profile information. Profile in core place (easy maint.)
- if stakeholders are just investigators, ok
- What about co. who recall drugs?  Insurance co.
- GOAL: Create 1 standard to measure to
- Firebird
- Needs to be operated under #1 (to stabilize)
- Now, open up to other entities (#2)
- Takes what’s been done and allows all to expand markets
- Designated certain functions that are infra from day 1
- Some functions that can be added by others – compatible standards

**Workshop 1 Results...**

## Workshop 1 Discussion

**What is entity**
- 501©3 w/brd., bylaws,
- Board: sets vision, prioritize, business development
- How active is board?  Needs to be active, at least initially
- Can government employees serve in that role? Ok if not profiting or divulging inside information
- FDA can be involved w/out formal role - Advisory board? Consumer
- Could have board sub-committees – could include outside experts
**What: categories of activities in governing structure**
- Technical development/prototyping
- Standards
- Certification
- Production/operations
- Commercialization (mkt strategy/portfolio mgt.)
- Incubation investment/bus. Development.
- Company organization
- Board voting (election)
**Who decides on new modules?**

**Workshop 1 Results...**

## Workshop 1 Discussion

**Governing stakeholders – formal working board (decision-making**)
- Regulators (FDA, OHRP, etc.)
- Other Govt agencies (natl & state?)
- Biopharma sponsors (through assns.)
- Research institutions (academic and others)
- Patients/patient advocates
- At large (international or other experts)
**Advisory board participation (input/influence)**
- Clinical investigators
- National cooperative groups
- Study coordinators
- Payors (healthcare) – CMS, HRQ)
- CROs
- Others?
- IRBs
- IT and standards (BRIDG)
- Registries
- Medical societies/assns.

**Workshop 1 Results...**

## Workshop 1 Discussion

**Some advisory categories may become formal board category as it evolves**
**Board responsibilities - ***Some level of sponsorship/commitment*

**Workshop 1 Results...**

## Workshop 2: Firebird Implementation Analysis 

- Who will pay for Firebird?
- What are the characteristics of the pricing model structure?
- What are the requirements for the hosting environment?

**Workshop 2 Results...**

## Firebird Stakeholder Analysis

| 1 | 2 |
| --- | --- |
| 3 | 4 |

**BENEFIT**

**Willingness to Pay**

**High**

**Low**

**Low**

**High**

**CROs**
**Academic Centers**

**Individual Investigators**
**CCOPs**

**Subjects/Patients**

**NCI**
**Bio-Pharma (Big/Small Pharma)**
**Regulators (e.g., FDA)**

**Workshop 2 Results...**

## Workshop 2: Firebird Implementation AnalysisWho will pay for Firebird?

- Receptive to paying for Firebird
- Bio-Pharma
- Regulators
- NCI
- Conditions for Bio-Pharma Buy-in (supported by ROI)
- Non-duplicative work
- Integrated with in-house systems (e.g., clinical trial systems)
- Clear responsibilities defined
- Conditions for NCI/Regulators (Govt’t)
- Discounted fee
- Requested money through PDUFA (FDA)

**Workshop 2 Results...**

## What are the characteristics of the pricing model structure?

- Two models discussed
- Seed money to get Firebird off the ground  and then get out
- Pricing structure that includes on-going maintenance cost
- Pricing Strategy Options
- Early investor discount
- Annual cost for membership
- Membership script price vary by functionality needed
- Tiered pricing structure (e.g., discount for Academics, non-profit)
- Cost per protocol vs. cost per investigator (preferred)
- No charge per transaction

**Workshop 2 Results...**

## What are the requirements for the hosting environment?

- Not for profit business structure (Everyone shares in cost)
- Needs an IT infrastructure to support Global registration
- Ind. Vendor to host Firebird
- Has the relationships with the other entities
- Ability to share information easily
- Needs to be able to ensure confidentially of data

**Workshop 2 Results...**

## What are the requirements for the hosting environment? Cont’d

- Piggy Back on existing entity or establish a new entity
- Leveraging an existing entity (e.g., NBMS, ABIM) related to credentialing to host Firebird
- Academic Organization or other non-profits? Professional organizations as a consortium is attractive
- Is Pharma as a host attractive? Potentially limits the scope of Firebird as a tool

**Workshop 2 Results...**