N2 - The Network Networks: HIV Network

The Network Networks:
HIV Network
April 18, 2012

Karen Arts, Chair of the Board of N2
Director Business Development OICR

Administrative Office: Lawson Health Research Institute, London Ontario

2

Overview of Presentation
 N2’s Background
 Mission and Objectives
 Membership
 Committees & Deliverables
 Collaboration
 Next steps

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Current Environment:
 Rising Costs of Development & Pressure on R&D Budgets
 More complex research and regulatory environment
 Local issues
 Rising cost and deficits
 Patient Recruitment issues
 Inefficient processes
 Lengthy delays to start up trials
 Lack of time to do the work….
 Lack of formal uniform, nationwide standards and research best practices
 Inadequate research support from government and institutions
 Silos; “we are special” phenomenon
 Global Competition
 Research moving away from Ontario/Canada, currently at a rate of 12% per
year

These result in reduced access to new and innovative treatments for patients

Health Canada Inspectorate Findings:
N=360

Adapted from Health Canada’s HPFB (Health Products and Food Branch) Inspectorate Report (December. 2004)

6

Health Canada Inspection Findings

The Most Common Deficiencies
• Regardless of the location of the investigator site, or REB the
same types of deficiencies are noted

• Updated document available at:
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/compli-
conform/clini-pract-prat/report-rapport/2004-2011-eng.pdf

• Action is required…..

Trends in the biopharmaceutical industry
 Business is becoming tougher
 Research and regulation are more demanding
 Wave of patent expiries by 2011
 Payers looking for short-term savings - rationing access to drugs

 Modern drug discovery more complex
 Public institutions, biopharmas, and pharmas – the “triple helix”

 Emerging economies successfully competing for R&D dollars
 China, India, Eastern Europe, South America

 Clinical research – a major part of industry’s R&D investment
 78% of R&D in Canada or 950M$(PMPRB)
 Western governments trying to protect their share
 Firms respond to cost/productivity of trials and market access

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WE ARE LOSING GROUND……

Can we, and if so, how do we, as a Canadian clinical trial community
compete in global environment?

Can we work in harmony?
It makes sense to collaborate and to work towards
common practices and harmonization where
possible.
Are we all “Special” ? Do we all need our own version
of everything
How to create efficiencies and streamline process?
• Requires collaboration across Canada,
 across stakeholders and
 across therapeutic areas
Can we establish a framework that allows us to
work towards networking and collaboration?

YES, WE CAN! :
• A national alliance of clinical research stakeholders with common
interests
• Multiple existing disease networks, institutions, universities,
industry and other research stakeholders willing to join forces to
enhance Canada’s research capability and capacity.
• A virtual clinical research hub
• self-governed, with “self-help” environment to share best
practices, tools and resources)
• Currently ~45 member organizations, each covering a multitude of
staff. Current estimate is >3000 PIs and associated staff……
(In 2010, we had 28 organizations)

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N2 Mission & Objectives
 To establish an alliance of Canadian disease oriented research
networks and organizations willing to join forces to facilitate and
enhance Canada’s research capability and capacity
 To provide a self-governed, “self-help” environment for sharing of
best practices, tools and resources to enable and enhance the
provision of new and innovative treatments to Canadians in a timely
and effective fashion

More Background:
February through May 2006
 Establish common basis and test pan- Canadian approach
> SOP working group
> GCP working group
June 2006
 Follow-up meeting: 16 representatives from 8 networks & 4
stakeholder organizations
November 2006
 N2 proposal developed
August 2007
 N2 is Incorporated under the Canadian Corporations Act as a
non-profit corporation
February 2008
 First annual meeting of members (February 2008) & election
first Board of Directors

Governance & Funding
 CIHR support
> 2007-2008 – annual meeting and training day
> Development & hosting of Web portal
> Translation of SOPs & GCP materials into French
> 2009 – grant to support development of CITI Canada
 In-kind contributions from current members
> Quality materials
> Working groups
> Meeting planning support
 Membership fees
 New Board structure Feb 2011
> 12 members
> Representational
> 1 seat for Rx&D

15

Current Board of Directors
Ms. Karen Arts, Chair
Ms. Ruth Bullas, Vice-Chair
Ms. Linda Bennett, Treasurer (outgoing)
Mr. Patrick Clifford, Treasurer (incoming)
Ms. Eric Cherban, Secretary
Mr. Jim Pankovich
Ms. Kathy Brodeur-Robb
Dr. Rachel Syme
Ms. Heather Harris-Harper
Mr. Jeffrey Toward
Dr Ray Saginur
Ms Farida Dabouz
Rx&D

Indispensable…..Ms Shelley King
Lawson Health Research Institute
London Ontario

Aligning Efforts from the Single Stakeholder Level to the National Collaborative
Level
Independent Stakeholders
 Well-established clinical trial expertise
and process Collaborations
 Sites, Institutions, Sponsors (Networks; Institutions;
CAHO; Rx&D, etc)
Independent Trial Site
Solution #1 Come together to

 Collaboration between stakeholders to address individual clinical trials
issues & survive in competitive
Hx: compete with other
Canadian sites for trials
work on common challenges environment

Solution #2 – Network of Networks
 National, multi-disciplinary, multi-
stakeholder group to focus on the
challenges that cross
indications/institutions/stakeholder
groups and require a national
solution Network of Networks

 Can create strategic synergies and Common Challenges that
collaborations leading to solutions require national solutions
REB, Contracts, SOPs,
 Move them back out into groups Education, Budget etc

Areas that cross borders and boundaries
For Example:
Standard Operating Procedures (SOPs)
Education
Quality Initiatives
Clinical Trial Agreements
Costs and budget development
Mentoring
REBs
And many more…….

N2 Committees
• SOP Committee
• Education Committee
• CITI-Canada Program
• Membership/Advocacy Committee
• Mentoring Committee
• Quality Committee
• Pediatric Special Interest Committee
• Recruitment Strategy/Trials Awareness Committee

SOPs
We know this already:
• SOPs are a regulatory requirement for the conduct of clinical
research at Research Institutions and Networks across
Canada
• Lack of or non-compliance with SOPs result in:
- GCP compliance audit difficulties
- Regulatory Inspection non-compliance findings
• Can be used across Canada, across therapeutic areas
• Having them is not optional
• Great source of education

One of N2’s projects
• To create a set of investigative site SOPs
• to be a national standardized set of operating procedures,
• applicable to any therapeutic area.
• in any given institution or research environment.
• Facilitate distribution, adoption and maintenance of one
standard.
• SOPS need to reflect and be compliant with the regulations
and guidance documents that govern clinical research
• Do NOT need to be site/institution specific.
• Must have a mechanism in place to ensure ongoing
compliance (by way of regular expert review)

N2 SOPs
Currently have 30 SOPs available to N2 members
 ( include “regular”, IIS and eDM, Biospecimen SOPs to follow)
Compliant with Health Canada and US Food and Drug (FDA)
regulations, the ICH-GCP Guidelines and the Canadian Tri-
Council Policy Statement on Research Involving Human
Subjects
Available to all members of N2, across institutions, networks and
therapeutic areas
Formal process for maintenance
Education Program
FAQs and Quiz
Continue to work on developing SOP’s and training tools to
support conduct of clinical trial research

Education Committee:
Collaborative Institutional Training Initiative (CITI)-Canada
 N2-CITI Partnership :
 U of Miami
> Online clinical research training – extensive program
> CITI-Canada launched Aug 2010, N2-developed Canadian
content
> To date >1800 users
> At recent CT Summit, N2 tools/programs recommended
> Pfizer, Novartis, and BMS has accepted the N2-CITI
Canada program; with a current CITI certificate no
company GCP training required
> AZ, Abbott, Astellas, Celgene, EMD Serono, reviewing
> Reciprocity is the key…
» Savings in time and $$

CITI-Canada Program, where are we at?
 Phase 1
• MOU N2-CITI (2009)
• N2-CIHR commitment :
• Allowed us to hire .5FTE in Miami
• Bi-Lingual Help-desk function in place
• N2 Part of the CITI-Developers group
• N2 Education Committee
• GCP Content Adaptation
• Consultants
• Timelines
• Process
• Initial Roll-out plan completed (to date >2200 learners have accessed
and >1200 learners completed the GCP course)
• Additional materials under development and being uploaded

CITI-Canada Program, where are we at?
 Phase 2
• to adjust the content for the final draft of the Tri-council Policy Statement on
Research Ethics, to be accomplished with input and collaboration from
stakeholders
• Adaptation/Incorporation and development additional modules
• Basic Biomedical
• RCR
• Dangerous Goods (TDG/IATA)
• SPIRIT
• Maintenance (ongoing)
• Formal process
• Canadian Developers group
• Link to US
• Comments review and content modification
• N2 represented on global executive committee
• To start exploring reciprocity with industry
• Several companies have accepted CITI program as meeting GCP requirement

N2 - CITI-Canada: what’s next?
Phase 3
• New CITI-UoM agreement, effect on Canada
• Formal contract
• Legal fees
• Risk assessment of reliance on US
• Grow program
• At recent summit of decision makers, N2 recommended as
catalyst for harmonization. This includes the CITI-Canada
program
• Ongoing discussion with Health Canada
• Sustainability
• To add additional programs:
• RCR, Basic Biomed, TDG/IATA, Privacy, Protocol
Development, Biomedical safety
• Other? E.g. RECIST

Recruitment Strategy/Trials Awareness Committee

Demonstrates how work at the stakeholder level (CRRC) can be
pushed up and driven out through N2

Consequences of Diminished Trials Activity

If clinical trials cease to come to Canada, future patient care will
be negatively impacted by reducing:
• Patient access to novel therapies
• Clinician early exposure to novel therapies
• Clinician uptake of new therapies once in the marketplace
• Canadian data in regulatory dossiers (impact on coverage)
• Knowledge translation/exchange related to clinical research in
Canada
• Non-trial research related to patient care which is often
conducted within trial infrastructure (investigator-initiated studies,
registries, academic research, etc.)

Strategies to Improve Patient Recruitment
CRRC October 23, 2010 meeting - five main areas identified to
increase recruitment:
• Improving the design of clinical trials (board initiative)
• Getting the right trial to the right site
• Reducing administrative demands
• Raising patient awareness and understanding of clinical trials
• Increasing physician comfort with approaching patients
(deferred; above identified as higher priority)

Multi-stakeholder working groups established to develop
strategies
• Goals and work plans established
• Implementation underway
• Link to other stakeholders; N2, CISCRP

Raising Patient Awareness and Understanding of Clinical Trials
1. Ensure potential participants have access to the info they need to
understand trials & participation
 Create a repository of info for the public
> Disease information
> Drug development; safeguards; currently approved therapies (study
lay summaries); drugs currently under development
> Understanding clinical trial participation; how to find a trial
 Note: overarching goal is to utilize currently available materials (& link
to other organizations) rather than re-invent the wheel
 In partnership with other stakeholders – build a communication strategy to
get the information to the public
2. Support sites in their efforts to raise trial awareness locally
 Create a “plug & play” tool kit for sites (brochures; posters; dvds for waiting
rooms/patients to take home; web-based resource lists; publications of
completed trials; thank-you letter templates, standard research info board
for waiting rooms, etc.)
3. Build an alliance with other stakeholders (Pharma, N2, Institutions, Networks,
patient groups) to champion a national clinical trials awareness and
rebranding campaign (i.e. CISCRP)

Where Do We Start – Pulling The Common Strategy Together
• Improve recruitment into trials – meet targets on time = return on investment
• Reduce the start-up timelines (expand the opportunity to recruit)
• REB streamlining, contract standardization, streamline GCP training
(CITI), improve trial operations management/efficiency
• Enhancing the Canadian trial capacity
• New site development (SOPs, training, mentoring)
• Established site support (SR&ED credits)
• Getting the protocol to the right sites
• Refining trial designs
• Improve feasibility & site selection
• Engage the public
• Build & execute a national trials awareness campaign and recruitment
strategy
• Increase patient understanding of trials so that trial discussions can
occur
• Broaden patient awareness of & access to clinical trials

Note – green text denotes current N2-related activities.

N2 Strategically
Gaining significant momentum
It IS possible to build it from the ground up and capture people’s
attention.
We need a national voice as clinical research stakeholders: N2
This will allow us to be at the table and help drive the agenda
National scene: N2
» Clinical Trial Summit, Ottawa, September 2011
» Canadian General Standards Board
» CIHR: SPOR
Provincial scene:
» BC, Alberta, Quebec
» CTO in Ontario
Are the starts aligning?

N2 Challenge
 Phase I: Success!!
 Bottom-Up
 Connect with Top-Down
 Nimble
 Volunteerism
 Little cost

 Phase II
• Long term strategic planning
• ++ Growth
• Need formal mechanism to manage growth and additional output
• Sustainability
• Need additional resources and infrastructure to grow
• Business review completed, Survey of the membership
completed
• Strategic Plan under development

33

N2’s Opportunity and future vision
 Networking, teamwork & collaborating continues
 At crossroads
 Growing rapidly,
 Addition of different stakeholder groups
 Recognition of N2’s value growing
> Clinical Trial Summit Ottawa, Sep 15, 2011
 Collaboration moves us toward one common voice;
across therapeutic areas, across organizations, across
Canada
 Well on our way to the ultimate vision:
> Dynamic & collaborative research community
> Speak to clinical research issues with one voice
> Canada becomes globally competitive and a
preferred research partner

Clinical Trial Summit
 2006 - 2010 Canada’s clinical trials activity declined ~ 30%.
 Canada to remain competitive by overcoming operational barriers
and inefficiencies, and addressing the high costs of conducting
clinical trials.
 Investment and opportunity in and for Canada
 Impact on patients
 Sept 15, 2011: Canada’s first-ever National Clinical Trials Summit
 Organized by the Association of Canadian Academic Hospital
Organizations (ACAHO), CIHR and Rx&D
 > 150 of Canada’s leading experts from academic healthcare
organizations, research, governments and the private sector.
 Goal: Action plan to help restore the human, social and economic
benefits of clinical trials.

Clinical Trial Summit
 Areas discussed:
 Globalization of Clinical Research and Metrics survey results (industry)
 CIHR – Strategy for Patient Oriented Research (government)
 Starting the Conversation “A SWOT, So What and Now What” –
Summary, Implications and Next Steps.(Site/Academia)

 5 Break-Out Sessions:
 Ethics Review
 Recruitment-Retention
 Administrative Issues
 Cost Issues
 Strategic Infrastructure Issues

 Summary and Action Plan: in Progress
 N2 submitted Request to Reader form
 9 Recommendations in 3 categories

N2-Collaboration and Opportunities for you
• YOU are member of N2
• N2 jointly with stakeholders to build a strategy to enhance Canada’s
competitiveness in the global clinical trials environment
• Quality
• Speed
• Access
• Deliverables
• Collaborate in areas of overlap
• Become active in N2
• Committees
• Conference calls
• Annual meeting
• Your Representative

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Next Steps
 Discuss wishes, survey results, and N2 strategy with membership
 Develop 5 year strategic plan by summer 2012
 BoD to collaborate to develop Business plan
 BoD and Committees to deliver on goals for the upcoming year
 Explore additional strategies and opportunities to create a well-
resourced and sustainable organization
> Survey results
> Summit outcome
> Assess alternate streams of revenue
> Assess membership structure and fees
 Continue collaboration and communication with CIHR, Rx&D, Health
Canada and other stakeholders on national projects and initiatives
where feasible

What is key to Success?
Can we harmonize? Are we really “Special”?
Let’s build bridges instead of barriers
Share, and collaborate like crazy!!!!!

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Contact Information
N2 Board of Directors
Ms. Karen Arts, Chair
karen.arts@oicr.on.ca

N2 Administrative Office

Ms Shelley King
Lawson Health Research Institute
London Ontario
Shelley.King@LawsonResearch.com

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Questions or Comments???????????

N2 - The Network Networks: HIV Network

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