Administrative Office: Lawson Health Research Institute, London Ontario

Karen Arts, Chair of the Board of N2Director Business Development OICR

The Network Networks:HIV Network

April 18, 2012

2

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

3

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

4

Health Canada Inspectorate Findings:N=360

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

Health Canada Inspection Findings 6

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

9

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)

12

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 organizationsNovember 2006

N2 proposal developedAugust 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 DirectorsMs. Karen Arts, ChairMs. Ruth Bullas, Vice-ChairMs. Linda Bennett, Treasurer (outgoing)Mr. Patrick Clifford, Treasurer (incoming)Ms. Eric Cherban, SecretaryMr. Jim PankovichMs. Kathy Brodeur-RobbDr. Rachel SymeMs. Heather Harris-HarperMr. Jeffrey TowardDr Ray SaginurMs Farida DabouzRx&D

Indispensable…..Ms Shelley KingLawson 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 Sites, Institutions, Sponsors

Solution #1 Collaboration between stakeholders to

work on common challengesSolution #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

Can create strategic synergies and collaborations leading to solutions

Move them back out into groups

Independent Trial Site

Hx: compete with other Canadian sites for trials

Network of Networks

Common Challenges that require national solutionsREB, Contracts, SOPs, Education, Budget etc

Collaborations (Networks; Institutions;

CAHO; Rx&D, etc)

Come together to address individual clinical trialsissues & survive in competitive

environment

Areas that cross borders and boundariesFor Example:Standard Operating Procedures (SOPs)EducationQuality InitiativesClinical Trial AgreementsCosts and budget developmentMentoringREBsAnd 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

SOPsWe 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 SOPsCurrently 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 maintenanceEducation ProgramFAQs 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 StrategicallyGaining significant momentumIt IS possible to build it from the ground up and capture people’s

attention.We need a national voice as clinical research stakeholders: N2This will allow us to be at the table and help drive the agendaNational 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

38

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!!!!!

40

41

Contact InformationN2 Board of DirectorsMs. Karen Arts, Chairkaren.arts@oicr.on.ca

N2 Administrative Office

Ms Shelley KingLawson Health Research Institute London OntarioShelley.King@LawsonResearch.com

42

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