CLINICAL TRIALS
IN CANADA

As global competitiveness intensifies, our Canadian industry must ramp up and implement strong competitive strategies. This conference is specifically designed to facilitate this process through exchange of expertise and timely dialogue on:

• Managing risk in international clinical trials
• Regulatory developments at home and abroad – from research to approval to access
• Designing trials to meet Common Drug Review and the provincial funding process requirements
• Web 2.0 and patient participation, protection and emancipation
• Taking strides to make personalized medicine a reality
• Recent developments in vaccine research and implications for the industry
• Collaboration, Networks and Partnerships – do they really deliver?
• Making the most of information technology tools while minimizing the risks
• Oversight reform – the latest on Research Ethics Boards and approvals
• Meeting the challenges of paediatric clinical trials

PROGRAM CO-CHAIRS

Rav Kumar B Pharm, MRPharmS, PhD
Vice-President, R&D Operations
GlaxoSmithKline Canada

Elaine Kielo
Director, Clinical Trials
Eli Lilly Canada Inc.

Add value to your registration:
In-Depth Workshop | October 20, 2010

WORKSHOP A – Negotiating and Drafting Clinical Trials Agreements and Related Documents – Best Practices for Streamlining the Process

This program has been accredited by the Law Society of Upper Canada towards the professional development requirement for certification. Health Law – 10.5 hours

Workshop A has been accredited by the Law Society of Upper Canada towards the professional development requirement for certification. Health Law – 3 hours

Bronze Sponsor

Copper Sponsors

Sponsor

MARKETING PARTNERS

Industry representatives (sponsor and CRO), clinical investigators, study coordinators, contracts negotiators (hospitals and law firms), hospital research administrators, civil servants involved in provincial initiatives to encourage clinical research, and federal and provincial regulatory agencies from pharma, biotechnology and medical devices including:

• Chief Medical Officers and Medical Directors
• Heads of Medical Affairs and Clinical Research
• Heads, Directors and Managers of Clinical Operations / Heads of Quality Control / Assurance / Compliance / Ethics / Research
• Directors or VPs, Scientific Affairs / Government Relations
• Research Ethics Board Members
• Clinical Researchers
• Clinical Study Coordinators and Study Nurses
• Clinical Project Leaders and Research Associates
• Clinical/Site Monitors and Auditors

• Clinical Statisticians / Data Managers / Co-ordinators
• Health Canada, Senior Advisors, Researchers and Policy Developers
• Health, Pharma, Medical Device and Biotech Lawyers / Trade Association Representatives
• Clinical Trial Consultants and Service Providers
• Regulatory Managers and Clinical Investigators
• Insurers/Defence Providers
• Heads of Agencies that Fund Research, including Governments, Research Charities, and Medical Research Councils

Dear Colleague,

We are pleased to be co-chairing the 11th Edition of Insight Information’s CLINICAL TRIALS IN CANADA conference this coming October in Toronto. As the challenges of globalization continue to confront our industry we are moving ahead with creativity and initiative to build our future. This conference will focus on how we are doing that and where the promise lies for the industry as we go forward. This is a crucial time for us to develop and implement strong and competitive strategies and this conference is designed to facilitate this through dialogue and exchange of expertise.

Strengthening Canada’s clinical research and innovation sector requires that we make the most of new directions and opportunities such as genomics, personalized medicine and biologics. It means confronting head on the new challenges and sources of competition by building on our strengths and successes as we continue to improve in the areas of technology use, patient safety, clinical trials efficiency and cost management, effective governance and oversight and streamlined process. All of this while also keeping an eye on the risks inherent to the clinical trials processes as we search for the best solutions to managing and minimizing that exposure while safe-guarding the research agenda and the safety and privacy of the patients.

You will leave this conference with new contacts, renewed energy, updated skills and strategic information, competitive strategies and insights into how the industry is positioning itself for growth and a strong future. Topics covered will include:

• Cross border and outsourced clinical research activities
• Oversight and governance on the wild west of the internet
• Adverse event reporting and follow up
• Managing communication and consent issues in paediatric trials
• Overseeing Investigator initiated trials

For added value, participate in the in-depth interactive workshop. You will fine-tune your skills on Negotiating and Drafting Clinical Trials Agreements and Related Documents.

We and the expert faculty look forward to seeing you at this timely and essential industry event.

Rav Kumar B Pharm, MRPharmS, PhD
Vice-President, R&D Operations
GlaxoSmithKline Canada

Elaine Kielo
Director, Clinical Trials
Eli Lilly Canada Inc.

Monday, October 18, 2010

8:15

Registration and Coffee

9:00

Co-chairs’ Opening Remarks and Welcome

Rav Kumar B Pharm, MRPharmS, PhD
Vice-President, R&D Operations
GlaxoSmithKline Canada

Elaine Kielo
Associate Director, Clinical Research Operations
Eli Lilly Canada

9:10

Biotech’s Boost to Clinical Trials

Graeme Fraser
Director, Health Policy
BIOTECanada

10:00

Networking Coffee Break

10:15

New Horizons in Research and Clinical Trials

Moderator: Mark Ferdinand 
Vice President
Rx&D

Pierre Gervais, B. Pharm., M.Sc.
President, Research Director
Q&T Research, Sherbrooke
Research Director
Q&T Research, Outaouais and Chicoutimi

Norman Viner, M.D.
Chief, Clinical Trial Division
Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics
Biologics and Genetics Therapies Directorate
Health Products and Foods Branch
Health Canada

• Industry trends and consolidation
• Alliances and joint ventures
• Cross border and outsourcing activities
• Healthcare reform and funding
• Meeting supply and demand challenges
• Placebo trials
• Where the promise lies for future clinical research
  • personalized medicine and genetic therapies
  • nanomedicine
  • biologics, biogenerics and biosimilars
  • cosmeceuticals and nutraceuticals
  • new applications for existing products

11:30

Making Personalized Medicine a Reality: Implications of New Imaging Technologies from Bench to Bedside

Justin Lee, MD, MSc, FRCPC
Assistant Professor, Department of Radiation Oncology
University of Toronto
Odette Cancer Centre
Sunnybrook Health Sciences

In the field of personalized medicine, important new cancer response imaging methods are now being developed. In this presentation we will explore the implications of these innovations and examine the treatments that will be enabled as a result. Exploring the processes entailed in taking these discoveries from the context of trials and clinic work to industry and front line delivery within the next 1-2 years will also be part of our focus.

12:15

Networking Luncheon

1:30

Personalized Medicine and Clinical Trials

Philip Plotnick
Managing Director
Mount Sinai Services

Ron Heslegrave
Chair, Research Ethics Board
University Health Network

P. Bradley Limpert
Partner, Patent and Trade Mark Agent
Cameron Mackendrick LLP

• Progress in personalized medicine and implications for clinical trials
• The three “Rs”: Right treatment, Right person, Right time
• Regulatory frameworks and guidance
• Use of biomarkers – implications for clinical trials
• Impact on recruitment and patient management
• Adaptive design issues
• Modifying the clinical trials process for personalized medicine
• Approval process and challenges
• Legal issues and consents
• Ethical issues
• Privacy and confidentiality

2:15

Vaccine Development

Dr. Monica Bologa
Director, Clinical Development
Sanofi Pasteur

• Overview of vaccine development
• Recent developments
• New horizons emerging for vaccines
• Next steps and directions

2:45

Growing Canada’s Fair Share of Clinical Trials in the Global Marketplace

Elaine Kielo
Associate Director, Clinical Research Operations
Eli Lilly Canada

• The challenges
• Overcoming the obstacles
• Concerted strategies
• Selling the benefits
• Hospital versus community based trials
• Where the promise lies in Canada
• Cutting edge research developments
• Commercialization potential

3:15

Networking Refreshment Break

3:30

From Research to Approval to Access – Regulatory Developments and Innovations at Home and Abroad

Krista Nevin
Director, Trial Delivery CV and NS
AstraZeneca Canada

Kim McDonald-Taylor
President
Clinical Research Association of Canada

• From research to approval to access: how to ensure your drug is accessible to Canadians
  • the HC approval process
  • the Common Drug Review process and provincial funding processes
  • how you can design trials to meet the requirements of both
• Governance, accountability and oversight
  • inspections and audits
  • environmental risk assessment
• Compliance and due diligence
• Harmonization and coordination
• Building patient protection and participant confidence and trust
• Post market review and surveillance
• Independent versus academic research and review – regulatory issues
• Comparing Canadian, FDA and EMEA regulatory frameworks

4:15

Recruitment, Enrollment, and Retention: Maximizing Your Return on Investment (ROI)

Darren Cowan-Bittner 
Regional Team Leader
Clinical Research - Western Canada
Pfizer Canada Inc.

• How to calculate your access to patients
• Converting a patient to a subject
• How to retain subjects
• How to assess ROI and manage risk

5:00

Conference Adjourns for the Day

Tuesday, October 19, 2010

8:15

Coffee and Facilitated Roundtable Discussions

9:00

Co-chairs’ Opening Remarks

9:05

Collaboration, Networks and Partnerships – Can They Really Resolve Your Worst Clinical Research Headaches?

Moderator: Rav Kumar B Pharm, MRPharmS, PhD
Vice-President, R&D Operations
GlaxoSmithKline Canada

Dr. Carter Thorne MD
Principal Investigator, The Arthritis Program Research Group
Secretary-Treasurer, Canadian Rheumatology Research Consortium

Maria Rossin B.A., LL.B., JD
Research Counsel
The Samuel Lunenfeld Research Institute
Mount Sinai Hospital

Ronald Fehst
Institutional Review Board Services

• Research trends and networks – community/hospital based research
• Benefits provided; challenges encountered
• Timelines and efficiency of process
• Cost benefit analysis
• Recruitment
  • principal investigators
  • patients
• Accountability for research quality control and results
• Payment structures and fees
• Partnership/consortium structure and roles
• Legal considerations and strategies

10:00

Managing, Minimizing and Allocating Risk in Global Clinical Trials

Jean Langlais, Ph.D.
Research Agreements Manager
Director, Office of Research Agreements
CHU Sainte-Justine (Montreal)

Andrew Loh
Partner
Borden Ladner Gervais LLP

• Areas of greatest legal risk in global clinical trials (including trials developed by universities and research institutes)
• Managing different national regulatory regimes governing investigational product approval
• Addressing different healthcare regimes governing services provided by institutional sites
• Risk containment strategies
• Indemnity and insurance considerations

10:45

Networking Coffee Break

11:00

Managing, Monitoring, and Overseeing Clinical Trials – Making the Most of Information Technology Tools while Minimizing the Risks

Khaled El Emam, PhD
Associate Professor
Canada Research Chair in Electronic Health Information
Faculty of Medicine and the School of Information Technology and Engineering
CHEO Research Institute and the University of Ottawa

• The extent of adoption of electronic data capture tools in Canada
• Privacy preserving tools for tracking patients who participate in multiple trials
• Tools for finding out eligible patients without a data warehouse and without sharing patient data

11:45

Web 2.0 and Patient Participation, Protection and Emancipation in Research Trials

Pierre Gervais, B. Pharm., M.Sc.
President, Research Director
Q&T Research, Sherbrooke
Research Director
Q&T Research, Outaouais and Chicoutimi

Karine Côté, RN, Bsc. Adm.
Associate Director, Patient Recruitment Specialist
Q&T Research, Sherbrooke

• Impact of web 2.0 and social media tools on patient advocacy and knowledge
• Patient communities and medical research
• Recruitment challenges and web possibilities
• How well is direct patient recruitment via the web working?
• Transparency, confidentiality and privacy
• Oversight and governance on the wild west of the internet
• Increasing patient access with e-networks
• Maintaining an image of trust and care
• Building patient retention and loyalty
• Case studies of uses to date and issues going forward

12:30

Networking Luncheon

1:30

Balancing Privacy and Care Objectives in Clinical Research

Patricia Kosseim
General Counsel
Office of the Privacy Commissioner of Canada

2:00

Oversight Reform – Latest Thinking and Developments on Research Ethics Boards and Approvals

Moderator: Michelle Moldofsky LLB, LLM
Policy & Legal Advisor
Office of Research Administration
St. Michael’s Hospital

Jack Corman
President
Institutional Review Board Services

Richard Sugarman
Chair, Research Ethics Board
The Hospital for Sick Children

Susan Zimmerman
Executive Director
Interagency Advisory Panel on Research Ethics (PRE)

• Trial registries and transparency
• Review harmonization
• Standardization of processes
• Adverse event reporting and follow up
• Investigator initiated trials
• Conflict of interest
• Ongoing review of trials
• Governance and accountability
• Accreditation and quality control
• REB education and training
• Public versus private REB – best practices
• Privacy and confidentiality protection
• Tri-council Policy Statement (TCPS) developments

3:00

Networking Refreshment Break

Sponsored by

3:15

Strong Financial Management in Clinical Trials – The Latest Tools and Strategies

Sandra Gazel
Associate Director, Clinical Research
Abbott Laboratories Limited

Lisa Johnston, RN, BScN, CCRP
Manager
Department of Clinical Research Practice
University Health Network

• Costs of industry-sponsored clinical research in Canada, where are we at?
• Budget projections and management:
  • determination of per-patient fees: tools and methodology
  • start up fees and overhead costs
  • the do's and don’ts of budget negotiations
  • cultural differences in budget negotiations
• Ensuring service quality for cost
  • PI participation and compensation
  • Avoiding inflated costs
• Time is money – fast track opportunities
• Funding applications and eligible/ineligible funds: an industry perspective
• Canadian SR&ED tax credits: an overlooked opportunity?

4:00

Meeting the Challenges of Paediatric Clinical Trials

Richard Sugarman
Chair, Research Ethics Board
The Hospital for Sick Children

• Regulatory requirements and compliance
• Are paediatric trials over-regulated?
• Some examples of difficult versus straight forward paediatric trials
• Patient recruitment and retention strategies
• Operational and process issues
• Ethical challenges and approaches
• Communication and consent

4:45

Post-conference Workshop | Wednesday, October 20, 2010

Workshop A | 9:00 a.m. to 12:00

Negotiating and Drafting Clinical Trials Agreements and Related Documents
– Best Practices for Streamlining the Process

P. Bradley Limpert
Partner, Patent and Trade Mark Agent
Cameron Mackendrick LLP

Michelle Moldofsky LLB, LLM
Policy & Legal Advisor, Office of Research Administration
St. Michael’s Hospital

Clinical Trials Agreements are complex documents that need to be tailored to the specifics of the research and the entities involved. However, delays at this stage of the clinical trial process could be costly and even endanger the entire feasibility of the work. Join this workshop to ensure you understand the legal issues from all the relevant perspectives and can quickly and successfully translate them into agreed upon terms and contract clauses. Topics to be covered include:

• Streamlining the negotiation process
• Preliminary and ancillary documents: non-disclosure, confidentiality and letters of intent
• Key contract considerations and clauses
• Plain English and standard clauses
• Defining the parties, the roles and the responsibilities
• Follow the money – who pays for what?
• Grants and funding sources
• Subcontractors
• Risk and litigation avoidance and management within the contract
• Indemnification and insurance
• IP ownership and protection
• Dispute resolution
• Enforcement, accountability, milestones

You will receive specially prepared materials and precedents that will be of future value to you and your colleagues and you will be afforded plenty of opportunities to discuss specific scenarios and concerns of interest to you and your organization.

Michelle Moldofsky is the Policy & Legal Advisor at St. Michael’s Hospital in Toronto where she is leading a project to review and update research policies. She is a member of the Council of Academic Hospitals of Ontario (CAHO) Steering Committee on Harmonization of Clinical Research Agreements and has contributed to the development of Ontario-wide standards regarding legal and ethical requirements in clinical research contracts.

P. Bradley Limpert is a partner, and patent and trade mark agent with Cameron Mackendrick LLP. He has been involved in litigation, dispute resolution and licensing across a broad range of technologies including pharmaceuticals, food processing, software, and biotechnology.

Register 3 delegates for the main conference at regular price at the same time and you’re entitled to register a fourth person from your organization at no charge. For other group discounts, please call 1-888-777-1707. All discounts must be redeemed when booking, discounts will not be valid or applied after this time.