CLINICAL TRIALS IN CANADA

OCTOBER 17, 2011

8:15

Registration and Continental Breakfast

9:00

Welcoming Remarks from Insight Information

9:05

Opening Remarks from the Co-Chairs

Agnes V. Klein, MD, DPH
Director
Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics
Biologics and Genetic Therapies Directorate
Health Canada

Nestor Nituch
Unit Director, Regional Clinical Operations
Bristol-Myers Squibb Canada

9:15

KEYNOTE ADDRESS

Strengthening the Legislative Framework for Clinical Research in Canada

David K. Lee
Director, Office of Legislative and Regulatory Modernization
Health Canada

10:00

Where is the Untapped Opportunity? Canadian Economic Development and the Field of Clinical Research

Peter Pekos
President & CEO
Dalton Pharma Services

• Areas of competitiveness for Canada’s clinical research sector
• Where are the global and the local opportunities?
• How can Canada maximize on these?
• What kind of funding is being made available to grow and support Canadian competitiveness?
• How each level of government contributes to building a strong base for clinical trials and clinical research

10:45

Networking Coffee Break

11:00

Standardizing Oversight of REBs – Latest Developments from the Health Canada Sponsored REB Standard Committee

Jack Corman
President
Institutional Review Board Services

• Why an REB standard for biomedical research is important
• Background to the creation of the Canadian General Standards Board Committee
• Current developments and implications going forward

11:30

Hardwiring Harmonization into the Clinical Research Infrastructure – Report on Standardized Master Clinical Trials Agreements and Other Harmonization Initiatives

Normand Laberge
Vice President, Regulatory & Scientific Affairs
Rx&D

12:15

Networking Luncheon

1:00

KEYNOTE ADDRESS

The CIHR Strategy on Patient Oriented Research

Dr. Jean L. Rouleau
Scientific Director
Institute of Circulatory and Respiratory Health
Canadian Institutes of Health Research

1:45

Regulatory Developments at Home and Abroad – The Latest Guidance and Best Practice

Agnes V. Klein, MD, DPH
Director
Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics
Biologics and Genetic Therapies Directorate
Health Canada

• Biosimilars and subsequent entry biologics
• Orphan drugs
• Electronic filing
• The value of pre-submission and other consultation meetings
• Regulating drug life cycles

Jack Corman
President
Institutional Review Board Services

• Mandatory use of standardized CTA and IRAS in the UK
• FDA guidance on computer use and electronic filing
• FDA developments on IRB
• Fast tracking and parallel tracks for Orphan Drugs
• Pharmacogenomics – biologic sample collection, storage, and secondary use of the samples
• New guidance/draft guidance on reporting suspected fraud and conflict of interest
• The CTTI (Clinical Trials Transformation Initiative) and increased outsourcing of clinical trials to developing countries

2:40

Ethical Review – What Progress on the Reform Agenda?

Laurel Evans
Associate Director, Research Ethics
Office of Research Services
University of British Columbia

Jack Holland MD FRCP FRCP(C)
Chair, Ontario Cancer Research Ethics Board
Ontario Institute for Cancer Research

• Progress on standardizing ethical review
• Streamlined/centralized review – is it working?
• Compare and contrast to other jurisdictions
• Regional and networked models of ethics review
• Other models for ethical review
  • What are the options
  • Pros and cons
  • Networks and reciprocal recognition
  • Indemnification issues
• Quality assurance and accountability
• Efficiencies and time lines
• Ongoing challenges
• Next steps

3:30

Networking Refreshment Break

3:45

Report on Health Canada Inspections – A New Day?

Candace Hilder
A/Manager, Good Clinical Practices Compliance Unit
Compliance Coordination and Licensing Division
Health Products and Food Branch (PFB) Inspectorate
Health Canada

4:30

Patient Centred Clinical Trials – What Do They Look Like?

Nestor Nituch
Unit Director, Regional Clinical Operations
Bristol-Myers Squibb Canada

Sherry L. Dupuis, Ph.D.
Director, Murray Alzheimer Research and Education Program (MAREP)
Professor, Recreation and Leisure Studies, University of Waterloo

Sandra Gazel
Associate Director, Clinical Research
Abbott Laboratories Limited

• Education
• Safety
• Participation and participatory research
• Communication
• Informed decision making
• Quality of care
• Support and health system navigation
• Process and protocols
• Community building
• Recruitment methods and practices
• Retention – what keeps patients engaged and motivated?

5:30

Conference Adjourns for the Day

5:30 – 6:30

Wine and Cheese Reception
Co-Sponsored by

October 18, 2011

8:30

Continental Breakfast

9:00

Co-Chairs' Opening Remarks

9:05

KEYNOTE ADDRESS

Delivering on the Promise of Pharmacogenomics

Dr. Robert Roberts MD, FACC, MACC, FRSM, FRCPC, FACP, FESC, FAHA, FISHR
President, Chief Executive Officer and Chief Scientific Officer
Director, Ruddy Canadian Cardiovascular Genetics Centre
University of Ottawa Heart Institute
Adjunct Professor of Medicine
Baylor College of Medicine

9:35

Action Items for Canadian Clinical Research in a Global Marketplace

Moderator: Agnes V. Klein, MD, DPH
Director
Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics
Biologics and Genetic Therapies Directorate
Health Canada

Nestor Nituch
Unit Director, Regional Clinical Operations
Bristol-Myers Squibb Canada

Elaine Kielo
Clinical Operations Integration Manager, North America, Latin America and AMERIT Regional Clinical Operations
Eli Lilly Canada Inc.

• The demographic trends and impact on the industry
• Healthcare trends and implications for clinical research
• Global industry trends and strategies
• Canadian industry trends
  • The growth of Investigator Initiated Research
  • Building on new waves of research
  • Orphan drugs
  • Biologics
  • Bioequivalence
  • Phase 3 and 4 research
  • Priority reviews
• Implications and directions

10:30

Networking Coffee Break

10:45

New Models for a New Marketplace – Outsourcing, Collaborative Networks, Reciprocal Arrangements and More

Pamela Degendorfer
Chief Operating Officer
Ozmosis Research Inc.

• The Ozmosis model
• Structures and rationale
• What is different/the same about this model?
• Lessons and experiences to date
• On the horizon

Elaine Kielo
Clinical Operations Integration Manager, North America, Latin America and AMERIT Regional Clinical Operations
Eli Lilly Canada Inc.

• Eli Lilly’s experiences – diverse models and partnerships for clinical research
• Key elements and paradigms
• Pros and cons of the different models and approaches
• Lessons learned and future directions

Joanne E. Watson MSc
President and CEO
Integrated Research Inc.

• Outsourcing and preferred vendors
• Selective outsourcing
• Specialization
• Sponsor vs. site vs. investigator concerns
• Investigator initiated trials
• Enhancing the bottom line and the quality of the work

11:45

Quality Assurance Strategies and Monitoring Best Practices

Pierre Gervais
President and Executive Director
Q&T Research Sherbrooke Inc
Research Director
Q&T Research Outaouais / Q&T Research Chicoutimi

• Quality assurance at a site level
• What are the standards?
• What are the expectations?
• What are the deliverables?
• What are the comparables?

Jason Ridderikhoff
Clinical Operations Manager
North America Field Monitoring Group
Quintiles

• New techniques for quality assurance
• Sample data use
• Key performance measures and indicators
• How technology is changing the oversight of clinical research
• Web enabled site monitoring
• Cloud computing
• Mobile devices

12:30

Networking Luncheon

1:45

KEYNOTE ADDRESS

Ethics, Science, and the Oversight of Clinical Research – A Brave New World Ahead?

Greg Koski PhD, MD
Associate Professor of Anesthesia, Harvard Medical School
Senior Scientist, the James Mongan Institute for Health Policy
Co-Founder, Alliance for Clinical Research Excellence and Safety (ACRES)

2:30

Networking Refreshment Break

2:45

How Information Technology is Shaping Patient Participation in Clinical Research

Khaled El Emam
Canada Research Chair in Electronic Health Information
University of Ottawa

• Patient portals and online support groups
• Patient care management
• Patient education and communications
• PatientsLikeMe.com

3:30

Achieving Excellence in the Conduct of Investigator Initiated Research (IIR)

Lisa Johnston RN, BScN, CCRP
Research Training Coordinator, Research
Centre for Addiction and Mental Health (CAMH)

Margaret H. Kerr BA, LLB, MA, PhD
Barrister & Solicitor

Sharleen Maley B.Sc., P.G.D., CCRP
Clinical Research Associate Saskatchewan Drug Research Institute (SDRI)
Royal University Hospital, University of Saskatchewan

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

Investigator initiated clinical trials are a growing trend in Canada, representing an important area of clinical research with its own unique challenges and requirements. The most critical challenges will be addressed in this session, as well as the diverse approaches being utilized to address them.

• Top challenges in IIR
  • Funding
  • Costing and budget design
  • Compliance and SOPs
  • Outsourcing/subcontracting
  • Site selection
  • Insurance issues
  • Legal issues and negotiation of contracts
• Alternative strategies
  • Friendly audits
  • Training and oversight
• Which works best when?
• Essential processes for ongoing gains

4:30

POST-CONFERENCE WORKSHOPS | WEDNESDAY, OCTOBER 19, 2011

Half Day In-Depth Workshop B – 9:00 a.m. to Noon

The Clinical Trials Budget Process – Navigating the Turbulent Waters

Lisa Johnston RN, BScN, CCRP
Research Training Coordinator, Research
Centre for Addiction and Mental Health (CAMH)

Khalid Sabihuddin, MBA, BSc
Manager, Business Operations
Applied Health Research Centre (AHRC)
St. Michael's Hospital

Designing and managing Clinical Trials budgets and related processes are among the most challenging and crucial elements for good clinical trials project management. In this in-depth workshop session, you will learn about the current strategic approaches and the best practices for success in this challenging area where outcomes may impact everything from early stage negotiations to successful trial completion.

• Budget design options and key principles
  • Global and local
• Projections and revenue maximization
  • Per-patient fees
  • Infrastructure and overhead costs
  • Nickles and dimes
• Essential negotiation points and strategies
  • What can be negotiated and what will not be
• Most common stumbling blocks and how to approach them
• Ensuring service quality for costs
  • PI participation and compensation
  • Avoiding inflated costs
  • Fast track and savings opportunities

You will have plenty of opportunities to ask questions of concern to you and your organization and will receive specially prepared materials of lasting value.

Lisa Johnston, RN, BScN, CCRP graduated from Laurentian University with a nursing degree, and is a SOCRA certified clinical research professional. Among other roles, Lisa was a clinical research coordinator for over 10 years, and since 2007 has been involved in training, education and support in research at UHN and CAMH. She is currently the Research Training Coordinator at CAMH in Toronto.

Khalid Sabihuddin, MBA, BSc has seven years of clinical research experience, as well as extensive experience in IT, the not-for-profit sector, and project management. As the Manager, Business Operations at the Applied Health Research Centre (AHRC), an academic research organization (ARO) based out of St. Michael’s Hospital in Toronto, Khalid oversees AHRC business activities, which include strategic and operational planning and implementation, as well as HR, financial, and contract management.

12:00 – 1:00 Light lunch will be served for delegates attending both workshops

Half Day In-Depth Workshop C – 1:00 p.m. to 4:00 p.m.

Maximizing the Benefits of Tax Credits and Research Funding in the Life Sciences

Denis Lajoie
Partner, Tax Services-Scientific Research & Experimental Development
Ernst & Young LLP

Krista Robinson
Senior Manager, Tax Services
Ernst & Young LLP

Elizabeth Pringle M.Sc.
Associate Partner
SR&ED Tax Credit Practice

Stretching the research dollar is crucial to ensuring that limited resources are able to go further to produce clinical results. In this workshop, experts in the field of research tax credits will walk you through a detailed session on how to maximize returns through this tax vehicle and bring you up to date on the latest developments on what research qualifies and the submission process. Among the key topics to be addressed are:

• Contractual arrangements to maximize tax credits
• Earning credits for investigator-initiated studies
• Earning credits for payments to hospitals and universities
• Being prepared for an audit

Receive all the latest information and strategic insights at this in-depth workshop.

Denis Lajoie is a Chartered Accountant and a Partner with Ernst & Young. Denis has been working in the area of SR&ED tax credits since 1994 with a strong focus in the life sciences sector.

Krista Robinson is a Chartered Accountant and leads Ernst & Young's tax credit practice in Montreal. Krista works closely with the pharmaceutical companies ranging from small start ups to large multinationals.

Elizabeth Pringle M.Sc. is the Life Sciences Lead for Ernst & Young's tax credit practice. She holds an MSc and has over 15 years of experience with research tax credit programs including 9 years working for the Canada Revenue Agency.

• 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
• Directors / Members of Research Ethics Boards (REBs)
• 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 Compliance Managers and Clinical Investigators
• Heads of Agencies that Fund Research, Including Governments, Research Charities, Hospitals and Medical Research Councils
• Heads and Representatives of Federal and Provincial Regulatory Agencies from Pharma, Biotechnology and Medical Devices

Dear Colleague,

We are pleased to co-chair this 13th Edition of the CLINICAL TRIALS IN CANADA conference, the annual industry event produced by Insight Information for Canada's clinical research communities. Over the years, we have seen the pace of change in the life sciences quicken as globalization of clinical research continues to accelerate. It is now more important than ever before to ensure access to the latest expert insights on industry developments and innovations, not just at home, but beyond our borders. The continued excellence and sustainability of Canada's life sciences research work, and the health of countless patients, depend upon it.

At this 2011 Clinical Trials in Canada conference, Insight Information is bringing together an impressive slate of expert speakers from numerous jurisdictions and practice areas. Organizations you will hear from include:

• Health Canada
• Bristol-Myers Squibb
• Rx&D
• Canadian Institutes of Health Research (CIHR)
• University of British Columbia
• Ontario Institute for Cancer Research
• Health Products and Food Branch (PFB) Inspectorate
• Murray Alzheimer Research and Education Program (MAREP)
• Dalton Pharma Services
• University of Waterloo
• Abbott Laboratories Limited
• University of Ottawa Heart Institute
• Eli Lilly Canada Inc.
• Pfizer Canada Inc. (Invited)
• Ozmosis Research Inc.
• Integrated Research Inc.
• Centre for Addiction and Mental Health (CAMH)
• Quintiles

For added educational value two special half day workshops have been added, focusing on important topics that call for extended coverage. The first half day post-conference workshop will cover Budget Design and Negotiation and the other will focus on Maximizing the Benefits of Tax Credits and Research Funding in the Life Sciences. In addition there will be a full day seminar exploring the latest thinking on the topic of Managing Investigator Initiated Research.

You will not want to miss this unique opportunity to receive comprehensive and strategic updates on important developments for Canada's clinical research communities and to dialogue with your colleagues.

We look forward to seeing you there!

Agnes V. Klein, MD, DPH
Director
Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics
Biologics and Genetic Therapies Directorate
Health Canada

Nestor Nituch
Unit Director, Regional Clinical Operations
Bristol-Myers Squibb Canada

SPONSORS

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.