CLINICAL TRIALS
IN CANADA

PRE-CONFERENCE WORKSHOPS | APRIL 13, 2011

A | 9:00 A.M. to NOON

MASTERING NEGOTIATION SKILLS AND EARLY STAGE AGREEMENTS FOR STREAMLINED CLINICAL TRIALS

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

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

Early stage agreements and effective negotiations can avert countless later problems and delays in the conduct of clinical research. In this in-depth workshop, legal and industry experts will lead you through a detailed discussion of how to successfully use these tools to help ensure smooth and timely deployment of clinical trials. Among the topics to be addressed in depth are:

• Different negotiation styles/models and when to use them
• What are the goals of the negotiation?
• What do you need to do to get there?
• Who are the players and how does this impact the negotiations?
  • CRO vs SMO
  • nvestigator initiated trials
  • Collaborations and partnerships
• Checks and balances
• Golden rules of negotiation (don't ask if you would not give)
• Do the homework and the prep
  • Site feasibility
  • Investigator and research talent issues
  • Cost and budgets
• Addressing negative tactics
• The negotiation process – phases, dance steps and resolution
• Avoiding the deal breakers
• Investigator initiated studies
• Early stage agreements and tools
  • Confidentiality agreements
  • Letters of intent
  • Non-competition agreements
  • Other early stage tools and techniques

You will have ample opportunity to ask detailed questions on issues of concern to you and your organization and will receive specially prepared materials and sample documents to be used and valued long after the event has concluded.

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.

12:00 | 1:00 LIGHT LUNCH WILL BE SERVED FOR DELEGATES ATTENDING BOTH WORKSHOPS

B | 1:00 P.M. to 4:00 P.M.

DRAFTING, NEGOTIATING AND IMPLEMENTING MASTER CLINICAL TRIAL AGREEMENTS – DO'S AND DON'TS

Andrew Loh
Partner
Borden Ladner Gervais LLP

Master Clinical Trial Agreements are complex documents that need to be carefully drafted and tailored to allow for coverage of numerous possible scenarios. They can accelerate subject enrolment, allow earlier access to potential therapies and generate sufficient data for analysis and publication, in addition to enabling efficient use of time and resources by researchers and institution – a win/win situation. Learn the best approaches, contexts and applications for their use. Ensure that you understand the logic behind their structure and can use them effectively to streamline and fast track your contract negotiation and drafting process, and to structure the effective implementation of your research projects.

Topics to be covered include:

• Structuring a master agreement
  • Single-study template vs. master agreement
  • Who should be the contracting parties
  • What is the nature and scope of the clinical trials
  • How to address potential involvement of CROs and SMOs
  • What should be the duration (term) of the master agreement
  • What provisions should be included, and what should be excluded
  • How to build in flexibility, to address different PIs, various clinical trials, additional products
  • When and how should a master agreement be amended, and its impact on existing clinical trials
• How to include a clinical trial under a master agreement
  • Which clinical trials are covered by a master agreement, and for how long
• Terminating a master agreement
  • Terminating a master agreement vs. terminating a clinical trial

Andrew Loh is a partner and regional leader of the Life Sciences and Health Sector Services practice groups at the law firm of Borden Ladner Gervais LLP. He has extensive experience in the drafting and negotiation of clinical trial agreements for pharmaceutical, biotech and medical device companies as well as for teaching hospitals, research institutions, CROs, and physician groups. He has a science degree in Microbiology and law degrees in Ontario and Michigan and is called to the bars in Ontario and British Columbia.

APRIL 14, 2011

8:15

Registration and Continental Breakfast

9:00

Welcoming Remarks from Insight Information

9:05

Opening Remarks from the Co-Chairs

Tracey Allin BScN, RN
Regional Research Manager, Clinical Operations
Eli Lilly Canada, Inc.

Marie-Luce Fortier LL.L, LL.B
Technology Transfer and Legal Affairs Office
CRCHUM
Centre Hospitalier de l'Université de Montréal (CHUM)

9:15

Global Opportunities for Canadian Life Sciences

Krista Robinson
Senior Manager, Tax Services
Ernst & Young LLP

Elizabeth Pringle M.Sc.
Senior Manager, SR&ED Tax Credit Practice
Ernst & Young LLP

10:00

Networking Coffee Break

10:15

Standardizing Business and Legal Practices for Clinical Trials Excellence

Karen Arts, BSN, RN, CCRC
Director, Business Development
Ontario Institute for Cancer Research
Chair, Network of Networks

Joanne E. Watson MSc
President and Chief Executive Officer
Integrated Research Inc.

Marianne Vanderwel
Director, Human Research Protection Program
IRB Services

• How SOP make for better quality research and business results
• How to set about standardizing and streamlining research, sites and processes
• Using system redesign and process approaches
• How collaboration, networks and partnerships make business sense for standardization
• Designing the structure and the systems
• Technology and other tools to help streamline and manage processes and standards

11:30

Laying the Bedrock of the Clinical Trial Framework – Negotiation and Early Stage Best Practices

Tracey Allin BScN, RN
Regional Research Manager, Clinical Operations
Eli Lilly Canada, Inc

• Investigator Site Selection – how do institutions, sites and Investigators get identified
• Evaluation of Investigator sites and selection decision
• Compliance protocols and best practices
• Site performance – predicting enrolment success

Olga Farman
Adviser, CECR and ARO
Partner
Lavery de Billy LLP

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

• The slate of key issues
• Can they be narrowed?
• What are the goals of the negotiation?
• Checks and balances
• Golden rules of negotiation
• Do the homework and the prep
  • Site feasibility
  • Investigator and research talent issues
  • Facilitating participation
  • Cost and budgets
• Addressing negative tactics
• The negotiation process
• Avoiding the deal breakers
• Early stage tools and techniques
• Principal investigator trials – special concerns

12:30

Networking Luncheon

1:30

The Patient Perspective and Patient Interests in Clinical Trials – Aligning Best Interests

Nadine Prévost 
Director, Client Services and Social Action
Quebec Division, Multiple Sclerosis Society of Canada

Hana Salaheddine
Multiple Sclerosis Patient Representative

Pierre Geoffroy MD, CM, MSc, FCFP
Chief Medical Officer
Lambda Canada

• Public interest, ROI and research subject rights
• High standards of practice and protection of research subjects
• Strong research process while respecting interests of patients
• Dependable outcomes, oversight and accountability
• Patient recruitment, informed consent and transparency
• Patient wellbeing and innovative therapies

2:15

Budget Negotiations and Budget Templates – Getting Down to Brass Tacks

Dr. Jean-Marie Leclerc
Chief Scientific Officer and Senior Vice-President
Clinical and Regulatory Affairs
Novartis Pharmaceuticals Canada Inc.

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

• Overall approach and philosophy
• Master budgets
• What does not work
• Category approach vs. line by line
• Define the process
• Avoid the pitfalls – but deal with them
• Risk allocation – work out the approach
• Win-win negotiation
• Pricing the service
• Providing for change
• Key areas of focus
  • Per patient costs
  • Start up costs
  • Site fees
  • IP and publication rights
  • Principal investigator related issues and costs

3:15

Networking Refreshment Break

3:30

Using Information Technology to Facilitate Successful Clinical Trials and Manage Privacy

Case Study - Cooperative Subject Registry Offers a Precise Method for Validating Participant Wash-Out

Darran Boyer, MAcc
President
Independent Data Integrator

Both investigators and research participants stand to benefit greatly from a registry that validates participant wash-out periods prior to enrollment. This case study examines the key aspects surrounding the use of one such registry by a group of Ontario CROs. The key aspects to be addressed are:

• Blending strategic objectives
• Registry design for privacy and confidentiality
• Challenges overcome
• Site adoption and participant response
• Future steps

Rady Khuong
Partner
Stein Monast LLP

• Health privacy requirements in the province of Quebec
• Privacy – managing compliance
• Avoiding privacy breaches in clinical trials

4:30

Maximizing International Opportunities in Clinical Trials – A Global Review of Clinical Site Selection

Fabio Thiers, MD, MSc, PhD.
CEO, ViS Research Institute
Director, Global Clinical Trials Research Program, MIT-NBER

5:15

Co-Chair Wrap-Up and Conference Adjourns for the Day followed by Wine and Cheese Reception

APRIL 15, 2011

8:30

Continental Breakfast

9:00

Co-Chairs' Opening Remarks

9:05

Strengthening the Competitiveness of the Clinical Research Sector in Canada

Dr. Jean-Marie Leclerc
Chair, Medical Sub-committee
Rx&D

The Rx&D Medical Clinical Committee has been working with CIHR and ACAHO on the analysis and competitiveness of the clinical research sector in Canada. This work has led to the development of a prototype clinical trial agreement and a comparison of how Canada is performing in the Global market of clinical research.

The analysis is showing an important drop in clinical trials in Canada and pointing to the need to streamline the legal framework as well as the ethical reviews process and timelines. Furthermore the analysis is pointing to the need to look at the research infrastructure, costs and support framework in this country if we are to be more competitive.

These initiatives represent crucial steps in strengthening the competitiveness of the clinical research sector in Canada, and will serve to facilitate researcher participation as well as patient involvement and protection.

Respondents: Pierre Geoffroy MD, CM, MSc, FCFP
Chief Medical Officer
Lambda Canada

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

10:00

Using the Web to Facilitate Patient Participation in Clinical Trials

Sandra Gazel, MSc.
Associate Director, Clinical Operations
Abbott Canada

Sima Chiva-Razavi
Clinical Research Interim
Abbott Laboratories Canada

Abbott has successfully created a web-based portal for patients, designed to accompany and assist patients during their participation to clinical trials. Among the key aspects of the initiative to be addressed in the presentation are:

• Strategic objectives
• Web portal design for achieving results
• Addressing the challenges encountered
• Privacy and confidentiality protection
• Patient response and adoption
• Lessons learned
• Next steps

10:30

Networking Coffee Break

10:45

Monitoring Best Practices and Contract Enforcement for Positive Results

Stephan Fullum
Head of Monitoring – Clinical Operations
Pfizer Canada Inc.

Donna Mitchell LLB
Saskatchewan Drug Research Institute (SDRI)
Royal University Hospital, University of Saskatchewan

• Understanding the roots of resistance and the source of research headaches
• Relationship management and effective partnering
• Milestones and timelines
• Establishing SOP for contract compliance and accountability
• Site visits – maximizing the impact and getting the results
• Ensuring inspection ready sites
• Adapting procedures for international trials
• Ensuring the ROI – what to focus on
• Patient recruitment, participation and retention

Respondent: Franca Cantini MScN
Chief, Research Ethics Office
Jewish General Hospital

11:30

Legal, Ethical and Regulatory Compliance – Getting to Good (and Knowing When it is Good Enough)

Franca Cantini MScN
Chief, Research Ethics Office
Jewish General Hospital

Felicia Tiseo
Research Ethics Quality Assurance Coordinator
Jewish General Hospital

• Quality Assurance Program/Quality Improvement Model
  • What is the goal of the program?
  • Why do we need an oversight for research?
• Main areas of focus
  - Education (Investigators/Research Community) - Monitoring (Regulatory Affairs and Research Conduct)
• Oversight, performance review and education
  • Report findings to research teams
  • Report trends and findings to the Board
• Standardizing practice and compliance
  • Re-enforcing use of standard operating procedures
  • Re-enforcing standardized regulatory tools
• Lesson learned and next steps
  • Target academic research
  • Create partnership with private industry

Marie-Luce Fortier LL.L, LL.B
Technology Transfer and Legal Affairs Office
CRCHUM
Centre Hospitalier de l'Université de Montréal (CHUM)

• Meeting the demands of many masters – how to manage the juggling act and do quality work
  • Health Canada
  • Ethics review
  • Legal and regulatory
• Nit picking vs. real concerns
• Links between the informed consent document and the clinical trial agreement
• Investigator initiated trial agreements

12:30

Networking Luncheon

1:30

Health Canada Inspectorate – Latest Developments and Directions

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

2:15

Meeting Ethical and Business Challenges in Adaptive Design

Murray L. Jensen, MSc
Director of Clinical and Scientific Affairs
ethica Clinical Research Inc.

As Adaptive Design gains more currency in today's research environment, strategies for meeting business and ethical challenges in this field are key to ensuring results.

• Ethical and compliance challenges
  • Main areas of concern
  • Proven strategies
  • Patient participation and protection
• Project design to avoid problems later
  • Scheduling
  • Data gathering
  • Patient recruitment

3:00

Networking Refreshment Break

3:15

Investigator Initiated Trials – Untangling that Tangled Web

Moderator: Marisa Selig
Manager, Research Contracts
Centre for Addiction and Mental Health

Dr. Gerald Batist MD
Jewish General Hospital

Pierre Geoffroy MD, CM, MSc, FCFP
Chief Medical Officer
Lambda Canada

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

• Investigator initiated trials agreements – how are they different?
• Impact on the role of sponsors and of site/host institutions
• Challenges and working solutions
• Regulatory compliance and accountability
• Intellectual Property issues and contractual terms
• Financial resources, grants and budgets
• Risk allocation and indemnification
• Streamlining the process and the contract terms
• Making contract language plain, transparent and accessible
• Sound standard clauses, templates and checklists for streamlined contracts

Respondent: Tracey Allin BScN, RN
Regional Research Manager, Clinical Operations
Eli Lilly Canada, Inc.

4:15

Tackling IP and Related Legal Issues Through Effective Clinical Trial Agreements

Andrew Loh
Partner
Borden Ladner Gervais LLP

Beverley Moore
Associate
Borden Ladner Gervais LLP

• Intellectual Property (IP) protection issues in a clinical trial
  • What it can cover
  • Pre-existing vs. improved vs. new IP
  • "Inventorship" vs. ownership of IP
  • Jurisdictional rules, laws and implications
• Importance of IP protection
  • Patent filings
  • Market protection
• Loss of IP rights from disclosure through a clinical trial
  • How, when, what, and where – examples of claims made by third parties
  • Common drafting pitfalls (e.g. confidential information, intellectual property, publication, etc.)

5:00

This conference has been approved by the Barreau du Québec for 5 continuing education hours.

• 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
• Insurers / Defence Providers
• 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,

The challenges facing Canada's clinical research community today are serious and require close attention. What is also undeniable is that today's research world offers significant opportunities for those who are nimble enough to embrace and make the most of them.

This 12th edition of Insight Information's landmark CLINICAL TRIALS IN CANADA conference will focus on constructive and exciting initiatives that are underway to build Canada’s competitiveness both at home and beyond.

You will benefit from special presentations on:

• Global Opportunities for Canadian Life Sciences from Ernst & Young
• Maximizing International Opportunities in Clinical Trials – A Global Review of Clinical Site Selection from MIT
• Strengthening the Competitiveness of the Clinical Research Sector in Canada from Rx&D
• The Patient Perspective and Patient Interests in Clinical Trials from the MS Society of Canada
• Health Canada Inspectorate – Latest Developments and Directions from Health Canada

Achieving a high level of excellence and participation in clinical research and competing successfully depends more than ever on streamlining legal and business processes so that they enhance rather than obstruct research goals. How can you ensure top research quality and integrity while achieving a better ROI? Hear about practical solutions such as:

• Standardizing business and legal practices for clinical trials excellence
• Laying the bedrock of the clinical trial framework – negotiation and early stage best practices
• Budget negotiations and budget templates – getting down to brass tacks
• Using information technology to facilitate successful clinical trials and manage privacy
• Monitoring best practices and contract enforcement for positive results
• Legal, ethical and regulatory compliance – getting to good (and knowing when it is good enough)
• Meeting ethical and business challenges in adaptive design
• Investigator initiated trials – untangling that tangled web
• Tackling IP and related legal issues through effective clinical trial agreements

This is a must attend conference that will focus on practical, strategic building-blocks for research excellence, success and competitiveness while also examining new and exciting opportunities for growth and renewal in the industry. A distinguished faculty will be available and eager to enter into dialogue and exchange with you.

We look forward to seeing you there,

Tracey Allin BScN, RN
Regional Research Manager, Clinical Operations
Eli Lilly Canada, Inc.

Marie-Luce Fortier LL.L, LL.B
Technology Transfer and Legal Affairs Office
CRCHUM
Centre Hospitalier de l’Université de Montréal (CHUM)

COPPER SPONSOR

MARKETING PARTNER

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.