Learn from these Leaders: |
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Farah Jivraj
Director, Market Access
Janssen-Ortho & Ortho
Biotech |
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Wayne Critchley
Senior Advisor
Canadian Agency for Drugs and
Technologies in Health |
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Barbara Ouellet
Executive Director
Patented Medicine Prices Review Board |
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Philip Schwab
Vice President, Industry Relations
BIOTECanada |
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Vic Medland
President, Group Insurance Services
Ontario Teachers Insurance Plan |
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Dr. Philip A. Baer, MDCM, FRCPC, FACR, Chair, Section of Rheumatology,
Ontario Medical Association |
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Detailed Conference Agenda |
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| 7:30 AM Registration and Continental Breakfast |
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| 8:15 AM Opening Comments from the Chair |
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Wayne Critchley,
Senior Advisor,
CADTH |
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8:30 AM The Patented Medicine Prices Review Board (PMPRB)
Understanding the impact of the new Excessive Price Guidelines |
After many consultations, the final report on Excessive Price Guidelines is scheduled to be released in May 2009, and come into effect in July 2009. This session will help shed light on the issues that affect you most. |
- What changes can you expect to see?
- How will the guidelines be implemented?
- What will be required of you?
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Barbara Ouellet,
Executive Director,
Patented Medicine Prices Review Board |
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9:15 AM Private payer panel
Assessing the current and future challenges for biologics within a private payer context |
The private insurance industry is adjusting alongside the evolution of biologic therapies in Canada. The greater availability and use of high-price biopharmaceuticals raises some questions: |
- How is the model for insurance delivery adapting to these changes?
- How are private payer client demands being met?
- Where is the industry headed? What are the implications?
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Consider the implications of the cost of biologics on the industry, and hear how the challenges will be met. |
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Vic Medland,
President, Group Insurance Services,
Ontario Teachers Insurance Plan |
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Scott Warner,
Director of Underwriting,
D and R Insurance Administrators |
Suzanne Lepage,
Co-Chair,
Group Insurance and Pharmaceutical Committee (GIPC)
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Kevin West, (Moderator)
Vice President, Operations, Specialty Services,
Innomar Strategies Inc. |
 More to come...
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| 10:00 AM Networking Break |
| Interact with conference speakers and fellow attendees. |
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10:30 AM Canadian Agency for Drugs and Technologies in Health (CADTH)
The role of CADTH in Canada’s health care system |
At the heart of CADTH’s mandate is providing health care decision makers with independent, evidence-based information about the clinical and cost-effectiveness of drugs and other health technologies. What are the implications of this work for biologics?
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- Examine how CADTH reviews biologic drugs
- Review the criteria CADTH considers as it relates to biologic therapies
- Subsequent-entry biologics and other emerging issues
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Wayne Critchley,
Senior Advisor,
CADTH |
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11:15 AM Bill C-51 Update: Progressive Licensing
Assessing biologics on a risk-benefit-based approach to improve treatment |
Health Canada continues to assess Canada’s approach to regulating therapeutic products. Hear how Health Canada:
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- Monitors benefits and risks of biologics
- Develops more progressive lifecycle management tools
- Works with all stakeholders to increase accountability
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Take away the latest developments in progressive licensing and biologics.
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Joanne Garrah,
Program Officer, Office of Legislative and Regulatory Policy, Planning and International Affairs,
Directorate of Health Canada |
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| 12:00 PM Networking Luncheon |
| Join the conference speakers and your peers for a relaxing luncheon. |
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1:30 PM Case Study: Stelara
Patient outcome and quality of life improvements through biologics |
Biologics have shown some remarkable therapeutic successes, in many cases vastly improving patient lives. However, these successes can only occur if there is adequate access to the medications. |
- Understand the role of clinical evidence in demonstrating therapeutic benefits
- What creative strategies work best for improving access?
- Be aware of the challenges that can hinder your access to patients
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Farah Jivraj,
Director, Market Access,
Janssen-Ortho & Ortho
Biotech |
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2:15 PM Planning the Launch of a Biologic
Specific considerations for launching new biologics into the Canadian market |
The first few months of a new product launch are critical to gaining patient access, and to gaining trust of both physicians and patients. It is therefore essential that your biologic not only comply with Canadian regulations, but that access is as efficient and simple as possible. |
- How should your product position itself in its therapeutic area and the healthcare setting?
- What reimbursement/access is expected or required?
- Have you thought about launching a patient assistance program and if so, have you considered compliance, education and support for your therapy?
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Gain a more solid understanding of how to best launch a biologic in Canada. |
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Kevin West,
Vice President, Operations, Specialty Services,
Innomar Strategies Inc. |
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| 3:00 PM Networking Break |
| Interact with conference speakers and fellow attendees. |
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3:30 PM Patient’s Perspective
How access and education improves patient outcomes: Understanding biologics from the patient’s perspective |
Private and public payers continue to push for lower cost treatments, particularly for medications. This presents a challenge for biologics, especially because patients continue to advocate for their use, often citing increased efficacy. |
- What challenges are patients facing when assessing and accessing biologics?
- Understand the true value of access, and how it can be improved
- Hear the rewards of access from the patient’s perspective
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Improve your understanding of patient access to biologics.
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George Tolomiczenko,
Executive Director of the CCFC Inflammatory Bowel Disease Research Institute and Scientific Liaison,
Crohn’s and Colitis Foundation of Canada |
Christine Jackson,
Executive Director,
Canadian Skin Patient Alliance |
| More to come... |
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| 4:15 PM Conference Adjourns to Day Two |
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5:00 PM Social Activities...
A number of social activities will be arranged for the evening of day one -bring our business cards and interact with your peers!**
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| 8:00 AM Registration & Continental Breakfast |
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| 8:45 AM Opening Remarks from the Chair |
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Denis Morrice,
Executive Director,
Ontario Rheumatology Association |
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9:00 AM Update: State of the Industry
Gain a better understanding of the biologics environment to better prepare for the years ahead |
| The role of biologics in therapeutic treatments continues to grow. Over the past year, there has been some important developments, and a few portentous ones. |
- Recap some of the most significant decisions in biologics this year
- Recognize some of the future challenges and opportunities
- Take stock of the biologics environment today, and plan for tomorrow
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Philip Schwab,
Vice President, Industry Relations,
BioTech Canada |
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9:45 AM Subsequent Entry Biologics Panel
What Health Canada’s recent guidelines surrounding Subsequent Entry Biologics and means for the industry: Comparability and other regulatory factors |
Regulatory guidelines dealing with Subsequent Entry Biologics (SEBs) are forthcoming. One of the most contentious issues is comparability/similarity to innovator reference products, but there are other areas Health Canada is reviewing. |
- Assess the overall policy on SEBs and how the industry is responding
- Discuss the latest developments for SEBs
- Understand how comparability is/should be gauged, and challenges to the industry and regulators
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Join us for an engaging discussion of the upcoming changes to the biologics market and SEBs.
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Karen Burke,
Director of Regulatory Affairs,
Amgen |
Philip Schwab,
Vice President, Industry Relations,
BioTech Canada |
Patrick Bedford,
Sr. Policy Analyst,
Health Canada |
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| More to come... |
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| 10:45 AM Networking Break |
| Interact with conference speakers and fellow attendees. |
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| 11:15 AM Addressing patient needs to facilitate superior patient outcomes |
Patient support is an important factor in achieving positive therapeutic outcomes, particularly for those taking biologics. Given the unique nature of biologics, stakeholders are realizing they must take an increasingly stratified approach to patient support.
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- Analyze the requirements of the “typical” patient, and how needs can vary
- Determine which types of patient support produce the best results for various disease states
- Understand how to optimize your patient support program and increase your ROI
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Gain a better understanding of how to manage patient outcomes better. |
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Martin Esterhammer,
President,
Shoppers Drug Mart Specialty Health Network |
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| 12:00 PM Networking Luncheon |
| Join the conference speakers and your peers for a relaxing luncheon. |
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| 1:30 PM Pharmacovigilance: Monitoring biologics to ensure continued safety and limit adverse effects |
All pharmaceutical manufacturers take drug safety seriously, with pharmacovigilance programs playing a significant role in drug monitoring. Because biologics are approved with only pre-market data, there must also be long-term post market surveillance of biologics to ensure adverse drug reactions are captured. |
- How safety issues are monitored by the industry
- What constitutes adverse reactions; how should they be assessed and reported?
- How should conflicting data be viewed, and what needs to occur for products to be delisted?
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Gain valuable insight into how to improve your pharmacovigilance program. |
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Andrew Erdman, MD,
Sr. Drug Safety Scientist,
Genentech |
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| 2:15 PM Understanding The Physician’s Perspective In Facilitating And Improving Outcomes |
On the front lines of health care, physicians are constantly striving
to improve patient outcomes. This session will present one physician’s view on the current benefits and risks physicians consider when prescribing biologics. |
- Understand the practical challenges facing physicians in recommending and prescribing a biologic
- Hear the hopes and fears of the medical practitioner
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Hear first-hand the physician’s point of view on biologics and how they envision their role in Canadian health care. |
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Dr. Philip A. Baer, MDCM, FRCPC, FACR,
Chair, Section of Rheumatology,
Ontario Medical Association |
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| 3:00 PM Networking Break |
| Interact with conference speakers and fellow attendees. |
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3:30 PM Legal Update
Biologics, intellectual property law, and the future challenges for the pharmaceutical and biotechnology industry |
Some of the most contentious issues surrounding biologics lie in the area of intellectual property protection and the regulatory policies supporting it. New challenges continue to arise, but there are some key points that need to be clarified. Gain a better understanding of the: |
- Current interplay between the PM(NOC) Regulations, the Patent Registry, and its application to biologics
- Challenges to patenting and listing patents related to biologics that provide protection against subsequent entry biologics (SEBs)
- Data exclusivity provisions as they apply to SEBs
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Lesley Rapaport,
Associate Chair, Vancouver Biotechnology Practice Group,
Borden Ladner Gervais |
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| 4:15 PM Meeting the challenges of cost reimbursement to meet patient needs better |
The reimbursement of biologics in Canada has been challenging due to several factors, and patients have often been left to fend for themselves. What do you need to do to gain reimbursement so that the right patient gets the most appropriate care in this environment? |
- Understand the recent directions in private and public payer policy
- Consider reimbursement program alternatives
- Craft a solution that addresses the challenges for your
patient groupv |
Take away strategies on how to face the pressing issue of reimbursement.
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George Wyatt,
Managing Director,
Wyatt Health Management |
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| 5:00 PM Conference Adjourns |
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Maximize Reimbursement 
