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Detailed Conference Agenda

DAY ONE:
Tuesday June 10th, 2008

7:30 AM

Registration Opens

8:15 AM

Opening Remarks From The Chairperson

8:30 AM

Keynote Address

Health Canada’s Perspective On Subsequent-Entry Biologics: Demonstrating Comparability And Other Regulatory Issues

Health Canada maintains that regulatory decisions regarding the quality, safety and efficacy of medicinal products should be based on scientific evidence, and accepts that copies of biologics originally licensed by innovator companies will have a role in health care. While they should not be considered true generics, information in the public domain regarding safety and efficacy of an innovator product over many years of use can be considered relevant if suitable data is provided demonstrating comparability/similarity to that specific reference product.

• Hear about the development of a formal regulatory process for SEBs
• Consider issues such as appropriate choice of reference product, post-market requirements and interchangeability
• Understand the elements in establishing comparability and challenges to the industry and regulators

Use this session to prepare for the changes on the biologics market with SEBs set to burgeon in Canada.

Anthony Ridgway, Ph.D., Senior Regulatory Scientist, Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics, BGTD, Health Canada

9:15 AM

Progressive Licensing Framework

Towards An Integrated Benefit-Risk-Based Approach To Licensing Biologics

Health Canada is modernizing the regulatory framework for drugs with legislative renewal. The ultimate goal is to optimize the benefits and minimize the risks in the use of these products by taking a benefit-risk approach to regulation across product life cycle through…

• Considering layers of evidence during review and providing necessary and current information
• Enhancing decision-making across the development, regulatory and downstream use communities (e.g., health professionals and patients)
• Transforming life-cycle management, good planning and accountability

Hear how the Progressive Licensing Project will impact your business and enhance Canada’s role in worldwide pharmaceutical science and drug development.

Dr. Robyn Lim, Progressive Licensing Project, Therapeutic Products Directorate, Health Canada

10:00 AM

Networking Break

Interact with conference speakers and fellow attendees.

10:30 AM

Key Strategies For Advancing The Innovation Agenda For Canadian Biologics

The atmosphere for the development and distribution of biologics in Canada is rapidly evolving, and companies must adapt to stay productive and competitive. This address will inspect…

• Opportunities presented through further collaboration between biotech and pharma
• Trends and developments from the biotechnology that support Canadian biologics
• Strategies for greater efficiency and cost effectiveness

Get an update on the state of affairs in the biotechnology industry and hear how collaboration can foster innovation.

Peter Brenders, President and CEO, BIOTECanada

11:15 AM

Biologic Vaccines

Increasing Awareness Of Requirements For Pandemic Planning And Preparedness

Biologic vaccines provide enormous potential for pandemic preparedness and planning, but also present associated challenges. Manufacturers must be aware of the requirements for market authorization (or licensing) of pandemic influenza vaccines, including for novel vaccines and for stockpiling. This presentation will address issues such as…

• Regulatory guidance to increase speed and efficiency of development and production
• Coordination and communication between government and private sector parties
• Sufficient and safe vaccine production and development of cross-protective immunity

Develop a better understanding of the place for biologic vaccines in pre-pandemic and pandemic planning.

Harold Rode, Chief, Pandemic Influenza Division, Centre for Biologics Evaluation, BGTD, Health Canada

12:00 PM

Networking Luncheon

Join the conference speakers and your peers for a relaxing luncheon. Sponsored by Sampling Technologies.

1:30 PM

Determining The Impact Of WHO’s Global Vaccination Program On Canada’s Biologics Manufacturers

The World Health Organization is actively tackling disease rates with its Global Vaccination Program, including exploring the benefits of biologic vaccines. This program requires compliance with WHO standards.

• Ensure your biologic meets standards beyond national regulations
• Review drug submissions for vaccines and other biologics for Canadian and other markets
• Discover the global marketing opportunities

Jerry Calver, President, Calver Biologics Consulting

2:15 PM

Opening The Patient Pathway To Your Biologic For Improved Compliance And Outcomes

The process for improving patient access to specialty drugs is far more complex than most. A targeted distribution model, coordination of care, drug administration, specialization, and an aligned sales force are all crucial elements to ultimately improving the patient experience.

• Maximize the value of your biologic to all stakeholders
• Provide a solution-based value proposition to patients
• Optimize your patient-centric model

Stay ahead by developing a strategic patient pathway to maximize ROI and provide optimal patient care.

Martin Esterhammer, President, Calea HealthAccess

3:00 PM

Networking Break

Continue the discussion with your peers while enjoying a refreshing break.

3:30 PM

Assessing The Impact Of Design Space And Quality By Design On Your Business

New guidelines are emerging to advance innovation, which reflect new concepts in the regulation of quality. Design space and quality by design will promote improvement in product quality and production capacity.

• Understand how these concepts will increase consistency in manufacturing
• Recognize how these concepts can contribute to boosting your product quality and expedite approval

Hear how one company is taking on the challenge of quality by design.

Jeffrey Hartry, Director, Quality Systems and Information, Cangene Corporation

4:15 PM

Winning Strategies For Niche Pharma Products Throughout The Product’s Lifecycle

This session will explore new and evolving strategies to improve patient capture and retention, including loyalty programs, patient assistance, reimbursement assistance and programs to improve adherence. It will help your organization to:

• Minimize risk and maintain the quality of your product
• Optimize the supply chain for your biologic
• Ensure you protect your product, your business and your patients

Use this session to take away tips on achieving market access with niche products.

Craig Martin, President, Cameron Stewart LifeScience Inc.

5:00 PM

Conference Adjourns To Day Two

Day Two:
Wednesday June 11th, 2008

7:30 AM

Registration Opens

8:15 AM

Recap Of Day One By The Chair

8:30 AM

Common Drug Review: The Next Steps For Biologics In Sustainable Canadian Public Drug Plans

Biologics can pose a significant challenge to assess the relationship between clinical and cost effectiveness, with resultant impacts on patients, physicians, payers, and manufacturers. However, the ultimate goal of the CDR is to ensure that public resources are used wisely to purchase improved health outcomes.

• Hear about the experience of CDR in reviewing biologic agents
• Understand how an evidence-based approach is used in developing recommendations from CEDAC
• Learn about ongoing changes at CDR

Get a better understanding of the role of the CDR and its impact on the biologics market.

Mike Tierney, VP, Common Drug Review, Canadian Agency for Drugs and Technologies in Health

9:15 AM

Panel Discussion

Evaluating The Current And Future Challenges Of Biologics For The Private Payer Industry

The private insurance industry must adjust alongside the evolution of biologic therapies in Canada. A greater availability and use of high-price biopharmaceuticals raises the following questions:

• How is the model for insurance delivery changing to adapt?
• How are private payer client demands being met?
• Where is the industry headed? What are the implications?

Consider the implications of the cost of biologics on the industry, and hear how the challenges will be met.

Blair Coffin, Team Leader Actuarial Pricing, Medavie Blue Cross
Bob Kamino, Vice President, Consulting Services, Brogan Inc.
Kevin O’Connor, Director, Federal and Private Healthcare, Janssen-Ortho and Ortho Biotech

10:00 AM

Networking Break

Interact with conference speakers and fellow attendees.

10:30 AM

Optimizing Cost Reimbursement Strategies To Make The Most Of The Benefits Of Biologics

Determining a payer-appropriate reimbursement strategy requires considerable forethought, comprising clinical evidence, economics, pricing, and much more. This session will inspect the ways to prepare an effective submission.

• Understand both public and private payer perspectives
• Determine the best solution for your patient group
• Consider all the criteria of the internal and external reimbursement environment

Develop a winning strategy to expedite reimbursement approval for your biologic.

Wayne Critchley, Partner, Gowling Lafleur Henderson, former Executive Director, Patented Medicine Prices Review Board

11:15 AM

Reimbursement Panel

Putting The Pieces Together: Developing An Integrated Reimbursement Plan For Your Biologic

Tie together the various perspectives presented through the morning and take advantage of this interactive panel to address your particular reimbursement challenges.

• Find out how to develop an optimal integrated approach
• Get straight answers to your pressing questions

Take advantage of the interactive nature of this panel to address your particular reimbursement challenges.

Mike Tierney, VP, Common Drug Review, Canadian Agency for Drugs and Technologies in Health
Wayne Critchley, Partner, Gowling Lafleur Henderson
Blair Coffin, Team Leader Actuarial Pricing, Medavie Blue Cross
Bob Kamino, Vice President, Consulting Services, Brogan Inc.
Kevin O’Connor, Director, Federal and Private Healthcare, Janssen-Ortho and Ortho Biotech

12:00 PM

Networking Luncheon

1:30 PM

Case Study: EMD Serono

Achieving And Expanding Market Access For Breakthrough Biologics

With increasing complexity in the path to market access, biologics producers must develop creative solutions, which can be crafted at the provincial level to enable access, and which work toward proving economic health benefits. Framed by case study examples, this session will address…

• The role industry associations play in addressing bottlenecks
• The challenges in Canada vs. other developed nations with respect to access
• Creative strategies built around risk sharing, caps, bundling, centre of excellence authorizations, and more

Engage in a frank discussion of practical strategies to prevail on the complex route to increasing access.

Robert Kulik, Director, Market Access and Government Affairs, EMD Serono Canada Inc.

2:15 PM

Optimizing Patient Education And Adherence With Real Time Measures For Biologics

The pharmaceutical market receives aggregated data when it comes to accurately measuring new patient starts and patient retention. Although currently the biologics market can receive more robust data through certain patient assistance programs, this data can still lack timeliness and be very difficult to segment. This practical presentation will provide examples that…

• Highlight simple patient assistance programs with real time utilization data
• Provide methods of incorporating real time measurements to complement existing patient assistance programs
• Explain how best to leverage real time data for optimal resource allocations on consumer education initiatives

Get exposed to innovative programs that provide more accurate and timely measures on biologic patient acquisitions and retention.

Jason Steele, Director of Marketing and Strategic Partnerships, Sampling Technologies, Inc.

3:00 PM

Networking Break

Continue the discussion with your peers while enjoying a refreshing break.

3:30 PM

Case Study: Hoffmann-La Roche And Cancer Care Ontario

Collaborating To Optimize Patient Access: Two Perspectives

This presentation will review the market entry and key factors in securing reimbursement for one of the most successful targeted biologics in oncology, Herceptin. Two different perspectives — sponsor and payer — will examine how this drug transformed the landscape for drug review and secured increasing use in a difficult funding environment.

• Hear how clinical and economic evidence was used to convincingly demonstrate benefit
• Recognize the essential components in any communication strategy and the complexities of decision-making
• Understand the particulars of post-marketing surveillance and monitoring

Come away with successful market entry and reimbursement tips, with the story of Herceptin framing the discussion.

David Shum, Director, Reimbursement Strategy and Health Economics, Hoffmann-La Roche Canada
Scott Gavura, Director, Provincial Drug Reimbursement Programs, Cancer Care Ontario

4:15 PM

Patient Biologics Registries

Bridging The Gap Between Progressive Licensing And Appropriate Patient Access

Patient registries are essential mechanisms to link drug management plans and patient needs, though in many cases there are preventable disconnects. While biologics registries are making some progress in parts of Canada, there is still much work to be done.

• Understand the importance of a shift from post-market to continuous surveillance for early entry of drugs with higher data uncertainty
• Recognize the value of patient consultations in optimizing registries, and in particular for innovative biologics for smaller patient populations

Ensure that the ultimate goal — meeting the needs of patients — is attainable and accessible through comprehensive registries.

Durhane Wong-Rieger, President, Canadian Organization for Rare Disorders

5:00 PM

Conference adjourns