2019 Agenda

New technology has enabled the development of drug/device and biologic combination products that target specific areas of the body and some which are genetically based.  While these innovative therapies are more effective, determining the applicable regulation and path to market can be challenging.  Gain insights to:

• Help you determine the ‘Primary Mode of Action’ that will classify your product
• Understand where drug/device regulations intersect and current progress of The Regulatory Review of Drugs and Devices (R2D2)
• Assess how RWE will be gathered and applied to these products particularly those that require companion diagnostics

Anticipate and adapt to changes underway in the approval of combination products

With the recent federal announcement that the proposed changes to the PMPRB regulations are now a reality, assessing their impact and preparing for implementation will now become a priority.  Gain in-depth information to elevate your understanding of the new drug pricing landscape.  Walk away with an action plan to hone your market access strategy for Canada by learning:

• What the implementation timeline is and what you will need to have in place to meet it
• How the new pricing factors will be applied and what thresholds of pharmacoeconomic value will need to be demonstrated
• The new reporting requirements including third-party rebates

Be sure your organization is prepared for this new market access reality

Continuing developments in personalized medicine are having a transformative impact on the lives of patients with rare diseases.  The Care 4 Rare Research Program is on the forefront of this innovative shift in diagnosis and treatment.  Take away insight to help you understand how the path to treatment is evolving for patients with rare diseases by learning:

• What advances have been made with genome sequencing and its adoption as a diagnostic tool
• How Care 4 Rare is working with ministries of health to implement genome-wide sequencing into the diagnostic pathway for rare disease
• What impact the work done by Care 4 Rare could have on the advancement of treatment for rare diseases of the larger population

Prepare your organization for the transformation precision medicine will bring

Developing, delivering and funding treatment for patients with rare diseases has become the single biggest challenge for payers, patients and manufacturers.  With a growing consensus that a new drug development model is needed, the question becomes what form should it take?  Get the latest on how this question may be resolved.  Shape your strategy by hearing the latest views on:

• What options could be pursued for the funding and development of ‘orphan’ drugs so they are more affordable for payers and patients
• What new routes to commercialization for these medications may need to be forged
• What types of partnerships will be key to successful development going forward

Understand how the drug development model could fundamentally change for rare diseases.

• engage your team in a new way of designing your stakeholders' experience
• take an insightful and systematic view of the people whose behaviours affect your goals
• uncover innovations and strategies to convert challenges to fresh opportunities

• How the human body responds to cannabis and why it is so effective
• About the growing body of evidence to support its use
• How the Canadian medical cannabis system works including workplace accommodation and reimbursement from government programs such as Veterans Affairs

Research on patient patterns of use and the effectiveness of medical cannabis has not kept pace with its rate of adoption by patients.  The result is large gaps of knowledge about the types of patients who benefit most and its value as a substitute for pharmaceuticals such as opioids.  Advance your game plan with insights to help you:

• Determine where medical cannabis fits within your health benefit plan
• Evaluate the benefits of partnerships between mainstream pharmaceuticals and medical cannabis companies
• Understand how market access is increasing through the education of pharmacists and physicians

Be on top of the latest cross-sector developments in pharma and medical cannabis

The growth of the biosimilar market has been sluggish due to a number of reasons that include regulatory requirements, production costs, patient preferences and a reluctance on the part of some physicians to prescribe them.  Yet as they represent significant cost savings, their adoption will only increase.  Heighten your awareness of the increased market impact and future direction for biosimilars. Obtain useful insights to help you:

• Determine how the Canadian regulatory process can be better aligned with that of the EU where they receive more favourable treatment
• Assess the impact of greater take-up rates for biosimilars on public and private formularies
• Include greater knowledge of biosimilar advancement in your market strategy

Improve the path to market for biosimilars and achieve lower treatment costs.

The new North American trade agreement extends data protection for biologics from 8 to 10 years.  While this provides greater opportunities for Brand manufacturers, it may create greater push-back from payers trying to keep their costs at sustainable levels.  Discover the probable outcome of this extended protection and fine-tune your strategy by learning:

• What progress has been made toward ratification of the CUSMA
• What economic impact the data protection extension could have on drug prices in Canada
• Whether any new Canadian market developments are likely to change the upward price trajectory for new biologic medications given extended protection under CUSMA

Prepare your company for additional data protection for biologics under USMCA.

The pan-Canadian Pharmaceutical Alliance (pCPA) administers the formal process for getting new drugs to the marketplace.  Source insights to manage and optimize your submission.  Tap into both public and private perspectives in this interactive workshop and walk away with knowledge to:

1. Understand the pCPA process and submissions
2. Prepare for pCPA in the planning stages of your products
3. Use pricing models to assist your product’s positional during negotiations
4. Gain an understanding of different types of Canadian PLAs
5. Take advantage of potential opportunities in private sector PLAs

Develop your successful pCPA strategy through this hands-on interactive workshop.

Your company has spent a decade or more and large amounts of money developing a new and promising treatment. The last thing you want to see is your product falling flat on the market with sales far below expectations. This session will provide a deep dive into the essentials for a successful launch.

Learn how to:

1. Differentiate your drug in the market pre and post launch

2. Coordinate across your organization to include market access,
patient services, medical and regulatory affairs, marketing and
sales for greatest impact

3. Understand and eliminate internal challenges that may impede
your success

Make the most of your investment with a well-executed launch

Your product has been tested repeatedly during the clinical trial process and has been cleared to launch when shortly afterward, a patient reports and adverse reaction. Reporting is mandatory, and so is preserving your company’s stellar reputation for integrity as well as your investment.

Create a blueprint for managing adverse reaction reporting by:

1. Evaluating the reaction reported for severity and classification

2. Working with patient support groups to get ahead of the
problem and minimize impact

3. Learning how to prepare correct documentation and reports to
Health Canada and the Marketed Health Products Directorate

Don’t let an adverse reaction destroy your product’s positive reputation