Pharmaceuticals and life sciences

From innovation to regulation, defining and delivering value-creating solutions to complex challenges affecting your business

The pharmaceutical and life sciences landscape

We are transitioning to an era where commercial success for pharmaceuticals will depend on profitably managing contingency-based payer agreements.   As real world evidence (RWE) becomes more consistent and comprehensive, payers will place the onus on drug makers to guarantee outcomes.

This new access environment, combined with scientific breakthroughs, developments in alternative medicines, and emerging digital and analytic capabilities is pushing companies to explore unconventional business models and build value-based customer relationships.

PwC Canada's Pharma Life Sciences practice helps pharmaceutical, biotech, medical device, pharmacy and medical cannabis companies with all aspects of this transition.

We will work with you to develop future focused business strategies and implement the time critical programs and procedures essential to success within the Canadian regulatory frameworks.

How we can help

Commercial Excellence

Commercial Excellence

Grow and create a competitive advantage

The environment in which pharmaceutical and life sciences companies operate is being driven by an increasingly demanding healthcare agenda. The need for innovative, cost effective medicines continues to rise while payers, healthcare providers and patients are demanding greater value for money. Through a capabilities driven approach to strategy we are supporting companies to align their strategic direction to the core capabilities necessary to thrive in Canada’s evolving pharma market. From breakthrough commercial innovation to disciplined portfolio management, we are working with our clients to optimize their business models, form alliances and partnerships for sources of innovation, add value with beyond the pill services and develop outcomes evidence generation for today’s value driven environment.

A critical makeover for pharmaceutical companies: Overcoming industry obstacles with a cross-functional strategy

This is a difficult time for pharmaceutical companies — so difficult, in fact, that many are reconsidering their business models. The litany of concerns that pharmaceutical companies face includes payers tightening up on cost management, strained government healthcare budgets, the need to understand and adopt new technologies, and challenges to their traditional pricing mechanisms by empowered stakeholders, from patients to payers.

Compounding the external obstacles, however, is the internal culture of most pharma companies. This is an industry that has long operated through disparate components — silos that separated R&D, commercial, production, and supply chain. And, in turn, these walled-off parts of the organization have been disconnected from the external-facing parts, which are responsible for managing relationships with regulators, policymakers, the medical community, and the rest of the industry. These silos can obstruct patient access and breed inefficiency and waste. They affect drug approval time and pricing, influence support for specific drugs by theme.

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Effectively manage your product lines, from initial innovation to sale

As a Canadian life sciences or pharmaceutical company, you know that managing the product pipeline is one of your biggest responsibilities. The road that most health-related products follow — from research and development and patent acquisition to regulatory compliance and finally commercialization — is long and full of pitfalls. Canadian players are especially vulnerable to pipeline jams, as our country's regulatory regime makes it hard for both large and small companies to reap the benefits from innovation.

Anticipating and combating threats to your product pipeline require targeted strategies.

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Stimulate commercial innovation

Commercial leaders in the pharmaceutical and life sciences industry face a rapidly changing healthcare landscape. There are significant concerns about patent expirations, consolidating customers and the increased use of generics as well as other hurdles such as new regulations, greater scrutiny of pricing and value, healthcare cost trends and advancing technology. We can work with you to effectively manage these obstacles to ensure your organization remains stable and profitable. We help you to identify and frame the issues most relevant to your business and we partner with you to resolve those challenges. Our expertise in commercial strategy, operations and compliance creates high-impact recommendations that work in the real world.

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Loss of Exclusivity

Patent expiry is no longer the end of the road for drug commercialization that it once was but rather a bend in the road during a drug’s lifespan.  Successfully navigating that bend in the road of often a challenge for pharmaceutical companies because the approach and skill sets required for post-LOE commercial success are much different from when a product is commercialized under patent.

Focus for branded drug products is generally rooted in expanding reach as wide as possible and driving Rx volume as high as possible.  Post-LOE strategy, on the other hand, is rooted in patient retention and focusing only on those segments where you know you can derive value long term.

At PwC, our post-LOE offering includes a framework to transition your team to view the market through a non-exclusivity lens.  We’ll help you uncover multiple options for value delivery and patient retention that go beyond traditional card programs.

Through joint business relationships with a number of partners, we have exclusive access to patient-level and physician-level data sets.  This supports scenario modelling that allows you to assess strategic options and the impact of various tactics with confidence. 

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Evidence Generation

Evidence Generation

Developing RWE Generation Capabilities

We are transitioning to an era where commercial success for pharmaceuticals will depend on profitably managing contingency-based payer agreements.   As real world evidence (RWE) becomes more consistent and comprehensive, payers will place the onus on drug makers to guarantee outcomes.

Canadian-market affiliates of global life sciences organizations face unique challenges in establishing local RWE competencies.  The global trend to leverage RWE for expanding therapy indications and access is widely recognized.  However what’s expected from local affiliates from Canadian payers is less clear.

We can work with you to develop a Canadian market strategy for RWE generation that is tailor made to reflect what Canadian payers will want in terms of evidence for your therapies as well as fitting with your global organization’s plans.

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Accelerate digital and technology impact

With the cost of genome sequencing beating Moore’s law since 2008, the amount of Big Data is exploding and enabling disruptive technologies including machine learning, artificial intelligence and cognitive analytics to deliver new insights into human and pathogen biology. The pharmaceutical and life sciences industry is now taking personalized medicine seriously and companies are using digital technologies to connect genetic information with real world data. Understandably, many people are ultra‑cautious about sharing their medical data, and worried about privacy and security. The introduction of blockchain technology enables pharma companies to provide immutable proof of provenance, with less risk of counterfeiting – helping pharmaceutical companies protect both their brand and patients.

Finally, all of this data is helping pharma companies better understand the patient and their unmet needs enabling them to better engage with patients and healthcare practitioners. Multi-channel marketing campaigns are replacing the old sales rep model.

We are helping pharma and life science organizations:

  • Understand the opportunity of nascent digital and genomic technologies
  • Implement digital solutions from blockchain to beyond the pill ideas like wearables
  • Integrate real-world evidence (RWE) into their development plans and commercial strategies to better develop and market treatments that address the real unmet need of patients

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Assurance

Assurance

Navigating risk and regulatory complexity

Pharma, Biotech and medical device companies are facing unprecedented compliance challenges, as closer regular scrutiny is unlikely to abate any time soon. Companies cannot afford to ignore corporate reputational and personal risks attaching to their business activities. Everything from; commercial operations practices, transparency of company spend on healthcare professionals and organizations. Clinical trial activity, patients’ safety to issues of privacy of patient and consumer information have been under the regulatory microscope.  Highly visible investigations and aggressive prosecution have resulted in significant financial judgements against leading companies. Squeezed on all sides by business, economic and regulatory pressures, companies need a new approach to meet the challenges of integrating new governance compliance practices at a global level.

We help pharma companies:

  • Assess the impact and implementation strategies for new accounting methodologies, such as revenue recognition
  • Strategize complex merger or sales transactions
  • Perform due diligence on potential target companies
  • Analyze the impact of the changing regulatory landscape on the integrity and accuracy of financial reporting
  • Review the accounting and tax implications of a transaction
  • Assess contract compliance and value generation (commercial assurance)

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Mitigating Fraud and Overpayments in PAPs

Patient Assistance Program Profit Enhancement

PAP use is growing considerably but controls to mitigate fraud and other overpayments often don’t keep pace with program enhancements. Canadian PAP programs offered nationally often have over $1M in fraud and overpayment annually.

Our teams have capabilities to support across:

  • Analytics to identify likely instances of fraud and overpayments
  • Advisory on how to mitigate fraud and overpayment issues

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Align costs with business strategy

The environment in which pharmaceutical and life sciences companies operate is being driven by a more and more demanding healthcare agenda. The global need for innovative, cost effective medicines continues to rise while regulators, payers, healthcare providers and patients are demanding greater value for money, proven effectiveness of products, more transparency and access to information. To meet these demands, companies are seeking ways to generate real-world evidence that demonstrates value, increase the efficiency of its operations, rationalize spending on commercial operations and enhance financial performance.

The Pharma, biotech and medical device industries are under severe pressure. R&D costs are spiraling, development timelines are growing, payer push back is increasing and consumers are becoming more knowledgeable about care options. The industry is reducing development time and becoming smart about stopping projects early in the development cycle, and increasing efficiency through rationalization or outsourcing of non-core activities. As scientific advances enable the industry to move from a one-size-fits-all approach to care, to one of segmentation, personalization and wellness, so the supply chain will need to evolve. The supply chain of the future will be built around flexibility, responsiveness and reliability shifting the supply paradigm from a stock-based model to an order based model.

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Deals

Deals

Optimize deals

Competitive forces and changing market dynamics makes navigating deals in the pharmaceutical and life sciences complex. But for those organizations that can manage through the complexity the potential value is compelling. We can bring a global perspective to help pharmaceutical and life sciences companies align strategy and capabilities and we can work with you to adapt your company culture and build your long-term performance.

Our teams have capabilities across the deal continuum, including valuation, deal structuring, implementation, and post-deal integration.

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Raise capital

Competition for capital in the life sciences and pharmaceutical industry is fierce. Access to Canadian and US venture capital funding is an ongoing issue for many of our country's most innovative players. Uncertain capital markets coupled with rising drug development costs are leading to a lot of anxiety in the industry. Canadian biotechnology companies in particular are finding it a bumpy road to complete almost any round of financing and an initial public offering (IPO) is a rare event.

Without adequate capital, Canadian entrepreneurs cannot transform their scientific innovation into commercial opportunities.

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Contact us

Rami El-Cheikh

Partner, National Pharma & Life Sciences Leader, PwC Canada

Tel: +1 647 669 4555

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