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

Pharmaceutical, biotech, and medical device companies face a challenging, competitive health landscape. Pricing pressures, scientific breakthroughs, developments in alternative medicines, expanding demand for health care access, and emerging digital and analytic capabilities push companies to explore unconventional business models and build value-based customer relationships.

PwC Canada's pharmaceuticals and life sciences practice helps pharmaceutical, biotech, medical device, pharmacy and medical cannabis clients develop future focused business strategies and implement the time critical programs and procedures essential to success within the Canadian regulatory frameworks. We also have a wide network of contacts in the venture capital and private equity sectors and can quickly connect you with the people you need to know.

How we can help

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 few capabilities that make them unique. From breakthrough innovation to disciplined portfolio management, we are working with our clients to optimise their R&D models, form alliances and partnerships for sources of innovation, add value with beyond the pill services and develop new commercial models fit 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 the medical community, and seriously hinder financial performance.

It is time for pharmaceutical companies to restructure their operating models in a way that brings all of these interdependent functions together.

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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 improve R&D productivity, 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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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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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

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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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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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Improve R&D effectiveness

No other sector relies on research and development for future success as much as the life sciences and pharmaceutical industry. Getting R&D effectiveness right is vital for Canadian players both large and small. During the era of blockbuster drug development (1985 - 2000), the global industry's market value grew 85-fold; today, the sector is investing twice as much into research and development as it did a decade ago but producing only two-fifths as many new medicines. This is not a sustainable business model.

Many of the challenges facing Canadian pharmaceutical and life science companies concern improving research and development effectiveness. It's not just about getting more bang for those R&D bucks. It also means having a dedicated financial and operational strategy that enhances the discovery of new blockbuster drugs as the patents on older ones expire and move into the generic sphere.

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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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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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Insights

Contact us

Rami El-Cheikh
National Pharma & Life Sciences Leader, PwC Canada
Tel: +1 647 669 4555
Email

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