Services

The environment in which Pharmaceutical and Life Sciences companies operate is increasingly challenging, being driven by a more and more demanding healthcare agenda. The global need for innovative, cost effective medicines continues to rise whilst regulators , payers, health care 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, rationalise spending on sales and marketing and enhance financial performance. Pharma 2020: The vision , Pharma 2020: Virtual R&D , Pharma 2020: Marketing the future, Pharma 2020: Challenging business models, Pharma 2020: Taxing times ahead and Pharma 2020: Supplying the future

Working closely with our clients, ranging from small entrepreneurial life science companies to large global corporations, we aim to achieve increased performance by improving the efficiency and effectiveness of a company’s key business operations.

Across the whole Pharmaceutical and Life Sciences value chain , PwC's trusted professional advisors use their wealth of industry based experience, knowledge and expertise to help our clients evaluate their strategic business options, improve management and control, and identify cost saving initiatives.

Our service areas include:

Regulatory and compliance environment

  • Overview
  • Regulatory compliance
  • Risk Management
  • Regulatory Affairs

The Pharmaceutical and Life Sciences industries are among the most heavily regulated industries in the world. The regulatory environment is continuously changing in response to the effects of globalisation and harmonisation, emerging markets, increasing complexity of disease targets, introduction of new technologies and the rising sophistication and demands of both patients and regulators.

Yet adherence to regulatory requirements is vital to both a company's and the industry's reputation. Keeping pace with changing regulation requires good processes and procedures which ensure adherence and enable effective global, national and local management. We work with our clients to audit and develop management systems which enable greater transparency across the firm, inform the development of new approaches to a broad range of regulatory compliance, risk management procedures and help improve performance.

However, increasingly firms recognise the need for a new approach. Companies and regulators will need to work more closely together on the future development of rules and regulations for both obtaining market approval and ensuring products remain on the market. Whilst today much of the dialogue between industry and regulators is around safety, efficacy and value for money; in future the discussion will be about providing total health care solutions, improving patient compliance, earlier access to medicines through shortened development cycles, and product development risk sharing arrangements.

Global
Partner
+1 (410) 659 3390
US
Partner
+1 (415) 498 5024
US
Partner
+1 (973) 236 7880
Switzerland
Director
+41 (58) 792 2880
China
Principal
+86 (21) 2323 2262

At every part of the product life cycle, from research and development, though manufacturing, supply, distribution and marketing of products, pharmaceutical companies must adhere to the regulations local, national and international authorities. Ensuring regulatory compliance at every level in multiple territories around the world is a complex process. We have a dedicated team of experts who help our clients identify ways to improve their processes that enable and enforce compliance at every stage of their business.
Inherent in any business are risks. Managing and minimising risk is crucial yet often overlooked. In the pharmaceutical industry the risks are many and varied. How do companies manage risks associated with clinical trial vendors, outsourced manufacturing, in-licenced R&D, and increasingly risk sharing marketing agreements with health care payers and providers? With so many in-licensing and out-licensing arrangements it is often hard to keep track of and ensure compliance with the terms of such agreements. Our team of advisors are able to help companies review existing arrangements with third parties, identify non-compliance risks and work together towards the most appropriate solutions. Additionally healthcare and pharmaceutical and life-science companies face unique challenges as they develop a strong privacy culture to comply with privacy and data protection regulation. They need to ensure ensuring information security without impeding the necessary exchange of patient care information. Our advisors assist with the development of integrated privacy, security and information risk management framework within your organisation.

We understand that most Regulatory Affairs departments are some of the best in their companies- nevertheless they need a different perspective. Working with our clients we can help them to take a different view which is encompasses the customer view; taking a broader and deeper perspective, aligned with continuous focus to SAFETY and to building trust amongst its stakeholders. Working with our clients we can help them develop a regulatory affairs strategy for the organisation, aligned with the business vision, review and develop new approaches to information and portfolio management, provide individual unbiased point of view, and help them to respond to the challenges of NML, eCTD, Critical Path management. As companies begin to focus on changing their business models for the future, the regulatory affairs function will need to consider how it can support this change. We help our clients explore and begin to understand the new requirements of collaborating with regulators and providers. Today much of the discussion is around product risk sharing schemes, negotiating value for money and enabling shorter times to market for their products. In future these discussions will include not just the provision of medicines but the provision of a package of care, patient compliance and monitoring schemes, data and information sharing about clinical trials and marketed products in a way which is beneficial to all on a global scale.

 

Manufacturing

A combination of regulatory, market, scientific, and technological forces is likely to mean that pharmaceutical manufacturing will undergo rapid change in the next five to ten years. Many companies are already investing in change projects, but they are often piecemeal and not accompanied by a clear manufacturing vision. The absence of such a vision also means that companies sometimes feel caught between ‘big leap’ and more incremental changes. In fact, incremental change is vital to achieve a longer term 'big leap.' But, in the absence of a manufacturing vision, companies find themselves with no roadmap. The consequence is that changes are made in relative isolation without maximising their potential incremental contribution to longer term improvement or, worse, moving the company further away from the manufacturing it will need in the future. There is a need for companies to more consistently align investment in IT and manufacturing with their vision of the manufacturing that will be needed in the future. In doing so, companies will be able to ensure that investments don't just deliver specific gains, but also help accelerate the company's progress toward longer term goals. We can help companies achieve the change required and their goals by utilising our firm's in-depth industry expertise.

India
Director
Tel: +91 (22) 6669 1000
UK
Partner
Tel: +44 (20) 7804 8234

 

Corporate and financial strategy

  • Overview
  • Business strategy
  • Corporate Finance
  • Valuation
  • Alliances
  • Transactions
  • Tax

The Pharmaceutical and Life Sciences industries are at a pivotal point in their evolution. Companies and stakeholders are looking for new sustainable business models for the longer term. Strategic options include vertical integration versus virtual company, generic versus innovative product manufacturer, traditional medicines versus biologics, makers of medicines versus provider of health care packages. These companies are addressing important questions about existing and future revenue generation, and how to align operational and financial tactics to enable their chosen corporate strategy. We are working with our clients to explore strategic options and begin the process today of restructuring their business for tomorrow. We help to identify those areas with the most realistic potential and devise and review pragmatic business plans that maximise value. We know the difficult decisions and trade-offs that executives face when managing their businesses, allocating resources or contemplating deals. We know the traps of large and small company cultures.Mergers, acquisitions and licensing are vital enablers to corporate strategy. Most companies will use some form of equity or debt finance to fund future plans, Life Science companies often use private equity or an initial public offering (IPO). Whatever the new venture, buying at the price, integrating the different elements, and ensuring tax efficiencies through out is key to ensure maximum value. We help to develop a corporate finance strategy, which will appropriately raise and structure the finance needed to support operational changes, and the future strategy of the company.

UK
Partner
Tel: +44 (20) 7804 3744
UK
Director
Tel: +44 (20) 7213 4622
Audit and Assurance services -
Principal contacts
Financing New Ventures and Transactions
Corporate Finance
Transactions
Sujay Shetty(IN) |
Alliance Management
Melanie Butler (UK) | Ben Wilcox (US) | Doug Strang (US) | Joe Braido(US) |
Commercial Due Diligence
Valuations
Jo Pisani (UK) | Peter Kurtz (UK) | Dimitri Drone (US) | Andreas Ohl (US) |
Tax
Mike Swanick (US) |
Alliances

Given the decreasing R&D productivity in the industry, companies need to review how best to operate. The choices in operating model range from an entirely virtual company where research, development, manufacturing and sales are outsourced, to a fully integrated company maintaining all functions in-house. The optimal configuration will depend on the company and will reduce complexity and increasingly deliver value for money in a cost efficient manner.

Business Strategy & Business Plan Validation

Business strategy is about setting the right course of action, getting commitment and implementing. We help our clients validate their business plans or those of their targets. We also help them identify the best strategy for their businesses, leveraging our knowledge of the industry, identifying areas with most, realistic potential, and devising sensible action plans. We help our clients create pragmatic, flexible strategy and deliver real value.

R&D Strategy & Portfolio Management

Setting the right R&D strategy requires making many hard choices while being pragmatic: choice of therapeutic areas, in-licensing vs. in-house, small vs. large molecules, primary vs. secondary care. Once these decisions are made, then prioritisation of resources is key: Which projects should get priority? Where should any additional budget go? We give decision-makers the information they need to make these decisions about R&D strategy and resource allocation. Our portfolio management team also works seamlessly with PwC’s Integrated Operations and Business Planning (IOBP) practice. We help our clients avoid pitfalls, choose the right, fit-for-purpose, approach and analyses. We deliver implementable strategies and portfolio management processes.

Supply Chain Decisions

Often manufacturing issues impact the value of a product or R&D project. A delay in the launch of a major new product can cost millions, but decisions about manufacturing capacity must often be made well before product registration. Securing insufficient capacity can result in lost sales opportunity whereas building too much can result in unacceptably high cost of goods – a second dimension is whether to build capacity in-house or to use third parties. These challenges are magnified in biotechnology, where regulatory and technical hurdles can mean lead times of several years to implement new capacity. We help our clients make the right decision at the right time and integrate manufacturing capacity decisions with the decisions and risks inherent in the development of the product. Our work leads to a more complete picture of the value and risk in development and commercialisation.

Corporate Finance

As companies review their corporate growth strategy, they will need to consider the optimal approach to funding, whether through debt, private or public equity fundraising. Early stage companies may need to raise funds or enter into strategic alliances with big pharma. Companies with products coming to market may be ready to float on a public stock exchange. Established companies may wish to grow by acquisition, or to divest some of their activities. Some of these divestments may be to management teams, backed by private equity.We have a Corporate Finance team dedicated to providing advice to companies in the pharmaceutical sector. Our team combines extensive corporate finance expertise with deep industry knowledge. Our services include:

  • Mergers and acquisitions advisory



    • Acting for a vendor we can use our knowledge of the pharmaceutical sector to identify the most appropriate buyers and implement a competitive sale process to maximise value.
    • When acting for an acquirer we can help companies to identify targets that represent a good strategic fit and assist in negotiating an acquisition that will add value to our client’s business.
  • Public company advisory and IPOs



    • For companies looking to raise capital via the public markets we advise on Initial Public Offerings (IPOs). We can either act as sponsor alongside your broker or, when an investment bank is acting as both sponsor and underwriter, we can provide independent financial advice.
    • For companies in the sector that feel that their pipelines are undervalued by the public markets, we can advise on public-to-private transactions (PTPs) and de-listings.
  • Private equity advisory and advice on fundraising



    • For management teams wanting to acquire the businesses which they run, and private equity houses looking for the right investments for their funds or seeking to exit current investments, we provide advice and execution expertise on private equity transactions.
    • For pre-IPO companies seeking to raise funds, we can advise on approaches to private equity houses.
  • Debt advisory



    • We provide advice on the raising of debt to finance both private equity deals and corporate acquisitions.
    • We advise companies on refinancing their existing debt and raising new debt.
Belgium
Partner
Tel: +32 (2) 710 7422
UK
Partner
Tel: +44 (20) 7213 2105

Companies and investors are constantly seeking to measure, manage and increase value. We work with our clients operating across healthcare, pharmaceuticals, biotechnology, medical devices, diagnostics, animal health, nutraceuticals and services to these industries - Contract Research Organisations (CRO) and Contract Manufacturing Organisations (CMO).

Strategic Valuation

Companies need to value alternative strategic options. We help clients understand the value of their assets, often R&D projects and technology, and how value can be improved or realised via a sale or licensing agreement. We help our clients consider key risk factors, such as clinical failure, regulatory, product profile and competition, leading to a robust estimate of value and risk. We help our clients proceed with development of their assets or a transaction with greater certainty of the value to be created and how to explain that value to different parties

Financial Reporting Valuation

Accounting standards of US GAAP and IFRS require rigorous identification and valuation of intangible assets, including R&D pipelines, acquired as part of a business combination. Intangible assets identified as part of the purchase price allocation (PPA) typically include; in-process R&D, developed technology, licenses and marketing rights, customer relationships, other intangible assets such as trade names, know-how, supplier agreements and databases. Working with our experts in financial reporting valuation (US GAAP and IFRS) we ensure our valuations stand up to the scrutiny of both auditors and regulators.

Dispute Valuation

Valuations in contentious circumstances require a team who (1) understand the “rules of the game”, including the legal process, interaction with lawyers and opposing experts and (2) have expert witness experience on the stand. Such valuations are performed in a broad range of contexts, including international arbitration, commercial litigation, valuations under shareholders agreements or articles, providing independent valuation opinions in high profile transactions and licensing disputes. We provide fast, independent and robust valuation analysis on all aspects affecting a dispute. We help our clients be well-informed and best-positioned to present their case and quickly resolve complex disputes or avoid them altogether.

UK
Partner
Tel: +44 (20) 7804 3744
UK
Director
Tel: +44 (20) 7213 4622
UK
Director
Tel: +44 (20) 7213 4622

Strategic Alliances continue to grow at a staggering pace in the pharmaceutical, biotech and medical device industries. These alliances most commonly take the form of licence agreements, requiring independent due diligence of the assets under consideration, and on completion of the deal, an appropriate alliance management review system.Business development & licensing is key to obtaining fresh funding, validating new technology or simply growing the business. In creating the deal, prospective licensees will be considering the potential value of the product, synergy with the R&D portfolio, the risks and costs of developing the product. We help to explore these questions and how different licensing parameters (Milestone Payments, Royalties, Equity) affect the value of the deal. Equally potential licensors will be querying whether to license now or later, if the partner is capable of exploiting the product to its maximum potential and what the product or the deal means to the partner. We help potential deal partners explore the different licensing parameters, and how they affect the value of the deal. We help our clients understand when they should do a deal, how far they can go with the terms they are negotiating and how alternative deal structures are likely to impact their cash flows over time.



Commercial Due Diligence

Investors looking at a potential target require a comprehensive review of the target’s business plan, strategic positioning, the projected market conditions and possible actions of expected competition. Similarly, stakeholders contemplating selling an activity often require a vendor due diligence to maintain control of value issues, reduce business interruption and keep ownership of the business plan. Our commercial due diligence reports help bidders and vendors make acquisition and disposal decisions, and help financiers make debt funding decisions.



Alliance Management

However once the deal is closed the complexity of terms, geographic locations and resources can make it difficult to monitor partners' compliance with self reporting obligations, an issue which often results in financial implications. Approximately 90% of PwC's contract examinations identify mis-reporting that leads to increased revenue or decreased expenses.



PwC's global team of licensing and contract specialists provide and independent, forensic based approach to examining self-reporting aspects of contractual arrangements. The findings from the examinations can be reviewed to determine root cause and subsequently implement steps to mitigate future revenue leakage, through clarification of contract terms, enhanced reporting procedures and financial controls. Our proactive approach will build stronger relationships between you and your business partner.

UK
Partner
Tel: +44 (20) 7804 3744
UK
Partner
Tel: +44 (20) 7804 5158
UK
Director
Tel: +44 (20) 7212 5924
US
Partner
Tel: +1 (973) 236 3045
Director
Tel: +1 (973) 236 4050

Link here for full details of our Transactions services

  • Financial Due Diligence

    All businesses involved in an acquisition, as buyers or sellers, need to ensure that the financial information they hold is as accurate as possible, not only to prevent paying too much (or in a seller’s case receiving too little) but also to ensure that their governance and risk management objectives are met. Financial due-diligence can help to identify and focus attention on the factors in the business that will be critical to its future success. Our integrated service combines financial, operational and commercial due diligence and can help you interrogate and justify your vision for a deal.
  • Post deal services

    We help our clients before, during and after the deal, focusing on the areas that require the most attention to protect the value of the deal. We know how to integrate fully or integrate in a strategically aligned and operationally independent way. We focus on ensuring successful integration of all functional areas. In many ways, a deal starts at completion as from here the benefits and value that the deal was designed to deliver need to be realised. We have extensive experience of helping businesses integrate new acquisitions. Our teams comprise many individuals with "in-line" industry experience. Our broad knowledge of HR issues allows us to give practical advice on employee management. We help our clients to navigate through the wide variety of employee programmes used and to help them choose the best programmes to achieve all potential synergies.
  • Bid support and bid defence services

    Life in the public markets can be tough, sometimes requiring robust tactics to either make or defend a hostile bid. We can help companies to examine the substance behind their fears by carrying out a "dummy" defence bid that will identify issues that from an external point of view may give rise to a bid. We provide financial due diligence analysis to validate the financial, commercial, operational and strategic assumptions underpinning the deal.
  • Commercial and market due digilence

    Any business seeking to make an acquisition needs to understand not only the specific performance of the intended target, but how this relates to projected market conditions and its competition within the industry. We have carried out numerous commercial due diligence and consulting assignments worldwide. The extent of our global reach means that we can help our clients spot opportunities and advise them on all the relevant factors to help them establish themselves in the appropriate markets. We can help assemble the teams which they need on the ground and share with them our in-depth industry and market know-how to identify and address the key issues quickly and cost-efficiently.
  • Structuring services

    A number of different considerations can influence the optimal structure for a deal requiring a balance between the objectives behind the deal and accounting, tax, regulatory and commercial considerations. No two deals are exactly alike and all are developed under unique circumstances. Other factors, such as cross-border elements of a transaction add further complexity. We help clients to identify the principal concerns that will determine the right structure for a transaction. We can assist with marshalling the complex range of factors including tax, legal, accounting and regulatory issues that will need to be considered together. We create a feasibility plan to assess the chosen structure and once this is confirmed as the right choice we will provide continuous support throughout implementation.
India
Associate director
Tel: +91 (22) 6669 1305
UK
Partner
Tel: +44 (20) 7804 2629
UK
Partner
Tel: +44 (20) 7212 3673
US
Partner
Tel: +1 (646) 471 2645
US
Partner
Tel: +1 (678) 419 4152
US
Partner
Tel: +1 (213) 356 6245

In creating strategies to address many of today’s business issues, companies often overlook tax considerations. We examine these industry activities with tax in mind, and respond with tailored ideas that can have a bottom-line impact on your business. R&D , Transfer Pricing



Maximising R&D

In a time of rising development costs and declining pipeline productivity, the critical work of research and development (R&D) organisations is the lifeblood of the industry. However, R&D credit and incentive schemes in various national and local jurisdictions often impose stringent requirements for R&D-intensive companies, and calculating and defending these credits is a significant part of their overall tax strategy. PwC works with pharmaceutical and life sciences companies to:

  • Increase sustainable R&D credit while providing documentation for the credit;
  • Identify and analyse areas of qualifying activities, accumulate costs, produce documentation, summarise the findings and manage the IRS process; and
  • Increase cash flow, improve procedures for tracking and managing future research costs and realise permanent tax savings.
Related link: Tax M&A



Acquisition structuring

In an industry where strategic alliances are essential, PricewaterhouseCoopers help companies develop sound business practices to maximise cash flows from these arrangements. We work with clients to use their transactions to reach their business goals. We help clients assess the impact of regulatory changes, screen acquisition or alliance candidates, prepare for divestitures, and uncover hidden opportunities, risks and deal issues, whether the objective is to diversify, enter new markets, reduce costs, exit businesses, or raise capital. Most commonly, we work with clients to:
  • Perform due diligence analysis of the tax attributes of potential domestic and international targets to determine historical exposures, recommend tax-efficient acquisition structures, assist in post-acquisition tax planning and recommend appropriate accounting methods.
  • Analyse third party arrangements to identify proper characterisation of intangible acquisitions and increase use of the research tax credit.
  • Reduce structural rates with debt push-down strategies and foreign tax credits.


Managing human capital

The pharma business is a knowledge and experience business, and the knowledge and passion of its people have always been one of the most important resources for any pharmaceutical company. PricewaterhouseCoopers' Human Resource Services practice was developed to provide organisations with access to a full range of services, from HR planning and strategy through to the details of tax efficient reward or advice on employment law. We can advise on:
  • Structuring rewards and incentive plans for senior executives
  • Regulatory risk in the locations where your global workforce is deployed
  • Tax- efficient international assignment structures and policies
  • Savings sought in the areas of tax, social security/pension and expatriate policy.
Related links: Human Resource Services (HRS) or International Assignments



Transfer pricing

Transfer pricing is a critical element in the tax strategy of global pharmaceutical companies. Today, inter-company transactions across borders are growing rapidly and are becoming much more complex, and compliance with the differing requirements of multiple overlapping tax jurisdictions is a complicated and time-consuming task. At the same time, tax authorities from each country are imposing stricter penalties, new documentation requirements, increased information exchange and increased audit/inspection activity. PwC helps businesses allocate functions, risks, and tangible and intangible assets among affiliated groups in order to create efficient tax structures. Examples of such strategies include:
  • Developing approaches to evaluate potential R&D, marketing, and manufacturing intangibles, including innovative comparability adjustments to the potential comparables
  • Creating defensible models for companies to migrate product intangible property into affiliates in tax advantaged locations and with sufficient substance to manage the intangible property
  • Developing models to support sustainable contract research and development, marketing and other “high value” services transactions
  • Developing approaches that use the client’s collaboration, cooperation or other arrangements with third parties in order to address integration, collaboration or other cooperative intercompany ventures.
Related link: Transfer Pricing or Transfer Pricing Perspectives



Compliance

Expanding regulatory forces are driving pharmaceutical companies to develop practical and effective solutions for meeting the challenges of integrating governance, risk and compliance on a global level. Such an integrated approach must properly address culture, process and technology to address current and emerging requirements and performance expectations, including:
  • Depart compliance with Sarbanes-Oxley and IRS requirements relative to disclosure, reconciliation of tax and financial reporting, restated earnings and record retention.
  • Determining uncertain tax positions
  • Keeping up with IFRS
  • Help multinationals improve their VAT compliance function
  • Global or multi-territory regulatory and tax compliance services
Related link: Global Compliance Services (GCS)
Global
Global Pharmaceuticals and Life Sciences Tax Leader
Tel: +31 (0)88 792 63 22
Europe
European tax partner
Tel: +44 1895 52 2104
 

Human resources

Pharmaceutical companies invest heavily in their people. The challenge is to ensure that that investment is effective, attracting and retaining people with great skills, and motivating them to do the right things in the right way.

By combining our expertise in HR strategy and business effectiveness, reward and compensation, employment services, retirement benefits, actuarial, international mobility and transactions, we are able to deliver solutions on all issues relevant to the development, reward and management of employees within pharmaceutical organisations.

Human Resource Services help organisations with HR planning and strategy through to the details of tax efficient reward or advice on employment law. We can advise on structured rewards and incentive plans for senior executives and how the principles of equity and performance-related earnings can cascade through the organisation, including for example the design and implementation of flexible benefits plans.

UK
Partner
Tel: +44 (20) 7213 1644

 

Information technology

  • Overview
  • Research & development
  • Manufacturing
  • Supply chain & distribution
  • Commercial operations

Technology is an important enabler of business transformation. In the Pharmaceutical and Life Sciences industry new technologies will enable greater understanding of disease, reduce costs in R&D, manufacturing, and the supply chain. Technology will also encourage closer relationships with regulators, payers, providers and patients through a more integrated approach to product development and marketing and health provision through greater transparency and sharing of information across companies, and with third parties including industry regulators and potentially patients in the future.

Together with our clients, we use a combination of industry and technology expertise to develop process improvements that assist you in getting value from technology investments, We bring knowledge in IT strategy, IT architecture and design, enterprise applications, sourcing, project management and IT operations management as well as experience of our professional advisors who have worked within R&D, Supply chain and manufacturing within the industry.

China
Partner
Tel: +86 (21) 2323 2011
US
Partner
Tel: +1 (703) 918 4522
US
Principal
Tel: +1 (312) 298 2160

The volume of information generated at all points from research and development process through clinical trials to submissions to industry regulators is rising exponentially. Concurrently approaches to the use of information technology to store, find and link information has evolved beyond simple data collection to finding the novel approaches to new solutions is evolving. Semantic technology will enable more intelligent searching across data bases containing information from R&D outputs, plus clinical trial data, regulatory submissions, and post launch marketing surveys.

Process Analytical Technology (PAT) is a system for designing, analysing, and controlling manufacturing through timely measurement of critical quality and performance attributes of raw materials and in-process materials and processes with the goal of ensuring final product quality. The goal is to understand and control, the manufacturing process, through a drug quality system: built-in or by design. The PAT framework concerns designing and developing processes, that can consistently ensure a predefined quality resulting in real-time release of products. Underpinning the implementation of PAT is technology, i.e. the introduction of new process analytical equipment, data management, and software.

However to realise the full potential of PAT, appropriate broad organizational and business perspectives should be taken into account. We work with our clients to realise the results of enhanced product quality, reduced time– to–market, and the facilitation of improved patient safety and competitive advantage. PwC offers you, by its Quality by Design Services, the opportunity to upward the implementation and use of PAT.

In the future manufacturing will become make to order rather than bulk manufacturing. The development of more complex products such as biologics make the manufacturing process more complex and difficult to manage and so will require a greater degree of control through the use of technology.

China
Director
Tel: +86 (10) 6533 7223
India
Director
Tel: +91 (22) 6669 1000
Germany
Senior manager
Tel: +49 (69) 9585 5049

The supply chain of the future will offer alternate supply models to match shifts in the provision of care - direct to consumer rather than via the wholesaler/pharmacist. It will promote the use of advanced product design and packaging techniques to drive patient compliance and protect Intellectual Property and the adoption of inventory tracking tools to eliminate counterfeit product and parallel importing risks.

Currently technology enables real time tracking of product deliveries in other industries such as couriering services. The technology not only provides information about the speed, and direction, but gives real time data on heat and vibration experienced by the product in transit. Given the rising trend in sensitive biologics that need to be delivered from a manufacturing site in perhaps China or India to its final destination, this technology will become an increasing important in the tracking transport of medicines around the globe. It will also be technology that enables manufacture to order rather than mass production of products.

In addition the future supply chain will rely on more sophisticated technology. Pharmaceutical manufacturers will be able to improve patient compliance by inbuilt automatic reminders for patients to take their pills, through remote monitoring services to determine if a patient is taking their medication correctly and of course informing the manufacturer that the patient needs a new script filled and batch of medicine manufactured.

US
Director
Tel: +1 (312) 298 3368
US
Director
Tel: +1 (617) 530 4314
UK
Director
Tel: +44 (20) 7894 8234

As the pressure to improve sales force productivity, the latest technology devices are becoming increasingly important to pharmaceutical sales and marketing function. Deploying the right technology is crucial to increase productivity in the field; decrease administration workloads for the reps; facilitate information availability and sharing and improve synchronisation between tools.

PwC can help in utilising and integrating IT to make the sales and marketing team more effective

 

Research & development

As the industry faces a whole host of individual yet challenging issues, it is difficult to see how best to navigate the immediate and long term future. How best to deal with an increasing R&D spend which results in fewer approvals than ever before; increasing numbers of products coming off patent which requires the pipeline to be filled with candidates which are likely not just to make it to market but also provide an adequate return on investment and provide replacement revenues to sustain growth; ever increasing R&D complexity and a vast number of new technologies to harness; how best to move away from the blockbuster model towards launching many more drugs with individually smaller revenues while reducing the number of line extensions and "me too" drugs; where to locate new R&D facilities and whether relocate existing ones in order to balance skills with costs. Overcoming such challenges can seem overwhelming and internal resources may be insufficient or already over-stretched to be able to come up with new strategies and business practices to succeed in this changing environment. To read more... Pharma 2020: Virtual R&D We work closely with our clients to help formulate a new strategy for success and achieve increased performance by improving the efficiency and effectiveness of the company’s R&D operations. Our advisors have a wealth of industry based R&D experience and expertise with a deep understanding of finance, tax, risk management/compliance, IT systems, operations and human resources, we help our clients evaluate their R&D Strategy & Portfolio Management, improve management and control, and identify cost saving initiatives.

US
Principal, Global and US Leader
Tel: +1 (646) 471 2268
US
Principal, US Co-leader
Tel: +1 (617) 530-4913
UK
Partner
Tel: +44 (20) 7804 2268

 

Supply chain & distribution

Today companies are concerned about the cost and efficiency of thier supply chain. Increasingly pharmaceutical companies are seeking to outsource manufacturing and distribution to countries like China and India. However for the newer technologies such as biologics this may not be possible due to the complexity of the manufacturing and delivery processes. We work with our clients to help them identify options at an early stage of the business and product planning process. We work with them to understand the potential risks , find solutions and identify the appropriate overseas partners to help them reduce costs or gain entry in to new markets.

As science moves the industry from a 'one size fits all' approach to care, to one of segmentation, personalisation and wellness, so the supply chain will need to evolve. The successful supply chain of the future is one built around flexibility, responsiveness and reliability - shifting the supply paradigm from costly make to stock to efficient make to order. Supply chains will offer the techniques to commission and decommission supply chains at the touch of a button, to rapidly service new products and markets. The supply chain of the future will offer alternate supply models to match shifts in the provision of care – direct to consumer rather than via the wholesaler/pharmacist. It will promote the use of advanced product design and packaging techniques to drive patient compliance and protect Intellectual Property and the adoption of inventory tracking tools to eliminate counterfeit product and parallel importing risks.

The supply chain of the future will provide these capabilities with lower transaction costs and with much reduced capital expenditure. The rise of the virtual supply model, the selection of best or breed partners, will allow the supply chain to develop a catalogue of services driving the transition from order processor to strategic enabler of the business – a partner fully aligned and integrated into the broader business and driven by the evolving requirements of the end consumer – the patient.

UK
Partner
Tel: +44 (20) 7894 8234
US
Director
Tel: +1 (312) 298 3368
Partner
Tel: +1 703 918 4522

 

Commercial operations

In the current environment of poor product pipelines and broader customer bases, the traditional sales and marketing model of driving revenue with ever larger sales forces is no longer sustainable. Rather organisations will evolve to become more efficient and deliver differentiated effective messages tailored the specific needs of diverse customer segments including patients, insurers, government and physicians, and the changes on product mix. PwC can work with you in targeting sales and marketing resources accordingly to the customer needs and the relevant regulations (compliance), avoiding components that are not helping to maximise the return on invesment; improving the division of roles between the headquarters and local maketing companies with redefinition of planning and communication systems that work effectively between global, regional and marketing affiliates. To read more... Pharma 2020: Marketing the future.

US
Director
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