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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. Contact Brian Riewerts , or Jeff Rosenbaum
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.
Regulatory complianceAt 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. Contact Brian Riewerts, Peter Claude or Jeff Rosenbaum
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. Contact Markas Marriott
Business strategy
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.
Contact Jo Pisani or Peter Kurtz
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 corporate finance advice to companies in the pharmaceutical sector. Our team combines extensive corporate finance expertise with deep industry knowledge. Contact Neal Ransome or Sujay Shetty for further information. Our services include:
Valuation
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.
Alliances
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. Contact Jo Pisani
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. Contact Jo Pisani
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. Further information can be obtained from Melanie Butler, Ben Wilcox, Doug Strang or Joe Braido
Transactions
Further information on Transactions can be obtained from Joe Balog, Gregory McGahan, Greg Nahass, Sujay Shetty, Lucy Stapleton, or John Sunderland. Link here for full details of our Transactions services
Tax
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
Contact Mike Swanick or John Kelly
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:
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.
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For further help in this area, please contact Sandy Johnston, Michael Mentesana, Kate Moss, Neil Patel or Andy Brown
| 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. Contact Sujay Shetty or Beatrijs Van Liedekerke 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. For further information on this issue please contact: Todd Evans, Mike Keech, or Johnathon Marshall |