The debates over the Obama Administration’s health care reform law, and, more recently, the federal budget deficit and national debt have focused attention on the growth in costs of the Medicare program. Three approaches to reducing Medicare expenditures command the most attention. Under the first, changes to the Medicare delivery system – such as accountable care organizations (ACOs) and medical homes – are believed to have the potential to reduce the growth in costs in the program over time. Under the second, tinkering with the reimbursement formulae in the Medicare program – pejoratively, government “price fixing” – will reduce the price that Medicare pays for an item or service, thereby reducing the growth in costs. A third approach – converting Medicare to a premium support or defined contribution model – has been passed by the House of Representatives, but has failed in the United States Senate.
This article addresses the effect of these various approaches on Medicare payment for outpatient prescription drugs and biotechnology products. It begins by analyzing the Administration’s ACO regulation and the effect that this regulation may have on reimbursement for outpatient prescription drugs and biotechnology products. It then addresses legislative proposals to alter the Medicare reimbursement formulae for these products. It concludes by speculating on how the Medicare reform legislation passed by the House of Representatives might affect reimbursement for outpatient prescription drugs and biotechnology products.Full details at the Journal of Commercial Biotechnology
The mission of the Food and Drug Administration (FDA) is to promote public health by ensuring the safety and quality of food and medical products sold in the United States. At this year's annual Biotechnology Industry Organization (BIO) convention, significant discussion revolved around the appropriate interpretation and execution of that mission.
The BIO meeting hosted 15 646 participants from across industry, government and the nonprofit sector, focusing on the current state of the biotechnology industry, as well as its challenges in seeking to further improve public welfare. Perhaps partly because this year's meeting was held in Washington, DC – the seat of the federal government and of BIO's headquarters – much attention was paid to the US regulatory environment. In particular, attendees debated the quandary faced every day by the FDA: how to enable access to novel therapies quickly, but only once their safety has been certified.Full details at the Journal of Commercial Biotechnology
As a result of the global recession that began in 2008, life sciences companies face a groundswell of new business and regulatory pressures that includes health care and patent reform, increased pricing pressures, and diluted markets. Bringing new products from discovery to market is becoming more expensive and unpredictable. In the pharmaceutical sector, some predict that the age of the blockbuster drug has ended as generics present a growing threat to the pharmaceutical giants. Further, with a large number of key patent expirations looming through 2014, analysts expect that large pharmaceutical companies will lose over US$150 billion of revenues of brand name drugs.
In response to declining sales and rising R&D costs, the life sciences industry is pursuing new market opportunities by expanding beyond the developed markets of the United States, Europe and Japan, and into emerging markets such as China and India. Despite market uncertainties, however, venture capital funding in the life sciences sector (including pharmaceuticals and medical devices) is on the rise with $2.1 billion going into 206 deals during the second quarter of 201l, an increase of 37 per cent in dollars and 12 per cent in deal volume. To survive – and thrive – in these tumultuous times, both large and small life sciences companies face pressure to develop new products and technological advancements.
Patents are pivotal to the life sciences industry. In order to succeed, life sciences companies must distinguish themselves from their competitors through their intellectual property portfolios. A successful patent portfolio represents a well-reasoned business strategy, where each patent is a single strategic building block in a larger portfolio that reflects present and future business objectives. A strong patent portfolio is also important in the current life sciences investment climate, where venture capital funding is often dependent on whether a company has secured its intellectual property assets, thereby validating a company's technology and demonstrating its commercial potential. Although building and maintaining a strong patent portfolio is important for all life sciences companies, it is most critical for early-stage companies. Patent portfolios are often the driving force for major events in the life cycle of a life sciences company, including mergers and acquisitions, public offerings, venture capital investment, strategic collaborations, joint ventures and litigation.
As a result of recent measures taken by the US Congress, the US Patent and Trademark Office (USPTO) and the US Supreme Court to reform the current US patent system, life sciences companies must respond with strong patent strategies that address these reforms without sacrificing the company's competitive edge in the marketplace. Such comprehensive technology strategies must maximize patent coverage of a company's current core technology and future improvements, monitor the patent landscape and explore ways to patent white space, and consider cross-licensing opportunities with competitors. With these strategies in place, life sciences companies can withstand patent reform and ensure their success in today's competitive and rapidly evolving global commercialization landscape.Full details at the Journal of Commercial Biotechnology
There are various definitions of an entrepreneurial university, yet there is a lack of agreement about its core components. This article defines the five key characteristics of an entrepreneurial university based on examples of successful bio-clusters in the United States and Europe, and suggests an agenda for stakeholders.Full details at the Journal of Commercial Biotechnology
This article, written from an industry perspective, examines the current trend towards the implementation of single-use disposable technologies in the biopharmaceutical and biotechnology sectors. Single-use technologies are generally sterile, plastic disposable items implemented to replace traditional pharmaceutical processing items that require recycling, cleaning and in-house sterilisation. The forces driving the technological change are a mix of process efficiencies (including cost reduction) and sterility assurance. This article examines the advantages of some single-use systems used for aseptic processing, although in doing so a cautionary approach is adopted, particularly with regard to the validation requirements and practical considerations when such technologies are implemented.Full details at the Journal of Commercial Biotechnology