CHICAGO, July 6 /PRNewswire/ -- Foley & Lardner LLP today released the results of its first annual Life Sciences Survey which examined key issues and opportunities facing executives within the life sciences industry. Despite an anticipated increased impact of Sarbanes-Oxley and tighter regulatory involvement, the survey reveals that innovation due in part to increased funding is expected to continue across the board. "The survey results indicate several unexpected trends," said Steve Bent, chair of Foley & Lardner's interdepartmental Life Sciences Industry Team and founder of the firm's life sciences practice. "Life sciences executives are hopeful for increased funding, but the question is whether the funding will be enough to offset the expenses of HIPAA, Sarbanes-Oxley and stricter FDA approvals." Below is a brief overview of key findings. Respondents expect Sarbanes-Oxley will impact life sciences industry more in 2004 vs. 2003 -- One-third of life sciences companies surveyed feel that Sarbanes-Oxley disclosure and confidentiality requirements are impacting their business more this year (30.3%) than last (23.2%), due to a greater emphasis on corporate governance and an increased awareness of its impact. Life sciences executives view increased regulatory involvement to have significant impact -- Nearly one fifth (17.8%) of all respondents feel that federal enforcement action on drug pricing or marketing will have a significant impact on their business in 2004. One fifth (19.6%) feel that Congressional follow up on 2003 Medicaid/Medicare reforms will be the most significant industry development in 2004. FDA will maintain strict requirements -- Despite the increase in medical device applications, more than half of the survey respondents from Foley's study feel the FDA will maintain the same strict level of approval in 2004 as in 2003 (55.3%). There is an inconsistency, however, since the FDA has indicated that it will become stricter in the approval process moving forward. The clinical trial process continues to complicate drug development -- 56.3% of industry executives believe the clinical trial process will stunt pharma development if left unchanged. A majority of respondents say the clinical trial process continues to have a negative impact on pharma development. The biggest obstacles include conflicts of interest and unavailability of subjects. Venture capital will continue to be an important source of funding -- Respondents indicated that biotech companies can expect more VC funding in 2004 (51.7%), a sign that the economy is turning around. However, the investment expectations of life sciences companies have yet to be realized fully. Life sciences innovation will continue across the board According to Foley & Lardner's survey respondents, life sciences executives expect the most significant 2004 industry developments to come from the following three areas: -- Nanotechnology applications in biomedicine (21.4%) -- Consolidation in the global pharmaceutical sector (19.6%) -- Congressional follow-up on 2003 Medicaid/Medicare reforms (19.6%) Other areas include accessibility of financing for early-stage biotech (16%), advances toward "personalized medicine" (12.5%) and regulatory policy on "biological generics" (10.7%). That the respondents were evenly split among these areas seems to signal both the dynamism and the uncertainty that characterizes the life sciences sectors. Biotech spending will increase to protect against terrorism -- According to 80.3% of survey respondents, biotech spending is on the rise in response to Homeland Security issues following the events of the past three years. Despite the fact that Congress has indicated its willingness to support the "Project BioShield" initiative, questions remain over where the federal dollars will come from and which companies will benefit. Life sciences executives are concerned their R&D is not protected internationally -- Half of the executives surveyed in the study feel R&D is not safe from overseas patent infringement (50%). Unfortunately, there is little companies can do to correct this, aside from working with international trade representatives, and most companies cannot afford to have effective lobbying arms outside of their jurisdiction. Many feel the Blockbuster Drug model still works -- Even with an outdated approach, more than half of the life sciences executives surveyed in Foley's study feel the model is still applicable in today's environment (55.3%). While the industry has spoken about the need to reevaluate drug development and marketing, these results are further proof that an economic reorganization of the pharmaceutical sector is lagging behind consolidation. Methodology In May 2004, Foley & Lardner worked with research firm Estrela Marketing Solutions to facilitate and analyze the results of a national survey to measure the attitudes within the life sciences industry. Estrela Marketing Solutions distributed a survey to 10,000 CEOs and General Counsel of life sciences companies. The survey was distributed to and completed by organizations via an interactive Web site. A total of 56 surveys were returned from life sciences companies. About Foley & Lardner Foley & Lardner is a provider of legal counsel to global companies. The firm's experience encompasses a full range of corporate legal services. Foley & Lardner's nearly 1,000 attorneys understand today's most complex business issues including corporate governance and compliance, securities, mergers and acquisitions, litigation, labor and employment, intellectual property and IP litigation, and tax. The firm offers total solutions in the automotive, life sciences, financial services, insurance, health care, energy and sports industries. The Web site can be found at http://www.foley.com .
SOURCE Foley & Lardner LLP