2009 BIO International Convention Session List
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Purchase Access to all sessions or buy by Track and you are guaranteed to gain insight into biotechnology business issues from world-renowned speakers and panelists on global issues and discoveries.

Buy the complete set of 22 tracks (170+ sessions and all Super Sessions). You will have access to 1,000+ speakers and their PowerPoint slides (where available.) The Super Sessions are only available in the complete set. They are not sold separately.

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Super Sessions

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The U.S. biotechnology industry today faces a confluence of legislative, judicial and executive branch developments that will profoundly affect its business model for decades to come. Biotechnology, as an industry singularly dependant on its intellectual property assets, must consider the impact of ...
 
A deep global recession. Risk-averse investors. Depressed valuations. Demanding regulators and payors. By any measure, these are challenging times. But are they unprecedented? What makes this crisis different? How are companies adapting, and what lies ahead? Ernst & Young — which has been ...
 
Biotech has developed treatments and cures and also created high quality jobs, yet continued investment and innovation cannot be taken for granted. With the global economy in a tailspin, job losses are mounting and investments are decreasing. The new U.S. administration plans to reform health care a...
 
Biotech 2009 — Life Sciences: Navigating the Sea Change is Burrill's 23rd annual report on the state of the biotech industry, highlighting the critical developments in 2008 (across all sectors, not just human health care but also biogreentech, both in the U.S. and globally). The presentation w...
 
The U.S. government is engaged in the full spectrum of product development from discovery to delivery. It is in the unique position to characterize emerging public health problems, foster innovation, conduct research and establish unique partnerships to introduce life saving products to global popul...
 
This session will explore the intersection between public health and business, which has been heightened by the domestic and global economic crisis. The burden on public health programs and the cost of chronic disease conditions provide, in part, an impetus for the health reform debate in Washington...
 
Controversy has been swirling around current legislative and administrative efforts to reform the U.S. patent system. But equally important, and less discussed, is the future of the Patent Offi ce itself. This super session will focus on longer range views of what the model patent office of the futu...
 
Achieving Regulatory Approval

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In October 2007, Congress passed new legislation giving the FDA a number of new powers, the most important of which is the authority to require companies to establish risk management programs called REMS (Risk Evaluation and Mitigation Strategies). REMS are widely expected to have an enormous impact...
 
Bioethics

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Advances in biomedicine increasingly allow researchers and clinicians to address disease on the fundamental, molecular level and tailor treatments to a patient's individual genetic makeup—creating a powerful movement among patients to harness their own clinical and genomic data in support of m...
 
Biomarkers

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Biomarkers are very much in focus since the critical path initiative of the FDA has put pressure on new and valid biomarkers accompanying pharmaceutical development. The session is to give an overview of the status of approaches across the industry and also discuss business models for biomarkers in ...
 
Business Development

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M&A activity reached historic levels in 2007, and while activity is expected to dip in 2009, M&A will continue as companies are expected to continue to make acquisitions at fi re-sale prices in an attempt to fi ll sluggish pipelines. All of this means that intellectual property due diligence —...
 
Clinical Research/Clinical Trials

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Enrolling trials is difficult, costly and competitive for industry sponsors. For study sites, trials are time-consuming and labor intensive, yet a way to be part of cutting edge research and resulting publication. For patients, clinical trials offer hope, access to the most current approaches to the...
 
Devices and Predictive Diagnostics

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Some of the deadliest cancers are due to the lack of early detection, leaving cancer unchecked into late stages of disease. Here we focus on compelling nanomedicine solutions to address early cancer detection, especially for pancreatic and ovarian cancers. The panelists represent academic, clinical ...
 
Drug Delivery

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Drug Discovery and Development

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In-life toxicology studies are expensive in terms of man-power, amount of materials and time required to perform a complete evaluation. Lower cost, faster and higher throughput screens that can predict those compounds that are not worth the cost and expense of conducting pilot toxicity studies will ...
 
Exciting Science 2009

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In 2007, scientists published research indicating that they had been able to induce mouse skin cells to be "reprogrammed" to an embryonic state. Science has continued to build upon iPS cells, broadening their applicability and learning more about how they might fit into personalized medici...
 
Finance

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Stiff government competition to attract and retain biotech has created a slew of tax credits, incentives and cash grants. Firms — from development stage to multinationals — can supplement operating capital with incentives and grants. The US federal government recently enacted refundable ...
 
Food and Agriculture

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The new generation of high-performing energy crops requires a compelling value proposition for the landowner/farmer, an economic source of energy for the end-user, and effective collaboration with all participants in the supply chain. Representatives from both development and commercial-stage feedst...
 
Global Biotechnology Issues

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With the biosimilar regulatory pathway in sight in markets around the world, companies from the biopharma innovators to traditional small molecule generic houses to well-funded start-ups are exploring how they can enter the biosimilar business. A biosimilar strategy can be either defensive or offens...
 
Growing the Biotech Workforce

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Biotechnology companies around the world face the challenge of finding enough of the right people to make their dreams real. As China and India build their own biotech industries, the "brain drain" from less developed countries is beginning to flow back. Smaller developed countries like Ir...
 
Industrial and Environmental

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The capacity via modern biotechnology to control phenotype via gene regulation and expression in a highly targeted manner is a vital component in the new methodologies for value-adding in biological systems. In a forestry context, control of tree phenotype via such precise methods has and will conti...
 
International R & D Presentation

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This session will explore several successful examples of cooperation between industry and academia in order to advance medical science and transform therapeutic development. It will show the pitfalls and best practices of Public Private Partnerships and the 'open innovation' model that is so quickly...
 
Legal Issues

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Biotechnology companies routinely enter into contracts with a variety of business partners. Too frequently, they are signed without considering the downstream consequences of overly generous/one-sided indemnification provisions or the liberal granting of additional insured status. Failing to realize...
 
Manufacturing of Biologics & Drugs

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FDA recently announced the initiation of a pilot program for QbD submissions for biotech products. While this has been viewed positively, it has also generated some concern within biotechnology companies on the exact nature of submissions that the FDA is expecting as part of this pilot, and the pote...
 
Policy

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Companies that develop therapies for rare diseases and conditions face unique challenges that stem from the small patient populations available for enrollment in clinical trials and the inherently small markets for these products. Starting with the enactment of the Orphan Drug Act, the federal gover...
 
Public Relations/Investor Relations

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Failure to efficiently, timely and effectively communicate clinical trial results and FDA actions can result in massive stock price declines, angry stockholders and employees, EMEA, FDA and SEC investigations, painful delays in future trials, and even compromised patient safety. Extreme care must be...
 
Technology Transfer/Licensing

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Research collaborations between academia and industry along the entire partnership continuum have been a cornerstone of the biotechnology industry for many years. But today, rather than serving primarily as a corridor for technology transfer, innovators on both sides of the fence are exploring new p...
 
Translational Medicine

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These are hard times for early stage ideas to become commercial realities. Patients are not benefi ting from promising new treatments. Until recently industry was only interested in less risky later stage products. Today, there is a better win-win approach. Start-ups provide promising programs to pu...
 
Vaccines

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The emergence of molecular approaches to diagnosis and treatment has led many to believe that the era of the blockbuster, the one size fits all, premium priced, primary care product, is giving way to specialty products targeting genetically defined niche populations. In fact a new generation of bloc...
 
Associated Educational Opportunities

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Biotechnology Entrepreneurship Bootcamp

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CD-ROM: $225 attendees, $325 non-attendees
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The intensive two-day course is designed for CEOs, CSOs, business development professionals of early stage companies in the life sciences (emphasis on human health therapeutics and diagnostics) and academic scientists who are aspiring entrepreneurs. Participants will come away with a clear idea of t...
 
The intensive two-day course is designed for CEOs, CSOs, business development professionals of early stage companies in the life sciences (emphasis on human health therapeutics and diagnostics) and academic scientists who are aspiring entrepreneurs. Participants will come away with a clear idea of t...
 
Demo Sessions