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Plenary Sessions
Therapeutic Workshops*
Business Roundtables
One thing is evident about Pharma’s R&D strategies – they’re changing. The focus is now more heavily on D than R, and what’s left of R has been concentrated into fewer therapeutic areas of priority. Add to that pervasive personnel cutbacks and reorganization of research teams, and many in our industry are left wondering where biotech fits into Pharma’s R&D strategy now and in the future. Kick off the BIOCEO event with an opening plenary session comprised of the senior executives from Big Pharma who are tasked with analyzing, recommending and executing on the decisions that affect the future of R&D for pharma…and biotech.
Join an interactive discussion with investors and analysts who have experienced the ups and downs of the biotechnology industry over the last 10-plus years. How is the economic downturn affecting their decisions on investments in the sector? Will biotech lead or lag the recovery? Does the biotech business model need to change? Where are they placing their bets in 2009?
Obesity has reached epidemic proportions, and the few novel therapies currently available to treat the condition produce only modest weight loss. Obesity is also a precursor to several other chronic conditions with high unmet medical need including diabetes and cardiovascular disease. 2009 will be an eventful year with several companies planning to announce pivotal obesity data. Hear from several leading companies and clinicians discuss the most promising obesity products that could dramatically expand this therapeutic category.
With safety concerns plaguing the use of erythropoietin stimulating agents (ESAs), the last two years have brought controversy to the anemia treatment market. Declining use of ESAs has left a gap in the anemia treatment paradigm that remains to be filled with safer and more convenient options. New treatments stand to be approved in 2009— how will the FDA react to the next generation and how will physicians incorporate these into their practice? Listen to experts in the field address these and other questions related to treatment landscape for anemia.
In an era when biotech drugs are under intense reimbursement pressure, it may come as a surprise that exceptionally high cost treatments for rare genetic disorders continue to attract the attention of industry and investors. The promise of market exclusivity, molecularly defined patient populations and clearly understood mechanisms of action are ideal profile in today’s challenging regulatory, pharmacoeconomic and capital environment. With 2008 sales of over $2 billion, genetic disorders known as Lysosomal Storage Diseases (LSDs), continue to be an area of high unmet medical need. Join us as leading physicians and companies specializing in this unique field discuss how best to address these development and commercialization challenges.
The paradigm for the treatment of Hepatitis C is changing rapidly with the introduction of Direct Acting Anti-Viral therapies (DAAV). Leading the way are the protease inhibitors which may offer shorter treatment durations with improved cure rates as measured by sustainable viral load reduction. Not far behind are other classes of DAAV therapies such as the nucleosides and non-nucleosides. In 2009 the market will get its first look at phase III efficacy from an oral combination DAAV therapy. This panel will explore the changing HCV landscape, role of new diagnostics, and factors driving the market. Our experts will also compare and contrast HCV and HIV treatment patterns and discuss the implications on product life cycles and the future of HCV combination therapy.
With no new treatments approved since 1959 and currently available therapies hindered by lack of efficacy and low compliance, gout, or metabolic arthritis, has recently garnered attention from biotech investors. Two new drugs to treat gout have demonstrated efficacy and await FDA approval in 2009, but questions regarding safety remain. If approved, how will the availability of new drugs change the treatment landscape? Listen to companies at the forefront of gout drug development as well as experienced rheumatologists discuss the future of this dynamic therapeutic landscape.
As the seventh most common cancer in the United States, malignant melanoma represents 75% of skin cancer deaths in the U.S. However, the large and growing unmet medical need is also a siren song for hopeful oncology drug developers. Spontaneous remissions make early studies notoriously unreliable. Will pivotal melanoma studies in 2009 once again disappoint, or will an emerging company triumph in oncology’s most coveted and elusive indication? Hear oncologists from industry and academia opine on the future of melanoma treatment options and how best to circumvent the difficulties of clinical trial design.
With the approval of Betaseron in 1993, the treatment paradigm for multiple sclerosis (MS) dramatically changed from merely treating the symptoms of the disease to having the ability to modify its actual course. Avonex , Rebif and Copaxone followed soon after, and more recently Tysabri, which has been a game-changing drug, yet fraught with controversy. Although these agents have succeeded in reducing disease activity, relapse rates and progression of disability, more effective, safer and (easier) modalities remain the new frontier for disease modification. Several oral agents have emerged in late stage clinical trials—will the data live up to the promise? If so, will they immediately replace the potentially unpleasant and compulsory infusions and injections that have become customary? A panel of multiple sclerosis experts will explore the future of MS treatment with an emphasis on where new oral disease modifying therapies (DMTs) will fit in.
*BIO is pleased to partner with Gerson Lehrman Group (GLG) for the Eleventh Annual BIO CEO & Investor Conference Therapeutic Workshops. A number of the physician experts participating on these panels are members of the GLG Councils who educate and provide insight to decision makers through a wide range of consulting methods, including telephone consultations, expert surveys and seminars. For more information about GLG, please visit www.glgroup.com.
After one of the most exciting and historic presidential elections in recent history, it’s now time to get back to business and ascertain how the current, yet ever-changing, political environment will affect the biotechnology and pharmaceutical industries. Join a lively discussion among congressional staffers, biotech political experts, and policy lawyers as they predict the impact of the change of power on the industry and discuss how the incoming administration will likely come down on the policy matters most critical to the drug development process.
The 2009 BIO Thomson Reuters Investor Perception Study is an in-depth assessment of Wall Street’s views of the biotech industry, its current challenges, its relative valuation, and the outlook for the coming year. The study was fueled by a combination of telephone interviews and an online survey of investment professionals. The purpose of the study is to inform and improve communications between biotech executives, shareholders and policymakers. BIO and Thomson Reuters look forward to announcing the results in February at the 11th Annual BIO CEO & Investor Conference.
Licensing deals allow big companies to tap into the entrepreneurial spirit of their smaller counterparts and to fill in their pipelines without having to do the upfront work. Likewise, these sought-after alliances give the small companies the non-dilutive capital and scientific validation that they crave. This panel will focus on recent deals that were characterized by especially impressive upfront payments. Business development professionals from some of the companies involved in the past year’s licensing deals will discuss how they successfully forged these deals, how they and their licensing partner calculated the deal terms and upfront payment$ that they did, and whether their deals serve as realistic benchmarks for future licensing around the industry.
Alternate financing strategies are a hot topic these days as more and more companies turn to sources other than Wall St. to fill their cash coffers. The concept of monetizing royalties is not a new one, but as the market for these transactions has matured, so should a biotech company’s thinking about the best strategies and tactics for negotiating deals of their own. Participate in a discussion with top royalty investors and industry executives, as they review the critical factors to consider in evaluating and executing a monetization deal and how to extract the most value from your assets.
In a recession year, characterized by a non-existent IPO window, more risk-averse public and private investors, and the constant need to conserve cash, 2008 was the year of M&A. Many companies in the past year turned to mergers and acquisitions, some of historic scope, as a way to preserve their assets or put their stake in the ground to hold a strategic position. Listen to the foot soldiers who were involved in some of the notable M&A deals of 2008, as they discuss how license deals and partnerships evolve into M&A, the rationale for doing these deals, and what makes for a successful transaction.