2009 Plenary Sessions and Panels
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Plenary Sessions
Therapeutic Workshops
Business Roundtables
Plenary Sessions
President Obama’s commitment to passing comprehensive health reform this year has heated up Washington in 2009. The ins and outs of health reform are complex, and this panel will provide an in-depth look at health care reform – politics, policies, and impact on the biotechnology industry. Expert panelists entrenched in the debate will discuss the current political atmosphere surrounding health care reform, what policies are being deliberated, what policies are likely to be implemented as well as examine specific issues such as biosimilars and reimbursement strategies that affect the biotech industry. Audience members will have the opportunity to pose their own questions to panelists.
The prospects for an IPO window, in addition to new investment models, creative big pharma pipeline deals, government research funding and healthcare reform – are key catalysts for the growth of the biotech industry in 2010. What do we need to offset investor reticence around drug development risk and to reinvigorate public capital access and capital inflows into the biotech sector again? Which companies are likely to benefit? Is it possible to anticipate which business models or strategies will be out of favor? This year’s BIO Investor Forum closing panel will focus on upcoming milestones, events in the industry that might signal, despite a challenging environment, the biotechnology industry is poised for a new phase of growth.
Therapeutic Workshops*
Progress in the prostate cancer pipeline in 2009 both captured the attention of healthcare investors and drew the oncologist closer to the field. Today prostate cancer affects 1 in 6 men during their lifetimes, and despite remarkable advances in early diagnosis and in the fundamental understanding of prostate cancer biology in the last 30 years, the disease remains a leading cause of cancer death worldwide. Targeted therapies, genetic research and combination therapies have been key to driving innovation, and the prostate cancer drug market is projected to experience $2 billion in growth through 2018. Hear from clinical-stage companies and the thought leaders in the field on new therapies in development and implications for clinical practice.
The world is no stranger to flu pandemics, but the focus for influenza in 2009 has been on the emergence of a new strain, one that falls outside well-documented viral and epidemiological patterns. H1N1 reached pandemic status in less than six months, and the U.S. continues to report the largest number of cases worldwide. While a majority of the cases have been resolvable, the concern that H1N1 could intensify has drawn considerable attention to vaccine development in the biotech industry. The threat of this strain, real or hyped, underscores the importance of the government’s collaboration with the pharmaceutical and biotech industries and the race to complete clinical development and scale-up manufacturing. This panel will explore the challenges presented by H1N1 and focus on companies vying to emerge as the frontrunner in flu vaccine development.
Insights into the molecular and genetic basis of disease are driving new product opportunities and categories in patient diagnosis, prognosis, monitoring and treatment. Promising improved treatment outcomes and treatment tailored to genetic etiology and disease pathology, the field of molecular diagnostics and genomics offers the opportunity to invest in new products with reduced development costs, faster product cycles and more quickly realized returns. Perhaps even more exciting, product innovation in personalized medicine may play a role in optimizing and expediting the development of targeted therapies for many cancers, and other conditions among validated patient populations. Focusing on these new markets, industry executives and investors will guide a discussion of some of the most compelling new therapeutic products, technologies and applications in personalized medicine.
Arthritis, lupus, gout and other debilitating inflammatory conditions are chronic autoimmune illnesses characterized by an immune system that has become misdirected. An estimated 43 million people in the United States alone develop autoimmune rheumatic conditions. By 2020, there will be 60 million diagnosed. Unfortunately, many patients do not fully respond to available treatments and those treatments that are available are known to cause further complications, such as PML. With the discovery of new molecular targets and pathways, companies are advancing new classes of medicines for autoimmune inflammatory diseases, including oral kinase inhibitors in RA and monoclonal antibodies in lupus. The current pipeline may hold the answer for millions of patients. Companies with late-stage compounds for arthritis and inflammatory diseases, key opinion leaders and advocates will provide insights on experimental new autoimmune therapies, clinical need and application and the development landscape.
*BIO is proud to be working with Panel Intelligence, Inc., formerly MedPanel, Inc., to provide leading industry experts on these therapeutic workshops. As a fully committed and capable research partner, Panel Intelligence works closely with BIO to identify objectives, recruit experts, elicit information, and synthesize results. Panel Intelligence's domain expertise, global network of experts, and proven online methods can provide due diligence on one particular company, investigate a particular space, evaluate an IPO, or identify market trends and consumer preferences.
Business Roundtables
The window for biotech initial public offerings has been virtually locked tight since 2007, when only a few quality biotech companies successfully sold shares at reasonable valuations. For many that made the leap between 2004 to 2007, the public market ride has been anything but smooth. Today a majority of these companies are in desperate need of cash infusion and contributing to the current low tolerance for risk among new issuance investors. What will it take to open an IPO window, and will this public financing opportunity resemble any windows of the past? Biotech investors and market observers agree that only the companies with late-stage products, strong clinical data and solid pharmaceutical partnerships may squeeze through, attracting only the sophisticated investors more comfortable with taking on risk. Come hear banker, buy-side, venture investor and industry perspective - and new definitions - for initial public offerings, an IPO window, and what is needed to bring the industry a breath of fresh air and capital.
Clinical trial design is of critical importance for successful product development and marketing outcomes on the pathway to building new brands and lifesaving therapies. As clinical studies grow costlier and more complex from a regulatory perspective, biotech companies are faced with the challenge of designing studies that achieve solid clinical and long-term commercial objectives within a truncated spending model. Companies need to choose the right indication and consider the best route of drug development to yield the highest success rate and value. Some companies are electing to only perform development through Phase 2. Another area of current focus is adaptive clinical trial design, which allows for shorter and less expensive clinical studies, but has the potential to produce more complex statistics. This panel will explore how to undertake meaningful clinical trials design with a broader objective in mind – to attract big pharma or biotech as a future business development partner. Panelists will discuss traditional design vs. adaptive design issues, and how short-sighted and rational clinical trial practices can limit partnering opportunities or drive more appealing transactions.
The challenges posed by today’s economic environment have given way to a new class of deal structures. Traditionally part of licensing agreements, option-based deals have now ventured into M&A as way for pharma and biotech to de-risk the portfolio. In addition, many recent acquisitions are with existing partners – a way to get on the inside before making the plunge. Is this trend here to stay or do tough times equal tougher terms for Biotech M&A? Are these deals net positive for biotech, pharma or both? In this panel we’ll discuss these new deal structures and those that might be seen in coming months.