If you are heading to 2009 BIO International Convention in Atlanta, we thought we'd save you a little time and highlight some of our picks for the most interesting sessions at the conference. They are listed below in no particular order. There's plenty more to choose from. You can download an electronic guide to the conference here.

The Challenges and Opportunities Surrounding Healthcare Reform
Wednesday Keynote Luncheon
Category: Keynote Luncheons
Date/Time: Wednesday, May 20, 2009, 12:00PM - 1:30PM
Location: Hall A3, Building A, Level 1

Driving Health-Care Reform: Cruise or Crash? The wheels are in motion for U.S. health-care reform. The Obama Administration and Congress are exploring how to restructure the delivery of the nation’s health-care services with an eye toward improving quality, expanding coverage, and reducing costs — a lofty, sometimes a conflicting, set of goals. President Obama has signaled that reform is best determined through a rigorous debate in Congress. As part of this deliberation, efforts are under way in the House and Senate, driven by teams from both political parties, to legislate this summer. This panel will preview the congressional debate as republican and democratic policy leaders and political operatives discuss their differing perspectives on the challenges and opportunities associated with the comprehensive reform of the U.S. health-care system.
Moderator: Susan Dentzer Panelists: - Senator Tom Daschle - Senator William H. Frist, M.D - Governor Howard Dean - Karl Rove

Public Health And Business: Is the Sum Greater than the Parts?
Category: Super Sessions
Date/Time: Wednesday, May 20, 2009, 2:00PM - 3:30PM
Location: Georgia World Congress Center
Speaker: Joshua Boger

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. The burden of disease globally is expected to be focused upon with even greater intensity under the Obama Administration, creating the need for health care businesses to reassess their own focus. Panelists will also discuss the implications of a constricting global economy as it relates to meeting the global public health challenge. Join this panel session and hear from public and private sector leaders who will play a key role in shaping the public policy and business response to the public health challenges we face here and around the globe.

 

Global biotechnology Innovation: Connecting the Laboratory, the Field and the MarketplaceCategory: Super Sessions
Date/Time: Wednesday, May 20, 2009, 8:00AM - 9:30AM
Location: Georgia World Congress Center
Speaker: Jim Curran

The US 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 populations for improved health. Most biotechnology companies are unaware of the untapped, powerful and comprehensive potential for partnering with government scientists or agencies around R&D, market research, and product uptake or implementation. This session will showcase the breadth of opportunities for public-private partnerships though illustrative case studies from the CDC, the CDC Foundation, NIH, Carter Center, Bill and Melinda Gates Foundation that include partnerships with NGOs, Proctor & Gamble, Google, WHO, big PHARMA, and Ministries of Health.

Category: Super Session
Date/Time: Tuesday, May 19, 2009, 4:00PM - 5:30PM
Location: Georgia World Congress Center
Speaker: G. Steven Burrill

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 healthcare but also biogreentech, both in the US and globally). The presentation will discuss the sea change that has occurred with the permanent restructuring of the capital markets making capital more difficult and expensive to secure. The changing world of healthcare innovation and delivery, and the increased concern for global climate change, energy security and environmental sustainability are the major issues that will make 2009 very challenging as we come to terms with a business, policy and economic environment that is largely unfamiliar to us all.

Biotech Intellectual Property at the Crossroads
Category: Super Sessions
Date/Time: Monday, May 18, 2009, 2:00PM - 3:30PM
Location: Georgia World Congress Center
Speaker: Gregory Glover

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 the biggest proposed changes to the patent laws in over 50 years. In addition, Congress is poised to create an abbreviated FDA regulatory pathway for follow-on biologics while, at the same time, attempting to establish a framework that will fairly protect the intellectual property, including patents and clinical trial data, developed by biotechnology innovators. In this session, experts will identify key policy issues at the intersection of intellectual property and healthcare, and apply lessons learned from 25 years of generic drug regulation to explore the role of patents, clinical data protection provisions, and other policy tools to ensure continued incentives for biotechnology innovation.

Out or In, Big or Small: Industry and Venture-backed Out Licensing Deals and New Companies – What Are We Looking For?
Category: Breakout Sessions
Track: Business Development
Date/Time: Tuesday, May 19, 2009, 2:00PM - 3:30PM
Location: Georgia World Congress Center
Room: B313
Speaker: David Rosen

This panel will discuss two out licensing deals with different emphases and outcomes. We will focus on the management strategies of big Pharma and venture investors. We will attempt to highlight the emphasis different investors place on investment criteria.

 

FDA Town Hall
Category: Breakout Sessions
Track: Achieving Regulatory Approval
Date/Time: Wednesday, May 20, 2009, 10:00AM - 11:30AM
Location: Georgia World Congress Center
Room: B315
Speaker: Douglas Throckmorton, MD

In this session, senior U.S. Food and Drug Administration leaders will discuss current hot topics in each of the centers for review of drugs and biologics, CDER and CBER, including implementation of the FDA Amendments Act of 2007 & PDUFA IV, drug safety initiatives, Critical Path programs and other key FDA organizational and policy initiatives. Time is planned for interactive discussion with attendees.

 

Shaping Biosimilars Policy: The Interplay of Data Exclusivity, Patient Safety, and Patents
Category: Breakout Sessions
Track: Legal Issues
Date/Time: Wednesday, May 20, 2009, 10:00AM - 11:30AM
Location: Georgia World Congress Center
Room: B303
Speaker: Maggie Shafmaster, PhD

Under the new Obama administration, analysts believe that Congressional legislation on follow-on biologics will pass in 2009. President Obama has high ambitions for healthcare reform and follow-on biologics is clearly part of that agenda. What key factors will help shape this framework for competition and continued innovation? The three objectives of this session will look at the interplay of at least data exclusivity, patient safety, and patents as the congressional bills begin to be recirculated and debated.

The Fountain of Youth: Drugs Targeting Pathways Regulating Aging
Category: Breakout Sessions
Track: Drug Discovery and Development
Date/Time: Tuesday, May 19, 2009, 4:00PM - 5:30PM
Location: Georgia World Congress Center
Room: B309
Speaker: Andrzej Bartke, PhD

Every month we see headlines about very early-stage scientific research with possible implications in life extension and diseases of aging. Leading life science firms discuss compounds and approaches with the greatest potential to address diseases of aging and the process of aging itself, as well as how can we separate the hype from real hope.

 

Spreading the Word: New Technologies Mean Everyone Is a Journalist
Category: Breakout Sessions
Track: Public Relations/Investor Relations
Date/Time: Tuesday, May 19, 2009, 4:00PM - 5:30PM
Location: Georgia World Congress Center
Room: B316
Speaker: Marc Monseau

2008 was a landmark year in health-related communications, but not in the typical ways. High-profile science reporters at publications from USA Today to the Washington Post accepted buyouts and exited traditional media, as new and varied voices emerged in all areas related to biotechnology. New technologies, such as the micro-blogging site Twitter, have emerged and “old” technology, like blogging, has matured, allowing an unprecedented level of communication among scientists, the media and the public. This discussion will explore the new world of biotechnology communications and how researchers, academic institutions, government officials and companies can all participate in the conversation.

Diagnostics: When Disease Information Enables Treatment Decisions
Category: Breakout Sessions
Track: Devices and Predictive Diagnostics
Date/Time: Wednesday, May 20, 2009, 2:00PM - 3:30PM
Location: Georgia World Congress Center
Room: B406
Speaker: Michael Bristow, MD

As the nascent field of genomics has begun to rapidly expand, diagnostic testing results increasingly inform treatment options. Individuals may now access testing for individual risk factors including breast cancer, Alzheimer’s disease and heart disease, but physicians may not have all of the information they need to understand the preventive measures and/or treatment options available that tie in to patients’ results. At a time when individuals are taking more control over their own health care, how can they and their physicians determine the most appropriate, clinically useful testing options?

Raising Capital in an Economic Slowdown
Category: Breakout Sessions
Track: Finance
Date/Time: Monday, May 18, 2009, 2:00PM - 3:30PM
Location: Georgia World Congress Center
Room: B314
Speaker: Todd Davis

Raising capital during good economic times can be challenging. But in tough economic times it can be difficult for a biotech without a proven technology or commercialized product to raise the necessary cash to fund its pipeline. This panel will provide a broad perspective on the latest financing trends and how biotech’s can overcome the challenges of raising capital in a tight financial market.

Biotech M&A - How to Sell Your Company in an Environment of Consolidation
Category: Breakout Sessions
Track: Business Development
Date/Time: Tuesday, May 19, 2009, 10:00AM - 11:30AM
Location: Georgia World Congress Center
Room: B313
Speaker: Robert Easton

Consolidation among biotechs is an increasingly important and expanding trend in the life-science arena. As large biotechs face the upcoming expiration of patents on many of their important drugs, they are focusing on mergers and acquisitions as a means of expanding their product pipeline. Smaller biotechs offering both proven drugs as well as promising products in development are prime targets for acquisition. Moreover, the challenging economic environment has made it difficult or impossible for many smaller biotech companies to fund research and development making a sale more necessary or desirable. Our panel, consisting of a life-science investment banker, a life-science consultant, a CEO who has previously sold her company and an M&A attorney, will present information on how emerging biotechs can prepare for the possibility of being acquired. We will discuss the types of M&A biotech transactions, the risks involved, and ways in which target companies can successfully navigate through the acquisition process. We will also discuss alternative financing structures to facilitate making transactions.

Media Speed-Dating: Get Up Close and Personal with Biotech Journalists
Category: Breakout Sessions
Track: Public Relations/Investor Relations
Date/Time: Tuesday, May 19, 2009, 8:00AM - 9:30AM
Location: Georgia World Congress Center
Room: B311 - Roundtable/Workshop setting
Speaker: Glen Harris

Get your business cards ready, because this is your opportunity to network with biotech reporters from major media outlets. After a brief introduction, each reporter will join a small table of attendees, providing an intimate setting for networking. Go ahead and ask about how they handle embargos, if they honor conversations off the record, where they get story ideas, and how best to work with them. And don’t worry if your favorite reporter’s table fills up fast – journalists will rotate among the tables, so you’ll get to meet them all. The Burrill Report’s Daniel S. Levine will participate in this session. Note: capacity at this networking session will be limited; seats are first-come, first-served.

 

The Emerging Promise of Personalized Medicine
Category: Breakout Sessions
Track: Policy
Date/Time: Tuesday, May 19, 2009, 8:00AM - 9:30AM
Location: Georgia World Congress Center
Room: B301
Speaker: Courtney Harper, PhD

The emerging promise of personalized medicine has been widely touted. The potential for more tailored and targeted therapies is great, but the development of a profitable business focused on targeted therapies and companion diagnostics presents scientific challenges. Additional challenges include protecting the firm’s intellectual property and satisfying FDA regulators. This session will address the business, scientific, and legal challenges for the commercialization of personalized medicine.

 

The Ongoing Quest for the $1,000 Genome – Are We There Yet, and Are We Ready?
Category: Breakout Sessions
Track: Bioethics
Date/Time: Tuesday, May 19, 2009, 4:00PM - 5:30PM
Location: Georgia World Congress Center
Room: B306
Speaker: Arthur Caplan, PhD
DNA sequencing technologies are advancing at breakneck speed, and science can now sequence for $60,000 what took $300 million seven years ago. Looming around the corner is the $1,000 genome, but are we ready? This panel will examine the technologies that promise to enable the economical sequencing of an entire human genome. In addition, thought leaders will discuss how new sequencing technologies broaden the utility of genetic information in healthcare and enable advances that will revolutionize medicine. Finally, bioethical thought leaders will highlight the potential downfalls for a society that can realistically sequence the entire genome of every person.

Adaptive Research in Practice: Key Elements and Implications for Development
Category: Breakout Sessions
Track: Clinical Research/Clinical Trials
Date/Time: Wednesday, May 20, 2009, 4:00PM - 5:30PM
Location: Georgia World Congress Center
Room: B405
Speaker: Jason Connor

More clinical studies are using adaptive strategies because of their success in reducing development time and cost. However, their implementation is often suboptimal because of an exclusive focus on statistical (design) issues. Adaptive strategies can have a far more powerful benefit by considering a comprehensive approach. Unlike design adaptations, operational adaptations do not require regulatory approval and thus can be rapidly and flexibly adopted. Since both design and operational adaptations rest on a common technology platform, both types of adaptations should be considered. Used together, design and operational adaptations can reduce development times. This session examines lessons learned from conducting more than 50 adaptive programs.

Undiscovered Capital! Realizing the Potential of Government Incentives and Grants
Category: Breakout Sessions
Track: Finance
Date/Time: Tuesday, May 19, 2009, 4:00PM - 5:30PM
Location: Georgia World Congress Center
Room: B314
Speaker: Richard Olivier

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 R&D and AMT tax credits. States such as Massachusetts have established incentive and grant programs for FDA filing fees, staff training and hiring costs, property and sales tax exemptions, refundable research credits, investment credits, and extensions to the carryover periods for NOLs. Our panel will provide an overview of incentive and grant programs and how to locate and obtain them.

Darwinism Comes to Strategic Finance: Evolving Business Models and Implications for Biotech & Pharma
Category: Breakout Sessions
Track: Finance
Date/Time: Thursday, May 21, 2009, 8:00AM - 9:30AM
Location: Georgia World Congress Center
Room: B314
Speaker: Bill Ringo

Big pharma faces radical business model transformation as firms tackle declining R&D productivity and reexamine the need for economies of scale. To survive, firms will need to look at financial decisions through a more strategic lens - deploying capital more efficiently, examining their value chain focus and managing alliances with a portfolio approach. How can large firms link capital allocation and transactions to strategy? How can emerging firms approach deals in the strategic context of acquirers? Will biotechs still need to become FIPCOs? How will pharma’s changing business models impact small firms’ allocation of scarce funds?

 

Hype or Hope: The Real Prospects for Success in Cleantech
Category: Breakout Sessions
Track: Industrial and Environmental
Date/Time: Tuesday, May 19, 2009, 10:00AM - 11:30AM
Location: Georgia World Congress Center
Room: B305
Speaker: Elspeth MacRae

Biotechnology offers considerable opportunities for creating new processes, products, energy sources and performance efficiencies while reducing costs, energy consumption, waste or pollution – or so say the proponents of “cleantech”. But is cleantech truly viable for the long term and capable of transforming current processes and industries into truly sustainable ones? Or is it just the next investment fad? And what is the appropriate role of government in promoting and fostering these technologies – which if indeed successful could provide enormous benefits worldwide? This panel will take a close look at the promise – and issues – surrounding cleantech and the push towards “sustainability.”

 

M&A for U.S. Biotech: Think Outside the Box
Category: Breakout Sessions
Track: Business Development
Date/Time: Tuesday, May 19, 2009, 4:00PM - 5:30PM
Location: Georgia World Congress Center
Room: B313
Speaker: Chuck Abdalian, MBA

Discuss current M&A market trends for U.S. biotech companies, focusing on traditional and non-traditional exit routes.and explore trends and creative deal structures, such as reverse mergers of private companies with strong assets into “wounded” public companies with cash, but no clinical assets. As part of the session, the panel will also discuss provisions in license/collaboration agreements that are most critical to biotech companies preserving an ultimate M&A exit, including standstills, change of control provisions, retention of commercial rights and other provisions that create or preserve value for a future M&A transaction.