From Resilience to Growth: Mapping a New Direction for Life Sciences (San Diego, CA)

In today's rigorous health care environment new products must present a high profit and value proposition to potential investors and acquirers. Along with this increased level of scrutiny, payers are reviewing comparative effectiveness data and more carefully examining economic data for reimbursements. In this session panelists will discuss:

• Medicare product coverage strategy
• Proper planning for product pricing
• Preparing comparative effectiveness data
• Working with payer expectations
• Data that should be in place for partnering or acquisition deals

Panelists:

• Judith A. Waltz, Partner, Foley & Lardner LLP
• Anita Chawla, Ph.D., Vice President, Analysis Group
• Antoun Nabhan, Director of Corporate Development, Onyx Pharmaceuticals

In an era of health reform, diagnostic technologies that focus on prevention and test the viability of expensive treatment options are becoming increasingly valuable to health providers, payers, and patients. Historically, investment in this sector has not seen the vigor demonstrated with medical devices or biotech innovations. However, in today's environment, diagnostics are becoming attractive opportunities for companies looking for collaborations or acquisitions as well as investors looking for cutting-edge technologies, all creating a robust industry on the brink of breaking through to the mainstream.

In this presentation, panelists will:

• Provide insight on the diagnostic industry on a local and national level
• Discuss key elements that are reviewed when assessing start-up opportunities
• Discuss where opportunities exist for maximizing profits
• Provide new strategies for raising funds in this dynamic marketplace

Panelist:

• Ronald S. Eppen, Partner, Foley & Lardner LLP
• Lucy Lu, Vice President of Business Development, Crescendo Bioscience
• Natasha Paul, Ph.D., Scientific Investigator, TriLink Biotechnologies, Inc.
• Jon Vance, Director, Avondale Partners, LLC

In today’s business climate, medical device and life sciences companies need to be properly positioned at each phase of development with the appropriate plans in place for later portfolio development stages. Panelists will review key business and intellectual property management tools and strategies that are needed at the early-, mid- and late-growth stages as well the types of funding needed to fuel growth throughout the product life cycle. We also will address how and when you should plan for an IPO as well as other exit strategies, including merger and acquisitions.

Topics include:

• How companies can balance the need to continually innovate while minimizing the failure rate
• How to realize revenue streams earlier in the process
• How to evaluate innovation based on potential business value

Panelists:

• Jeff Draa, Board of Directors, Tech Coast Angels
• Gabor Garai, Partner, Foley & Lardner
• Vanessa Herbert, Senior Manager, PricewaterhouseCoopers
• Keith Lindenbaum, Partner, Foley & Lardner LLP
• Robert Mashal, M.D., President & CEO, NKT Therapeutics
• David Parrot, M.B.A., Managing Director, BMO Capital Markets Corp.

Collaborations with big biotech and big pharma are on the rise as innovators forge ahead in a challenging economic environment. This growing trend demands creativity and diligent focus on the structure of these agreements to maximize their corporate and product development potential. Panelists will address the following issues and provide case studies that demonstrate how to ensure a successful collaboration:

• Unique arrangement structures at specific product life cycle stages
• Protecting IP
• Avoiding short-term fallout
• The impact of collaboration on future growth and exit strategies
• Strategies from both sides of the agreement: increasing the opportunity for future collaborations

Panelist:

• Richard A. Kaufman, Partner, Foley & Lardner LLP
• David Webb, Vice President, Research & Site Director, Celgene
• David J. Weitz, Senior Vice President, General Counsel and Chief Intellectual Property Counsel, Takeda Pharmaceuticals
• Linda Pullan, Ph.D., Pullan Consulting

With the signing of the Patient Protection and Affordable Care Act the biotechnology community now has a clearer view of the road to approving Biosimilars. Such clarity, however, has given way to new questions on the FDA’s standards for Biosimilar products and how this new approval process will impact the business of innovative biotech. One thing is for certain, that this emerging industry can no longer be denied with an estimated global market totaling over $20 million.

In this session panelists will provide:

• Insights on how Biosimilars may impact current product portfolios
• Techniques for developing a secure patent portfolios
• Strategies for early and late stage biotech companies in creating business models that address the challenges and opportunities created by Biosimilars
• Navigating the regulatory process from both the applicant and BLA holder perspectives
• Discussion on how Biosimilars have impacted the biotechnology investment community

Panelists:

• Nathan Beaver, Partner, Foley & Lardner LLP
• Douglas Carsten, Partner, Foley & Lardner LLP
• Dr. Sami Guzder, Chief Scientific Officer, Avesthagen Limited
• Jeffrey W. Winkelman, Ph.D., J.D., Vice President, Oncology Programs, BioSante Pharmaceuticals

Panelists will address the expanding opportunities in the wireless health industry and discuss steps in meeting the unique challenges that come with innovation and investment in this emerging technology.

• What plans should be in place prior to phase III
• Medicare product coverage strategy
• Proper planning for product pricing
• Preparing comparative effectiveness data
• Working with payer expectations
• Data that should be in place for partnering or acquisition deals

Panelist:

• Bill Molloie, Partner, PricewaterhouseCoopers
• Andy Serwin, Partner, Foley & Lardner LLP
• Tom Watlington, Chief Executive Officer, Sotera Wireless