During this panel discussion, the following questions will be discussed and answered by the distinguished speakers: Are we ready for personalized medicine and the big changes in discovery, development, diagnosis. treatment, and reimbursement that will come with it? How do we preserve and incentivize innovation? how can we ensure that comparative effectiveness will be used to inform about treatment options, not to limit access? Can we create a new paradigm for innovation? How will real-world data be used in the innovation process?

PCMA's Incoming and Outgoing Chairmen will offer thoughts on the public policy, and market dynamics that have impacted the PBM industry during the last year, and how they will affect it in years to come.

In light of the challenges facing research-based pharmaceutical companies, some say the industry's innovation model is dead. However, the science has never been more promising, and the need for innovation never more compelling. The future of pharmaceutical innovation lies in creating value by addressing unmet patient needs - including going beyond the medicine itself to improve patient outcomes.

The topic of data transcends all aspects of our business. The demands for real world data and evidence are ever-present and not going away. This session's presentations and panel discussions will cover:

• How can manufacturers respond quickly enough to meet the demands for outcomes based, real world research?
• How do we leverage real world evidence to focus the access decisions on value beyond rebates?
• How does the product value proposition from manufacturers need to evolve given the emerging models of care, specifically Accountable Care Organizations?
• What level of health economics outcomes research resources and expertise will be required for the pharmaceutical account executive of the future to meet payer requirements?

Biosimilars has been a session topic at PCMA conferences for years. The rubber is about the meet the road in terms of broad US market introduction of these products. This session presentation and discussion will cover:

• A brief overview of biosimilar history, science, global market realities, and current US regulatory pathway developments
• Issue of extrapolation - uses in varying indications
• EU versus US experience in bringing products to market
• Pricing, rebates, and prescribing / usage incentives
• Physician & payer prespectives - challenges for utilization
• What happens when these products start hitting the market in 2014 and beyond?
• Data requirements and considerations by P&T Committees
• Interchangeability, sustainability, and naming requirements

Wall Street's take on our respective industries is always of special interest to PCMA conference attendees. Join us to hear the pharma and PBM industry's most highly regarded analysts - Seamus Fernandez and Lisa Gill respectively - discuss what they view as the primary market dynamics impacting our businesses today and in the future. This session discussion will cover:

• The future of formularies, rebates, cost containment, and all aspects of the PBM and pharma business models are in flux due to the move to specialty / biologic products
• Blockbuster generic introduction will cease in about 2015. What impact is this having now?
• Diagnostics and pharmacogenomics: What are the current tools and future opportunities available to managed care to control costs? How is pharma using these tools to reinvent itself?
• Healthcare reform's impact on the PBM, specialty pharmacy, and pharmaceutical industries
• How could oral small molecule drugs change long term cost trends (next decade) for specialty drugs?

This panel of pharma, PBM, and specialty pharmacy thought leaders will discuss how our industries are changing, the challenges and opportunities we are faced with, and how they will impact our business interactions in the years to come. A particular focus will be on the following:

• Evolution of the pharma / bio model
• Aggressive trend management in specialty
• The impact of the Accountable Care Act on SP drugs
• Utilization and reimbursement for diagnostics and pharmacogenomic offerings
• Finding common ground in the area of data management and outcomes
• Opportunities to improve quality of care and prove the value of pharmaceuticals

This session marks the first time PCMA has presented a conference session on the topic of pharmaceutical product support HUBs. The operation of product hubs has become one of the most important tools used in the marketing of specialty medication, causing controversy in many instances. We aim to present the perspectives of all stakeholders, and give attendees information to consider as HUB interface with their day-to-day business. During this session, Dr. Galardi will cover:

• The history, purpose, and various types of hubs
• Manufacturers' approach to hub development
• Benefits to the prescriper, patient, and caregiver
• The pharmaceutical care managers approach to interfacing with hubs
• Differing perspectives and their likely resolutions

Legislative and regulatory action at the state and federal level is greatly impacting the pharmaceutical supply chain. The drug manufacturing and PBM industries have been, and will continue to be, effected both collectively and exclusively. Many of these regulations are currently unfolding on a weekly basis. Staying current, and to the extent possible, ahead of the curve is top of mind for us all. PCMA has brought two of the most well versed and informed experts to walk you through the ins and outs of all government actions impacting your business. Brady and Ian will present and discuss topics that include:

• The "Super Committee" and Sequestration: Possible scenarios and implications
• Health Reform Implementation: Key issues and opportunities including: (a) legal challenges; (b) establishment of health benefits in exchanges; (c) essential health benefits and the regulation of benefits in exchanges; (d) accountable care organizations; (e) Medicaid expansions; (f) IPAB's future
• FDA Legislation and Regulation: PDUFA and drug shortages
• Possible regulations of PBM practices including transparency
• Integrated models specific to dual-eligibles
• Pricing strategies, utilization strategies, and managed care strategies

At the conclusion of the Annual Meeting, Susan will have served as moderator for two PCMA conferences. For those of you who attended our Summit in the spring, you know that Susan's vast knowledge of the healthcare industry brought a fresh and informed perspective to all of the topics covered at that event. After two days of intensive Annual Meeting sessions, Susan will offer her insights and conclusions regarding the issues impacting our industries. Of note, Susan will continue to serve at PCMA's conference moderator for our 2012 events as well.