Key themes and messages of Mr. Paz's remarks will include:

• Payers are becoming increasingly anxious about the specialty and biotech drug trend, and thus, are relying heavily on specialty pharmacy to manage these therapies
• Specialty pharmacy delivers value to pharma and payers alike, in terms of care, quality and cost
• The future for payers, PBMs and pharma has to be about working together to ensure patient access to new, innovative products. We must ensure that we can continue to bring these new discoveries to the marketplace

For much of the latter part of the 20th century the pharmaceutical industry was highly regarded and very successful. Many would say that is not the case today - so what went wrong?

Ian Clark, CEO and Head of North American Commercial Operations, Genentech, will present a practical perspective on the challenges in the pharmaceutical industry during the past few decades and offer reason for renewed optimism as we enter the era of personalized medicine with opportunities to significantly impact patient care.

Session Details:

The panel will cover some of the most pressing issues facing our industry today, including -

• Biosimilars market impact in the U.S.
• The realities of bringing new products to market
  • Biomarkers & companion diagnostics
• Product security & integrity
• Drug shortages
  • Injectables
  • DEA controlled substances

•  Pay for delay

By attending this program, you should be able to:

• Describe the current state of the medical benefit drug management by payors
• Understand the primary factors driving change and impacting trend in the medical benefit drug sector
• Explain the challenges of developing workable solutions for managing the coordination of drugs in the pharmacy and medical benefit
• Restate the latest information regarding the Episode Payment Structures program at UnitedHealthcare
• Describe payer review processes for specific drug therapies
• Discuss the emerging role of oncology pharmacy in this sector
• Outline how employer groups view the challenges of medical benefit drug management

Activity type: Knowledge-based (K); Audience: Pharmacists (P); CEUs: 0.10

Universal Activity Number (UAN): 0841-0000-12-012-L04-P

Session Details:

By attending the program, you should be able to:

• Understand the drivers behind the development of average acquisition cost benchmarks
• Describe how various payers and providers are moving away from average wholesale price (AWP)- based reimbursement to new payment metrics
• Explain the likelihood of adoption of new reimbursement metrics

Activity type: Knowledge-based (K); Audience: Pharmacists (P); CEUs: 0.075

Universal Activity Number (UAN): 0841-0000-12-013-L04-P

By attending the program, you should be able to:

• Explain how personalized medicine technology is being used in the market today in both drug and diagnostic products.
• Discuss how this technology is changing drug prescribing, utilization and management.
• Understand the challenges to be overcome for broader use of personalized medicine
• Outline the implications and opportunities for key stakeholders and industries

Activity type: Knowledge-based (K); Audience: Pharmacists (P); CEUs: 0.075

Universal Activity Number (UAN): 0841-0000-12-014-L04-P

The advent of specialty drugs has required an evolution in the pharmaceutical care delivery model. Specialty drugs have driven this change, by forcing pharmacy operators to develop comprehensive service models that meet the needs of patients and prescripbers while addressing the third-party payers mandate to contain healthcare costs.

During this session, the panel will discuss:

• The definition of specialty pharmacy, and the operating models used to support the needs of the healthcare market
• The daily operational baseline of specialty pharmacies that seek to provide access to specialty drugs
• The role of the payers in the creation and on-going drive to specialty pharmacy
• Services provided to manufacturers
• Linking data
• The future and state of the industry

The operation of manufacturer product HUBs has become one of the most important tools used in the utilization, marketing, and reimbursement of specialty medications. 

By attending this session, attendees will be able to:

• Describe the history, purpose, and types of HUBs in the market
• List the rational and benefits for manufacturers to operate HUBs
• Discuss the role and perspectives of patients, pharmacies, payers and providers
• Understand the friction that some HUBs create
• Explain the existing scenarios for how HUBs will evolve in the market

Activity type: Knowledge-based (K); Audience: Pharmacists (P); CEUs: 0.10

Universal Activity Number (UAN): 0841-0000-12-015-L04-P

As the usage of specialty and biotech drugs continues to grow, drug managers continue to refine the ways to meet the many challenges of effective specialty pharmacy benefit integration.  By attending this program, you be will be able to describe the implications and challenges of integration that face all industries and parties in the SP chain of commerce.

Activity type: Knowledge-based (K); Audience: Pharmacists (P); CEUs: 0.10

Universal Activity Number (UAN): 0841-0000-12-016-L04-P

Background: The FDA administered REMS program began in 2008 when the FDAAA legislation took effect directing the FDA to develop a systematic, scientifically sound approach to managing the risk-benefit ratio of a drug throughout its lifecycle, with an explicit focus on post approval safety.  Now, five years later, our panel reviews the program and discusses its future.   

By attending this session, you should be able to:

• Explain how generic drugs, the looming patent cliff, and  biosimilars will impact the program
• Discuss what moves the FDA is making in the direction of “class wide” REMS
• Recite how the FDA is modifying REMS in light of program evaluations
• Understand how technological innovation is an integral component to REMS future
• Explain the ties between limited distribution products and REMS 

Activity type: Knowledge-based (K); Audience: Pharmacists (P); CEUs: 0.10

Universal Activity Number (UAN): 0841-0000-12-017-L04-P

By attending the program, you should be able to:

• Discuss key considerations of a specialty drug launch and commercialization strategy, including key trade- off decisions
• Describe market access strategies that take into account payer mix, payer coverage/benefit category, pricing and contracting
• Understand product acquisition scenarios
• Describe provider reimbursement methodologies
• Evaluate channel distribution options and ancillary patient/provider services

Activity type: Knowledge-based (K); Audience: Pharmacists (P); CEUs: 0.10

Universal Activity Number (UAN): 0841-0000-12-018-L04-P

By attending the program, you should be able to:

• Discuss 340B contract pharmacies’ role and operations in the market
• Restate the implications of the program for payers, SP, pharmaceutical manufacturers, and others
• Describe program integrity
• Explain recent and future changes to the program
• Outline the impact ACA (health reform) will have on the program

Activity type: Knowledge-based (K); Audience: Pharmacists (P); CEUs: 0.10

Universal Activity Number (UAN): 0841-0000-12-019-L04-P