Jim Butschli, Editor in Chief, Healthcare Packaging

Mike Wokasch, Author and Pharmaceutical Industry Professional

Author of Pharmaplasia and long-time pharmaceutical industry veteran, Mike Wokasch will address what today's pharmaceutical manufacturers must do to weather the uncertainties in the healthcare marketplace. As in his blog (http://www.PharmaReform.com), Wokasch will underscore the need for a financially healthy pharmaceutical industry, and will identify specific actions companies must take to remain prosperous in an increasingly demanding and less-tolerant marketplace.

With experience in retail pharmacy, with the U.S. Public Health Service, and in sales and management positions at Merck & Company, Abbott Laboratories, and Miles Pharmaceuticals, Wokasch comments on how manufacturers can position themselves for success. Among other areas for improvement, Wokasch will highlight the importance of reducing production and packaging costs and increasing patient compliance. Learn from an expert and gain practical intelligence to shape your company's strategy for the future.

Mike Drues, Ph. D., President, Vascular Sciences

Consultant, Adjunct Professor and popular industry speaker, Mike Drues returns with an insightful and energizing presentation covering the latest developments in combination products and the FDA. This session promises to offer food for thought and conversation, long after the conference closes! Attendees who have heard Dr. Drues present can look forward to his intelligent observations and unique perspective.

Laure L. Larkin, Packaging Validation Supervisor, Synthes USA

Synthes is a leading international medical device company, specializing in the development, manufacturing and marketing of instruments and implants. Ms. Larkin’s presentation will focus on package stability aspects and validation of combination products. Ms. Larkin brings more than 20 years of experience in FDA-regulated industries, and has worked with both larger Fortune 100 companies and smaller entrepreneurial organizations. She has functional experience in validation activities related to stability, packaging, cleaning, equipment, software, and test methods, as well as general compliance and risk management.

Karen K. Greene, CPP, Vice President Sales and Technology, Life Packaging Technology
Jan Gates, Staff Packaging Engineer, Abbott Vascular

What is package integrity and how is it tested? This is easy to understand but can be difficult to deliver. Essential steps in the package development process will be detailed with an emphasis on regulation and industry standards and practices for package integrity. The presentation will explain package integrity as a design input for sterile medical packaging, pharmaceuticals and biotechnology products. Greene and Gates will also discuss the broad spectrum of “what is package integrity?” (primary, secondary, tertiary level) and the tools and methodologies to evaluate and successfully achieve package integrity.

James Evans, The Novartis-MIT Center for Continuous Manufacturing

The batch-based manufacturing system currently employed by the pharmaceutical industry is costly and inefficient. A drug's active ingredients are synthesized in a chemical manufacturing plant and then shipped to a separate facility where they are converted into large batches of pills, liquids, or creams. Production can take weeks. What's more, the manufacturing design and scale-up required to produce a new drug can be financially unsustainable and exceedingly time-consuming.

The Novartis-MIT Center for Continuous Manufacturing is a 10-year research collaboration combining the industrial expertise of Novartis with MIT's scientific and technological leadership; the Center develops new technologies to replace industry's conventional batch-based system with a continuous manufacturing process. Benefits include:

- Accelerating the introduction of new drugs through efficient production processes
- Requiring the use of smaller production facilities, with lower building and capital costs
- Minimizing waste, energy consumption, and raw material use
- Monitoring drug quality on a continuous basis rather than through post-production, batch-based testing
- Enhancing process reliability and flexibility to respond to market needs

Learn how packaging fits into this new vision during this informative session, presented by Jim Evans.

Russ Napolitano, Vice President Strategic Development, Wallace Church, Inc.

The Rx and OTC pharmaceutical segments are highly competitive with potential confusion between brands. In order to optimize success, brand identity, packaging structure, packaging graphics, professional and DTC advertising, Internet and sampling strategies must consistently embrace the brand’s core essence.

Wallace Church is a New York City consultancy providing brand identity strategy, packaging and self-promotional materials. Mr. Napolitano will take attendees through the process of moving Pfizer and Wyeth brands from Rx to OTC. These case histories will demonstrate how to create a visual positioning strategy that articulates a clear, compelling, and relevant image for core loyalists, early adopters, and potential enthusiasts. A branding and package design session you won’t want to miss!

Jim Chrzan, Publisher, Healthcare Packaging

Beta tests reveal real world insights about a new compliance-prompting package. Healthcare Packaging Publisher Jim Chrzan talks candidly about his own life with 14-year-old son Casey, who has Down Syndrome and Autism, and how a compliance-prompting package has changed the entire family. A real life case history that celebrates the innovation healthcare packaging brings to one Midwest family.

Ed Bauer, Pharmaceutical Packaging Veteran

There are many influences on the pharmaceutical industry that will effect the way drug products are packaged. The presentation will look at a policy change that will effect packaging, how sustainable materials will make inroads into pharmaceutical packaging, and ideas on new manufacturing technologies that are needed to sterilize and package future products. Ed Bauer, Packaging Hall of Fame award-recipient and former employee of GNC and multiple end-user firms, offers an informed look at how brand owners can prepare for a changing marketplace.

Talking points include:

- Government policy has highlighted the need for improved preventative medicine. With an aging population and rising medical costs, packaging will play a significant role in meeting this policy goal, especially where packaging can result in lower costs.
- Sustainable materials and concern for the environment have risen to the top of consumer and business agendas. Included will be a look at some of the sustainable packaging materials options for pharmaceutical and medical device packagers.
- Will industry be able to produce, sterilize and deliver drugs and vaccines using current manufacturing technology? This session looks at a few types of manufacturing systems needed, not only for new drugs, but also for new delivery forms.

This year's workshops will be led by solution providers who are experts in their particular subject area. Currently, we have:

• Three Guiding Principles to Ensure Your Blister Package Passes Stability
Zuzana Sabova- Kepic, Manager, Barrier Packaging Analytic Lab and Lead Technical Specialist, Honeywell

The performance of drug products is so dependent on the primary packaging that this packaging is considered to be part of the drug formulation and is regulated accordingly. The goal of pharmaceutical companies is to ensure a drug formulation passes stability and to demonstrate to regulatory organizations that they can deliver safe and efficacious drugs. The goal of the Three Guiding Principles is different as the focus is on the package passing stability – not the drug. During our discussion we will present three different beliefs that if followed, allow pharmaceutical companies to gain early insight on the integrity of their blister packaging.

• Moisture, Oxygen & Shelf Life: Keys to Packaging Performance
Valere Logel, Product Development Manager, Sud-Chemie

It is paramount that drug manufacturers take into consideration the latest information regarding how the atmosphere of a package can be controlled to achieve ideal conditions for drug products during shelf life. Shelf life, or "Time of Protection," is not an absolute number, but depends on several parameters including package design, climactic conditions, and drug properties. Novel drug delivery and diagnostic systems are also requiring innovative ways to protect active ingredients from moisture and oxygen degradation. We will explore the impact that package design, materials and climactic conditions have on shelf life. We will consider how to incorporate protection from moisture and oxygen through the use of specially engineered polymers, desiccants, oxygen scavengers, and barrier packaging. Furthermore, simulated calculations can help drug manufacturers decide on the types and quantities of active packaging materials to incorporate into a package.

• No Container Left Behind: How Early Tracking Ensures a Higher Standard of Quality Control
Glenn Siegele, President, Omega Design Corporation

Building off the success of last year's workshop, No Container Left Behind shall continue the conversation on the importance of early (pre-label) container identification and tracking. This session will offer new insights and strategies for implementing cost-effective serialization solutions. In addition, there will be a live, interactive demo, via webcam, of a serialization solution in action.

• A Practical Approach to Improve Quality, Efficiency and Flexibility in a Continuous Manufacturing Solution
Delta Industrial Services

Each medical device/pharma product poses unique manufacturing challenges. However, through using a modular mechnical and software design approach, numerous medical device and pharma companies have solved their product design and quality challenges in a continuous manufacturing line.

This session is for you if any of these challenges apply to your operation:

• Making product in several distinct steps causes material waste during startup and changeovers
• Labor-intensive packaging steps slow the whole manufacturing process
• Pre-made pouches are expensive and difficult to handle
• Product materials pose challenges, because they require very careful tension control and/or re-registration to a physical feature or printed mark
• Relying on hands and eyes to verify product quality cuts into efficiency and profits

• Maximizing Throughput for Continuous Packaging
Ben Garvey, General Manager, Garvey Corporation
Michael Earling, VP of Sales, Garvey Corporation

Companies go to extraordinary measures to reduce costs and increase throughput, but decisions that improve a single machine's performance may not improve overall efficiency.

Applying the theory of constraints to new or existing production lines helps decrease production cost, decrease labor and increase line availability, and improve throughput by up to 30%. These tools give you quantifiable decision making power for purchasing new equipment or revisiting existing technology.

This workshop is for you if you are responsible for the quality and efficiency of your packaging line.