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3rd Annual Pharmaceutical/Medical Packaging Leadership Summit


June 6-7, 2012
Sheraton Baltimore North Hotel
Baltimore, MD
United States

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Conference Details:
With the healthcare industry rapidly changing, pharmaceutical and medical device industry leaders need, now more than ever, to be equipped with the strategies and technologies to produce and distribute quality and cost-effective drugs. Our Pharmaceutical and Medical Packaging Leadership Summit will present these strategies and facilitate the development of a new age for the pharmaceutical industry.

By joining together leaders and innovators from the packaging, labeling and pharmaceutical industries, The Pharmaceutical and Medical Packaging Leadership Summit will bring its guests the most up to date and important information on hot topics such as: serialization- from the theoretical to practice and how to ensure compliance and excellence by 2015, insight to the new sustainability efforts the industry is planning, incorporating human factors research into package testing and development to adapt to evolving populations and much more!
Intended Audience:
Opal Events' Pharmaceutical and Medical Packaging Leadership Summit has been researched and developed specifically for: Pharmaceutical, Medical Device and Packaging Industry Professionals, including Managers, Directors and VP's of:
  • Research & Development
  • Clinical Research
  • Supply Chain
  • Logistics
  • Distribution
  • Security
  • Global Logistics
  • Regulatory Affairs
  • Transportation
  • Risk Management
  • Engineering
  • Product Development
  • Scientific Affairs
Our Distinguised Speaking Faculty Includes:
Richard Smith, Managing Director- Life Sciences and Specialty Services, Global Trade Services, FedEx Express
William E. McCune, DrPH, CPP, Consultant, McCune Consulting
George Wright IV, VP, Consulting and Business Development, Product Identification & Processing Systems Inc
Delmar R. Mineard, Manager Packaging Engineering, Boehringer-Ingelheim
Shanna L. Moore, Global Director of Sustainability, DuPont Packaging and Industrial Polymers
Richard K Bank, Director, Sustainable Supply Chain Foundation
Ray McCabe, Sr. Product Sales Specialist, Bahnson Environmental Specialities
John Rocco, Executive Vice President, The Mundy Companies
Michael Greenholtz, Vice President Reliability Solutions, Genesis Solutions
Joe Rettinger, VP, Soliance
Mike Mills, Senior Manager, Mundy Companies
Oliver Stauffer, VP Inspection Technologies, PTI inspection Systems
Patrick McGrath, General Manager USA, Berlinger
Jeff Mesaros, Board Member, Florida Board of Pharmacy
Don Singer, Global Manager, GlaxoSmithKline
Walter Berghahn, President, SmartRmeds for Life, Executive Director, HCPC
Dave Restaino, Attorney, Fox Rothschild LLP
Dr. Laura Bix, Associate Professor, Michigan State University School of Packaging
Reid Graves, Manager, Global Master Data Management, Pfizer
Minal Mistry, Senior Manager, Sustainable Packaging Coalition, GreenBlue
Joe Samudovsky
, Managing Director, Alaska Airlines
Speaker Bios
Hotel Info:
Sheraton Baltimore North Hotel
903 Dulaney Valley Road
Baltimore, MD 21204
Tel: 410-321-7400

We are pleased to announce that the Opal room block is open and we are accepting reservations. Please click on the ONLINE HOTEL RESERVATION link to book your room. The hotel will not accept individual call-ins.

Online Hotel Reservations

  • Rooms are available only to those participants who are registered conference attendees.
  • Rooms will not be guaranteed without a credit card.
  • Rooms are allocated on a first come first serve basis. Room types/rates are subject to availability.
  • The name on the form will be the name of the guest room.
Conference Registration Prices:
Early Bird Rate
(Expires 4/27/12)
Standard Rate
Service Providers
$795
$995
*Pharmaceutical/Medical Device Companies, Academia, Government, Non-Profit
First 100 Free, after $495

Register Now!

Group Discounts:
Register 3 people and receive 10% off ***
Register 4 people and receive 15% off ***
Register 5 people or more and receive 20% off ***

If you'd like to be invoiced, please submit your contact details on the registration page and select "Please invoice me" at the bottom of the page.

If you are interested in sponsorship, exhibiting, or speaking opportunities, please call 212-532-9898 or email information@opalevents.org
* TERMS & CONDITIONS
Subject to approval. To qualify you must be currently employed by a non-vendor company. Eligibility will be verified by conference producer. Opal reserves the right to allocate places and to refuse applications.

Registration price reflects $100 online discount
Diamond Sponsor
The Mundy Companies
Silver Sponsor
Bahnson Environmental SpecialtiesBerlinger
Media Partners
3PLNewsBvents.com Medical Billers and Coders PackagingSuppliers Pharm Cast Pharma Focus Asia Pharmatching Pharma Mirror PharmaPhorum PharmaSuppliers Pharma Voice SelectScience
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Current Attendees
Group Leader/Manager, Abbott Vascular Inc
Senior Packaging Engineer, Abbot Vascular Inc
Associate Director of Supply Chain and Logistics, Agennix
Managing Director, Alaska Airlines
Senior Director Supply Chain, Alexion Pharmaceuticals Inc
Supply Chain Manager, ALK Abello
Managing Director, Alliance for Foam Packaging Recyclers (AFPR)
Product Sales Specialist, Bahnson Environmental Specialties
Product Sales Specialist, Bahnson Environmental Specialties
Global Demand and Supply Manager, Becton, Dickinson and Company
Sr. Business Director, Becton, Dickinson and Company
Packaging Engineer, Becton, Dickinson, and Company
Senior Packaging Engineer, Becton, Dickinson, and Company
Director, Quality Management and Regulatory Compliance, Becton, Dickinson and Company
Manager Packaging Engineer, Boehringer-Ingelheim
Director, Boehringer-Ingelheim
Senior Packaging Engineering, Boston Scientific
Packaging Engineer, Boston Scientific
Packaging Engineer, Boston Scientific
Packaging Engineer, Bristol Myers Squibb
President and CEO, Cary Pharmaceuticals Corp
Technical Specialist Labeling, Celgene Corporation
Public Health Analyst, Centers for Disease Control
Manager, Project Logistics, CoreRx Inc.
Director of Strategic Devo, Council of Supply Chain Management Professionals
Sales and Marketing Coordinator, CSC Laboratories
Global Market Manager, Packaging, DuPont Packaging and Industrial Polymers
General Manager, Dynasil Products
Director of Operations, Dynasil Products
Consulting Engineer, Eli Lilly
Managing Director, Life Sciences & Specialty Services, Global Trade Services, FedEx Express
Vice President, Pharmaceutical Development, Femmepharma Global Healthcare Inc
Commissioner’s Fellow, FDA
Consumer Safety Officer, FDA
Consumer Safety Officer, FDA
Public Health Analyst, FDA
Board Member, Florida Board of Pharmacy
Attorney, Fox Rothschild LLP
Vice President Reliability Solutions, Genesis Solutions
VP, Channel Strategy/Pharmacy Solutions, GlaxoSmithKline
Global Manager, GlaxoSmithKline
President, Gold and Domas Research
Senior Manager, Sustainable Packaging Coalition, GreenBlue
Vice President Marketing & Business Development, Haselmeier
Executive Director, Healthcare Compliance Packaging Council
Packaging Engineer/ Sr. Device, Human Genome Science, Inc
Bioprocess Associate III, Human Genome Sciences
Sr Device and Packaging Engineer, Human Genome Sciences
Editor in Chief, International Pharmaceutical Quality
Senior Director, Supply Chain, Johns Hopkins Hospital
President, Lifoam Industries, LLC
VP of Operations, Lifoam Industries, LLC
VP of Sales, Lifoam Industries, LLC
Director, Clinical Supply Operations, MacroGenics, Inc
Pharmacist Compliance Officer, Maryland State Board of Pharmacy
Pharmacist Compliance Officer, Maryland State Board of Pharmacy
Consultant, McCune Consulting
Manager, Merck
Product Protection & Optimization Lead, Merck
Senior Engineer, Merck
Senior Packaging Engineer, Merck
Biologic Project Lead, Merck
Distinguished Professor of Communication, Michigan State University
MSN, RN, Director, Michigan State University Learning and Assessment Center
Associate Professor, Michigan State University School of Packaging
Chief Operating Officer, Mobius Therapeutics, LLC
Executive Vice President, The Mundy Companies
Senior Manager, Mundy Companies
VP Business Development, Mundy
Executive Director, Niagra University
Director, Owens and Minor International
CEO and Founder, Pateints’ and Consumers’ Pharma
EVP, PBM Pharma
Product Engineer, Perrigo
Engineer, Pfizer
Director of Regulatory Affairs, Pfizer
Director, Global Conveyance Security, Pfizer
Senior Packaging Equipment Engineer, Pfizer
Manager, Global Master Data Management, Pfizer
Manager, Pfizer
Supply Chain Manafer, Pharmathene
Consulting and Business Development, PIPS
Sales representative, Praxis Packaging
Sales representative, Praxis Packaging
VP Inspection Technologies, PTI Inspection Systems
Regulatory and Compliance Officer, Pulsecor
VP Supply Chain Manager, Quiagen
QA Appliance Manager, Quiagen
Director, Quiagen
Director, Quiagen
Director, Quiagen
Director, Quiagen
Manager, Quiagen
Manager, Quiagen
Manager, Quiagen
Director Manufacturing and Logistics, Quinnova
Director, Global Supply Chain Management Program, Rider University
Consultant, S4 Consulting
Process Engingeer II, Sangart, Inc
Marketing Manager, SenseAware
Senior Manager Product Labeling and User Documentation, Siemens Healthcare
VP, Soliance
Senior Packaging Engingeer, St. Jude Medical
Senior Vice President, St. Barnabas Hospital
Director, Sustainible Supply Chain Foundation
Assistant Branch Chief, TSA
Planner, UC Davis
Vice President, Sales, Uromed LLC
President, Van Bodegraven Associates
Attorney, Vinovations
Quality Director, Virdante Pharmaceuticals
Professor, Virginia Tech
Project Specialist, Package Development, West Pharmaceuticals
Project Engineer, West Pharmaceuticals
President, White and Company LLC
Conference Day 1: Wednesday, June 6, 2012
7:15 am
Continental Breakfast & Registration
Co-located with our Pharmaceutical Supply Chain Summit!

8:00 am
Opal Events' Opening Remarks
8:05 am
Chair’s Welcome and Audience Demographics

William E. McCune,
DrPH, CPP, Consultant, McCune Consulting
8:15 am
The FDA Presents New Regulations in the Pharmaceutical Industry
  • Learn as the FDA reviews important requirements for Drug packaging and labeling
  • Discover best practices in Supply Chain regulations
  • Attain a step by step guide to successful establishment registration for new 3PL companies
  • Discuss ASTM International D4169 and why the system changed
Speaking opportunities available!
9:15 am
Global Network, Visibility, and Cold Chain Solutions – Keeping Cool with FedEx Healthcare Solutions
  • Commitment to the Healthcare Industry
  • Global Market Forces
  • Cold Chain Logistics at a Glance
  • Innovative Technologies

Richard Smith, Managing Director- Life Sciences and Specialty Services, FedEx Express

Fed Ex Md
10:15 am
Morning Refreshment & Networking Break
10:45 am
Crossing the Line: Bar Coding and the Supply Chain
  • Discuss how improvements in product, supply, and material management coordination can be achieved by use of bar codes. 
  • Discover ways of using barcodes for Unit-of-use items for inventory control/tracking
  • Learn techniques for using barcodes for tracking of reusable/refurbished equipment and supplies, product recalls, and warnings throughout the entire chain
  • Implement test labels to ensure labeling accuracy
  • Identify best Practices for using Bar codes on high-usage drugs so systems can easily and quickly address the most prominent threats to patient safety
Speakers:
William E. McCune, DrPH, CPP,
Consultant, McCune Consulting
George Wright IV, VP, Consulting and Business Development, Product Identification & Processing Systems Inc
Delmar R Mineard
Manager Packaging Engineer Boehringer-Ingelheim
11:45 am
Sustainable Initiatives in Packaging
  • Evaluating the potential viability of reusable packaging and sterilization measures to ensure integrity
  • Leveraging reusability of secondary packaging with suppliers as a means of reducing waste and costs in the production process
  • Case study: cost savings through process streamlining, source reduction and use of sustainable materials
  • The challenges of trying to 'go green'
  • Strategies to lowering Environmental Impact
  • An overview of what your sustainability strategy road map should include
Shanna L. Moore, Global Director of Sustainability, DuPont Packaging and Industrial Polymers
Richard K Bank,
Director, Sustainable Supply Chain Foundation
12:30 pm
Here's Looking at You Kid: Mastering Your Label Through the Eye of the Patient
  • Hear about the University of Michigan's latest test series of studies related to label accuracy
  • Understand what draws the human eye on a package and how to optimize these targets to increase patient safety and medical accuracy in drug delivery
Dr. Laura Bix, Associate Professor, Michigan State University School of Packaging
1:15 pm
Luncheon
2:25 pm
Communicating With Your Temperature Controlled Distribution Centers
  • Keeping pharmaceuticals in cargo areas of distribution or shipping centers at constant temperature
  • Making decisions for contingency plans based on scientific data
  • IATA label requirements and implementation
  • Working with the FDA to ensure measurements are followed
  • Working with walk-in temperature and humidity chambers, cascade low temperature freezers for critical long term storage
  • Staying on top of container threshold requirements
Ray McCabe, Sr. Product Sales Specialist, Bahnson Environmental Specialities
Bahnson Environmental Specialties
3:00 pm
Afternoon Refreshment & Networking Break
3:30 pm
Asset Management:  A Supply Chain Value Proposition for Gaining Competitive Advantage
  • Linking Maintenance to achieving Operational Excellence
  • Reducing cycle time and conversion costs
  • Improve visibility to packaging at every point in the supply chain
  • Converting Maintenance from a Cost Center to a Competitive Advantage
  • minimize loss and optimize supply chain efficiency
  • Six Sigma Process for developing an Asset Management Master Plan

John Rocco, Executive Vice President, The Mundy Companies
Michael Greenholtz, Vice President Reliability Solutions, Genesis Solutions
Mike Mills
, Senior Manager, Mundy Companies

The Mundy Companies
4:30 pm
Roundtable Workshops
  • Choose 2 half hour long workshops to attend, and join other industry leaders as they host in-depth discussions on a variety of topics
  • After 30 minutes, attendees will be given the opportunity to switch rooms and hear from a different industry leader on a while new topic
  • Remember to sign up for your workshop early to ensure your seat!!! Each workshop will be hosted in a separate room
The Mundy Companies
Mike Mills, Senior Manager, Mundy Companies
Joe Rettinger
, VP, Soliance
Joe Samudovsky
, Managing Director,
Alaska Airlines

Workshop 3: Speaking opportunities available!
Workshop 4: Speaking opportunities available!

5:30 pm
Day One Closing Remarks and Mundy Presents a Cocktail Reception (in the Exhibit Hall)
The Mundy Companies
Conference Day Two: Thursday, June 7, 2012
7:15 am
Continental Breakfast & Registration
8:00 am
Chair's Welcome and Day One Re-Cap
8:05 am
Recycling Opportunities in Packaging
  • Explore technical optimizations in packaging that mitigate waste, while advancing sustainable packaging and the supply chains served
  • Take an in-depth look at the adjustments required in order to fulfill greater sustainable product goals
  • Identify relevant end-of-life systems, including recycling and waste-to-energy technologies, that optimize the overall sustainable supply chain

Minal Mistry, Senior Manager, Sustainable Packaging Coalition, GreenBlue

Speaking opportunities available!
9:00 am
Temperature Monitoring Devices and Your Package
  • Identify different packaging innovations including insulated shippers to manufacturing phase change material, gel packs and temperature monitors
  • Determine possible packaging trends in the future (ie a temperature containing vile package) and how they will improve patient safety and cold chain accuracy
  • Learn about temperature monitoring and why it is important for product quality and your business
  • Gain insight into some of the latest trends in technology and innovation
  • Educate yourself on matching technology with quality and regulatory expectations
Jeff Mesaros, Board Member, Florida Board of Pharmacy
Patrick McGrath, General Manager USA, Berlinger
Berlinger
10:00 am
Medical Devices and Pharmaceutical Packaging Integration
  • Insight into package integrity and how it is tested
  • Discover essential steps for the package development process
  • Examine best practices for obtaining package integrity
  • Implement package integrity as a design input for sterile medical packaging, pharmaceuticals and biotechnology products
Oliver Stauffer, VP Inspection Technologies, PTI inspection Systems
Don Singer,
Global Manager, GlaxoSmithKline
10:45 am
Morning Refreshment & Networking Break
11:15 am
Liability and Compliance in Supply Chain/Packaging
  • Top law industry professionals discuss litigation protection
  • Determine strategies to protect yourself from fraud and malfunction charges in your pharmaceutical packaging and shipments
Dave Restaino, Attorney, Fox Rothschild LLP

Speaking opportunities available!
12:00 am
Understanding Users Needs Through Simulation: Michigan State's Medical Simulation Program
  • Industry focus is shifting from protecting the product to protecting the patient
  • More therapies are being applied by the patient and a quickly growing geriatric population- packaging needs to keep up with these developments
  • Learn how Michigan State's simulated 'hospital' is allowing students to look critically at how packaging issued, (and misused), in real-world settings, and what the industry has learned from their tests
Dr. Laura Bix, Associate Professor, Michigan State University School of Packaging
12:45 pm
The Last Mile: From Pharmacist to Patient
  • Prepare for the new ways drugs are being handled and administered in pharmacies
  • Learn to navigate the difference in regulatory standards when moving from Distribution to Neighborhood
  • Pharmacy territory, and develop systems compliant with both
  • Implement Strategies for incorporating Pharmacies and Patients into Your Supply Chain
  • Determine how distribution should handle working with pharmacy chains networks
Walter Berghahn, President, SmartRmeds for Life, Executive Director, HCPC

1:30 pm
Utilizing Emerging Technologies in Pharmaceutical Delivery
  • New package delivery systems increase package integrity challenges. New technologies are required to determine package integrity of complex delivery systems.
  • Container closure integrity is growing in importance with respect to package distribution. Deploying more accurate, reliable, and quantitative methods for determining package integrity increase control of product released for distribution.
Reid Graves, Manager, Global Master Data Management at Pfizer
Oliver Stauffer,
VP Inspection Technologies, PTI Inspection Systems
2:30 pm
Conference Adjourns
Speaker Biographies
Richard K. Bank, Director, Sustainable Supply Chain Foundation

Richard K Bank, a founder and Director of The Sustainable Supply Chain Foundation, is also president of Millennium International Consultants, a Washington, DC-based consulting firm specializing in commercial, governmental and international matters with particular emphasis on transportation, logistics/supply chain and international security issues.

Richard's career spans more than three decades as an attorney, a diplomat and an international consultant. He has worked with U.S. and foreign clients in the United States, Europe, Asia, South America and the Middle East.

While at the State Department, Richard developed and implemented U.S. international shipping policy and supervised diplomatic activity in connection with the shipping, vessel-source marine pollution, supply chain and transportation-related trade practices and policies of foreign governments.

Richard headed U.S. delegations to the United Nation's International Maritime Organization (IMCO/IMO) where he was instrumental in establishing the Marine Environment Pollution Committee in response to oil tanker accidents which had created severe environmental damage to European shorelines. He also headed delegations to the U.N. Conference on Trade and Development (UNCTAD), and for six years led the U.S. delegation to the Organization for Economic Co-operation and Development (OECD) Maritime Transport Committee.

Since leaving the State Department, Richard has worked with clients as an attorney and senior partner with a major international law firm, and as a consultant employing his understanding of the essential confluence of issues which involve business, governments and national and international regulatory structures.

Richard has represented and has been a consultant to European providers of environment-friendly power generating facilities employing waste-to-energy gasification systems, and is working with a UK/Norwegian company which uses leading edge technologies in the use of carbon-capturing production of clean, hydrogen-sourced energy to be employed, in part, in the transportation field.

Richard has written articles on supply chain security and transportation/logistics, international business and government relations. Richard chaired the 2009 and 2010 Sustainable Supply Chain Summit which is attended by major corporate, government and academic leaders engaged in sustainable supply chain issues. He is an active member of the Council of Supply Chain Management Professionals.

Dr. Laura Bix, Associate Professor, Michigan State University School of Packaging

Dr. Bix is an Associate Professor at the School of Packaging at Michigan State University. She specializes in healthcare packaging at the School, where she has taught: Principles of Packaging, Plastics and Packaging, Packaging Design and Development, Medical Packaging, Packaging Laws and Regulations and Scientific Writing. In 2007, she was the recipient of the CANR New Teacher Excellence in Teaching Award.

Dr. Bix has served as the Vice-Chair of ASTM Committee D10.32, the Committee on Consumer, Pharmaceutical and Medical Packaging, from 2004-2008, and as a member of ASTM Committee F-02, since 2002. In 2008, she was named one of the Medical Device Industry's most notable people by Medical Device and Diagnostic Industry magazine.

She is also a member of the Institute of Packaging Professionals and the RCA Include Network, and has recently been designated as the US expert on ISO/TC 122, a guideline aimed at creating inclusionary packaging.

She is on the editorial boards of The Journal of Testing and Evaluation (West Conshohocken, PA) and Pharmaceutical and Medical Packaging News (Los Angeles, CA), as well as the advisory boards of Shelf Impact! (Chicago, IL) and Medical Device Developments (Nottingham, UK) She is currently an executive leader Philips Healthcare, Royal Dutch Philips, based in Amsterdam, The Netherlands and the U.S. and is an international published author and speaker on business intelligence, competitive, market intelligence and marketing, strategic planning and the application of these to business functions.

Reid Graves, Manager, Global Master Data Management at Pfizer

Reid H. Graves served at Merck & Co., Inc. for 33 years in a wide variety of responsibilities. Most recently, he was the Senior Business Lead for Supply Chain Master Data. Reid led the SAP Supply Chain Master Data team responsible for the global blueprint of Merck's ERP system. He built several custom web-based systems managing worldwide sales, inventory, and value chains for end-to-end supply chain management. He directed the global Inventory Management program for Merck's Manufacturing Division ($1.8 billion) resulting in demonstrated supply chain improvements. Reid has a Master's degree in Biology from the College of William and Mary in Virginia. He currently serves on the Advisory Board for 20/20 Pharma magazine.

Michael Greenholtz, Vice President Reliability Solutions, Genesis Solutions

Mike Greenholtz is the Vice President of Reliability Solutions at GenesisSolutions.  Mike's role is to provide leadership for creating operational and financial advantages for GenesisSolutions customers across industrial sectors. This includes identifying and implementing measures that enhance asset reliability, increase production capacity, extend asset lifecycles, while reducing cycle time and maintenance costs.

Previous to joining Genesis, Mike worked for 28 years at Wyeth Pharmaceuticals (Pfizer) where he managed all aspects of plant engineering. In his role as Assistant Vice President, Engineering Operations, Mike developed the business case and implemented a Best-in-Class Global Maintenance Excellence Program across all of Wyeth's operating units.

Mike holds a Bachelors of Science in Mechanical Engineering from Virginia Polytechnic Institute.

William E. McCune, DrPH, CPP, Consultant, McCune Consulting

William E. McCune, Doctor of Public Health and Certified Packaging Professional, has over 25 years of department leadership, innovation, and patents for healthcare package engineering and label design with several Fortune 500 companies. Direct reporting area has been in both R&D and Operations with key responsibilities to Quality, Regulatory, Marketing, Sales, and Legal. Healthcare products have included Rx, OTC, and diagnostic for both human and veterinary use as well as household and food products.

McCune's Doctoral Dissertation addressed the critical and in depth relationship of Public Health policy and packaging from primary stability to protective aspects needed for CR, TE, and prevention of counterfeits.

Personal hands on experience has been with test method development in the lab, actual lab construction, line optimization and new line installation, container design for unique functional improvements, and package/formulation testing for microbial, chemical, and leak properties. Key to success has been leadership ability to identify the essentials for priori tization within a project and also priority changes across multiple projects.

McCune is innovative and energetic with both individual company and across industry efforts for efficiency and regulatory compliance. Efforts have required ongoing involvement with FDA, CPSC, USP as Expert Committee Member, SPI in support of USP efforts, ASTM, ISTA, IATA, and colleagues in other pharmaceutical companies. Bill has also led full NDA and MAA product teams and worked with the full range of packaging materials and processes.

Most rewarding career successes resulted from innovative contributions, including patents, in the areas of operations improvements, total package problem solving for primary through POP, complex package issues for product chemical stability, implementation of novel aspects in packaging, and a graphics computer program that was utilized at NASDAQ.

McCune identifies new opportunities for successes in packaging to be presented by ongoing evolutionary needs in areas such as sustainability, enhanced bar codes, patient compliance, counterfeit prevention, and beyond. In the past equally difficult challenges were met with efforts for CR, UPC, cGMP, TE, and needle stick protection.

Patrick McGrath, General Manager USA, Berlinger

Mr. Patrick McGrath is the General Manager for Berlinger USA, developer and manufacturer of temperature monitoring products designed to be intelligent decision tools for the proper storage and transportation of temperature sensitive products. Prior to this position he held various commercial roles at the ThermoSafe Company, a leading provider of temperature assurance packaging solutions. The last four years with them as Director of US Sales. He has helped develop products and services that improve temperature control and visibility throughout the entire distribution cycle of a drug. This includes API and bulk drug product handling, shipments from major pharmaceutical manufacturers and final distribution through the big 3 and pharmaceutical benefits managers (or PBMs).

He is a member of the Parental Drug Association. He co-authored the article, "The Changing Landscape for Vaccine Administration in the US" found in ContractPharma, July 2011. He is also a contributor to a CDC sub-group for vaccine handling.

David Restaino, Partner, Fox Rothschild

David provides compliance counsel in many subject areas, including regulatory matters that concern pharmaceutical companies. In addition, David's practice encompasses complex litigation in federal and state jurisdictions including, by way of example, cases relating to the transportation and storage of goods. He handles pre-transaction due diligence issues and the negotiation of appropriate protections in transaction agreements. As a former Deputy Attorney General, David also brings a working knowledge of government enforcement proceedings. David graduated cum laude with a B.S. from Ithaca College and received his J.D. from the University of Virginia School of Law.

John Rocco, Executive Vice President, The Mundy Companies

John M. Rocco currently serves as Executive Vice President, Mundy Companies of Houston, Texas. In addition to business development, he has direct responsibility for the Mundy PharmaTech Division and Mundy Caribe LLC. Before joining the Mundy Companies, John was a member of Bayer’s senior management team in the USA until his retirement in 2006. As Vice President, Bayer Material Science LLC and General Plant Manager, he was responsible for Bayer’s largest multi-business chemical manufacturing complex in the Americas.

Previous positions included Vice President, Technical Operations USA with responsibility for multi-site pharmaceutical, biological and chemical manufacturing operations in the USA ; Vice President, Manufacturing, Rubber and Rubber Chemicals USA, and Director, Manufacturing for Animal Health Products.

Before joining Bayer, John served in various levels of manufacturing operations and financial management within Pfizer, Inc from 1978 to 1995.

John has been principally responsible for manufacturing strategy and operations, including manufacturing support operations. He has led successful strategy implementations in a number of key change management, productivity improvement and cost reduction efforts. These include pursuit of the Malcolm Baldridge Award and Class A Manufacturing at Pfizer, as well as Operational Excellence and SAP implementation at Bayer. In each case, productivity improvement, team work development, safety consciousness, cost reduction, asset utilization, culture change, and competitive advantage were key deliverables in positioning for world class manufacturing status.

Richard Smith, Managing Director- Life Sciences and Specialty Services, FedEx Express

Richard Smith has a deep understanding of the valuable role logistics serve in connecting people and goods and creating economic growth. As the son of FedEx founder Frederick W. Smith, he literally grew up with the business watching FedEx evolve from an express shipping company to a worldwide portfolio of services. In his role as Managing Director of Life Sciences & Specialty Services, Smith provides strategic direction for developing customized logistics and supporting specialized services.

Smith joined FedEx Services in 2005 as a Senior Solutions Analyst. In 2007 he was promoted to Manager of Supply Chain Solutions, responsible for FedEx SupplyChain. In 2009 he was promoted to Managing Director of Life Science and Specialty Services.

Smith earned his undergraduate degree from George Washington University and his Juris Doctor from the University of Mississippi School of Law. He serves on the following Boards: Greater Memphis Chamber, LeBonheur Children's Hospital Foundation, and Blue Streak Scholarship Fund.

Oliver Stauffer, VP Inspection Technologies, PTI Inspection Systems

Oliver Stauffer received his Bachelors of Science degree from the University of Michigan and completed his MBA at Georgetown University - The McDonough School of Business. He worked for several years in analytical and R & D laboratories. His expertise and focus has primarily been new technologies and test method development specific to package testing. Stauffer joined PTI in 2005 as a member of the research and development team working on non-destructive testing of blister packaging. In 2006, he joined the sales team as sales/applications engineer for PTI Inspection Systems. He held the position of International Business Development Manager for PTI through 2010, focusing on global quality solutions for package inspection that are robust, faster, cleaner, cheaper to maintain, and that reduce manufacturing waste. In 2011, he was appointed as V.P. Inspection Technologies.
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