Opal's Life Sciences, Pharmaceutical and Healthcare Events
Pharmaceutical Packaging Leadership Summit
2nd Annual
Pharmaceutical/Medical Packaging Leadership Summit
 
November 7-8, 2011
Baltimore Marriott Inner Harbor at Camden Yards, Baltimore, MD
 
 
Register Now for the Pharmaceutical/Medical Packaging Leadership Summit
 
VIEW CONFERENCE DETAILS
(Agenda current as of 11-2-11)
  2011 Attendees:
 

Marketing Director, American Chemistry Council
CEO, Algaeventure Systems, Inc.
Associate Director Supply Chain and Logistics, Agennix
Business Development Manager, AIT Worldwide Logistics
Director, Global Security, Alexion
Director, Alkermes
Logistics Manager, Almac
Distribution Manager, Almac
CEO, AlphaGenics
National Accounts Manager, Amcor Flexibles
Sales Manager, AFSP Pharma, Amcor Flexibles
President, Am-Tran
President and CEO, Applied DNA Sciences
Principal Engineer Packaging and Device Technology, AstraZeneca
Director of Distribution and Transportation Supply Chain, B Braun
Senior Sales & Marketing Assistant, Bahnson
Product Sales Specialist, Bahnson Environmental Specialties
Product Sales Specialist, Bahnson Environmental Specialties
Packaging Engineer, Becton, Dickinson, and Company
General Manager, Berlinger
President & CEO, BioMarck Pharmaceuticals
Laboratory Director, Bioserve
Bioserve
Director, Healthcare Regulatory Affairs, Biotechnology Industry Organization
Sales Manager, Bluebird Express
Director, Bluebird Express
Distinguished Research Fellow, Boehringer Ingelheim
Drug Information Specialist, Boehringer Ingelheim
Packaging Engineer II, Boston Scientific
Rick Fry, President, Boxseals
Dan Fry, VP of Sales, Boxseals   
Consultant, BPTM, LLC
Strategic Market Director, Brink’s Inc.
Associate Director Worldwide Packaging Technology, Bristol Myers Squibb
Associate Director Worldwide Packaging Technology, Bristol Myers Squibb
Director Worldwide Packaging Technology, Bristol Myers Squibb
Manager, Bristol Myers Squibb
Cangene Biopharma
Materials Manager, Cangene Biopharma
Capital Pharmaceutical
President, Cary Pharmaceuticals Corp.
Senior Consultant, CenterPoint Security Associates, LLC
Public Health Analyst, Centers for Disease Control
Manager, Cephalon
Director, Quality Assurance, Cephalon
Administrative Assistant, Children's Hospital of LA
Managing Director, ColdWave Systems LLC
President, Commodity Forwarders
Regional Sales Manager, Commodity Forwarders
Director of Strategic Development, Council of Supply Chain Management Professionals
Senior Director Supply Chain, Daiichi Sankyo, Inc.
Senior Vice President, Disc Graphics, Inc.
CEO, DNS London Trading
Senior Account Manager, Domtar Specialty Papers
Associate Director, Dr. Reddy’s Laboratories Limited
North America Regulatory Affairs Manager, Medical and Pharmaceutical Protection, DuPont
Business Development Manager, Medical Packaging, DuPont
Director of Executive Accounts, Early Alert
Account Executive, Early Alert
Regional Account Manager, Envirotainer
President/CEO, Epic RX Pharmacies, Inc. , Epic Pharmacy Network
Analyst, ESC Group
CEO, Excellis Health
Commissioner's Fellow, FDA
Managing Director- Life Sciences and Specialty Services, Global Trade Services, FedEx Express
Director, FedEx
Senior International Sales Executive, FedEx
Worldwide Account Manager, FedEx
Worldwide Account Manager, FedEx
Worldwide Account Manager, FedEx
Senior Marketing Project Manager, FedEx
Manager, International Business Development, FedEx
Business Development Advisor/Healthcare, FedEx
Manager of Quality and Validation, FedEx Custom Critical
VP Pharmaceutical Development, Femmen Pharma Global Healthcare, Inc.
Site Design and Development Quality Manager, FlexTronics
Director of QS Pharma, Fresenius Medical
Partner, Fox Rothschild
Senior Manager, Corporate Security, Genentech
Buyer, Genzyme
Sourcing Group Manager, GlaxoSmithKline
Director, Risk and Regulatory Administration, H.D. Smith
VP Clinical, Regulatory, & Quality, Hawaii Biotech
Executive Director, Healthcare Compliance Packaging Council
Director, Healthcare Plastics Recycling Council
Howard Hughes Medical Institutes
Quality Assurance Compliance, Human Genome Sciences
Bioprocess Associate III, Human Genome Sciences
Senior Device and Packaging Engineer, Human Genome Sciences
Manager of Business Processes and Standards, IATA
Marketing Manager, IATA
Assistant Director, Content Services, IATA
Vice President, Operations, Ingenus Pharmaceuticals LLC
Nursing Director, Inspira Behavioral Care
Business Development Manager, International Pharma Packaging & Distribution
Editor and Chief, International Pharmaceuticals Quality
Associate Professor, Departments of Medicine, Oncology, and Pharmacology, Johns Hopkins
Manager, GRCF BioRepository and Cell Center, Johns Hopkins Medical Institute
Senior Scientist, Johnson & Johnson
Supply Chain Temperature Control Leader, Johnson & Johnson Global Transportation Organization
Senior Transportation Analyst, Johnson & Johnson Global Transportation Organization
Director, Supply Chain, Jubliant Cadista Pharmaceuticals, Inc.
Marketing and Sales Manager, Klinge Corporation
President, Klinge Corporation

 

Sales and Marketing Manager, Klinge Corporation
Sales and Marketing, Klinge Corporation
Sales and Marketing Manager, Klinge Corporation
Packaging Supervisor, Kremers Urban Pharmaceutical
VP of Sales, Life Packaging Technology
Director of Global Quality, Life Technologies
Senior Manager of Quality Assurance, Life Technologies
Director of Supply Chain, Lonza
Purchasing Manager, Lonza
Distribution Manager, Lonza
Research Associate, Macrogen
Legislative and Regulations Manager, Maryland State Board of Pharmacy
Pharmacist Compliance Officer, Maryland State Board of Pharmacy
Principal, McCune Consulting
President, Medicine Differentiation Analytics, LLC
Managing Director, Medicines Differentiation Analytics, LLC
Director IT, MedImmune
Senior Manager if Regulatory Affairs, MedImmune
Transportation Manager, MedImmune
Senior Quality Engineer, Medtronic
Staff Development Engineer, Merck
Senior Engineer of Packaging Technology, Merck
Manager, Merck
Technical Manager, Merck
Senior Manager, Global Transportation, Merck
Global Logistics Manager, Merck
Senior Supply Chain Analyst, Merck
Biologic Project Lead, Merck
Former Senior Business Process Lead for SCM-Master Data, Merck
Senior Engineer, Merck
Simulation Laboratory Coordination, Michigan State University- College of Nursing
Associate Professor, Michigan State University- School of Packaging
Director Program Management, Michigan State University
Corporate Vice President of Pharmacy, MMM and PMC Health Plans
Chief Operation Officer, Mobius Therapeutics
Director of Sales, Morpho Detection
Manager Industrial Design, MPR Associates
Program Manager, National Institute of Standards and Technology, Manufacturing
Extension Partnership Division
President, Numedics
Manager, Otsuka America Pharmaceutical, Inc
Director, Sterile Technology, Otsuka America
Director, Owens and Minor
Principle Packaging Engineer, PackWise
Executive Vice President, PBM Pharma
Supply Chain Analyst, Perrigo
Engineer, Pfizer
Regulatory Affairs Scientist, Pfizer
Director, Global Transport & Logistics Services, Pfizer
Director Global Specialty & Cold Chain Logistics, Pfizer
Senior Manager, Global Transport & Logistics Services, Pfizer
Pfizer
Editor and Chief, Pharmaceutical Commerce
Supply Chain Manager, PharmaThene
Platinum Press
Consultant, PricewaterhouseCoopers
Manager, Business Development, Purolator International
President and Founder, Purple Diamond Testing
Manager, Design and Innovation, Quality Packaging Specialists International
VP Americas, Reconnaissance International
Professor, Rider University
Manager, Quality Engineer, Roche
Pharmaceutical buyer, Royspec
Medical Purchasing Supervisor, Royspec
Assistant Vice President, RX Response
Senior Consultant, RX Response
General Manager, Saf-T-Pack    
Haemophilia/Haemovigilance Project Manager, Saint James's Hospital
3rd Party Compliance Associate, Sandoz
SDIX
Manager, Distribution and logistic Management, Shire Pharmaceuticals
Sales Manager, Southwest Airlines-Cargo
Senior Manager, Southwest Airlines-Cargo
Manager, Product Development, Stryker Orthobiologics
Executive Vice President, Sun Laboratories LTD
Portfolio Manager, Supernus Pharmaceuticals, Inc.
Director, Business Development, SCHAWK Digital Solutions
Solution Architect, Take Solutions
Adjunct Professor, Temple University
Marketing Specialist, Temptime
Business Development Manager, Temptime
CCO, Temptime
Vice President, The Pharma Compliance Group
System Engineer, Thermedical
Executive Director, Tissue Banks International
Principal Consultant and Owner, Trotter Biotech Solutions
Assistant Branch Chief- Certified Cargo Screening, TSA
UCLA Anderson MBA Student, UCLA Anderson School of Management
UCLA Anderson MBA Student, UCLA Anderson School of Management
Manager, Sustainability Solutions, UPS Customer Solutions
Healthcare Solutions Manager - North America, UPS Supply Chain Solutions
Global Logistics and Distribution Marketing, UPS Supply Chain Solutions
Director, Global Healthcare Compliance, UPS Supply Chain Solutions
Marketing Manager, Healthcare Segment, UPS - Chesapeake District
Consultant, Urmila Keyshore Consulting
Senior Manager, Business Development, US Airways
Sales Manager - Product Specific Sales, US Airways
Chief Technology Officer, Vertex Pharmaceuticals, Inc
Operations Research Scientist, Vertex Pharmaceuticals, Inc
Director, Transportation, VWR
Vice President, Water Street Healthcare
Associate Director of Package Development, Watson Pharmaceuticals
Senior Labeling Associate, Watson Pharmaceuticals
Key Account Manager, Weiss-Rohlig USA
Project Engineer, West Pharmaceutical Services
COO, West-Ward Pharmaceuticals
Sales Logistics, XTL

 
  Monday, November 7, 2011
7:00a Continental Breakfast & Registration
Co-located with our Pharmaceutical Supply Chain Summit!
8:00a Chair's Welcome
William E. McCune, DrPH, CPP, Consultant, McCune Consulting
8:15a Keynote Address
Smarter Pharmaceutical Packaging: A Hero in Healthcare Reform?

Walter Berghahn,
Executive Director, Healthcare Compliance Packaging Council
9:00a Serialization- from Hypothetical to Reality: Strategies and Solutions for 2015

Greg Cathcart, CEO, Excellis Health LLC
Barry A. DeDominicis, Associate Director, Technical Operations, Bracco Diagnostics Inc.

10:00a Morning Refreshment & Networking Break
Co-located with our Pharmaceutical Supply Chain Summit!

10:30a The Union Between Drug and Packaging- Managing Leachables and Extractables
  • Understand the issue of leachables and extractables
  • Identify the difference between "high-risk" and "low-risk" dosage forms
  • Understand the FDA CDER/CBER risk-based approach
  • View industry case studies
  • Testing and detection techniques and technologies, HPLC, GC/MS, LC/MS, NVR, TOC, etc.
  • Discuss Modeling, Profiling and Actual testing methods; why, when and the benefits/drawbacks.
  • Current industry trends & global regulatory requirements / expectations for extractable/leachable testing.

Daniel Norwood, Distinguished Research Fellow, Boehringer Ingelheim Pharmaceuticals, Inc.
Mark Trotter, Principal Consultant, Trotter Biotech Solutions

11:15p How and Where a Sterile Barrier is Used in Medical Device and Pharmaceutical Packaging
  • What is a sterile barrier system
  • The applications for sterile barrier in Healthcare Packaging
  • The challenges of distribution and the attributes of packaging materials that meet those challenges
  • The importance of a microbial barrier in your packaging material
  • An overview of sterilization methods
  • Compatibility of common materials with sterilization methods

John Bamberger, North America Regulatory Affairs Manager, Medical and Pharmaceutical Protection, DuPont
Leslie Love
, Business Development Manager, DuPont Medical & Pharmaceutical Packaging

12:00p Luncheon Presentation - Co-located with our Pharmaceutical Supply Chain Summit!

Keeping Your Cool: Taking advantage of a robust global network, 24/7 monitoring and visibility services while creating innovative cold chain solutions

  • Understanding the importance of global air network, visibility and intervention capabilities to develop cold chain solutions
  • Commitment to the global healthcare industry
  • Evaluating a portfolio of services and temperature controlled capabilities to overcome challenges faced by either pharmaceutical or biopharmaceutical companies
  • Developing cost-effective global room temperature solutions to maintain product temperature

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

1:15p Augmenting Your Package Integrity: Best Practices in Package Validation

  • Packaging integrity with design and development
  • Process validation and distribution conditioning
  • Standards and guidance documents

Jan Gates, Principle Packaging Engineer, PackWise and Former Staff Packaging Engineer, Abbott Vascular
Karen Greene, Packaging Engineer Specialist, Life Packaging Technolgy LLC

2:00p DNA Authentication

James Hayward, President and CEO, Applied DNA Sciences

2:45p Afternoon Refreshment & Networking Break
Co-located with our Pharmaceutical Supply Chain Summit!

3:00p

Protect the Product, Protect the Patient: Anti-Counterfeiting Issues and Strategies
  • Effective utilization of lifecycle histories and new track and trace technologies to ensure patient safety, increased security and regulatory compliance
  • Benchmarking innovative track and trace technologies like RFIDs, barcoding, holography and more- how do these technologies work to ensure the safety of your product, and which is best for you?
  • Utilizing mobile technology to ensure compliance and safety

Feargal McGroarty, Haemophilia/Haemovigilance Project Manager, IMS Division, St. James Hospital (Ireland)
Randall Burgess, VP Americas, Reconnaissance International

3:45p Thinking Cold, Thinking Green: Re-usable Thermal Shippers for Healthcare Products
  • Definitions
  • Developing package design
  • Applicable regulations and guidelines
  • Which approach is suitable for your needs?
  • Developing shipping protocols for temperature sensitive  healthcare products
  • Process steps and quality controls
Boriana Cavicchia, Senior Associate, PricewaterhouseCoopers LLC
4:30p Examining Global Initiatives in Responsible Packaging
  • Take a look at how countries around the world are addressing issues of reducing waste and maximizing return in packaging
  • Spotlight on the UK's Packaging Waste Directive!
  • The challenges of trying to "go green"
  • Saying "no" to PVC packaging and finding alternative recyclable solutions
  • Lowering Environmental Impact
  • What your sustainability strategy road map should include

Arnold Barlow, Manager Sustainability Solutions, UPS Customer Solutions
Tod Christenson, Director, Healthcare Plastics Recycling Council

5:15p Day One Closing Remarks and Cocktail Reception (in the Exhibit Hall)
Co-located with our Pharmaceutical Supply Chain Summit!
 
  Tuesday, November 8, 2011
7:30a Continental Breakfast & Registration
Co-located with our Pharmaceutical Supply Chain Summit!

8:30a Chairs' Welcome
William E. McCune, DrPH, CPP, Consultant, McCune Consulting
8:45a Understanding Users Needs through Simulation: Michigan States Medical Simulation Program
  • Industry focus is shifting from protecting the product to protecting the patient; with more therapies 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 is used, (and misused), in real-world settings, and what the industry has learned from their tests

MaryKay Smith MSN, RN, Director, Michigan State University- Learning and Assessment Center
Dr. Laura Bix,
Associate Professor, Michigan State University- School of Packaging

9:45a Morning Refreshment & Networking Break
Co-located with our Pharmaceutical Supply Chain Summit!

10:15a Thinking Outside the Box: What Does the Future Hold for Pharmaceutical and Medical Packaging?
  • What will the next ten years hold for pharmaceutical packaging? How will new directives, materials and players impact the industry as it stands?
  • Where should the industry look next for innovation and leadership?

William E. McCune, DrPH, CPP, Consultant
Michael Forehand, Principal Engineer, Packing and Device Technology, AstraZeneca

11:00a Pharmaceutical Theft Prevention — How to Manage Supply-Chain Risk
  • What are the risk factors associated with shipping pharmaceuticals?
  • Comprehensive planning can reduce the risks, e.g., insurance and contractual protections.
  • How shipping documents can alter the assignment of risk.
  • Risk management includes planning for loss before it occurs

David Restaino, Partner, Fox Rothschild

12:00p Luncheon Presentation: Co-located with our Pharmaceutical Supply Chain Summit!
1:00p Meeting Regulatory Needs by Leveraging Packaging Design

  • What innovative new designs will enable manufacturers to incorporate the necessary amounts and types of information into their labeling
  • How can we incorporate labeling needs into early packaging design?

William Bosley, Senior Labeling Specialist, Watson Pharmaceuticals
Troy E. Walker, Director Business Development, Schawk Digital Solutions

1:45p Monitoring the Volatility of Pharmaceuticals and Biologics
  • Creating an integrated systems approach... A Temperature Sensitive Solution
  • Explore why supply chain integrity and temperature management are critical to the overall healthcare goals
  • Discover how an integrated systems approach can have a profound impact on patient access and results
Deb Skelnik, President, Numedis and President & CSO, Insight Biomed, Inc.
2:30p Afternoon Refreshment & Networking Break
Co-located with our Pharmaceutical Supply Chain Summit
2:45p IATA Standards: Transportation of Time and Temperature Sensitive Products
  • From Guidance to Regulation – how has this been achieved?
  • Importance of Standards – IATA development of a standard label
  • What are the challenges and how are these addressed?
  • 2012 Time and Temperature Sensitive Roadmap
  • The way forward and future requirements
Andrea Graf-Gruber, Manager Business Process & Standards, International Air Transport Association (IATA)
3:30p Utilizing an Active vs. Passive System: Enhancing Shipping and Optimizing Operations
  • Access to regulations
  • Active vs. passive system
  • Integrating rules and operations
  • Starting with a validated shipping declaration
  • Optimized shipment preparation
  • Persistence of content
  • Effect on training
  • IATA's new EasyDGR solution: A system that increases confidence and helps avoid delays, re-checking costs and possible fines by creating and using a validated Dangerous Goods Declaration to create compliant shipments
Bob Schaffel, Assistant Director, Content Services, International Air Transport Association (IATA)
4:00p Closing Remarks, Refreshments and Event Debriefing with attendees from the Pharmaceutical Supply Chain Summit.