US Seminar

Collaborative Learning that FUELS your Temperature Controlled Pharmaceuticals

May 3rd & 4th 2016 – Princeton Marriott at Forrestal, New Jersey

Unique Format
Think industry retreat. No, not paintball or karaoke. Instead bringing together the best minds from pharmaceutical manufacturers and supply chain partners to resolve very real, specific challenges. The Leading Minds Seminars are created to have an open dialogue, no pressure, relaxed environment that FUELS the cold chain. The majority of the program is discussion-based. Download the 2016 program here.

Fusion of
Useful
Experiences in
Logistics and
Storage

No press, no sponsorships at Leading Minds Seminars only further FUELS a positive, open exchange environment.

→ Register now

Why
Being responsible for your company’s temperature controlled shipments, you know the challenges are complex and require well thought through, structured and collaborative approaches. There are no quick fixes, unless you have an unlimited budget.

ELPRO and Envirotainer have been involved in developing cold chain systems for decades. We want to facilitate the right discussions, between the right supply chain partners help you build the components together create a cost-effective, compliant temperature control chain.

Tradeshows serve a purpose, but sometimes you need more than «information overload». Rather you need a focused group of people, concentrating on developing a detailed, step by step process approach to find the complete solution that you need for your intended business outcomes.

Seminar Presentation and Discussion Topics:

Tuesday May 3rd

7.45   |   Welcome Coffee and Registration
         
8.25   |   Welcome Remarks
        Chairperson: Tom Grubb, Manager Cold Chain Strategy, American Airlines
         
8.30   |   Leading Minds FUELS the Cold Chain – Industry Colleague Team Building
         
8.50   |   Regulatory Inspector Presentation: Good Distribution Practices in Today’s Pharmaceutical Supply Chain
        - Feedback from actual investigations - advice for pharma manufacturers to comply with new GDP and GMP regulations
        - Best practices using stability data for temperature controlled shipments
        - How the new UK Data Integrity Guidance applies to the GDP shipping environment
        - MHRA feedback on shake and vibration stability testing of biologics
        Ian Holloway, Senior GMP Inspector, MHRA
         
9.30   |   Interpretation of GDP for Temperature Sensitive Shipments in the Pharma Supply Chain
        - Feedback from Leading Minds Brussels – are we aligned to Europe?
        Steve Winyard, Pharma Cold Chain Industry Expert, Envirotainer
         
10.10   |   Networking Break
         
10.40   |   Developing a Robust Temperature Controlled Logistics Strategy
        - Background and environmental factors shaping pharmaceutical logistics
        - Goals of a robust logistics strategy
        - Key internal stakeholders in developing a strategy
        - Dimensions of a comprehensive logistics strategy
        Nish Chudasama, Group Leader Integrated Supply Chain Operations, Bristol-Myers Squibb
         
11.20   |   Problem-Solving Small Group Discussions (choose one)
         
        A) Implementing a Global Data Monitoring System Part I – Getting the Project Moving Internally, Securing Senior Sponsorship, Defining New System Requirements & SOPs
        Discussion Leaders:
        Katherine Woodcock, Senior Specialist, Clinical Business Operations, Biogen
        Luke Kucala, Senior Logistics Specialist, Clinical Drug Supply, Biogen
        Terri Montes, Informationist, Knowledgent
         
        B) Weak Points in the Data Supply Chain – Where and How Would More Logistics Data and Visibility be Helpful?
        Discussion Leader: Steve Winyard, Pharma Cold Chain Industry Expert, Envirotainer
         
        C) Handling Ultra Cold Temperature Clinical and Commercial Shipments and Their Data Monitoring Challenges
        Discussion Leader: Bruce C. Simpson, Director, Commercial Operations, Fisher BioServices
         
        D) The Future of Monitoring, and the Present Truth of the Total Cost of Distribution
        Monitoring 100% of the shipments, most people will agree, is the future and ideal state of temperature
        controlled shipments - however, cost and operational challenges may make this prohibitive today. When looking
        at distribution, the cost of materials, assembly, conditioning and shipping costs are considered the Total Cost - but, what about qualification and risk related costs? Lane qualification has many variables, and even with
        testing, how can you be sure that you are not taking too much or too little risk? And how could Total Costs be
        actually greatly reduced with 100% monitoring? (e.g. 100% monitoring leading to cheaper boxes/shipping for
        some low risk products) If accounted for, these may make 100% monitoring cost effective even today. Join this
        group to discuss this topic!
        Discussion Leader: Ben Romero, Senior Engineer, formerly Genentech
         
12.20   |   Lunch
         
1.30   |   Five Minute Recap and Summary on Problem Solving Group Discussions
         
1.50   |   Community Forum Discussion – Defining Your CRT Policy
        2012 was probably the turning point for many companies, when the revised EU GDPs draft guidance came out. It was clear then, and certainly in 2013 when the final version was published, that 15-25C, or Controlled Room Temperature Products (or as some say ‘ambient products’), were a focus of the regulators. OTC products that had any labelled temperature requirements, were brought into the fold of temperature control logistics. So several years later, why are we still talking about this?
        - Questions regulators are asking in audits now
        - Aligning CRT and labelling policies across multi-national sites
        - Are there scenarios where you are justified in having different storage and shipping conditions?
        - What’s stopping you from having a solid CRT policy in place?
        Moderator: Michael English, Associate Director Engineering, Merck
         
2.40   |   Using Temperature Data Analysis to Statistically Evaluate your Cold Chain Performance and Reduce Logistics Costs
        - New Data Integrity regulatory guidelines – how using a central document management system for temperature data fits in this new world of Data Integrity requirements
        - Building the data sets required for meaningful statistics
        - Defining what type of statistics will help you make cost cutting decisions
        Cyril Winkler, Head of Product Management, ELPRO
         
3.20   |   Networking Break
         
3.50   |   Community Forum Discussion: Transport Qualification
        - Differing Approaches setting up qualification of lanes, vs shipping systems
        - CRT vs Cold Chain product qualifications
        - Access to, use of stability data
        - Network mapping – analyzing the data, defining profiles
        Panelists:
        Arminda Montero, Global Supply Chain QA Manager, Supply Chain and Commercial Quality, AbbVie Inc.
         
4.40   |   Problem-Solving Small Group Discussions (choose one)
         
        A) Implementing a Global Data Monitoring System Part II: Bringing Inline External Partners, including Clinical Sites, Manufacturing, CROs and Logistics Partners
        Discussion Leaders:
        Katherine Woodcock, Senior Specialist, Clinical Business Operations, Biogen
        Luke Kucala, Senior Logistics Specialist, Clinical Drug Supply, Biogen
        Terri Montes, Informationist, Knowledgent
         
        B) Maintaining Performance and the Partnership with Solution Providers Post Implementation Discussion Leader: Jim Bacon, Principal, Stay Cool Logistics Consulting LLC
         
        C) Temperature Deviations Management – Closing the Alarm to CAPA Time Gap
         
        D) Temperature Mapping and Humidity Considerations for Warehouses – When, How, Why to Map or Perform Full Qualifications based on New Regulatory Guidelines
        Discussion Leaders:
        Micalyn Harris, Vice President, Sales & Marketing North America, ELPRO
        Teresa Parayil, Key Account Manager, ELPRO
         
5.40   |   FUEL Session – Industry Team Building
         
6.00   |   Closing Remarks
         
6.05   |   Networking Drinks Reception
         
6.45   |   BBQ and Patio Party


Wednesday May 4th - User Group Meetings
9am – 4pm (concurrently running in separate rooms)

ELPRO User Group Meeting
The ELPRO User Group day will consist of several formats including a series of “Data in Action” breakout groups, groups structured by experience level, and focused topics such as clinical supply that allows for more focused, detailed discussions. If you have a suggestion for topics or format for the UG day, please email cbecker-james[at]elpro.us. Topic include:

  • Incorporating stability data into your profiles and monitoring approach. «Data in Action» – Looking at possible allowable excursions
  • Stability Budget 201 - next steps to establishing a usable approach to track excursions throughout the lifecycle of your products
  • PQ / OQ Requirements: Does your approach meet regulatory and industry standards
  • Transport Qualification – Benchmarking with other company approaches
  • Thermal mapping strategy and analysis of trucks, and warehouses
  • Setting up a centralized database for temperature data. Correct data input = meaningful data out
  • Challenges in working with third parties in implementing a new data monitoring system
  • Multi component shipments – releasing partial shipments
  • Challenges in shipping cryo – does your API or clinical materials have special requirements?
  • End User Group Live Shipment Study – Handling the release, upload to database, evaluation of stability data and correct handling alarms in elproVIEWER
  • End User Group for Clinical Supply and Site Monitoring – How to get most use of out of CONFIG Utility – correct report titles, file names, where to put certain information
  • End User Group – using liberoMANAGER to perform searches, segment data, start defining trends
  • Advanced User Group – Using liberoMANAGER to Track TOR or Stability Budget

Envirotainer User Group Meeting
Envirotainer will present the first part of the day on reliability in the cold chain and present an update to our Telemetry solution from last year. Throughout the day, groups will have a chance to break-out in smaller teams and have closer discussions on these topics:

  • How do industry leaders build the highest quality into a reliable cold chain?
  • What does the most sustainable cold chain look like?
  • What are the common pitfalls in attaining a reliable cold chain and what are the solutions in prevention?
  • What is the promise of telemetry?
  • Relevant and actionable data to secure decisions and minimize risks across the supply chain
  • Case studies: real life pilots on RAP e2 containers using Envirotainer’s integrated visibility solution

→ Download 2016 Program

Program and Networking
Day One – presentations, small group discussions, problem solving breaks outs. The day concentrates on current affairs, regulations and practical case studies that seek to solve business critical issues.

Day Two - User Group meeting(s) in two separate rooms that discuss ELPRO/Envirotainer specific technology and trends in that technology area including implementation challenges and sharing of customer experiences

Evening Networking – BBQ and Patio Party on the lawn of the beautiful 25 acre Marriott property.

So many events, so little time. Why this one?

Projected forecasts predict higher volume of products requiring temperature control; however at the same time the industry continues to consolidate and move toward more strategic partnerships with supply chain partners. ELPRO and Envirotainer have been involved in developing cold chain systems for decades. Applying our extensive experience we want to facilitate the right discussions, between the right supply chain partners to ensure successful business outcomes now, and for the long term. Tradeshows serve a purpose, but sometimes you need more than «information overload». Rather you need a focused group of people, concentrating on developing a detailed, step by step process approach to find the complete solution that you need.

Additional Information

Format
The seminar is complimentary (no fee) attendance to pharmaceutical manufacturers.

Bringing together the best minds from pharmaceutical manufacturers and supply chain partners; the first day program will consist of presentations and group discussions concentrating on current affairs, regulations and practical case studies that seek to solve business critical issues. The second day will be User Group meeting(s) in two separate rooms that discuss ELPRO/Envirotainer specific technology and trends in that technology area including implementation challenges and sharing of customer experience to solve day to day issues participants are facing.

Participants will enjoy networking with other temperature control logistics and QA professionals during informal discussions, luncheon and networking evening in Princeton, New Jersey.

Location and Hotel
Princeton Marriott at Forrestal, 100 College Road East, Princeton, New Jersey, 08540

The Leading Minds Seminar has a negotiated rate of $199 USD/night for bedrooms. Please use the link below to book.
→ Book your group rate for ELPRO Seminar

Seminar hosted by:

ELPRO, founded in 1986, is a leading Swiss manufacturer of innovative monitoring solutions and data loggers for documenting environmental conditions in cold chain transportation, production facilities and warehouses. ELPRO partners with clients to develop solutions that integrate ELPROs high-quality measurement components into their business processes. Clients include biotechs, diagnostic manufacturers, and top 20 pharmaceutical companies. As the inventor of the LIBERO PDF Logger, ELPRO supports pharmaceutical and healthcare companies around the world in simplifying their cold chain while having less manual work thus reaching quicker release times. ELPRO’s US subsidiary has been established in Marietta, OH since 2003 with a full turnkey support and technical staff.

Envirotainer is the world leader in secure cold chain logistics solutions within the life science industries. The company manufactures and leases active temperature-controlled container solutions for air transportation, including validation, support and service. Envirotainer operates through an open, global network of airline companies and logistics partners. The company is represented in over 50 countries around the world with headquarters in Upplands Väsby just outside of Stockholm, Sweden. Envirotainer is a registered trademark of the company Envirotainer AB.

2015 Impressions

The first Leading Minds Seminar was May 2015 in New Jersey with 64 pharmaceutical manufacturers attending, plus MHRA and US Pharmacopeia speaking. Learn from key highlights – click here for the detailed post-event report.