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Risk Assessment on the Clinical Supply Chain

When:

September 29, 2020 10:00 amSeptember 29, 2020 11:00 am (PDT)

Where:

WEBINAR

,

Registration Closed

Risk Assessment on the Clinical Supply Chain


Clinical trial supply inherently carries many risks. Since March, the world has had to adapt to a drop of nearly 90% in available commercial flights, and yet the transportation needs of clinical trials remain the same. In this webinar, PCI Clinical Trial services will discuss the risks that trial sponsors need to consider, including:

  • The most common risk areas in cold-chain such as: distribution, temperature control, geography, and timelines
  • What risk assessment tools can be used to manage risk in clinical trials
  • How to use technology to lower risk

Speakers:

Edward Groleau, Director of Clinical Supply Chain for North America, PCI Pharma Services

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Billie Wayne Key Jr, Sr. Manager, Supply Chain, PCI Clinical Trial Services

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Co-Host Sponsor: User-added image


ELPRO has been a partner to biopharma companies for three decades developing compliant data monitoring systems for facilities and products in-transit. ELPRO’s data loggers and software protect your biotech assets from lab to supply chain: growing and adapting as your products move through trials and into market. ECOLOG Monitoring Solutions for Rooms and Equipment allows great flexibility to access your facility remotely via internet browser to see temperature, CO2, RH, Pressure differential or any 4-20mA signal. LIBERO PDF multi-alarm data loggers monitor shipments to control a wide-range of biotech applications (-200C…+200C) including clinical trial kits, ultra-low shipments and APIs. Ask us about new developments in real-time monitoring and wireless monitoring. ELPRO’s US headquarters is in Marietta, Ohio since 2003 with a full technical support staff; and offices in San Diego and San Francisco.

www.elpro.com


Presenting Sponsor:


PCI Pharma Services


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Supporting Sponsor:

Pelican BioThermal


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About the Series:

Biocom is once again collaborating with ELPRO, a global provider of environmental monitoring solutions, to co-host a series of educational webinar sessions taking place this summer and early fall. The webinar series is for all life science practitioners in Supply Chain, Logistics, Packaging Engineering, Cold Chain, Quality Control/Quality Assurance, Clinical Supply and Commercial Operations or Warehousing. The sessions will include case studies, strategies and tools to preserving the safety and efficacy of temperature-sensitive products in-transit and in-storage.

Price of Admission

Non-Members

Today’s Price: 15

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  • Speaker Bios

    Edward Groleau, Director of Clinical Supply Chain for North America, PCI Pharma Services

    Ed Groleau has over 30 years of experience in the Pharmaceutical industry. He joined PCI Pharma Services in 2018 and became the director of his group in 2019. Ed leads the Supply Management And Readiness Team (SMART) at PCI where his team partners with clinical trial sponsors to manage drug supply from protocol development through final destruction. 


    Prior to PCI, Ed worked in numerous departments at Eli Lilly. The first 15 years were spent in a variety of laboratories for small molecule drug development. He developed and validated analytical testing methods at Merrell Dow Pharmaceuticals and Eli Lilly. Ed moved to Lilly’s Clinical Trial Supplies group in 2003 starting with responsibilities for packaging and labeling of IP. His responsibilities increased as the department changed over the years to include all aspects of CT supplies from planning through distribution. In 2011 he became part of a small, highly integrated CM&C team responsible for overseeing the development of compounds from discovery through proof-of-concept stage. On this team Ed developed the procedures and processes required to conduct all aspects of the supplies for clinical trials from manufacturing through reconciliation. In 2016 Ed moved to Elanco, Lilly’s animal health division, where he established a global clinical trial supplies group for developing companion and food animal projects.


    Ed has a Bachelor of Science in Chemistry from Illinois State University.



    Billie Wayne Key, Jr. Sr. Manager, Clinical Supply, PCI Pharma Services

    Billie Key has over 25 years of experience in the pharmaceutical and academic research areas. He spent over 14 years working in research laboratories, ultimately managing target discovery and pharmaceutical development groups for both small and large molecules. In 2009, he moved to Lexicon Pharmaceutical’s clinical operations group as a Pharmacy Liaison managing IP logistics and secondary packaging vendors as well as trial master file and interactive response technology platform support. In 2011 he lead the creation of a clinical supplies department responsible for development of the procedures and processes required to conduct all aspects of the clinical supply chain from packaging through reconciliation.  


    In 2013 Billie assumed additional roles by joining the small, highly integrated Commercial Supply team responsible for developing the procedures and processes required to oversee and control global production, packaging, and distribution for the consecutive marketing approvals of Lexicon’s drugs for carcinoid syndrome and diabetes.  


    In 2019, he joined the Supply Management And Readiness (SMART) team at PCI Pharma Services where he partners with clinical 


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