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Events and Networking

Expand Your Network at One of Biocom’s 150+ Annual Events

Temperature Controlled Distribution of Biologics

When:

Tue Sep 11 15:00:00 GMT 2018 - Wed Sep 12 02:00:00 GMT 2018

Where:

The Alexandria
10996 Torreyana Road
San Diego, CA 92121

Register

Temperature Controlled Distribution of Biologics
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 Biocom and ELPRO are delighted to bring cold chain practitioners the first Leading Minds Seminar in San Diego September 11th. The Temperature Controlled Distribution of Biologics seminar is designed for biotech companies, which are often virtual, rely heavily on partnerships, and have very specialized products.

Temperature sensitive biotech products, clinical supplies and active ingredients require more complex logistics handling in-transit and in-storage, especially across multi-national supply chains. While at the same time adhering to strict, and sometimes unclear, regulatory requirements.
 
Confirmed Speakers:

  • Kevin Hickman, Manager, Supply Chain Distribution, Gilead Sciences, Inc. 
  • Ana Laura Guerrero, PH.D., Sr. Logistics Analyst, Packaging Engineer, Illumina
  • Craig Vermeyen, Sr. Manager, Packaging Engineering, Kite Pharma
  • Joroen Van Loo, Global Account Manger, ELPRO 
  • Saya Mehta Godwin, Director, Supply Chain and Logistics, Heron Therapeutics

Topics include:

  • Personalized medicines home delivery challenges in packaging design and compliant temperature monitoring
  • Strategic logistics collaborations in clinical supply chains and commercial bulk supply; including examining importance of CMO, CRO Quality Agreements and transparent communications
  • How to use stability data in the cold chain and understanding what regulatory compliant approaches are for ‘allowable excursions’ and shipping to label claim
  • Controlled Room Temperature (CRT) shipping: Bringing all partners (internal and external), warehouses, and shipping systems into compliance for a cost-effective supply chain
  • Ensuring data integrity in the clinical supply chain in a biologics world
  • GDP and GMPs for temperature sensitive APIs: Considering new 2018 FDA Guidance in practice
  • Process consideration for cryogenic shipping of cell-based and other biologic

**To view and download the full agenda, click here


Additional Sponsors:

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Why
Southern California’s Life Science community is a leader in novel drug discovery, genomics research and extensive clinical trial research. With a long history of innovation and trail already ablaze with next gen therapeutics, diagnostics and biologics, what level of consideration and investment is being allocated to the protection of in-process, clinical, active ingredient and finished good during distribution?

The distribution environment is challenging, even more so when distributing high-value temperature-sensitive products. To preserve the safety and efficacy of these products through each stage of the distribution process, they must be adequately and compliantly protected against thermal and physical stress. 
 
The Seminar
This one-day seminar will discuss the many challenges facing Life Science organizations when distributing temperature sensitive products including types of stability testing; selecting the solution that is right for your product and its distribution environment; temperature data monitoring and management; quality agreements with partners; using multi-modal transport; clinical trial site quality control; and of course – how to best meet regulatory requirements with the resources you have.
 
Leading Minds Format
Leading Minds Seminars are unique in format and intent: we call it FUELS.
Fusion of
Useful
Experiences in
Logistics and

Storage
 
Experience sharing and problem solving are at the core of our seminars. Our Seminar programs are 65% discussion based. Step in, sit down, benchmark with other practitioners.
 
Collaborative and community-based learning at its best.
 
Who
All Life Science, Biologics, Pharma, and Medical Device practitioners who are faced with the challenges of preserving the safety and efficacy of their organization’s temperature-sensitive products are welcome to attend.
 
Job titles most likely to benefit in attending are:

  • Supply Chain, Logistics
  • Packaging Engineering
  • Cold Chain
  • Commercial operations or warehousing
  • Quality Control/Quality Assurance
  • Clinical Supply
  • Regulatory Affairs


Also, manufacturer’s partners:

  • CROs
  • CMOs
  • Freight forwarders, 3PLs, specialty couriers
  • Packaging suppliers

***Please note: This event is only open to industry members of Biocom and ELPRO's Leading Minds Network, unless sponsoring or exhibiting at the event. This event is closed to any service provider company (member or non-member.)  A service provider is a company that does not directly work with a substance that needs approval by the FDA and/or does business-to-business sales. They provide a service to the biotechnology and pharmaceutical industry and includes, but is not limited to, law firms, banks, laboratory equipment suppliers, consulting firms, or IT services.

**Biocom has the right to cancel and refund your registration, should the system allow you to register by mistake. If you are unsure about your status, please contact Angela Wieszchowski at angelaw@biocom.org. 

Price of Admission

Biocom Member (Industry)

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Non-Member (Industry Only)

Today's Price: 250.0

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Refund before Fri Aug 24 00:00:00 GMT 2018

250.0

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Today's Price: 450.0

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450.0

Refund before Thu Jul 26 00:00:00 GMT 2018

450.0

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  • About ELPRO

    ELPRO, a Swiss engineering firm, 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 (-200°C...+200°C) 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.

    http://www.elpro.com

     

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  • About ELPRO

    ELPRO, a Swiss engineering firm, 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 (-200°C...+200°C) 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.

    http://www.elpro.com

     

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