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Temperature Controlled Distribution of Biologics

When:

September 10, 2019 8:00 amSeptember 10, 2019 7:00 pm (PDT)

Where:

The Alexandria
10996 Torreyana Road
San Diego, CA 92121

Registration Closed

Temperature Controlled Distribution of Biologics

Brought to you by:

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Now in its second year, Biocom and ELPRO are delighted to bring cold chain practitioners our Leading Minds Seminar in San Diego on Tuesday, September 10th. 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:

Denise Valentino, Director, Global Trade Compliance & Logistics, Neurocrine

Chris Haddad, Senior Director, Global Logistics, Thermo Fisher Scientific

Kevin Hickman, Senior Manager, Supply Chain Distribution, Gilead Sciences, Inc.

Enid Payne, Healthcare Industry Segment Manager, Southern California, UPS

Laurie Rockwell, Global Account Manager, ELPRO

Bob Seevers, Senior Advisor, Pearl Pathways & Member, USP <1079> Packaging and Distribution Committee

Sean Merrill, GxP Validation Engineer, ELPRO

Frank Obrad, Senior Packaging Engineer, Kite Pharma

Heather Lane, Senior Supply Chain Specialist, Heron Therapeutics

Denise Valentino, Director, Global Trade Compliance & Logistics, Neurocrine

Topics include:
  • Knowing the ins/outs of import/export: Follow the rules while saving cost
  • Preparing for commercialization: What data will you put in the BLA?
  • GDP regulations updates across the globe
  • Biopharma and partners: Deeper dive into specific SOPs and contingencies
  • Qualification of shippers or thermal protection systems
  • Using temperature data for quality control and compliance
  • Quality and compliance GxP requirements for facilities

Attending Companies:

Abzena
AG Scientific
Allergan, Inc.
Arena Pharmaceuticals
Astute Medical
Bachem Americas
Biocept
BioNano Genomics, Inc.
DNA Electronics
ELPRO Services, Inc.
Fate Therapeutics
Gilead Sciences
Heron Therapeutics, Inc.
Illumina, Inc.
Inmark Worldwide
Kite Pharma
Marken
Neurocrine Biosciences
Pearl Pathways
Pelican BioThermal
Pfenex
Polypeptide Group
Retrophin
San Diego Blood Bank
Seattle Genetics
SMS Biotech
Sorrento Therapeutics
Stemcyte, Inc.
TCRCure BioPharma
Thermo Fisher Scientific
Tocagen
Triphase Accelerator
Unitrans
UPS
World Courier

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 supplier

Sponsors:

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Supporter:

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**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)

Today’s Price: 85

Important Dates

Amount

Registration before 2019-08-01T00:00:00.000+0000

50

Registration before

Registration before

Registration cost

85

Refund before 2019-09-02

85

Refund before

Refund Before

*Refunds will no longer be accepted after 2019-09-02

Non-Member (Industry Only)

Today’s Price: 150

Important Dates

Amount

Registration before 2019-08-01T00:00:00.000+0000

115

Registration before

Registration before

Registration cost

150

Refund before 2019-09-02

150

Refund before

Refund Before

*Refunds will no longer be accepted after 2019-09-02

Biocom Member (Service Provider)

Today’s Price: 450

Important Dates

Amount

Registration before 2019-08-01T00:00:00.000+0000

415

Registration before

Registration before

Registration cost

450

Refund before 2019-09-02

450

Refund before

Refund Before

*Refunds will no longer be accepted after 2019-09-02

  • About ELPRO
    ELPRO, headquartered in Switzerland, has been a global 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 biotech assets from laboratories to supply chain: growing and adap­ting as 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 USA main office is in Marietta, Ohio since 2003 with a full technical support staff; and offices in San Diego and San Francisco.  www.elpro.com
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  • Testimonials
    Getting access to the many small pharmaceutical companies in Southern California is not easy, but Biocom & ELPRO did a great job of getting important contacts to the event and delivering some great info for them to manage critical and vulnerable shipments.
    -Adam Tetz, Pelican Biothermal
  • SPONSORSHIP MENU
    PLATINUM SPONSOR 

    Program
    • Positioned as a strategic partner sponsor during the event and in all marketing materials
    • Opportunity to moderate/facilitate a discussion during the program (This includes introducing the keynote and facilitating the Q&A portion) based on committee approval
    Corporate Messaging
    • Primary placement of logo and link to your website on the event registration site
    • Primary placement of logo on event signage and TVs during the event
    • 6 foot display table during the supplier showcase
    • Opportunity to participate in showcase, if applicable
    High Level Networking/Business Development
    • Four (4) complimentary event registrations
    • Final attendee list with all contact information
    • Invite to participate on the planning committee
    Investment $5,000
     
    BRAND ENHANCEMENT SPONSORSHIPS
    Networking Break Sponsor GOLD 
    Program
    • Designated as a gold sponsor in event program and in all promotion on the event
    • Opportunity to provide giveaways during the refreshment break
    • Opportunity to participate in showcase
    Corporate Messaging
    • Logo Recognition on signage during the event breaks
    • Logo recognition on all promotional materials, including but not limited to, email blasts, social media, etc.
    • Company logo included in the final program in sponsor section
    • Logo recognition and link to your web site on the conference web site
    • Logo recognition on-site during the conference
    • 6ft display table during the supplier showcase
    High Level Networking/Business Development
    • Two (2) complimentary event registrations
    Investment $4,000

    Daily Download Sponsor GOLD 
    As the exclusive Daily Download sponsor each attendee of the event will receive a recap of the event via email that will feature your company logo at the top of the email header, along with a brief description about your company with a direct link to your website. This allows for optimal visibility that goes directly to each attendee at the end of the event.
     
    Program
    • Positioned as the “Daily Download” Sponsor during the event and in all promotion of the event
    • Opportunity to participate in showcase
     
    Corporate Messaging
    • Logo recognition on all promotional materials, including but not limited to, email blasts, social media, etc.
    • Company logo included in the final program in sponsor section
    • Logo recognition and link to your web site on the event page of Biocom website
    • Logo recognition on-site during the conference
    • 6ft display table during the supplier showcase
     
    High Level Networking/Business Development
    • Two (2) complimentary event registrations
     
    Investment $3,750
     
    Showcase Sponsor BRONZE 
    Program
    • Positioned as a bronze sponsor during the event and in all promotion of the event
    • Opportunity to participate in showcase
    Corporate Messaging
    • Logo recognition on all promotional materials, including but not limited to, email blasts, social media, etc.
    • Company logo included in the final program in sponsor section
    • Logo recognition and link to your website on the event page of Biocom website
    • Logo recognition on-site during the conference
    • 6 foot display table during supplier showcase
    High Level Networking/Business Development
    • Two (2) complimentary event registrations
    Investment $2,000


    **IF INTERESTED IN SPONSORSHIP CONTACT: Angela Wieszchowski angelaw@biocom.org 

Registration Closed