Temperature Controlled Distribution of Biologics

Date
8:00 AM - 7:00 PM
Location
The Alexandria at Torrey Pines 10996 Torreyana Road, San Diego, CA 92121
Speakers:
Kevin Hickman , Senior Manager, Supply Chain Distribution, Gilead Sciences, Inc. , , Bob Seevers , Senior Advisor, Pearl Pathways & Member , , Heather Lane , Senior Supply Chain Specialist, Heron Tx , , Jeroen van Loo , Global Account Manager, ELPRO , , Denise Valentino , Director, Global Trade Compliance & Logistics, Neurocrine , ,

Temperature Controlled Distribution of Biologics

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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
Kevin Hickman, Senior Manager, Supply Chain Distribution, Gilead
Bob Seevers, Senior Advisor, Pearl Pathways & Member, USP <1079> Packaging and Distribution Committee
Heather Lane, Senior Supply Chain Specialist, HeronTx
Jeroen van Loo, Global Account Manager, ELPRO

​​​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

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: