The Leading Minds Seminars Online Series #2 will begin August 4th, and run every other Tuesday through September 29th, co-hosted with Biocom, California’s Biotech Association.

Those that will benefit most from the webinar series are life science practitioners in Supply Chain, Logistics, Cold Chain, Quality Control/Quality Assurance, Clinical Supply and Commercial Operations or Warehousing responsible for the distribution of biologics and clinical products.

You will gain new ideas and strategies by learning from other’s experiences in preserving the safety and efficacy of temperature-sensitive products in-transit and in-storage.

August 4 | 10am PST / 1pm EST
GxP 101 – Creating a Workable User Requirement Specification (URS) for your Life Science Facility

• Validation and Qualification explained as part of a Quality Management System
• Guidance for setting up your User Requirements Specifications (URS)
• GMP Premises, Equipment and Calibration considerations
• Ensuring your facility monitoring is a quality system of record

Sean Merrill, Validation Engineer Global Qualification / Validation Expert, ELPRO

*Please use special code ELPROGuest20 when registering.
** Attend to receive a URS template as a ‘quick start’ guide

About the Speaker:

Sean Merrill, GxP Validation Engineer, ELPRO supports pharmaceutical, medical device, and pharma/device logistics companies to bring their processes, systems and facilities in compliance with global GxP regulations. Customer projects Sean leads focus on Risk Management, Quality Management Systems, FDA GMP and Systems Validation. Sean has a Bachelor’s Degree in Chemistry from Marietta College, Ohio.

August 18 | 10am PST / 1pm EST
Import Export & Customs Acceptance in Today’s BioPharma Supply Chain Climate

• Recently released NAFTA requirements and impact to policies
• Requirements for shipping small parcels and bulk internationally

  • New rules for Russia and China September 2020

• Day to day errors and lessons for working with the logistics partners (specialty couriers, forwarders, integrated carriers)
• Clinical trial material valuation for customs
• Communications for avoidance and intervention in case of long FDA or other hold

Denise Valentino, Director, Global Trade Compliance and Logistics, Neurocrine Biosciences Inc.
Rich Nelson, Senior Manager of Global Logistics, PCI Pharma Services

*Please use special code ELPROGuest20 when registering.

About the Speakers:

Denise Valentino, Director, Global Trade Compliance & Logistics, joined Neurocrine Biosciences in December 2016 bringing over twenty-five years of logistics, import/export operations and compliance experience. She is responsible for the movement of materials and components worldwide along with the oversight of freight forwarders, customs brokers and other carriers. She is also responsible for commercial distribution. Prior to joining Neurocrine, Denise was responsible for Global Trade and Logistics at BioMarin. Denise began her logistics career at HM Electronics where she started as a buyer/planner. She then continued her career at Pfizer, La Jolla (formerly Agouron/Warner-Lambert) and Amylin Pharmaceuticals. Denise received her Bachelor of Arts degree in Business Administration and her MBA in International Business in 2002 from National University in San Diego. She also holds a US Customshouse Broker license which was obtained in 1997.

Rich Nelson, Senior Manager of Global Logistics at PCI Pharma Services has over 12 years of clinical and commercial distribution and logistics experience. In his current position at PCI, Rich works with clients to provide seamless global distribution for their investigational drug products, ensuring cost-effective and time-efficient delivery throughout the clinical trials process. Rich has a B.A in Criminal Justice and Law Enforcement from Monmouth University.

September 1 | 10am PST / 1pm EST
Logistics Requirements for Cell Based Therapies

• Product stability and physical characteristics that determine how to handle the materials or product: Why cell based is unique
• Long term cell banking operations and requirements
• Raw material inventory management, sampling and quality release procedures
• Assessing all supply chain touchpoints (manufacturing, packaging and distribution) and their temperature management capabilities
• CAPAs, need for transport partners to have QMS and GDP processes
• Documenting quality control throughout the cell based supply chain

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

*Please use special code ELPROGuest20 when registering.

About the Speaker:

Kevin Hickman, Senior Manager, Supply Chain Distribution, Gilead Sciences, Inc. has over 25 years in the pharmaceutical and biopharmaceutical supply chain, distribution and transportation management world. His primary focus has been on operational and quality improvements while also maintaining or achieving additional cost savings through gained efficiencies. He has extensive experience overseeing the daily operations of in-house distribution centers as well as over 17 years of experience managing third party warehousing, transportation, cold-chain and contract manufacturing vendors and suppliers. He has had responsibility in managing all distribution & logistics operations and vendors for both domestic and international customers & partners. Kevin has experience in managing shipping lanes for all temperature ranges (+15 to +25°C, +2 to +8°C, Frozen [Dry Ice], and Deep Frozen [LN2]), and using various active and passive solutions to meet all shipment size requirements (small parcel, pallet sized air shipments, Truckload, Less Than Truckload, and Sea Container). Kevin has worked for various manufacturers over the years and has lived in multiple regions of the country, most recently moving to the San Diego area to work with Gilead Biologics at their Oceanside, California site.

September 15 | 10am PST / 1pm EST
Understanding how Wireless Monitoring & Real-Time Tracking Changes the Biologics and Clinical Supply Chain

Gaining temperature, location and other sensor data ‘live’ from your supply chain provides significant opportunities to prevent product loss and make proactive decisions for high-value, irreplaceable biologics. Join us for an exploration of how real-time monitoring changes supply chains and to learn about ELPRO’s new LIBERO G. We will discuss:

• The technology landscape behind Mobile IoT
• ELPRO’s new LIBERO G real-time monitoring solution
• Breaking down the monitoring processes for time critical biologics
• Risk of false alarms and loss of product considerations
• Tracking special containers (cryo, dry ice)
• Follow your product in-transit to in-storage clinical trials
• In-storage wireless cloud monitoring as a key piece of the quality and compliance puzzle

Speaker: Emanuel Schäpper, Team Leader Key Account Management, ELPRO

*Please use special code ELPROGuest20 when registering.

About the Speaker:

Emanuel Schäpper, at ELPRO has over 25 years experiences in sales, marketing and key account management. He is responsible for global business development with key pharmaceutical companies and thus involved in many temperature monitoring projects in healthcare logistics. Emanuel has been a member of ELPRO’s management team for three years based at the company’s headquarters’ in Switzerland. Emanuel holds a Master’s degree in economics and information management from University of Sankt Gallen Switzerland.

September 29 | 10am PST / 1pm EST
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:
Billie Wayne Key Jr, Sr. Manager, Supply Chain, PCI Clinical Trial Services
Edward Groleau, Director of Clinical Supply Chain for North America at PCI Pharma Services

About the Speakers:

Billie Wayne Key, Jr. is Sr. Manager, Clinical Supply at PCI Pharma Services with 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 trial sponsors to optimize supply strategies and assess risk across the supply chain. Billie has a bachelor of microbiology from Texas Agricultural and Mechanical (Texas A & M).
 

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

Seminar hosted by:

For over 30 years, ELPRO is widely recognized as the global knowledge leader in innovative, Swiss engineered environmental monitoring solutions and data loggers for pharma, healthcare and life science. ELPRO partners with clients to develop solutions that integrate ELPROs high-quality measurement components into their business processes. Clients include biotechs, diagnostic manufacturers, and the top 20 pharma companies. As the inventor of the LIBERO PDF Logger, ELPRO solutions have the lowest total cost of ownership and assist pharmaceutical and healthcare companies around the world preserve and manage stability budgets and simplify their cold chain by reducing manual work, resulting in quicker release times.

Biocom is the largest, most experienced leader and advocate for California’s life science sector. We work on behalf of more than 1000 members to drive public policy, build an enviable network of industry leaders, create access to capital, introduce cutting-edge STEM education programs, and create robust value-driven purchasing programs.