There are many obstacles to overcome when managing temperature sensitive materials during clinical trials. Planning ahead in order to reduce the risk involved in Cold Chain management practices is of continued focus for Clinical Trial Supply professionals.
Benefits of attending this webinar:
- Receive information on what to look for when determining a vendor
- Gain a better understanding of how materials are packaged and tracked throughout the process
- Discover the different methods used when labeling product
- Learn about various shipping options available for temperature sensitive materials
- Hear about the challenges associated with International shipping and the issues to be aware of that could cause delay
- Have your questions answered by industry professionals
Brian S. Hilton, Product Manager, Almac Clinical Services
Brian Hilton has maintained his role as Production Manager with ALMAC Clinical Services for the last 11 years, during this time he has gained extensive knowledge of the processes, equipment, and materials utilized in clinical trials packaging. As a presenter at the “Inaugural U.S. Conference on Comparator Studies”, Brian led audience members through the processes and challenges of blinding IMP’s. He has also developed training sessions for numerous customers who wanted to gain knowledge of the clinical trials packaging industry.
Brian received his degree in Business and Police Administration and is a member of various Pharmaceutical and Packaging professional organizations.
Anthony Mistretta, Distribution Manager, Almac Clinical Services
Anthony graduated from Delaware Valley College with a BS in Business Administration. He has been working in the Pharmaceutical industry for over 20 years, holding the position of Distribution Manager at Almac for the past 8 years. Tony currently works out of Almac’s North American Headquarters in Souderton, PA and also lends his expertise to various summits and workshops globally.
Anthony Leone, International Customer Service Manager, World Courier, Inc
World Courier specializes in the international transportation of clinical supplies and diagnostic materials supported by a global network of over 140 offices. Anthony Leone is the International Customer Service Manager for World Courier. In this capacity it is his responsibility to oversee several departments involved in the exports of time & temperature sensitive shipments globally. In the 15 years that Anthony has worked with the company he has developed expertise in the areas of; implementation of client specific and operational SOP’s, import/export and regulatory issues, and packaging options all in support of customers shipping clinical supplies and/or diagnostic materials.
In addition to his in house role, Anthony has presented at various biopharm conferences, as well sharing his cold chain expertise at individual company meetings at CROs, labs, pharmaceutical, clinical packaging and biotechnology companies.
Who Should Attend?
Clinical Trial Supply Managers and co-ordinators from global pharma / biotech companies
Providing a wide range of drug development and clinical trial supply services, Almac assists global Pharma and Biotech companies reach their critical clinical milestones and ultimately commercialisation.
Offering innovative pharmaceutical development services for solid oral dose drug products, Almac can work with client partners to produce an optimum formulation and manufacture clinical batches from initial First in Human supplies to phase IV / registration.
Following your protocol designs, Almac can additionally provide a range of solutions for blinding and over-encapsulation from single tablet filling to multiple mixed input units and controlled powder / excipient dosing.
Almac has invested heavily in these service areas to ensure recognition as a market leader. With processing capabilities ranging from small-scale manual filling of capsules to large-scale fully / semi automated technology, Almac ensures high quality, efficient clinical supplies to meet client / clinical requirements.
For over 30 years World Courier has supported the pharmaceutical community in investigational pharmaceutical distribution. In the ever more challenging regulatory and cold chain environment, we pride ourselves in providing logistics solutions that ensure patient safety and global compliance. Our global network is comprised of over 140 company owned offices in 51 countries. We are committed to meet and exceed our customers’ expectations by delivering their pharmaceutical products in the fastest and most efficient manner available. Within the investigational drug storage and distribution market, we strive to provide the clinical development community with services that enhance the performance of their R&D investments. We do this with state of the art GMP compliant facilities strategically located in the emerging markets and other key locations. We continue to invest in our people and facilities, providing a valuable resource to sponsors, CRO’s and CMO’s. We offer a wide variety of both passive and active packaging solutions to support our role as the industry leader in cold chain transportation.