The proliferation of multinational clinical trials for medicinal products has spurred rising demand for global cold chain supply services. This cold chain supply management case study of a Phase III medicinal product will outline some of the unique challenges in maintaining cold chain continuity to study sites in emerging markets across the globe. This case study will use examples from the Phase III trial to address:
- Security: Protecting against damage, loss, or theft while en route or upon arrival
- Maintenance of cold chain conditions in air and on the ground
- Planning, adaptability and contingency plans to ensure supply continuity
- Required documentation and deciding on the stated value of the material - a complex business decision that carries a certain level of risk
- Regulatory compliance: Ensuring correct valuation of material to decrease any risk of potential delays with many country's regulatory authority agencies
- Improvements in kit design: Smaller, lighter, cost-effective packaging
- Technology enabling tracking of temperature and location: Real assurance
Dan Gourley, Director of Logistics at Catalent Pharma Solutions, is responsible for global distribution, returns and warehousing of clinical supplies for Catalent’s Philadelphia clinical site. He has previously worked as the Controller and Director of Finance, handling global financial business for Catalent’s Clinical Supply Services. Prior to Catalent, Mr. Gourley held management roles in the finance arena having a direct influence on day-to-day operations. Mr. Gourley has a Bachelor’s of Science degree in Business Administration/Accounting from the University of Slippery Rock.
About Catalent
From drug and biologic development services to delivery technologies to supply solutions, Catalent Pharma Solutions has the deepest expertise, the broadest offerings and the most unique technologies in the industry. With over 75 years of experience, Catalent helps customers get more molecules to market faster, enhance product performance, and provide superior, reliable manufacturing and packaging solutions. Catalent employs more than 8,200 people at 24 facilities worldwide and in fiscal year 2010 generated more than $1.7 billion in annual revenue. Catalent is headquartered in Somerset, NJ. For more information, visit www.catalent.com.
more products. better treatments. reliably supplied.™
Media Contact: Patricia McGee
T +1 (732) 537 6407
patricia.mcgee@catalent.com
