Today, biotechnology is the fastest-growing segment of biopharma. It has created more than 200 new therapies and vaccines, including products to treat cancer, diabetes, HIV/AIDS and autoimmune disorders, and has deployed more than 400 drugs and vaccines in clinical trials; making their way through the supply chain in an attempt to reach consumers following FDA approval.

Prior to reaching patients, biotech products enter a complex supply chain that involves many collaborators and a significant number of handoffs from raw material suppliers all the way to end users. Pharmaceutical and biotechnology companies follow strict standards for packaging, labeling and documentation, particularly when shipping biological or hazardous materials. It is during this complex process where the management of the supply chain is most critical. Weaknesses or failure at any point in the chain can compromise product integrity, breach security, delay shipments and ultimately result in financial losses or liabilities.

In the life sciences sector, logistics has made a major shift; moving from the back office to the forefront with executive management becoming more active than ever in the strategy and execution of their supply chain operations. This is particularly true today due to the intense competitive landscape, shrinking profit margins and regulatory compliance requirements.

Taking advantage of this new intensity, LifeScience Logistics (DFW Airport, TX; www.lslog.com) has built up capacity for handling expanding volumes of biopharma products, as well as the special services needed for their safet shipment and delivery. As part of this build-up, the company recently went live with a supply chain/distribution management system from Tecsys (Montreal; www.tecsys.com).

About LifeScience Logistics (LSL)
LifeScience Logistics is an up-and-coming third party logistics services provider in the healthcare industry. It provides a full range of standard and specialized logistics services scalable to the changing needs of its customers. The company has 440,000 sq. ft. of storage capacity at its two locations, Dallas-Fort Worth Airport and Louisville, KY. These locations make it convenient to receive shipments, even from abroad, and deliver them, via the UPS WorldPort in Louisville, nationally with next-day service.

Through its cGMP compliant facilities, LSL enables its clients; small to mid-size manufacturers in the pharmaceutical, biotech and med-surg fields, to outsource the warehousing and distribution of frozen (-30°C), refrigerated (2-8°C), and ambient (20-25°C) products as needed to meet their business objectives. It has been approved by USDA for bulk delivery into the US.

”In today’s competitive environment, healthcare products manufacturers are taking a hard look at capital requirements and are shedding non-core business activities like warehousing and distribution. We specialize in making distribution easy for them,” says Richard Beeny, cofounder & CEO.

Building a shared utility infrastructure
LSL’s strategy; to create and deploy a shared-utility infrastructure, establishes a highly-secure distribution operation with a virtual data center, providing logistics services that can be shared by a number of customers, regardless where they are globally. It is an operation that provides customers with unique but standard technology and regulatory-compliant processes to be able to consolidate their distribution operations.

COLD CHAIN MANAGEMENT AT LIFE SCIENCE LOGISTICS. credit: LSL

In addition to its domestic clients, LSL has targeted offshore small to mid-size pharmaceutical and biotechnology manufacturers, particularly in Europe. Small biopharma companies’ core value is R&D, typically driven by dynamic scientists and researchers, their need is: structure to outsource their logistics operations and enter the US market. U.S. presence for these offshore Pharma/Biotech manufacturers requires USPPI (US Principal Party & Interest) to facilitate their customer support and imports to the United States.

“There is an appetite for total logistic solutions that encompass an order-to-cash model for offshore manufacturers,” says Beeny. “In reality, we are the local representatives for these offshore companies in the US.”

With LSL’s shared utility infrastructure, Biotech and Pharmaceutical manufacturers are able to:

• Leverage LSL’s already established and maintained facilities, supply chain technology and visibility tools to support their expanding product portfolio and supply chain operations.
• Have contingency capabilities to mitigate the risk inherent in having “all eggs in one basket”, due to the high dollars of controlled substances in one location.
• Focus resources, reduce costs and improve quality by leveraging LSL’s already established FDA-compliant, integrated technology and processes.

Software as a Service
Following an extensive research among several distribution management software companies, LSL opted for Tecsys’ EliteSeries for Healthcare SaaS (Software as a Service) offering. “Tecsys’ EliteSeries had already been validated by others; including McKesson and Cardinal Health, making it a proven product for healthcare,” says Beeny. “That was a big plus in our decisionmaking process.”

LSL selected Tecsys because on these criteria:

• Experience and expertise in healthcare products distribution
• Robust, FDA-compliant, integrated distribution, warehouse and transportation management applications that are easy to deploy, learn and use
• Visibility technology for business intelligence as well as lot and serial-number tracking
• Web-based, open technology platform
• Hosting capability with a solid support organization

With Tecsys’ EliteSeries, the underlying IT infrastructure of LifeScience Logistics is a fully-redundant, remotely hosted distribution application that includes order management, warehouse management, transportation management and financial management. The system supports an order-to-cash model and includes chargeback and accounts-receivable functionality. According to Tecsys, the platform is one of the few supply-chain systems dedicated exclusively to healthcare products distribution, and is supported by a product development team with decades of experience in healthcare distribution.
Tecsys’ EliteSeries SaaS Model allows LifeScience Logistics to:

• Invest in its core values: Its logistics operations, and allocate funds to support its core competencies.
• Capitalize on the Web: Take advantage of Tecsys’ EliteSeries web-based applications, scalable and available anytime anywhere. The short deployment cycle of the EliteSeries SaaS model, and the application’s continuous improvements with no disruptions.
• Leverage a light-weight IT Infrastructure: No servers or major network infrastructures, hassle-free support 24x7, and no IT department.

“The SaaS model resonates well with healthcare because of the budgetary and speed to market needs. In addition, our focus is on the customer and we didn’t want to have to occupy ourselves with an IT infrastructure and a large IT department, both of which are not our core competency but key to delivering our services,” Beeny notes.

LSL customer orders flow from order taking, order processing, through to warehousing activities including: picking, packing, kitting, shipping, and reverse logistics with the guaranteed accuracy of radio frequency and bar coding technologies. LSL’s customers can easily, securely and selectively have access to the back office functions such as order tracking, shipment status, invoicing history, inventory visibility, and financial information, confident with the visibility provided by the system.

“With our order-to-cash model, customers reap big benefits,” says Beeny. “While some customers only want to outsource warehousing and distribution, others take advantage of the opportunity to focus on their core competency of manufacturing and leave the rest to us.” We are able to manage the business cycle that starts with reception of a customer sales order and ends with collection of accounts receivable generated in the sale of the final product, including: receiving orders, entering sales orders, approving sales orders, fulfilling orders, billing for the orders and collecting payment.

Visibility via metadata
The EliteSeries platform has recently been updated with what Tecsys called the iTopia visibility technology for event management (see chart). iTopia is an architectural framework that uses metadata for extending information to users no matter where information is in the enterprise or with collaborators. It can generate queries in XML (in a Simple Object Access Protocol, or SOAP, envelope) and then can present it in a wide variety of formats, including Web Services, EDI flat files, or output to an Excel spreadsheet. The goal is to provide easy, broad visibility to any activity inside the EliteSeries system, and to be accessible via Web browsers in networked or mobile displays and devices.

With iTopia, designated individuals can be alerted by key events, exceptions or routine monitoring, and then be able to respond quickly. To further increase the system’s usability, Tecsys ships it with over 1,000 predesigned “views” that provide a display of common supply chain and distribution activities. Users can tailor these predefined views to user requirements, or build entirely new views easily.

Benefits
Today, LifeScience Logistics’ share-utility infrastructure is empowered by Tecsys’ FDA- compliant EliteSeries for healthcare, enabling LSL’s logistics management to securely deliver, on behalf of their customers, healthcare products at the right price without sacrificing on quality. Tecsys’ integrated applications freed LSL from the burdens of having to deal with multiple IT providers, and enabled it to focus on its customers and staying focused on its logistics services.

LifeScience Logistics says that it is routinely achieving 99.98% accuracy in its warehouse activities, which translates into reliable, cost-effective services for its clients. “Today, we have a reliable IT infrastructure that can be tapped anytime, from anywhere, securely. The system is always available; it can be likened to a supply chain network of applications, giving us and our healthcare customers the peace of mind and visibility of what is happening, where and when. Most importantly it is helping us achieve a high level of customer satisfaction.” PC