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Mid-Sized Pharma Company Gains Business Efficiencies on the Road to DSCSA Compliance

By November 2, 2016March 16th, 2021Company News, DSCSA, Serialization

The Business

Kowa Pharmaceuticals America specializes in acquiring, developing, licensing, and marketing pharmaceutical products for cardiovascular conditions. Kowa’s popular marque product, LIVALO (pitavastatin), a fully synthetic statin that helps patients around the globe improve their heart health.

The company was founded in 2001 with the mission of developing and commercializing safe, effective, and high quality pharmaceutical products at a reasonable cost. Headquartered in Montgomery, Alabama, the company employs 350 people and, since its acquisition in 2008, is part of the multinational Kowa Company.

The Challenge

When the Drug Supply Chain Security Act (DSCSA) was signed into law in the U.S. in 2013, the pharmaceutical industry was faced with its biggest challenge in decades. With new regulations around monitoring drugs through serialization, every manufacturer, wholesaler, and distributor would need to make deep operational and technical changes to their business to be compliant. The supply chain would never be the same.

“The biggest challenge with the act is its complexity. And for a company of our size the question was – where do we start?” That’s how Joseph Barna, Chief Financial Officer at Kowa Pharmaceuticals, summed up the organization’s feelings about the DSCSA and serialization. “We knew it was time to get started with DSCSA requirement. We needed outside assistance to get compliant, help us with our technologies, and streamline our processes.”

Kowa contracted LSPediA to perform DSCSA strategic planning work. Partnering closely with a cross functional team at Kowa, LSPediA’s first task was to perform a gap analysis. The results of that analysis made it clear where the company stood from regulatory and operational readiness points of view, and revealed several additional areas of opportunity within Kowa.

The Solution

What was initially a small-scale project quickly growing into what would be a long-term relationship. “We settled on several major goals,” said Riya Cao, CEO of LSPediA. “The first would be to put Kowa on track to meet DSCSA compliance and serialization requirements. Secondly – and in many ways, more importantly for their long-term success – our aim was to streamline several operational processes, update IT systems, and give employees new skills. These together would enable the business to adhere to compliance, meet customer demand, and scale to growth.”

Over and above serialization, LSPediA’s gap analysis shed light on several “unknown unknowns” – inefficiencies within processes and systems that Kowa hadn’t even considered, and which were hurting the company’s bottom line. Based on those findings, LSPediA recommended several initiatives:

  • Transition the company from paper-based warehouse processes to a fully automated warehouse management system
  • Select and implement a new EDI system that is DSCSA proven and tailored to the pharmaceutical industry
  • Establish a single enterprise resource planning (ERP) system as the system of record and eliminate a redundant system
  • Move the company away from underperforming technology vendors who failed to meet timely deliverables
  • Identify new technology architecture that would reduce slowdowns and eliminate other inefficiencies throughout the enterprise
  • Create and launch a detailed, organization-wide DSCSA roadmap that would ensure on-time compliance

Establishing a timeline that would ensure Kowa was DSCSA compliant in advance of the deadline, the LSPediA and internal teams went to work: implementing the DSCSA strategy and Serialization Toolkit; building out the EDI, warehouse, and EPCIS technology infrastructure; managing CMOs; and reviewing and revising all standard operating procedures (SOPs).

Business Outcomes

“LSPediA’s project management skills have been terrific.” Said Ken Riester, Vice President of Trade and Supply Chain at Kowa, “the expertise and knowledge around manufacturing, regulations, serialization, integrating systems has been incredibly valuable to us.”

As of June 2016, Kowa had seen some significant business benefits because of working with LSPediA, including:

  • Organization-wide alignment on serialization
  • Faster order filling and shipment
  • Improved management of CMOs
  • More efficient enterprise processes and strong ROI
  • Reduced overhead based on technology updates

Riester is delighted with the outcomes the company is seeing, and with the newfound internal cohesiveness. “Our team has come together. We are now ahead of the curve with our pharmaceutical peers, and we have plans to take it even further.”

LSPediA is currently working with Kowa on CMO serialization, serialized data exchange, and other important regulatory and quality projects, and plans to continue assisting the company in their efforts to meet regulatory requirements and ensure effective supply chain operations.

What Can LSPediA Help Your Business Achieve?  

We have a growing list of clients that are seeing real-world, bottom-line benefits around compliance, ERP, serialization, technology enhancements, and other areas. Watch some of our customer testimonials to see for yourself. And, to learn how LSPediA can help you achieve the same results, contact me today.

 

About LSPediA – Life Sciences Solutions

LSPediA is a leading provider of enterprise software and services designed for pharmaceutical manufacturers, wholesale distributors, and dispensers. With LSPediA, customers can better implement serialization and aggregation processes to meet global regulations, DSCSA requirements, and future track-and-trace mandates.

We value long-term relationships and work with our clients’ internal teams to properly define roadmaps, create architectures, and implement systems that align to vital business goals, ultimately helping them derive maximum value from their investments, both now and well into the future.

For more information about LSPediA, call +1 (248) 973-2008, email [email protected], or visit our website at www.lspedia.com.

For additional information, contact: Julianne Jahn [email protected]