Tawni Koutchesfahani, Director of Supply Chain at Relypsa, recently attended our 2018 American Biomanufacturing Summit. One of her key takeaways from the event was around how the paradigm of manufacturing and QA operations is changing and the ways in which it needs to change. We asked her to share her thoughts on the Generis blog. The Future is Bright By Tawni Koutchesfahani, Director of Supply Chain, Relypsa Let’s take a step back and think about where we were 38 years ago. In 1980, Martin Cline made the first attempt to modify human DNA. By 1989, National Institutes of Health approved the first nuclear gene transfer in humans. Since 1989, there have been over 2,000 clinical trials completed. If we fast forward to where we are now, gene therapy is now being viewed as the key to our future for many therapies. Last year, the industry hit some key milestones. Kite Pharma received its approval with Yescarta, and Novartis succeeded with Kymriah. Though these are significant highlights, the past addresses rare diseases. In turn, manufacturing of the gene therapy meets the market for a small population. As these therapies get approval for commercialization, the manufacturing models are not currently made for large scale, which poses a threat for the market. Thus, the whole notation of how we have been manufacturing has to change. How we have been producing in GMP environments has to change. How we have been implementing our quality systems …
Read More →GDP for APIs New Regulations
The Shift to Monitoring BioPharma Product Quality Throughout Their Lifecycle For years, pharmaceutical manufacturers have talked about the last mile. With mail order pharmacies, direct to pharmacy/patient channels, and things like orphan drug clinical trials, the last mile can be complex yet largely unregulated. The other end of the pharmaceutical supply chain, the inbound supply of ingredients, has received more solid guidance from regulators. In 2000, major markets including the EU and US supported the ICH Q7 initiative by publishing their own guidelines specifically for GMP for APIs. Although GMP guides have included some elements on storage and distribution, the only GDP focused guide was the WHO Guide on GTDP for Pharmaceutical Starting Materials until recently.
Read More →Case Study: How Lundbeck uses ELPRO cold chain monitoring solutions to streamline processes
Project Partner Lundbeck is a global pharmaceutical company highly committed to improving the quality of life of people living with psychiatric and neurological disorders. For this purpose, Lundbeck is engaged in the research, development, production, marketing and sale of pharmaceuticals across the world. The company’s products are targeted at disease areas such as depression, schizophrenia, Parkinson’s disease and Alzheimer’s disease. Project As a large R&D organization with clinical sites around the world, Lundbeck needed a cold chain monitoring solution that streamlined end to end processes communicating temperature data that would ensure successful clinical trial progression and cost-effectiveness. In addition, it was their priority to meet new GDP requirements to demonstrate control during transport by collecting data and having an auditable database.
Read More →Pharma Supply Chains: Transitioning to the Modern World of Data Monitoring and Analysis
In the world of pharmaceutical supply chains, where cost reduction is king and a growing number of products are temperature-controlled – collecting, communicating and analyzing temperature and logistics data is critical to success. If data is the foundation of business intelligence, why are Pharma companies still using old practices for data analysis – reviewing data by hand, doing manual entries and archaic reporting methods? All of these outdated practices and long processes create human error and surging hidden costs. Today, all of the important temperature data and automation tools are at the industry’s fingertips, so why not use them?
Read More →Digital Transformation, End-to-End Visibility, and the “Data Problem”
Given the macroeconomic climate and the “Amazon effect,” many companies are looking to digitally transform their businesses. For decades, businesses have largely derived efficiency and profitability through scale. This led to a focus on larger store footprints, warehouse space and buffer stock, and the ability to transport goods on mega vessels for unit cost savings. In the last few decades, however, customer expectations have gone up, largely dovetailing off the service that Amazon provides. Retailers and manufacturers have been forced to modernize and deliver with much higher reliability and timeliness. Many executives are now looking to transform their supply chains from a reactive cost-center to a strategic advantage.
Read More →Chemical company serves customers better and faster with Siemens AX4
Global chemical giant BASF operates production plants in several countries and is committed to creating additional value for its customers and increasing the efficiency and effectiveness of their processes. For its logistics, the company relies on a network of hundreds of carriers. One of BASF’s objectives was to manage logistics processes and enable teams to collaborate smoothly along the transport chain. The goal was for each shipment from BASF to automatically move through a standard workflow, from the production site to the recipient. With the installation of the Siemens AX4 cloud-based logistics platform, BASF could optimize management of their logistics network, automate communications to the carriers, transfer accompanying shipment documents from AX4 to the carrier system, and get status reports from the carrier. This new digital technology set the foundation for successful collaboration between BASF and its logistics network for all transport data. Siemens AX4 allowed for the integration of partners into the BASF network, and better control of transportation-related costs through the standardization of logistics processes. If you want to discover how Siemens AX4 can increase the transparency of your entire supply chain, visit http://www.axit.de/en/digitalization to learn more.
Read More →Smart technology for a smart future connect Siemens and Dürr
Dürr is a mechanical and plant engineering firm seeking to become a global leader in digitalization by actively promoting this transformation through core “smart” areas. One aspect involved increasing end-to-end visibility in logistics processes. A focal point was on information – the faster information is available, the more value it offers. Based on this strategy, the Siemens AX4 platform would act as a single point of entry for Dürr by bundling data, documents, and information from various sources for status updates, provide constant monitoring of a component’s location, and supply real-time tracking information for precise ETAs. Dürr benefits from the Siemens digital tools which has resulted in more control of the global enterprise’s construction and worldwide assembly projects, end-to-end supply chain visibility and complete process integration of plants, customers, and service Providers, and visualization of the supply chain from loading at production to the construction site staging area. To learn how to keep your company highly efficient, visit http://www.axit.de/en/digitalization for more information.
Read More →Demand Driven Supply Chain Management
Traditional MRP/ERP systems use forecasts of demand to drive replenishment through supply schedules. Unfortunately, even if a company is achieving a world-class level of forecast mix accuracy (e.g. 80%, a number which is skewed by the highly accurate high-volume item forecasts), the majority of items (with lower volumes and higher variability) will be achieving accuracy of below 60%, which leads to unbalanced stocks and service threats. This, in turn, leads to expediting and firefighting, which uses up unplanned capacity, causes lead times to be extended and requires yet more inventory without resolving the real problem, which is that the supply chain is being driven by the wrong demand signal: an inaccurate forecast instead of actual demand. Learn all about Demand Driven Supply Chain Management in this interview with Markus Geutler, Partner, Supply Chain & Operations, at Camelot Management Consultants.
Read More →Leadership Spotlight: Dan Key, SVP, Chief Supply Chain Officer, Axalta Coating Systems
Dan Key is an accomplished senior executive with a 30-year track record in leading operations, supply chain, distribution, procurement, product management, and general management of global businesses. He is an expert in transforming, acquiring, growing, divesting, and repositioning assets throughout the world within both public and privately-owned companies. Dan is known for his approachable and inclusive style of leadership and he excels at rallying cross-functional teams around a unified vision. Over the course of his career, he has repeatedly contributed to EBITDA growth year-after-year through rigorous cost control and throughput improvements, leveraging deep experience in leading end-to-end supply chain and operations across 31 countries. Dan is currently the Senior Vice President, Chief Supply Chain Officer, at Axalta Coating Systems. Axalta is a $4B paint and coating company serving the transportation, refinish, and industrial markets. Dan manages 50 global sites with over 6,000 employees in 19 countries with an annual COGS spend of over $2B.
Read More →Siemens AX4 helps drive success for Deutz
Deutz is a worldwide provider of diesel and gas engines, and a company that prides itself on spirit, passion and a commitment to quality. To achieve better performance, Deutz initiated measures to increase the quality and reliability of inbound and outbound shipments. In addition to simplifying workflows, the IT solution needed to adapt to Deutz’s SAP system and eliminate manual input along the entire process. Deutz also wanted to avoid investing in its own IT infrastructure and cut its process costs. Siemens AX4 logistics platform offered solutions including that integrated global suppliers, carriers and service providers into a single system and provided central access of logistics data for Deutz as well as its suppliers and carriers. By significantly increasing productivity, and improving reliability and on-time performance through automated workflows, the AX4 cloud-based platform allowed Deutz to maintain their “customer value, quality, and technology come first” philosophy. With this implementation, their desire to cut costs was also realized because there was no need for an additional investment to increase warehouse space. To find your digital logistics solutions and get on the road to success, visit http://www.axit.de/en/digitalization for more information.
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