SAP Business Advantages: Gallus BioPharmaceutical

Transcription

2 Gallus BioPharmaceuticals LLC Industry Life sciences Products and Services Contract manufacturing and development services for the pharmaceutical and biotechnology industry segment Web Site SAP s An SAP Business All-in-One solution Partner EzLifeSciences, a qualified SAP Business All-in-One partner solution offered by Answerthink and based on the SAP Business All-in-One for Life Sciences solution Gallus BioPharmaceuticals enables clients to bring novel drugs to market quickly, safely, and cost-effectively. Gallus selected EzLifeSciences, a qualified SAP Business All-in-One partner solution offered by Answerthink and based on the SAP Business All-in-One for Life Sciences solution, to support operations and compliance on an integrated, scalable application. The solution is hosted and managed by SAP hosting partner Freudenberg IT, making it cost-effective to deploy, operate, and maintain. 2 / SAP AG or an SAP affiliate company. All rights reserved.

3 Producing medication that improves people s lives St. Louis, Missouri based Gallus BioPharmaceuticals is a contract manufacturer that acquired a biologics facility from Johnson & Johnson in May With more than 200,000 square feet of space and an expanding team of more than 200 employees, Gallus is dedicated to the clinical and commercial manufacture of mammalian cell culture based biologics. The company leverages deep experience in process optimization to simplify complex technical and scalability challenges while maintaining an exemplary global regulatory record. We ve been inspected and licensed by every major regulatory agency in the world, says Gallus CFO Steven Kasok. One aspect of its operations that makes Gallus unique is its business model. Ours is not a standard pay-as-you-go process where our customers bring a product, do a run, and leave, Kasok explains. We offer a virtual ownership SuiteSPACE model. We dedicate an area within our facility to a customer, operate the area under our regulatory platform, and manufacture the products for our customers when they want the products. Ultimately, everything Gallus does is focused on producing medications that improve people s lives. Among its clients is Johnson & Johnson, for whom Gallus produces Remicade and Stelara. These medications affect people s lives every day, Kasok adds. We need to make sure they re made perfectly, are operationally tracked, and are supplied to the people who rely on them. 200,000 Square foot biologics facility 3 / SAP AG or an SAP affiliate company. All rights reserved.

4 Providing trusted biopharmaceutical manufacturing services When Gallus acquired Johnson & Johnson s facility, operations were in full swing. So not only did the business need to carry on as usual, but it also needed to carry on while Gallus planned and conducted a migration from Johnson & Johnson s software environment to its own. The cells we use in our processes didn t know they were sold. They just kept doing on Friday what they were doing on Thursday. We needed to support those processes without interruption, Kasok says. Choosing the right software was critical to Gallus making a quick transition and supporting its business model. Some pharmaceutical companies would prefer to control the manufacture of their products rather than contract it out, Kasok says. We help these companies overcome any hesitation by offering a service that provides the benefits of owning at a lower cost and a higher degree of reliability. Our software is a part of supporting that model. The right software is also critical for Gallus to realize its vision to be the most trusted industry provider of contract manufacturing and development services. As Kasok explains, Our customers are entrusting the single most important aspect of their operations to us. We uphold that trust by documenting and carefully controlling the manufacturing process. Without the right software, without the documentation and the regulatory framework, our customers are unable to sell their products. We re running large-caliber pharmaceutical operations. Our software needs to be of equal caliber while supporting safe, fast, and cost-effective processes. Steven Kasok, CFO, Gallus BioPharmaceuticals 4 / SAP AG or an SAP affiliate company. All rights reserved.

5 Choosing a fast, reliable, industry-tested solution To help it evaluate its software options, Gallus worked with an independent consultant. After a multimonth process, two finalists emerged a qualified SAP Business All-in-One partner solution and software from another company. For Gallus, the choice was clear. Gallus selected EzLifeSciences, a qualified SAP Business All-in-One partner solution offered by Answerthink that is built on the SAP Business All-in-One for Life Sciences solution. The solution is hosted and managed by SAP hosting partner Freudenberg IT, which minimizes Gallus s up-front hardware costs and ongoing in-house IT requirements. It s a well-thought-out solution that fits the general parameters of what a company like ours needs. Plus, it has all of the customization possibilities we require, Kasok says. The quality of the solution, the quality of the provider, and the fact that the solution could clearly grow with us were compelling reasons. The question then boiled down to cost, and in reality the cost difference between the SAP solution and the smaller solution was insignificant. Kasok was confident in the company s decision to go with SAP software, knowing that it s the software of choice for many Gallus customers. He felt running the same software would offer a competitive advantage. When asked what kind of software we re running to answer SAP really made it a very easy decision. Why rethink it? Kasok explains. The SAP software outperformed on virtually every aspect of the selection criteria. Frankly, we couldn t find a single substantive advantage with the other software solution. Steven Kasok, CFO, Gallus BioPharmaceuticals LLC 5 / SAP AG or an SAP affiliate company. All rights reserved.

6 Realizing a rapid implementation with hosted software By performing careful planning, collaborating with Answerthink, and then focusing on the task at hand, Gallus went live with a qualified SAP Business All-in-One partner solution after a 14-week implementation. The project was completed both on time and within budget. There s no magic behind it. We choose the right solution and the right implementation partner and just worked very hard, Kasok adds. We allowed people to focus on getting the implementation done to the maximum degree possible. With an experienced partner managing the software and the underlying infrastructure, Gallus can focus on running its business instead of IT. Our job is to produce product for our customers, Kasok says. We want our IT infrastructure to be managed by someone who does that every day. To say the transition to a qualified SAP Business All-in-One partner solution went smoothly is an understatement. The most important thing that happened was frankly nothing. We lost no time, Kasok adds. We ve been up and running each day from the time we acquired the facility through the implementation and ultimately when we flipped that switch. Nothing fundamental changed. And nothing happening was the most important outcome for us. 14 Weeks to implement the software 6 / SAP AG or an SAP affiliate company. All rights reserved.

7 Supporting industry best practices and regulatory compliance Gallus s software environment includes integrated functionality in the areas of finance, materials management, production planning, quality management, and sales and distribution. It supports industry best practices and provides extensive inquiry and reporting functionality for regulatory compliance. It also enables digital signatures and audit trails as well as full support for Sarbanes-Oxley Act compliance and FDA validation. The software is hosted on servers in highly secure data centers, which are paramount to Gallus s operations. The company maintains all of the records Our day-to-day manufacturing operations run flawlessly. That s because of the hard work of our people and because they re supported by a tremendous software solution. Steven Kasok, CFO, Gallus BioPharmaceuticals LLC and compliance-related data gathered during the manufacturing process. It provides access to a portal where customers can see data about their products access that needs to be controlled and secure. As Kasok explains, We can t allow customers to see each other s information, so our software environment needs to be very secure. Our software offers that security. That data is an essential part of the products Gallus makes. You can t separate the product from the data, Kasok says. By providing our customers with information and having solid data, a secure environment, and software that can scale with us, we re able to provide medications that help save lives and help people live better lives. 7 / SAP AG or an SAP affiliate company. All rights reserved.

8 Enabling world-class service and fostering growth EzLifeSciences, a qualified SAP Business All-in-One partner solution offered by Answerthink, is costeffective for Gallus. The cost to run our entire IT operation is less than half of what Johnson & Johnson was spending to run this part of their business, says Kasok. Our IT headcount was four people prior to implementation. Now, with 25% more employees and more customers, we have the same number of IT employees on-site. Other benefits apply to supporting operations. We have timeliness of response, Kasok says. Our operators enter information into the software and retrieve the information they need. It s all timely, it s seamless, and it simply works. The reliability they see from every Gallus employee is supported by the SAP software we run today, Kasok adds. The benefits of having implemented a qualified SAP Business All-in-One partner solution go beyond present operations. The real benefit is that the software will support our growth and will scale as our operations become more complex, Kasok says. Having the reliability, the structured business processes, the regulatory framework, and the support of SAP and Answerthink those are important elements for our growth. Contract manufacturing requires the support of a trusted partner to reduce risk and help ensure delivery. Knowing that the software supports full documentation and precise operational control provides a level of assurance that Gallus s customers require. The fact that we were able to implement an easy, relatively turnkey hosted solution and keep a modest number of IT people on-site is a clear part of our financial success. Steven Kasok, CFO, Gallus BioPharmaceuticals LLC 8 / SAP AG or an SAP affiliate company. All rights reserved.

9 Gallus BioPharmaceuticals Building relationships Gallus is a Scottish term meaning pure dead brilliant. So as Gallus pursues its vision to become the most trusted biopharmaceutical contract manufacturer, it will do so while maintaining focus on delivering world-class operations and service. Over the next five years, Gallus will continue to build relationships and expand its reach to help more customers bring products to market. An outstanding customer relationship to me means that we don t think of ourselves or each other as customers. We think of ourselves in one business, performing together, Kasok says. SAP software is a core part of our ability to monitor, maintain, and produce products for our customers. It allows us to support our customers. It allows us to perform better. It helps us to be pure dead brilliant. CMP21714 (13/05) 2013 SAP AG or an SAP affiliate company. All rights reserved. 9 / 9

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