The life sciences industry is heavily regulated, and as such it faces unique product management and supply chain challenges. Enterprises deal with constantly evolving supply chains and requirements for businesses within these sectors. Inspirage has developed a range of solutions specifically tailored to making sure these companies remain compliant while at the same time keeping up with demand and innovation.
Inspirage has worked to develop industry-focused services and tools designed specifically for pharmaceutical companies, biotech, nutraceuticals, medical device manufacturers and the distributors of those products. Supplier collaboration is key, and making sure every piece in the supply chain puzzle is functioning optimally is a big task. Therefore, there are a number of supply chain management challenges associated with each vertical, and Inspirage’s Supply and Operations Planning solution helps to address each one.
Inspirage’s S&OP Solution for Pharma leverages Oracle Demantra, APCC and ASCP with a standardized integration approach and framework that integrates data residing in both Oracle and non-Oracle source ERP systems. Under the pharmaceutical umbrella, several key players have specific challenges associated with maintaining and managing the supply chain:
Challenge: This segment of the pharmaceutical industry uses living systems and organisms to develop or make products, such as cancer drugs and other high-priced pharmaceutical items. While these companies enjoy high margins, the lead times associated with developing the related cultures can often be long, leading to supply chain planning challenges.
Inspirage Solution: Cell cultures are living organisms with a constrained growth period, meaning they must be used by a certain date. Due to the limits placed on capacity because of this growth period, demand planning and forecast accuracy are critical. Inspirage’s Global Sales & Operations Planning (S&OP) Business Process Blueprint for the Pharmaceutical Industry serves as an important solution for biotech companies to be able to accurately forecast demand.
Customer Success: Biogen, Inc.
Biogen is a multinational company that develops therapies for the treatment of neurological, autoimmune and hematologic disorders. With the help of Inspirage, Biogen was able to implement a S&OP process and deploy Value Chain Planning applications in order to support that process.
Challenge: The lead time for traditional pharmaceutical manufacturers is much longer than for biotech companies, giving these organizations more agility when it comes to adjusting production volumes to meet demand. However, these companies constantly have to innovate to replace drugs that are nearing the end of their patient protection lifespan (around 20 years or so). Supplier change management is therefore a sizeable challenge of traditional pharma companies.
Inspirage Solution: Inspirage can help companies manage the innovation process from concept to commercialization – from an idea to when the customer purchases the drug. Pharmaceutical companies of the future will need to form orchestrated drug development networks and support a more integrated R&D and regulatory process with a globalized, scalable and secure supply chain. Therefore, partnering with Inspirage and integrating your supply chain with the S&OP Solution can help you determine the scope of your multinational networks and orchestrate change management across the globe.
Challenge: This sector generally deals with lower-priced products but needs to manufacture a higher volume. As the pharmaceutical sector has patents expire, generic medications are formulated by competitor companies. This creates somewhat of a balance between so-called “blockbuster” pharmaceuticals and generics, but the latter group needs a different kind of supply chain solution, since the volume for these products is higher than with traditional pharma.
Inspirage Solution: Pharmaceutical companies need to bring the right people to the table on the regular basis; use systematic business processes to connect the markets to manufacturing sites and to third-party suppliers; leverage sophisticated planning tools to enable paradigm of plan by exceptions; and measure and improve on key business KPIs.
This is where the S&OP solution comes in. With Inspirage’s tried-and-true formula, companies can achieve their goals of connecting all parts of the business in order to manufacture higher volume of products and leverage these planning tools.
Medical Device Manufacturers and Distributors
Companies that fall under this umbrella are facing regulatory changes that have an impact on lifecycle and innovation management. The constant fluctuation of regulations within the medical device sector creates a supply chain environment wherein companies have to be flexible and need to respond quickly to such changes – or face hefty penalties. Inspirage’s critical experience in this area gives organizations an advantage.
Challenge: The U.S. Food and Drug Administration’s Unique Device Identifier mandate was initiated to enable better traceability of medical devices throughout the supply chain and to improve the information available for managing product quality issues that could potentially impact the patient. Other global health authorities are also enacting similar requirements, with which multinational companies will soon have to comply.
Compounding this problem is the fact that medical device companies have complicated trading partner networks. Often, parts and components of medical devices become obsolete as regulations and technologies evolve, leaving other parts to take their places.
Inspirage Solution: Inspirage has developed a unique UDI solution that leverages the Oracle Agile Product Collaboration application. It connects Agile PLM with the Global Data Synchronisation Network (GDSN) that enables trading partners to globally share trusted product data in an automatic and efficient way that ensures brand integrity.
This solution helps enterprises achieve seamless integration of internal and external design, supply and manufacturing data. It also enables the management and collaboration of product record information and processes across the extended supply chain.
Download our data sheet for more information about Inspirage’s UDI compliance solution.
Customer Success: Sorin Group
One of our biggest customer success stories comes from Sorin Group. In September 2013, the US Food and Drug Administration (FDA) ruled that medical devices distributed in the United States must carry a unique-device identifier, or UDI, which will help the FDA identify product problems quicker, target recalls more effectively, and improve patient safety. Companies that miss the submission deadline can be restricted from selling their products in the US market. The scope of this effort, combined with the short time line within which to comply, made UDI compliance a top priority for Sorin Group. The company started a global initiative across different business units and manufacturing sites and departments, such as R&D, design, production, quality assurance, and regulatory affairs, which impacted all therapeutic areas. With help from Inspirage, Sorin was able to become the very first European company to become UDI compliant in 2014. For more information about how Sorin achieved compliance, check out our blog article outlining their success.
Challenge: Not unlike CPG companies, nutraceutical companies that deliver products like vitamins and supplements are dealing with thin margins and omni-channel distribution methods that span wholesale, retail and direct-to-consumer channels.
Inspirage Solution: These organizations need to have a promotion planning system of some kind in order to keep up with competition and demand. Trade Promotion Management tools from Inspirage can help companies manage these complex supply chains and distribution channels.
For more information about TPM tools, check out our informative data sheet.
Customer Success: NBTY
NBTY is the largest manufacturer of nutritional supplements in the U.S., with a $4 billion annual revenue stream. Using Inspirage’s Value Chain Planning solutions, NBTY was able to create a single source of truth to drive financial and related plans. They are analyzing data to forecast demand and have benefited immensely.
For more information, watch a replay of our webinar with NBTY on-demand.
Plan to Innovate
The life sciences industry has to deal with changing regulations and accelerated product lifecycles, and having the right tools to support supply chain management is crucial for success in this vertical.