Pharmaceuticals and BioPharmaceuticals

Pharmaceutical and Biopharma Supply Network and Contract Manufacturing Challenges

The pharmaceutical and biopharmaceutical segments of the life science industry are evolving at a rapid pace. The historical foundation of a high margin, large production lot, make-to-stock, channel-driven supply chain protected from competition by patent exclusivity is being pushed to evolve into a global, price sensitive, more personalized, more agile customer-driven supply network.

These market dynamics impact pharmaceutical companies in different ways and to different degrees. Regardless, the net result across the industry has been a deep reassessment of traditional operating models, supply chain structures and supply network relationships. In particular, the business model of relying on vertically integrated operations has been under scrutiny.  Traditionally, pharmaceutical companies have tended to be vertically integrated, combining R&D, clinical trials, manufacturing, distribution and sales under one umbrella. 

In contrast, most biopharma and specialty pharma firms have started out with a virtual execution model which focuses on core competencies such as R&D and marketing while using a flexible partnership model for areas such as contract manufacturing and packaging. Integrated pharma is now making a push towards a virtual model because of the numerous benefits. According to numerous market studies, a virtual pharmaceutical organization has:

• Greater agility in the face of uncertain demand
• Better access to technical and operational expertise
• Improved productivity for internal resources
• Enhanced risk management across product portfolios
• Increased product line flexibility to respond to personalized medicine trends
• Operational improvement in numerous areas such as cash-to-cash cycle time and finished production cost

Increasing levels of contract manufacturing has several benefits, but it does force pharma, biopharma and generics companies to rethink manufacturing and supply chain planning and execution processes. Without the proper level of connection, collaboration and control established between the brand owner and the contract manufacturers, packagers and suppliers, pharmaceutical products that are outsourced can feel like they have disappeared into a black hole.

How TraceLink can help Pharmaceutical and Biopharma companies

• Improve supply predictability.  Increasing customer demand, growing competitiveness of similar products and lean channel inventories all mandate the delivery of manufactured product on time, on spec and where needed.  With outsourced manufacturing, synchronizing production schedules, supply deliveries, quality reviews and other production processes to ensure smooth predictable supply of drug product can be a challenge.
• TraceLink’s Predictable Supply Suite can help by improving visibility and coordination at each step in the drug manufacturing process. Across your entire outsourced network, gain insight into current production status, identify potential manufacturing, material or quality issues before they threaten schedules and reduce delays along the entire production lifecycle. 

• Reduce operational costs.  Increased material costs, price reduction pressures and intense competition threaten to reduce even today’s tight margins. To maximize operational cost reduction, you need to look everywhere in your internal operations and external supply network for opportunity. This includes operating overhead, on-hand and safety stock inventory levels, cash-to-cash cycle times and utilization of capital and human resources.
• TraceLink’s Predictable Supply Suite can help by reducing process delays, eliminating manual work steps and improving accuracy at all points in the production lifecycle. Automate data collection and analysis, lean inventory levels by leveraging accurate supply inventory data and optimize production planning with enhanced metrics on outsourced manufacturing, contract partner and supplier performance.  

• Manage outsourced product and channel complexity. A pharma/biopharma firm needs to synchronize a global manufacturing process that is spread across numerous internal sites as well as tens to hundreds of API and raw material suppliers, contract manufacturers and packagers. Coordinating orders and production schedules across this supply network is tough and efficient interoperability is virtually impossible when relying on phone, FAX, email and other out-of-band communications. Traditional ERP systems seem like an answer until, facing the divergent data requirements, unique business process specifications and diverse technical capabilities in existence among supply partners, they create a Portal management nightmare across the network.
• TraceLink’s Predictable Supply Suite can help by providing a flexible manufacturing and supply collaboration environment that gets your virtual teams sharing information and insight with Tier-1 and long-tail contract partners. Quickly create secure business Clouds that connects the people, business processes and information that you need on a per-partner, per-product or per-project basis. Without massive overhead and technical complexity, get team members sharing production status, quality documents, inventory information, notes, discussions and other contextual information in whatever form they need when they need it. 

• Reduce production and business risk. Missed production schedules, missed quality levels and missed customer orders are often caused by lack of communication, coordination and actionable data, not bad intent. Production data and related artifacts are rarely stored in one form and are rarely accessible to everyone who needs it when they need it. Internal and contract manufacturing production teams often have different views of reality because they are working off of different information. Delays pile up as teams wait for reviews and signoffs.
• TraceLink’s Predictable Supply Suite can help by enabling your internal and contract manufacturing teams to securely keep production documentation and communications in one workspace, easily available to team members. Reduce risk by using built-in visibility and analytics tools that provide proactive insight when current production plans are going wrong, allowing you to intervene before an unanticipated issue becomes a lost sale or worse.   

• Protecting patient safety. Patients, pharmacists and care givers trust the products they are given. While the drug supply chain is relatively secure, it is also constantly under attack by counterfeiters, diverters and thieves looking to make a quick profit. Extensive trials ensure that most drug products are safe for consumers but occasionally new health threats emerge. In addition, tainted ingredients and poor product handling can impact the safety and efficacy of drug products. Should any of these adverse events occur, knowing immediately where the affected products are in the supply chain, where they were manufactured, what ingredients went into them and who in the distribution channel handled them is paramount.
• TraceLink’s Predictable Supply Suite can help by providing unique product identity and end-to-end chain of custody for all products from time of manufacture to time of consumer purchase. Create package-level and case-level identity. Enable product authentication, both in bulk and per-package, throughout the channel. Support fast recall of product through proactive notification to channel partners of adverse events. Securely share quality documentation and artifacts with channel partners as needed. 

Next steps

• Try It Yourself.  In minutes, launch a no obligation FREE TRIAL of our Predictable Supply Suite. Create your own Process Link collaborative team workspace, invite and quickly connect to virtual team members, then experience a new world of production visibility and tracking across your contract manufacturing operations!
• Demo Production Tracking.  Request a guided PERSONAL DEMO of our Production Tracking and ProcessLink solutions. On your schedule, one of our team members will take you through our solution.

Explore More

• Discover Production Tracking.  Find out how the TraceLink Production Tracking solution can give you visibility and control throughout the entire contract manufacturing lifecycle. Go Production Tracking
• Experience ProcessLink.  Review TraceLink's innovative approach to connecting you and your internal contract manufacturing teams to your partners both fast and flexibly. Go ProcessLink