Successful collaboration is a key to innovation in today’s pharmaceutical industry. Even though pharmaceutical companies and their contract manufacturing organization (CMO) partners both seek to favorably impact patients’ lives, there are issues that may stand in the way of a truly successful collaboration.

Pharma companies ultimately engage the services of CMOs to help get products to market faster at lower scale-up costs. It is a trend that continues to grow with CMOs increasingly engaged in every stage of a drug’s lifespan from development, to manufacturing, to packaging and fulfillment across the pharma landscape partnering with large firms to small virtual startups and everything in between. Whether it’s simply providing additional capacity, or serving as the sole source of drug production, CMOs are a vital component and lifeline for (bio)pharma companies.

However, along with the benefits of outsourcing come challenges and risks to sponsors, including efficient data exchange, managing multiple contacts, successful tech transfer, and reliable and consistent product delivery, to name just a few. At the same time, CMOs face an increased amount of quality control scrutiny both from their sponsor partners and regulatory agencies.

In her article, “The 3E Principle & Outsourcing,” Chitra Lele, chief scientific officer at Sciformix Corporation, offers some considerations in selecting an outsourcing partner. She says three key areas should be analyzed, specifically in the context of outsourcing knowledge-based functions in drug development and post-marketing in the areas of safety and risk management and regulatory affairs. 

Also on the theme of partnership between pharma firms and their contract service providers, Stuart Needleman, president of Laurus Synthesis, offers his thoughts on how to handle issues that might arise when companies come together. From the start, he says in, “CMOs, Pharma and Outsourcing: Perception vs. Reality,” it’s vital that both companies understand each other’s culture, mission and values all the way up the corporate ladder or else issues will arise that put success in jeopardy. Mr. Needleman thinks companies sometimes have a tendency to misread or underestimate each other’s motives and competencies. It’s only natural then that having a better understanding of misconceptions could foster a more authentic collaboration and deliver more reliable results.

With the growing trend of virtual pharma, life sciences companies today face a new era of collaboration across digital networks where data management is becoming just as important a factor as any other aspect of the drug production process. Sponsors and CMOs need to create a transparent window through which data becomes powerful, shared knowledge. Whether you’re a sponsor organization or CMO, getting your organization’s digital operations up-to-speed is crucial if you want to be successful in the pharma industry of the future.

In, “Beginning Your Digital Transformation,” Emilie Branch, scientific content manager, Nice Insight/That’s Nice, gives an overview of what a digital transformation means both practically and philosophically for a pharmaceutical company or contract development and manufacturing organization (CDMO). She offers some practical advice on the first steps an organization should take in order to achieve a successful digital transformation.

Also on the digital front, in the first of a two-part series, “Deploying MES in the Cloud: Challenges & Solutions,” Christian Fortunel, vice president, LZ Lifescience, addresses the migration of manufacturing execution systems (MES) technology to the cloud and how this makes MES accessible and affordable to small and mid-sized manufacturers. Mr. Fortunel says the life sciences industry is adopting MES at a faster rate than any other vertical market because pharmaceutical manufacturers are recognizing the benefits of managing and monitoring operations in real-time, while there is also a growing appreciation of how these systems can help simplify compliance processes.

Tim Wright, Editor
twright@rodmanmedia.com