The mounting public outcry over drug prices — fueled by dramatic increases in cost for a few high-profile, older, life-saving drugs — has put intense pressure on the pharmaceutical industry to lower list prices and curtail price increases or face government controls.
Unlike Big Pharma, which may outsource internally developed processes and formulations, small and midsize pharma/biotech firms are dependent on contract development and manufacturing organizations (CDMOs) for much of their product development and GMP manufacturing activity.
It is increasingly rare that early-stage compounds or platform technologies are acquired without demonstration of clinical effect. Many years ago you could get funding for an idea, a piece of data, or a novel platform. With little exaggeration, funding could be generally raised as long as there was promise and the ability to tell a story, or until the concept was fully disproven.
Many biotechnology and pharmaceutical companies are struggling with what I call the “sourcing dilemma”: How do I achieve redundancy in my supply chain while keeping costs down and incentivizing my primary suppliers — whether internal or external? Redundancy is expensive, it consumes precious time and resources, and it distracts your team from driving all-important development milestones.
The following are new leaders on the Outsourced Pharma Editorial Advisory Board, and they’re not hesitant to provide bold analysis on outsourcing drug development and manufacturing.
In the summer of 2016, Louis Demers brought his outsourcing experience — including at a J&J company and Genentech — to the newly created role of director of development and manufacturing outsourcing at XOMA, a drug discovery and development company with a portfolio of innovative therapeutic antibodies. His mission: Turn this historically self-reliant biotech into a reliable outsourcer.
A renewed crossing into Asia or U-turn back to Europe and the U.S.? Thoughts of capacity and costs running over filling your head these days? Perhaps some of the following comments from Outsourced Pharma editorial board members will help answer some of the questions you have regarding outsourcing in 2017.
At risk of speaking about an overdiscussed topic, knowledge management continues to be a challenge at the interface between sponsors and CDMOs.
Over the past several decades, the practice of outsourcing has evolved from transactional, client-vendor relationships where cost savings were the primary focus, to preferred provider relationships with pre-vetted companies to start up projects quickly and then to relationships more strategic in nature to gain access to technologies, skills, or expertise not possessed in-house.
Today, most biopharma development programs include the support of a contract service provider (CSP) for everything from early development contract research to commercial manufacturing and analytical support. The factors that drive the decision to engage a CSP for commercial manufacturing are many, and there are multiple collaboration elements that impact organizations’ ability to work together effectively.