Several of LBG’s consultants recently published a joint article on Return on Investment (ROI) calculations and tools used by pharmaceutical and biotechnology companies in evaluating product returns, guiding decisions on further product development or terminating programs prior to company losses. In the article they present a framework for executing ROI calculations to enable investment or termination decisions for research and development projects. This is augmented with insight on how to apply the framework to academic, government and non-governmental organization (NGO) program evaluations where ‘profits’ are not always measured in purely economic terms.
LBG consultants interviewed CAR-T Innovators and Manufacturers to better understand the difficulties surrounding manufacturing. Specifically, the Innovators were asked about the criteria they look for in a CDMO. Without exception, Innovator companies stated CDMO capacity and flexibility were top priorities. These criteria are priorities for Innovators because the drug product needs to be manufactured when the patient material is available. Ensuring Innovators can fulfill clinical development milestones is also a consideration with respect to CDMO capacity and flexibility. In determining who to use for a CDMO, there was no perfect solution, however early CDMO selection and scheduling are critical to maintain Innovators’ clinical development timeline.
LBG interviewed six executives at companies that are either sponsoring biosimilar candidates or are CDMOs that manufacture biosimilars to identify some challenges and understand how CDMOs are adapting to capture this portion of the biopharmaceutical market.
For a growing number of biopharmaceutical companies, the world is getting smaller. They are operating in smaller, more flexible facilities; servicing potentially smaller markets; and managing local products. Local manufacturers are looking for ways of doing standard processing less expensively without making changes that carry regulatory risk.
“Single Use Becoming an Established Tool: Vendors’ Attention to Users’ Requirements and Familiarity Are Driving Increased Implementation”, May 15, 2010 (Vol. 30, No. 10), GEN|Genetic Engineering & Biotechnology News
As single-use bioprocessing approaches its first decade, integration and standardization are on everyone’s short list of desirable features. Suppliers are responding with significant initiatives to streamline the specification, acquisition, assembly, and deployment of disposable equipment.
There are two major components in making new biologic medical countermeasures available for bio-defense and pandemic response: (1) the detection/discovery of effective countermeasures, and (2) their subsequent Process Development (PD) and manufacture. PD and manufacturing, however, are often the most costly and time-consuming parts of the process, potentially taking years and costing hundreds of millions to billions of dollars.
To address these long timelines, governments have historically stockpiled countermeasures for known biothreats. Unfortunately, this kind of stockpiling is very expensive, and does not provide protection against novel threats. Fortunately, there currently exist many new technologies that, when combined strategically, have the potential to significantly reduce the time and cost associated with the PD and manufacturing of biologic countermeasures.