You are on your weekly project conference call with your CMO, discussing a product-filling project which is on track. The CMO’s project manager says, “Oh, I am going to go off agenda and ask for your signature by today to go forward with a machine-testing plan. If we don’t do it tomorrow, we might need to push your production run by a couple of weeks.” This is the first you have heard of it, so you are reacting on several levels.
At small pharma companies, most of the CMC (chemistry, manufacturing, and controls) knowledge base is generated by a global array of outside providers. The companies are challenged to create and manage a high-functioning knowledge base of information with little or no support staff. Let’s start with some examples of the current state.
Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system is the integration of risk-based thinking. While the concept of risk management is not new, previous practice was more reactionary, primarily focusing on detection after the fact, root cause analysis, corrective actions, and preventing recurrence of the failure. Contemporary thinking places the emphasis on considering risks up front (prevention) and having a solid approach to address risk in planning, managing, and driving actions.
Generic drug prices are falling. For confirmation, look no further than the recent earnings reports from generic manufacturers and pharmaceutical wholesalers whose profits from distributing generic pharmaceuticals are also declining.
New York City has long aspired to become a life sciences hub, but while the city seems to have all the elements necessary to foster such industry growth, it has continually fallen short of this goal. New York currently ranks a distant third behind both Greater Boston and the San Francisco Bay Area, and there’s some work to do if it hopes to catch up.
There is always a lot of discussion and debate related to the challenges faced by companies within the industry broadly described as life sciences. Price pressure for mature pharmaceutical products, shortage of supply for critical vaccines and other life-saving compounds, pipeline management for promising molecules and therapies — the list goes on. There are many proposed approaches to address these challenges, all with a common thread: Adopting a life cycle management approach will assist in identifying risk factors and constraints and provide structure and control, with a clearly defined methodology to identify and mitigate risk.
In part 1 of our article on biocontainment, we discussed the history of biocontainment as an outgrowth of medical research, especially the effort to develop vaccines for various worldwide diseases. We provided some definition of the biosafety levels (BSLs) established by the Centers for Disease Control and Prevention (CDC) based on risk considerations. We also discussed the regulatory regime for biological agents and, specifically, for designing a facility for an FDA or EU regulated product within the confines of the safety practices dictated by the CDC and design requirements of the NIH.
Serialization in the pharmaceutical sector is a direct response to the problems of counterfeit, stolen, and gray-market drugs. There's been a huge incentive for counterfeiters to duplicate high-profit-margin products. According to the 2016 Brand Protection and Product Traceability Market Research Report from PMMI, the black market for counterfeit drugs is about $75 billion annually.
In this final installment of a three-part series, managing directors Jonathan Kfoury and Ricardo Brau of L.E.K. Consulting share their perspectives on six biosimilar company archetypes, emerging biosimilar development and business strategies (as well as mistakes to avoid), and the market’s future.
This article discusses a strategy to implement risk management during the process design stage of process validation for quality product, and to use as a proactive means of addressing quality controls during the subsequent stages of development.
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