Mindset is important to working in the biopharmaceutical industry. Three distinguishing behaviors will enable new entrants to build rich and fulfilling careers: keeping an open mind, serving a purpose for the benefit of a greater good, and making risk-based decisions. The range of experiences in our own careers can help to illustrate the broad array of opportunities that you can find in the life sciences when such a mindset is applied. Below, we discuss some of those experiences and lessons learned from the past 20 years.A
Mindset for Success
Lindberg:
As Heraclitus wrote over 2,500 years ago, “Change is the only constant in life.” But some human aspirations are timeless, including striving for a sense of purpose and achievement in life. The biopharmaceutical industry offers both of those and presents career opportunities that are limited only by your time and approach. Advancements over the past 20 years are expanding this field to provide myriad pathways for professionals seeking to make a positive imp...
The commercial successes of the biopharmaceutical industry over the past 20 years are a reflection of a maturing industry whose increasing focus on efficiency and cost effectiveness will expand the adoption of digital technologies into knowledge management, process/cost optimization, and manufacturing. The ultimate goal continues to be reducing costs to manufacture effective medicines efficiently and broaden patient access to life-saving drugs. Here, we review the journey of bioprocess cost models and how they have helped the industry build process knowledge as well as optimize costs and assess manufacturability of product candidates. The latter includes determining fit of a process to a facility along with scalability, economics, and sustainability.
Although concepts of manufacturability and cost of goods (CoG) are discussed and considered widely in the industry today, they were not seen as important from the mid-1980s to the 2000s. A view often expressed in the 1990s was that the pharmaceutical industry...
+2The pace of regulatory change in the pharmaceutical industry over the past 20 years has been rapid. Although heightened emphasis on patient safety, data transparency, and harmonization has prompted new guidance’s and requirements, perhaps what is most notable is the rate at which technology has changed how processes are documented and regulated.
Today, digitization is entrenched in day-to-day life and is steadily becoming the norm among health authorities and at pharmaceutical companies. But just two decades ago, incorporating technology-led regulatory developments placed a great strain on existing office equipment and know-how within biopharmaceutical companies. Indeed, what we take for granted now were just pie-in-the-sky ideas at the turn of this century.
From PDFs and eCTDs to Complete Digitalization
The shift to electronic submissions began in the 1990s when the US Food and Drug Administration (FDA) started requesting that labeling content and most other documents for electronic submission be sent in...
Stanton closed the BPI Theater at BIO 2022 with this analysis. Watch his full presentation and others online at
https://www.bioprocessintl.com/BIO-Theater-2022
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Contract development and manufacturing organizations (CDMOs) have evolved from simple service providers to full partners. Such companies now offer development and end-to-end services for highly complex biologics in a transition from contract manufacturing organizations (CMOs) and contract research organizations (CROs) to CDMOs.
Before 2000, some drug companies (e.g., Merck, Novarits, Boehringer Ingelheim, and others) offered their excess manufacturing capacity to other drug makers. Chemical companies provided fill–finish and related services. Between 2000 and 2008, a number of dedicated CMOs emerged: Patheon, Roche, CMC Biologics, Lonza, Catalent, Recipharm, and so on. With easy access to capital, many purchased or built biomanufacturing facilities. The financial crisis in 2008 actually created a boom for CMOs. Rather than small biotechnology co...
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