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Rita Peters is editorial director of Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International.
By minding knowledge gaps, bio/pharma companies can avoid development pitfalls.
Graduation ceremonies fill the calendar during this time of year as students mark their promotion from one level of schooling to another, or from academic life to the business world. The familiar rhyme “no more pencils, no more books …” rings across schoolyards and college campuses as students mark the end of formal learning.
Don’t toss away those books too quickly, however. While ‘commencement’ ceremonies celebrate the achievements of graduates, another meaning of the word denotes a beginning or start. Countless graduation speakers have reminded graduates that one must never stop learning, a subtler way of saying “you don’t know everything” and “you will forget what you have learned if you do not put the knowledge into practice.”
These messages also have meaning for experienced bio/pharmaceutical development and manufacturing employees and companies. Evonne Brennan, international technical marketing manager, IMCD Ireland, urged the audience to “mind the gap” in their knowledge base during a presentation, “Bridging the Knowledge Gap in Formulation and Processing,” at ExcipientFest 2018 in San Juan, Puerto Rico in May 2018. Brennan cited examples of failures in drug formulation and development due to a lack of knowledge or expertise by members of the development team. She also noted how a lack of communication between formulators and equipment manufacturers can lead to development delays.
Knowledge gaps form in several ways. When experienced chemists, formulators, and other development, manufacturing, or quality personnel leave a company or the industry, they take their knowledge with them. And, when companies are resistant to change-due to financial constraints or regulatory concerns-a gap in technology or scientific expertise can grow.
In some cases, information to resolve a potential drug development problem may exist within an organization; however, it resides in data silos, inaccessible to the experts who can interpret the data into knowledge. In other cases, industry players are hesitant to share knowledge due to competitive concerns.
Emerging technologies, such as continuous manufacturing and 3D printing, demand new ways to address formulation and manufacturing. Gaps in know-how for material handling, properties, and behaviors, as well as process analytics can slow adoption of these technologies.
Industry publications, conferences, reference books, compendial organizations, and academia are valuable information sources for ongoing career knowledge development. Despite improvements in communication channels such as the Internet, however, it is more difficult to get industry experts to share technical expertise on core pharma development topics. Bio/pharma companies and contract service organizations are sharing less in the trade press, citing confidentiality concerns.
At several recent industry events, I listened to several experts from different segments of the bio/pharma spectrum-APIs, medicinal chemists, formulators, regulators, process developers, equipment manufacturers, and more-engage in verbal finger pointing, arguing that the other industry players were the roadblocks to progress in drug development. Others argued that the industry needs to work together on these issues.
Christopher Welch, a principal with Welch Innovation, shared two examples of cross-pharma collaborations during a presentation at CPhI North America in Philadelphia in April 2018. The Enabling Technologies Consortium, a collaboration of pharmaceutical and biotechnology companies, works on a pre-competitive basis to identify, develop, and improve scientific tools and techniques to support drug development and manufacturing. Projects include an automated solubility platform, a probe for drying processes, and particle measurement. Welch also is involved in a new venture, the Indiana Consortium for the Analytical Sciences, scheduled to launch in 2019.
These collaborations are bridging the knowledge gaps and promoting the route to ongoing learning essential to industry advancement.
Vol. 42, No. 6
When referring to this article, please cite it as R. Peters, “Let the Learning Commence" Pharmaceutical Technology 42 (6) 2018.