Experts Statements: Ingrid Hegbom Ekman, Cambrex
Despite tremendous challenges facing the pharmaceutical industry, it continues with its commitment to innovation and the discovery of novel drugs to address unmet medical needs. Indeed, medicinal chemists face a challenge of their own. Trying to survive in a changing environment where pharma is focusing on biologics drug candidates will require chemists to adapt.
CHEManager International asked R&D experts of chemical and pharmaceutical companies to elaborate on their research strategy and share their opinion with our readers. In detail, we interviewed professionals ranging from CEOs to heads of R&D and process development about:
The crucial success factors in chemical and pharmaceutical research.
Ingrid Hegbom Ekman: It will become increasingly important to better integrate and adopt regulatory and environmental requirements into R&D organizations, and more specifically, get the development chemists to consider these factors at an early stage.
“It will be … important to better
integrate and adopt regulatory
and environmental requirements
into R&D.”
Ingrid Hegbom Ekman,
Director R&D,
Cambrex
Automation will also become ever more valuable to improve process understanding and “seeing the process window,” as will the adoption of “enhanced development in combination with the traditional way of developing processes,” as outlined in ICH Q11. This also includes the use of risk assessments/quantitative risk assessments from an early development stage.
High-tech analytical instrumentation and integrated, computerized systems to support data evaluations, as well as storage and tracking of data, will be extremely valuable going forward. Internal and external collaboration in specialist areas is also very important, but takes time to establish and a key is open collaboration with external partners, who may have specialist knowledge and expertise beyond that which is available internally.
Challenges and changes affecting the work of R&D chemists in the future.
Ingrid Hegbom Ekman: Chemists need to be more aware of all regulations and requirements for a process to be both efficient and sustainable into the future. It is important not to view regulations as being painful but as a natural variable that must be taken into consideration, as very often they are nothing more than common sense.
