MISSION

PharmaQbD will advance a smarter approach to drug development — a more scientific, more efficient, less hit-and-miss approach. This advancement will be achieved via solutions-oriented, actionable information and ideas to improve the drug development process.

There is an urgent need for "best practices" for implementing Quality by Design programs and thinking within the drug industry. Currently, as the pace of new drug introductions slows and some established "blockbusters" are found to have serious safety issues, it can take 10-12 years and $1 billion to develop a new drug. Drug makers need to optimize quality and safety, as well as "manufacturability" from the earliest stages of any drug's development.

This critical industry movement is being advanced by FDA and global regulatory agencies, including the ICH (International Council for Harmonization).

QbD DEFINED

A new approach to drug development that requires getting the product, process, packaging and manufacturing "right the first time."

QbD requires that drug development teams develop a deep scientific understanding of critical processes and product attributes, design controls and testing based on the limits of scientific understanding at developmental stages and utilize knowledge gained over the product's lifecycle to operate in an environment of continuous improvement.

QbD promotes better science and facilitates more economically efficient product development. Two core concepts that are new to the drug industry are those of the "design space" and "design for manufacturing" — developing processes and a product that will optimize manufacturing efficiencies and product quality.

CLEARING THE CONFUSION

Recent polling of PharmaManufacturing.com's audience has found that most industry members ranked internal company QbD programs as "extremely important" or "important."

Although this movement is very important, many are confused about the terminology and concepts behind QbD. They also view senior and middle management as the main obstacles to implementing QbD, which requires investment in the right tools (among them, the analytical systems required for Process Analytical Technologies) early in the product development cycle.

PharmaQbD.com will serve both practitioners and management, at all levels, offering best practices and technical articles for engineers and scientists, QA and QC professionals, IT and regulatory affairs professionals. In addition, PharmaQbD will feature economic and business case discussions of interest to senior and C level management.

PharmaQbD CONTENT FOCUS

PharmaQbD's content will include feature articles, news, white papers, video content discussing Design (Design of Experiment, Design Space, Design for Manufacturing), Control and Continuous Improvement. In short, developing pharmaceuticals with better science and better business in mind.

AUTHORITY

Launched by the publishers of Pharmaceutical Manufacturing, The Drug Industry's Voice for Manufacturing and Operational Excellence, PharmaQbD will be directed by an expert editorial team and advisory board. Advisory board members and contributors will include representatives from R&D, manufacturing, mid-level management and senior management, as well as from FDA and ICH committees.