From the Editor: Information Access Is the Key to High-Tech Pharma

Concrete steps are being taken to help drug manufacturing reach the level of technical sophistication that other manufacturing fields take for granted.

By Agnes Shanley, Editor in Chief

This issue marks the first time that we’ve featured one of you on our cover. We’ve experimented with artistic, abstract and conceptual covers. This time we’re going for “verismo.” Chemical engineer Paul McKenzie and his team, like many of you, are taking concrete steps to help drug manufacturing reach the level of technical sophistication that other manufacturing fields take for granted. Don’t worry. We’re not selling out or becoming industry sycophants. We simply couldn’t help but notice that a number of things stand out about the far-reaching automation and IT platform that BMS has been developing for the past nine years:

  • The work was initiated by automation engineers.
  • Even though it will improve the manufacturing of both APIs and finished drugs, the platform’s roots are in R&D and the lab, rather than the plant floor.
  • Open control concepts, notably S88, provide the foundation of the work.

In fact, McKenzie says that S88 needs to become the DNA of drug development and manufacturing. Could this be the same S88 that so many of you have characterized as “too cumbersome and costly”? Or the S88 that many of you couldn’t even identify? It might be time to read up on what might appear to be an irrelevant control engineering concept. As BMS is proving, it has ramifications for every aspect of drug development.

We selected the cover subject because the work involved goes beyond what other pharma companies are doing to bring a scientific and engineering basis to drug development and manufacturing. The crux of the project is rapid and transparent data access.

FDA’s Associate Commissioner Janet Woodcock and CDER’s OPS Director Helen Winkle (interviewed on p. 39) have both pointed to the need for drug manufacturing to become more science-based. The Critical Path may be focused on biomarkers, but its unofficial underpinnings are an efficient manufacturing base. There will be a growing need for more modeling, simulation and the engineering tools being applied in other industries.

Information transfer is the prerequisite for establishing that base. It is also the focus of a Cooperative Research and Development Agreement (CRADA) involving FDA and the software company Conformia, to uncover issues that are preventing industry and FDA from reaching the “desired state,” based on scientific manufacturing.

The research focuses on drug development, but applies to all pharma operations, including manufacturing. Conformia cofounder Anjali Kataria identifies the industry’s data challenges as:

  • Pharma companies waste too much time trying to understand system validation and GMP documentation requirements.
  • Multiple systems, silos and handoff points, particularly geographically dispersed handoff points.
  • Information is often scattered, held in the heads of subject matter experts.

All of these issues prevent industry from achieving what FDA is calling for, which Kataria describes as “the systematic capture of process understanding and the ability to go back and demonstrate the rationale of why you did what you did, or of what you didn’t do.”

What are you doing to address this issue? Please write in and tell us. Or perhaps you’d like to attend some of the joint CRADA workshops that Conformia and FDA are sponsoring?

We still haven’t heard from many of you, but we’re patient. As journalists, we have to be. Several of this year’s Team of the Year applicants had to withdraw their nominations when they couldn’t obtain corporate clearance to participate (and provide concrete data). It took us quite a long time (I won’t say how long) to land an interview with Dr. McKenzie.

We can wait, but you are the ones who are advancing drug manufacturing. For a moment, don’t think about your counterparts as “the competition,” but as peers who, with you, will bring down the cost of drug manufacturing and increase value to the patients whose lives your products save.

Only you can help drug making reach its full potential. We hope to feature more of you trailblazers on future covers.

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