In the Field - Pharmaceutical Technology

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In the Field

Pharmaceutical Technology


Among the fields represented in the survey—consumer packaged goods, retail, manufacturing and distribution, healthcare, media, insurance, financial services, high tech, travel and hospitality, professional services, utilities, and the federal government—the pharmaceutical group (70%) came in higher than all others in stating that their strategic planning processes are "highly effective."

This may have to do with the nature of the pharmaceutical business model, explains Diamond partner Richard Findlay. Because pharma is "heavily dependent on high levels of research and development investment ... (that) can take 10 to 12 years to bring a new product from the bench to the patient .. coupled with the fact that new products can be cancelled at any stage ... leads to a culture intensely focused on long-term strategic planning. "

In the pharmaceutical group, 77% said their Chief Information Officer was involved in business strategy development compared to an average 72% of the other surveyed groups. However, the pharma group came in 10% lower when asked if their strategic planning helps them understand the competition they face from an IT perspective. "This may call into question whether pharmaceutical companies are as effective as they should be," adds Findlay. "Many top-20 companies have thin pipelines, and some of these firms are experieinceing unexpected product withdrawals and prepatent expiry competitive launches." It's likely that the role of IT strategy is going to change, he says.

Already catching on to the importance of IT, the US Food and Drug Administration released a draft plan to advance its own IT infrastructure by improving internal and external communications, and supplying the FDA-user community with better technology tools and services. The agency's long-term goal is to create an automated, fully electronic, standards-based, submission-and-review environment for human drugs. The plan is open for public comment until Feb. 22, at http://www.fda.gov/opacom/backgrounders/voice.html.

Zone in on: Regulation

FDA's Draft Annex to ICH Q8 Clarifies Key Concepts

by Erik Greb

The US Food and Drug Administration published in January a draft annex to its International Conference on Harmonization (ICH) Q8 Pharmaceutical Development guidance that clarifies the document's key concepts. Titled ICH Q8 (R1) Pharmaceutical Development Revision 1, the annex describes the principles of quality by design (QbD) and explains how manufacturers can implement concepts listed in ICH Q8 (e.g., design space) for all dosage forms.

In the draft document, FDA encourages manufacturers to adopt a systematic method for understanding their products and manufacturing processes. Such a strategy "can create a basis for more flexible regulatory approaches," according to the annex.

One major section of the annex examines the elements that should be included in pharmaceutical development. The section suggests systematic ways for manufacturers to gain a thorough understanding of the products and processes they develop. It lists the purposes and advantages of tools such as target product profiles, critical quality attributes, risk assessment, design space, control strategy, and life-cycle management.

A subsequent section of the annex offers advice about submitting pharmaceutical development information in a common technical document format. The annex states that data derived from tools that are part of the applicant's pharmaceutical quality system (e.g., product life-cycle management and continual improvement) do not need to be submitted in a registration application. The draft guidance says "the degree of regulatory flexibility is predicated on the level of relevant scientific knowledge provided in the registration application."


FY 2008 Funding Increases
To read the full draft guidance, visit http://www.fda.gov/Cber/gdlns/ichq8pharmann.htm.


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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
27%
Breakthrough designations
9%
Protecting the supply chain
41%
Expedited reviews of drug submissions
9%
More stakeholder involvement
14%
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Source: Pharmaceutical Technology,
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