CARY (NC) – January 26, 2006 – Last week, the FDA released the Guidance for Industries: INDs – Approaches for Complying with cGMP During Phase 1 ushering in a new era in Phase 1 GMP manufacturing. The Guidance states, “the same area or room could be used for multiple purposes, including production of investigational products [Phase 1] or laboratory research, provided the appropriate cleaning and control procedures are in place.” A drug development company can now use the same facility or area for both non-GMP and GMP manufacturing of Phase 1 clinical materials. This new development is particularly beneficial for small to mid-sized companies that don’t have the resources or demand for a separate cGMP pilot plant.

PharmaDirections is uniquely positioned to help our clients/partners benefit from the new Guidance. Our clinical trial manufacturing (CTM) electronic record, SOPs and systems are specifically tailored to employ the new Guidance in the research laboratory environment. To this end, PharmaDirections offers Instant GMP Manufacturing and opens the door to unprecedented control and flexibility for small and mid-sized pharmaceutical and biotech companies. FDA Guidance link - http://www.fda.gov/bbs/topics/news/2006/NEW01296.html

PharmaDirections offers multiple strategies to take advantage of the new regulations.

Option 1 – Utilizing PharmaDirections’ electronic record and complete cGMP manufacturing SOPs, design your facility to manufacture Phase 1 cGMP batches using existing lab space, staff and equipment. [Instant GMP Manufacturing]

Option 2 – Use PharmaDirections’ cGMP clinical manufacturing facilities to manufacture Phase 1 and 2 clinical batches … API, solid dosage forms, topicals and parenterals. [Virtual Manufacturing]

Option 3 - Hybrid – Utilize both Instant GMP Manufacturing and Virtual Manufacturing options

Scenario 1: Start with Virtual Manufacturing (outsourcing) for your Phase 1 and 2 clinical batches and migrate to internal Instant GMP Manufacturing on your own time schedule. Since we use the electronic record for all Virtual Manufacturing projects, your team will become intimately familiar with the application prior to bringing the manufacturing function in-house.

Scenario 2: Start with internal Instant GMP Manufacturing and utilize Virtual Manufacturing for Phase 2 and specific projects when your internal capability is insufficient (i.e. special equipment required) or capacity is unavailable

Yes, this concept is a major change in the thinking for both the FDA and the industry … and a bit confusing as well. But the new FDA Guidance gives you more flexibility and greater control than the current paradigm. PharmaDirections provides the tools to take advantage of the new rules. Now you can have unprecedented control over process, scheduling and costs.

Please contact Chris Morrison at (919) 657-0660 or CMorrison@PharmaDirections.com to schedule your FREE facility assessment conference call to discuss how your company can benefit from the new FDA Guidance and meet your development milestones efficiently and economically.

About PharmaDirections

PharmaDirections is a specialized consulting firm that partners with pharmaceutical and biotechnology companies to quickly advance their drug development programs. With a team of 50+ associates experienced in guiding companies through the strategy and management of drug development, our core areas of expertise are:

• Pre-Clinical Development
• Regulatory Affairs
• Outsourcing Management.

Each PharmaDirections associate has more than 20 years of experience. Combined, they represent tenure at more than 40 of the world’s largest pharmaceutical companies. Whether working independently or as part of a unified team, PharmaDirections offers one of the most extensive networks of drug development professionals in the industry.