FDA CPath Industry Collaborations to Solve Common Roadblocks in Medical Product Development

Approval Drugs, Biologies, Devices

Approval Drugs, Biologies, Devices

NDAs,

BLAs, Guidances

C-Path Institute

Fig. 2. FDA-C-Path-Industry (29). Reprinted with permission.

5. Developing products to address urgent public health needs.

6. Specific at-risk populations—pediatrics.

Another major factor in adapting clinical pharmacogenomics is the education outreach to both patient and clinician. To that end, the International Society of Pharma-cogenomics recently published a position paper recommending the education effort for the deans of schools of medicine, pharmacy, and allied healthcare (30). The following 10 recommendations are proposed.

1. Encourage the deans to include the teaching of pharmacogenomics.

2. Global outreach to policy makers and government leaders to educate physicians, pharmacists, and nurses.

3. Basic medical teaching to include 4-8 h of lecture.

4. Graduate school.

5. Continuing medical education.

6. Pharmacogenomics for oncology.

7. Pharmacogenomics update.

8. Pharmacogenomics dedicated issues in journals.

9. Educational tools using web-based learning.

10. Better general education to outreach to patient and general public.

If these recommendations are adopted by the deans, it would pave way to prepare graduating physicians for clinical pharmacogenomics. For example, a Personalized Medicine e-Symposium held on June 21, 2006 addressed the various issues [http://www. e-symposium.com/pm/archive.php (12)].

Another major educational effort in enhancing the practice is the Laboratory Medicine Practice Guidelines for Clinical Pharmacogenetics, prepared by the National

Academy of Clinical Biochemistry (NACB) the academy of the American Association for Clinical Chemistry (AACC) (31). The document was drafted with input from NACB, AACC members as well as selected colleagues from other professional societies and regulatory agencies both in the United States and in the Europe.

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