BTRA 640 University of Maryland Global Campus Preclinical and Clinical Research

1) For this week’s writing assignment, pretend you are working for a pharmaceutical company with a drug that is about to finish Phase IIB clinical trials. This means it is time for your company to have potential meeting(s) with the FDA and you have been tasted of requesting such FDA meeting(s). In a 2-4 double spaced pages easy, summarize the different types of FDA regulatory meetings and discuss the different types of meetings that you would request for further clinical development (i.e. Phase III trial) of the Company’s investigational medicinal product

2 GXP is a collective term for Good Manufacturing Practice, Good Laboratory Practice, Good Documentation Practice and any other “Practice” that contributes to the manufacture of high quality clinical material suitable for human use. Review the materials in the course content area for the week.

A. Importation and use of contaminated raw material from a foreign source was linked to the death of US citizens. (See http://www.washingtonpost.com/wp-dyn/content/article/2008/04/08/AR2008040803032.html)

There have also been reports of contaminated pet treats suspected to have originated from external sources:

http://www.wjla.com/articles/2014/05/contaminated-jerky-pet-treats-linked-to-at-least-1-000-canine-deaths-many-more-illnesses-103320.html

The case has been made that these incidents might be avoided by having US FDA staff inspect foreign manufacturing facilities. The obvious problem with this is the prohibitive cost and resource associated with this approach.

a. Where does this leave the average consumer? What do you think should be done?

b. Take a look at the GMP for phase I guidance document in the course content area (again). Based on this document, do you feel that material used for phase I clinical trials are less safe than materials used for later stages (phase II, III)

3 Explore the following site on Institutional Review Boards and Comment on the following: https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/index.html

and http://wayback.archive-it.org/org-745/20150930181805/http://www.hhs.gov/ohrp/archive/irb/irb_guidebook.htm

Comment on the following:

A . What important function(s) do they serve?

B (I) Is their role in clinical trials obligatory or mandatory?

(II) Cite a regulation to support your response

C. What kind of records is an IRB required to keep?

4 Some guidances were listed in the BIMO section of the week’s course material. Navigate through Bioresearch Monitoring web page (see following link) to find some of these guidances and post comments on at least one of the relevant available ones – 2010 and 2011 (ignore the CFR and GLP references)