Abstract
The Regulatory Forum was initiated in 2007 as a joint undertaking by the Scientific and Regulatory Policy Committee of the STP and Toxicologic Pathology. This new venture was in response to two perceived needs. First, although the regulatory environment is constituted by official guidance documents, application of the guidance by companies and by regulators varies and evolves over time through increasing scientific knowledge and cumulative experience. Consequently, the sum total of “regulatory knowledge” may vary from person to person and company to company, and it is very difficult to access all such available information unless one has exceptionally good contacts. Secondly, Jim Klaunig, recently retired editor-in-chief of Toxicologic Pathology, encouraged associate editors to look for ways to increase the impact, citation index, and ultimately the readership of Toxicologic Pathology, in the face of significant competition with other prestigious journals. One of those editors, Roy Kerlin, with support (read heavy prompting) from Dan Morton, then chair of the SRPC, conceived of the Forum as a place within the journal pages where topical issues in regulatory toxicologic pathology could be aired, whether as formal STP position papers; articles on best practices; comments on draft and final regulatory guidance; opinion papers by individuals from government, industry, or academia; short commentaries or letters by individuals or groups; and informal advertisements of events of regulatory interest. We believed that a free exchange of ideas (using reasonable journalistic good taste) within this framework on subjects of topical interest would allow the membership to have an entry into this “idea space” previously limited to interpersonal exchanges, and as a direct consequence make Toxicologic Pathology a more widely read journal. It was felt that bringing more of this information into a broadly available public forum will benefit everyone.
Regulatory Forum articles have appeared in three of the five most recent journal issues, often with some commentary to introduce the reasons for having this topic appear in the journal. We have published the STP position paper on imaging; two papers outlining the STP’s recommendations for organ weighing in regulatory studies; and an opinion paper about the use of statistics to guide decisions about terminating dose groups for carcinogenicity studies.
Since this initiative is too much work for a single individual with a day job, and we wanted to involve a larger demographic of the membership, we decided to develop a committee of energetic, well-connected individuals to help drive it and ensure success. The current committee consists of Roy Kerlin (Pfizer; SRPC member) as chair, David Hutto (Biogen Idec), Lee Silverman (Millennium Pharmaceuticals), John Vahle (Lilly; SRPC member), and Sabine Francke-Carroll (CFSAN/FDA; SRPC member). The group connects regularly via e-mail and meets monthly by teleconference, discussing the progress of ongoing projects as well as the new topics that may be of interest. Most of the topics to date are being developed as opinion articles on such broad areas of interest as phospholipidosis, the “Tegenero Incident” and the EMEAs guidance for high risk compounds, a response of the SRPC to a recent paper on carcinogenicity studies, nanoparticle safety issues, and many more. The committee members’ main job is to identify issues, find an author willing to commit, and then drive the project to publication. It takes a bit of time, but it is rewarding and quite exciting to be able to fill this gap on behalf of the STP. As you may note, we have a need for committee members representing the chemical industry as well as EPA. To cover issues abroad, we would also welcome interest from members in the European Union, Japan, and other areas. Although we do not want to grow too large and cumbersome, another two or three members from these demographics with plenty of energy and enthusiasm and a persuasive personality would be very welcome.
We expect the Regulatory Forum to become a regular feature of Toxicologic Pathology for many years to come. However, the future of this initiative will be driven by you, the membership, who need to get behind it if you believe in the mission we outlined above. Let us know what you want to see, and give strong consideration to becoming an active member on the committee in the future, or a contributor right now. Please comment on this column’s topic, suggest future Regulatory Forum content, or volunteer by sending a message to
Sincerely,