FDA's new Chief Scientist Frank Torti will be asked to concentrate on clinical research when he assumes the newly created position in May, FDA announced April 9.

The new office under Torti, director of the Comprehensive Cancer Center at Wake Forest University, "will place a special emphasis on the importance of clinical trials that are part of the foundation of the FDA's regulatory structure," the agency said.

At a time when much of FDA's focus is on improving its post-market surveillance capability and implementing new drug safety oversight authorities, the agency has several clinical trial issues that require attention.

Among other things, Torti will need to address the backlog of Phase IV trials that either are running behind schedule or have never been started. Effective management of post-marketing commitments by the agency will only become more important as the FDA Amendments Act grants the agency the ability to require post-approval trials.

Among many other headaches, results from Merck/Schering-Plough's ENHANCE recently raised questions about proper disclosure of trial data that FDA may need to settle (¹ 'The Pink Sheet,' Dec. 17, 2007, In Brief).

The limited efficacy seen with Merck/Schering's Vytorin and the safety issues discovered with GlaxoSmithKline's Avandia have raised questions about the use of surrogate markers for approval. Advocates of outcome trials have become more vocal in their criticism of some FDA programs - including the Critical Path Initiative and the Reagan-Udall Foundation - that support the creation of new tools and measures to expedite drug development.

The new office will also oversee FDA's intramural research programs and help launch the FDA Fellowship Program. Despite the absence of congressional funding, the Reagan-Udall Foundation also will be involved with the effort to bring in as many as 2,000 new professionals to FDA (² Also see "FDA Commissioner Says Funding Imperils Agency Mission, Modernization" - Pink Sheet, 31 March, 2008., p. 5).

Who is Frank Torti?

Torti shares FDA Commissioner Andrew von Eschenbach's background as a researcher and program administrator. According to FDA, its new chief scientist is a molecular oncologist who "has written extensively on prostate and bladder cancer, designed and executed a number of clinical trials, and has substantially contributed to the understanding of the molecular mechanisms that underlie inflammatory diseases and cancer."

Torti's clinical interest is listed as genitourinary oncology, and he is involved in examining the relationship between cellular iron and ferritin and disease.

The most recent articles that list Torti as an author have been published in Cancer Chemotherapy and Pharmacology, Cellular and Molecular Life Sciences, Lung Cellular and Molecular Physiology, and Molecular Biology of the Cell.

According to PubMed, Torti has been the lead author of 26 articles, but he has not actively published academic articles in recent years.

The most recent article for which he served as lead author is an editorial review appearing in the Current Opinion in Oncology in 2005 entitled "Questions Without Answers."

In the article that covers a range of issues within clinical oncology, he encourages the development of diagnostic biomarkers for clinical use and the development of screening algorithms to better identify high-risk patients. He also mentions the need to take clinical practice considerations into account in the evaluation of drug dosage and administration.

The only other article he authored in the last decade is a review of studies of the regulation of ferritin genes and protein published in Blood in 2002.

In addition to his work at Wake Forest University, Torti serves on the NIH National Advisory Council for Complementary and Alternative Medicine. He is also president of the Cancer Biology Training Consortium.

Commissioner's Office Nearly Full

Torti will serve as principal deputy commissioner as well as filling the chief scientist post, which was created by the FDA Amendments Act. The "principal deputy" title is noteworthy because it is not specified in the legislation and would seem to place Torti on a different tier then the other deputy commissioners.

The current deputy commissioners are Randall Lutter (policy, planning and preparedness) and Murray Lumpkin (international and special programs) and Chief Operating Officer John Dyer. Under a reorganization announced last year, Chief of Staff Susan Winckler serves as the primary liaison between the centers and the office of com-missioner (³ Also see "FDA Re-Org Makes Chief Of Staff Liaison Between Centers And Commissioner" - Pink Sheet, 3 September, 2007., p. 10).

The "principal deputy" title has been used for career FDAers who served as acting commissioner during periods of transition, and the designation suggests that Torti could be tapped to oversee FDA following von Eschenbach's expected departure at the end of the Bush Administration.

Torti's posting may also be short-lived, however. The Winston-Salem Journal reports that "Torti's colleagues at Wake Forest expect him back after a leave of absence of between nine months and a year."

Torti's appointment appears to be essentially a replacement for Janet Woodcock, who was deputy commissioner and chief medical officer before she returned to head the Center for Drug Evaluation and Research (⁴ Also see "Woodcock Stays At CDER: Drug Center’s Gain Is FDA Science Program’s Loss" - Pink Sheet, 17 March, 2008., p. 9).

However, the chief medical officer post is still open, FDA said. Filling that position seems unlikely, though, given FDA's concerns about the overlap between the responsibilities of the chief medical officer and chief scientist (⁵ Also see "FDA Reform Bill Leaves Senate With Reduced Safety Powers But Stiffer Fines" - Pink Sheet, 14 May, 2007., p. 16). But in a report that has generated considerable congressional interest, the agency's Science Board has advocated for two commissioner-level positions to enhance FDA's research focus (⁶ Also see "FDA Should Look Through IIRIS To Improve Science, Panel Says; Funding Is Worry" - Pink Sheet, 10 December, 2007., p. 15).

- Brian Marson (b.marson@elsevier.com)

FDA’s First Chief Scientist Is Wake Forest Oncologist Frank Torti

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