CBER/CDER Consolidation: Weiss Named Acting Director Of New ODE VI

CBER Office of Therapeutics Research & Review Acting Director Sharon Risso will continue to serve as the point person for biologics staff transition questions after the consolidation with FDA's drugs center.

Effective June 30, Risso will be detailed to the immediate office of Center for Drug Evaluation & Research Director Janet Woodcock, MD, "in a senior management role to continue working on transition issues," Woodcock said in a June 19 memo.

Woodcock noted that "questions about 'who is responsible for what' can be addressed" to Risso.

Risso has served as chair of the Center for Biologics Evaluation & Research/CDER "Transition Team" to implement product transfer from CBER to CDER (¹ , p. 3).

Woodcock also confirmed that CBER Clinical Trial Design & Analysis Division Director Karen Weiss, MD, will become acting director of the new Office of Drug Evaluation VI, encompassing OTRR's non-laboratory-based divisions (² (Also see "CDER May Form New Office Of Drug Evaluation For CBER Reviewers" - Pink Sheet, 20 Jan, 2003.), p. 10).

Weiss became the most likely choice to head up the new ODE after the 2002 retirement of former OTRR Director Jay Siegel, MD. Unlike Weiss and the other five current ODE directors, Risso does not hold a medical degree.

Components of CBER's therapeutics review program will be detailed from CBER to CDER effective June 30. The detail is effective until the reorganization officially moving the review program, and the reprogramming of funds, to CDER takes effect Oct. 1.

DCTDA, including Acting Director Patricia Keegan, MD, and Acting Deputy Director Marc Walton, MD, will be detailed to the Office of New Drugs. The Division of Application Review & Policy - headed by Director Glen Jones, PhD, and Deputy Director Earl Dye, PhD - also will be detailed to OND.

"For administrative simplicity and continuity," both CBER divisions will function as a new office within OND, FDA Commissioner McClellan said in a June 19 memo to employees.

Keegan is expected to head a new oncologic biologics division at CDER (³ (Also see "FDA Oncology Reviews Could Remain Split After CBER/CDER Reorganization" - Pink Sheet, 25 Nov, 2002.), p. 3).

Similarly, the laboratory-based Division of Monoclonal Antibodies and the Division of Therapeutic Proteins will be detailed to, and function as a new office in, the Office of Pharmaceutical Science.

DMA Director Keith Webber, PhD, and Acting Deputy Director Steven Kozlowski, MD, as well as DTP Director Amy Rosenberg, MD, and Deputy Director Barry Cherney, PhD, are part of the detail.

Former CDER Office of New Drug Chemistry Director Yuan-yuan Chiu, PhD, is overseeing the transition of CBER's laboratory-based divisions to OPS and will head up the new Office of Biotech Products upon its creation in October (⁴ (Also see "CDER Office Of Biotech Products To Oversee Biologics Quality After Transition" - Pink Sheet, 26 May, 2003.), p. 16).

"Although all the review activities for biological therapeutics will be the responsibility of staff detailed to CDER, certain other support functions will continue to be provided by CBER staff, e.g. some budget activities," Woodcock said.

"Likewise, OTRR staff will continue to review certain biological products that remain the responsibility of CBER. Starting in October, any such cross-utilization of resources between the centers will be conducted on a more formal basis."

Products identified for consolidation from CBER will be transferred to CDER effective June 30. A listing of specific products, as well as IND, BLA and NDA file numbers, that will be transferred to CDER was posted on ⁵ CBER's Web site June 20. FDA also released a ⁶ letter to sponsors about the product transfers.

The CBER/CDER consolidation's impact on personnel in the biologics center's advertising review division also has become clearer recently.

The agency will create a separate ad review team for biologics in CDER's Division of Drug Marketing, Advertising & Communications. Two reviewers on CBER's Advertising & Promotional Labeling Staff will shift over to the CDER team, leaving four reviewers in APLS (see ⁷ (Also see "CDER Ad Division To Create Separate Biologics Review Group" - Pink Sheet, 23 Jun, 2003.) ).