Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



Executive Summary

FDA CYTOKINE BIOLOGY DIVISION IN BIOLOGICS CENTER STAFFING will total 40 scientists, according to a proposed organizational chart for the new division. Of the 40 scientists, 25 are switching from the Division of Virology and 15 will be "new hires." It is projected that at least some of the newly hired employees will actually be transfers from FDA's Division of Blood and Blood Products. The division scientific staff will include nine fellows. FDA announced the official establishment of the Cytokine Division in an Aug. 30 "Talk Paper." The formation of the division and the appointment of Kathryn Zoon, PhD, to director from Acting Director Division of Virology had originally been signaled at a Food Drug Law Institute annual meeting by FDA Commissioner Young in December 1987 ("The Pink Sheet" Dec. 21, 1987, p. 30). Former head of the Pediatric, Enteric and Neurologic Diseases Lab, Paul Albrecht, MD, replaces Zoon as Acting Director Division of Virology. FDA is also planning to set up another separate division as a successor to the current Lab of Retrovirology in an organizational response to the influx of AIDS and antiviral products. The new Cytokine Division is an offshoot of the Division of Virology. It will specialize in AIDS products joining four other divisions under the Office of Biologics Research: the Division of Biochemistry and Biophysics; the Division of Virology; the Division of Blood and Blood Products; and the Division of Bacterial Products. According to the Center for Biologics and Research staff manual guide, the duties of the new division will be to conduct research on "lymphokine, interferon, cell biology, and cellular and molecular immunology to obtain data bearing on the safety, purity, potency and effectiveness of cytokines and cellular immunotherapeutics produced using cytokines." The Cytokine Division will also review applications and serve "as a source of information within the agency on cytokine biology products."

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts