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

UsernamePublicRestriction
UsernamePublicRestriction

OTA WORKSHOPS ON BIOTECHNOLOGY ISSUES PLANNED

Executive Summary

OTA WORKSHOPS ON BIOTECHNOLOGY ISSUES PLANNED for May 2 and July 6-7 in Washington, D.C. The workshops will be part of the Office of Technology Assessment's study on the U.S. competitive position in biotechnology. Plans for the workshops were discussed at the first meeting of the OTA advisory panel for the biotech project on April 17. The meeting addressed the scope of the overall project and the first two of three reports planned by OTA ("The Pink Sheet" April 10, T&G-4). The May 2 workshop will address federal coordination of biotechnology research and regulation. The session will focus on regulatory agencies involved in research and development policy issues as well as international regulatory issues. International investment in biotechnology will be the subject of the July workshop. OTA will invite papers from government and private sector representatives in 16 countries on the importance given to biotechnology research. European countries as well as Japan, Taiwan, Singapore and Australia will be among those invited to make presentations. Both meetings will be open to the public. The April 17 meeting provided opportunity for a preliminary discussion between OTA staff and the panel of biotech experts on the scope of the study. The session addressed OTA's reports on "International Investment in Biotechnology" and "The International Regulatory Environment for Biotechnology." In the first report, for example, members of the panel pointed out that limited domestic investment in biotechnology should be addressed as a current problem. Among the issues raised with regard to the second report were regulations in areas such as recombinant DNA research, animal welfare and good laboratory practices. The group also noted that intellectual property and product liability laws as they relate to biotechnology should be reviewed. Discussion on the first report was led by OTA Study Director Rand Snell; Project Director Kevin O'Connor introduced the second report. Among the industry/financial representatives on the 12-member OTA panel are: Robert Benson, Genentech; Jerry Caulder, Mycogen Corporation; Peter Drake, Vector Securities; Michael Hsu, Asia/Pacific Strategic Bioventures; Dennis Longstreet, Ortho Pharmaceutials; James Sherblom, Transgenic Sciences and Sarah Shoaf, Centocor.

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

UsernamePublicRestriction

Register

ID1135947

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

Cancel