Shortcomings of pediatric clinical trials one of hot topics at AAPS Annual Meeting

October 11, 2001

ARLINGTON, Va. - October 11, 2001 - Scientists from academia, industry, government and other research institutions worldwide will gather at the Colorado Convention Center for the 2001 Annual Meeting of the American Association of Pharmaceutical Scientists (AAPS): "Pharmaceutical Sciences: Climbing New Heights." Dr. Donald Francis, whose efforts to call attention to AIDS were chronicled in the movie "And The Band Played On," will formally kickoff the meeting October 21 at the opening session.

The meeting features roundtable discussions and the presentation of thousands of new scientific research studies. Here is a sampling:

Public's Involvement in Design of Pediatric Trials Sought - With new regulations currently under review regarding pediatric drug clinical trials, the FDA is inviting the public to help ensure that ethical boundaries are observed in the design and implementation of pediatric trials. During a press conference/teleconference on Wednesday, October 24 at 10:30 a.m. EST (9:30 a.m. CST, 8:30 a.m. MST, 7:30 a.m. PST), Steve Hirschfield, M.D., Ph.D., of the FDA will address the current shortcomings of the process and how the public can join Institutional Review Boards. In addition, AAPS will provide tips for parents wanting to enroll their children in a clinical trial. Pharmaceutical scientists and FDA officials will focus on the challenges of pediatric trials in two sessions.

New Weapon Against HIV and STD's - In the U.S., more than one in three adults have an incurable STD. The unavailability of vaccines to combat HIV and STDs has created an urgent need to stop the spread of the infection. Using the same compound currently employed for coating pills, scientists have developed a new product form to be used in cream and sponge form that inactivates HIV and STDs in animals, thereby stopping the transmission of the viruses.

Link Between Liver Damage and Prescription Drugs - Drug-induced liver toxicity, caused by certain drugs or the combination of drugs with other substances such as OTCs, herbal remedies, dietary supplements and alcohol, is the leading cause of acute liver failure. This is a huge concern for consumers and a tremendous financial drain on pharmaceutical companies who are often forced to withdraw drugs from the market after spending millions in R & D. John Senior, M.D., from the FDA Office of Drug Safety will address the reasons behind the growing problem, offer solutions for identifying potentially toxic drugs, and recommend mechanisms to spot problem trends once a drug is available to the consumer.

Detecting Counterfeit Medicines - According to the World Health Organization, more than eight percent of pharmaceuticals imported into the U.S. are counterfeit. Phony drugs can cause dangerous interactions with other drugs, or harm consumers by not delivering the medicines their body needs. Laws passed allowing the importation of prescription medicines from other countries have opened the floodgates to counterfeits and created a rapidly growing problem in the U.S. A new study being presented at the AAPS meeting, made possible by a corroboration of scientists from the London Medicines Control Agency and University of London, will disclose new near-infrared methods that detect counterfeits without damaging the integrity of the medication.

New Vaccination Hope for Fish Farms - With the demand for fish outpacing nature's capacity to put it on the table, fish farms have become a necessity. Currently, almost one quarter of seafood consumed globally is "raised" rather than caught. The U.S. alone sustains a $50 billion seafood industry. Unfortunately, raising large populations of fish in tight quarters can allow for the fast spread of viral infections, forcing the destruction of thousands of valuable fish within days of outbreaks and creating huge financial loses for farmers. Current vaccination methods are antiquated and labor intensive. A new oral vaccine and antibiotic treatment that uses coated fish pellets is an excellent alternative to the current method whereby each fish is injected, by hand, with a vaccine or immersed in treated solutions.
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About AAPS PharmSciSM

All abstracts presented at the AAPS Annual Meeting are published in a supplement to AAPS PharmSci (www.pharmsci.org), the organization's peer-reviewed, online journal. AAPS PharmSci offers a forum for the rapid exchange and dissemination of scientific knowledge in the pharmaceutical sciences.

About AAPS

AAPS is a professional, scientific society of more than 11,000 members employed in academia, industry, government and other research institutes worldwide. Founded in 1986, AAPS aims to advance science through the open exchange of scientific knowledge, serve as an information resource, and contribute to human health through pharmaceutical research and development. For more information about AAPS, visit AAPS Pharmaceutica at . www.aapspharmaceutica.com

American Association of Pharmaceutical Scientists

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