Released on: June 18, 2008, 10:47 am

Press Release Author: GTC Bio

Industry: Biotech

Press Release Summary: Dr. Brahm Goldstein, Director of Clinical Research -
Biopharmaceuticals at Novo Nordisk will be speaking at GTCbio's Global Clinical
Trial Operations conference on September 25-26, 2008 in San Diego, CA. Dr. Goldstein
will present a rational approach towards global pediatric drug development in the
pharmaceutical industry.

Press Release Body: Both the FDA and EMEA have passed regulations intended to ensure
that healthcare professionals can make treatment decisions for pediatric patients
using medicines that have been properly evaluated. Logically this requires that
product development programs should include pediatric studies when pediatric use
could be anticipated based on the product's mechanism and properties. While these
new regulations are not intended to delay adult studies nor granting marketing
authorizations for adult use, each pharmaceutical company filing a new marketing
authorization application nonetheless now needs to develop a strategy for a complete
and balanced scientific, medical, regulatory, business, and ethical evaluation of
new drugs and biopharmaceuticals including data for all pediatric age groups. The
scope of these regulations also affects already approved products. Based on
compliance with these regulations, the final responsibility to improve children's
health will be shared by pharmaceutical companies, regulatory authorities, health
professionals, and society as a whole. Dr. Goldstein will provide a brief overview
of FDA and EMEA pediatric regulations and presents a rationale for a sequential
multi-disciplinary approach to pediatric drug development. He will discuss three
main points including the establishment of a global, multi-disciplinary team
approach for pediatric drug development, continuous review of pediatric drug
development throughout the lifetime of a drug and across all drugs to ensure within
project continuity and cross-project synergies and joint development of the
pediatric investigational plan (PIP) for EMEA and the pediatric assessment (PA) for
the FDA.

The Global Clinical Trial Operations conference brings together leaders, directors,
vice presidents, heads, managers, supervisors, and CROs from all over the world to
collaborate and discuss the latest developments in clinical trial operations and
logistics and covers clinical trials in emerging markets, first-in-man clinical
trials, pediatric clinical trials, material storage, distribution, site selection,
patient recruitment and retention, technology in clinical trials and case studies of
running global clinical trials.

For more information including a detailed agenda, exhibitor opportunities and
registration information visit http://gtcbio.com/conferenceDetails.aspx?id=127.

ABOUT GTCbio

GTCbio organizes conferences specifically for the biomedical and biopharmaceutical
industries. Our goal is to facilitate the exchange of biopharmaceutical and
biomedical intelligence between industry leaders, academic and government
organizations, and the financial community.
GTCbio is a subsidiary of Global Technology Community, LLC, a privately held company
founded in 2002.


Web Site: http://gtcbio.com/conferenceDetails.aspx?id=127

Contact Details: 434 W. Foothill Blvd.
Monrovia, CA 91016
Tel: (626) 256-6405
fax: (626) 256-6460
email: nina.tran@gtcbio.com