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Speaker: Peter J. Ryan, Ph.D., P.E., Engineering Consultant
Company: Bayer Corporate and Busineiss Services, Technical Services Americas

Date/Time:
Tuesday, April 5, 2005
7:00 am - 8:30 am

Location:
Crowne Plaza
6701 South Main St.
Houston, Texas 77030
713.797.1110
Map and Driving Information

Title:
Improving Data Analysis in Research and Development for New Drug
Development

Abstract:
The 2003 Tufts CSDD study on drug development estimates that the fully capitalized cost to develop a new drug is $897 million. The 2003 estimate includes post regulatory approval studies to assess long-term safety and efficacy of the drug in a broader patient population or specific patient subgroups. A significant portion of the drug development costs involves initial screening of the new chemical entity (NCE) and the clinical trials of the investigational new drug (IND). Design of experiment (DOE) analysis, coupled with datamining technologies, Pharmacokinetic (PK) and Pharmacodynamic (PD) simulation results, can significantly improve the analysis of the experimental results of these phases of drug development.

The optimized experimental analysis can be used to better design follow-on screening experiments and clinical trials. The optimized screening and clinical trials results translates immediately to shorter drug development phases and eventually to improved process validation once the drug is commercialized. The major advantage to the drug developer is a faster time-to-market for the therapeutic. The total return for a shortened drug development phase and an enhanced process validation effort can be very significant, arguing for a better "front-end package" in drug development. The tools, methodology and consultant services offered by BTS to the pharmaceutical and biotech communities will be discussed.

Speaker Bio:
Dr. Peter J. Ryan received his BS in Chemistry in 1983 from the University of Massachusetts at Lowell and a Ph.D. in Chemical Engineering in 1989 from the University of Massachusetts at Amherst. Dr. Ryan is a registered Professional Engineer for the state of Texas. He started working for Bayer immediately after
graduating from UMass in 1989, starting in project engineering and then process technology with the Bayer Technology Services' (BTS). The focus in BTS is process optimization using a Six Sigma approach to minimize the variance and enhance the controlability of a (batch or continuous) process. The BTS process technology group has developed a methodology and a tool set to extract useful information form historical data to achieve the targeted optimization goals.

Pricing: Includes Hospitality and Parking
$15 - Members with online reservations
$20 - Members with no reservations or non-members with online reservations
$25 - Non-members with no reservations

Reservations:

Reservations:
Registration Closed

RSVP by Wednesday, March 30, 2005
No-show reservations will be billed.
Cash or check payments due on or before day of event.

PHONE RESERVATIONS
713-982-3333
Phone reservations require cash or check payment on or before day of event.
Payments by cash or check prior to the event are to be mailed to BMTC, P.O. Box
66488, Houston, TX 77266.

Reservations due by: 03/30/2005 5:00 PM

No-show reservations will be billed.

Note: Online registration requires all members AND non-members to setup
an account on the BMTC web site. To setup your account, please visit:

http://www.bmtchouston.org/members/setup.asp

DAY OF EVENT REGISTRATION
On site registrations are welcome the day of the event. Payment on site is by
cash or check only.

 

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