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Meeting Topic: "Manufacturing Hurdles on the Road to Market"

Speaker:
Betty Holland is Director of Regulatory Affairs at Tanox, Inc., a position she has held the past 5 years. Before joining Tanox, Betty was with Hoffmann-La Roche Inc. in Nutley, New Jersey for more than 20 years, where she was involved in regulatory affairs, project management, scientific writing and chemical research. She obtained her Bachelors Degree in chemistry from Iowa State University and her Master's in Organic Chemistry from Purdue University.

She has 15 years of regulatory experience, in both drugs and biologics and both clinical and manufacturing aspects. She has negotiated labeling for several marketed products and been involved in risk management discussions with the Agency.

These interactions have been with multiple groups within FDA: the Divisions of Dermatologic and Ophthalmologic Drug Products; Neuropharmacologic Drug Products; Antiviral Drug Products; Special Pathogen and Immunologic Drug Products; Anesthetic, Critical Care Drug and Addiction Drug Products; and Metabolic and Endocrine Drug Products in CDER, along with the Division of Review Management and Policy and Division of Therapeutic Biological Internal Medicine Products in the previous ODE VI of CDER, formerly the Office of Clinical Trial Design and Analysis and the Office of Therapeutic Research and Review of CBER. Betty is one of the original members of the Regulatory Affairs Roundtable Steering Committee of BioHouston.

Company:
Founded in 1986, Tanox's focus has been on the discovery and development of innovative biotherapeutics. The company's products are genetically engineered antibodies that target specific molecules or antigens in the body for the treatment of immune-mediated diseases, infectious disease, inflammation and cancer.

Tanox's first marketed product, Xolair® (omalizumab), was approved by the U.S. Food and Drug Administration in 2003 and is currently marketed for the treatment of adults and adolescents (12 years of age and above) with moderate-to-severe allergic asthma. Xolair was developed in collaboration with Genetech, Inc. and Novartis Pharma AG and was the first anti-immunoglobulin (anti-IgE) antibody to be brought to market. Tanox currently has several therapies in its product-development pipeline, the most advanced being TNX-355, a humanized, anti-CD4 monoclonal antibody to treat HIV and AIDS. Tanox completed its $244 million initial public offering in 2000, which was the largest biotechnology IPO in history at that time. Tanox's corporate headquarters are located in Houston, Texas, while its primary manufacturing facility is in San Diego, California.

Date/Time:
Tuesday, November 1, 2005
7:00 am - 8:30 am

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

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

Reminder: Time to check your membership expiration date listed in your online account profile. An active membership provides premium discounts on meeting fees.

Reservations:
Registration Closed

Note: Online reservation requires all members AND non-members to setup an account on the BMTC web site.

Payments by cash or check prior to the event are to be mailed to:
BMTC
P.O. Box 66488
Houston, TX 77266-6488

No-show reservations will be billed.

Day of Event Registration:
On site registrations are welcome the day of the event. Payment on site is by
cash or check only. Correct change is appreciated.

Thank you and we look forward to seeing you at this event.

Bio/Medical Technology Club of Houston
www.bmtchouston.org

 

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