Susquehanna Valley Section

November 2006 Meeting

The three hundred and sixty-seventh meeting of the American Chemical Society Susquehanna Valley Section will be held on Wednesday, November 8, 2006 at the Marywood University campus in Scranton, PA. A dinner will be followed by Local Section announcements and a guest presentation by Ms. Denise L. Rieker from Sanofi Pasteur, Inc. entitled "FDA Overview and Regulatory Aspects of Prescription Drug Development in the U.S."

Dinner: 6:00 PM at La Cucina Restaurant in Dunmore, PA.
Meeting and Presentation: 7:30 p.m. in Room 206 in The Center for Natural and Health Sciences on the Marywood University campus.

Dinner: Dinner selections include $12.50 + tax for Manicotti Ripieni (pasta); $12.75 + tax for Petto Di Pollo Alla Cacciatora (chicken) or $16.75 + tax for Piccata Di Vitello (veal). Meals are served with a tossed salad. The chicken and veal dinner is served with a side potato or vegetable, and side of pasta. Beverages are an additional cost. Please contact Lacey Hessling, Science Department Secretary, Marywood University for dinner reservations on or before Friday, November 3rd by phone (570-348-6265) or by e-mail at lhessling@marywood.edu.

See directions below.

FDA Overview and Regulatory Aspects of Prescription Drug Development in the U.S.

Regulatory requirements imposed by the government (in the form of food and drug law) for the approval of new prescription drugs and biologics are extensive and result in lengthy development times. This presentation will provide a brief history of FDA and its roles and responsibilities with respect to the pharmaceutical industry, as well as the pathway from research to licensure of a new drug or biologic and post marketing activities.

Ms. Rieker earned an M.S. degree in biochemistry from Lehigh University and a B.S. degree in Biology from Cedar Crest College. At Sanofi Pasteur, she is responsible for analyzing and disseminating regulatory information to keep the company current with respect to FDA regulation, guidance, and trends as they apply to the vaccine industry. Denise also represents company interests through participation in pharmaceutical trade organizations. In addition, she is responsible for regulatory oversight of advertising and promotional activities of all licensed vaccines. Prior to returning to Sanofi Pasteur in 2004, Denise spent eight years in the biologics industry working on regulatory strategies for vaccines and plasma derivatives. Before that time, she spent six years in research at Sanofi Pasteur, developing analytical assays for vaccine candidates and their serum immunological responses.

Directions:

DIRECTIONS TO LA CUCINA RESTAURANT: From U.S. Interstate 81, take exit 188 (Dunmore/Throop Rt. 347). If exiting from 81N, then turn left onto the O'Neill Hwy. If exiting from 81S, then turn right onto the O'Neill Hwy. Proceed 1.2 miles on the O'Neill Hwy, which becomes N. Blakely Street in Dunmore. At the Y-intersection, bear right. The restaurant is on the right.

DIRECTIONS TO MARYWOOD UNIVERSITY: From U.S. Interstate 81, Exit 188 (old exit 55): follow directional signs at the end of the exit ramp toward Dunmore (If you are traveling north on 81, make a left at the light at the O'Neill Highway, which becomes Blakely Street.) Follow Blakely Street to traffic light at Drinker Street. Turn right onto Drinker Street which merges with Electric Street. Proceed to second traffic light. At this intersection, turn right onto North Washington Avenue, and proceed four blocks. At third stop sign on North Washington, turn right onto Seminary Street. Proceed up the hill to the Memorial Arch. Parking areas are located near the Memorial Arch and on other designated sections of campus.