
NEWSLETTER			September 2009, Volume XIX, No. 5

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In This Issue

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President's Message: Back to School!

Meet incoming Chapter President Sylvia Beaulieu and find out what the upcoming year holds for Chapter members...

Upcoming Chapter Events - Mark Your Calendar

Save October 7th for the Annual Product Show at Gillette Stadium and fill your fall calendar with an exciting array of upcoming Chapter activities.

Join the Excitement: Visit Product Show XVIII at Gillette Stadium on October 7th

This year the Chapter has planned the biggest and best Product Show ever, loaded with educational content, new products & vendors, an exciting keynote speaker, unlimited networking opportunities and much, much more.

Keynote Speaker & Global Thinker Juan Enriquez Takes a Look into the Future

World-class speaker Juan Enriquez describes how genomics & other forces will change our lives in the future - but get there early, space is limited.

Triple-track Educational Program Offers Something for Everyone

Can't get enough education? Then the Product Show could be just what you need to satisfy your craving for information whether you're new to the biopharm industry or an experienced professional.

Attend GAMP Forum for a Comprehensive Look at Good Automated Manufacturing Practices

This special pre-Show event takes place from 8am to 12:30pm and includes lunch & afternoon breakout sessions. Pre-registration for this event is mandatory. Visit www.ISPEBoston.org/Events register online.

Product Show Schedule of Events

Don't miss out! Consult the Schedule of Events to plan your visit to Gillette Stadium on October 7th, then register online at http://www.ispeboston.org/events/registration.htm?eventID=18.

Fun in the Sun at the Boston Area Chapter’s 7th Annual Golf Outing

Find out who the lucky winners were at this year's Golf Outing...

Golf Tournament Photo Gallery

Recent Chapter Activities: Golf Tournament Photo Gallery

Tech Talk: An Introduction to Single-Use Technology: Flexible Technology That Gives the User Choices

The need for operating plants to be flexible, minimize costs and risk, while keeping ahead of the ever-ticking clock has created opportunities for single-use products. This article introduces the basic components found in single-use equipment or systems.

Industry News In Brief

Industry News In Brief, a regular feature of the Boston Area Chapter Newsletter, presents news items concerning companies in the pharma, biotech, medical device and related fields, with an emphasis on companies with a local presence and topics of special interest to our readers.

GE Healthcare and Geron Enter Stem Cell Alliance - Read the full story . . .
Glaxo Hopes to Supply Flu Vaccine by Early 2010 - Read the full story . . .
Sanofi Plans to Overhaul Research and Development - Read the full story . . .
Sanofi Agrees to Take Control of India's Shantha - Read the full story . . .
Bristol-Myers Squibb to Acquire Medarex - Read the full story . . .
GTC Agreement Takes Aim At MS - Read the full story . . .
Genzyme Sues Sandoz over Dialysis Drug Patent - Read the full story . . .
Biopure Files Chapter 11, Plans Sale - Read the full story . . .
Early Rollout of Shire's Drug for Gaucher Disease Okayed by FDA - Read the full story . . .
New England Biotechnology Firms get Venture Capital Boost - Read the full story . . .
Epix Pharmaceuticals to Shut Down - Read the full story . . .
WPI, CellThera Researchers Turn On Stem Cells - Read the full story . . .
RXi Pharmaceuticals Acquires Exclusive License to RNAi Delivery Technology - Read the full story . . .

Regulatory & Legislative Highlights

Regulatory & Legislative Highlights, a regular feature of the Boston Area Chapter Newsletter. It reviews recent actions by the FDA and other regulatory agencies and governmental bodies, both federal and regional, with the potential to impact the pharma, biotech and device industries, and related fields.

FDA to Require Boxed Warning for Chantix (Pfizer) and Zyban (GlaxoSmithKline) - Read the full story . . .
FDA Approves Sanofi-Aventis Drug Multaq to Treat Heart Rhythm Disorder - Read the full story . . .
FDA Approves First Maintenance Drug Therapy for Advanced Lung Cancer - Read the full story . . .
FDA Approves Eli Lilly's Effient to Reduce the Risk of Heart Attack in Angioplasty Patients - Read the full story . . .
FDA Reviewing Preliminary Safety Information on Genentech's Xolair - Read the full story . . .
FDA Approves Vaccine for 2009-10 Seasonal Influenza - Read the full story . . .
FDA Authorizes Emergency Use of Another Test for H1N1 Influenza Virus - Read the full story . . .
FDA Approves Colchicine for Acute Gout and Mediterranean Fever - Read the full story . . .
FDA Approves New Drug Treatment for Type 2 Diabetes - Read the full story . . .
FDA and EMEA Launch Good Clinical Practices Initiative - Read the full story . . .
FDA Requires Cancer Warnings Required for TNF Blockers - Read the full story . . .
FDA Commissioner Outlines Vision on Enforcement to Support Public Health - Read the full story . . .
FDA Issues Final Rules to Help Patients Gain Access to Investigational Drugs - Read the full story . . .
FDA Approves Schering-Plough's Saphris for Schizophrenia and Bipolar Disorder - Read the full story . . .
European Commission Approves Genzyme's Mozobil - Read the full story . . .
FDA Moves to Speed Access to Gaucher Drugs in Wake of Genzyme's Plant Shutdown - Read the full story . . .
FDA Accepts Shire's Treatment Protocol for Gaucher Disease Drug - Read the full story . . .

New Members

The Boston Area Chapter continues to grow at a record rate. For a full list of new members...

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Chapter Manager: Amy Poole, CAMI - Tel: 1.781.647.4773 and E-mail: ispe@camihq.com