
NEWSLETTER			February 2008, Volume XVIII, No. 1

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In This Issue

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President's Message: When Cancer Hits Home

Chapter President Rick Pierro shares his story about his mother's life threatening diagnoses with non-Hodgkin's lymphoma and her treatment with a drug manufactured by a local biotech.

Upcoming Chapter Events - Mark Your Calendar

Plan your attendance at the many exciting Chapter events - educational seminars, plant tours and more - that fill the next several months.

Project Management: “The Tail Wags the Dog?

The November educational program explored different aspects of project management, including the creation, care and feeding of project teams and the development of a global project management standard for a multinational corporation.

Another Successful Holiday Party at Flat Top Johnny’s

Although rescheduled to January due to an ill-timed snowstorm, the annual holiday party still drew a crowd with its festive combination of food, drink and camaraderie.

Its All in the DOCS: Planning CTD/eCTD CMC Submissions

In January, the Chapter devoted its educational program to the topic of regulatory documentation with an overview of the current worldwide standard for submission of Investigational New Drug Applications (INDs) and New Drug Applications (NDAs).

The Challenges in Integrating a Process Control System with Skid-based Equipment: A Case Study

Most projects involve the same questions and challenges regarding the integration of the Process Control System (PCS) with skid-based equipment. This case study contrasts two different approaches to PCS integration.

Optimizing Your Steaming Operation: A Steam-In-Place Primer

The author identifies the main Steam-In-Place (SIP) components, describes how component selection can shift costs between capital and operating budgets and explains the ROI calculation for an automated vs. manual steaming operation.

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.

Biogen Idec Opens Incubator - Read the full story . . .
Vertex Pharmaceuticals Plans Deal with Harvard to Fund Research Projects - Read the full story . . .
Bristol-Myers Squibb Agrees to Sell Billerica Unit - Read the full story . . .
Lacking Definitive Offers, Biogen Idec No Longer for Sale - Read the full story . . .
Millennium's Cancer Drug May Prove to be a Blockbuster - Read the full story . . .
Japan's Eisai to Buy MGI Pharma for $3.9 Billion - Read the full story . . .
Sirtris Describes Three New Antiaging Drugs - Read the full story . . .
Pfizer to Buy Coley for $164 Million - Read the full story . . .

Regulatory & Legislative Highlights

Regulatory & Legislative Highlights, is 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 Approves First-of-its-Kind Drug for Treatment of Phenylketonuria (PKU) - Read the full story . . .
FDA Launches E-mail Alert Subscription Service via Public Web Site - Read the full story . . .
FDA Approves Nexavar for Patients with Inoperable Liver Cancer - Read the full story . . .
FDA Announces Steps to Improve Advisory Committee Processes - Read the full story . . .
FDA Adds Boxed Warning for Heart-related Risks to Anti-Diabetes Drug Avandia - Read the full story . . .
FDA Strengthens Warning Labeling for Erythropoiesis-Stimulating Agents (ESAs) - Read the full story . . .
FDA Requests Marketing Suspension of Bayer's Trasylol - Read the full story . . .
FDA Approves Novartis' Tasigna for Treatment of Chronic Myeloid Leukemia - Read the full story . . .
FDA Approves New Uses for Eli Lilly's Evista - Read the full story . . .
Court Ruling May Stall Opening of Boston University Biolab - Read the full story . . .
FDA Panel Votes Against Use of Genentech's Avastin to Treat Breast Cancer - Read the full story . . .
AstraZeneca's Nexium Clears FDA Hurdle - Read the full story . . .
FDA Rejects Merck's Bid for Over-Counter Sale of Mevacor - Read the full story . . .
FDA Rejects Momenta Pharmaceuticals' Generic Version of Lovenox - Read the full story . . .
Abbott Stent Gets FDA Panel Backing Despite Clot Worries - Read the full story . . .
Report Criticises Lack of Expertise at FDA: Says Staff, Funds are Inadequate - Read the full story . . .
GlaxoSmithKline Cervical Cancer Vaccine Approval Delayed - Read the full story . . .
AstraZeneca's Crestor Gets New FDA Approval - Read the full story . . .

New Members

A list of new members to the Boston Area Chapter of ISPE.

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