
NEWSLETTER			November 2009, Volume XIX, No. 6

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In This Issue

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President's Message: Chapter Wins Top Award at ISPE Annual Meeting

Yes, Boston. We did it! The Boston Area Chapter was awarded the 2009 "Platinum Grand Award for Excellence and Innovation" at the ISPE Annual Meeting in San Diego. Thanks to the many Chapter volunteers who worked to make this happen.

Upcoming Chapter Events - Mark Your Calendar

It's too late to sign up for the sold-out tour of the Devens Bristol-Myers Squibb facility but not too late for the other upcoming fall & winter events. Educational programs, networking events & more - take your pick.

18th Annual Product Show Attracts Record Turnout

The Boston Area Chapter pulled off another outstanding success and once again enjoyed a record turnout (over 1800 attendees) at the 18th Annual Product Show at Gillette Stadium.

Keynote Speaker Juan Enriquez Provides a Fascinating Look into the Future

World-class speaker Juan Enriquez described the New England life sciences community - and the Boston area in particular - as a powerful engine of innovation in a unique position to help the US survive its financial crisis.

CEO Dinner Series Opens with Lantheus Medical Imaging Execs

Over a hundred Chapter Members and guests turned out for a networking reception, sit-down dinner and riveting presentations by Lantheus execs in a first-of-its-kind event for the Chapter.

Process Control and Automation Expert Discusses PAT and QBD

Chapter Members and guests spent an evening in September learning the fine points of PAT and QBD, and the need for a paradigm shift from "what has always worked" to the "business drivers" when designing (or redesigning) a production process.

Young Professionals Launch Series of Events

The Boston Area Chapter Young Professionals (YP) have sponsored several recent events, including a September Boston harbor cruise and three of the nine educational seminars at the October Product Show. Learn more about this dynamic group geared to the needs of those new in their careers or new to the pharma, biotech and life sciences industries.

Tech Talk - Leadership in Biotechnology: Is Anyone Following You?

Based on a panel discussion presented at the October Product Show, this article explores the five main aspects of leadership and highlights the individual experiences and insights shared by the panelists during the live session. An extensive reference list is included.

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.

What is the Impact of Sepracor-DSP Deal? - Read the full story . . .
UMass Med To Break Ground on New Facility - Read the full story . . .
Genzyme Continues Its MetroWest Expansion - Read the full story . . .
AstraZeneca to Cut 113 Jobs in Massachusetts - Read the full story . . .
Genzyme Expects Shortages of Two Drugs to End by 2010 - Read the full story . . .
Two Biotechs Moving Operations to Boston - Read the full story . . .
Eli Lilly to Cut 5,500 Jobs by 2011 - Read the full story . . .
Epizyme Gets $32M for Gene Regulation Research - Read the full story . . .
Paratek and Novartis Strike Licensing Deal - 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.

Accelerated Approval of Hiberix to Help Sustain Adequate Vaccine Supply - Read the full story . . .
FDA Proposes Mandatory Electronic Postmarket Safety Reporting - Read the full story . . .
FDA Conducting Safety Review of Weight Loss Drug Orlistat - Read the full story . . .
FDA Authorizes Emergency Use of H1N1 Test for US Troops Serving Overseas - Read the full story . . .
FDA Study Indicates Most Industry Postmarketing Studies Meet Timelines - Read the full story . . .
FDA Clears a Test for Ovarian Cancer - Read the full story . . .
FDA Approves Vaccines for 2009 H1N1 Influenza Virus - Read the full story . . .
FDA Approves Blood Donor Screening Test for Antibodies to HIV - Read the full story . . .
FDA Awards Grants to Stimulate Development of Pediatric Medical Devices - Read the full story . . .
Institute of Medicine to Study Premarket Clearance Process for Medical Devices - Read the full story . . .
FDA Approves First Drug for Treatment of Peripheral T-cell Lymphoma - Read the full story . . .
FDA Approves New Drug to Treat Psoriasis - Read the full story . . .
FDA Transparency Task Force to Hold Second Public Meeting - Read the full story . . .
Wyeth Sues FDA to Block Generic Rival of Antibiotic Zosyn - Read the full story . . .
FDA Panel Backs Glaxo Cancer Vaccine Cervarix & Merck's Gardasil - Read the full story . . .
FDA Approves New Hologic Therapy - Read the full story . . .
Shire Submits Gaucher Drug to FDA - Read the full story . . .
FDA Seeks New Trial of Genzyme Leukemia 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