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In This Issue

Winter is finally nearing its end! With the arrival of spring comes a whole host of Chapter activities - some old standbys and a few brand new ones - so shake off the winter doldrums and join in!

The spring months are jam-packed with a variety of Chapter activities - educational programs, social events ("Improv Magic," anyone?), networking & more. There's plenty to interest every Member, so be sure to plan ahead for the events you don't want to miss.

The Holiday Social was held at Flat Top Johnny's on January 14th and attracted our biggest and most enthusiastic turnout ever - and we have the photos to prove it!

In addition to the wealth of practical information presented, attendees benefited from a chance to network with members of an allied organization.

Many area biotech engineers attended this program, drawn by a topic central to the development and manufacture of pharmaceutical drug substances - and many lingered long after the formal program to continue networking.

Find out more about the Young Professionals, a new organization within ISPE formed to foster the ideas and professional needs of individuals new to their careers and/or the biotech and pharma industries.

With a focus on those new to biotech and pharma, this program provided an opportunity to brush up on Process Analytical Technology (PAT) and bioreactor basics.

Paige describes her transition from animal sciences major to Director of Knowledge Management for Pfizer Global Manufacturing - with a little help from ISPE along the way.

The ISPE Boston Area Chapter is a proud sponsor of BioBall - a one-day basketball tournament and Special Olympics fundraiser. Chapter Members can join the excitement by volunteering at the event.

Want to earn the coveted CPIP credential? Beginning this spring, the Chapter will help by hosting weekly meetings with free educational materials, expert input and a friendly group learning environment.

The international ISPE organization is seeking subject matter expert (SME) volunteers to provide assistance in two areas.

Improvements in hygienic design and cleanability of process piping systems are considered essential for the production of bioengineered pharmaceutical products. Barbara Henon, PhD, of Arc Machines, sheds light on the changes in this area that have taken place over the last twenty years, including development of the ASME Bioprocessing Equipment (BPE) Standard.

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.

• RXi Pharmaceuticals and UMass Medical Announce Research CollaborationRXi Pharmaceuticals and UMass Medical Announce Research Collaboration - Read the full story . . .
• Charles River To Close Shrewsbury Lab - Read the full story . . .
• Acton Pharmaceuticals Hopes to Hire 100 in 2010 - Read the full story . . .
• Genzyme Expands Framingham Campus - Read the full story . . .
• Caliper Life Sciences Makes Time Magazine's Top Discoveries List - Read the full story . . .
• Life Sciences Investment Outpaces Other Industries - Read the full story . . .
• Glaxo to Stop Research on New Antidepressants as It Shifts Focus - Read the full story . . .
• Pfizer Plans to Cut R&D by Up to $3 Billion - Read the full story . . .
• Novartis Puts Bet on Heart Treatment in Deal Worth Up to $620M - Read the full story . . .
• AstraZeneca to Acquire Novexel - Read the full story . . .
• Biogen Idec Has To Look Beyond Facet - Read the full story . . .
• FDA Rejects J&J Antibiotic Developed with Swiss Partner - Read the full story . . .
• Novartis to Gain Full Ownership of Global Leader in Eye Care - Read the full story . . .
• Genzyme Shifting Work from Allston Plant; Jobs Unaffected - Read the full story . . .
• Vertex Cystic Fibrosis Drug Meets Goals - Read the full story . . .
• $3 Million for Life Sciences Grants Approved by Massachusetts Life Sciences Center - Read the full story . . .

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 Present Workshops on Applying for Orphan Drug Designation - Read the full story . . .
• FDA to Study Safety of Medications Taken During Pregnancy - Read the full story . . .
• FDA Contracts with Harvard Pilgrim to Develop Pilot for Safety Monitoring - Read the full story . . .
• FDA Approves New Genentech Drug for Rheumatoid Arthritis - Read the full story . . .
• FDA Unveils First Phase of Transparency Initiative - Read the full story . . .
• FDA Approves Ampyra to Improve Walking in Adults with Multiple Sclerosis - Read the full story . . .
• FDA Panel Rejects Early Use of Tarceva - Read the full story . . .
• First Percutaneous Heart Valve Wins FDA Approval - Read the full story . . .
• FDA Approves New Treatment for Type 2 Diabetes - Read the full story . . .
• FDA Approves Morphine Sulfate Oral Solution as Part of Unapproved Drugs Initiative - Read the full story . . .
• FDA Expands Use of Approved Breast Cancer Drug - Read the full story . . .
• FDA Collaboration Seeks to Speed Development of Pneumococcal Vaccines for Children in Developing Countries - Read the full story . . .
• FDA Announces Safety Risk Associated with Bristol-Myers Squibb HIV Drug - Read the full story . . .
• FDA Approves Xiaflex for Debilitating Hand Condition - Read the full story . . .
• FDA Issues Guidance to Help Streamline Medical Device Clinical Trials - Read the full story . . .
• FDA Approves New Indication for AstraZeneca's Crestor - Read the full story . . .

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