President’s Message: Looking Forward to the Coming Year in ISPE…

Posted by Jack Campion
On January 4, 2018

We have much to celebrate and look forward to in 2018. First, our industry continues to boom, especially in the Boston area. We’re now strongly established as the top biopharma region of the country, having eclipsed the Bay Area some time ago. We all know the reasons – top educational, research and medical institutions, a thriving […]

Join the ISPE Women in Pharma Initiative in 2018!

Posted by ISPE Boston
On January 3, 2018

Do you have a penchant for event planning? Are you interested in meeting your fellow women in the ISPE chapter? Then please join our team in bringing Women in Pharma to the ISPE Boston Area Chapter! We are looking for volunteers to plan this inaugural event to help fellow women ISPE members meet each other and to […]

Back to the Future of Biotech Automation

Posted by rpierro
On January 3, 2018

What’s currently happening in automation and where are we going? Will batching be gone forever in favor of single-use components in a continuous process? Will we be wearing Google glasses and following instructions from some brainy robot with our heads in the electronic cloud? The biotech industry has benefited enormously over the past 30 years […]

FDA and Spark Therapeutics Make History with Gene Therapy Approval

Posted by Janet Tice
On December 21, 2017

The FDA has approved Luxturna, an innovative one-time gene therapy treatment from Spark Therapeutics used to improve vision in patients with vision loss due to inherited retinal diseases (IRD). As the first adeno-associated viral (AAV) vector product approved for clinical use in the United States, Luxturna represents a historic landmark, not only in the field […]

End of the Year, Grab a Beer!

Posted by Kevin Keating
On December 15, 2017

For the Young Professionals’ final social event of 2017, we met up at the Lord Hobo Brewing Company taproom and brewery in Woburn. The YP’s sampled some of the brews on tap (including Lord Hobo’s flagship IPA, Boomsauce) and took a tour of the brewing and canning facility. Those who read our previous blog post […]

Single-Use vs. Stainless: Experts Weigh In…

Posted by ISPE Boston
On December 15, 2017

By Bill Garvey and Howard Sneider: Single-use technology has exploded onto the scene in the last two decades to offer a practical alternative to costly stainless steel process systems. But will single-use systems render a mature and reliable technology eventually obsolete? This outcome is unlikely as a large group of ISPE members and other industry […]

Biosimilar to Genentech’s Herceptin Wins FDA Approval

Posted by Janet Tice
On December 14, 2017

The FDA has approved Ogivri as a biosimilar to Herceptin for the treatment of patients with breast or metastatic stomach cancer whose tumors overexpress the HER2 gene. Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the U.S. for the […]

FDA Approves First Short-Acting “Follow-On” Insulin Product

Posted by Janet Tice
On December 14, 2017

The FDA has granted approval to Sanofi-Aventis U.S. for Admelog, a short-acting insulin product. Admelog is the first short-acting insulin approved as a “follow-on” product and was submitted through the agency’s 505(b)(2) abbreviated approval pathway. A new drug application submitted through this pathway may rely on the FDA’s finding that a previously approved drug is […]

Chapter Member Anniversaries: November 2017

Posted by ISPE Boston
On December 6, 2017

Please congratulate the following members celebrating milestone anniversaries in November 2017. Their dedication to ISPE, the Boston Area Chapter and the industry is applauded! Over Twenty Years Charles H. Brown, II, MS James R. Dube, Associate Director, Technology Transfer, Global Technical Services, Alexion Pharmaceuticals Thomas G. Larkin, Jr., Sr Project Engineering Manager, Amgen Inc Pasquale […]

Welcome New Members!

Posted by ISPE Boston
On December 6, 2017

We would like to introduce the members who joined ISPE in November 2017, welcome them to the Chapter and encourage them (and all of our members) to take advantage of the many professional development, networking and information resources available through ISPE. Fellow ISPE members are a terrific resource for help with everyday professional challenges. And […]

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