Foundation Medicine Wins FDA Approval for Breakthrough Cancer Test

Posted by ISPE Boston
On December 5, 2017

The FDA has approved the FoundationOne CDx (or F1CDx), a breakthrough cancer diagnostic test developed by Cambridge-based biotech Foundation Medicine. F1CDx detects gene mutations that may be found in any solid tumor. This information can be used by physicians to manage cancer patients. Moreover, it can be used as a companion diagnostic to identify patients […]

Chapter Members Learn “How to Deal with Difficult People”

Posted by Jimmy Hughes
On November 30, 2017

In contrast to the typical technically-focused educational events, the Boston Area Chapter’s November educational program – “How to Deal with Difficult People” presented by Amber Galou, Stephanie Fedak, and Bruce Sohmer – was a chance for attendees to shift their focus to “soft skills” that effect every aspect of life in the workplace. The speakers […]

Call for Presentations: Product Show 2018

Posted by ISPE Boston
On November 28, 2017

The ISPE Boston Area Chapter will hold its 27th Annual Product Show on September 26, 2018 at Gillette Stadium in Foxborough, MA. This notice is a call for presentations for a limited number of speaking opportunities. Our charter is to deliver valuable educational programs to our members and their guests, based on specific topics of interest […]

Stainless Steel and Single Use – More Similar than You Think…

Posted by Howard Sneider
On November 27, 2017

Over the past 20 years, the benefits and detriments of single use technologies for the manufacturing of biologics have been stated by proponents and detractors throughout the industry. Some issues are well defined (capital investment) while other topics lack clarity. This post will address a couple of often misunderstood facets of stainless steel and single […]

Fermentation Powers Biopharma…and Breweries

Posted by Brian Kennedy
On November 21, 2017

The fermentation process used in beer brewing is similar to the process used in the biopharmaceutical industry to produce therapeutic molecules. To see fermentation up close and personal, make sure you register for the November 30th brewery tour and networking social at Lord Hobo Brewery in Woburn. In a few words, fermentation is the process […]

Learning from the Experts at ISPE Annual Meeting

Posted by Jack Campion
On November 16, 2017

This year’s ISPE Annual Meeting in San Diego featured some exciting “Wow-they-really-did-that!” educational sessions, inspiring keynote speeches, and awards for the best and brightest, as well as meetings to advance the Society’s governance. Not to mention a healthy dose of great fun! About 85 Boston Area Chapter members traveled west for the four-day meeting in […]

Young Professionals Meet Up at Product Show

Posted by Ben Crewdson
On November 16, 2017

The Chapter’s Young Professionals Networking Hour at this year’s Product Show was a hit! After a day filled with educational presentations and visiting vendor booths, the event was a relaxing way to connect with other young professionals, recent grads and students. Over 50 people with various backgrounds attended, from young professionals working in Boston to […]

MLSC and Takeda Partner to Advance Women Entrepreneurs in Life Sciences

Posted by ISPE Boston
On November 14, 2017

The Massachusetts Life Sciences Center (MLSC) has announced the launch of the Massachusetts Next Generation Initiative (MassNextGen), a new competitive program for women entrepreneurs in early stage life sciences companies. MassNextGen will begin as a five year, $1 million commitment focused on advancing diversity and providing support for the next generation of life science entrepreneurs. […]

FDA Approves AstraZeneca Drug for Mantle Cell Lymphoma

Posted by ISPE Boston
On November 9, 2017

The FDA has granted accelerated approval to AstraZeneca’s Calquence (acalabrutinib) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy. “Mantle cell lymphoma is a particularly aggressive cancer,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology […]

Posted by ISPE Boston
On November 9, 2017

The FDA has announced it will recognize eight European drug regulatory authorities as capable of conducting inspections of manufacturing facilities that meet FDA requirements. The eight regulatory authorities are those located in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom. This achievement marks an important milestone in the implementation of a Mutual […]

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