Monthly Archives: November 2017

Chapter Members Learn “How to Deal with Difficult People”

By | 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… Read More »

Call for Presentations: Product Show 2018

By | 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… Read More »

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

By | 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… Read More »

Fermentation Powers Biopharma…and Breweries

By | 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… Read More »

Learning from the Experts at ISPE Annual Meeting

By | 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… Read More »

Young Professionals Meet Up at Product Show

By | 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… Read More »

MLSC and Takeda Partner to Advance Women Entrepreneurs in Life Sciences

By | 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.… Read More »

FDA Approves AstraZeneca Drug for Mantle Cell Lymphoma

By | 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… Read More »

European Regulators to Begin Conducting FDA Inspections

By | 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… Read More »

CRISPR Engineered to Edit RNA in Human Cells

By | November 7, 2017

The Broad Institute and MIT scientists who first harnessed CRISPR for mammalian genome editing have engineered a new molecular system for efficiently editing RNA in human cells. RNA editing, which can alter gene products without making changes to the genome, has profound potential as a tool for both research and disease treatment. In a paper… Read More »