Author Archives: ISPE Boston

Foundation Medicine Wins FDA Approval for Breakthrough Cancer Test

By | 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… 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 »

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 »

Welcome New Members!

By | November 7, 2017

We would like to introduce the members who joined ISPE in October 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… Read More »

Chapter Member Anniversaries: October 2017

By | November 7, 2017

Please congratulate the following members celebrating milestone anniversaries in October 2017.  Their dedication to ISPE, the Boston Area Chapter and the industry is applauded! Over Twenty Years Thomas W. Moss, President, Applied Process Solutions, Inc. Peter M. Solazzo, Senior Director Project Development, Turnkey Modular Systems Inc Stephen R. Higham, PE, Sr. Mgr. Facilities Engineering, Sanofi… Read More »

Critical Utilities De-coded

By | November 2, 2017

The following information has been provided by Chapter Young Professionals Committee members Christopher Ciampa and Kevin Keating: Attendees learned the basics of two systems critical to life sciences at Northeastern University on October 19, thanks to the ISPE Boston Area Chapter Young Professionals. The program was designed to ensure that process engineers and other industry… Read More »

How to Deal with Difficult People – The Crucial Conversation

By | October 30, 2017

The following post was co-authored by Stephanie Fedak and Amber Galou, both of whom will be presenting at the Chapter’s upcoming educational program on November 8. It’s inevitable. We all have to deal with difficult people from time to time. And sometimes that difficult person is in a position of influence – you need that… Read More »