Drive Innovation – Attend the Education Programs Planning Session

Posted by Janelle Carretero
On July 12, 2018

“No matter what people tell you, words and ideas can change the world” – R.W. A few months back, I was approached by Chapter President Jack Campion – a man for whom I have great respect – and was asked to help support the ISPE Education Planning Committee (EPC) as Co-Chair alongside Bob Lucas. Having […]

Pay it Forward – Help Attract New Grads to Our Industry

Posted by Brian Hagopian
On July 9, 2018

Have you ever thought about volunteering but stop short of signing up because you’re afraid it may require more time than you’re ready to commit? Deep inside, if you’d like to give back but aren’t sure how, we have a great way for you to get involved. Please read on because we would really appreciate […]

Concurrent Multi-Product Dance Steps

Posted by Howard Sneider
On July 5, 2018

Manufacturers, especially contract manufacturing organizations, have recently faced challenges to provide numerous small inventories to achieve first-to-market penetration. As more products vie for manufacturing space, manufacturers are exploring options for providing a diverse mixture of formulations from their facilities all at once. One potential option is concurrent multi-product ballroom processing. In this processing model, manufacturers […]

Rubius Therapeutics Selects Rhode Island for Manufacturing Facility

Posted by ISPE Boston
On July 5, 2018

Rhode Island Governor Gina Raimondo has announced that biotech company Rubius Therapeutics is planning to establish a manufacturing facility in Rhode Island that will create 160 high-skilled jobs in manufacturing, biotech operations and other support functions. Rubius intends to invest up to $155 million over a more than five-year period to renovate a 135,000-square-foot manufacturing […]

Local Biotechs Akebia and Keryx to Merge

Posted by ISPE Boston
On July 5, 2018

Akebia Therapeutics and Keryx Biopharmaceuticals (based in Cambridge and Boston, respectively) have announced a definitive merger agreement under which the companies will combine in an all-stock merger. The transaction will create a fully integrated biopharmaceutical company called Akebia Therapeutics focused on chronic kidney disease (CKD), with an implied pro forma equity value of approximately $1.3 […]

Broad and Bayer Expand Partnership, Launch New Research Effort

Posted by ISPE Boston
On July 5, 2018

The Broad Institute of MIT and Harvard and Bayer are launching the Precision Cardiology Laboratory (PCL), a new endeavor that will pursue scientific insights aimed at developing new therapies for heart failure. According to the American Heart Association, more than 900,000 people are diagnosed with heart failure every year in the United States. The condition, […]

Chapter Member Anniversaries: June 2018

Posted by ISPE Boston
On July 5, 2018

Please congratulate the following members celebrating milestone anniversaries in June 2018. Their dedication to ISPE, the Boston Area Chapter and the industry is applauded! Over Twenty Years Keith A. Farnsworth, Zajac LLC Warren A. Hill Timothy J. Horgan, Alnylam Pharmaceuticals David L. Hyde, CBA, CPIP, Lantheus Medical Imaging, Inc. Richard G. Kotosky, PE, CPIP, […]

Welcome New Members!

Posted by ISPE Boston
On July 5, 2018

We would like to introduce the members who joined ISPE in June 2018, 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 […]

Case Study: Risk Mitigation of Critical Data Loss

Posted by Josh Stewart
On June 28, 2018

By Josh Stewart and Kevin Stout Introduction A commercial drug manufacturer in collaboration with a controls systems integrator recently implemented a stability monitoring enhancement project that required critical environmental data recorded by data-loggers to be stored in a 21 CFR Part 11 compliant manner. The end-user chose instrumentation with the capability to provide data buffering […]

Kaleido Biosciences Raises $101 Million to Develop Microbiome Therapies

Posted by ISPE Boston
On June 28, 2018

Bedford-based Kaleido Biosciences, a clinical-stage healthcare company developing novel chemistries to drive functions of the microbiome organ, has raised $101 million in an oversubscribed Series C financing. Kaleido plans to use the proceeds from this financing to advance its pipeline, including conducting multiple clinical studies across several therapeutic areas, and to expand its platform. “We […]

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