Alexion Restructuring, Moving Headquarters to Boston

Posted by ISPE Boston
On September 12, 2017

Alexion Pharmaceuticals has announced an operational plan to “re-align the global organization with its refocused corporate strategy.” The plan is expected to save approximately $270 million by 2019 and will reduce the Alexion’s global workforce by approximately 20 percent. The restructuring includes the closing of multiple Alexion sites, including the Alexion Rhode Island manufacturing facility. […]

Stay on Top of New Developments at the FDA

Posted by Mark Lookabaugh
On September 11, 2017

Sustained regulatory compliance is a goal that should be emphasized at all pharmaceutical firms, and for that matter at any firm regulated by FDA. From a post-market perspective, FDA’s Office of Regulatory Affairs (ORA) is the organization that is most likely to interact directly with a firm. ORA comprises the group of FDA investigators, who […]

What is Gene Therapy?

Posted by ISPE Boston
On September 7, 2017

Human gene therapy is the administration of genetic material to modify or manipulate the expression of a gene product or to alter the biological properties of living cells for therapeutic use. Gene therapy is a technique that modifies a person’s genes to treat or cure disease. Gene therapies can work by several mechanisms: Replacing a […]

Novartis CAR-T Gene Therapy Wins FDA Approval

Posted by ISPE Boston
On September 7, 2017

The FDA issued a historic action on August 30, making the first gene therapy available in the United States. With its approval of Novartis’ Kymriah therapy for a form of acute lymphoblastic leukemia (ALL), the FDA ushered in a new approach to the treatment of cancer and other serious and life-threatening diseases. “We’re entering a […]

Chapter Member Anniversaries: August 2017

Posted by ISPE Boston
On September 5, 2017

Please congratulate the following members celebrating milestone anniversaries in August 2017. Their dedication to ISPE, the Boston Area Chapter and the industry is applauded! Over Twenty Years Randolph A. Cotter, Sr., Engineering Manager, Cotter Brothers Corporation Denis M. Mathiowetz, President, DM BioPharm Associates Inc. William S. Seaver, Director of Sales, TEK Stainless Piping Products Joseph […]

Welcome New Members!

Posted by ISPE Boston
On September 5, 2017

The following members joined ISPE in August 2017. We welcome you to the Chapter and encourage you to take advantage of the many professional development, networking and information resources available to you at ISPE. Other ISPE members are a terrific resource for your everyday professional challenges – we encourage all members, current and new, to […]

With Renewed Purpose… Engage, Explore & Enhance

Posted by Jack Campion
On August 29, 2017

Greetings, Fellow Members! ISPE helps us further an important mission that is bigger than ourselves – to bring effective and safe medicines to the world. As a 24-year member of the Boston Area Chapter of the ISPE, I am gratified to be part of this mission, and to have benefited greatly from this organization. I […]

Even an Eclipse Couldn’t Eclipse the Annual Golf Outing!

Posted by ISPE Boston
On August 29, 2017

It was a perfect day at Kernwood Country Club in Salem: the sun was shining, the tide was high for beautiful ocean views and the course was in spectacular shape. The camaraderie was at an epic level and the beer was effervescently flowing, almost like it was coming up from the fairways and tee boxes […]

ISPE Needs Your Continuous Manufacturing Expertise

Posted by ISPE Boston
On August 25, 2017

ISPE would like your help in providing comments to the US FDA on the topic of continuous manufacturing. ISPE and its members have a wealth of experience in this area and we believe our comments can have a positive influence on the regulatory landscape moving forward. ISPE has revitalized the team that was formed after the […]

Ironwood Pharmaceuticals Announces FDA Approval for Duzallo

Posted by ISPE Boston
On August 23, 2017

Cambridge-based Ironwood Pharmaceuticals has announced Duzallo was approved by the FDA as a treatment for hyperuricemia, or elevated serum uric acid levels (sUA) in the blood, associated with gout. Duzallo is the first drug that combines the current standard of care for the treatment of hyperuricemia associated with gout, the xanthine oxidase inhibitor (XOI) allopurinol, […]

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