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 […]

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, […]

Apply for a 2018 Facility of the Year Award (FOYA)!

Posted by ISPE Boston
On August 22, 2017

Has your firm recently designed, built, or renovated a state-of-the-art pharmaceutical or biotechnology facility? Share your facility’s achievements by applying for a 2018 Facility of the Year award! The deadline for FOYA 2018 submissions is Monday, 20 November 2017. Thanks to your innovative designs, we are changing the way we deliver quality medicines to patients […]

What is the Innate Immune System?

Posted by ISPE Boston
On August 17, 2017

The innate immune system is the body’s first line of immunological response and the master regulator of subsequent immune activity. In cancer, the innate immune system mediates presentation of tumor antigens, priming and activation of tumor-specific immune cells that enable optimal development of adaptive anti-tumor immunity. Existing immunotherapies are mostly focused on harnessing the adaptive […]

IFM Therapeutics Acquired by Bristol-Myers Squibb

Posted by ISPE Boston
On August 17, 2017

Bristol-Myers Squibb (BMS) has agreed to pay $300 million to acquire Cambridge-based IFM Therapeutics, a venture-backed startup founded in 2015 focused on innate immunity and the role it plays in regulating the immune system. IFM’s team has discovered and developed small molecules that modulate novel targets in the innate immune system as next-generation therapies for […]

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