Chapter Member Anniversaries: October 2020

Posted by ISPE Boston
On October 5, 2020

Please congratulate the following members celebrating milestone anniversaries in October 2020. Their dedication to ISPE, the Boston Area Chapter and the industry is applauded! Over Twenty Years Ric Feldt, Jeff Smith & Associates Michael T. Ku, PharmD, MBA, Pfizer Inc John S. Magyar, Hodess Cleanroom Construction Thomas W. Moss Daniel J. Rufo, Jr., Industrial […]

Welcome New Members September 2020!

Posted by ISPE Boston
On October 5, 2020

We would like to introduce the Members who joined ISPE in September 2020, 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 […]

Takeda Opens New R&D Cell Therapy Manufacturing Facility in Boston

Posted by ISPE Boston
On October 1, 2020

Takeda has expanded its cell therapy manufacturing capabilities with the opening of a new 24,000 square-foot R&D cell therapy manufacturing facility at its R&D headquarters in Boston. The facility provides end-to-end research and development capabilities and will accelerate Takeda’s efforts to develop next-generation cell therapies, initially focused on oncology with potential to expand into other […]

Moderna and Vertex in New Collaboration to Treat CF Using Gene Editing

Posted by ISPE Boston
On October 1, 2020

Moderna and Vertex have announced a new strategic research collaboration and licensing agreement aimed at the discovery and development of lipid nanoparticles (LNPs) and mRNAs for the delivery of gene-editing therapies for the treatment of cystic fibrosis (CF). The three-year research collaboration initially will focus on the discovery and optimization of novel LNPs and mRNAs that […]

Ironwood to Reduce Workforce Based on Phase III Trial Results

Posted by ISPE Boston
On October 1, 2020

Following confirmation that the Phase III trial of GERD drug IW-3718 failed to achieve the primary endpoint of achieving a statistically significant improvement in heartburn severity, Ironwood has announced plans to implement an organizational restructuring, reducing headcount by approximately 100 full-time employees, or nearly 35% of the current workforce. Following the changes, Ironwood expects to […]

More About Lilly’s mAb Therapy for COVID-19

Posted by ISPE Boston
On September 30, 2020

Eli Lilly has announced proof of concept data from an interim analysis of the BLAZE-1 clinical trial, showing a reduced rate of hospitalization for patients treated with SARS-CoV-2 neutralizing antibody LY-CoV555. The randomized, double-blind, placebo-controlled Phase 2 study evaluated LY-CoV555 for the treatment of symptomatic COVID-19 in the outpatient setting. LY-CoV555 is a potent, neutralizing […]

Lilly and Amgen Announce Manufacturing Collaboration for COVID-19 mAb Therapies

Posted by ISPE Boston
On September 30, 2020

Eli Lilly and Amgen have entered into a global antibody manufacturing collaboration to significantly increase the supply capacity available for Lilly’s potential COVID-19 therapies. Lilly is currently studying several potential neutralizing antibodies for the prevention and/or treatment of COVID-19 as either monotherapy or in combination. Through this collaboration, the two companies will have the ability to quickly scale up […]

13 Tips for Writing Effective Quality System Investigative Reports

Posted by ISPE Boston
On September 24, 2020

By: Howard Sneider Completing an investigation is one of the most strenuous responsibilities of individuals that work in quality system compliance. The investigation usually includes an investigative report to document the events and analysis of the proceedings. The investigative report is, with few exceptions, an irrevocable account of what has occurred and will largely determine […]

Update Your Clean Room Knowledge with Industry Pros

Posted by ISPE Boston
On September 16, 2020

Join us at our next webinar on September 24, 12-1 pm, with presentations by two industry experts followed by a live Q&A session. This program is perfect for professionals working in validation, quality control, quality assurance, operations, cleanroom management, regulatory affairs or production and those who test and monitor cleanroom environmental conditions, airflow and the accuracy […]

Over 160 CEOs Sign MassBio’s Pledge to Create a More Equitable and Inclusive Life Sciences Industry

Posted by ISPE Boston
On September 14, 2020

The Massachusetts Biotechnology Council today announced that 164 CEOs representing the breadth of the life sciences have signed its Open Letter 2.0 – The CEO Pledge for a More Equitable and Inclusive Life Sciences Industry. This pledge serves as a call to action for CEOs across the life sciences to create change within their respective […]

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