Chapter Member Anniversaries: August 2024

Posted by ISPE Boston
On August 5, 2024

Please congratulate the following members celebrating milestone anniversaries in August 2024. Their dedication to ISPE, the Boston Area Chapter and the industry is applauded! Over Twenty Years Robert E. Alden, Regeneron Pharmaceuticals Inc Patrick A. Chambers, AbbVie Bioresearch Center Randolph A. Cotter, Sr., Cotter Brothers Corporation John S. Gogolos, PE, Process Facilities Group, LLC Michael […]

Welcome New Members July 2024

Posted by ISPE Boston
On August 5, 2024

We would like to introduce the Members who joined ISPE in July 2024, welcome them to the Chapter, and encourage them (and all 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 the […]

Moderna Wins $176 Million from U.S. for Late-Stage Testing of Bird Flu Vaccine

Posted by ISPE Boston
On August 2, 2024

Moderna is receiving $176 million through the Rapid Response Partnership Vehicle (RRPV) to accelerate the development of mRNA-based pandemic influenza vaccines. The RRPV is a Consortium funded by the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services (HHS). The project award will support late-stage development for an […]

FDA Approves Eli Lilly’s Alzheimer’s Drug

Posted by ISPE Boston
On August 2, 2024

The FDA has approved Kisunla, Eli Lilly’s Alzheimer’s treatment for adults with early symptomatic Alzheimer’s disease (AD), which includes people with mild cognitive impairment as well as people with the mild dementia stage of AD, with confirmed amyloid pathology. Once-monthly Kisunla is the first and only amyloid plaque-targeting therapy with evidence to support stopping therapy when […]

BioInvestigate Challenge: Nurture the Next Generation of Biopharma Innovators

Posted by ISPE Boston
On July 18, 2024

Calling all biopharmaceutical industry leaders! Your expertise can shape the future of our field. The BioInvestigate Challenge invites you to mentor bright, ambitious students as they tackle real-world industry investigation challenges. As a mentor, you will: Guide teams through complex problem-solving scenarios Share your invaluable industry insights and experience Help cultivate innovative thinking in emerging […]

Celsius Acquired by AbbVie for $250 million

Posted by ISPE Boston
On July 17, 2024

AbbVie has announced the acquisition of privately held Cambridge biotech Celsius Therapeutics. Celsius is pioneering new therapies for patients with inflammatory disease. Celsius’ lead investigational asset is CEL383, a potential first-in-class anti-TREM1 antibody that has completed a Phase 1 clinical study for the treatment of inflammatory bowel disease (IBD). TREM1 has been identified as a key […]

Alnylam Reports Positive Results from Phase 3 Study

Posted by ISPE Boston
On July 17, 2024

RNAi therapeutics company Alnylam has announced positive topline results from its Phase 3 study of vutrisiran, an investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM), a rare heart condition that is both progressive and fatal. Transthyretin amyloidosis (ATTR) is an underdiagnosed, rapidly progressive, debilitating and fatal disease caused by […]

Sarepta Wins FDA Approval for Muscular Dystrophy Drug

Posted by ISPE Boston
On July 17, 2024

Sarepta Therapeutics has received FDA approval of an expansion to the labeled indication for Elevidys, a single-dose, adeno-associated virus (AAV)-based gene transfer therapy designed to address the underlying genetic cause of Duchenne muscular dystrophy – mutations or changes in the DMD gene that result in the lack of dystrophin protein – through the delivery of a transgene […]

Another win for the Red Sox and for the ISPE Emerging Leaders Committee!

Posted by Tyler Haywood
On July 16, 2024

The 3rd annual Emerging Leaders Red Sox Game was another smashing success! Thank you to everyone who showed up to support the event, especially our generous sponsors BWT. It was great seeing some new and some familiar faces. ELC looks forward to putting on more fun and educational events. Go Sox!

Why a User Requirement Specification is more than just an Exercise

Posted by Howard Sneider
On July 8, 2024

Since the proliferation of the V model of Computer System Validation (CSV), The User Requirement Specification (URS) has been on a figurative roller coaster of public opinion and proper use. The URS was originally conceived to enable as-built performance testing of a design against specifications as part of the V-model. While it served a vital […]

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