Student Chapters Need Your Help to Meet Goals for 2017-18

By | August 16, 2017

The Chapter’s Student Development Committee held a strategic planning meeting in early August to review progress and plot a strategic direction for the upcoming year.  This annual event brings together student leaders, faculty advisors, committee members and other interested volunteers to brainstorm ways to strengthen support for our Student Chapters, which now number 13 throughout… Read More »

Welcome New Members!

By | August 15, 2017

The following members joined ISPE in July 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… Read More »

Chapter Member Anniversaries: July 2017

By | August 15, 2017

Please congratulate the following members celebrating milestone anniversaries in July 2017. Their dedication to ISPE, the Boston Area Chapter and the industry is applauded! Over Twenty Years Shelly Henderson Jose Miguel Soto, Facility and Equipment Lead, Pfizer Inc Dr. James V. Blackwell, PhD, MBA, President, The Windshire Group, LLC Nicholas J. Casale, Vice President, MA… Read More »

Success and Succession

By | July 26, 2017

It is with gratitude and humility that I write this post marking the end of my term as Chapter President. Leading the largest Chapter through a year of surpassing excellence has taught me much and left me in awe of what can be accomplished by committed, well-organized volunteers. Some numbers: 1,700 members, spread over 80,000… Read More »

Student Members Earn Chapter Scholarships

By | July 26, 2017

The Chapter is proud to award $12,500 in scholarships to the following winners of the June 2017 round of the Joel Goldenberg Memorial Scholarship Program: Adam Blackwell, UMass Amherst John de la Parra, Northeastern University Michael Doane, UMass Lowell Chelsea Fox, University of Rhode Island Jamie Freud, Worcester Polytechnic Institute Daniel Kallin, UMass Amherst Aislinn… Read More »

Avecia Expanding Drug Manufacturing Facility in Milford

By | July 19, 2017

Avecia, a pharmaceutical manufacturer in Milford, says it is building what will become the largest manufacturing site in the world for a specialized drug ingredient called oligonucleotide. The expansion, which will add 20,000 square feet of space, will more than double the Milford site’s total capacity, the company said in a recent announcement. Oligonucleotide, a… Read More »

MassBioEd Predicts Job Trends Forecast for the Biopharma Industry

By | July 19, 2017

The MassBioEd Foundation released its 2017 Annual Job Trends Forecast at Life Sciences Workforce 2017, its second annual conference on life sciences workforce trends.  The event was held at Northeastern University and featured twenty-seven industry and higher education speakers, as well as Lt. Governor Karyn Polito, who provided keynote remarks. The Forecast included the following… Read More »

Novartis Gene Therapy Recommended for Approval by FDA Advisory Committee

By | July 17, 2017

Novartis has announced that the FDA Oncologic Drugs Advisory Committee (ODAC) unanimously (10-0) recommended approval of CTL019 (tisagenlecleucel), an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of children and young adults with B-cell acute lymphoblastic leukemia (ALL) that has relapsed or resisted treatment (r/r). A Biologics License Application (BLA) for this… Read More »

What is Novartis CAR-T Therapy?

By | July 17, 2017

CAR-T (chimeric antigen receptor T cell) therapy is different from typical small molecule or biologic therapies because it is manufactured for each individual patient using their own cells. During the treatment process, T cells are drawn from a patient’s blood and reprogrammed in a manufacturing facility to create T cells that are genetically coded to… Read More »