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Featured Image

Broad Institute and Novo Ventures Launch Drug Discovery “Greenhouse”

  • Posted by ISPE Boston
  • On November 21, 2019
Novo Ventures and the Broad Institute of MIT and Harvard have announced the launch of the Novo Broad Greenhouse, a joint initiative to discover and propel transformative new therapies from academic science into the clinic. To drive the development of the next generation of molecular medicines, the Novo Broad Greenhouse unites three core ingredients: deep […]
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Painting the Town with Women in Pharma

  • Posted by Kathy Marini
  • On November 20, 2019
Always on the hunt for new ways to bring members together, Women in Pharma held our first ever Paint Night on November 14. About 40 folks showed up at Muse Paint Bar in Marlborough ready to practice our painterly skills and socialize with colleagues. We painted the Boston skyline with the famous Citgo sign and […]
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Fall Social Survives Challenges

  • Posted by Mina Jung
  • On November 15, 2019
A huge thank you to Life Science Cares, the Chapter’s Young Professionals, CAMI and the many who braved the cold wind-driven rain to join us at the 2019 Fall Social at Flat Top Johnny’s. The evening came with some unanticipated challenges but as always, the ISPE community came together in great spirits to mingle with […]
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Vegas a Best Bet for Poster Contest Winner

  • Posted by Rob Crory
  • On November 14, 2019
What’s the old saying? What happens in Vegas stays in Vegas? Well, what if one of the Boston Area Chapter’s talented student members was part of a team resolving the “infamous cold supply chain challenges” of Car-T cell therapies? What if this student was in Vegas to present his award winning research poster at the […]
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Combination Gene Therapy Treats Age-Related Diseases in Mice

  • Posted by ISPE Boston
  • On November 13, 2019
A new study from the Wyss Institute at Harvard University and Harvard Medical School (HMS) reports that a single administration of an adeno-associated virus (AAV)-based gene therapy delivering combinations of three longevity-associated genes dramatically improved or completely reversed multiple age-related diseases in mice, suggesting that a systems-level approach to treating such diseases could improve overall […]
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New Draft Guidance to Support Risk-Based Computer Software Assurance

  • Posted by Heather Longden
  • On November 7, 2019
FDA continues to encourage the use of innovative new technologies to support the development of quality new drugs and ensure that patient safety is uppermost in the development and manufacture of drugs. As Scott Gottleib noted when discussing medical devices, FDA wishes to encourage device manufacturers to “make investments to re-tool their manufacturing processes” to […]
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January GAMP Forum Tackles Computer Software Assurance

  • Posted by ISPE Boston
  • On November 7, 2019
Save the date – January 16, 2020 – for a half-day GAMP Forum with a focus on risk based computer system validation and computer software assurance sponsored by the ISPE Boston Area Chapter. Hear GAMP experts discuss these topics in the context of new technologies like Cloud and Software as a Service applications, Artificial Intelligence […]
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Biogen and Alkermes Win FDA Approval of MS Drug

  • Posted by ISPE Boston
  • On November 7, 2019
Biogen and Alkermes have announced that the FDA has approved Vumerity (diroximel fumarate) for the treatment of relapsing forms of multiple sclerosis. Biogen holds the exclusive, worldwide license to commercialize Vumerity and intends to make it available in the U.S. in the near future. The FDA approval was based on a New Drug Application (NDA) […]
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Dicerna in $200M Deal with Roche on Drug for Hepatitis

  • Posted by ISPE Boston
  • On November 7, 2019
Dicerna Pharmaceuticals has announced a research collaboration and licensing agreement with Roche to develop novel therapies for the treatment of chronic hepatitis B virus (HBV) infection using Dicerna’s proprietary GalXC RNAi platform technology. The collaboration will focus on worldwide development and commercialization of DCR-HBVS, Dicerna’s investigational therapy in Phase 1 clinical development. The collaboration also […]
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Chapter Member Anniversaries: November 2019

  • Posted by ISPE Boston
  • On November 4, 2019
Please congratulate the following members celebrating milestone anniversaries in November 2019.  Their dedication to ISPE, the Boston Area Chapter and the industry is applauded! Over Twenty Years Charles H. Brown, II, MS Ronald J. Friedman, Exyte Michael J. Mirabito, Saybrook Associates Donald A. Ross, BSCE, MSCE, A/Z Corp Pasquale M. Sacco, Translate Bio Peter M. […]
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