PBOA Links and News
Updates from around the industry
Welcome to the Pharma & Biopharma Outsourcing Association's weekly collection of news, regulatory guidance, opinion, video and other links from the bio/pharma outsourcing sector!
Not much time for an update this week. I spent yesterday on The Hill talking about Rare Disease issues and how CDMOs can help companies pursue treatments and cures more effectively. On the train ride home, I got the news that Sen. Bernie Sanders is eyeing the ranking Democratic slot on the Senate HELP (Heath, Education, Labor and Pensions) Committee, which would certainly be an . . . interesting development. As promised, I've included a link to the PBOA's presentation from the OTC Monograph User Fee public meeting (PDF); we'll submit a full set of comments to the FDA's docket on that topic shortly. Our presentation, given by Cornell Stamoran of Catalent, is part of the meeting recordings at the bottom of this page.
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PBOA continues to work with FDA and other industry groups on GDUFA's reauthorization for FY2018-2022. We're invested in helping bring quality, cost-effective generic drugs to patients, and we're working to make sure that a fair, equitable and sustainable funding model is in place to make the GDUFA program sustainable.
PBOA Member News and Links
Industry News, Opinion, Guidance
- June 28-29 - Biotech Outsourcing Strategies CMC 2016 (Basel, Switzerland) - Catalent Presentation 6/29, 10:30 a.m.: "Accelerating Oral Drug Development Through Systematic Early Technology Selection," Pascale Clement, Director Science & Technology, Catalent
- June 29 - Webinar: TraceLink and Supply Chain Wizards Share CMO Onboarding Strategies: "With global serialization deadlines looming, pharmaceutical companies are in search of the lessons and best practices for onboarding their CMO partners. CMO onboarding projects are complex and there are many components to consider when crafting a successful approach."
What I'm Reading
Living with a Dead Language: My Romance with Latin - Ann Patty (Viking) - Maybe it's too "written just for Gil" but I enjoyed this memoir of a logomaniacal former book publisher who retires from NYC for a wooded enclave and decides to learn Latin in her 60s. The author uses the four-year process of studying Latin (at Vassar and Bard) to reassess her relationship with her mother, who struggled to find her own identity outside of being a wife and mother. Ms. Patty intercuts this with anecdotes of her rise in the publishing world (she discovered Flowers in the Attic and unleashed the V.C. Andrews blockbuster franchise on an unwitting public). It's an unsentimental book, and Ms. Patty is unsparing in depicting herself as a senex in classes full of 18- to 21-year-old students. Beyond the process of learning Latin as a language, she also delves into key pieces of Roman literature and uses them to spur her self-examination. It's a quick read and you don't need to know Latin to enjoy it. (I don't, although I did study Attic Greek in the summer of 1992.)
That's it for this week! To keep up with PBOA and its members, follow our Twitter feed, join our LinkedIn group, and check out our PBOA in the Press page. And visit the PBOA to learn how you can join the only trade association dedicated to advancing the legislative, regulatory and general business interests of CMOs and CDMOs!