Feb 4

Mr. Roth Goes To Washington (and Vegas, New York and Bordeaux)

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Long time, no blog! There’s a been a lot of activity for the Pharma & Biopharma Outsourcing Association in the last few months, and it’s only going to get busier! We’ll be participating in PDA and INTERPHEX, making the rounds at DCAT, hosting our own members-only workshop, and launching our first industry survey. There’s a lot of pent-up demand for information and action in the CMO/CDMO sector, and we’re ready to help provide them.

On Tuesday, I made a day trip to Washington, DC to begin introducing the PBOA to Capitol Hill. Our DC firm, Arnall Golden Gregory (AGG), set up appointments with the offices of a number of Representatives and Senators, and I spent the day cris-crossing Congressional buildings to talk about the CMO/CDMO sector. We had a lot of fruitful conversations, and I was gratified to find that some of the aides we spoke to were familiar with the industry and excited to see that an association was now working to represent it.

I’d give out more details of the meetings, but that’s proprietary information for our members. Still, I’m awfully excited about making our first foray into Washington. I was concerned about walking into a scenario where I had no prior experience, but my guide from AGG was great, and once I realized that the Congressional sets from Veep are pretty much 100% accurate, the environment felt pretty familiar to me.


In other DC-area news, we just finalized the speaker lineup for our first workshop! This is a members-only event that we’ll be holding in Washington on March 5, with presentations and conversation about regulatory and legislative trends that affect CMOs and CDMOs. We just confirmed a pair of FDA speakers who will talk about GDUFA and Quality Agreement issues, respectively, and we’ve complemented them with sessions on FDA’s Quality Metrics initiative, Data Integrity inspection trends, and an overview of 2015-16 expectations.

The Regulatory/Legislative Workshop is free, but it’s only for members of the PBOA. If you’re a member and you’d like to attend, RSVP us so we can make sure there’s space (and lunch!) for everyone.


Also this week, the Parenteral Drug Association’s Outsourcing Operations Interest Group asked me to participate in their panel at the PDA’s annual meeting in Las Vegas in mid-March. That session is 4:00 to 5:30 p.m. on March 17.

I decided to pull a St. Francis of Assisi bilocation trick and attend that event as well as DCAT Week in New York City. Don’t be surprised if I’m a little bleary-eyed by the end of that week!


In April, the PBOA will provide three presentations at the annual INTERPHEX show in New York City (April 21-23). On day 1, our Advisory Committee member Mike Ultee will deliver a presentation on The Road to a Biologics IND. On day 2, the PBOA will have two panels to present:

  • CDMO CEOs – top executives from several of our member companies talk about industry trends, consolidation, client demands, and more! (moderated by Jim Miller, president of PharmSource, and chair of the PBOA Advisory Committee).
  • Quality Agreements – CDMOs discuss the uses, misuses and best practices of Quality Agreements with clients. What are they meant to cover? Should a CDMO have its own Quality Agreement template? How much flexibility should the client be provided? Our panelists will discuss these topics and more.

Visit interphex.com to find out about the schedule of events and participants. Along with many of our member companies, we’ll also be exhibiting at INTERPHEX (booth 1044), so come see us and learn more about the PBOA!


There’s plenty more to come from PBOA! We’ve got our first industry survey to launch (more on that next week!), position papers to publish, and Business Solutions partnerships to announce. If you’re interested in learning more about the PBOA, what we do, and how membership can benefit your CDMO, then drop me a line!

Until then, I’m going to watch some Veep reruns so I’m ready for my next DC visit.

–Gil

P.S.: If you’re interested in my old What I’m Reading editorials, here are some selections from my recent reading list:

What I’m Reading
How to Live: Or A Life of Montaigne in One Question and Twenty Attempts at an Answer – Sarah Bakewell – This is a semi-biography of the great French essayist Michel de Montaigne. The author structures the book as twenty different ways of answering the question, “How to live?”. It’s a wonderful book about one of the greatest writers in history. If you’ve never read Montaigne, do yourself a favor and give this a read; it should tempt you to start reading his Essays, which might just change your life.

Blood Will Out: The True Story of a Murder, a Mystery, and a Masquerade – Walter Kirn – This may be the best nonfiction book I read in 2014. It’s about “Clark Rockefeller,” the man who turned out to be a German national named Christian Gerhartsreiter. I was fascinated by the Rockefeller case when it was revealed that he was a fraud; I couldn’t imagine how his wife went so many years without figuring out her husband’s false identity. Turns out that the author, Walter Kirn, knew Rockefeller for years, and also never suspected the fraud. As Rockefeller is exposed and then charged with murder, Kirn grows more engrossed in the case, and his (and our) propensity to be fooled, to want to be fooled, by the promise of high society. Kirn does a fantastic job of balancing his reporting on the case with his own anecdotes and analysis, playing up his own weaknesses and trying to explore how a novelist, who’s so immersed in understanding character, can fail to see through such an audacious fraud.

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