Time for another blog update! This Monday (March 30) is the Pharma & Biopharma Outsourcing Association’s first Regulatory/Legislative Workshop in Washington, DC (rescheduled from March 5, due to snow). It’s a free event, only for members of the PBOA, and features speakers from FDA, PDA, PharmSource and TraceLink (our newest Affiliate Member!). I’ll write all about it, and some of our media partners may also give us post-workshop coverage, so keep an eye out!
Your intrepid President kicked off the spring trade show season last week by attending the Parenteral Drug Association (PDA) Annual Meeting in Las Vegas, then taking a redeye to New York to attend DCAT Week. (In case you’re wondering, I’m longing for the day when we have staff that can split coverage of overlapping events.)
The PDA event began with a touching keynote presentation by magician and motivational speaker Chad Juros, who used his magic to punctuate and accentuate his story of surviving leukemia through an experimental protocol. He was diagnosed at the age of three and spent years in hospitals and recovering from surgeries, during which time his dad performed magic tricks to keep him distracted. Chad’s the founder of the Spread the Magic Foundation, a nonprofit corporation that performs magic to raise money for pediatric cancer patients.
After that, I spent most of day 1 in the Exhibit Hall, talking to current members of the association, our media partners, and other companies that are interested in what we’re up to. This was the first major trade show I’d been to since AAPS last November, and there’s definitely a lot more to talk about, both in terms of what the PBOA is up to and where the CMO/CDMO industry is headed. The association is engaged in a lot of work for its members, including that workshop I mentioned, as well as Congressional visits, FDA conversations, industry research (fill out our Quality Agreements survey!), negotiating Business Solutions partnerships, assembling member-company-based panels at INTERPHEX (here and here, plus this single-speaker session by Advisory Committee member Mike Ultee), and more.
(Just between us, it’s like night and day. Last year, I was still talking about the potential of the PBOA, and now we’re engaged in the actual.)
During the annual meeting, I also connected with PDA leadership to discuss a partnership/alliance idea, which I hope to tell you more about in the next few weeks.
I should mention that it isn’t all about me. The PBOA has a lot going on, but it’s just as important for me to hear from all those other parties about what’s going on in the industry, what we should be covering, who we should be talking to, and how we can all work together. So, despite the monologue-tendency of these blog posts, I’m really all about conversation and interaction.
At this point, some of you might be wondering: Gee, Gil, you were in Las Vegas [at the Red Rock Casino & Resort, which is miles away from The Strip], so what about all the fun stuff you did? Truth is, I’m actually a pretty boring guy, and I got Vegas out of my system around 10-12 years ago. The only remotely interesting thing that happened was when I decided to pay my “Las Vegas tax” around lunchtime on Monday. I put $40 in a slot machine, and four pulls later, I had $238. I concluded that it wasn’t going to get any better than that, so I cashed out. If this serves as any sort of lesson to you, there’s probably a lot of other things you need to learn.
At the end of day 2, I was a panelist for the meeting of the Outsourcing Operations Interest Group (OOIG). I was invited by Karen Ginsbury of PCI Pharmaceutical Consulting Israel Ltd. to panel with her and Sue Schniepp (Regulatory Compliance Associates Inc.). I gave a brief introduction about the PBOA and our goals for regulatory and legislative advocacy for CMOs and CDMOs, and provided my disclaimer about not having worked in pharma (I came to the industry as the editor of Contract Pharma magazine), and then we were off to the races.
Ms. Ginsbury led the conversation, in terms of exploring what the attendees were seeing and hoping to address, while Ms. Schniepp reveled in the role of Devil’s Advocate / Devil’s HR Department. The audience of around 40 people consisted of both CDMOs and clients/customers, as well as consultants and other affiliated parties. The conversation centered on quality issues, while also touching on CMO management/governance, knowledge transfer, the RFP process, differing (and conflicting) regulatory requirements, the FDA’s Quality Metrics Initiative, and more. I thought it was pretty illuminating, and I tried to chip in where I could, in terms of what I’ve gleaned from PBOA members and from industry-watching for 15 years.
The attendees were largely from the manufacturing and operations side, and it was interesting to hear their perspectives on the business of CMO/CDMOs. When the conversation turned to the topic of Quality Agreements — and that happened pretty often — there were plenty of anecdotes (none of which named names) about the process of hashing one out, of resource constraint, of the time that someone proposed that the Quality Agreement be settled before a contract is signed with a client. It was a fascinating 90 minutes for me, and I’m hoping to stay involved with the OOIG going forward.
After that session, I packed up, headed to McCarron Airport on the hotel shuttle, and waited for my 10:30 p.m. flight to Newark so I could attend two days of DCAT Week at the Waldorf-Astoria in NYC. I got in at 6 a.m. and, rather than sleep, I trusted in the energizing powers of caffeine and conversation to keep me going.
If you’ve never been to DCAT Week, you may have trouble conceiving of how it works and why this was a viable strategy for me. Rather than a standard trade show with an exhibit hall and educational sessions, DCAT is more of a Happening. There’s no exhibition, but many companies rent out hospitality suites at the Waldorf and surrounding hotels and host pre-arranged meetings with decision makers. Some of those companies don’t even register for DCAT; they just book a suite or a conference room and set up meetings before the event. This can actually be a problem when someone recognizes you and starts a conversation, but you can’t recall their name or what company they’re with, because you’ve only met them in their company’s booths at shows wearing name badges. Not that this happened to me.
While the PDA meeting is focused primarily on science, the players at DCAT are All Business. One of my friends told me that he and his two coworkers had a grand total of 90 minutes without meetings, over the course of Monday to Thursday.
(Note: there’s no exhibit hall, but there is a series of presentations/sessions during DCAT. I was bummed that I had to miss the one on FDA’s Quality Metrics Initiative, but it took place while I was at PDA, and I had a good conversation with PDA’s Denyse Baker, who’ll be giving a presentation about the Quality Metrics Initiative at our workshop on March 30.)
For my part, I began meetings at 7:30 a.m. on Wednesday and, well, never really stopped until 9 p.m., between prearranged meetings and bumping into people in the Waldorf, or on the street to and from other hotels. I talked with member companies, prospective members, media partners, other trade associations, people who have moved from the CMO side to the client/customer side, and the shoeshine guy at the Waldorf. (I wish I could characterize those conversations for you, but like I said, DCAT is All Business. Okay, the shoeshine guy and I talked about keeping the chestnut shade on my Allen-Edmonds.)
All those conversations kept me from feeling the lack of sleep (judicious doses of coffee helped), and I rode that wave right through the CMO Leadership Awards that night, hosted by Life Science Leader magazine at the W Hotel. There was plenty of good conversation and networking (and great food) to be had at that event, and the organizers talked about getting the PBOA involved with the awards next year. (I’ll keep you informed!) (And here’s photosets of the event: candids and awards!)
The next day I returned to the DCAT fray, discussing the PBOA’s goals and activities with several companies that are interested in joining. For a few of them, I offered to set up calls with our current members, so they can learn more about the PBOA from the companies that actually constitute it.
I also had a great DCAT conversation with Terry Novak, a former CMO/CDMO industry stalwart who last year took the COO role at Pernix Therapeutics. When I arrived at DCAT in 2014, one week after I left Contract Pharma, ready to take my very first pitch-meetings for the association, I bumped into Terry on the sidewalk outside the Waldorf. He told me about how he’d taken this new role, going to the client/customer side, and I told him about what I hoped my new role would be, as we walked down Lexington.
It was pretty fun to catch up with him one year later and compare notes on how far we’ve each come in the span of a year.
DCAT Week culminates in a black-tie dinner on Thursday night, and I was gratified to be invited to it by WellSpring Pharma Services, one of our Founding Members. (I’d been invited once before during DCAT, but the company disinvited me 10 minutes later. They said it was because the CEO had invited someone in my spot, unbeknownst to them.) When I left for Las Vegas on Sunday, I packed my tuxedo, bow tie and black shoes in the car, then re-arranged my suitcase upon my return to accommodate them on this leg of the trip.
I’ve developed plenty of skills in the past year since I launched the PBOA, but I will admit that learning to tie a bow tie is not one of them. Lucky for me, a high society acquaintance of mine in NYC offered to meet up with me and tie it with a certain degree of sprezzatura.
The 89th Annual Dinner was fine in terms of food, and there were lots of great opportunities to network, but the big draw is the guest speaker that DCAT brings in for the event. Past years have featured Hillary Clinton, George W. Bush, and Arnold Schwarzenegger, and this year’s guest was former UK Prime Minister Tony Blair. He didn’t really talk pharma or healthcare, so much as global security and the rapid pace of technological change, but no one seemed to mind. He was able to balance the heavy topics with a light touch, but I did tell my wife that evening that he reminded me less of Tony Blair than of Hugh Grant’s Tony Blair-ish PM in Love, Actually (which I hated; don’t get me started). On a meta-level, you could argue that Blair’s focus on security threats, especially in the Middle East, are part of his campaign to justify his decision to join the U.S. in the 2003 invasion of Iraq, which is likely what he’ll be remembered for in generations to come, if generations to come have any memory (again, don’t get me started).
Following the dinner, there were a series of receptions taking place throughout the Waldorf, but it had been an exhausting 100 hours for me, so I thanked my hosts, had a dozen or so “I’m on the way out the door” conversations, finally picked up my coat and bag, and headed back to NJ.
That’s probably more detail than you were looking for in some areas, and not enough detail in others, but overall, it was quite a start to the spring season. The PDA Annual Meeting was a great experience, bringing the PBOA in front of the scientific and quality people whose perspectives we’re trying to represent, while DCAT involved a lot of top-level conversation to help develop a better picture of where our industry is headed. And when I look at how far we’ve come in one year, I can’t wait to see where 2015 takes us!
More next week, after our Regulatory/Legislative Workshop!
Our next trade show is INTERPHEX, at the Jacob Javits Center in NYC, April 21-23. We’ll be at booth #1044. Click the banner below to register!
Nice blog, Gil. A whirlwind, indeed.