The 2017 Healthcare Distribution Alliance (HDA) Traceability Seminar is now in our rearview mirror. We’ll have to wait another full year for the next one. As usual, this year was filled with the most pertinent presentations and conversations for those interested in serialization and traceability in the US pharma supply chain—particularly in meeting the Drug Supply Chain Security Act (DSCSA). I use events like this to discover really great new topics that need to be covered in RxTrace in the future, and this year, this event (including the IEEE Blockchain pre-event) resulted in an explosion. That is, an explosion in the number of good topics to cover.
Normally I come away from an event with one or two solid topics. From this event, I came away with seventeen topics called out in my notes. I’ve never come close to that many from a single event. In the end, not all seventeen of these topics will likely see the light of day on RxTrace as a standalone essay topic, but most will over the next six months. And that doesn’t even include the number of topics I noted for the Systech blog, which I also contribute to.
As any long-term reader of RxTrace knows, the HDA event has always been a favorite of mine. People who’ve never been to the event often ask me “why?”. Those who’ve been there never ask me that question. The reason for the discrepancy comes from the way we normally “shop” for a traceability conference. We look at the agenda. If you do that with this event you might not see anything special. It’s called a “seminar” rather than a “conference”. That implies, once you’ve attended it one year, why would you need to attend it the next year? Would you ever want to repeat a seminar course you took in college? Not likely. The agenda doesn’t really change much from year to year. Even the speakers are mostly the same each year. Sounds like a recipe for boredom. How can something like that be considered a favorite event every year?
Here’s how. The biggest value in this conference is not visible from the agenda. It comes from the other attendees and your opportunity to meet and talk with them during the breaks, lunches and networking events. The sessions cover the latest thinking of leading members of the supply chain. This event is always packed with those leaders. To multiply the value of that, all you need to do is strike up a conversation with almost anyone else at this event during the next break and ask them what they think about any relevant topic. I try to talk with a wide diversity of people, and sometimes I engage them in debates—sometimes even when I agree with them.
For example, I sat down at a table for breakfast that included several drug manufacturers. I was taking an informal poll to find out what the most common approach was to printing the human readable text next to the DSCSA 2D barcode. This is for an upcoming essay so I won’t go into that here, but the table included someone from GS1 US and several people I didn’t know. I got into a somewhat heated debate with those at the table over the topic as I tried out my current thinking on them. You’ll all benefit from that discussion when I finalize that essay in the future because it allowed me to hear the counter-arguments from people with different perspectives and backgrounds. You don’t have to be planning a blog essay to learn from that kind of encounter. And it had little to do with specifics in the agenda.
I was also able to ask some pertinent questions of the speaker from the FDA after her presentation. That was really interesting. Watch for it in a future essay.
Some of the topics I added to my list came directly from the presentations, but others came from ideas that came to me when I extended something the speaker said into areas that were not intended by the speaker. For example, one panel discussed the non-regulatory benefits of serialization that will likely arise after all drugs are serialized. Some of the benefits raised on the panel were typical. Some of those I am deeply skeptical of. But the conversation led me to come up with my own thoughts on the surprising benefits we are likely to see, and that will be an interesting topic to write about. Watch for it.
I’ve written several essays in the past about the blockchain topic (see “Could Blockchain Technology Be Used For DSCSA Compliance?” and “Blockchain Reigns At GS1 Connect 2017”). After attending the pre-conference blockchain meeting moderated by Maria Palombini, Director of Emerging Communities & Development at IEEE, I concluded that there is more to write about. In fact, I think it will turn into a series of essays.
Perry Fri, Executive Vice President, Industry Relations, Membership & Education and COO, HDA Research Foundation, Healthcare Distribution Alliance touched on the newly published, second annual HDA Manufacturer Serialization Readiness Survey results. I will review it in a future essay. He also said that they will publish a new barcode guidance document in the next week or so. I will cover that important document as soon as it is made public.
The panel I look forward to the most each year is the one with Elizabeth A. Gallenagh, Senior Vice President, Government Affairs and General Counsel, Healthcare Distribution Alliance, Tish E. Pahl, Principal, Olsson Frank Weeda Terman Matz PC and Brian P. Waldman, Partner, Arent Fox LLP. This year the topic was “HDA Perspective on FDA Draft Guidance Documents”. I recently reviewed several of the HDA’s responses to FDA dockets and you may recall me gushing over how well-crafted they were (see “HDA Schools FDA On DSCSA”). Here were the primary thinkers behind those letters, and this session reviewed some of the key concerns they have over some of those recent FDA drafts. I hung on every word because I’ve spent some time analyzing those same documents and I loved hearing their take on them. Interestingly, I did not note any future RxTrace topics during their presentation, but, of course, there will be more publications from the FDA which we will all need to analyze. That doesn’t need to be noted.
Didn’t make it this year? No problem. You may need to wait a full year to attend the next HDA Traceability Seminar, but you won’t have long to wait for the next golden opportunities to hear the FDA speak and hear what others think about it. On December 5th and 6th the FDA holds its next DSCSA Public Meeting in Silver Spring, MD, and then the next two days, the 7th and 8th, in Washington DC, IQPC will hold their Pharmaceutical Traceability Forum (see “Don’t Miss These Back-To-Back Pharma Serialization and Tracing Events”). With these two events happening back-to-back, you will be able to listen to the FDA, and then the very next day, find out how everyone else interprets whatever they said. Don’t miss it. Look for me at both events!
Dirk.
