“The social brain is in its natural habitat when we’re talking with someone face-to-face in real time.”
Author, Psychologist, and Journalist
Welcome back to live and in-person compliance congresses!
This year’s Pharmaceutical Compliance Congress is a “hybrid event,” with the in-person conference scheduled for April 25 – 27 at the Ritz-Carlton in McLean, VA. And I am sure I speak for my fellow sponsors and vendors, as well as attendees from industry, when I say, “woot, woot!”
As much as conference organizers like Informa and PCF made every effort to replicate the live experience with their virtual conferences, networking and sharing ideas and experiences is simply more effective and rewarding in a live setting, with everyone focused on the common goal of reducing risk and building a better compliance program.
So, it is with great anticipation I offer this preview of the “in-person” agenda for PCC 2022 and highlight those sessions that look interesting from a training standpoint. After all, it’s what we do at PharmaCertify.
Day 1: Monday, April 25
9:30am – 10:00am
The annual PhRMA presentation appears early on the agenda this year, and the presentation by Jim Stansel should be particularly compelling in light of recent updates to the Code and the Statement on the Application of PhRMA Code Section 2 During Emergency Periods from back in June of 2020.
I’m anxious to hear how the organization plans to incorporate the guidance on virtual interactions as the world continues to emerge from the pandemic and we return to a little less of an “emergency period.” By the way, the PharmaCertify Foundations eLearning module, The PhRMA Code, has been updated to cover the changes to the Code and the language in the Statement.
10:30am – 11:00am
Building a Compliance Program and Educating Internal Stakeholders to Gain Alignment, Support and Ownership
Well, that title is a mouthful, but if anyone can handle so much content in a 30-minute session, it’s this impressive lineup of panelists. Industry leader, Terra Buckley, Vice President of Compliance Advisory Services at MedPro, is joined by Jeremy Lutsky from PhaseBio, Ann Beasely of Zai Lab, Christie Camelio from TG Therapeutics, and Emily Gainor of Ironwood Pharmaceuticals. Hopefully, they will touch on training, because if you’re going to push the envelope to build a better curriculum, you’re going to need buy-in from the C-Suite.
11:00am – 12:15pm
Keynote Enforcement Panel — Stay on the Pulse of Emerging Trends
I know I sound like a broken record (I am assuming that metaphor still works since albums have made such a comeback), but do not miss the enforcement panels. Nowhere else will you hear directly from those responsible for establishing the “emerging areas of focus and recent trends in enforcement oversight,” as it is described in the agenda. No less than six government representatives, including the Assistant Director of the Consumer Protection Branch of the DOJ, will be there to offer their thoughts on their top priorities. I will be listening carefully for how those trends inform our custom and off-the-shelf training courses.
12:15pm – 1:15pm
Come visit the PharmaCertify booth! Well, you may have to if the folks at Informa strategically place the food in the Exhibit Hall. But seriously, we do look forward to catching up with our existing clients and contacts and even making new connections. We’ve got new and really cool demos to share, and we even have a new theme for our booth. Just look for the compliance training heroes flying around the room (or at least flying around our booth – we’re still working on permission from the hotel to fly around the room)!
1:15pm – 3:00pm
The afternoon sessions are divided into three tracks titled, Patient and Advocacy Compliance; Auditing, Monitoring and Advanced Analytics; and Digital Health for the Compliance Professional. A number of the sessions from each track look inviting from a training content standpoint. As always, I recommend teaming up to cover multiple sessions if you are attending with coworkers, or even finding a study buddy onsite (I am always willing to share notes if you want to attack this together) and devise a strategy for covering as many sessions as possible. Here are the ones that catch my “training topic relevance eye” at first glance:
1:15pm – 1:45pm
Optimize Advocacy-Compliance Interactions by Minimizing Barriers and Enhancing Successful Partnerships,with Christopher Canada and Amanda Sowinski, both from Amicus Therapeutics.
Spotlight on Rare Disease Compliance Risks, with Danielle Pelot from Choate, Hall & Stewart, Kelly Pitt from MorphoSys, Stephen Bychowski of Sanofi Genzyme, and Michael Hercz from Sentynl Therapeutics.
1:15pm – 1:30pm
Enforcement Update, with Gustav Eyler from the DOJ
2:00pm – 2:30p
Key Oversight Areas for Critical Compliance Insights from Sales to Patient Support, with Karen Lowney of SUN PHARMA, Tiffany Tang from Covis Pharma, Mark Scallon of Baker Tilly, and Brian Kasnowski from SK Life Science.
1:15pm – 1:45pm
Social Media – Risks vs. Benefits, with Brian Van Hoy of G&M Health
3:30pm – 4:15pm
Following a networking break at 3:30 (during which you will, no doubt, make a beeline to the PharmaCertify booth to learn more about how we can help you be a compliance training hero), two concurrent breakout sessions both look enticing in consideration of how the topics potentially affect our clients’ training courses. So, I am going to need a note-sharing partner on these two:
Oversight and Best Practices for Speaker Programs, HCP Engagement and Sales Interactions
There it is! The first appearance of that “sp” word. Actually, speaker programs are sure to be covered in an enforcement panel or two by now, but anytime I see it in the title of a session, I want to be there. It’s an ever-evolving topic and the OIG Special Fraud Alert sill reverberates through the industry and in our training programs. This is yet another panel featuring an impressive lineup, with Catherine St. John from Sanofi, Cynthia Cetani of Indivior, Rore Middleton from Blueprint Medicines and Emily Gainor of Ironwood Pharmaceuticals.
Examination and Application of Key Learnings from Industry’s Most Recent CIAs
Speaking of guidance, Corporate Integrity Agreements hold the fine-print details on the topics and training requirements the government considers a priority. If you want to know where to focus your training, CIAs (and this session with Elizabeth Jobes of Amryt and Nikki Reeves of King & Spalding), are good places to start.
Day 1 closes with two more concurrent sessions, divided by company size. The Emerging and Small Company panel holds particular sway for me since so many of our clients face the challenge of building an effective curriculum with the limited resources and time restrictions inherent to smaller companies. I’ll be curious to hear how Jake DeBoever of Dermavent Sciences, Jeremy Lutzky of PhaseBio, and Hunter Murdock of Axsome Therapeutics take on these challenges.
5:00pm – 6:00pm
Networking and Cocktail Reception
Hopefully, this is in the Exhibit Hall, so come see us again! We’ve got giveaways you’ll really dig.
Day 2: Tuesday, April 26
The morning opens with an industry-only summit, and since I am over here on the vendor side, I am sure to be denied access at the door. And I was so prepared to write glowing reviews of everything that happens in that summit in my conference review on this blog. Are they talking about us in there?
8:45am – 9:15am
Compliance Top 10 — Clear and Concise Overview of the Top Areas of Concern for the Compliance Professional
Following his review of Day 1, John Oroho, from Porzio Life Sciences, offers this enticingly titled session covering the topics that should be of primary concern to the attendees. And if they are areas of concern in general, they areas of focus for compliance training. I’ll be taking copious notes in this one.
Following a CCO Innovation Panel at Panel at 9:15, a networking break at 10:00 (meet me for coffee in the Exhibit Hall everyone!) and a session focused on monitoring at 10:30, the spotlight turns to the Former Prosecutor Spotlight (see what I did there?) featuring Rachel Honig, the former Acting U.S. Attorney’s Office for the District of New Jersey and George Varghese, of WilmerHale. As with the enforcement panels, the former prosecutor sessions offer revealing insight into the topics the industry should prioritize and those that should be a focus for training.
12:15pm – 1:55pm
Lunchtime! You really need to visit the PharmaCertify booth this time because this is when I break out all the new comedy material I’ve been working on just for this conference. Here’s a small sampling: what do you call a monument of a horse with his back legs firmly on the ground? An Anti-Kickback “Statue!” Get it?! Okay, here’s another one…a chief compliance officer, a sales representative, and a former Assistant U.S. Attorney walk into a bar (and you only get to hear the punchline if you visit the booth).
1:15pm – 4:00pm
After lunch and more bad jokes, the agenda is divided into three breakout sessions. I will be focused on the session covering the previously mentioned OIG Special Fraud Alert on Speaker Programs. I’m anxious to hear what the panel of seven speakers, including Sarah Whipple of Akebia Therapeutics, Hannah Putnam of Fresenius Medical Care, Andrea Kocharyan of Zealand Pharma, Ernie Hernandez of Global Blood Therapeutics, and Averi Price of Radius Health have to say on the enduring guidance, especially regarding how it affects their training.
Since medical affairs and the sales representative/MSL dynamic is always of interest from a training standpoint, the session titled, A Look at Commercial and Medical Affairs to Understand Changes to An Organization’s Evolving Compliance Needs with David Ryan of Epizyme, Jake DeBoever of Dermavant, Amy Wilson of Esperion, and Ed Sleeper of HUTCHMED is my first choice among the 2:00pm – 2:45 breakout options.
Among the 3:15pm breakout sessions for the day, the Third-Party Risk and Oversight presentation, with Ling Zeng of Dicerna, is most interesting for me considering how often we are asked to build and deliver training to global third parties. By the way, the Access LMS from PharmaCertify is a streamlined and cost-effective platform for delivering training to those vendors who don’t have access to your enterprise LMS. Let me know if you’d like to see a demo at the conference or otherwise.
From 4:00pm – 4:45pm, you do not want to miss the breakout session, Reduce Compliance Risk Using a Continuous Learning Approach by my colleague Dan O’Connor, Ed Sleeper of HUTCHMED, Dhara Moro from Sage Therapeutics, and another player to be named later. In leading the PharmaCertify team, Dan has helped forge a new approach to compliance training, based on improving retention through continuous delivery of training assets across a learner’s timeline. I have known Ed Sleeper for many years, and his experience developing engaging compliance training brings a strong and practical perspective to the presentation. And Dhara Moro and Sage have been rolling out some of the more unique and engaging compliance training we’ve seen in the last 20 years. Trust me, this is a strong presentation, featuring experienced training professionals showcasing compelling work.
Day 3: April 27, 2022
Following an important and timely breakfast summit on Diversity, Equity, and Inclusion, John Oroho’s review of Day 2, and a Policy Reforms, Pricing Pressures and Payer Marketplace Changes Impacting the Life Sciences session with Chris Sloan and Katherine Chaurette, both of Blueprint Medicines at 9:15am, you have your final chance to visit the PharmaCertify booth in the Exhibit Hall!
The conference closes with back-to-back agency addresses with Veronika Peleshchuk Fradlin from CMS and Catherine Gray from the Office of Prescription Drug Promotion at the FDA.
This year’s Pharmaceutical Compliance Congress promises to be a special one as industry leaders, vendors, and government regulators gather face-to-face for the first time in years to share experiences, expertise, and advice on building and maintaining an effective life sciences compliance program. If you haven’t yet registered for the conference, contact me at email@example.com to receive a discount on the registration fee. You don’t want to miss this one!
If you aren’t able to attend the conference, you can schedule a brief session to see examples of how we help reduce risk with better core training, reinforcement, and performance support solutions by emailing firstname.lastname@example.org.
See you in Virginia and thanks for reading!
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