A Preview of the 10th Annual Life Sciences West Coast Compliance Congress

CBI’s West Coast Compliance Congress is scheduled for Tuesday, October 22nd through Thursday, October 24th in San Francisco, and a review of the pre-conference agenda reveals a compelling mix of panel presentations and master classes focused on the most pressing challenges facing life sciences compliance professionals. Here are the sessions we have noted as most intriguing.

Tuesday, October 22, 2019: Pre-Conference

Attendees face an interesting choice right from the start of the conference with two Pre-Conference Summits scheduled simultaneously for 1:30 – 5:00 on Tuesday. Both are focused on topics critically important considering recent industry settlements.

During Summit A, Patient Assistance and Support Programs – Ensuring Patient Centricity Through Compliant Frameworks, summit leaders, Terra Buckley of Celgene, Daryl Kreml of Sage Therapeutics, and Kari Loeser of Relypsa will delve into the risks associated with assistance programs, hub services, nurse educator programs, and reimbursement services. It’s a comprehensive look at the topic by an impressive group of panelists. Don’t miss it.

In fact, the only valid reason to miss Summit A may be to take in Summit B: Third-Party Risks and Oversight – Innovative Models Driving Compliance. The increasing trend toward outsourcing services in the life sciences industry has led to the need for even greater diligence around the selection and management of third-party vendors. According to the agenda, representatives from Advanced Bionics, Merck, and Varian Medical Systems will “share best practices, uncover red flags and set a tactical plan for enhancing oversight.”

Wednesday, October 23, 2019: Day 1

After opening remarks by Erik Atkinsson of Cytokinetics, Day 1 begins with a session intriguingly titled, Trailblazer Talk. Averi Price of Radius Health, Sharon Delshad of Nalpropion Pharmaceuticals, and Daryl Kreml of Sage Therapeutics will focus on “adapting and evolving compliance programs in support of innovation.” I expect it to be an enlightening program from three highly-regarded industry veterans.

When attending any compliance conference, I make a note not to miss the sessions featuring government prosecutors and regulators. The Current and Former Prosecutor Panel is no exception as former prosecutors Tiffany Mosely of Loeb & Loeb, LLP and Joes Verla Jr. of Bass, Berry & Sims will join Adam Reeves from the United States Attorney’s Office in the Northern District of California to discuss trends for next year and beyond. Hearing from the government side always offers important lessons and insights.

Later, on Day 1, the “New Guidance” session subtitled, Walk Through the Evaluation of Corporate Compliance Programs – Foundational Understanding and Future Impact, is compelling based solely on the use of “evaluation” in the title. If this is indeed a step-by-step review of what makes a successful compliance program, the time invested should be more than worthwhile. I wouldn’t miss it.

The afternoon of Day 1 includes two sets of simultaneous “master classes,” beginning at 1:30 with the Transparency and Aggregate Spend session and Data Privacy and Cybersecurity session.  At 2:15, it’s a choice between Promotional Compliance in one session and Non-Promotional Activities in the other. I understand the need to schedule simultaneous sessions to pack as much content as possible into the conference, but it makes for difficult choices. If you are attending with coworkers, I suggest a divide and note-sharing approach to maximize the opportunity.

Day 1 ends with a networking wine and cheese reception, which may be your best opportunity to network with peers and industry leaders. This makes for a great exchange of tips, suggestions, best practices, and business cards.

Thursday, October 24, 2019: Day 2

Day 2 opens with two concurrent master classes at 8:30 and two more at 9:30. The HCP Engagement and Contracting – Mitigate Compliance Risk and Improve Operational Efficiency session stands out as one I would not miss considering the current regulatory focus in that area.

Speaking of HCP contracts and current regulatory focus, the in-conference workshop at 10:45, Strengthen Speaker Program Compliance Through Innovative Initiatives and Best Practices is certainly worthy of an asterisk in your agenda. And if speaker programs are high on your list of risk areas, we now offer a Compliance Foundations™ eLearning module titled, Managing Speaker Program Risk. The 30-minute module covers topics like program planning, speaker compensation, attendee management, and speaker responsibilities, to list just a few. And it’s easily customized with your specific policies and contact information. Let me know if you’d like to a content outline.

Before the conference closes with an Exclusive Benchmarking Think-Tank, Greg Moss of Kadmon Holdings, Sunita Ramamurthy from Loxo Oncology, and L. Kathleen Durousseau of Rigel Pharmaceuticals will cover Governance Best Practices and Working with the Board. We often hear about the importance of “tone from the top” at compliance conferences and any discussion centered on ideas for working with the board to establish the proper tone is worthwhile. It’s a strong topic for the end of the conference.

Thanks for reading this preview of the 10th Annual Life Sciences West Coast Compliance Congress. As always, I welcome your comments, feedback, and stories from the conference. If you are attending the conference, please say hello to my colleague from PharmaCertify, Dan O’Connor, who will be there as well.

Sean Murphy
Marketing and Product Manager
PharmaCertify by NXLevel Solutions

9th Annual Life Sciences West Coast Compliance Congress: A Preview

CBI’s 9th Annual Life Sciences West Coast Compliance Congress is less than three weeks away and we’re looking forward to yet another opportunity to catch up with colleagues and clients and showcase our newest life science compliance training products. The conference gives those of us located on the other side of the country an opportunity to hear tips and best practices from industry professionals who don’t normally participate in the East Coast conferences. A quick scan of the agenda reveals company names as diverse as. Here’s a brief preview of the sessions and panel presentations scheduled for the two-day conference.

Day 1: Wednesday, October 17th 

Chief Compliance Officer Keynote Panel

After two pre-conference summits, one covering aggregate spend and the other patient support programs, the conference sets the stage with a panel of former and current chief compliance officers, moderated by John Kelly of Bass Berry & Sims, and formerly of the Department of Justice. As someone who attends a significant amount of conferences, I support this idea of diving right into the topics at hand, rather than leading off with a speaker who may bring some name recognition or star power but doesn’t necessarily speak to the primary concerns of the audience.

Enforcement Panel: Fraud and Enforcement Trends – Current and Former Perspectives

The enforcement panel scheduled for 2:15 is an interesting blend of those currently in an enforcement role (Chinhayi Coleman Cadet from the Northern District of California and Rachael Honig from New Jersey) with those who formerly served in an enforcement role and now work in the private sector (the aforementioned John Kelly of Bass Berry & Sims and Robert Marasco from Dinsmore & Shohl LLP and former AUSA from New Jersey and the Southern District of California).  The duel perspectives should provide compelling insight into the current prosecutorial trends in the life sciences industry.

Roundtable Discussion: Lessons Learned and Continuing Implementation of General Data Protection Regulation (GDPR)

After a networking and refreshment break, the conversation turns to the timely topic of GDPR. Clearly, there are questions and confusion around the regulation, and we’re especially hoping to hear how these panelists build and deploy training on the hot topic of GDPR. Who are they training in the organization? What topics under the GDPR umbrella are they covering? How often are they updating that training?

Immediately following the GDPR session, Day One closes with a networking, wine, and cheese reception. As you chat with your colleagues and network with new associates, we invite you to stop by the PharmaCertify Booth to learn more about our training solutions. While there, don’t forget to enter the drawing to win an Amazon Echo Smart Speaker with Alexa!

Day 2: Thursday, October 18th

Interactive Exchange: Strengthen Speaker Programs through Innovative Compliance Initiatives and Lessons Learned

Following two sessions on monitoring and auditing, the focus turns, not surprisingly, to yet another hot topic currently under the regulatory microscope, speaker programs. This session should prove to be even more enlightening and revelatory since it is billed as an “interactive exchange” with panelists listed as “conversation contributors.” Those contributors, Ishita Arora of Horizon Pharmaceuticals, Danielle Davis of Insys Therapeutics, Eric Jen of Horizon Therapeutics, and Jenny Shire of Daiichi Sankyo, are sure to have the full attention of an audience hungry for suggestions on how to manage risk in planning and executing the programs.

Choose Between Two Master Classes (A-B)

Before a networking lunch break, attendees have the option to choose between two “master classes” focused on topics that continue to be a source of risk.

Master Class A: Take Action in Light of New Regulatory Updates Surrounding Promotional Compliance and Off-Label Communication

During CBI’s Compliance Congress earlier this year, we learned that the regulatory focus on off-label promotion has shifted somewhat from larger companies to emerging companies and start-ups. Off-label concerns continue to be at the top of qui tam cases, and we’ll be curious to hear the steps Sharon Delshad of Nalpropion Pharmaceuticals and Gary Messplay from King & Spalding recommend for reducing off-label risk

Master Class B: Navigate Third-Party Relationships and Outsourcing Arrangements

For companies that utilize third-party entities for global transactions, Richard J. Ciamacca of Amring Pharmaceuticals, which positions itself as a company that “sells uniquely positioned and harder-to-manufacture generics that bring value to customers and patients,” will offer his insights on navigating the potential risks of those relationships.

Calibrate to Your Organization’s Size – Compliance Program Benchmarking Based on Company Resources

Anytime I see “benchmarking” in the title for a session, I am intrigued. It’s one of the reasons attendees are so interested in attending conferences like these, they want to benchmark their activities and programs against others in the industry. This hour-long session is divided into three presentations: How Companies Can Collect Leads and Advertise Digitally Without Violating Patient Privacy with Sharon Delshad of Nalpropion; Managed Markets Compliance – Mitigate Risks in Relationships with Payers; and Collaborate with Medical Affairs and Elevate MSL Oversight with Tim Ayers from Life Science Compliance Consulting LLC and Gregory S. Moss from Kadmon.

Summary

CBI has a well-earned reputation for organizing compliance conferences that bring together an impressive array of professionals and government representatives to share tips, best practices, and lessons learned. The 9th Annual Life Sciences West Coast Compliance Congress is no exception.

As a proud sponsor of the 9th Annual Life Sciences West Coast Compliance Congress, we can offer you a $500 discount on the regular registration price. It’s not too late to register at this special rate, but the discount certificates are limited. Contact me at smurphy@nxlevelsolutions.com if you are considering attending. If you’re already registered, we look forward to seeing you in San Francisco!

Thanks for reading!

Sean Murphy
Marketing Manager and Compliance Training Insights Blog Editor
PharmaCertify by NXLevel Solutions