A Preview of the 5th Annual Life Sciences Compliance Congress for Specialty Products

 

 

Cambridge, Massachusetts, the site of the 5th Annual Compliance Congress for Specialty Products.

The 2019 compliance conference season is just around the corner and the PharmaCertify™ team is gearing up for a slate of sessions beginning with a two-day stop at CBI’s 5th Annual Life Sciences Compliance Congress for Specialty Products.

This conference holds particular interest since the compliance challenges faced by specialty companies, including a number of our clients, are somewhat unique to the industry. With that in mind, I have perused the agenda for the sessions that look compelling for the specialty audience.

Day 1: Thursday, September 12, 2019

8:30 a.m. Keynote Panel: Focal Points and Top Enforcement Trends for Specialty

Set your iPhone alarm and don’t be late for the opening session! The enforcement panels are often a source of valuable information at compliance conferences in general and in light of the focus on specialty biotech companies in this conference, this is an intriguing choice to kick off the conference. Assistant U.S. attorneys from Massachusetts, New York, and New Jersey will join the panel to hopefully discuss the trends specifically relevant to this audience.

11:30 a.m. Creative Training Techniques for Out-of-the-Box Engagement

Okay, I confess, I am a little biased since this session will be moderated by my colleague Dan O’Connor. But being on the “inside” has afforded me the opportunity to hear and see the plans for the presentation and trust me, you don’t want to use this time to refill your coffee. Dan and the panelists from Avanir Pharmaceuticals, Sanofi Genzyme, and Sarepta Therapeutics will share real-world and tested techniques for creating and deploying training that sticks.

1:15 p.m. Where is the Line? Tackling the Overlap in Medical and Commercial Activities

Understanding the divide between MSLs and sales representatives remains a key topic for training consideration in the pharmaceutical industry in general. And that line does change over time. In fact, presenters at the 16th Annual Pharmaceutical Compliance Congress in April stressed that the recent trend toward a principles-based culture requires even more collaboration between Medical Affairs and Field Sales. Expect the panelists from Radius Health, Sunovion, TESARO, and Akebia to address that change.

2:15 p.m. How Far is Too Far? Navigate the Risks While Maintaining the Merits of Patient Support Activities

Patient support programs are in the news. I know…tell you something you don’t know, right? I find the title of this session interesting though in that it highlights the need for risk awareness while pointing out that the programs hold benefits for the patients that pharmaceutical companies are committed to serving. Keeping those programs compliant is a worthwhile and noble effort and we look forward to the panelists from Sage Therapeutics, Sanofi Genzyme, and Acceleron Pharma sharing their suggestions for accomplishing that task.

5:00 p.m. Networking Wine and Cheese Reception

While this may seem like an obvious choice for a favorite session (somewhat akin to saying “lunch” was my favorite subject in high school), I make note of it for reasons beyond the libations. The networking sessions at compliance conferences offer a great opportunity to learn from your peers in face-to-face conversations. You’ll even get to chat with the vendors who made the time and financial commitment to share their products and services with you. Don’t forget to stop by the PharmaCertify booth to say hi – the wine is on us! Oh wait…it’s already on CBI.

Day 2: Friday, September 3, 2019

8:30 a.m. The Impact of Recent FDA Guidance on Product Communications – Dramatic Change in Operations or Business as Usual?

After a review of Day 1 by the conference chair, Day 2 begins with this cleverly titled session. I admit, I was pulled in by the title and I’m intrigued to hear the answer. My best guess, based on recent presentations by the FDA’s Office of Prescription Drug Promotion, is that the truth lies somewhere between “dramatic change in operations” and “business as usual.”

11:30 a.m. Cell and Gene Therapies Learning Lab – Compliance Considerations for Highly Complex, Potentially Curative Treatments

While the two “comprehensive breakouts” scheduled for 11:30 a.m. both look intriguing and educational, I lean to this one simply because of the title. After all, what’s better than a specialty pharmaceutical product conference that features discussions about well…specialty pharmaceutical compliance considerations? This is a great example of how such smaller, more focused conferences can present learning opportunities that are rare in the larger compliance congress settings. We look forward to hearing the presenters from EMD Serono and IQVIA discuss how those considerations differ from the broader risks and concerns.

2:00 p.m. Fireside Chat What You Need to Know and What You Wish You Had Known – Compliance for the Beginner and the Expert

Great title!  Described as an interview session with participants from Sage Therapeutics and Acceleron Pharma, this is certainly a unique and bold way to end the conference. Hopefully, it fills attendees’ minds and notebooks with memorable tips, suggestions and reminders to help them build a stronger culture of compliance and reduce risk. Well played, CBI, well played.

Discounted Registration Fee!

As a conference sponsor, the PharmaCertify team is offering a discount registration voucher for the 5th Annual Life Sciences Compliance Congress for Specialty Products. Contact me at smurphy@nxlevelsolutions.com if you’d like to take advantage of this opportunity to network with your peers and hear industry leaders share best practices and tips for building, maintaining, and training on a strong compliance program. While at the conference, stop by the PharmaCertify booth to see demos of our newest Compliance Foundations™ eLearning modules, custom training courses and the newly updated Access LMS.

Thanks for reading!

Sean Murphy
Marketing Manager, PharmaCertify by NXLevel Solutions

Off-the-Shelf Compliance Training Myths

Myth #3: It won’t run properly on my learning management system.

In this third installment of our series on the myths associated with off-the-shelf compliance training, I discuss the concern that only training sold in conjunction with an LMS, or other type of online content delivery system, will run properly and accurately record data with that LMS. This theory is based on the idea that training modules from other vendors are not developed with the specifications of that system and therefore hold the potential for technical difficulties and “clunky” performance.

So, if you’ve already committed to an online compliance training content management system, the only way to ensure eLearning modules function correctly is to utilize the training that is packaged with the system, right? In a word…no.

The Myth 

Companies selling whole compliance training systems are understandably interested in fostering the notion that customers have no need to search elsewhere for training after they have made the commitment to purchase an enterprise-wide system to manage and deliver compliance training. The modules are a natural extension of the core product and offer myriad opportunities to garner additional revenue throughout the life of the system contract.

Adding fuel to the “it won’t run properly” fire is the idea that since there are so many varieties and brands of systems available to life sciences companies, including the large, well-known names; small systems targeted to compliance; industry upstarts; and systems intended more for GMP training where 21 CFR Part 11 compliance is a requirement, consistent performance across all platforms must inherently be a difficult, if not impossible, challenge. It’s a logical conclusion, even when SCORM compliance is factored into the compatibility equation as indicated by the fact that LMS compatibility continues to be one of the first questions our clients ask when we map out a strategy for deploying our Compliance Foundations™ off-the-shelf eLearning modules.

The Reality

If an LMS is built to modern specifications by a technical team that understands the need for it to house a range of training types, and the training is built with an eye toward flexibility and SCORM compliance, compatibility and performance of the individual components should never pose a problem. An effective compliance training curriculum requires a thoughtful and well-planned mix of training modalities delivered continuously across a learner’s timeline. That formula sometimes consists of elements from a variety of development vendors and the ultimate success of that curriculum must never be threatened by the limitations or lack of flexibility on which the training is housed.

So not only is the suggestion that off-the-shelf training won’t run properly on a wide range of systems a misleading and counterproductive myth, it is anathema to the very notion of what is at the foundation of successful compliance training.

The Bottom Line

In 15 years of delivering online life sciences compliance training, the technical team behind PharmaCertify has never faced an LMS communication and compatibility issue we could not overcome quickly and efficiently. The training we build for our pharmaceutical and medical clients is launched on systems large, small, and everything in between. Communication with the LMS team on the client side is key and early in the project, we learn the specifications of the system and provide a test module to that team to ensure seamless integration into the LMS.

Since we work with companies in various stages of training preparedness, including some that do not have an LMS in place, we also offer our Access LMS as a cost-efficient solution for deploying training to employees and third-party vendors alike. But, no matter the LMS, our first goal is to ensure your training reaches your learners according to your planned schedule and without technical concerns, and the critical completion and reporting data you need to verify learner compliance with your training curriculum is accurate, accessible, and reliable.

To see a demo of the PharmaCertify compliance training solutions, including the Access LMS, contact Dan O’Connor at doconnor@nxlevelsolutions.com.

Thanks for reading!

A Preview of the 2019 Pharmaceutical Compliance Congress

The 16th Annual Pharmaceutical Compliance Congress is scheduled for April 16-18, 2019 in Washington DC.

The 16th Annual Pharmaceutical Compliance Congress begins April 16-18 in Washington DC and as is often the case, the agenda promises a compelling mix of presentations covering topics important to new and experienced compliance professionals alike.

Tuesday, April 16th is dedicated to the Congress “prelude” and one of the sessions looks particularly interesting based on its subject matter. Nurse educators are a trending topic in life sciences compliance with the potential for patients misinterpreting the line between medical advice and a commercial sales pitch. The description for the Compliant Nurse Educator prelude includes the timely suggestion that attendees will “gain foundational and operational needed to structure and maintain compliant programs.”

On Day One, Wednesday, April 17th at 11:15 AM, the Highly-Acclaimed U.S. Healthcare Fraud and Enforcement Panel begins with current prosecutors reviewing “Top Enforcement Trends and Focal Points for 2019 and Beyond.” During the Former Prosecutors Panel that follows, three former Assistant US Attorneys will focus on “New Developments on High-Profile and Settlements Uncovering Healthcare Fraud.” The perspective from the regulator side of the table is not readily accessible outside of this type of conference and attendees will be listening carefully for suggestions and tips from those responsible for regulation.

Following the networking lunch (important tip: the networking sessions offer great opportunities to learn from your peers), Day One continues with a series of “content streams” divided by general topic matter.

Patient assistance programs (PAPs) and Patient support programs (PSPs) are certainly under scrutiny (see our recent blog post on the programs here), so we have to recommend Content Stream A: PAPs and PSPs. A team of panelists, including Jennifer McGee from Otsuka, Chetan Shankar from GSK, Francisco Ribeiro Filho of Tesaro and Ann-Marie Tejcek of Eli Lilly will speak in two sessions: Navigate the Complex Legal Landscape of PAPs and Examine PSP Enforcement Trends as Scrutiny Heats Up. Content Stream C: Transparency and Aggregate Spend is also of interest considering the pending expansion of the Sunshine Act to include Advance Practice Nurses and Physician Assistants. It’s time to update that Sunshine Act and Open Payments training!

A series of interactive workshops follow the content streams and I’m looking forward to the Beyond Due Diligence – Auditing and Monitoring Third-Parties session, in particular. Third-party vendor compliance continues to be an area of focus in the industry and Lori Queisser of Teva should bring an important global perspective to the challenges of bringing vendors into compliance as they conduct business of the company’s behalf around the world.

Speaking of hot topics – Interactive Workshop 4: Risks Associated with the Hub and Field Reimbursement Teams so I expect the impressive list of panelists, including Sarah Whipple from Akebia, Joe Philipose from Alexion, and Richard Konzelmann from Sanofi to be speaking to a crowded room of attendees anxious to hear how they are managing the compliance risks that are inextricably linked to the use of Hubs for specialty products.

After a networking and refreshment break at 4:25 PM (don’t forget to stop by the PharmaCertify Booth to see demos of our newest compliance training products), the conference transitions to a series of “think tank sessions.” Frankly, I am not sure of the difference between a workshop and a think tank, but I suppose the changing up the name does make for a more organized agenda.

Anyway, on the think tank front, the Speaker Programs – Best Practice Benchmarking is right at the top of my list. Our recently completed Managing Speaker Program Risk Compliance Foundations™ module is already popular among our client base and for good reason. The programs are fraught with risk at every stage, including planning and execution, and this session, featuring Jennifer McGee from Otsuka again, as well as Maggie Feltz of Purdue Pharma, and Rebecca Spitler of Johnson & Johnson, should prove to be a valuable primmer on how to navigate those risks.

Add Social Media – Practical and Pragmatic Guidance to our target list among the think tanks because, well, it’s social media. We’ll also be in the PAP and PSP Benchmarking – How is the Industry Adapting? think tank to hear how Casey Horton and Stefanie Doebler from Navigant are working with their clients to help minimize program risk.

Day 1 closes with an end-of-day cocktail reception and I do recommend taking the time to attend this important networking event before you run out to dinner. It’s a great opportunity to interact with your peers and learn how they are dealing with some of the same challenges you face every day.

Following the Chairman’s Review of Day One, Day Two, Thursday, April 18th opens with an interesting session titled, From the Trenches: An Inside Look at the Forces and Pressures that Drive People to Violate the Law. The idea of approaching compliance from a higher “ethics” level has been a topic for discussion in recent years and companies are clearly seeking ways to integrate the concepts into their policies and procedures. I’ll be interested to hear how the speaker, who is the CEO of Business Ethics Advisors, LLC, how is working with clients to do just that.

After a session dedicated to recent trends in enforcement, featuring Eric Rubenstein from the OIG and Heather Johnson from the FTC, the agenda takes a turn to the future with Rethinking the Compliance Profession Where Should We Go from Here? Including such forward thinking presentations is appreciated and this look at the future of the industry should dovetail nicely from the opening session on ethics.

Next, attendees choose from what are described as “five in-depth summits.” The Small to Mid-Sized Company Resource Center holds interest for me based on the uniqueness of its title, and simply because I find the small to mid-sized company focused sessions so informative from a standpoint of learning what those with limited resources are doing to address the same challenges their peers at larger companies face.

With HCP interactions still representing so much of the compliance risk companies face, the Compliant Patient Interactions summit should be worthwhile, with an impressive array of industry professionals ideally sharing tips and suggestions for ensuring those interactions are conducted in a compliant manner. Hopefully, training is included on the list of talking points.

Following the final networking luncheon, the conference closes with the reveal of an inaugural benchmarking survey. The agenda does not list what organization conducted the survey, but I’m sure attendees will be listening closely to learn what their peers from “brand/generic, large/small and private/public” companies consider to be their top priorities on the established and emerging compliance risk areas.

Summary

The panel presentations, workshops, think tanks, and summits I touch on in this preview represent just a few of the sessions CBI has planned for this year’s conference. The Pharmaceutical Compliance Congress never fails to deliver the content and networking opportunities industry professionals need to stay abreast of current risk areas, policies, and best practices. I highly recommend the conference for the new and established life sciences compliance professional.

If you are considering the conference but have yet to register, we are still offering discounts on the regular conference registration rate. Contact me at smurphy@nxlevelsolutions.com if you’d like to take advantage of that discount. If you are attending, don’t forget to stop by the PharmaCertify booth to say hi and let me know what you think of our blog. As always, your feedback is appreciated.

Thanks for reading and I will see you in Washington!

Sean Murphy
Editor
Compliance Training Intelligence Blog

Lessons Learned at the 2018 Pharmaceutical and Medical Device Congress

Lesson 3: Learning to Listen

“There is only one rule for being a good talker – learn to listen.”
Christopher Morley

The importance of effective communication and more specifically, listening, wasn’t lost on the speakers at the 19th Annual Pharmaceutical and Medical Device Compliance Congress. The consequences of poor listening were summarized by one panelist on the Qui Tam Roundtable when she said, “the vast majority of whistleblowers who contact me have tried to report their concerns to the company, but the company didn’t want to hear it.” In an era when the nuances of an effective compliance program are discussed and debated in detail, the simple yet often lost art of effective listening needs to be a priority.

The value of listening extends across all departments and business units and it starts with field-based employees. A presenter in the Compliance Considerations for Small to Mid-Size Companies session echoed that sentiment, saying, “the stream of questions from the field is not going to stop, but those questions tell a story and you need to monitor them carefully and build your plan from there.” The data from those responsible for interacting with healthcare professionals is critical as you evolve your program and look for gaps and redundancies that need to be addressed in personal interactions and in your continuous training curriculum. And listening for that data begins with open, non-judgmental relationships across the company. Or, as another presenter in the Compliance Considerations for Small to Mid-Size Companies session stated it, “when employees interact with the compliance department, they should not feel like they are being judged.”

The need for open lines of communication doesn’t stop with the field. The industry trend toward “building a culture of ethics and compliance,” and frankly, the regulatory focus on the culpability of those in the C-Suite and boards of directors, more than ever, dictates the need for open and regular communication with company leadership. The proverbial “seat at the table” for Compliance extends upward in the organization. As was stated during the AUSA Roundtable, “Compliance should have a good relationship with the Chief Executive Officer, and the officers of the company. The two departments need to communicate openly and honestly.” He continued, “when issues do arise, the Department of Justice needs to see that you are being proactive and responding to those issues.” In other words, listening to one and another.

During the Chief Compliance Officer Roundtable, the risks associated with the use of third-party vendors was discussed in detail and the need for open lines of communication beyond the walls of the company was stressed. “Work with the stakeholders in the third party and make them feel like you are partnering with them,” one participant said, “be transparent, if you hear that people aren’t disclosing information, that’s a warning sign. If there is any confusion, ask questions.” And listen carefully to the answers.

The key takeaway: to build a truly effective and modern compliance program that proactively addresses the risks across the organization, a policy of open communication must be established from the top down. The concept of an ethics-based approach to compliance may seem nebulous and difficult to quantify, but it begins with fostering a level of respect across the company. And respect begins with real listening. When employee questions, feedback, concern, and complaints are welcomed, appreciated and nurtured in a respectful manner by Compliance and the C-Suite, all aspects of the compliance program, including the training, are enhanced.

Thanks for reading! I welcome your feedback.

Sean D. Murphy
PharmaCertify by NXLevel Solutions

Lessons Learned at the 19th Annual Pharmaceutical and Medical Device Compliance Congress

Lesson 2: The More Things Change…

Tessa Hoyer of PharmaCertify greets attendees at the 19th Annual Pharmaceutical and Medical Device Compliance Congress.

The French journalist and novelist, Jean-Baptiste Alphonse Karr, is credited with coining the phrase, “the more things change, the more they stay the same.” For anyone who has attended multiple compliance conferences in the last five years, his words certainly ring true. Terms like “partnering with the business,” “tone from the top,” and “third-party risks” are still staples during conference presentations and this year’s Pharmaceutical and Medical Device Compliance Congress was no exception. For good reason.

As an example, the Compliance 3.0 presentation on Day 2 of the conference began with one panelist expressing his concern that “we still have to fight for a seat at the table.” In other words, while the concept has been bandied about for years now, the reality is that raising compliance to the organizational level of respect it requires to affect true behavior change is still a struggle. He and his co-presenters emphasized the need to not only find that seat alongside the businesses but truly understand their business policies as well as what they do and who they are. As another presenter put it, “bring value to the business as a compliance representative, educate them every step of the way, and help them educate their people.” She added, “when they get to the point where they are doing it themselves, that’s nirvana.”

Not surprisingly, the need to train and manage third-party vendors continues to be stressed. In the session covering the Foreign Corrupt Practices Act, one government representative even delved into the need to extend the corporation’s culture to the vendors. She added “you really need to know your third-party vendors and they need to understand you. You need to know who it is that is making payments on your behalf.” The presenters in the Third-Party Lifecycle Management session agreed, citing the need to “have vendors take the same training that is rolled out for your employees. Treat them as partners and make sure they understand the risks involved.  They are more likely to care about being compliant if they feel like a partner and if they will be held responsible.”

As with the conversation and debate over an “ethics-based approach to compliance,” concepts like “tone from the top,” “partnering with the business,” and “third-party risks” warrant our focus and consideration simply because they are that relevant and critical. Industry conferences offer the valuable opportunity to hear our peers share their latest insights and success stories around the themes that seem to drive the conversation. While the world of life sciences compliance is evolving, in some cases, the more things change, the more they stay the same…at least at the compliance conferences.

Thanks for reading!

Sean Murphy
Editor
Compliance Training Intelligence Blog

Lessons Learned at the 19th Annual Pharmaceutical and Medical Device Compliance Congress

Lesson 1: Rules and principles can coexist.

Welcome to the first in a multi-part series based on lessons learned from the recent Pharmaceutical and Medical Device Compliance Congress in Washington D.C. Our goal in this series is to share best practices and tips for strengthening your compliance culture and reducing risk based on the themes and best practices heard during the three-day conference and provide suggestions on implementing those concepts from a training perspective. We begin this week with a twist on a topic that has been on the agenda for a few years now…rules vs. principles.

During the Compliance Considerations for Small to Mid-Size Pharma and Device Companies panel presentation, a team of industry compliance officers and consultants discussed the challenges and opportunities brought on by limited resources and personnel. The suggestions were varied and intriguing, but one stood apart for me, especially from a training perspective. When he was offering the details of how he approached his transition to a small company compliance department, one chief compliance officer said, “it’s important to start with foundation training, and then have a conversation about culture.” In the milieu of conversation about the importance of principles, and the need for “an ethical approach to decision making,” it was refreshing to hear acknowledgement that rules-based and principles-focused approaches can co-exist and work in conjunction.

Foundational training lays the groundwork for the rules and policies that are critical for all life sciences employees to understand and incorporate into their daily activities. Although the “check the box” approach to training has been much maligned in recent years, being able to document that your staff, especially those who interact with healthcare professionals on a regular basis, have successfully completed training in topics such as HIPAA, on-label promotion, the False Claims Act, and the Anti-Kickback Statute, is a critical first step. Once that foundation is established, on-going opportunities and touchpoints can be utilized to establish the “why” behind the decisions as you strive to strengthen the culture across the organization.  As was emphasized during the presentation, you need to “have a plan that builds across all work streams” to do that throughout the year. As one example, workshops with interactive activities that immerse employees in ethical scenarios are an effective method for reinforcing the principles. In addition, assessments, microlearning, and games deployed across an employee’s timeline remind learners that compliance isn’t just about rules and regulations, it’s about “doing the right thing, for the right reason.”

During the Chief Compliance Officer Roundtable at the conference, one participant made the point that “a principle-based philosophy helps ensure compliance throughout the company and not just at the surface level.” That’s certainly true, but from our perspective, a principle philosophy is more effective when its built on a solid foundation of policy and rules-based training.

Thanks for reading!

Sean D. Murphy
Editor
Compliance Training Intelligence Blog

Key Takeaways from the 2018 Compliance Congress West

Early morning over San Francisco, the site of the 2018 Compliance Congress West.

To say the audience at the 19th Life Sciences Compliance Congress West was energized and engaged is an understatement. The size and scope of the two-day conference led to unusually interactive discussions, with the audience eagerly sharing their experiences along with the presenters and panelists.  For someone relatively new to the field of life sciences compliance training, I found the exchange of ideas and advice quite educational and enlightening.

PharmaCertify was there as a conference sponsor and we found an agenda filled with information designed to help attendees strengthen their compliance cultures and reduce risk, which of course is a mission close to our hearts from a compliance training standpoint.  Here are my takeaways, with a focus on training of course (it’s what we do):

1. Build an ethical culture, not just a compliant one.

This was a recurring theme, and it’s a compelling one. On the surface, the line between ethics and compliance may appear inconsequential and not significant enough to be worthy of consideration. But more companies are evolving away from a rules-based approach to compliance to one that stresses ethical decision making as the foundation for their principle-based policies. It begins with a question: are people doing the right thing when no one is looking?

For us, the answer begins with a new approach to training. Modern life sciences companies need to teach the value of ethical decision making, and not just recite the rules and regulations. Training needs to instill in learners the understanding that the company trusts and expects them to do just that.

2. Hubs are in, so get that training out!

Patient support hubs are trending, and since they serve as the “connection point” for so many stakeholders (patients, providers, and physicians), they come with a high level of risk. With the influence of commercialized companies, and the lack of guidance from the Office of Inspector General and Department of Justice, patient support hubs are a hot bed of kickback and false claims risks.

Job aids, clear business rules and program guidance, and a robust training curriculum are necessary to mitigate that risk. All parties involved, including vendors, must be continuously trained on how to interact with patients and understand what they can or cannot say and do.

3. If you think PSPs and PAPs are in the regulatory spotlight, you’re right.

The scrutiny on Patient Support Programs (PSPs) and Patient Assistance Programs (PAPs) is intensifying, with a growing number of settlements (Jazz Pharmaceuticals, United Therapeutics) raising questions over the idea of companies donating to independent charities. In addition to causing potential false claims and HIPAA violations, the donations raise concerns that they may be intended to induce patients to purchase certain products and implicate the Anti-Kickback Statute.

As was highlighted during the conference, PSPs and PAPs can be beneficial to patients, but commercial organizations cannot have any influence on the support being provided. Training needs to emphasize that sales representatives are not permitted to discuss specific PAPs or disease state funds with patients or healthcare professionals. And as prescription costs climb, the scrutiny and risks will continue to grow.

4. Nurse Educators: Are they here to stay?

The jury is still out. As defined during the presentation on nurse educators, “white coat marketing” refers to the use of healthcare professionals in marketing or sales activity, and therein lies the risk with the use of nurse educators. According to the Office of Inspector General (OIG), the practice is scrutinized under the Anti-Kickback Statute because patients rely on the advice of physicians, they may “have difficulty distinguishing between medical advice and a commercial sales pitch.”

Recently unsealed qui tam cases highlight the risks and cause for concern, with one company deploying “nurse ambassadors” directly to patients’ homes and another implementing nurse-led adherence programs designed to increase product refills. Patients tend to trust the opinion and advice of their physician, and by extension, their nurse educator. However, it can be confusing for a patient to decipher advice from marketing, and exposure points emerge when nurse educators are trained similarly to sales representatives and conducting calls with those representatives. Asking yourself key questions about the training:

  • What materials do the nurse educators use (disease state, promotional, fair, balanced, etc.)?
  • Does the training focus on adherence and education instead of sales and marketing?
  • Does the training resemble sales training (e.g., overcoming objections, cold calling)?

5. Speaker Programs: How is this still happening?

The idea that speaker programs bring high levels of risk is not a secret, so much so that one audience member even asked, “how is this (insert expletive) still happening?” Good question. Selling in the life sciences industry is a relationship-based activity, and back in the “good old days,” there was little monitoring around meals, vacations, golf outings, etc. Now, the risks are rampant and include speaker selection (make sure they are credible), payments, receipts, the amount of money spent, spouses or guests in attendance, and analytics. The panelists also used Insys as a case study for the importance of communication, particularly email. Multiple documented emails within the company revealed how they were trying to utilize speakers. Training needs to emphasize the need for open, honest and communication, with no hidden agendas because as was quoted about the Insys case, “it takes a very long time to turn your ship around.”

6. Calibrate Your Compliance Training for Greater Impact

There’s plenty of guidance available from the DOJ and OIG to assist ethics and compliance professionals with determining their training priorities. The OIG guidance alone offers 49 distinct metrics for communication, education, and training. It can be a bit overwhelming, so what’s a compliance officer to do?

A presentation by Dan O’Connor of NXLevel and Jeremy Lutsky of Theravance offered attendees a practical framework for designing, developing, and implementing compliance training, beginning with the questions, “Is there a training need?” In other words, is there actually a knowledge and/or skill deficit or is there a problem with incentives, motivation, unclear expectations, etc.?

Assuming there is a training need, ethics and compliance officers can use the long-established ADDIE (Analysis-Design-Development-Implementation-Evaluation) process to efficiently attack the problem, beginning with analyzing risk by role in the organization. Several pragmatic approaches were shared by Dan and Jeremy, including use of the “3F” Curriculum Framework, Bloom’s Taxonomy, and a structured process for evaluating existing training.

7. The food choices in San Francisco are, well, pretty good.

The restaurant choices are clearly bountiful in the City by the Bay and we leave you today with a brief note on two that we enjoyed during our stay:

We couldn’t resist the chowder at the Hog Island Oyster Co. and we weren’t disappointed!

The Hog Island Oyster Company is nestled in the Ferry Building Marketplace, where you can watch the ferries come and go as you enjoy freshly-shucked oysters on the half shell. Choose oysters from various locations or order a dozen or two to try them all! They all come with a fresh vinaigrette or cocktail sauce if you so desire. While their main stake is oysters, the rest of the menu is not neglected. The chowder comes stacked with clams in a nice cream base with veggies, potatoes, bacon and cheese! And the fish sliders are perfectly crispy paired with a tangy coleslaw that compliments the fish nicely. From the bar, the Chardonnay from Napa was crisp and light, and the Wolfback Ridge IPA was a perfect pairing for the fish sliders.

The Douglas Room is a quaint restaurant located adjacent to the Tilden Hotel that offers a boutique gastropub vibe to transport diners to another time (think speakeasy era). The talented mixologists curate creative spins on classic martinis behind the bar to help authenticate the experience. For dinner or late-night snacks, the innovative menu features locally sourced and seasonal ingredients. We enjoyed the shishito peppers, duck confit wings, wedge salad, and Tilden burger. The portions were perfect for sharing, and the presentation was stunning. We’ll be back when the conference returns to San Francisco!

Tessa Hoyer, PharmaCertify by NXLevel Solutions