Lessons Learned for Compliance from the Global Pandemic

For a compliance partner, developing relationships with business units and the people within them, engendering trust, and creating an environment of collaboration is a challenging process, pandemic aside. However, since COVID-19 has forced companies and their employees to work remotely, new challenges for building relationships from a compliance partner’s perspective have emerged. In this episode of our Enforcement and Investigations Updates podcast series, Emily Hodge, a partner in our Government Enforcement & Compliance Group, is joined by Heather Golding, General Counsel and Chief Ethics and Compliance Officer at Sobi North America, and David Ryan, Vice President and Chief Compliance Officer at Epizyme, to discuss strategies compliance partners can implement to overcome a range of challenges in the virtual world.

Welcome to Choate’s Enforcement and Investigations Updates, hosted by our Government Enforcement and Compliance Group. In this podcast series, we discuss timely analysis of legal and compliance developments, court decisions, and changes in legislation and regulations.

Emily Hodge: Welcome Heather and David, thank you for joining me today.  My name is Emily Hodge.  I’m a partner in the Government Enforcement and Compliance Group at Choate.  As you both know, we’re going to talk a little bit today about best practices and lessons learned from COVID as it relates to managing compliance risks within life sciences companies.  And for those of you listening, Heather Golding is the General Counsel and Chief Ethics and Compliance Officer at Sobi North America and David Ryan is the Vice President, Chief Compliance Officer at Epizyme.  Heather and David both have extensive legal and compliance experience over many years so we are grateful to have you both here with us today.

Let’s start by talking a little bit about relationship development.  As we all know, developing relationships with the business, engendering trust and creating an environment of collaboration where folks feel that compliance is a partner and someone who can help them come up with creative yet compliant solutions is something we always struggle with, the pandemic aside.  But the pandemic has of course added some particular challenges in that regard.  David, do you want to start us off and tell us a bit about strategies you have implemented to tackle this challenge particularly in the remote COVID world?

David Ryan:  Sure, thanks Emily.  Thanks for having me on the podcast today.  I do think that building relationships of trust with our business colleagues is one of the most important components of an effective compliance program and a big part of that is having, what I think of, is a steady and practical approach to problem solving and analysis.  But another key part of that is really when we give the advice and in the moment is best and the moment it’s needed is even better and it’s usually done when we are in person in those hallway conversations that are harder to replicate when we’re in the remote environment and I do think it’s very important to maintain the ability to have those multiple touchpoints with compliance in the remote setting.  What I’ve done is to really embrace an open-door video meeting policy.  There’s a lot of talk of Zoom fatigue, but I think it’s critical to take the opposite perspective in compliance and essentially take every ad hoc spur-of-the-moment meeting that’s sought.  When people know they can just instant message you and get you on the video call with really little or no notice, they feel that it approaches that hallway chat and you can surface a variety of issues as needed for advice.  I think another strategy that is useful to leverage is training opportunities.  For example, in our company, we’ve continued to add employees during the pandemic.  We onboard them virtually including virtual compliance training and while I might normally leverage my team to perform some of this training, I’ve been performing almost all of it to establish those early touchpoints with new employees so they can really build that familiarity with me and feel good about coming in with questions.

EH:  Great, thank you, and Heather, I know this has been on the forefront of your mind as well.  So tell us a bit about how you’ve been managing this challenge. 

Heather Golding:  I agree with a lot of what David said and we really wanted to focus on making sure that we had the right touchpoints with people and I think something to sort of give us background is we had a lot of new people join our organization during this time both within the organization generally and then also within the legal and compliance team.  So it wasn’t just maintaining relationships it was a lot of developing them as well.  So, we did a couple of different things.  One is we’ve set up virtual office hours.  I know these are sort of more tactical things, but really times when people can just come to compliance and sort of ask any questions that they might have.  We’ve also made more of an effort, I would say to make sure that we show up at sort of functional meetings, franchise meetings, have our videos on, make sure we’re introducing ourselves so people get used to having us part of the team.  One other thing we did is - we’ve always had sort of meetings with field leadership and had members of the sales teams who are sort of the compliance liaisons, but we actually set up a couple of additional compliance liaison teams within our various sales forces and we’ve had meetings with those teams every two weeks just to sort of stay in touch to understand what’s happening and to continue to develop those relationships.  Another thing we’ve done, again sort of tactical, but I think it’s sort of interesting to think about these things is, we’ve had everyone in the company put together these “about me” slides that has a picture of you, sort of four different pictures that reflect who you are.  Things you like to do in your personal life, a little bit of your professional life and we’ve started a bunch of meetings with people sort of presenting those so everyone can kind of get to know each other and it takes you out of the box of just you know, I’m Heather, I was at Takeda before, now I’m at Sobi, and more of what you like to do in your life.  Because I think that’s one of the things that’s really been lost with, like David said, the hallway conversations and even just showing up to meetings live.  You kind of have that banter and the chatter before those meetings and that’s one of the things you really lose in the virtual environment so we’ve just been trying to find ways to create those relationships as well. 

EH:  Great, thank you both, those are very helpful insights and creative approaches to this challenge that we’re facing.  So, I want to talk for a few minutes now about life cycle considerations that have posed particular challenges in the time of COVID.  So David, you’ve had the experience of having to navigate a product launch including an added indication in the current environment.  So tell us a bit of what strategies you implemented or lessons you learned from a compliance perspective throughout this process.

DR:  Yes, so at my company, we launched our first ever product in January 2020, what felt like minutes before the world shut down before COVID.  Then we launched our second indication for that product in June 2020 really in the heartland of the pandemic time.   This presented challenges but also opportunities in a strange way.  So, for example, we launched our product with virtual speaker programs so the very first speaker programs we did were all virtual.  So our experience and well-trained sales representatives had a number of questions about how to do those programs compliantly.  So we actually had what I think was closer coordination with the field about the details of implementing those programs than we might have had absent the pandemic which really helped foster some of those relationships that Heather was talking about.  Similarly, once we did start in-person programs which we have begun as some of the restrictions have lifted.  We’ve been working very closely with the field to ensure that venues are appropriate.  So here we are trying to balance that and the considerations of privacy and making sure there’s an atmosphere that’s conducive to scientific exchange with the local restrictions which in many cases still say it has to be outdoors.  So, this is really a case-by-case analysis, less conducive to a mechanical SOP and more requiring in many cases a video walk-through of the venue each time.  Which is what a lot of our team has been doing, which has been very helpful.  I think also, launching a product in the pandemic raises some unique challenges and kind of a unique dynamic.  So for us, launching a product with a novel mechanism of action we were able to leverage a significant amount of interest that the medical community had in learning about this epigenetic medicine and so it was offering more than just your routine sales call on Zoom with the normally expected interaction.  There is just some more science to it.  Which I think was engaging for the people participating.  But on the other hand, a significant challenge was that and continues to be that with respect to doctors seeing their patients in person, some of that still hasn’t come back yet.  And in many cases in oncology, which is the area of medicine that we are in, in my company, particularly in the later lines of therapy, many physicians will not switch their patients to a new medicine without seeing them in person and those in-person visits have been slowed by the pandemic. 

EH:  Indeed.  All great considerations and Heather, you were leading the charge from a compliance perspective you mentioned earlier sort of adding a bunch of people, but on a significant acquisition and integration during this time.  So, tell us about the challenges that posed and the strategies that you implanted. 

HG:  One of the things is just to understand the framework – what we were in the environment that we’re living in when we did those integrations and acquisitions.  We had already started working with the business like every other company to understand how to continue to do their work in an effective way but also to obviously make sure that they were being compliant.  And one of the things that I think that we, as lawyers, really brought to the table for both compliance and from a legal perspective is, we do this all the time – right.  We have new sort of fact patterns and new things, we’re trying to sort of figure out, hey, how do we do this up against sort of the laws and regulations that we have and so where we were I think really agile and sort of innovative in terms of helping the business figure out what they needed to do in a way that still made sense.  Like, the swift move to virtual speaker programs, virtual meetings with doctors, how are we going to monitor and audit those?  Can we still bring meals?  So I think working through a lot of those things.  Then what we did is we had a merger of another company and then a couple weeks later we also had an acquisition of another product in North America.  So that also in addition to bringing new companies and new assets it also brought new ways of working.  Because we also brought in a number of different employees from those two companies.  So what we had to do I think what we focused on were two things.  Sort of being visible and then being you know innovative and agile.  So when I say being visible, same thing David said, we made sure we got in front of people at the beginning.  When it came to compliance trainings, making sure that people knew who we were, they knew where to go for information, they understood our processes, they understood our sort of overall approach to being in a compliant organization and one that puts the focus on ethics and value-based decision making.  Then I think also this agility and knowing that these other people at different companies have different ways of working.  And we had to make sure that they understood that sort of what Sobi’s way of working was, in order to make sure the company continued to be successful but also was doing it in a compliant way and one of the ways that we did that was we sat down and we wanted to actually make sure we really understood how people were doing their work at these other companies so that we could sort of help them understand where there may have been some differences and what the expectation is here.  But a lot of it still based on relationship building and making sure people had the right sort of connections.

EH:  Great, thanks so much and thank you both for your time today.  It’s always great to catch up with each of you and you bring such extensive experience and great insight to the table.  So we really appreciate hearing from you.

The information presented in this recording is for education purposes only.  It does not constitute legal advice for specific situations.  If you wish to obtain legal advice, you should retain an attorney and explain the facts of your particular situation.