November 16, 2020

Coffee & Conversation - Building an Effective Compliance Program: Key Considerations for the Pharmaceutical Industry

In this episode of Coffee & Conversation, Elissa McClure and Sydne Collier chat with Virginia Fitt, the head of commercial law and compliance at biopharmaceutical company ChemoCentryx. They talk about key compliance takeaways from recent settlements in the pharmaceutical industry, including the importance of "careful communications" and related protocols. Ms. Fitt also shares her approach to ensuring transparency around policies and guidelines, getting executive buy-in for compliance programs and using data to refine those programs. The conversation concludes with Virginia's insights into what makes for good outside counsel and what law firms can do to meet companies' expectations in this area.


Elissa McClure: Welcome everyone to Coffee & Conversation. Today my colleague Sydne Collier and I are delighted to be discussing building an effective compliance program and key considerations for the pharmaceutical industry with Virginia Fitt. She is head of commercial law and compliance at ChemoCentryx. After graduating from Duke Law, where I had the opportunity to meet her, she began her practice at a major international law firm and has had extensive experience bringing products to market and supporting major blockbuster products across a multitude of publicly traded companies. Virginia, welcome.

Virginia Fitt: Thank you for having me. I am joining with Coke Zero & Conversation, but I know many folks started the morning with coffee.

Elissa McClure: Excellent. Very good. Well. Without further ado, let's talk compliance.

Virginia Fitt: Sounds great.

Elissa McClure: So you have a lot of experience building an effective compliance program essentially focused on the OIG key seven elements that they have recommended that the pharmaceutical industry take into consideration while building a compliance program. So can you tell us a little bit about how that's influenced your training and your education and how that has specifically affected your role in your position at your current company?

Virginia Fitt: Sure. So, you know, in larger companies, often the legal and compliance departments are separate streams, but I've always had at least some crossover responsibility with a compliance program. And I have worked previously in a major international company that was also under a CIA as a result of a settlement. And so had a lot of experience with what the government expects from a compliance program and what they'd like to see. So that's a lot of my prior experience that I'm drawing upon now because we are at a pre-commercial posture for my current company and I have a combined role doing commercial law and compliance with the idea that eventually those departments will separate out as the company matures and grows. But I am the person who is starting to build that program, and so it's a really exciting time for us. One of the big moments, I think, for a commercializing company, there is a couple of major moments along the pathway. So one is filing — well, first is getting your positive results, and we've already gotten some of our positive phase three trial results — and then also filing your new drug application, your NDA. So then you have the acceptance of the new drug application, and you get what's called the PDUFA date, which is when you expect to hear back from the FDA on hopefully acceptance of your products, knock on wood. But we have a PDUFA date of July of next year. And so that's really the date that we're working for go live. Obviously, we would like to be prepared for our market readiness date and launch readiness. But another big moment for us is when you start to bring on the field and train the field for our sales team, and then you also have a field team of medical professionals. And so those are the people who will be interacting with healthcare practitioners and will be helping to share information about your product. So we're really building that program up from policies and procedures, monitoring, auditing and setting up the structure, as well as the training, for that field team, so that we'll be prepared for our hopeful launch for our first commercialized medicine in rare disease.

Elissa McClure: Excellent. And of course, we've seen in the news a lot of major settlements that are taking place or have taken place in the pharmaceutical industry. What have you learned from that, and what are the key takeaways from your perspective that maybe other people watching can apply to their roles?

Key Takeaways from Recent Settlements in the Pharmaceutical Industry

Virginia Fitt: So of course, there are certain areas that are going to be inherently higher risk. Those I think are products that are, have a higher likelihood of diversion or potential abuse, and where there may be a lot of value to patients but there is also a significant risk to patients. So hopefully one of those risk factors will not be present for us in terms of our mechanism of action for our proposed product and lack of a risk of abuse. But I think one of the key points and the key learnings from that is that we really need to stick to our values of putting patients first and ensuring that the way we're sharing information about our product leads to a lot of credibility for our company and helps us to effectively communicate both efficacy and safety information to healthcare providers and patients so that they can make informed decisions around the latest science. And of course, science is always a moving target because it's always evolving. We just closed a major National Congress, ASN, for nephrology, where constantly new data is being presented, but at least sticking to the current knowledge and being able to share that information. So that's one learning, I think, is being responsible with the information that we have and being truthful and non-misleading in promotion. I think one of the other learnings is to, from one major recent settlement, is to set up a program that has a structure that allows you to catch abuses of the program. There are a lot of spaces where it is not only important to provide transfer value to healthcare providers but actually critical. So if you think in terms of a clinical development, consulting with physicians who are actually seeing these patients in the clinic and understanding what the current needs are and how the product is performing and setting up clinical trials as well. So it really is important to use consultants in the healthcare provider world. However, there are ever more state laws that are governing how we can engage with healthcare practitioners and a federal transparency program as well on reporting those transfers of value so that at least there is a transparency with those relationships. I think one of the places that other companies have had a downfall is either a reversion to some of the earlier industry practices that have been started by companies that follow the PhRMA code or small situations of abuse that tend to grow and not catching those promptly. So I think that's the other area, is around monitoring and using data to monitor and then to help remediate those situations very promptly. So that tension will, I think, continue to be there in the industry because we do need to continue to have effective relationships with healthcare providers, and also to utilize their talent and skill and knowledge to help us in developing products that meet patients' needs and meet their needs in the clinic. So I think that will continue to be present, but I think we can draw upon both of those recent major settlements to understand some core principles we need to apply.

Elissa McClure: Right. You mentioned transparency and having open communications with your team to hopefully get out in front of any potential issues. Can you talk to us a little bit about how you apply that?

Virginia Fitt: Sure. So first of all, one of the major developments has been around the information that we are expected to share with the public and in the public domain. So some of those are state laws around pricing transparency. Some of those are state laws around marketing transparency. And I think having that open line internally first so that we are aware of all of the different places and have a full assessment. So I think an important part to building the infrastructure for a program that allows you to report out all of those transactions. So if you provide a lunch, for example, to a healthcare provider, that needs to be reported into a federal database with CMS. And so I think part of that building the structure, the first part, is going to be an assessment across the company of where are all the sources of where you may potentially provide any kind of transfer value to a healthcare provider. And of course, we have individuals with licenses who work at the company, and for example, interviewing expenses for prospective employees could be reportable as well. So there are a number of different places where those transactions could be occurring in the company, and one is making sure that we're ready for that commercialization because a lot of those laws first kick in for a company when they have a product that is reimbursable by the federal healthcare system. And so even though our company has been operating for quite a while and has been operating under a clinical development company, ethics and rules around engagements, now we are moving into a much more regulated space in terms of commercialization. So I think that transparency of understanding all of those different places and engaging in a risk assessment and a transparency assessment helps us to first get a handle on all of the places that may come into play. And then that will help us to ensure that we're appropriately reporting and that we're putting in place the right policies, the right procedures, the right check steps so that we can catch problems earlier and be able to analyze that for ourselves.

Elissa McClure: Absolutely. And I think you've talked to me a little bit about how you have this program of careful communications, that you really communicate and you hope that you'll get all of your sales representatives and everyone working for the company truly understands and feels comfortable using and applying. Can you talk to us a little bit about that? I thought that was very helpful.

"Careful Communications" and Implementing a Communications Protocol

Virginia Fitt: Sure. So I think one of the biggest risks to a company, particularly in an investigation, but really in any kind of adversarial proceeding or litigation, is around documents, and there are going to be — and I've worked at a company with 100,000 employees and I've worked at companies with several thousand, and now I'm at several hundred — but you're always going to have employees who are engaging in quick communication, whether it's by text or Zoom or email. And especially as we move into a more virtual world, I think these principles become even more important. And different companies have different training programs, but it's really around careful communications, and it's ensuring that our emails really reflect the conversation that was had or the intent. So it includes things around, for example, closing the loop. So often an email train will just sort of end, and from a documentary perspective, five years from now, it may not be clear that we then later had a meeting where we actually resolved everyone's concerns and issues. That may not have been documented, and so it leaves that chain unresolved. I think the other thing that is the key point is everyone stating things that are facts as known facts and things that are speculation as speculation. And of course, we don't want to discourage anyone from raising questions that are outside of their area of expertise because really one of the best things about working in the pharmaceutical industry is you have a lot of really smart people in a room who can contribute just with great ideas. So you don't want to stop that brainstorming or people who are raising concerns or objections, but I do think it's important that people qualify those statements, either phrasing them as questions or making it clear that they may not have the full background or that it's outside of their area of expertise, etc. I try not to draw medical conclusions as I don't have medical training, and so similarly, I would hope others would not draw legal conclusions without legal training. But of course, we want to continue to raise those because I do raise medical issues all the time and say, "Well, is this a potential issue for patients?" and I then rely upon your advice. So a lot of it really is around having values first, and then I think one of the things we've learned from prior litigation where we've seen other companies have major documentary failures is that sarcasm, jokes and sometimes the interdepartmental squabbles of a company don't necessarily translate well in emails, especially when something has gone wrong at the company. And those are pulled out of context, sometimes later, five or 10 years down the line. So it really is around trying to institute learning and training so that we're really building the record of the work that we have done at the company. And we want that record and that work to be something that we're proud of and that reflects what we're actually doing. Not that there are not problems and that we shouldn't discuss them, but that we're doing so responsibly and that we're closing the loop so it's clear from a documentary perspective where we landed, what concerns were resolved, what concerns may be outstanding and why we made the decisions that we did. So I think since we're still at an early stage, we have the opportunity to do that and set ourselves up for success and to really build upon some of those principles.

Elissa McClure: Excellent.

Sydne Collier: I think that's great. I know Elissa and I, and I'm sure you as well in private practice, have seen many examples of internal investigations where that sarcasm really just doesn't come across quite the same five years later. And I will tell you, Virginia, I am joining you for a non-coffee morning, and I'm going to opt for tea today in my whale cup.

Virginia Fitt: My job as an in-house counsel is to try to make your job as an outside counsel as boring as possible, especially in document review.

Creating Transparency Around Policies and Guidelines

Sydne Collier: I love it, love the boring ones. And Virginia, you mentioned just different state policies and federal disciplinary guidelines. How do you ensure transparency with these guidelines internally? And really, how do you want one, make sure your employees have access to these policies, and then two, that they actually understand the disciplinary guidelines that will mold what you all do?

Virginia Fitt: So I think one thing that's important, especially with a field-based employee group, is kind of having a central repository that everyone in the company has access to. And it can be high-tech or low-tech, right? Some companies have apps that are deployed for compliance to every field employee. Obviously, that's a significant investment, but really something as simple as a common SharePoint file that everyone can access at any time is important. Two, I think we're doing a lot with internal branding that will help the field know that there are resources that they can contact immediately, making that simple and a really open door policy. I think the other aspect of that is around bringing compliance in earlier. We have a dual function. We do have an investigatory and remedial function as well. But I think when we're up front and brought in as business partners, you can help to resolve problems before it occurs. So I think setting that tone that we are here to help and help you understand what the rules are and what you should do in a complicated situation is really integral to that. And I think also incorporating compliance in everything you do.

You can have your policies and procedures, and it is important to have training on the most important ones and the most relevant ones as well, but I think it's really important to incorporate that in everything you do.

So for me, it's important to have really supportive business colleagues who are incorporating compliance messages in the business conversation, so it's not just a corner where compliance is and it's kind of put into a compliance box, but it's really a consistent message that you're hearing across the company every time we gather.

Common Pitfalls for Commercializing Companies

Sydne Collier: No, that's perfect. And with these training policies — and you and Elissa just talked about some settlements — occasionally, though, firms are caught doing a few things that are wrong or in violation of those policies. What are some of the typical wrongdoings that you're seeing in the pharmaceutical industry, but specifically with the commercializing companies?

Virginia Fitt: Sure. So I think one of those areas is going to be, some of it is around budget and scaling up and what you prioritize to put in place first. I think the government recognizes that there is a significant investment in developing compliance programs and putting in that infrastructure in place. So at first, your financial infrastructures may be more basic and you're moving into a more integrated infrastructure. So I think one, some companies try to build everything themselves to a multinational company standard from the beginning, and I think that sets them up for failure. And so one of the things that I've been working with is third-party vendors who can come in and help to link the existing systems and back end programs that we already have. So whatever finance programs we have set up, our reimbursement, our purchase order and invoicing system, and connect those to gather that data from them, and then help us come up with a plan to internalize more of that work ourselves, but also make sure that we're working with vendors who are able to work with the systems that we have. And that's still a significant investment. It's quite expensive to put together a program from scratch and move into a new reporting structure. But pulling in really strong vendors who can work with what you have helps you be ready on time and be able to meet the needs of reporting. I think the second place where companies go wrong is around auditing and monitoring, and it can be really challenging to monitor a field-based employee force. Our industry was already spread out all over the country, and so now more companies are going to be facing some of the same challenges with having employees who are working from home and spread all over the country. Still doing some live monitoring, but I think ever more reliance upon data and using data to spot problems. And so I think that second step is important. And then engaging in ongoing risk assessments. So we've conducted a pre-launch risk assessment for our company and have identified areas of risk for us. But we will, of course, need to continue to engage in a risk assessment process, once that launch has already started and underway, so that we can continue to modify. So I think one of the other major problems is coming up with a plan and then not being able to modify that plan to meet needs as they're ongoing, and assuming that the needs from a compliance perspective always remain the same, which is not true.

Using Data to Refine Compliance Programs

Sydne Collier: That's perfect, and that actually blends into now kind of discussing data and just how do you ensure that there's periodic risk assessments are just based on continuing access to operational data and information across functions. I'm sure these vendors and just pulling that information help a lot with refining your compliance program.

Virginia Fitt: So I think one is communicating to executives the reason for the budget and why it's so important. And I have been really effective in having a really supportive executive team who, when I come to them with a presentation, I'm able to say that this is what the government is requesting as the ideal, and these are some of the features that are important to them and that we're leveraging data to be able to make those adjustments on a continuing basis. So for example, one of our vendors that we're bringing on can do all of this aggregation and reporting for us, but they also have a compliance dashboard that you can add on for a significant additional fee and be able to then review that. And so if you don't have a large number of personnel in your compliance program, you're in the process of growing that and building headcount — I think it's actually important for every company, no matter the size, to leverage data — but in that case, we can be really efficient. And so that significant upfront investment in those kinds of data analytics and systems can, to some degree, be as efficient as bringing on other headcount and full-time employees and, in some places, even more efficient. And so what we'll be able to do using these systems is to look on a healthcare provider basis at the transactions that are occurring or similarly be able to look on a regional basis for patterns or look at individual employees. So it allows us to do general audits, random audits, and then also allows us to engage in for-cause audits. So if there are problems that are occurring with a particular field employee, I can then go into these systems and then pull in all of their aggregated interactions and financial transactions involving a healthcare provider and spot that problem much earlier than sometimes on the back end, which is as an employee is exiting or with a whistleblower or when the government comes knocking. So I think being prepared in advance and being able to do that and be able to have a comprehensive solution where you can really look on different metrics and also look at it from different angles. So is it a potential healthcare provider who is a problem? Is it a potential field employee? Is it a group of field employees that are part of the problem? And look for patterns where things don't quite seem right and then digging in, because sometimes there is a reason, sometimes there is a misunderstanding, or they're doing the reimbursements incorrectly and putting things in the wrong category so it looks like you have expense in a category that you actually aren't having those actual expenses. And so I think, I always provide the benefit of the doubt, but you need to be watchful so that you can engage in that investigation. So I assume positive intent and work with the employee to try to figure out where the problem is. And then also, you can look for larger problems on where you need to do training.

My general philosophy is that if there's one employee who's doing something inappropriately, then it may be that employee either did not follow instructions or does not have positive intent and is deliberately flouting the rules, etc. If there are a lot of employees who are engaging in making mistakes, then that often means that there is a problem in our training or how we've communicated.

And so that can really be more of a headquarters problem, so we can spot those earlier as well with data analytics and saying, "Hey, everybody's making the same minor problem and we actually have 40 percent of people misclassify X versus Y," and that means we need to do more training from a headquarters perspective so that we're ensuring that we're communicating to them in a way that makes sense for their daily lives. And then also, it's that, helps with that adjustment. So if you see that there are common mistakes, it may be that we didn't understand or incorporate actual field practice, so what it's like in the real world versus headquarters' kind of "in theory." And so I think that's one of the other places where data can really help you understand and dig, know where to dig deeper and uncover those problems earlier.

Sydne Collier: Absolutely, and really to see that information flow and make sure, even if it made sense at the top, that the people who were actually out in the field understand it as well. That's great.

Elissa McClure: A lot of the DOJ settlements recently, sort of going back to the data issue, are including agreements that the company will ensure that all of their personnel across the board have access to data to ensure appropriate monitoring and catching any issues, hopefully before they become a larger issue. Do you have any advice on making sure that communication is sort of spread throughout the company top to bottom? Because I know you're talking about these different platforms and programs that you can use to gather and assess data, but I'm interested to see if — I assume the sales representatives wouldn't have direct access to that platform, but maybe I'm wrong, so I'd love to hear your thoughts on that.

Virginia Fitt: So there are there is actually some data that it increases potential liability for sales representatives to have access to, and most companies continue to provide a strong base level of compensation, but also provide incentive-based compensation. And so it's always a careful balance between what information is helpful to them to be able to perform and to provide information to physicians who need it at the time that they need it. And of course, as artificial intelligence and algorithms are providing ever more data, there are more potential signals for where physicians may be in terms of patients they're seeing or the decisions that they're making around treatment. And so, I think for that ongoing communication about what field sales representatives should have access to, I always will ask my sales team. So what compliant action can they take with the information that they have? Because with more data, there's always the desire to have all of that data, and one, for business purposes, it's really easy for field sales representatives to get lost in some of that data and over-analyze when really, it's, you know, some of the back to basics is sharing information and having live interactions with healthcare providers to be able to share information about our products. And then the other aspect of it is what can I, what action can I take? What can I do with the information that you've provided me? So one, if there's nothing compliant that they can do to engage based on the information that they have, then maybe they don't need that information. And I think that also dovetails with a lot of the privacy laws as well. We want to provide information that has a business purpose and use and not provide information to people who have no use for it. And then the other aspect is making sure that what we expect people to do with that information is communicated clearly. So are they able to then reach back out to the physician based on the information that they have? How should they do that? If they are not allowed to reach back out to the information, the healthcare provider based on the information that they have, then what's the value of providing that information to the field-based representatives? So I think those are our twin considerations with compliance in making sure that the data that's available to them is the data that can help them remain compliant and also the data that can help them advance the business objective in a compliant way. So, really making sure that we're articulating what it is that they can do with it and why they need it before just determining, yes, you can have that, no, you can't. So that's really, I think, the decision-making process that I'm engaging with, and that transparency that I engaged in with my business partners is, I need to understand what it is that we would expect them to do, and if there is something that they can do compliantly, then that's a stronger case for having the information.

Sydne Collier: And with transparency and filtering that information, making people feel comfortable and are relaying it back, I imagine that starts at the top. So how do you set the right tone at the top level to ensure it actually filters down in the manner that you want it to?

A Top-Down Approach

Virginia Fitt: So one, I have regular contact with our executive team, and I think that's an important part of a compliance program. And so they are aware of the general risks that are present in the company and do some education with them as well. But I think that awareness from their perspective is important, but also the ask, and so I have asked and shared, continue to incorporate some of these compliance principles. Some of them have done it even without that, that prompting, and we're still building a field representative force, and so I think it'll be integral that it's part of launch and that we really are talking about the patients. And I think we've all seen potential videos from launches, paths that are incorporated into late night shows or litigation and investigations where it was clear that it wasn't putting patients first. And so I think when people understand that what we're doing has a greater purpose and of course we would like to be commercially successful. That's important to our shareholders and we have an obligation to do that, and it's important to our patients that we're able to provide medicines. But we also have this very fundamental issue of retaining our license to operate and our credibility, and so that is the most fundamental thing that we must engage in. And so hearing that from the CEO, from your sales leader, from even your local team leaders, and having a consistent message all the way down is we're going to do this, but we're going to do it the right way and we're going to be successful for doing it the right way, and if we do things the right way, then the success will follow. And it's really, do we have a good product? We have the practices? Do we have good intent? And how can we incorporate that and translate it into commercial success? So that's really one of my expectations. I have a great team, and they're eager to incorporate this throughout, but hearing that message consistently instead of segmenting it as, well, now it's compliance time right and treating it — there are separate compliance trainings, of course, but compliance really should be a part of the main message as well. And to the extent that you have a supportive executive team, it's really easy to do that because it also makes the employees feel more valued in what they do and feel that they are contributing to something larger than numerical success for the company.

We all would like to win financially, but when you realize that a win for the company is also a win for patients and that's integrated, then I think that really helps employees to feel that they are doing something of value.

Sydne Collier: Absolutely. It sounds like the real goal was, like you said, just combining compliance with core values and just have it run throughout the company for a double win for all. I like it.

What ChemoCentryx Wants in Outside Counsel

Elissa McClure: It's excellent. It's inspirational, too. It's like, you can win and you can do it the right way, and you can make money. You can have it all. Excellent. Well sort of switching gears a little bit, in light of your company values, when you're going to hire outside counsel, we want to talk to you a little bit about what you're looking for. Obviously, that's something that's of interest to our firm. So when you are applying your values, how exactly do you go about that? Do you use data metrics? Are there certain things you look for in vendors or outside counsel? Can you tell us about that?

Virginia Fitt: So there's one thing that my CEO says during all of our Friday meetings. So we all gather, and before I joined the company, everyone would gather in person. Now we're all gathering virtually. And I love this, that the CEO says this, he always says, "And let's go do some science. Let's go do science." And a few weeks ago, somebody asked him, "How does that apply to me?" Because it used to be primarily a company full of scientists. He said, "Well, science is about knowledge, so 'let's go out and seek some knowledge' is what I mean. And you are all scientists by the way that you engage problems and the way that you seek to leverage new knowledge." And so I think what we're looking for there is outside counsel that shares that interest in innovation and being at the forefront and developing that knowledge. So "let's do some science" is what we're looking for. And then I think some of the other metrics are, of course, scientists and a science-based company are really good at managing budgets. So we want something that's efficient. And it doesn't always mean the cheapest. What it does mean is efficiency. So if there's something that can be resolved in a call versus a memo, then we'd rather have the call. And it's really around meeting needs. So there are some things that are proposals that have some flexibility, that may be capped, etc. So we're looking for innovation and efficiency there as well. And I think the other place that's important to us is seeing outside counsel that are respected in the field and are respected for their values as well and have credibility. And of course, it will become ever more important that they have credibility with the government and professional credibility as well. And so a lot of that does have to do with how they engage in an ethical fashion on behalf of their clients, and so never really sacrificing their belief and their core values. The other thing that I am specifically looking for is our patients and our employees and our healthcare providers and customers look like America, and I really want my law firms and vendors to look like America, too. So I want people to be represented, and I want to have that same, that we expect in our customers that same diversity that is wonderful about our company and about our patient population and the healthcare providers that we work with to also be present in our vendors.

Elissa McClure: When you go about looking for the diverse aspects of your law firms, do you request any specific data or information when you are trying to assess whether or not they sort of align with your goals?

Virginia Fitt: Sure. So we are still at a very early stage. However, I have previously worked at companies where we absolutely had metrics that we expected firms to meet, and if they did not meet those metrics, then we worked with them to develop a plan to help them meet those metrics, and that anyone we were engaging in a significant long-term relationship with and a significant investment on our behalf of placing a lot of our workload with them was a law firm that was going to be making advances in that respect. The other thing that I think is becoming more common, and it's something that's being talked about quite a bit in in-house circles and at conferences and conferences that I'm going to, is around, who's going to be working on my matter. Who do you have that can staff my matter? And I think it's important that firms not only bring out people for that purpose, but that the names that are billing on the matter do match up with the people who are being presented as available to work on the matter. The other thing that I think firms need to continue to think about is how credit is allocated for bringing in matters. And so it is very common, especially the concept of service partners and things like that, it is very common for people to put in significant work in developing the client relationship and being primary on particular client matters, but to not receive the bulk of the credit for that. And so we really do hope that firms will begin to change their practices and continue to change their practices to integrate a respect for the work that everyone is contributing and to how they're compensated on the backend. So that's still a new area for in-house to be talking about, and I know a lot of firms have not yet been responsive to that, but I think that it's an opportunity for firms to understand that we really want people to be rewarded for the work that they do for us and that the people who we see and communicate with all the time are also the ones who are receiving the back end credits. So I think also continuing to promote from associate to partner level. So there are a lot of senior associates who have really developed strong relationships with clients and making sure that the partnership continues to reflect that and continuing flexibility for employees. So I think policies around leave and things like that really help for individuals who just experience life, and whether that's through having children or elderly parents to care for or illness or disability, are able to then reintegrate into the professional life of the firm as well. And a lot of companies are working towards that. So we, as companies, have a long way to go, and I know firms also have a long way to go, but we're hoping that law firms will start on that path with us and continue to make strides along that. So I think some of it is around who's billing on the matters, what policies do you currently have that help you to retain employees through the associate lifecycle, and then also what are those metrics around diversity, and what efforts are you making. So I think being able to point to some of those as well. The other thing that I've heard — and I've heard this both from companies and from firms — is the talent's not there. And I think that represents a failure of innovation. One, the talent is there, and two, our jobs are to develop talent and to make sure that people are reaching their potential. And so if pipeline is a problem, then invest in the pipeline. And so that, I think, is important both from a corporate side, but also from the firm side as well. So those innovations that I would like to see in law as a lawyer are the same things that we're struggling with from a corporate perspective and hope that companies are making advancements on. But we want to continue to see firms evolve along that path with us and not after us.

Elissa McClure: Absolutely. And I know we have a lot of 2L scholar programs, things of that nature, where there is an effort being made to invest in the pipeline. But I mean, it's still, we're just so far from parity. There is, like you said, a long way to go. So we're optimistic and hopeful, but definitely a lot of work to be done. Sydne, did you have any more on that topic?

Sydne Collier: I do. Firms, it's no secret. I think that the law profession struggles with diversity, and the inequities are very apparent. But do you factor in the historical, I guess, efforts of a firm? Say, for instance, you have one firm that's always done really well and been upfront about putting diverse associates in place and they're actually billing boardings and you saw them progress from associate to counsel, versus a firm who maybe is jumping on this now and saying, "Oh, let me, let me have more diverse people actually included and learning and growing." Do you consider that at all in making your choice?

Virginia Fitt: So there are a couple of things. One is, some of it is about meeting people. And so, one great opportunity is women in life sciences, and when law firms send women or men to conferences where women in life sciences law gather, then we're going to connect and meet with people. And so that demonstrates a presence from earlier on. And so I know there are a lot of asks of firms to invest in this kind of marketing, but a presence matters. And so if I see someone on a panel or see someone that is attending an event for diverse people, whether or not they would count themselves as being in that group, I still think it's important for people to attend supportively and demonstrate support for the work that we're doing to advance women in life sciences law. That, I think, is helpful, and so I see those people as being allies. And then the other thing is that's where also we make connections with our potential outside counsel. And so, if we see someone who has consistently participated, if we see someone who has consistently developed a partnership where they are putting people who look like America forward, then I think that's important. We don't want to say that there's not an opportunity for companies and for firms to change their practices because I certainly don't want to penalize anyone for — I'd rather you get on the bandwagon and not at all. But I do think doing that earlier and investing earlier matters and also that it's a sincere and authentic effort. And so thinking about how you can continue to keep people. I'm at the point now where I'm seeing a lot of people that I went to school with or that I practiced with previously at the firms are now moving up and seeing who they were able to retain and how they retain them. Obviously, in-house lifestyle is a little bit different than the outside firm, but there are also people who just really enjoy that work of being able to kind of hop in on different cases and different matters. And then there are people who enjoy investing in one company and one industry and developing that knowledge. But I want to encourage anyone to continue to make those improvements, but those relationships matter, and the way you build relationships is over time and by being present. And so I think that's the real opportunity, is to develop people over time. And the firms that have been developing people over time are the ones who will have black partners because they've had black associates. And so that's part of that development, and so I think they'll have, certainly the leadership opportunities, but they need to continue to reinvest to retain that leadership.

Concluding Thoughts: The Ideal Firm or Vendor

Sydne Collier: I couldn't agree more. I mean, we can look at the partner board of many firms and say, and maybe be able to determine fairly quickly whether they have a pipeline that's worthy and that's successful. But this brings us to the ultimate question. And as we close this up, what — and I think I know the answer to it — but what can a firm or vendor do that just wows you, that they present something to you and you say, "I must have this firm or vendor representing and working with us."

Virginia Fitt: So I think outside counsel that just gets it, and that is a soft thing, but it's made up of some non-abstract components. So you've invested in understanding my industry. You understand my business goals, you understand where the product fits in the market and what our competitive landscape looks like. You also understand our values, and a lot of these things are available through our public statements, through our shareholder filings, etc., but really understand where we are. And then the other really important role, there's different things you look for in litigation versus ongoing advisory council. But what I look for in ongoing advisory council is, can they provide me what I need when I need it? And so is it, so I do need someone who's highly responsive, but it doesn't mean a significant investment any time. And so again, some of it's that cost consciousness, but it's really around what do I need and being able to provide that ala carte because that's the person that I'm going to invest with when I do have a significant project, is the person who has been able to help me meet my goals, which are in part budget-related as well. And also, it's that development of knowledge. So someone with a deep knowledge base can really pull things off the top of their head, and it saves research costs because they've invested in themselves as an asset to the firm. And so those are the kinds of things I look for. I tend to look quietly as well, which is by seeing people who are on panels and on, able to respond to questions off the top of their head at various congresses and conventions and things like that. So I am also watching there and then looking for someone like, "That person could be a real asset to me, and I don't really care what their hourly rate is because that person, I can make an argument that they're going to be the most efficient person to work with because they're able to do something that would take someone else many more hours to do. So it's worth paying more for that person's knowledge and experience." So, so that's the other calculus that I'm making. It's not always whose rates are lower, it's whose rates are most efficient for what they are able to offer and who is investing in themselves and thereby creating efficiency for me. So some of it is overt through presentations, and here's our plan for how we would address your litigation matter, etc., and then some of it is just that conscientious watching of what's going on in the legal world, other clients that you're representing and where I see you in my industry and at conferences and congresses and who I'm seeing as someone who's either a rising star or someone who has just a really sophisticated base of knowledge that I could draw upon and that will have a lot of credibility with my internal clients as well.

Sydne Collier: I have a lot of takeaways from our conversation, but I think what you just said, I'm going to steal your executive team's slogan. of "Let's do some science." Just get out there and learn, get the knowledge, keep learning, and I think that's probably a good path.

Elissa McClure: Wonderful. Well, I don't think I have anything else. Virginia, thank you so much,.

Virginia Fitt: Thank you guys. I really enjoyed the opportunity to have caffeine and conversation, since none of us actually had coffee today. But otherwise, thanks for having me. I really enjoyed speaking with both of you.

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