Before this week's interview with Kelly Willenberg on marketing events as networking tools in the life sciences, Darshan will introduce this episode with a recap for the week of Thursday, May 28th, 2020.

Darshan: So, as usual, this has been a busy week for COVID, and we'll talk a little bit about what are the updates in COVID based on what the FDA is doing. The agency took this opportunity to put out a guidance document called Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency. It came out in March, and it talks about information on reporting serious, adverse events amongst patients with COVID-19, and this obviously impacts clinical trials on developing therapies, also for non-covered conditions. This also looked into real world evidence and real world data, and the FDA actually created a partnership with a private company, and they believe that data sources such as electronic health records, insurance claims, patient registries, and lab results, will be used to inform the national response to the COVID-19 pandemic. So, this is great.

Darshan: This obviously raises some privacy concerns, so we should be careful about that and to see what the impact of that is going to be. If you are going to be subject to it, something to consider is HIPAA privacy issues.

Darshan: The next question to look at is questionable test performance. And there are concerns that the COVID-19 diagnostic tests by Abbott ID NOW point-of-care test, it may result in false negative results. And the problem with this is a lot of people are using these tests as FDA-approved. They're, in most cases, never FDA approved. They're sort of permitted to be on the market. The question to then take is, if there's a high enough level of false negatives, you're now looking at problems of people who tested negative, still have the symptoms, and are now spreading it, because they have this false sense of security.

So, are the rapid actions of the FDA in the public interest or are they actually falling out of the public interest? And the FDA is, without a doubt, in a very tough spot, but obviously it becomes the question that they need to evaluate. And these are judgment calls. That doesn't mean that the FDA is sort of only looking at approvals. This is also the opportunity where the FDA is looking at shitty products. There are multiple groups that the FDA is sending notes to. They're working sometimes with the FTC, sometimes alone, and sending letters to companies such as Energetics, Noetic Nutraceuticals, Golden Road Kratom, White Eagle Native Herbs, and Benjamin McAvoy, an Amazon associate firm. And these were all making claims that they could cure or treat COVID-19, which is obviously problematic.

Darshan: If you have questions about what COVID-19 means to you, if you think I missed an important bit of news, feel free to reach out to me, or leave a comment, or hit the subscribe button.

Darshan: One second here. I'm almost done looking at something here. Sorry for the delay here.

Kelly: No problem. Hey Kelly.

Darshan: Hey everyone. Welcome to another episode of DarshanTalks. We have Kelly Willenberg from Kelly Willenberg & Associates. I've known Kelly for a very long time, and we've been to many, many conferences together. We've worked together, and she is generally awesome. So she has my vote of confidence, if you will, but I'm really excited to have her on because she has some really unique perspectives to share. We're going to land up talking a little bit about conferences and we're going to land up talking about how those conferences are changing in this world of COVID and what the impact of that is and how we engage going forward. Kelly, you want to talk a little bit about what you do and how you work in clinical research?

Kelly: Sure. Hello. Good morning everyone. Thanks, Darshan for having me. I started this business about 12-and-a-half years ago, and I am a research healthcare compliance consultant, trainer, national speaker. I consider myself someone who leads the industry in clinical trial billing compliance. I have 15 people who work with me as independent contractors around the country. We do everything from a training and education and seminars and conferences to clinical trial billing audits, GCP audits, helping to start clinical trials offices, doing IRB work, doing contracts, budgets, consents, and coverage analysis work. Just a vast array of anything research compliance today.

Darshan: So couple of things to that, Kelly. We'll dive into this a little bit further, but you talked about clinical research billing. When I talk to people, they sort of look at me like, "Why is that a specialized field? It's something we do every single day. Why is that even necessary?" How did you develop your name in it?

Kelly: Clinical trial billing compliance revolves around submitting a proper claim to a payer, including the government payers, Medicare and Medicaid. That revolves from the start of the Clinical Trial Policy, which started in 2000, which basically took the Medicare rules, so to speak, and expanded those rules around what you could send out on a claim as a routine cost and a qualifying trial. For the lay person out there, most of the time they're going to call it, what is standard of care and how can I bill it?

Clinical trial billing is rather tricky because you have a lot of nuances and rules around Medicare contracting regions. You have a lot of significance with a drug trial in Medicare Advantage plans. And it is a science to be able to take a trial, evaluate what in it is research related and what in it is allowed to be billed under guidelines and rules around Medicare and other impacting things that's going to come out on a claim with a code and modifier. And the fact that you have to get all that right so you're not submitting a false claim to the federal government.

Darshan: Yeah, something you should be worried about. False claims to the federal government is not really where you want to be.

Kelly: Definitely.

Darshan: People like Kelly are the ones who are going to stop and help you prevent that. But Kelly, one of the key things, and one of the reasons we've known each other all these years, is because we go to these conferences and that actually just knowing you, that's been a source of you educating people, and that's been a source of you telling people about the pitfalls and the mistakes that you could make. In the time of COVID, one of the big things that's happened is that conferences have gone away. Or have they not? What do you see going forward for how you execute in your business?

Kelly: Well, I think that's a great question. You and I have had this conversation many times. I think that from my perspective, my business revolves around helping clients to do their work better in clinical research compliance. How I have spring-boarded into that field has been through my ability to speak at a variety of different events and conferences throughout the year. Sometimes upwards of 100 times a year, I was out speaking at a conference, and many times people would hear me or hear you and I, for example, speak at a conference, they'd call me months later and say, "Hey, I saw you at XYZ conference. I'd like to talk to you about what you could do to help us do a grant review or a billing review," or, "We need some training."

The conference world to me is a value to all of us in this industry because it's a place where we network and we share ideas, and we can see the strength in numbers and how having a community around you that does the same type of job actually does build trust and build harmony within the ranks. We reach out to each other throughout the year and help each other when things arise, just through various conferences, various seminars and various blogs, podcasts and things that people can reach out and get. The problem is now we're seeing this go in a different direction with nobody having the ability to be able to be at a large event anywhere.

Darshan: Considering that people can't be at a large event anywhere though, conference producers obviously aren't standing still. What do you see happening?

Kelly: No, I agree with you there. I think that there has been a lot of, they're swiveling. People are taking things and going, "Okay, we can't have an event. We need to do an online event." There is a tremendous amount of online opportunity right now. The caveat is a lot of what's out there right now is being provided at no cost for the individual listener. People are able to go from day to day find a different event, something to listen to, so to speak in. Even some of my team, they'll say things like, "Well, I have something on my calendar every day, this week that's a free webinar, I'm going to listen to it." And I think that's where the people have led to because number one, they're at home. Number two, they might have the time to listen while they're working at their desk. Number three, a lot of people right now are trying to figure out how they're going to stay up on the latest things. Albeit right now, a lot of what's out there is on COVID.

Darshan: Right. Now here's the big question. One of the key things you mentioned earlier was the value of networking. You talk about how you actually meet these people and they'll come back to several months later. Do you think that with these online meetings, you're getting the same value? You might get the same education, but are you getting the same networking?

Kelly: I think the education can be there. I think there are certain things that I think are very difficult to get in an online education. And honestly, that's why in some instances some of the things we do, as my company does, we're finding it a little bit more difficult to do some of the things that we've done face-to-face, because a lot of the events that I do are two, three, four-day events. So people don't have the time to sit at at their desk at home and do a four-day and be engaged in the entire time that they're at their computer. Whether or not they're actually interactive with it, it remains to be seen because you don't know what's really going on behind the scenes when people are not really face-to-face.

I think that the exchange of information that we do at the conference and the social contact that we have, the boundaries around how we can network when we're together and share ideas, I think that that is going to be missed. I don't think that can be brought back forth until we're able to meet again at conferences and events that are going to have a large number of people. Right now, that looks like that might be this time next year. Who knows? Because there are places right now that are limiting events to 50 people through the end of the year. So it's going to be that link that you have of interaction that I don't know that we're going to be able to figure out a way to do by doing things like this.

Darshan: You talked about how you've got, I think you said a conference, or at least a webinar you're going to listen to almost every single day this week. Where do you even find them?

Kelly: I would have to say that one of the places that has been very valuable in offering opportunity to learn has been through LinkedIn. There has been a lot of stuff being posted on LinkedIn that a lot of companies are sharing that they're having something that is free. Then you can always look at the professional organizations and I mean everything from ACRP, SOCRA, AHLA, HCCA. There's a lot of conferences that should have gone on that these companies, these organizations have almost pivoted into doing a non-live event through some sort of virtual platform. That has been something people have just, like I said to you before we started recording, people have just pivoted into that without even blinking. So you've got people who are now doing these conferences from their desk, and I wonder what's it going to take with where we are and where we might be headed with hospitals struggling, people cutting their budgets, where are we going to be when we try to get people back to a face-to-face meeting in the future?

Darshan: To me that goes to the value of the face-to-face meeting. You've sort of spoken about that a little bit more, and then we talked about how you end up missing it. But to the extent we are in this COVID environment, what have you seen in terms of things that have been done right? Obviously a bunch of reasons why it shouldn't and we'll talk about those as well. But what have you seen as done right?

Kelly: I think that that offering some of this information free for people right now has been a benefit. There's a lot of people that are working at home in new environment, they're struggling with having their kids at home and having to educate them, and their spouse and them are sharing an office. I think that's helped people's morale to have things that they could almost cling to and listen to right now because it does give them some sense of normalcy, and I think right now we need that. I think that some of this that we've been able to access has given us a positive when right now a lot of what we're seeing in the media is negative. I think it's going to be hard to get back to where we go to a conference and people are comfortable with how conferences have been in the past.

That being said, I think that some of the platforms that are out there, everybody's trying a bunch of different platforms. But at the end of the day, if you get people on and they're able to gain some level of a nugget of information that helps them, in my mind, you've got some success there and people are looking for that right now because right now people can't go anywhere. A lot of conferences were canceled in March, April, May, and June, and even into July now. I've even had one that was that's going to be virtual the second week of August. People are already looking at what's going to happen throughout the fall. I think it troubles people because there's going to be some people who need credit, a continuing education credit, that they may not be able to get between now and when that credit is due to renew a certification, so to speak.

Darshan: They've been talking about pushing certifications back so hopefully that'll help. But you're right, that continues to be a problem. Especially with someone like me, I'm trying to keep two different certifications going both as a lawyer and as a pharmacist. That gets more complicated right now.

But let me ask you this. One of the things that I've always been confused by, but you seem to do with ease almost, is conferences get expensive. Obviously that's part of your business model and you use it incredibly effectively, but how do you handle the cost associated with them once we go back to to a conference live event type scenario?

Kelly: I think that's a great question because I do believe that travel is going to increase in cost. From my perspective, I've used conferences as the marketing tool of my business. So it was a cost for me to travel and sometimes to attend. Sometimes I was able to do a conference in combination with something that I was also working at and had billable hours. But to me, it was instead of having a huge marketing budget and doing exhibits at conferences and various things like that, I was just able to be able to go to as many as I could and speak. Part of that reason was because I thought the exchange and the cooperation with the interconnectivity that I was doing with professional contacts was actually the positive part of what I was able to bring to the table for my business. I use that through the network that I have now, which has grown substantially since I started the business.

Darshan: I remember. Your network is straight up impressive. Let me ask you this though, because in a world where we're going towards potentially some level of balancing out, do you see your market strategy .. Again, I expect that you'll keep your personal market strategy pretty close to your heart ... But in general, do you see the market strategy changing?

Kelly: Well, I do because I think that there are going to be conference companies that are going to have to figure out how to do business. I think that some of the larger organizations that a lot of their business revolved around conferences is going to be impacted. I think there's going to be a very strategic thought process by hospitals and research organizations to evaluate whether the return on investment to attend a conference is actually a benefit to the organization. I think that, that's where people are going to have to figure out where do they balance that because I do think there is going to be a balance of that. Just like the care of our patients is going to be balanced somewhat in the future with in-person visits and telemedicine visits. It's bound to happen with where we've come over the past 90 days.

Darshan: I think it's been a bit of a seismic event, hasn't it? So let me ask you this though because I'm surprised all these years, I've known you, I've never asked you these questions. It's a really good opportunity for me. But when you go to these conferences, I always see you talking to people. I always see you networking. I always see you presenting. How do you split up your time in terms of networking versus actually meeting people? Do you find more value in one versus the other?

Kelly: I think that if I'm speaking at a conference, and I do attend conferences that I do not speak at occasionally. But if I'm speaking at a conference, I usually use the time that I speak with people and after that to make sure that if they have questions or if they have thoughts about what I brought to the table, about how they could use that, I try to make sure to interact with people and keep that line of communication open.

I think that going to conferences and attending, I'm careful to attend the sessions that I think that I will have some level of expertise at, or I will be able to bring something to the table or I will see people in the room that I know or that I have some sort of a relationship with, either through a previous client or through someone like you that I know jointly. Those are the types of things I look for. I think that not having that ability is going to somewhat impact not only my business, but I think it's going to impact yours and lots of people who do the things that we do to help clients with the challenges that they face because I also think challenges that they're facing now are going to be somewhat different in the future.

Darshan: I agree. I agree. I think it's going to change. I found myself using podcasting more as a marketing tool. You've obviously done the conferencing thing, and I know that you're able to pivot unlike most other people I know. I've seen you go from a tiny, I think it was one-woman organization when we met, all the way through to now 15, and I know it keeps growing every single time I talk to you.

But my big question for you would also be for those people who are listening who don't typically attend conferences or are curious what conferences might look like in the future and don't know what to prep for, what do you think are some skill sets they need to bring? So some people will say, "I don't like networking. I don't like going to these conferences because there's a lot of hobnobbing and there are these groups that are formed and I don't belong to them. It's just uncomfortable." What is your recommendation for them?

Kelly: That's a tough one because I think there are people that they'd rather do anything than go to a conference and have to walk through an exhibit hall and talk to other people. That's a personality thing. I think that choose your conference wisely because I think that there are conferences that have more of a community feel rather than a huge conference with thousands of people. Especially if you don't go to many.

Look at a conference with a very strategic eye that you are going to have the ability to attend sessions that might help to strengthen your knowledge base. Don't pick out the wrong conference and then be disappointed by what you were able to gain from it. Because even if you go to a conference and you don't network, you're going to be in a session with other people, and you're going to hear discussion and exchanges between people. Even if you're on the periphery, you're listening to that networking, which you might gain some nuggets of information that can help you in your job. So it's picking out the conference that has more information specific to you and not going to the great big, massive conferences and feeling like that there's so many things going on, you can't really figure out what lane to swim in, so to speak, as you're there.

Darshan: So when do you think the massive conferences makes sense?

Kelly: Oh, that's a question I can't answer. I don't know. Do you think they'll start by the end of the year? I can't tell.

Darshan: No, I'm sorry. I didn't mean it in terms of when they'll start again. What I meant more was you said that for someone who's starting out, a smaller group conference makes sense, because you can build a community.

Kelly: That's true.

Darshan: The larger events can get a little intimidating. My question is when should someone who's been going to these smaller events start saying, "You know what, I want to go to some of the larger ones." When do you think they'll start getting value out of those?

Kelly: I think that you can get value out of a larger conference when you're comfortable with walking into a room that might be full of people that you don't know on a topic that you have no idea about. I think that someone that's brand new in the research compliance field, I usually see those types of people at smaller workshop type events or smaller events, less than 200 to 300 people. I see them able to interact with others and possibly make some connections, even if they don't realize that they're doing it. Then they do have that connection, that interactivity with someone that they might see at another event in the future, which is how we met. We were at a conference together, and we became friends and knew that we had a mutual business that we both were involved in, in that group. That came from just being at a conference and meeting another person and being able to make that connection.

Now, you and I are always in the middle of the life of the party, but there's people that they stand back and watch others. I always remember, I was at a large event many years ago. I was at a healthcare compliance association compliance Institute. And there's I think around 3000 to 4,000 people at that event every year. I was at a table and I had a seat next to me that was empty. And a lady walked up and I turned around and smiled at her. I did not know her. I said, "I was saving that seat just for you."

Darshan: Great line.

Kelly: She sat down and we shook hands and introduced ourselves. And she said, "I just want you to know that I am brand new to this event. I am brand new to compliance. And you saying that to me made me feel welcome." She and I became friends and we sat together at many events throughout the past few years. She always said that, "You saving that seat for me that day brought me into the network." That's something that if you can connect with people and give them that one little bit of feeling of, "This feels like it's going to work, and I'm part of something." That's why when I go to these events, I try to meet new people. I try to make sure people feel welcome. When we go out in the evenings and do dinner and various things as activities, we try to invite people all the time that are brand new, because that's how they get into the fold of making those social contacts that are invaluable in our industry.

Darshan: Absolutely. Speaking of helping Kelly meet new people, because you're so shy. How should people contact you, Kelly?

Kelly: They can email at kelly@kellywillenberg.com or visit my website, kellywillenberg.com. I have some things on there. I have a new blog going up this week. I have some posts about some of the publications that I'm recently published in. I am out there pretty much. I just did a podcast for HCCA. So you type my name into Google. You should find something about me that you can connect with me.

Narrator: This is the DarshanTalks Podcast, regulatory guy, irregular podcast. With host Darshan Kulkarni. You can find the show on Twitter @darshantalks or the show's website at darshantalks.com.