Marketing Events As Networking Tools in The Life Sciences: An Interview with Kelly Willenberg
DarshanTalks Podcast - Podcast tekijän mukaan Darshan Kulkarni
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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 i...