September Summary Of #MedAffairsTalk on Clubhouse

Every week the #MedAffairsTalk group comes together to discuss current topics in Medical Affairs. Thanks to the amazing guest speakers and audience, we have engaging conversations that dive deeper into various topics. Our fantastic moderators are Luca Dezzani, Amy Pernell Cavers, Bora Erdemli, PhD, and myself.

Below are the summary points from each session, but we would love to hear you live! Please join us for our next sessions, which are each Friday at 1 PM EST on Clubhouse!

September 10, 2021 - KOL Engegament Tactics

Marathons, Mad Libs,?Amy Pernell Cavers, was on?? in our weekly?#MedAffairsTalk!

Here are my take-away points for this week:

???Sarah Snyder?came with the brilliant tip to listen to podcasts and webinars as background research before meeting with your KOLs. She uses?listennotes.com?to search by keyword. And go beyond the electronic contacts, send a handwritten ?? note!

?? Meeting the needs of your KOLs is important. It is not just one side of the relationship; both sides matter. Find out what the KOL needs. Do they want to be involved in the usual, or do they want to go further and be part of education, research, positioning, etc.?

?? Preparation for your meetings is key. We got a better look into what Omni from?LARVOL?is about and how it can help you prepare well for your meetings.

?? The value MA adds is based on the relationships we built with both our external and internal stakeholders. We want to be the preferred advisor to them, the person they will turn to when there's a question. We build that trust and loyalty by engaging with our stakeholders by being aware of their needs, how we stand in the relationship (we have to like them before they like us), and being authentic.

?? How we show up determines the way others feel, and how others feel determines the extent to which they can engage, and that impacts pretty much everything about the outcome of the relationship.

September 17, 2021 - Future Forward Tools for Medical Affairs

How can MA create more of an Apple-like tech platform? This was an extraordinary session of?#MedAffairsTalk! I've learned so much from our remarkable speakers?'Dave Gulezian',?Lana Feng, Ph.D.,?Bruno (hiring) Larvol ??and?Kirstan Summers?and our great audience members.

Here are my take-aways from this week:

?? Not all of the data is relevant all the time. What is the business question? How meaningful is all this data right now? And in the future? Why, where, when, and how? You want actionable data and access the right data at the right time.

?? Make the tools easily accessible, even for the less digitally advanced ones of us (cough, cough me). Yet some very user-unfriendly programs are tremendously popular and widely used. It is hard to change from a legacy program, and the differentiation has to be of substantial perceived added value.

?? Data is oil. It needs to be refined. If it doesn't solve a business problem, it is useless.

?? Fragmentation and lack of connectivity of information across the organization is not an optimized situation. Interoperability and interconnectivity between the different tech solutions will optimize the effectiveness of Medical Affairs. A big breath of operations and value offered can lead to a monopoly. At the same time, an Apple or Android-type platform will create a fundamental omnichannel approach to serve our stakeholders.

?? Resistance to change of MA professionals with new tech solutions is also a deterrent to success and maximum uptake and utilization of all the tech solutions when not adequately addressed.

September 24, 2021 - Operationalizing Expanded Access Programs in Medical Affairs

My head is spinning with info from this session of?#MedAffairsTalk! I've learned so much from our remarkable speakers! Our special guests were:?Christine Dyer-Ward,?Dennis Akkaya,?Jess Rabourn, CFA, and our great audience members.

?My head is still spinning with all the great information about operationalizing the Expanded Access Program that our panelists provided, and I'm afraid I can't do them justice. Another session is certainly necessary again!

?Here are my take-aways from this week:

?? Knowledge gaps are a problem, both within Medical Affairs and the medical community, regarding what EAP is and how it can benefit both the patients and pharma. An EAP is not a company-sponsored clinical trial. It is essential to both educate and align both internal and external stakeholders. The better educated all stakeholders are, the more successful your program will be. And they will become your advocates after marketing.

?? You need to start thinking about your EAP program in Phase 2, and at least 12-18 months before launch. You have to be very clear about the goals and what the strategic purpose of an EAP is. It historically started as 100% compassionate use, but it is also moving to be part of product development. When an EAP is set up strategically, the secondary evidence generated is part of the ROI of the programs.

?? Things to carefully consider are your locality; the US only, global, or even specific countries? Are you going to commercialize in those countries? Are you going to have unlimited entry, guaranteed entry, Medical Review entry to cap your program? Do you have a limited amount of funding or drug, or can you provide to all patients??

?? And who is your patient population? Were they in your target population for your clinical trial but screened out? Are they medically suited subpopulations of the overall disease community? Was there a geographic barrier to entry?

?? Think about market approval and the regulatory frameworks that you need to adhere to. Here a Cohort Protocol will have advantages of many single INDs (where the responsibility is with the MD). This will make EAP a scalable process and provide a central source of data generation.

Pfiew! I loved this session! Let me know your comments and additions, as I'm sure I forgot plenty again!

Thank you all for joining us each week and please join us on stage next time!

?? #medicalaffairs #MedAffairsTalk #medicalaffairsleader