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What questions do MSL have from KOLs or physicians?

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What questions do MSL have from KOLs or physicians?

Postby Jessie L » Sun Oct 15, 2017 10:04 pm

Dear fellows in the science careers forum,

I may have a presentation regarding a specific drugs' clinical data in the near future. The presentation is part of MSL interview.

I wonder how it is like regarding the clinical data communication as a MSL. When MSL communicates clinical trial results with KOLs, what questions will they usually have from KOLs or physicians? What are the toughest questions? If MSL doesn't know the answer, how should they communicate to make sure they still have their credibility?

Kindly suggest!

Jessie
Jessie L
 
Posts: 8
Joined: Tue Jul 11, 2017 2:34 am

Re: What questions do MSL have from KOLs or physicians?

Postby D.X. » Mon Oct 16, 2017 3:03 am

Hi Jessie,

If you don't mind, the question you asked me on private message regarding this topic is very similar, so I'll address it here on the open Forum ok?

You mentioned have made it to the next round of interviews, so congrats on achievng that milestone. Yes, a case-study is usually part of the interview process and in my experiences include giving a presentation about a product, focused on the clinical data. Usually, industry presetnations, and specifically MSL presentations follow a certain recipe or Story flow.

The Story is something to the tune of Setting the stage for the unmet medical Need the product meets, so usually you open by breifly talking about the diseaes state - mentioning top Level etiology/causes, some epidemiology, such as prevalance and incidence, and Brief discussion on current Treatments, their benefits and limitations. Then usually you brige into your producted talk presenting the clinical data (maybe you bring up ist mechnansim of Action first as Bridge) - and contextualzing it into how it meets the unmet Need with discussions of efficacy and saftey etc. Usually they give you a Phase III study.

My advice to you is don't get too lost in the data. You want to get the key message accross, I've been able to tell that Story above in about 12 to 14 slides, if pressured, I can do it in 10 slides. You don't have much time so key mesasges.

The questions you can get will vary depending on product and disease area, but usualy they fall into a HCPs/KOLs desire to learn more about how the product fits into their clinical practice, so they my ask for clarity on the Patient Population (so know your inclusion exclusion creteria), they'll want know about dosing, so depending on the study type they may ask questions around that, i.e. how many patients got X-dose, how frequent, how many patients stopped due to AE, what were those AEs etc. They'll want to know about safety as you noted. In Terms of efficacy they may want to know how many patients in the Treatment arm reponded vs. non-responded and may ask you to get to a Number needed to Treat (NNT) or in some cases for a certain safety Event, a Number needed to Harm (NNH). KNow your secondary endpoints, some answers are there and some questions you may get on Quality of Life, which is usually captured as the secondary endpoints. If your drug is to be used in hosptial Setting you may get questions on reduced hospitalizations (what to expect) and/or number of days reduced in hosptial...that will open a door to a health economic discussion so be ready for that.

The more science based KOLs will usually want to understand more on the study design (you'll have to present that anyways) specific to choiceof Primary endpoint and sometimes sample size Determination. You should anyways be ready to explain "Alpha" and "power" and realate that to statistical significance in Terms of ruling out a null-hypothesis (so your type 1 and type II Errors). This is very technical and very rare you'll get a quesiton like this but it can happen. If the study has a complex endpoint, i.e. a Composite endpoint as many have today, they many want know the Details of the endpoint and if any within endpoint domaines had any weighting that drove efficacy. Depending on the complexity of the study, they may ask you to explain the randomizaion scheme. Again technical.

But for your presentation, be top Level, don't dive into that stuff unless asked and do it crisply. Focus on knowing the Basics, becaue they may be testing you on other things a KOL wouldn't ask such as General clinical science knowledge, such as "what is randomization and why do you do it?" - or "why is that different than an Observational study and what does that mean?"

If you don't know the answer, state that you don't know the answer and that you'll return to them - DO NOT SPECULATE!!!DO NOT ASSUME!!

If you feel comfortable that you've seen the data in the paper you can ask to look for a second, if you don't find in 10 seconds then go back to what I said above. Say you don't know and you'll follow up with them.

Also, couple more Points. Remember you must be fair and balanced with your presentation, so that means with efficacy, you must present safety. Do not talk down to other products right? Also what could help, is if your product is already approved, find the Summary of Product Characteristics (SmPC) or in the US it' called the Prescribing Information. See how your study that you're asked to present falls ino the SmPC and you can totally (and should) use that as your front line reference (during the presentation).

Nothing says you can't ask a question to your interview Panel about an descrencies you see (this worked for me in one interview where i saw differences in the US vs. European Label re: dosing - that got me credibility to my interview Panel because they saw I took the extra-step, knew the data, and since I was interviewing for an international medical role they saw that I was sensitive to georgraphy.

OK a Long post as I said but I think should get you thinking. Don't get lost, I've said this a few times. One technique I use is to tell the the key message in the title of the slide - even if it includes a data Point - so that even if you dive in to the Details you have the key message on the slide to remind you and the audience will get it anyways. A nice crisp key message as the title to your slide. If you do it right, when you read all the titles on your slides together, those should tell a Story! Get it?

Best and good luck - hope you get the role and Keep us informed!

DX
D.X.
 
Posts: 1123
Joined: Tue Jan 10, 2012 11:29 pm

Re: What questions do MSL have from KOLs or physicians?

Postby Jessie L » Mon Oct 16, 2017 4:32 am

D.X. wrote:Hi Jessie,

If you don't mind, the question you asked me on private message regarding this topic is very similar, so I'll address it here on the open Forum ok?

You mentioned have made it to the next round of interviews, so congrats on achievng that milestone. Yes, a case-study is usually part of the interview process and in my experiences include giving a presentation about a product, focused on the clinical data. Usually, industry presetnations, and specifically MSL presentations follow a certain recipe or Story flow.

The Story is something to the tune of Setting the stage for the unmet medical Need the product meets, so usually you open by breifly talking about the diseaes state - mentioning top Level etiology/causes, some epidemiology, such as prevalance and incidence, and Brief discussion on current Treatments, their benefits and limitations. Then usually you brige into your producted talk presenting the clinical data (maybe you bring up ist mechnansim of Action first as Bridge) - and contextualzing it into how it meets the unmet Need with discussions of efficacy and saftey etc. Usually they give you a Phase III study.

My advice to you is don't get too lost in the data. You want to get the key message accross, I've been able to tell that Story above in about 12 to 14 slides, if pressured, I can do it in 10 slides. You don't have much time so key mesasges.

The questions you can get will vary depending on product and disease area, but usualy they fall into a HCPs/KOLs desire to learn more about how the product fits into their clinical practice, so they my ask for clarity on the Patient Population (so know your inclusion exclusion creteria), they'll want know about dosing, so depending on the study type they may ask questions around that, i.e. how many patients got X-dose, how frequent, how many patients stopped due to AE, what were those AEs etc. They'll want to know about safety as you noted. In Terms of efficacy they may want to know how many patients in the Treatment arm reponded vs. non-responded and may ask you to get to a Number needed to Treat (NNT) or in some cases for a certain safety Event, a Number needed to Harm (NNH). KNow your secondary endpoints, some answers are there and some questions you may get on Quality of Life, which is usually captured as the secondary endpoints. If your drug is to be used in hosptial Setting you may get questions on reduced hospitalizations (what to expect) and/or number of days reduced in hosptial...that will open a door to a health economic discussion so be ready for that.

The more science based KOLs will usually want to understand more on the study design (you'll have to present that anyways) specific to choiceof Primary endpoint and sometimes sample size Determination. You should anyways be ready to explain "Alpha" and "power" and realate that to statistical significance in Terms of ruling out a null-hypothesis (so your type 1 and type II Errors). This is very technical and very rare you'll get a quesiton like this but it can happen. If the study has a complex endpoint, i.e. a Composite endpoint as many have today, they many want know the Details of the endpoint and if any within endpoint domaines had any weighting that drove efficacy. Depending on the complexity of the study, they may ask you to explain the randomizaion scheme. Again technical.

But for your presentation, be top Level, don't dive into that stuff unless asked and do it crisply. Focus on knowing the Basics, becaue they may be testing you on other things a KOL wouldn't ask such as General clinical science knowledge, such as "what is randomization and why do you do it?" - or "why is that different than an Observational study and what does that mean?"

If you don't know the answer, state that you don't know the answer and that you'll return to them - DO NOT SPECULATE!!!DO NOT ASSUME!!

If you feel comfortable that you've seen the data in the paper you can ask to look for a second, if you don't find in 10 seconds then go back to what I said above. Say you don't know and you'll follow up with them.

Also, couple more Points. Remember you must be fair and balanced with your presentation, so that means with efficacy, you must present safety. Do not talk down to other products right? Also what could help, is if your product is already approved, find the Summary of Product Characteristics (SmPC) or in the US it' called the Prescribing Information. See how your study that you're asked to present falls ino the SmPC and you can totally (and should) use that as your front line reference (during the presentation).

Nothing says you can't ask a question to your interview Panel about an descrencies you see (this worked for me in one interview where i saw differences in the US vs. European Label re: dosing - that got me credibility to my interview Panel because they saw I took the extra-step, knew the data, and since I was interviewing for an international medical role they saw that I was sensitive to georgraphy.

OK a Long post as I said but I think should get you thinking. Don't get lost, I've said this a few times. One technique I use is to tell the the key message in the title of the slide - even if it includes a data Point - so that even if you dive in to the Details you have the key message on the slide to remind you and the audience will get it anyways. A nice crisp key message as the title to your slide. If you do it right, when you read all the titles on your slides together, those should tell a Story! Get it?

Best and good luck - hope you get the role and Keep us informed!

DX


Dear D.X.,

Thank you so much for your valuable sharing and guidance!!! These information really helps! Now I know how to prepare this presentation, and what I should pay attention to during preparation and presentation. Thank you so much!!

Hope myself good luck! I will keep you updated!:)


Best,
Jessie
Jessie L
 
Posts: 8
Joined: Tue Jul 11, 2017 2:34 am


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