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Pharma Trends: The Return of the FDA Warning Letters [Simone Ammons] Simone (George) Ammons
Yan Kugel is joined by Mohamed Amer, a seasoned executive with over 20 years of experience in strategic and commercial leadership in the healthcare industry. Mohamed emphasizes the significance of CME (Continuing Medical Education) accreditation when promoting pharmaceutical products. He further discusses the challenges companies face in different countries regarding ethical standards and regulations when promoting pharmaceutical products.
Table of Contents
Mohamed emphasizes the significance of CME (Continuing Medical Education) accreditation when promoting pharmaceutical products. This accreditation is a major attraction for healthcare professionals attending events and conferences. It demonstrates that the material and lectures provided are CME accredited, helping professionals fulfill their continuous medical education requirements.
Mohamed discusses the challenges companies face in different countries regarding ethical standards and regulations when promoting pharmaceutical products. He highlights the shift towards stricter regulations and compliance measures within the industry, driven by past examples of misinformation and exaggerated product claims.
The conversation delves into the scrutiny of clinical trials and marketing messages within the pharmaceutical industry. Mohamed emphasizes the importance of transparency and accuracy in presenting clinical trial data and marketing messages to avoid misleading healthcare professionals and patients.
Mohamed shares valuable advice for young professionals entering or advancing in the commercial operations and sales field within the pharmaceutical industry. He stresses the importance of maintaining a patient-centric approach and continuously learning about medications and treatment options.
In conclusion, Mohamed’s insights shed light on the evolving landscape of ethical standards, regulations, and commercial practices in the pharmaceutical industry. His valuable advice serves as a guiding light for professionals seeking to navigate the complexities of commercial operations and sales while upholding ethical practices.
Episode Chapters:
Please be advised that this is an AI generated transcript and may contain errors.
00:26 – 01:03
Yan Kugel: Welcome to our podcast episode focusing on the strategic aspects of the pharmaceutical industry. Today, we are honored to have Mohamed Amer as our special guest. Mohamed is a seasoned executive with over 2 decades of experience in strategic and commercial leadership in the healthcare industry. He has a remarkable track record of launching world-class pharmaceutical products and achieving outstanding sales results across the region. So join us as we delve into the world of pharmaceutical strategy with Mohamed exploring the right and wrong ways to promote products, considerations for market access, and the critical role of commercial due
01:03 – 01:12
Yan Kugel: diligence in bringing new products to the market. So, Mohamed, welcome to the show. Great to have you here today.
01:13 – 01:16
Mohamed Amer: Thank you, Yan. Great to be here. Thank you for inviting me.
01:16 – 01:48
Yan Kugel: It’s my pleasure. So let’s start with the beginning of the commercial drug journey. So you have so much experience in bringing new products to the market and you have quite a lot of insights into how pharma companies choose their portfolio. So could you share a bit on the strategic consideration of how pharma companies choose their portfolio and what factors do they consider when they’re choosing what products to bring to the market?
01:51 – 02:33
Mohamed Amer: Well, the journey of selecting a product for launch in a particular country starts even long before the drug gets its final approval globally from the authorities. So it starts with the assessment of the market for that product and by the market I mean the number of patients that exist for that particular indication or disease condition. Disease condition and how much are actually the regulators are keen to get that product approved and how much can the pharmaceutical company sell it for in order to turn a profit and generate revenue out of that particular product. And in that
02:33 – 03:16
Mohamed Amer: respect, it means that the pharmaceutical company will try as much as possible to register and find products that do not exist in the market, meaning to say that they will try to find the product which has no competitors that have been launched before it, which is something that we call first to the market. And in the same time, as much as possible, to have a sizable number of patients that need that particular medication and can use it to help them overcome this particular indication. And this will in turn drive the authorities, hopefully of course, to put
03:16 – 04:03
Mohamed Amer: their drug on a fast track for approvals, so accelerate its existence in the market. 1 other factor that the pharmaceuticals will take in consideration of course is how easy or difficult is it to manufacture this particular product in scale to cover the market that exists. And if I’m talking about the originators or the original developers of the product, So I would say that the more difficult is it to manufacture the product the more attractive is it for them because it means that after even it becomes a generic or becomes general size it will be difficult for
04:03 – 04:46
Mohamed Amer: others to manufacture the brand. But of course, if you are a generic manufacturer, you will take it the other way around. You will look for products that are easier to manufacture without so much complications related to the quality of the drug. Once the product goes out of patent or starts to be generalised, then it will depend on what side of the equation are you in. If you are an originator or a research-based company, you usually do not put as much commercial muscle, commercial power behind that product because you know that There are so many generic manufacturers
04:47 – 05:36
Mohamed Amer: that are going to start launching similar products to use into the market. So you usually divest that product. Although very lately in the past 20 years or so, many gYant pharmaceuticals started to launch their own generic sections as well. And we have seen that, for example, in Sandus, which was a spin-off from Novartis, and we have seen that in Viatris which is a spin-off from Pfizer to manufacture more their generics. And that would significantly extend the life cycle of their product. And once the patent is off and the product itself becomes a generic, then we can
05:36 – 06:25
Mohamed Amer: talk here about what generic manufacturers take in consideration when they are selecting their portfolio. Because the off-patent products, let’s say that this is a huge playing field and you have a magnificent portfolio that you can choose from in order to manufacture and help really your patients in the market get an alternative to the more expensive medications for treatment of their medical conditions. In order to select that, we will go to a second step, which is the portfolio prioritization. So you go in the market and you see which of the therapeutic segments have an unmet medical need,
06:25 – 07:12
Mohamed Amer: something that the doctors still need other products in that particular segment. And then you start to examine which of the products are there that can fill this segment or can fulfill what the doctors need and How difficult is it to manufacture and are the raw materials available or not? And what is going to make you different from the rest of the generic manufacturers that are capable actually of manufacturing that particular product? And you select based on that. Okay so when you select you put different criteria and you try to score the products that you are trying
07:15 – 08:05
Mohamed Amer: to select based on these criteria. Amongst the criteria, for example, is how many generics exist in the market. And is this market open or accepting for generalization or not? Is it accepting the generic products to be it or not? And I’ll give you an example of that. A market that is chronic like diabetes or hypertension is very accepting of generics. So you see a lot of generic products in these chronic markets. While the injectables, especially if it’s in a critical care market situation, for example, just like in oxaparin, it is less accepting of the generic manufacturing.
08:06 – 08:52
Mohamed Amer: And that is simply because manufacturing the molecule itself is much more difficult than manufacturing a solid molecule, such as atorvastatin, for example. So that is taken into consideration for the company in order to select which products are going to be manufactured. And After the selection, it comes the step of the commercial excellence or the commercialization of this particular product. So you decide what is going to be your strategy. Are you going to launch it in the private market or are you going to launch it in the tender market? And based on that, you start to take
08:52 – 09:18
Mohamed Amer: your own commercial due diligence steps in order to ensure that your strategy, while is going to be, let’s say, giving your doctors the best possible options for medication. It’s also going to be beneficial for your company and profitable to the company and the market shareholders.
09:20 – 09:53
Yan Kugel: So is this the point where the market access strategies come in? So after you decided on the portfolio, you did the research, now you need to decide on the best way to sell the products itself and access the market. So what considerations come here? Do you have examples for companies that didn’t do it well with different products? And you can give examples to what can go wrong if you don’t do your due diligence in the market access strategies?
09:54 – 10:40
Mohamed Amer: Yes, of course. There are several examples of companies that have, let’s say, have been very conventional in their approach to market access and try to do it, how to say it correctly, they try to do it in the conventional manner without taking in consideration some of the market changes or market evolutions that were happening. And for example, there have been a lot of products that have been launched into the hypercholesterolemia field, which is, I can say that it’s the statin. The statins have been dominant in the market of hyperlipidemia for a long time. And when some
10:40 – 11:27
Mohamed Amer: of the companies such as Amgen or Sanofi started to look for other products that can break the cycle of dominance of of the statins and they have launched some of their products or tried to launch a couple of products in that area, they were, let’s say, very careful in their market access strategy, trying to price it right and trying to define the segments that they are going to have the access for correctly in order to gain the support of not only the authorities in the registration process, as they are very novel products, but also to have
11:27 – 12:20
Mohamed Amer: the support of the prescribing communities, the doctors, the key opinion leaders, and all that. And what happened, actually, is that both companies have overlooked a very important fact, which is what is the failure rate of the previous gold standard for that particular class. So targeting the same class that the previous gold standard was treating has proven to be not a very successful strategy. Because eventually, everybody decided, and I mean everybody in the customer side, everybody decided that these products are too expensive to be used for those segments of patients and it kept the market access to
12:20 – 13:07
Mohamed Amer: a minimum because of the pricing that was done based on let’s say an inflated segment of patients that was not there. Okay So it turned out that the gold standard that was there, which is the statins, had a certain failure rate that was still acceptable by those who prescribed it. And they were not ready to prescribe something else to cover for the side effects, let’s say, of the statins, while it had its own side effects as well, and while it had its own failure rates as well. And they kept it for very niche indications that meant
13:07 – 13:56
Mohamed Amer: for the companies that it’s not worth it to keep investing behind commercialization of these products so they just kept it in the market for a very small segment of patients. That was an example of companies that have done the market access wrongly, defining a very high pricing strategy and a very, I would say, challenging corridor in the pricing to keep their products as a viable medical alternative to what was already being prescribed there as the gold standard. There are so many other examples of the correct market access strategy and the way that the product’s life cycle
13:56 – 14:46
Mohamed Amer: was managed by companies and 1 of the examples that I love really is how AstraZeneca has managed the transition from Lossic, which is Omeprazole, to Nexium, which is Omeprazole, by launching an intermediate product or an intermediate product to cover the life cycle gap that existed before the launch of Nexium, which is the fact that they have produced a new formulation of Lossic, which was for the first time at a global scale, something called MAPS, multiple unit pellet system. So instead of just a tablet, they produced Lossic MAPS and they launched it at a large scale in
14:46 – 15:22
Mohamed Amer: order to cover this cycle. And that was actually associated with a huge campaign for market access as well to convince all the regulators and everybody that was involved in the tender business that this product is a much better product than LOSEC, while in terms of the pharmacology, it was exactly the same product with a different delivery system. So that was also an example of good utilization of market access strategies to extend the product life cycle.
15:23 – 16:16
Yan Kugel: Okay great it’s very good examples for successful and unsuccessful ways what to think about in terms of pricing and other consideration. And what about the location of manufacturing and let’s say critical raw materials? Does that play also a role? So let’s say, for example, you want to go to the European American market, right? So where do you choose where to manufacture it as well in terms of quality, for example? So would you also change the location of manufacturing to make sure it upholds the right standards? Or would you prefer to change the quality in the current
16:16 – 16:22
Yan Kugel: manufacturing facilities? What are the options there to make sure that you uphold all the standards where you want to sell to?
16:24 – 17:07
Mohamed Amer: Well, the options are quite open, really, because let’s say that once you decide to take your product to the North American market, there is the FDA, mainly the FDA and Health Canada trying to convince of the quality of your product. And you have multiple options. First of all is to select a facility that is already approved by these regulators in order to manufacture your brand or to get the approval of these regulators on your particular manufacturing facility, whether it’s in Europe or in any other part of the world. So you obtain the FDA registration licensing of
17:07 – 17:55
Mohamed Amer: that particular facility. That is, of course, is slightly a longer route for the approval. But It guarantees that everything that’s related to manufacturing of your product is under your own control. So you will be able to increase the amount of product that is being manufactured or reduce it without any restrictions a partnership with an external manufacturer. On the other hand, regarding the raw materials, then if you are manufacturing in Europe, or in the US or any other country, there is a minimum standard that they approve for the finished product, the finalised product, the finished product that
17:55 – 18:47
Mohamed Amer: you have to adhere to. So if the raw materials do cannot make you or does not enable you to meet that particular standard, then of course you cannot import the raw materials from that source or utilize the raw materials from that source. And In many cases, the manufacturer would work diligently with raw materials manufacture in order to increase their standards and improve their standards to meet the standard that they want to reach. And talking about that, for example, historically speaking, 1 of the countries, which is India, had huge manufacturing capabilities for generic drugs. And if you
18:47 – 19:35
Mohamed Amer: tell me that about the reputation of generics manufactured in India, or with raw materials that are imported from India, 20 years ago is totally different from their reliability now and their capabilities now, which is, I can comfortably say that about 25 to 30 percent of the generics in the world are manufactured in India. So That also is a large improve over time that happened in the quality of manufacturing. So right now, if you are talking about what are the options in order to maintain the quality, then you have these 3 options. Either you manufacture with a
19:35 – 20:14
Mohamed Amer: manufacturer that is already holding himself to the highest standard and usually it’s not, it will take you time to find such a manufacturer and do the agreement and still you will be just 1 of the companies that has manufacturing with that. But still this is a very viable option if you have a small volume to manufacture. It doesn’t make sense to build your own manufacturing facility. If you are coming into the market still and you want to have your own manufacturing facility, then it might take you some years to build the manufacturing facility, and then 1
20:14 – 20:37
Mohamed Amer: or 2 years to get it certified by the European authorities and the North American authorities and the African authorities in order to start exporting to these countries. Of course, it’s usually easier to have your manufacturing facility in 1 of the countries that represent the major markets for your business anyway.
20:39 – 20:43
Yan Kugel: And is it common also to use CMOs for companies who are abroad?
20:44 – 21:33
Mohamed Amer: Of course. Of course. This is also 1 of the options. And like I said, if you are going to North America, for example, and you are not a very big manufacturer, you don’t have the manufacturing capacity, then you use a CMO in order to increase your manufacturing capacity, either for the long term or until you increase your own manufacturing capacity. So you either use it as an interim strategy until you build your own manufacturing capacity or you just decide for it. Maybe there are also other financial considerations. For example, a country like Saudi Arabia is working
21:33 – 22:15
Mohamed Amer: on their healthcare 2030 vision. And within that vision, they are trying to encourage all companies to come and build their manufacturing facilities in Saudi Arabia. Manufacturing facilities in Saudi Arabia, and that includes companies who are willing to give CMOs to the companies or the pharmaceutical manufacturing facilities inside Saudi Arabia itself. So there are different also considerations that you might want to consider when you are thinking of where are you going to manufacture your product.
22:17 – 22:57
Yan Kugel: Right And let’s jump to the next stage. So let’s say the companies did their due diligence. They have chosen their portfolio and they started manufacturing the drugs, which of course can take years until the commercial drug is ready for the market. So let’s talk a bit about the promotion of such drugs. So what pitfalls are there to promote and sell commercialised drugs and what best practices are there to uphold regulations and maybe you can also compare it with different countries around the world?
23:00 – 23:52
Mohamed Amer: Well, the process of commercialisation actually starts way before the product is ready for manufacturing. And that is actually taken in consideration by the regulatory authorities as well. So, for example, in several countries you are required to have clinical results for that particular product from the local population of that country. So you start before the official commercialization to run clinical trials in that country. And you start to involve the key people in that country or the key opinion leaders and the authorities in the preparation for the launch or the pre-launch. And you start the educational activities and
23:52 – 24:12
Mohamed Amer: all that stuff. And this is what we call a classical launch practices or a classical launch process where you start the pre-launch activity. And that can happen anywhere between T-3, which is 3 years prior to launch to 1 year before launch.
24:13 – 24:28
Yan Kugel: Right. So it can be that you already manufacture and sell the product in country X, but when you want to sell it now in country Y, you need again to run clinical trials on local population. So is that correct?
24:29 – 25:07
Mohamed Amer: Yes, That’s very much correct. And it can happen also before you start even to launch it anywhere in the world. So you prepare to knowing that, for example, you are going to launch it in Japan and in the US. And you need to run these clinical trials in centers in Japan and the US before it’s launched anywhere around the world. Okay, so you initiate these clinical trials as part of your clinical development program before you do the launch. And once you have started to launch, then you have to take in consideration, how are you going to
25:07 – 25:52
Mohamed Amer: educate the healthcare professionals about your product? And especially if the product is a new class of products or has an oval mode of action or all that stuff. And right now, everybody’s relying on omnichannel marketing approach where you have to engage a lot of marketing channels in order to reach your customers and to reach the healthcare professionals. And in order to get the message that you have developed and you have tailored for your product into that. And that includes the involvement of a sales team with the medical reps and medical science liaisons and everybody that is
25:52 – 26:40
Mohamed Amer: rated in the medical department, sales department, and marketing department working hand in hand and working together in tandem in order to start the launch process of that particular product. And with that, you have to keep a very, I would say, diligent eye, what we call the pharmacovigilance, on the launch process itself and what is reported about the product and if there are any side effects that are reported about the product from the patients or from the healthcare professionals that are using it and convey that feedback to the authorities as well as to the manufacturer in order
26:40 – 27:24
Mohamed Amer: to be able to answer to them correctly. Working hand in hand with these teams, with the commercial teams and the medical teams and the sales teams, is the regulatory affairs. And the regulatory affairs is keeping an eye on any change in the regulations of the country that may impact the availability of the product, and of course the supply chain as well. 1 of the ingredients of the manufacturing of the product, for example, may suddenly become prohibited in the country that you’re trying to commercialise in. Or they might impose a limit on 1 of the ingredients in
27:24 – 28:12
Mohamed Amer: the product. And if your product is not complying with that, then you will suddenly be faced by a restriction in the ability to manufacture or to import your product into that particular country. So the regulatory department works very closely with the authorities in order to update the manufacturer or the importer about such changes in due time in order to ensure a continuous supply of the product to the market. So, if you are talking about the process of commercialization itself, 1 of the very important starting points is to understand the market segments. So which markets are you
28:12 – 28:58
Mohamed Amer: going to or which market segments are you going to target? And of course, if you are going to sell it to the private hospitals and private clinics is a totally different approach from selling it to government hospitals or institutional hospitals because each of the institutional hospital has its own purchasing process. And that should be well understood by your tender team and your market access team and that preparation or this kind of preparation should have been done already during the pre-launch phase to understand how are you going to get your product listed or approved for reimbursement by
28:58 – 29:34
Mohamed Amer: the insurance companies. At the same time you have to understand which segments are going to be the early adopters, so that you are going to rely on them for the initial phases of launch, and who are going to be the late adopters, so that you keep them for the later parts of the launch. Who are your key opinion leaders that you are going to take for events or educational activities that you are going to conduct? Who is your main speaker? You should understand your product very well and the market segment and the particular disease and indication
29:34 – 30:23
Mohamed Amer: that the product is going to be used in. In some instances, you have to collaborate as well into all the events that are related to continuous medical education. Because in many countries, this is 1 of the main attractions that would drive the healthcare professionals to your event, is to show them that the material or the lectures and all the materials that you are preparing for them in the convention or in the conference are CME accredited. And that would help them a lot in extending their licenses showing that it is, they are fulfilling their continuous medical education
30:23 – 31:04
Mohamed Amer: requirements. So that is also something to be taken in consideration. I mean, it’s In the commercialization aspect, it’s very, very, I don’t want to say sophisticated, but there is a long list of items that you should fulfill in order to execute or to be able to execute a successful launch for a product. And the importance of each element in this list may vary based on the market segment that you want to penetrate or the country that you’re trying to launch in. But at the end of the day, they are all contributing factors to the successful launch
31:04 – 31:07
Mohamed Amer: of your product in this country.
31:08 – 31:47
Yan Kugel: Right. And when we are talking about the ethical standards and regulations when promoting the products, So what challenges do companies can face in different countries in the world? And if you can also give examples to some very harsh ethical standards and maybe countries where they are lower just to give us the comparison and the differences between the markets what is allowed and what is not allowed to do when promoting medicine in those countries.
31:48 – 32:50
Mohamed Amer: Well I must say that if we take it holistically speaking, pharmaceuticals as an industry has been, let’s say, in a very bad situation when it came to the credibility of the pharmaceutical companies talking about their medications. And there were so many examples of misinformation or giving exaggerated information about the actions of pharmaceuticals or about their products, or even promoting into the wrong indication or directly to the patients while they are not supposed to be doing that. And that has driven the authorities and the regulators around the world to have very harsh types of fines imposed on
32:50 – 33:42
Mohamed Amer: global pharma. And I don’t want to talk about examples here, but definitely you can find the companies that I’m talking about in excess of $2 billion in fines in order to compensate the patients who have suffered from side effects or even from fetal deformities that have resulted from utilization or use of some products. And that has driven the companies themselves to start being very strict in the way that they are promoting their products. And now all the pharmaceutical companies, they have their own complYance department that oversee the promotional materials and how their sales team members are
33:42 – 34:35
Mohamed Amer: promoting their own products to ensure that there is no misinformation or no exaggeration in the way that they are selling the pharmaceuticals or even in the advertising that exists for OTC brands or for OTC products that you can see on TV, for example. So in terms of the ethical consideration, and that has happened mainly because of The fact that the pharmaceutical companies initially were pushing their sales team to sell and to achieve their sales quotas. So the medical rep used to, let’s say, cut some corners when it comes to promoting their own products with some doctors.
34:36 – 35:26
Mohamed Amer: To the extent that there was a very famous, again, case about a pharmaceutical company that was inviting doctors to spas and to, let’s say, holidays and vacations in luxurious hotels and resorts just as a way to push them to promote their own brand. But that kind of practice has largely stopped now and is under severe scrutiny, not only from the regulators, but from the pharma itself as well. To the extent that some pharmaceutical companies have stopped linking the sales performance to the performance of their sales team. Meaning to say they do not give a sales bonus
35:26 – 36:20
Mohamed Amer: based on the sales performance of the medical representatives or the number of prescriptions that they generate from the medical professionals, but they are awarding them based on the educational activities that are being conducted in this particular field. So from an ethical perspective, I would say that the landscape right now is in a much better situation than it used to be 10 years ago, or 15 years ago, or 20 years ago. And still the scrutiny in that respect is very, very increasing, is increasing a lot. Of course, 1 of the other aspects that you can talk about
36:20 – 37:14
Mohamed Amer: ethics as well is the issue of the clinical trials itself. Because 1 of the main, I would say, key advantages that a pharmaceutical company might use in the promotion of their own product is the performance in clinical trials. How the drug performed when it’s compared to placebo and when it’s compared to the gold standard of therapy and when it’s compared to the market leaders right now. Okay. And of course, this is strongly scrutinized by all bodies, including the publication that the clinical trial is published into, whether it’s being the Lancet or any other world-class publication. And
37:15 – 38:16
Mohamed Amer: the peer review of that publication. But that, in some very rare incidences, has shown some signs of bias as well towards the product themselves. And This can happen in the way that the data is analyzed or the data is presented after analysis by, let’s say, excluding some cohort of patients and overstating the results in another cohort. But at the end of the day, because of the fact that the information is now accessible to everybody almost in all such clinical trials, it becomes scrutinized eventually and it is excluded from the clinical evaluations that are done by the
38:16 – 38:17
Mohamed Amer: authorities.
38:17 – 39:09
Yan Kugel: Right. And what is the scrutiny that is being done on the websites of the manufacturers themselves? So I’ve seen myself websites of drugs that should have the same, they treat the same disease. And we all know that statistics can be represented in various ways and there are an art into statistics where you can present the real results, but still make it look better in the various tactics or even for example, where you start your Y bar, for example, right? You can start from 0 or from 70. And this can, it has, it can have psychological different
39:09 – 39:32
Yan Kugel: representation. And I’ve seen different drugs that seem very positive, but when you really go into details, you see that actually the other drug has better results, although the other company made a better representation of that on their website. Right. So is there also a scrutiny and review of the websites themselves? Of course,
39:33 – 40:18
Mohamed Amer: Of course, of course, that is being reviewed by all the authorities that are involved in approval of the promotional material, because the website in itself is considered also a promotional material. And the example that you give is actually a brillYant example, because this has been a game that has been played by so many marketers for pharmaceuticals to exaggerate a difference between 2 products. For example, if 1 of the products is producing 68% and the other is producing 70%, then you show the curve only from 65 to 75 in order to exaggerate that difference. And of course,
40:18 – 41:11
Mohamed Amer: the statistics themselves, they play a role as well. Sometimes the difference between 2 products is not statistically significant. And they mentioned that in very, I would say, small letters under the curve that the difference is not statistically significant, although it is visually different. So this kind of scrutiny is done by the authorities themselves and is done by the regulators in each of the countries. And actually, I’ve seen letters and orders and directions to companies to change or to stop the use of certain marketing messages and to remove some pages from their websites or to remove some
41:11 – 41:46
Mohamed Amer: promotional materials based on misleading information. And don’t forget that all the competitors of the companies are also competing companies, are their own scrutinizer at the same time. So, for example, if Pfizer and Novartis, they have 2 different competing medications, then each of them will be having a very watchful eye on the promotional messages that are being disseminated by the other company.
41:46 – 41:52
Yan Kugel: Right. And they would be the first report, right? Exactly. Something is right. OK, that
41:52 – 42:01
Mohamed Amer: makes sense. They will report it to each other and they will report it to the authorities and to make sure that they are not utilised anymore.
42:02 – 42:46
Yan Kugel: Right. And what do you think about the issue that many people raise that sometimes pharma companies are willingly ready to pay fines because they think until they get caught, they will manage to sell more products than the fines. So it will be more beneficial for them to just do things not completely complYantly and do the sales. Sometimes, you know, Sometimes it’s not causing deaths, for example. So they say, okay, it’s not that critical, it’s still not complYant, so we are willing to take a chance to pay the fines. Do you see this really happening or it’s
42:46 – 42:49
Yan Kugel: something that has really decreased?
42:51 – 43:43
Mohamed Amer: Well, I would be very comfortable to say that all sorts of practices that are done in an environment where you are there to, let’s say, provide your shareholders with the maximum possible profitability. And recently, in the past year or the past couple of years, there has been examples of companies that have increased the prices of their products in an unacceptable way, like 200%, 300, sorry, 200 fold, simply because the manufacturer felt that he has a monopoly on this particular drug and there is a big need for it. So they started to increase the prices disregarding how
43:43 – 44:32
Mohamed Amer: the patients would get access to that particular medicine when the price is so expensive. And at the same time, there are many other manufacturers, exactly like you said, they willingly would disregard the regulations and Pay the fines if the fines are not a deterrent for them of doing so so in that in that case 1 of the things that the authorities have done is to enable the increase of the fine or to make it proportionate to the felony itself or the mistake that was done by the pharmaceutical itself. So this is why we have seen fines
44:32 – 44:50
Mohamed Amer: that have been imposed in billions. So that would make the manufacturer think twice before willingly doing that, because they know that if they are caught, that can impact their business significantly.
44:52 – 45:40
Yan Kugel: Right, right. So I do hope that this strategy by the regulators works, that they do, We see the price increase and of course every company needs to generate revenue but it should not come at the cost of human lives and it should be really strategic and there is the reason there are regulations. I do hope that we will see companies that play the fair game and avoid cutting corners where human lives are at stake. And I think what you’re saying is what regulators do really helps. And you said it yourself, we have seen a lot of
45:40 – 46:31
Yan Kugel: advancement in the ethics department in the last 10, 20 years. So I think we are in the positive direction here. And if you could give advice to young professionals who are starting their career or in the middle and want to go further in their career in the commercial operations and sales. So what could you tell them about what is the best way to move forward in the career and also maybe share a bit about what motivates you to support the success of the pharmaceutical industry and keeps you going and excites you about the opportunities and challenges
46:31 – 46:32
Yan Kugel: in this market?
46:34 – 47:20
Mohamed Amer: Well, I would say that the first thing, do not only go into that market for the sake of profit alone, or for the sake of the money alone. Be sure that if you are not there taking in consideration that your product is helping a patient improve his health condition or is helping a patient feel better about himself Then you will never be a successful person in that particular field. Because commercialization, whether you are doing it right or doing it wrong, in the end is about the patient, is about how can you improve the patient’s well-being and
47:20 – 48:02
Mohamed Amer: about being sincere in the way that the patient is improving his condition or the healthcare professional is utilizing your medication or your product or your medical device to improve the patient’s well-being and the patient’s condition. Of course, there is no such thing as a magic bullet. There is no such thing as a product that can fit to all the patients. And I can give you very simply the examples from the respiratory medications that have been recently launched into the market in the past 10 years to treat asthma. Okay, the monoclonal antibodies, They are less successful for
48:02 – 48:44
Mohamed Amer: some of the patients and much more successful for other patients. So you have to keep this in mind and you have to keep in mind that no matter how you push the doctor to prescribe your product, You have to keep him using your medication for the right patients only, not for all the patients. Because otherwise you are compromising the patient’s well-being, you’re compromising the patient’s condition, and you’re compromising your own credibility and the credibility of the product that you are promoting as well. And the second thing that you should keep on doing throughout your entire career
48:45 – 49:34
Mohamed Amer: is to keep learning. Keep learning about the medications. Keep learning about the improvements and the advancements in the field that you are working in. Keep learning about the treatment options in order to be able to talk to your healthcare professional or to the doctors that you are visiting about the field that they are working in, as a person who is knowledgeable about the field. Not only a person who is just promoting a product and not really aware of what other alternative therapeutic strategies exist for these particular patients. For these particular patients because you will be faced
49:34 – 50:17
Mohamed Amer: by let’s say a lot of barriers where somebody is telling you that no I don’t believe your product is the right option for my patient And you have to respect that and you have to understand that whatever you’re trying to promote, there are alternatives which might be better for some patients. And in that respect, you have to Let the doctor or maybe let is not the right term, but to respect the doctor’s decision to use an alternative because it’s better for that particular patient. It doesn’t mean that whatever therapeutic option that you are giving this doctor
50:17 – 51:03
Mohamed Amer: is a bad therapeutic option, but there are, let’s say, degrees of suitability of the therapeutic options to different patients, because at the end of the day, the human being is not a machine, it’s not a car engine, where you can say that you have to adjust the torque of this particular screw to that degree. Human being is a very complex organism that responds in its own way to any therapeutic option that you are giving, whether it’s a medicine or a device or whatever. What you can do is to make sure that your product is being given
51:03 – 51:16
Mohamed Amer: to the right patient and to be knowledgeable about the products and the alternatives and to keep the patient in the center of your thought process. So that’s it.
51:17 – 51:49
Yan Kugel: Great. Thank you very much for this great advice and for all the knowledge that you have shared today, it was very exciting and interesting conversation, Muhammad. So I want to thank you for coming to the show and wish you the best of luck and success further in the commercial operations and making the world a better place with the distribution of life-saving and beneficial drugs.
51:50 – 51:53
Mohamed Amer: Thank you so much, Jan. Thank you for having me.
In this episode, Kelly discusses her experiences in the pharmaceutical industry and the challenges of implementing cloud-based software tools. She also shares insights on improving processes and the impact it […]
